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Psychological Distress, Well-Being, and Cardiac-Specific Quality of Life among Patients with Hypertrophic Obstructive Ca...

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PAGE 1

PSYCHOLOGICAL DISTRESS, WELL-BEING, AND CARDIAC-SPECIFIC QUALITY OF LIFE AMONG PATIENTS WITH HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY UNDERGOING NONSURGICAL SEPTAL REDUCTION THERAPY By EVA RUSSELL SERBER A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY UNIVERSITY OF FLORIDA 2006

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Copyright 2005 By Eva Russell Serber

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“Consider it pure joy, my brothers, whenever you face trials of many kinds, because you know that the testing of your faith develops perseverance. Perseverance must finish its work so that you may be mature and complete, not lacking anything.” –James 1:2-4

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iv ACKNOWLEDGMENTS I thank God every day for giving me Samuel F. Sears, Ph.D., my advisor, chair, and, most of all, my mentor. He has been a mentor in every way—professionally, demonstrating a balance between patient care, research, and academia; and personally, modeling a balance between work and family. Sam had high expectations and pushed me, but allowed me to be independent and develop and mature in my own way. He provided me with countless opportunities that allowed me to excel and experience different aspects of our profession. I have been truly blessed to be able to work with Sam. Karen M. Smith, M.D., was my mentor in the medical world. She took me under her wing and taught me alongside her cardiology fellows in clinic and in the cath lab. I appreciate all that she brought to this project, and I am grateful for her initial ideas, collaboration, and mentorship. I also would like to thank the members of my dissertation committee, James Rodrigue, Ph.D., Duane Dede, Ph.D, and James Jessup, Ph.D. They have watched me progress through my education and research, challenging, guiding, and encouraging me to think more critically. With their help, my dissertation project became stronger. I also want to thank my friends and family who were with me every step along the way, and it has been a very long way. The support from my Sears Lab colleagues over the past 4 years has been invaluable. Most importantly, I could not have accomplished any of this without the love, encouragement, and prayers from my family. They have always been there for me, and I know they always will.

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v TABLE OF CONTENTS Page ACKNOWLEDGMENTS ................................................iv LIST OF TABLES.....................................................vii FIGURE.............................................................viii ABSTRACT...........................................................ix CHAPTER 1INTRODUCTION ....................................................1 2LITERATURE REVIEW..............................................3 Medical Background ..................................................3 Quality of Life ......................................................11 Psychological Distress................................................17 Psychological Well-Being.............................................23 Psychosocial Evaluation of Medical Treatment............................27 Statement of Purpose.................................................31 3METHODS ........................................................33 Participants.........................................................33 Procedure..........................................................33 Measures..........................................................34 4STATISTICAL ANALYSES ..........................................41 Power and Sample Size Calculations.....................................41 Aim 1: Describe HOCM Patients Pre-NSRT...............................42 Aim 2: Change PrePost-NSRT........................................50 Aim 3: Prediction Model..............................................56 Exploring the Relationship between Depression and Quality of Life ............59

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vi 5DISCUSSION...................................................... 63 Patient Pre-NSRT Characteristics....................................... 63 Efficacy of Nonsurgical Septal Reduction Therapy ......................... 66 Biopsychosocial Model and Prediction................................... 68 Extending the Findings............................................... 69 Limitations......................................................... 70 Clinical and Research Implications...................................... 71 Conclusions........................................................ 73 REFERENCES........................................................ 74 BIOGRAPHICAL SKETCH.............................................. 86

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vii LIST OF TABLES Table page 1Prevalence rates of depression and anxiety in the published cardiac literature ..... 19 2Descriptive statistics on demographic, medical, and psychosocial variables in preNSRT HOCM patients................................................ 44 3CES-D depression severity cut-off scores and HOCM prevalence rates.......... 47 4Zero-order correlations of relevant pre-NSRT variables...................... 49 5Summary of psychiatric history of patients preand 3-months post-NSRT....... 51 6Normative comparisons (t tests) with pre-NSRT and 3-month post-NSRT scores.. 52 7Mean scores across time from preto 3-month post-NSRT ( n = 20)............ 54 8Summary of hierarchical multiple regression analysis for predictors of CS-QOL using the LVD-36................................................... 57 9Summary of hierarchical multiple regression analysis for predictors of cardiacspecific QOL using the MLHFQ........................................ 58 10Zero-order correlations between depression subscales and QOL measures preNSRT............................................................. 61

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viii FIGURE Figure page 1Diagram of constructs tested........................................... 41

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ix ABSTRACT Abstract of Dissertation Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy PSYCHOLOGICAL DISTRESS, WELLBEING, AND CARDIAC-SPECIFIC QUALITY OF LIFE AMONG PATIENTS WITH HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY UNDERGOING NONSURGICAL SEPTAL REDUCTION THERAPY By Eva Russell Serber August 2006 Chair: Samuel F. Sears Major Department: Clinical and Health Psychology Patients with hypertrophic obstructive cardiomyopathy (HOCM) are presumed to have poor quality of life (QOL) and distress related to their cardiac symptoms and functional limitations. Nonsurgical septal reduc tion therapy (NSRT) is a rapidly emerging treatment for HOCM, designed to improve heart function and reduce cardiac symptoms. The purpose of this study was to evaluate ps ychological distress, well-being, and cardiacspecific QOL among HOCM patients preand post-NSRT. There were 45 adult participants ( M age = 54.3, SD = 15.62; 59.1% female; 97.6% Caucasian; 65.9% married) who were recruited during their initial evaluation or index hospitalization for NSRT. Psychological and medical measures were collected preand 3-month post-NSRT, including the Center for Epidemiological Studies–Depression (CES-D) Scale and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess depression and cardiac-specific QOL, respectively. Results indi cated that prior to NSRT, 55.8% reported

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x clinically relevant levels of depression (CES-D > 16), a higher prevalence than cardiac disease and general populations. Pre-NSRT HOCM patients also reported poor cardiacspecific QOL ( M MLHFQ = 49.86, SD = 29.83) and satisfaction with life ( M = 21.02, SD = 8.42). Repeated measures analyses of variance ( n = 20) revealed that NSRT is an effective procedure in reducing resting left ventricular outflow tract (R-LVOT) gradient ( M = 59.26 vs. 20.79, p < .001), depression ( M = 23.95 vs. 14.37, p = .005), and cardiacspecific QOL ( M MLHFQ = 58.16 vs. 30.32, p < .001). However, when including RLVOT gradient as a covariate, change in depression and cardiac-specific QOL were dependent on disease severity pre-NSRT. Contrary to the hypothesis, baseline depression did not predict 3-month post-NSRT cardi ac-specific QOL. Notably, post-hoc analyses revealed that baseline R-LVOT gradient and cardiac-specific QOL predicted 3-month post-NSRT depression, explaining 62.7% of the variance ( F [3,15] = 11.093, p < .001). This study was the first comprehensive, longitudinal outcome study examining HOCM patients and NSRT from a biopsychosocial model. Findings suggest that before intervention, patients may benefit from multidisciplinary care. Greater precision in depressive symptom identification independent of cardiac symptoms and QOL may point to a subset of depressed HOCM patients whose depression does not improve over time.

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1 CHAPTER 1 INTRODUCTION Cardiovascular disease (CVD) has been the number one killer in the United States every year since 1900, with the exception of 1918 (World War I). Nearly 2,600 Americans die of CVD every day, claiming more lives each year than the next five leading causes of death combined (American Heart Association, 2003). One in five adult males and females have some form of CVD. One type of C VD is cardiomyopathy (CM), which is defined as a structural abnormality limited to the myocardium. The computed mortality rate (actual confirmed occurrence) for cardiomyopathy in the year 2001 was 26,863, while the total mention mortality (predicted or assumed) for 2000 was 55,300 (American Heart Association, 2003). Further, hypertrophic cardiomyopathy (HCM) is the leading cause of sudden cardiac death in young athletes, estimated at about 36% of cases (American Heart Association, 2003). Mortality rates of HCM in the general population are between 1 to 6% annually (Cannan, Reeder, Bailey, Melton, & Gersh, 1995; Maron et al., 1999). With the high prevalence and mortality rates of CVD in general and specific types of disease (e.g., HCM), it is critical to examine its risk factors, resilience factors, and treatments from both a biomedical and a psychological standpoint. The incidence of CVD has climbed due to poor health behaviors and individuals living longer lives. Now is an era of expanding therapies for these disease states, which further leads to an increase in an aging population living with CVD and other comorbid conditions. With advances in treatment regimens (e.g., polypharmacy, interventional

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2 procedures, devices), there is a need for robust mechanisms to quantify the impact of new treatment on patients, their survival, their symptoms, and their quality of life (QOL). In addition to the patients, payers, practitioners and regulatory agencies are increasingly relying upon patient-centered outcomes to monitor and improve quality of care (Green, Porter, Bresnahan, & Spertus, 2000). There are several ways researchers may examine quality of care and QOL with the goal of improvement. The examination of predictors of QOL, physical well-being, psychological wellbeing, and most recently spiritual wellbeing provide information for potential intervention targets. The current study examined physical and psychological functioning among patients diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), using biomedical and self-report data. Further, this study examined the biopsychosocial status of HOCM patients before and after a cutting edge treatment procedure (Nonsurgical Septal Reduction Therapy; NSRT), which was designed to relieve the obstruction of the left ventricular outflow tract (LVOT), and, in turn, alleviate cardiovascular symptoms.

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3 CHAPTER 2 LITERATURE REVIEW This paper begins by briefly describing HOCM and its treatment. However, the focus is on the anticipated QOL and psychosocial implications that correspond with this disease and its ensuing treatment. Due to the paucity of psychosocial literature regarding HOCM, the majority of our knowledge stems from general cardiac populations. Medical Background Cardiomyopathies The cardiomyopathies are a group of heart disorders in which there is a structural abnormality limited to the myocardium. This group of disorders often results in symptoms of heart failure with the underlyi ng cause sometimes identifiable; however, the etiology is often unknown (Chen, Dec, & Lilly, 2003). There are three broad classifications of cardiomyopathy: dilated, restrictive, and hypertrophic, with the latter being the focus of this study. Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a primary, often familial disorder of heart muscle caused by mutation of one or more of the genes coding for sarcomeric proteins (Marian & Roberts, 2001). It is characterized by heterogeneous expression between genotypes and within the same family, unique pathophysiology and clinical course (Yoerger & Weyman, 2003). It results in an abnormally thickened ventricular wall with an abnormal diastolic relaxation but usually normal systolic (contraction) function.

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4 The septal or left ventricular (LV) thickening is not due to chronic pressure overload; that is, it is not associated with hypertension or aortic stenosis, which are the most frequent antecedents to congestive heart failure (CHF). Severity of symptoms can vary greatly, with some patients having minimal or no symptoms, and other patients experiencing severe symptoms including sudden cardiac arrest and/or death. Signs and symptoms include fatigue, exercise intolerance, shortness of breath (dyspnea) at rest and with exertion, chest pain (angina), dizziness, pre-syncope or syncope, palpitations, and arrhythmias. The most frequent symptom is dyspnea due to elevated diastolic LV pressures, which is further exacerbated by high systolic LV pressure and mitral regurgitation (Chen et al., 2003). Arrhythmias occurring with HCM, which may be due to the disarray of myocardial fibers, are the most concerning because they exacerbate symptoms. For example, atrial fibrillation further impairs diastolic filling and can worsen pulmonary congestion. Ventricular fibrillation is of greatest concern, and sometimes is the first clinical manifestation of HCM, resulting in sudden cardiac death (Chen et al., 2003). In some patients, a diagnosis is made only after they, or an affected family member, experience(s) sudden cardiac death. HCM affects approximately 0.2% (1:500) of the adult general population and is the most common genetic (familial) cardiovascular disease (Maron, 2002). Although HOCM affects individuals of all ages, sudden death in young people is its most devastating effect and is the most common cause of sudden cardiac death in young people (Chen et al., 2003; Maron, 2002; Roberts & Sigwart, 2001). Hypertrophic obstructive cardiomyopathy (HOCM) is considered a more severe condition in terms of anatomical and functional impairments compared to other

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5 nonobstructive conditions in the HCM disease classification (Chen et al., 2003). It is characterized by abnormal enlargement of the cardiac interventricular septum (asymmetric hypertrophy) which interferes with mitral valve function and creates an obstruction to outflow of blood from the left ventricle (LVOT obstruction) into the aorta. LVOT obstruction contributes to and may result in systolic anterior motion (SAM), commonly present with HOCM. SAM is the abnormal movement of the anterior mitral valve leaflet into the LVOT, due to the turbulence of the blood flow through the obstructed LVOT (Venturi Effect) (Yoerger & Weyman, 2003). This then causes greater obstruction because the anterior mitral valve leaflet makes contact with the septum during systole (Chen et al., 2003). Medical Management of HOCM The aim of medical therapy for HOCM is to decrease LVOT obstruction, improve diastolic function, and improve symptoms (Nielsen, Killip, & Spencer, 2002). Historically, there have been three types of treatment available for HOCM: medications, pacemaker, and surgery (Maron, 2002). Surgery is the only treatment designed to be curative in focus rather than to just reduce symptom burden. Medications (i.e., betablockers, calcium channel blockers, other negative inotropic medications) are used in attempts to “relax” the heart, decrease left ventricular wall tension, reduce obstruction, and alleviate symptoms. However, they frequently have limited effectiveness even in high doses. Implantation of a permanent pacemaker is thought to change the pattern of the contraction of the heart and may help improve left ventricular outflow, but there is considerable debate regarding the effectiveness of this treatment (Nishimura et al., 1997). Surgical excision of the thickened interventricular septal muscle (myectomy, myomectomy) and/or mitral valve replacement has been the gold standard of treatment of

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6 drug-refractory HOCM, although operative cases represent only 5% of the overall HOCM population (Maron, 2002). The newest treatment for HOCM is nonsur gical septal reduction therapy (NSRT; also termed alcohol septal ablation), in which absolute ethanol is injected into the area of hypertrophied muscle to induce infarction in the targeted area. As healing occurs, the thickened muscle is replaced with thinner, noncontractile scar tissue and the mechanical obstruction of the left ventricular outflow tract (LVOT) is relieved. NSRT has been shown to improve diastolic function, decrease left ventricular hypertrophy and mass, and cause changes at the cellular and molecular level, thereby improving myocardial function (Nielsen & Spencer, 2002). Maron (2002; Maron et al., 2003) has repeatedly criticized NSRT for lack of direct comparison to surgical therapy in randomized, controlled, clinical trials. However, studies have compared the two procedures in nonrandomized trials, and researchers have made comparisons through literature reviews. NSRT compares favorably to surgical myectomy in terms of LVOT gradient reduction, septal wall thickness, symptomatic improvements, and QOL improvements (Firoozi et al., 2002; Ruzyllo et al., 2000). Improvement in exercise capacity (i.e., peak oxygen consumption, exercise time) has been inconsistent, with some research demonstrating that NSRT is inferior to myectomy (Firoozi et al., 2002); yet, the majority of research demonstrates equivalent benefit between the two procedures (Ruzyllo et al., 2000), as well as analogous improvements in exercise blood pressure (Kim et al., 1999). In general, NSRT compares favorably to other treatments for HOCM and appears to provide greater symptom reduction (Lakkis, Nagueh, Dunn, Killip, & Spencer, 2000; Nagueh et al., 2001). While it is equally as effective as myectomy in regards to

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7 symptomatic improvements, NSRT has demonstrated superiority over surgery with respect to complications (Kuhn et al., 2000). NSRT is less invasive than open-heart surgery, therefore reducing surgical risk (Ruzyllo et al., 2000). For example preand post-operative mortality rates of myectomy range from 1-10% (Mayes et al., 2002). Because the procedure is less invasive, recovery time and rehabilitation are substantially shorter in patients undergoing NSRT than myectomy, and improvements continue status post procedure up to six months (Nielsen et al., 2002). Nonsurgical Septal Reduction Therapy Patients evaluated for NSRT are symptomatic despite medical treatment. To be considered an appropriate candidate for NSRT, patients must have asymmetrical septal hypertrophy (ASH) with septal wall thickness > 1.6 cm or a septal to posterior wall ratio of 1.3; SAM of the mitral valve contributing to the obstruction; and a resting LVOT gradient of > 30 mmHg or a provoked gradient of > 50 mmHg (Nielsen et al., 2002). In addition, many investigational studies include a criteria of NYHA > 3 functional classification (Chang, Lakkis, Franklin, Spencer, & Nagueh, 2004). Similar to myectomy and other interventional procedures, such as coronary artery bypass graft (CABG) surgery, the goals of NSRT are to bring symptom relief to the patients and to improve QOL. The procedure continues to be refined and perfected as more procedures are performed and the specialized interventional cardiologists determine the most effective strategies and approaches (Nagueh et al., 2001; Ruzyllo et al., 2000). Two-dimensional, Doppler, and contrast echocardiography are used throughout the NSRT procedure, as well as x-ray fluoroscopy (Mayes et al., 2002). Resting LVOT gradient is determined at rest and sometimes with provocative maneuvers such as during and after Valsalva and after extrasystole. Other methods that may reveal an LVOT

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8 gradient include exercise, administration of intravenous Dobutamine, and inhalation of amyl nitrite (Ommen & Nishimura, 2000). The ostium of the left coronary artery is cannulated with a guiding catheter and radiographic contrast is injected into the coronary artery under fluoroscopic observation. Septal perforator branches of the left an terior descending (LAD) coronary artery are identified on the coronary angiogram, determining the appropriate septal branch(es) that supply the hypertrophied septum, and allow for angioplasty techniques to administer the ethanol (Mayes et al., 2002). A small angioplasty balloon catheter is introduced over the guidewire into the proximal portion of the target artery. The balloon is inflated and appropriate positioning is confirmed by a ngiography. Radiographic contrast injected through the balloon is used to confirm that there is no leak of contrast (and therefore, alcohol) retrograde around the balloon into the LAD artery; and that there is no communication of this septal perforator with other arteries or cardiac structures (Karen Smith, M.D., personal communication, July 19, 2004; Mayes et al., 2002). Then, echocardiographic contrast medium is injected through the lumen of the balloon catheter and the septum is observed under echocardiography. This contrast “lights up” the area of the septum supplied by the artery, confirming that the selected septal perforator supplies the area of the hypertrophied septum responsible for the LVOT obstruction. Confident of anatomy and positioning, the interventional cardiologist then infuses absolute ethanol through this septal perforator artery into the basal septal myocardium. Depending on the size of the vascular territory, 1 to 4 mL of ethanol is instilled through the inflated balloon catheter over five to ten minutes at a slow injection rate of approximately 0.25-0.5 mL/minute (Karen Smith, M.D., personal communication, July 19, 2004). The ethanol also gives the basal septum a white or bright appearance under echocardiographic

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9 observation, allowing the area of infusion to be visible to the cardiologist. The total amount of ethanol infused is judged by the interventional cardiologist based on area of brightness of the septum, contractility of the septum, resolution of the gradient, electrocardiographic and hemodynamic changes, and experience (Karen Smith, M.D., personal communication, July 19, 2004). Upon completion of the ethanol infusion, the balloon is deflated and removed. Morphological results of the NSRT are examined by coronary angiography and the LVOT gradient measurements are repeated. The alcohol injected into the septum is directly toxic to the myocardium and kills the cells. Immediately, the effected septum becomes akinetic and therefore no longer bulges into the LVOT during systole, thus producing an immediate reduction in gradient (Ommen & Nishimura, 2000). Over ensuing weeks and months, the injured myocardial tissue is replaced, through the normal healing process, by much thinner scar tissue; thus reducing the obstruction, enlarging the effective LV chamber, improving blood flow out of the LV, reducing the turbulence of the ejected blood, and reducing the LV pressure gradient. Through improvement in flow charact eristics, SAM and mitral regurgitation are also improved or completely alleviated (Karen Smith, M.D., personal communication, July 19, 2004). Following the procedure, patients are hospitalized for three to five days for close cardiac monitoring. Most patients notice improvement in symptoms such as shortness of breath, chest discomfort, paroxysmal nocturnal dyspnea, and orthopnea almost immediately. As healing occurs and the septum thins over the next several weeks and months, they report further improvements especially in fatigue and exercise tolerance (Karen Smith, M.D., personal communication, January 7, 2004). Interventional cardiologists and primary care providers follow patients for the next several years.

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10 Generally, echocardiograms are performed three months post-NSRT and then yearly to evaluate septal thickness and contractility, LV gradient, and the mitral valve (Karen Smith, M.D., personal communication, January 7, 2004). The most common side effect of NSRT is an arrhythmia (irregular heart beat) called complete heart block (also called atrioventricular block). This occurs because the site of the ablation is located near the conduction system. Damage to this conduction system causes interruption of the electrical communication and synchronization between the atria and ventricles resulting in (sometimes profound) bradycardia, which may require implantation of a permanent cardiac pacemaker (Gietzen et al., 1999). The incidence of complete heart block is steadily declining with experience of the interventional cardiologists (Kuhn et al., 2000) Neither surgical myomectomy nor NSRT appears to significantly alter the risk of sudden cardiac death in patients with HCM. Some cardiologists have postulated that the scar tissue created by the alcohol ablation procedure might become a focus for development of arrhythmias, but this has not been confirmed (Kuhn et al., 2000; Ommen & Nishimura, 2000). Other noted complications include requirement of a second NSRT procedure to further relieve the obstruction, and death (< 1%) (Seggewiss, 2000). NSRT may be considered analogous to implantable cardioverter defibrillators (ICD) in the 1980s. For the past three decades, ICD implantation has increased exponentially. For example, approximately 20,000 devices were implanted in 1995 and as many as 125,000 were implanted in 2002 (Medtronic, Inc., personal communication, June 2, 2004). Today, ICDs are considered the first line of treatment for ventricular tachycardia/fibrillation, sudden death, ejection fraction (EF) < 30%, and it is even used prophylactically in many other cardiac conditions (Sears & Conti, 2003). With further

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11 refinement, modifications, better technology, and more experience, NSRT may prove to be the “gold standard” of treatment for HOCM. Currently, only a select few interventional cardiologists are trained in the procedure, but with increased patient demand and more refined procedures, better outcomes are expected. For example, Nagueh and colleagues (2001) modified their NSRT technique with the addition of contrast echocardiography after 7 procedures and demonstrated dramatic improvement in outcomes (heart block requiring permanent pacing in 22% vs. 8.6%) after the modification. In just a few years, outcomes of NSRT have improved substantially with the use of echocardiographic contrast agents, thereby enabling the precision of the delivered alcohol into the septum (Firoozi et al., 2002). NSRT procedures will never be as common as ICD implantation rates due to the fewer numbers of candidate patients, but it is reasonable to project that their rates will continue to rise as it establishes itself as an effective intervention for HOCM. Therefore, the examination of QOL and psychosocial factors along with biomedical indices of the condition and of the procedure are now indicated. Quality of Life At its heart, QOL is a nebulous subjective construct that may be assessed and determined in a number of ways. QOL implicitly focuses on the quality, value, meaning, or worth of life beyond that of number of years alive. The QOL construct strives to describe the components of “living” including emotional well-being or distress, social relationships or functioning, financial c oncerns, physical functioning or limitations, health status, and/or spiritual well-being (Swenson & Clinch, 2000). Health-Related Quality of Life Health-related QOL, irrespective of disease specificity or generality, combines physical, cognitive, emotional, and social functioning experienced and reported by the

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12 patient. It can be considered the appreciation of the pervasive and adverse effects of illness on the patient as perceived by the patient (Swenson & Clinch, 2000). In other words, it is the “ illness experience as opposed to the disease ” (Swenson & Clinch, 2000, p. 406). Aligned with that definition, Wenger, Mattson, Furgerg, and Elinson (1984) depict health-related QOL as comprised of three aspects: functional capacity, perceptions or patients’ personal judgments, and symptoms and their consequences. Health-related QOL instruments may either be generic measures of health status or disease-specific measures. Generic measures of health-related QOL incorporate a broad spectrum of function, health perceptions, and symptoms, which can be used in different patient populations including thos e without disease. This enables direct comparison of QOL across different disease states and conditions. The inherent limitation of generic measures is that they may overlook important aspects or changes that are of particular value for a specific medical condition (Swenson & Clinch, 2000). Disease-specific measures quantify more clinically relevant domains for a specific disease state than a generic measure. They are often more responsive to changes in health-related QOL and are more sensitive in discriminating the range of impairment in health-related QOL because their focus is on the most relevant aspects for the problem or condition assessed (Guyatt, Feeny, & Patrick, 1993; Swenson & Clinch, 2000). Given the breadth and complexity of QOL, it is important to include and assess multiple domains of QOL from a variety of perspectives usually incorporating both generic and diseasespecific measures. It is these reasons as to why the proposed study utilizes cardiacspecific QOL as the primary outcome and generic health-related QOL as the secondary outcome.

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13 Quality of Life Among Patients with Cardiac Disease The Medical Outcomes Study demonstrated that across nine chronic medical conditions, cardiac disease (e.g., myocardial infarction [MI], CHF) had the greatest adverse impact on broad domains of functi oning and well-being (Stewart et al., 1989). Stewart and colleagues (1989) found that QOL is more severely impaired in heart failure patients compared to other common chronic conditions, such as angina, diabetes, arthritis, and lung disease. Since then, investigators have consistently demonstrated that QOL is impacted in a variety of cardiac conditions, ranging from patients with CHF, angina, coronary artery disease (CAD), to arrhythmias and electrical desychronization (Dougherty, Dewhurst, Nichol, & Spertus, 1998; Dracup, Walden, Stevenson, & Brecht, 1992; Kamphuis, De Leeuw, Derksen, Hauer, & Winnubst, 2002). In addition, QOL is impacted among patients who have undergone treatment and/or procedures such as percutaneous transluminal coronary angi oplasty (PTCA) and CABG (Konstam et al., 1996; Majani et al., 1999). Not only are a vari ety of QOL domains influenced, but also they, in turn, can lead to declining health and/or death. For example, QOL components including emotional distress, social functi oning, physical functioning, perceived health, and life satisfaction were predictors of all-cause mortality in a sample of CHF patients (Konstam et al., 1996). Impairments in QOL are frequently evidenced in sleep disturbance, financial difficulties, dysfunctional eating patterns, and decreased sexual activity and sexual dysfunction (Majani et al., 1999). Quality of Life Among Patients with Cardiomyopathy QOL among patients with cardiomyopathy (CM) has received minimal empirical investigation, thus the value of the proposed study. There are two studies that provide some QOL information specific to HCM and dilated CM (DCM) (Cox, O’Donoghue,

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14 McKenna, & Steptoe, 1997; Steptoe, Mohabir, Mahon, & McKenna, 2000). Both studies were identical in procedure to enable comparison between samples of CM. Each study was a cross-sectional design with two aims: (1) to evaluate the level of health-related QOL and psychological well-being among CM patients, and to compare them to the general population and patients with other serious cardiac conditions, and (2) to identify the clinical, demographic, and psychosocial factors that predicted limitations in QOL in patients. The researchers used standardized measures: Health Survey Short Form (SF-36), Hospital Anxiety and Depression Scale (HADS), MOS sleep quality, questions on adjustment, and biomedical data to answer their questions. Examining QOL in HCM patients, Cox and colleagues (1997) found that these patients had significant impairments on all 8 scales of the SF-36 (i.e., physical functioning, physical role limitations, emotional role limitations, social functioning, mental well-being, general health perceptions, vitality, and bodily pain). The sample consisted of 171 patients diagnosed within the broad HCM disease spectrum (Cox et al., 1997). In other words, not all patients had an obstructed LVOT, but were rather characterized because of their enlarged heart muscle, which typically occurs in the left ventricle and the interventricular septum. Patients were divided into three groups: no known family history of HCM, those with fam ily history, and those with family history and one or more with premature sudden death. There were no significant differences among family history groups on demographic or clinical data, QOL, psychological wellbeing, or adjustment. As a whole, HCM patients reported impairments similar to patients with CHF, hypertension with CHF, complicated diabetes, MI, regular angina, and severe autonomic neuropathy ( p < .01). They also found that HCM patients reported significantly poorer QOL in terms of role limitations attributable to emotional problems,

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15 social functioning, and mental health compared to the general and cardiac populations. This suggests that QOL is severely affected among patients with HCM, particularly in mental health functioning, and even in comparison to known severe disease. Similarly, Steptoe, Mohabir, Mahon, and McKenna (2000) demonstrated that patients with DCM (N = 99) reported poor QOL in areas of physical functioning, activities of daily living, emotional and social functioning, vitality, and general perceptions of health, and sleep quality compared to the general population ( p < .025). However, DCM patients reported greater rest rictions in social functioning and pain compared to HCM patients ( p < .003). DCM patients reported similar depression rates but greater anxiety levels and social functi oning restrictions, compared to other cardiac disease populations. In addition to describing poor QOL among these patients, predictive relationships were also shown between physical role limitations and depression. Those who reported poorer QOL among the HCM patients were associated with experiencing chest pain and dyspnea (Cox et al., 1997). This finding suggests that physical symptoms lead to functional limitations and therefore reduced QOL, which may in turn lead to psychological distress. These two studies also examined predictors of QOL among CM patients. Adjustment to HCM was the most consistent correlate of QOL and psychological wellbeing dimensions, predicting a range of diffi culties across physical, social, and emotional domains, independent of demographic and clinical variables (Cox et al., 1997). The researchers hypothesized that patients with familial cardiomyopathy (e.g., DCM, HCM) might experience greater psychological distress since they have knowledge that their cardiac condition can be inherited or passed on to offspring. While this potential origin of distress would not be impacted by medical treatment, it is an area that may be addressed

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16 with psychosocial treatment, and currently, these patients are often neglected in terms of psychosocial care. Other significant relationships seen in these CM studies were between physical functioning and patients with comorbid CHF, lower left ventricular shortening fractions, and higher left ventricular end dias tolic diameters. Poor social functioning was seen in CM patients with moderate to severe mitral regurgitation. The most notable finding was that poor adjustment to CM pred icted poor physical function, mental health, and emotional distress. Summary and Implications of Quality of Life Literature The familial origin of HCM and its potential reason for distress may be one of the main differences in the development of psychological distress when comparing HCM patients to other cardiac populations. While QOL may be impacted in all cardiac populations, development and progression of disease and/or psychological problems may be vastly different. For example, HOCM is a structural abnormality caused by mutations on the genes encoding proteins of the muscle fibers (Marian & Roberts, 2001; Mayes et al., 2002). In other words, patients with HOCM did nothing themselves to cause the disease, whereas a significant proportion of CHD (i.e., CAD) develops from poor lifestyle and health behaviors (e.g., diet, physical activity) and is the leading preventable disease. Therefore, reported QOL and rates of psychological distress may be similar across cardiac disease; yet, worse than the general population, but emerging from different factors. These QOL impairments may then lead to further physical and emotional problems, including death. These CM studies provide rationale for the current study. They indicate the need for an increased understanding of psychosocial concerns and QOL, of which is pervasive and poorly understood. These studies also emphasize the importance of further

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17 examination of QOL among CM patients. Gaining this knowledge, we can better optimize both emotional and physical outcomes with CM patients. These specific CM studies also emphasize weaknesses and/or gaps in the literature. For example, these studies were only cross-sectional, and only longitudinal studies can attempt to determine how impairments in QOL develop and progress. While there is ample QOL research in other areas, it is extremely sparse among HCM patients, particularly HOCM patients. Further, psychosocial examination of treatments for HOCM is even more limited. Researchers not only need to study HOCM, but also its treatments from a physiological perspective, but also from a psychosocial perspective, the latter being the focus of this study. Psychological Distress Related to and independent of QOL, negative emotions play a role in psychological and physical health, particularly in cardiac disease. The experience of negative emotions such as anger, anxiety, and depression are probable risk factors for coronary heart disease (CHD) and may substantially account for poor cardiac disease outcomes (Kubzansky & Kawachi, 2000). Emotions may influence cardiovascular health through a number of pathways, including excessive activation of the sympathetic nervous system or the hypothalamus-pituitary-adrenal (HPA) axis, or altered autonomic regulation of the heart (Kubzansky & Kawachi, 2000). For example, anxiety may provoke electrical instability in the heart, promote increased atherosclerotic processes, and trigger myocardial infarction (Kubzansky, Kawachi, Weiss, & Sparrow, 1998). Depression may impact cardiac outcomes by altering neuroendocrine functioning, increasing sympathetic tone and decreasing vagal tone, and by increasing platelet aggregation (Carney, Freedland, Rich, & Jaffe, 1995).

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18 In addition to the influence of emotions on physiology, psychological distress can impact social and behavioral components of health. Anxiety and depression experienced before and during a recovery period from a procedure (e.g., CABG, PTCA) are as important as physical limitations and comorbidities in influencing outcomes such as length of hospital stay, ability to function, and QOL (Pirraglia, Peterson, WilliamsRusso, Gorkin, & Charlson, 1999). Negative emotional states have also been associated with reduced adherence to prescribed medical regimens (i.e., increasing self-care and decreasing health compromising behaviors) known to be important in cardiac rehabilitation (Januzzi, Stern, Pasternak, & DeSanctis, 2000; Ziegelstein et al., 2000). Mood and affective disorders appear to be common in cardiac patients, ranging from diagnoses of panic disorder, agoraphobi a, generalized anxiety disorder, and social phobia, to dysthymia, major depressive disorder, and alcohol abuse (Griez et al., 2000). Panic disorder is evident in patients with CAD, mitral valve prolapse, and it is also suggested in those with idiopathic cardiomyopathy (Kahn et al., 1987). See Table 1 for prevalence rates of depression and anxiety among cardiac samples. Depression Among Patients with Cardiac Disease Emotional distress and depression have been suggested as new risk factors for CAD (Rozanski, Blumenthal, & Kaplan, 1999). Rates of depression among cardiac patients range from 14% to 87%, among patients with CAD, ischemic heart disease, nonischemic heart disease, arrhythmias, and patients with ICDs (Blumenthal et al., 2003; Musselman, Evans, & Nemeroff, 1998; Sears, Todaro, Saia, Sotile, & Conti, 1999). Higher rates are more often seen in patients awaiting CABG, those with unstable angina, and those with ICDs (Blumenthal et al., 2003; Sears et al., 1999). Clearly, the wide range in depression rates depends, in part, on the method of measurement used as well as the

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19 specific condition examined. Despite the variation of rates, it is evident that depression is highly prevalent in cardiac populations and may predict psychosocial and physical health status, and therefore, warrants examination and treatment. Table 1.Prevalence rates of depression and anxiety in the published cardiac literature Sample/PopulationDepressionAnxietyInvestigator General population2-9%1-3%American Psychiatric Association, 1994 CAD14-47%Blumenthal et al., 2003 6-34%Jeejeebhoy et al., 2000 CHF30.2%Rumsfeld et al., 2003 36.5%Koenig, 1998 Idiopathic CM51%Kahn et al., 1987 Idiopathic DCMa19%19%Griez et al., 2000 DCMa22%52%Steptoe et al., 2000 HCMa,b Possible Probable 13.1% 9.5% 21.2% 28.5% Cox et al., 1997 ICD24-87%13-38%Sears et al., 1999 CABG12-76%Blumenthal et al., 2003 Pre 3-months post 32% 26% 55% 32% Rymaszewska et al., 2003 Angioplasty15%26%Lenzen et al., 2002 Heart transplant 0-4 months pre 5 year post >49% 11% Fisher et al., 1995 Note .a Comparable to other cardiac populations, but greater than the general population.b Greater than a cancer sample ( p < .0001). In addition to the high prevalence, depression holds predictive value. For example, among coronary revascularizati on studies, preoperative depression affects postoperative QOL and psychosocial functioning (Duits, Boeke, Taams, Passachier, & Erdman, 1997). Depression also influences morbidity and mortality, independent of

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20 cardiac disease severity, including left ventricular dysfunction (Burg, Benedetto, Rosenberg, & Soufer, 2003). It is associated with elevated cardiac mortality risk, similar to its impact on patients’ prognosis with unstable angina and post MI (Frasure-Smith & Lesperance, 2003; Zellweger, Osterwalder, Langewitz, & Pfisterer, 2004). Depressive symptoms are common in patients with CHF, which subsequently may be an important determinant of health status (Vaccarino, Kasl, Abramson, & Krumholz, 2001). Patients with CHF suffer with moderate to severe depression and moderate anxiety and appear to have higher levels of depressive disorders (36.5% vs. 17.0%, p = .002) compared to other cardiac patients, but no significant differences with Major Depression, specifically (Dracup, Walden, Stevenson, & Brecht, 1992; Koenig, 1998). Rumsfeld and colleagues (2003) found that depressed CHF patients reported markedly worse baseline health status compared to nondepressed patients ( p < .001). Further, after adjusting for baseline health status, demographic, cardiac, and treatment variables, depressive symptoms were a strong predictor of worsening heart failure symptoms, functional status, and QOL over a 6-week period. Not only were depressive symptoms a predictor, but also seen in multivariable models of change in QOL scores, symptoms scores, and social functioning scores, depressive symptoms had the largest magnitude of association with the outcome Rumsfeld and colleagues’ (2003) study was the first to demonstrate the unique impact of depressive symptoms on heart failure specific health status and indicate that patient-centered outcomes for heart failure patients may be improved with the recognition and treatment of depression. A large body of research provides evidence for a strong relationship between depression and cardiac disease, particularly after a MI. While, there is inconsistent evidence regarding the causative role of depression in CHD, the bulk of the evidence

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21 supports depression’s causal role in CHD. In the National Health Examination FollowUp Study, self-reported depression was associated with an increased risk of fatal and nonfatal ischemic heart disease (RR = 1.5 and 1.6, respectively) (Anda et al., 1993). A prospective, longitudinal study found that men with psychiatric diagnoses of clinical depression were at a significant risk of s ubsequent CHD (RR = 2.12) (Ford et al., 1998). Other follow-up studies have failed to show a relationship between depression and increased risk of CHD (e.g., ischemic heart disease, MI) (Vogt, Pope, Mullooly, & Hollis, 1994; Wassertheil-Smoller et al., 1996). Regardless of the unknown or unproven direction of the relationship between depression and CHD, there is notably a strong relationship between the two and that the relationship has critical clinical relevance and implications for outcomes and QOL in all examinations of cardiac disease, including HOCM. Anxiety Among Patients with Cardiac Disease Anxiety is another negative emotional state that is experienced in a large number of cardiac patients, and is more strongly asso ciated with CHD than depression or anger (Kubzansky & Kawachi, 2000). Symptoms of anxiety and symptoms of cardiac disease can often times mimic each other. For example, chest pain, shortness of breath, heart palpitations, and racing heart are all symptoms of both anxiety disorders and heart disease (including HOCM) (Jeejeebhoy, Dori an, & Newman, 2000). Patients with known heart disease, may be more susceptible to hypervigilance in monitoring their symptoms, have an increased somatic concern and body awareness, fear and worry about chest and heart sensations, along with avoiding activities that may elicit cardiac symptoms or activity (Jeejeebhoy et al., 2000; Lebovitz, Shekelle, Ostfeld, & Paul, 1967; Zvolensky, Eifert, Feldner, & Feldner, 2003). Accordi ng to Zvolensky and colleagues (2003) heart-

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22 focused anxiety is the fear of cardiac-related stimuli and sensations grounded in their perceived negative meaning. Therefore, cardiac symptoms and anxiety may perpetuate each other in a constant cycle. Further, the experience of health-related anxiety during the course of illness may occur as the patient engages in persistent worry about their condition, and not just their manifest symptoms (Zvolensky et al., 2003). Therefore, anxiety is not an uncommon condition among cardiac patients. The majority of researchers have reported associations between anxiety and CHD. For example, the Northwick Park Heart Study as well as the Health Professionals FollowUp Study found that phobic anxiety had relative risks of fatal CHD of 3.77 and 2.45, respectively, compared to men reporting low or no anxiety (Haines, Imeson, & Meade, 1987; Kawachi, Colditz, et al., 1994). In the Normative Aging Study, men reporting symptoms of anxiety had elevated risks of fatal CHD, particularly that of sudden cardiac death (Kawachi, Sparrow, Vokonas, & Weiss, 1994). In the Framingham Heart Study, anxiety symptoms were significantly related with MI and coronary death among homemakers but not among employed women (Eaker, Pinsky, & Castelli, 1992). Further, anxiety may cause acute cardiac events such as MI by stimulating the release of catecholamines that increase the heart rate, blood pressure, and cardiac output (Mittleman et al., 1995). Therefore, it may cause myocardial ischemia and electrocardiogram changes in those with already established heart disease (Tofler et al., 1990). Summary and Implications of Psychological Distress Literature This review has highlighted that not only do cardiac patients experience significant psychological distress, but also their distress can predict outcomes both psychologically and medically. Symptoms of cardiac disease (e.g., shortness of breath, fatigue, dizziness, chest pain) tend to lead to functional limitations in those who

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23 experience them, with greater limitations the more severe the symptoms. Along with the distressing symptoms, patients may be even more distressed by the limitations and impairments that are caused by these symptoms. Patients with HOCM who are evaluated for NSRT are usually at their last line of defense in terms of treatment, and consequently have been suffering for years with unrelenting symptoms of increasing severity. In addition, they report significant functional limitations in a variety of areas, and thus, report poor QOL. The current study evaluated these emotional states because it was assumed that symptoms of depression and anxiety would occur in HOCM patients due to their physical symptoms and functional limitations; however, it has not been evaluated in a systematic fashion. Further, congruent with the literature, it was expected that the symptoms of depression and anxiety would impact thes e patients’ QOL, physical health, and the effectiveness of and/or recovery from NSRT. Psychological Well-Being With psychological distress now an accepted risk factor for poor overall health, it is worthwhile to also examine positive emotions, resilience factors, and their relationship with cardiac conditions. Resilience factors are those that enhance one’s ability to recover quickly from distress or illness. Research indicates that positive emotions such as optimism, positive expectations, satisfaction, and spirituality may enhance one’s ability to cope with illness, treatment, and other related stressors. Optimism Among Patients with Cardiac Disease In the general population, optimism and satisfaction with life has been shown to be a mental health factor that positively influences both psychological and physical wellbeing (Taylor, Kemeny, Reed, Bower, & Gruenewald, 2000). Optimism may allow

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24 individuals to mobilize effective coping strategies and resources when faced with stress or adversity (Scheier et al., 1999). Optimistic individuals may believe that their attitudes or actions will positively influence their health outcomes. Initial optimism research among cardiac patients has yielded promising results. Positive expectations and an optimistic disposition predict fewer symptoms, lower levels of cardiovascular reactivity, and better health outcomes in CABG and cardiac patients (Cohen, de Moor, & Amato, 2001; Leedham, Meyerowitz, Muirhead, & Frist, 1995; Scheier & Carver, 1987, 1992). The prospective Veterans Affairs Normative Aging Study examined optimistic versus pessimistic explanatory style, revealing that a more optimistic explanatory style lowered the risk of CHD in that particular sample of older men, independent of health behaviors (i.e., tobacco or alcohol consumption) (Kubzansky, Sparrow, Vokonas, & Kawachi, 2001). A recent study supported the existence of resilience factors in a prospective study of ICD patients (Sears et al., 2004). Results suggested that optimism and positive health expectations differentially relate to specific health outcomes from baseline to a 14-month follow-up. Positive health expectations were more closely associated with general physical health, while optimism was more closely associated with mental health outcomes. Collectively, these resilience factors appear to hold some value in promoting future intervention studies in terms of QOL for the ICD patient (Sears et al., 2004). Positive health expectations and/or optimism may be beneficial by facilitating healthy behavioral practices, enhancing treatment adherence, and increasing motivation to engage in appropriate health behaviors such as exercise and healthy dietary choices (Salovey, Rothman, Detwieler, & Steward, 2000).

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25 Spiritual Well-Being Among Patients with Cardiac Disease Along with optimism, spirituality or spiritual well-being has been seen as a resilience factor. In health promotion literature, spiritual health has been defined as, “a high level of faith, hope, and commitment in relation to a well-defined worldview or belief system that provides a sense of meaning and purpose to existence in general and that offers an ethical path to personal connectedness with self, others, and a higher power or larger reality” (Hawks et al., 1995, p. 373). Accordingly, overall wellness may be conceived to include not only emotional and physical health, but also spiritual health. Researchers have begun to focus on the relationship between spirituality and health, providing ample data to suggest that there is a relationship between spirituality and physical and psychological health (Brady, Peterson, Fitchett, Mo, & Cella, 1999; Mytko & Knight, 1999). The relationship between spirituality and enhanced quality of life has been demonstrated in many populations, such as healthy individuals (Kaye & Robinson, 1994), HIV patients (Ironson et al ., 2002), cancer patients (Brady et al., 1999; Cotton, Levine, Fitzpatrick, Dold, & Targ, 1999), and cardiac patients (Morris, 2001; Sears, Rodrigue, Greene, Fauerbach, Mills, 1997). Individuals with a strong sense of spirituality tend to have less symptomatology compared to those without a sense of spiritual well-being. They are also found to ha ve less pain, anxiety, and isolation, as well as higher life satisfaction, better psychological adjustment, and lower mortality rates (Brady et al., 1999; Cotton et al., 1999; Levin & Schiller, 1987). In the Lifestyle Heart Trial, researchers assessed sense of spiritual well-being four-years after the completion of an interv ention to promote heart healthy behaviors (Morris, 2001). The intervention compared a group following a vegetarian diet, regular aerobic exercise, and practiced meditation daily for one hour to a group provided with

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26 standard medical care. The primary endpoint was computerized cardiac catheterization data, measuring disease progression or regression of coronary obstruction. The experimental group scored higher on spiritual well-being than the control group and spirituality was correlated with disease progression or regression. Participants with low spirituality scores tended to have progression of their disease, and participants with high spirituality scores tended to have regression of their coronary obstruction. In addition to demonstrating a significant relationship between spirituality and health, this study indicates that sense of spirituality influences objective health. It is the first to suggest a definable relationship between spirituality and documented physical data (Morris, 2001). A small amount of research exists examining relationships between spirituality and/or religiousness with both physical and psychological health among cardiac patients. Researchers have studied patients in the coronary care unit, awaiting cardiac surgery, and those with cardiac arrest and near death experiences. Among these studies, researchers have operationalized spirituality by measuring different components of spirituality such as, prayer, spirituality as a coping strategy, optimism, meaning of life, and love and acceptance of others (Ai, Peterson, Bolling, & Koenig, 2002; Byrd, 1988; Harris et al., 1999; van Lommel, van Wees, Meyers, & Elfferich, 2001). In studies examining intercessory prayer (someone praying on another’s behalf) and patients on the coronary care unit, using a severity-adjusted outcome score, they found a trend of lower overall adverse outcomes for coronary care unit patients randomized to a prayer group compared to those in a usual care group; however, results were not statistically significant (Byrd, 1988; Harris et al., 1999). Optimistic patients awaiting cardiac surgery tended to be individuals who used private prayer for c oping, and were less depressed and less anxious than those who were not considered optimistic (Ai et al., 2002). van Lommel and

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27 colleagues (2001) concluded that medical factors could not account for near death experiences. Instead, they reported that patients with near death experiences had significantly decreased fear of death, increased belief in an afterlife, and rated themselves higher on spiritual items, such as meaning of life, love, and acceptance of others, and were more religious than before their near death experience. Summary and Implications of Psychological Well-being Literature Collectively, research on optimism and spirituality indicate that patients reporting higher levels of these traits report less symptomatology in both medical and psychological indices. Also, QOL appears to be enhanced in patients with an optimistic disposition, positive expectations, or spiritual well-being. It may be that these resilience factors lead individuals to engage in better health behaviors. While it is important to examine risk factors and disease, it is equally important to examine resilience factors and disease. Positive psychology has only recently been receiving a great deal of attention, and the promising research and outcomes explain why (Seligman & Csikszentmihalyi, 2000). Evaluating QOL cannot be complete unless examining both risk factors and resilience factors together. Thus, psychological well-being was incorporated in the current study of HOCM patients. This study’s overarching aim was to capture the essence of HOCM patients, which includes negative and positive characteristics, QOL, and health. Psychosocial Evaluation of Medical Treatment Assessing QOL and other psychosocial components in cardiac patients can be especially useful in comparing differential treatment options, considering adverse treatment effects, and comparing mild mood symptom change (Wenger et al., 1984). First, QOL measurement is beneficial when examining a treatment that has the potential

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28 of showing a major improvement in survival over another clinical investigation or treatment option (e.g., NSRT in HOCM). Second, if a treatment is effective in reducing mortality but may have toxic or unacceptable side effects for some patients, including QOL measurement can help patients and physicians weigh out costs and benefits (e.g., ICD shocks, chemotherapy). Third, QOL measurement is helpful when a mildly symptomatic or asymptomatic patient is on long-term treatment to ensure QOL is not diminished, thereby creating a risk of poor compliance to treatment (e.g., antihypertensive medication). A particular application of psychosocial evaluation is to be able to provide information about the patients to the medical team or vice versa to the patients from the medical team in order to optimize treatment outcome. CABG and PTCA are the two most common cardiac procedures and the most well known in the general population. CABG surgery has been described as the most thoroughly studied operation in the history of surgery with angina relief and QOL improvement as the primary goals of CABG (American College of Cardiology/American Heart Association Task Force, 1991; Burg et al., 2003). Studies demonstrate that changes in emotional functioning and satisfaction following CABG and PTCA are generally favorable for most patients relative to their preoperative emotional status. However, patients reporting high levels of anxiety and depression prior to interventional procedures often do not feel satisfied with their life, have more complaints about their health, disregard positive effects of surgery, and are less apt to return to work after procedure; thus, impacting social functioning and occupational functioning, and may lead to continued and worse anxiety and depression (Duits et al., 1999; Rymaszewska et al., 2003; Swenson & Clinch, 2000; Timberlake et al., 1997).

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29 Advances have been made in the medical management of CABG; however, attention to the psychological management is warranted because of its prognostic importance. Blumenthal and colleagues (2003) examined the relationship between depression and mortality among 817 patients preand six-months post CABG. Participants were also followed for up to 12 years following data collection (mean follow-up time = 5.2 years). Results indicated that moderate to severe depression before CABG, or persistent depression (> 6 months) predicted increased risk of death over the course of 12 years. Patients with moderate to severe depression had a greater than twofold higher risk of death compared to nondepressed patients during the follow-up period. Further, depression was significantly associated with mortality after controlling for other risk factors, such as age, sex, number of grafts, smoking history, diabetes, ejection fraction, and previous MI (Blumenthal et al., 2003). Anxiety has also been seen among patients undergoing CABG and PTCA (Lenzen et al., 2002; McCrone, Lenz, Tarzian, & Perkins, 2001; Sirois, Sears, & Bertolet, 2003). Preoperative anxiety has been well documented in CABG patients, such that high, moderate, and even low anticipatory anxiety levels at baseline were maintained up to six months postoperatively (Fitzsimons, Parahoo, Richardson, & Stringer, 2003; Vingerhoets, 1998). In addition, preoperative trait anxiety has shown significant contribution to patient’s postoperative st ate anxiety in patients undergoing CABG or PTCA (Lenzen, Gamel, & Immink, 2002; Mc Crone et al., 2001; Vingerhoets, 1998). Five impacts of anxiety emerged from the data analyzed by Fitzsimons and colleagues (2003): (a) chest pain, (b) procedure uncertainty, (c) forthcoming operation, (d) physical incapacity, and (e) dissatisfaction with health service. Both the quantitative and

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30 qualitative analyses of anxiety revealed that anxiety is a pervasive feature of the experience of waiting for CABG (Fitzsimons et al., 2003). In addition to predicting future anxiety, baseline levels have been used to predict cardiac symptoms and clinical outcomes. Fitzsimons and colleagues (2003) found significant differences in both state and trait anxiety levels by angina severity (grades 14). Among patients undergoing PTCA, a factor of negative emotions (i.e., depression and anxiety) predicted anginal frequency at 6-months and 1-year post-PTCA, more than demographic and biomedical variables (Siroi s et al., 2003). Negative emotions were also the strongest predictor of anginal freque ncy at 6-months and 1-year post-PTCA, evidenced by the standardized beta weight (-0.35 and –0.42, respectively). Baseline symptom report was also found to be a significant predictor at all time periods (6-weeks, 6-months, and 1-year post PTCA). These st udies suggest that not only is anxiety prevalent in cardiac patients with differing di agnoses and awaiting different procedures, but that it should be included in interventions to help allay distress and promote physical health. In contrast to risk factors in cardiac procedures, such as preoperative anxiety or depression, resilience factors such as higher preoperative levels of positive expectations demonstrate a faster recovery rate after CABG (Scheier et al., 1989). In a similar study, patients with positive expectations undergoing CABG were half as likely to be rehospitalized six months later for complications or other cardiac symptoms (Scheier et al., 1999). Spirituality has also been associated with enhanced quality of life, as well as promoting adjustment to trauma, treatments, and recovery (Brady et al., 1999; Cotton et al., 1999; Morris, 2001).

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31 Summary and Implications of Psychosocial Management of Medical Treatment Research demonstrates that physical symptoms, medical procedures, and outcomes can impact psychological distress and well-being and likewise, distress and well-being can impact symptoms, procedures, and outcomes. NSRT is a new treatment of HOCM, and therefore, evaluating the procedure from a biopsychosocial perspective is beneficial and aids in determining whether NSRT is an effective treatment, not only from a medical standpoint, but also from the patients’ views. The current study took a biopsychosocial approach in examining this new medical procedure, which has already been shown to have good biomedical outcomes. Statement of Purpose The current study combined the cardiac psychosocial literature, and of particular relevance, are the two studies of CM patients and the use of psychological variables when studying CABG and PTCA. Findings demonstrate the critical importance of the inclusion of psychosocial components of QOL in the treatment of cardiac disease. Building upon the CM studies, this study also addressed limitations in this area. It focused on patients with HOCM, and was longitudinal in design to enable examination of progression and/or changes of QOL. Further, the current study took an additional step, not only examining patients longitudinally, but also evaluating the QOL impact for a specific treatment of HOCM (i.e., NSRT). The study aimed to provide descriptive information about HOCM patients and NSRT, but also to provide longitudinal and clinically relevant data, which may aid in future biomedical and psychological treatments. Therefore, the purpose was threefold: 1. Descriptive : To describe HOCM patient characteristics, including the rates of psychological distress, well-being, and cardiac-specific QOL pre-NSRT.

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32 2. Change Over Time: To determine if there were changes in distress, well-being, and cardiac-specific QOL in HOCM patients preand post-NSRT. 3. Predictive: To determine if psychological distress and well-being pre-NSRT predicted post-NSRT cardiac-specific QOL.

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33 CHAPTER 3 METHODS Participants There were 45 adult participants with HOCM from two sites: the Shands Teaching Hospital at the University of Florida (UF) ( n = 25) and the Medical University of South Carolina (MUSC) ( n = 20). Participants were recruited during their initial outpatient clinic evaluation or index hospitalization for NSRT. Patients were excluded from the study if they were younger than 18 years of age, or not able to read and write English. Procedure After checking into their outpatient medical clinic and completing their standard medical forms, a member of the medical team approached the patient with informed consent for the current study. The patient was informed that his/her responses to research questionnaires would not influence psychological or medical care that is part of standard clinical care, and vice versa. The physician, or a member from the cardiac psychology team, was available to answer any of the patient’s questions. After providing signed informed consent, the participants completed the packet of research questionnaires examining QOL and psychological factors (baseline). At the time of standard clinical care, the same research questionnaires were re-administered three-months post-NSRT. The battery of questionnaires took approximately 30 to 45 minutes to complete. In addition to self-report questionnaires, information was obtained from medical and/or

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34 psychological records available through their residing institution of care (i.e., University of Florida/Shands Teaching Hospital or MUSC). During standard clinical care or the research protocol, if a patient needed or requested psychological services, an appropriate referral was made. Completed questionnaire packets were returned to a member of the medical or cardiac psychology team, which were then given to the project coordinator (ERS). To control for treatment effects, throughout the study, participants were asked if they have or are currently receiving psychotherapy or other forms of psychiatric treatment. Measures Demographic Information The Background Information Questionnaire was included at each of the patients’ assessments. This measure is a brief self-report tool to facilitate collection of demographic information. It includes information such as, age, gender, education, work status, income, marital status, religion, and use of past and/or present psychological treatment. Biomedical Information Resting left ventricular outflow tract (R-LVOT) Gradient is the biomedical marker that was used as an outcome measure, collected at baseline and the 3-month follow-up, obtained from the patient’s echocardiogram. The gradient is the difference between the left ventricle (LV) systolic pressure and the aortic systolic pressure due to obstruction of the LVOT. Normal values for both resting and provoked gradient are less than 30 mm Hg.

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35 General Health-Related Quality of Life The SF-12 Health Survey (SF-12; Ware, Kosinski, & Keller, 1995) is a generic measure of health status and was used to measure general QOL. The 12 items that comprise this measure are a subset from the SF-36. The scale measures eight components: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and well being) (Ware et al., 1995). The SF-12 can be separated into two components: physical component summary (PCS-12) and mental component summary (MCS-12). All scores of the SF-12 are comparable and highly correlated with SF-36 scores (ranging from .63-.97) (Ware et al., 1995; Ware, Kosinski, & Keller, 1996). The SF-12 reproduced 90% of the variance in the SF-36 PCS and MCS measures in the United States and on crossvalidation in the MOS (Ware et al., 1996). Test-retest reliability for the PCS-12 scale in the United States was .89, and for the MCS-12 scale was .77 (Ware et al., 1996). Internal consistency has been demonstrated for the PCS-12 (.77) and the MSC-12 (.80) (Luo et al., 2003). In the current study, the PCS-12 demonstrated poor three-month test-retest reliability ( rp = -.018), and therefore results were interpreted cautiously. This may be because our sample reported improvements over time. Cardiac-Specific Quality of Life The Left Ventricular Dysfunction Questionnaire (LVD-36; O’Leary & Jones, 2000) was designed to measure the impact of left ventricular dysfunction on daily life and well-being. This 36-item questionnaire measured cardiac-specific QOL. Responses are dichotomous (true or false). True responses are summed, which are then calculated as

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36 a percentage; higher scores indicate worse functioning (i.e., 0 = best possible score). Analyses have also revealed that for this measure significant differences were found between all NYHA classes, except between classes III and IV (O’Leary & Jones, 2000). The measure demonstrated high internal consistency in a sample with chronic left ventricular dysfunction (Kuder-Richardson coefficient = .95) (O’Leary & Jones, 2000). In the current sample, high internal consistency was found (Cronbach’s = .95). Testretest reliability in this sample was moderate ( rp = .594). The Minnesota Living with Heart Failure Questionnaire (MLHFQ; Rector, Kubo, & Cohn, 1987) was used to measure cardiac-specific QOL, including components of symptom distress and function (Harrison et al., 2002). The 21 items that comprise the MLHFQ originate from the Sickness Impact Profile. Patients with congestive heart failure were asked to select items that they experienced and attributed to their CHF. Items are rated on a 6-point Likert-type scale from 0 to 5; scores range from 0-105. Lower scores indicate less disability from symptoms, or in other words, better QOL. A physical dimension and an emotional dimension can also be calculated from this scale. In this study, the primary variable used was the total score. Research demonstrates that the MLHFQ is more sensitive to changes across a six and twelve week period among CHF patients (Harrison et al., 2002). Analyses have also revealed that for this measure significant differences were found between all NYHA classes, except between classes III and IV (O’Leary & Jones, 2000). The scale has demonstrated strong internal consistency, yielding a Kuder-Richardson coefficient of .95 among patients with chronic left ventricular dysfunction (O’Leary & Jones, 2000). Internal consistency in the present sample was established (Cronbach’s = .96), and moderate three month test-retest reliability was found ( rp = .537).

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37 Depression The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) is a 20-item self-report measure that assesses depressive symptomatology. Respondents indicate how frequently they have experienced each symptom in the past week. Responses range from 0 (less than one day) to 3 (5-7 days). The total score can range from 0 to 60 and reflects both the number of depressive symptoms and their duration. In the general population, a standard cu t-off score of 16 can be used to indicate clinically significant symptoms of depression (Radloff, 1977). Heart disease and primary care literature has demonstrated that CES-D scores can be grouped into three depression classifications: mild/ subclinical symptoms (0-15), moderate symptoms (16-26), and severe symptoms (>26) (Blumenthal et al., 2003; Zich, Attkinsson, & Greenfield, 1990). Previous research has demonstrated that the CES-D is highly sensitive and specific and exhibits a high internal reliability coefficient of .85. It has been reported as a more generally useful self-report measure of depression than the Beck Depression Inventory, the MMPI Depression Scale, and the Zung Self Rating Scale of Depression (Turk & Okifuji, 1994). In the current sample of HOCM patients, the CES-D demonstrated to have strong internal consistency (Cronbach’s = .87) and moderate three month testretest reliability ( rp = .530). Anxiety The Revised State Trait Personality Inventory-Trait Scale (STPI; Spielberger et al., 1979) is a 40-item self-report measure used to assess dispositional anxiety. The full trait scale is comprised of 4 subscales (10 items each): anxiety, anger, depression, and curiosity. In the current study, only the first three subscales (anxiety, anger, and

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38 depression) were used; therefore the current measure consists of 30 items. Respondents rate how strongly they agree with each item on a 4-point Likert-type scale ranging from 1 to 4, with total scores ranging from 30-120. The scoring procedure for the STPI is the same as that used in the STAI and STAXI, with higher scores indicating greater presence of dispositional anxiety, anger, and depr ession (Spielberger & Reheiser, 2003). The current study utilized a total score only, which is a summation of the 30 items. In the current HOCM sample, strong internal consistency was seen (Cronbach’s = .77) and strong three month test-retest reliability ( rp = .777). Well-Being The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larson, & Griffin, 1985) was designed to assess overall satisfaction with life. It is a 5 item measure that respondents are asked to rate their agreement with each item using a 7-point Likert-type scale, ranging from 1 (“strongly disagree) to 7 (“strongly agree”). Possible scores range from 5 to 35, with higher scores indicating higher satisfaction with life. Strong reliability has been demonstrated, yielding a Cronbach’s alpha of .87 and a two-month test-retest reliability of .82. Adequate levels of convergen t validity with the Life Satisfaction Index were also seen (Diener et al., 1985). The SWLS did not correlate with the MarloweCrowne measure ( r = .02), indicating that it is not evoking a social desirability response pattern. In addition, it appears that individuals who are satisfied with their lives are generally well adjusted and free from emotional distress or psychopathology (Diener et al., 1985). The scale demonstrated high internal consistency (Cronbach’s = .91) and strong three month test-retest reliability ( rp = .818) in the current sample of HOCM patients.

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39 The Life Orientation Test-Revised (LOT-R; Scheier, Carver, & Bridges, 1994) is a 6-item, self-report questionnaire (with 4 additional filler items) that assesses generalized expectancies for positive versus negative outcomes. Respondents rate the items on a 5-point Likert-type scale from 0 (“strongly disagree”) to 4 (“strongly agree”). Half of the items are phrased in the positive direction (items 1, 4, 10). The scores for the negative items (items 3, 7, 9) are reversed, and then all items are summed to yield an overall dispositional optimism score. Range of scores is 0-24, with higher scores indicating a more positive disposition. The LOT-R has an acceptable reported reliability alpha of 0.78. Test-retest reliability of the LOT-R has been shown across 4 to 28 months to range between .56 and .79 (Scheier et al., 1994). The authors conclude that overall, the LOT-R has good predictive validity, and dispositional optimism (as measured by the LOT) is quite distinguishable as an independent construct, as compared to the constructs of neuroticism and negative affectivity (Scheier et al., 1994). In the current sample, internal consistency was poor (Cronbach’s = .26), but three month test-retest reliability was excellent ( rp = .769). The Spiritual Well-Being Scale (SWBS; Paloutzian & Ellison, 1982) is a selfreport measure comprised of 20 items assessing sense of well-being in the relationship with God and sense of purpose in and satis faction with life (Paloutzian & Ellison, 1982). Ten items assess existential well-being (EWB) and 10 items assess religious well-being (RWB). Half of the items from each subscale are positively-valenced, and the other half are negatively-valenced. Responses to items are on a 6-point scale from 1 (strongly agree) to 6 (strongly disagree). The SWBS yields three scores: (1) a total score; (2) a summed score for religious well-being items; and (3) a summed score for existential

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40 well-being items. Higher scores indicate greater well-being. The subscales have demonstrated both high reliability and internal consistency. Test-retest reliabilities were 0.93 (SWB), 0.96 (RWB), and 0.86 (EWB) (Paloutzian & Ellison, 1982). Internal consistency has been demonstrated for the three scores: 0.89 (SWB), 0.87 (RWB), and 0.78 (EWB) (Paloutzian & Ellison, 1982). This study intended to use the total score for spiritual well-being. However, in the current sample, the total score demonstrated poor internal consistency (Cronbach’s = .38) and low three-month test-retest reliability ( rp = .432). Due to the scale’s demonstration of poor consistency, reliability, and validity, it was dropped from all analyses in the current project.

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41 DISTRESS CES-D STPI WELL-BEING SWLS LOT-R CARDIACSPECIFIC QOL LVD-36, MLHFQ CHAPTER 4 STATISTICAL ANALYSES Analyses were conducted to evaluate psychological distress, well-being, and health related QOL among HOCM patients preand post-NSRT, with cardiac-specific QOL as the primary outcome. See Figure 1 for a diagram of constructs tested. General QOL (SF-12) was also examined as a secondary outcome, but only for normative comparisons to other general and cardiac populations. The Bonferroni alpha correction procedure was used to control familywise error (Tabachnick & Fidell, 2001). This procedure was used to reduce the probability of making a Type 1 error due to the multiple analyses conducted. Figure 1.Diagram of constructs tested Power and Sample Size Calculations In the original proposal, a rationale for a sample size of 30 participants for preand 3-month post-NSRT was presented. Significant challenges in patient recruitment were encountered indicating the need to review progress with n = 20 pairs of prepost-

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42 NSRT data. There were two notable findings with the current data related to sample size. First, the data on which power analyses were calculated (i.e., prepostLVOT gradient, QOL) demonstrated very large effect sizes (Cohen’s d > 1.00) and more than satisfactory power (> .85). These findings supported the decision of sufficient data to stop data collection. Secondly, to examine other psychosocial constructs (e.g., distress, well-being) while controlling for disease severity, it would take more than 4 years and be cost prohibitive to recruit a sample size ( N > 150) that would yield adequate power and effect sizes. For example, in the repeated measures analysis, controlling for disease severity, depression yielded a p 2 = .020, with observed power = .086. Aim 1: Describe HOCM Patients Pre-NSRT The first aim of the study was to describe HOCM patient characteristics, including the rates of psychological distre ss, well-being, and cardiac-specific QOL, preNSRT. Descriptive analyses (i.e., means, one-sample t tests) were used to describe HOCM patients at baseline, examining pre-NSRT HOCM patients on demographic, medical, and psychosocial variables. It was predicted that pre-NSRT HOCM patients would be comparable to other cardiac populations, but worse than the general population on measures of distress (CES-D, STPI), well-being (SWLS, LOT-R) and QOL (LVD-36, MLHFQ, SF-12). To correct familywise error, Bonferroni alpha corrections were applied to the descriptive analyses based on the eight psychosocial variables of interest (CES-D, STPI, SWLS, LOT-R, LVD-36, MLHFQ, PC S-12, MCS-12), yielding significance at alpha = .006 (.05/8). Patient Characteristics Pre-NSRT Descriptive analyses were conducted on the 45 participants ( M age = 54.3, SD = 15.62) who completed questionnaires during th eir evaluation for NSRT or at index

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43 hospitalization at time of NSRT. Patients also received an echocardiogram as part of standard medical evaluation. Participants were predominantly female (59.1%), Caucasian (97.6%), and married (65.9%). Fifty percent reported that they were retired or receiving disability or other financial assistance and 38.1% were working full-time. Majority of the sample reported having spiritual beliefs of a Judeo-Christian religious background (78.9%). Based on self-report, 8.6% reported that they were currently receiving psychotherapy and 17.1% reported currently taking psychotropic medications. Combining antidepressant or anxiolytic prescriptions from their medical record, 36.4% of the sample was taking a psychotropic medication. The percentage of HOCM patients who were receiving some kind of psychiatric treatment (i.e., self -report or medical chart review) was 45.9%. Patients’ biomedical parameters were comparable to the NSRT research (Chang et al., 2004; Ralph-Edwards et al., 2005). Average R-LVOT gradient was 60.36 mm Hg ( SD = 35.74), and average provoked LVOT gradient was 101.12 mm Hg ( SD = 52.57). See Table 2 for complete descriptive data of demographic, medical, and psychosocial variables at pre-NSRT. All variables, except demographic variables, were normally distributed and reflected the full ranges of scores, without ceiling or floor effects. Comparisons for differences between sites There were no significant differences in demographic variables between UF and MUSC participants. There were significant differences between sites on both pre-NSRT resting ( p = .001) and provoked ( p = .002) LVOT gradient, with MUSC scores being worse. However, the differences did not exist at 3-month post-NSRT ( p = .213, and p = .348, respectively). It is assumed that MUSC may have initiated the procedure on sicker patients; but, procedurally, the sites did not differ, evidenced by comparable outcomes.

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44 Table 2.Descriptive statistics on demographic, medical, and psychosocial variables in pre-NSRT HOCM patients Variable n Mean/ % SD MinimumMaximum Demographic variables Age4454.315.621877 Sex (male)4440.9%0.5001 Race420.6215 Caucasian97.6% African-American2.4% Marital status411.1415 Single12.2% Separated/Divorced9.8% Widowed7.3% Married/Remarried65.9% Living with partner4.9% Have children (Yes)4281.0%0.4001 Number of children332.581.4817 Religion381.0604 Not religious/None2.6% Catholic23.7% Protestant52.6% Jewish2.6% Other18.4% Employment status422.1916 Full-time38.1% Homemaker7.1% Unemployed4.8% Disability/ Financial asst.21.4% Retired28.6% Income361.6817 < $14,0002.8% $15,000 – 29,99938.9% $30,000 – 44,99913.9% $45,000 – 59,99913.9% $60,000 – 74,99919.4% $75,000 – 89,9992.8% > $90,0008.3% Medical Variables Heart rate4470.7013.6349110 Normal range:60100 Systolic blood pressure45131.2024.1279200 Normal range:90140

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Table 2. Continued 45 Variable n Mean/ % SD MinimumMaximum Diastolic blood pressure4566.8411.454494 Normal range:5090 Ejection fraction (%)4270.957.055585 Normal range:>55 Ventricular septal thickness4219.216.21736 Normal range:810 Ventricular posterior wall thickness 4213.123.89724 Normal range:79 Resting LVOT gradient4460.3635.740150 Normal range:<30 Provoked LVOT gradient33101.1252.5710210 Normal range:<30 Psychosocial variables Depression4320.5314.01154 Anxiety4357.0519.3431107 Satisfaction with life4221.028.42634 Optimism4114.826.20024 Cardiac-specific QOL (LVD)4359.5027.06094.44 Cardiac-specific QOL (MLHFQ) Median score = 50.00 4349.8629.830104 Physical health (SF-12)2831.478.6819.2953.78 Mental health (SF-12)2845.0012.7224.2366.76 Comparisons for differences between completers and noncompleters Examining participants, at baseline, who completed 3-month post-NSRT vs. those who did not, revealed no significant differen ces in demographic variables. There were also no differences between completers and noncompleters on medical variables. Significant differences were found betw een completers and noncompleters on QOL measures, with completers reporting worse QOL. Differences were seen in MLHFQ scores ( M = 62.70 [ SD = 19.81] vs. M = 32.71 [ SD = 32.74], respectively); higher scores indicate worse QOL ( F [1, 25] = 8.122, p = .009). Differences were also seen in the PCS12 scores, completers ( M = 28.07 [ SD = 5.02]) vs. noncompleters ( M = 35.05 [ SD =

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46 10.24]), with lower scores indicating worse QOL ( F [1, 25] = 4.923, p = .036). However, after Bonferroni alpha correction ( = .006) was taken into account, neither of these differences maintained significance. Normative Comparisons Pre-NSRT Examining HOCM patients at evaluation for NSRT, patients reported significant psychological distress, and poor QOL. Comparisons were made between the current HOCM sample pre-NSRT and other populations with previously published norms. It was predicted that scores would be comparable to other cardiac populations but worse than the general population. Psychosocial normative comparisons Depression scores were comparable to other cardiac populations. Notably, more than half the HOCM sample expressed, at minimum, mild levels of depression ( M CESD = 20.53, SD = 14.01). This sample was not statistically different from CHF patients ( M CES-D = 16.9, SD = 11.9) (Koenig, 1998) ( t score [42] = 1.701, p = .096). But scores were significantly worse compared to a sample of patients with other types of heart disease ( M CES-D = 12.2, SD = 11.9) ( t score [42] = 3.901, p < .001), and from other medical diseases ( M CES-D = 15.8, SD = 12.2) ( t score [42] = 2.216, p = .034) (Koenig, 1998). While ratings of depression may be similar to other cardiac populations, the point prevalence rate of depression in this sample of HOCM patients appears to be higher than other cardiac populations. Based on the three-group severity classification system (Table 3), 44.2% of pre-NSRT HOCM patients reported mild (subclinical) symptoms of depression, 20.9% reported moderate symptoms, and 34.9% reported severe symptoms of depression. Among patients pre-CABG, Blum enthal and colleagues’ (2003) found 26%

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47 scored moderate symptoms and 12% scored severe symptoms; thus, prevalence rates for meeting criteria for depression were 55.8% (HOCM) vs. 38% (CABG). Of the 55.8% of HOCM patients reporting clinically significant depression (CES-D score > 16), 47.6% were receiving some sort of psychiatri c care (i.e., psychotherapy or psychotropic medication). Normative comparisons for other psychosocial constructs that could be made with this sample were with the SWLS and the LOT-R. These pre-NSRT HOCM patients reported significantly less satisfaction with life compared to a general elderly population referenced in the scale’s validation analyses ( M = 21.02 vs. M = 25.8) ( t score [41] = 3.675, p = .001). Regarding optimism scores, there were not significant differences between these HOCM patients compared to patients awaiting CABG surgery ( M = 14.83 vs. M = 15.16) ( t score [40] = -.341, p = .735) or to college students ( M = 14.33) ( t score [40] = .515, p = .609). Table 3.CES-D depression severity cutoff scores and HOCM prevalence rates CES-D scoreDepression severity HOCM prevalence rates pre-NSRT HOCM prevalence rates post-NSRT 0 – 15Mild/subclinical symptoms44.2%65.0% 16 – 26Moderate symptoms20.9%25.0% > 26Severe symptoms34.9%10.0% Note Blumenthal et al., 2003; Zich, Attkinsson, & Greenfield, 1990 Quality of life normative comparisons Results of comparisons depended on normative data and measure used. QOL scores were commensurate to other cardiac populations with NYHA class III heart failure (Rector et al., 1987). However, when compared to a population with chronic left ventricular dysfunction (validation sample of the LVD-36), the current sample of preNSRT HOCM patients reported significantly worse cardiac-specific QOL on both the LVD-36 and the MLHFQ (O’Leary & Jones, 2000). On both the LVD-36 and the

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48 MLHFQ, lower scores indicate better QOL. HOCM patients scored a M LVD-36 = 59.50 ( SD = 27.06) compared to a normative sample M = 39.0 ( SD = 28.9) ( t score [42] = 4.968, p < .001). Using the MLHFQ, HOCM patients’ M = 49.86 ( SD = 29.83) compared to the same normative sample for the LVD-36, M MLHFQ = 29.7 ( SD = 22.7) ( t score [42] = 4.432, p < .001). While the cardiac-specific QOL scales did not indicate differences with CHF patients, the SF-12, measuring generic QOL di d capture significant differences between the current HOCM sample and a CHF population on physical health (PCS-12) ( M = 31.47 vs. M = 40.02) ( t score [27] = -5.217, p < .001) and on mental health (MCS-12) ( M = 45.00 vs. M = 51.12) ( t score [27] = -2.548, p = .017). HOCM SF-12 scores were also significantly worse than scores from a population of minor medical conditions for both PCS-12 and MCS-12 ( p < .001) (Ware et al., 1995). Collectively, these results indicate that QOL in these pre-NSRT HOCM patients is worse than the general population and worse than other cardiac populations. Relationships pre-NSRT Zero-order correlations with pre-NSRT data were examined to evaluate relationships of interest. Seen in Table 4, age, sex, and R-LVOT gradient were not significantly related to any of the psychological distress, well-being, or QOL variables, except for the relationship between sex and the MLHFQ ( p < .05). Depression was highly correlated with all the psychological and QOL variables, and exceeded the collinearity cutoff of r = .70 (Kleinbaum, Kupper, Muller, & Nizam, 1998) in its relationship with the STPI ( r = .856) and all QOL scales: LVD-36 ( r = .746), MLHFQ ( r = .762), and the PCS12 ( r = -.779). All depression and QOL correlations indicated inverse relationships, such that as depression increased, QOL decreased. However, in this sample, depression and QOL were seemingly too highly related or confounded at pre-NSRT. The measures used

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49Table 4.Zero-order correlations of relevant pre-NSRT variables Variable234567891011 1Age.166.043.014-.137.213.180-.031-.115-.093.211 2Sex.297.142.034.043-.057.213.319*-.146.242 3R-LVOT gradient.171.098.107.066.201.264-.218.031 4Depression.856**-.489**-.519**.746**.762**-.287-.779** 5Anxiety-.593**-.585**.597**.600**-.130-.750** 6Life satisfaction.710**-.433**-.246.088.496** 7Optimism-.338-.197.019.451* 8Cardiac-specific QOL (LVD-36).727**-.586**-.700** 9Cardiac-specific QOL (MLHFQ)-.424**-.643** 10Mental health (SF-12) -.002 11Physical health (SF-12) --Note. p < .05; ** p < .001. Sample size for all correlations ranged 41-43, except correlations with SF-12, n = 28.

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50 to assess these constructs appear to be tapping into shared components of the indices, and thus, may not be independent or unique when evaluated at the same point in time in this study. In addition to showing problematic collinear relationships, the correlation analyses also demonstrated good convergent validity between measures. Satisfaction with life and optimism were collinear ( r = .710), but also demonstrated convergent validity between the two well-being measures. The QOL measures also demonstrated good convergent validity. For example, the LVD-36 and MLHFQ ( r = .727) were highly related, as were the LVD-36 and the PCS-12 ( r = -.700), and the MLHFQ and the PCS12 ( r = -.643). Aim 2: Change PrePost-NSRT The second aim of the study was to determine if there were changes in psychological distress (CES-D, STPI), wellbeing (SWLS, LOT-R), and cardiac-specific QOL (LVD-36, MLHFQ) in HOCM patients across time, from preto post-NSRT. First, descriptive analyses (e.g., means, one-sample t tests) were conducted to compare 3month post-NSRT HOCM patients to other cardiac populations as well as the general population ( = .006). This was performed so that both (a) change and (b) how post-NSRT patients compared to cardiac and general populations were evaluated over time. Repeated measure analyses of variance (RM-ANOVA) were conducted to evaluate change from preto 3-month post-NSRT. Patient Characteristics at 3-Months Post-NSRT Of the 45 participants pre-NSRT, there were 20 participants (44.4%) who completed 3-month post-NSRT data (UF, n = 9; MUSC, n = 11). The average follow-up time was 3.55 months ( SD = .880), congruent with the design of the study, corresponding to standard clinical care. Participants ( n = 25) were lost to follow-up because they did not

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51 return to the clinic for their standard cardiology clinic follow-up appointment, and therefore did not receive and complete the packet of questionnaires nor did they have an echocardiogram taken. As seen by the completers vs. noncompleters analysis, those who completed 3-month post-NSRT data reported worse QOL at baseline. It is unknown if completers would still report worse QOL 3-months post compared to noncompleters, because data was not collected. It is presumed that the noncompleters did not attend their follow-up appointment because their health status had improved dramatically, and therefore, felt no need to see the cardiologist. See Table 5 for prevalence of past and current history of psychiatric treatment at baseline and post-NSRT. Table 5.Summary of psychiatric history of patients preand 3-months post-NSRT Pre-NSRT 3-month postNSRT Variable (no/yes) n % n % Past psychotherapy (SR)3411.8%1816.7% Past psychotropic medications (SR)3327.3%186.3% Current psychotherapy (SR)358.6%185.6% Current psychotropic medications (SR)3517.1%1822.2% Antidepressant prescription (CR)4427.3%2030.0% Anxiolytic prescription (CR)4415.9%2025.0% Total currently treated (SR)3517.1%1822.2% Total with prescription (CR)a4436.4%2035.4% Overall treatment (SR or CR)3745.9%1855.6% CES-D > 16, overall treatment (SR or CR)2145.7%757.1% Notes .SR = Self-Report, CR = Chart Review. There were no significant changes over time ( p values ranged .082 – 1.000). a Prescription includes only antidepressant or anxiolytic medication. Normative Comparisons Post-NSRT Normative comparisons of psychosocial status at 3-months post-NSRT, along with pre-NSRT findings are seen in Table 6. Notable findings were that scores had significantly changed over time, such that at pre-NSRT, HOCM patients reported worse scores (e.g., more depression, lower life satisfaction, poorer QOL) on a majority of the

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52Table 6.Normative comparisons (t tests) with pre-NSRT and 3-month post-NSRT scores Measure Norm M Comparison population Pre-NSRT HOCM Mp Post-NSRT HOCM Mp CES-D16.9CHF20.53.09614.1.277 12.2Other heart diseases20.53< .00114.1.457 15.8Other medical diseases20.53.03214.1.505 SWLS25.8Elderly21.02.00121.4.030 LOT-R15.16Awaiting CABG 14.83.73516.3.411 14.33College students14.83.60916.3.163 LVD-3639.0Chronic left ventricular dysfunction59.50< .00135.83.622 MLHFQ29.7Chronic left ventricular dysfunction49.86< .00130.1.943 PCS-1240.02 47.10 CHF Minor medical conditions 31.47 31.47 < .001 < .001 38.03 38.03 .540 .012 MCS-1251.12 53.62 CHF Minor medical conditions 45.00 45.00 .017 .001 47.61 47.61 .325 .102

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53 measures than the normative samples (i.e., both cardiac populations and the general population), and later, post-NSRT, HOCM patients report comparable scores to the normative samples. Similarly to depression findings pre-NSRT, scores of depression post-NSRT were not significantly differe nt from normative samples; however, prevalence rate of depression (CES-D scores > 16) continued to be noteworthy (35%). Thus, while these patients reported dramatic improvements, three-months post-NSRT, they were still comparable to other sick cardiac populations. Three-month post-NSRT, the only significant findings when compar ing HOCM to other populations were in satisfaction with life ( p = .030) and the PCS-12 ( p = .012). Thus, HOCM patients, postNSRT, reported worse life satisfaction compared to an elderly population. They also reported worse QOL compared to a population of minor medical conditions; however, they report equivalent scores to a CHF population. After Bonferroni correction ( = .006, based on the 8 measures for normative comparisons), these significant differences disappear. Repeated Measures Results It was predicted that HOCM patients would rate improvements on post-NSRT scores of distress, well-being, and cardiac-sp ecific QOL compared to their ratings preNSRT. Several significant time effects were found from pre-NSRT to 3-month postNSRT (See Table 7 for means and standard deviations across time). Bonferroni alpha corrections were applied to the repeated measures analyses based on the six psychosocial variables of interest (CES-D, STPI, SWLS, LOT-R, LVD-36, MLHFQ), yielding significance at alpha = .008 (.05/6).

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54 Table 7.Mean scores across time from preto 3-month post-NSRT ( n = 20) Pre-NSRT 3-month postNSRT VariableMean SD Mean SD R-LVOT gradient**59.2641.4520.7923.7 P-LVOT gradient**100.2156.3130.7128.09 Depression**23.9514.8114.3711.44 Anxiety*62.2121.9354.9516.94 Life satisfaction21.688.8321.638.53 Optimism15.615.9616.676.07 Cardiac-specific QOL (LVD-36)*67.1123.7234.8028.63 Cardiac-specific QOL (MLHFQ)*58.1625.0330.3225.38 Note p < .05; ** p < .01. Biomedical variables As expected, the medical outcome of both resting and provoked LVOT gradient decreased dramatically and demonstrated a large effect size (Cohen’s d adjusted with Hedges’ g = 1.12 and 1.52, respectively). R-LVOT gradient improved from M = 59.26 ( SD = 41.45) to M = 20.79 ( SD = 23.70) ( p < .001, n = 19). Provoked gradient improved from M = 100.21 ( SD = 56.31) to M = 30.71 ( SD = 28.09) ( p < .001, n = 14). Calculating power from differences in preto post-NS RT, R-LVOT gradient yielded power of .92, and provoked LVOT gradient yielded power of .99. Psychosocial variables Among the psychosocial variables, there were significant time effects for depression (Pillai’s Trace F [1, 18] = 10.226, p = .005) and anxiety (Pillai’s Trace F [1,18] = 5.251, p = .034). Depression demonstrated a strong medium effect size (Cohen’s d adjusted with Hedges’ g = .71) and power = .58. Anxiety demonstrated a small but strong effect size (Cohen’s d adjusted with Hedges’ g = .36). After Bonferroni corrections, the time effect for anxiety was no longer significant. There were no significant time effects for the constructs of satisfaction with life, and optimism.

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55 Quality of life variables Similarly to medical outcome, cardiac-specific QOL demonstrated highly significant improvements from pre-NSRT to 3-month post-NSRT, as well as very large effect sizes. Examining scores on the LVD-36, Cohen’s d adjusted with Hedges’ g = 1.20 (Pillai’s Trace F [1,18] = 34.468, p < .001). Power for the LVD-36 was .96. Additionally, examining scores on the MLHFQ, Cohen’s d adjusted with Hedges’ g = 1.08 (Pillai’s Trace F [1,18] = 25.05, p < .001), and power was .85. Repeated Measures Results: Controlling for Disease Severity Repeated measures analyses of covariance (RM-ANCOVA) were conducted using pre-NSRT R-LVOT gradient as a covariat e, to control for disease severity. It was predicted that HOCM patients would report improvements across time on scores of distress, well-being, and cardiac-specific QOL and would maintain significance, even after controlling for disease severity at baseline. Psychosocial variables There was no significant change in depression after controlling for disease severity, contrary to the hypothesis. However, the analysis revealed a negligible effect size indicated by p 2 = .020 and poor observed power (.086). There was a significant depression by covariate (pre-NSRT R-LVOT gradient) interaction effect (Pillai’s Trace F [1,17] = 7.613, p = .013, p 2 = .31, observed power = .74), indicating that change in depression was dependent on disease severity at baseline. There were no significant effects for anxiety (main effect p = .809, p 2 = .004; interaction effect p = .124, p 2 = .133). Similar to previous RM-ANOVAs, the a ddition of the covariate did not yield significant results with satisfaction with life and optimism.

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56 Quality of life variables Similar to the findings for depression, examining cardiac-specific QOL revealed no significant main effects of time. Both cardiac-specific QOL measures significantly interacted with the covariate. Scores on the LVD-36 significantly varied by pre-NSRT RLVOT gradient (Pillai’s Trace F [1,17] = 7.668, p = .013, p 2 = .311, observed power = .742). In addition, scores on the MLHFQ significantly varied by gradient (Pillai’s Trace F [1,17] = 25.719, p < .001, p 2 = .602, observed power = .998). Thus, change in cardiacspecific QOL was dependent on disease severity at baseline, and therefore, the hypothesis was not supported. After Bonferroni alpha co rrections were made, the only significant time effect with gradient as the covariat e was cardiac-specific QOL using the MLHFQ. Aim 3: Prediction Model To determine whether psychological distress and well-being pre-NSRT predicted 3-month post-NSRT cardiac specific QOL two hierarchical multiple regression analyses were conducted with the LVD-36 and MLHFQ at 3-month follow-up as the dependent variables. Disease severity (R-LVOT gradient) was entered on the first step. Depression (CES-D) was entered on the second step and satisfaction with life (SWLS) was entered on the third step. It was predicted that after controlling for pre-NSRT disease severity, patient’s baseline level of clinical distress and well-being would uniquely predict postNSRT cardiac-specific QOL. Initially, it was planned that both the CES-D and the STPI would be used to measure distress and SWLS and LOT-R woul d be used to measure well-being. After examining the zero-order correlations at baseline, both the STPI and LOT-R were eliminated from the hierarchical regression analyses because of their collinearity with CES-D and SWLS, respectively. The CES-D and SWLS were retained in the analyses

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57 because, in the current sample, they demonstrated not only good but also stronger reliability (Cronbach’s = .87 and .91, respectively) than the STPI (Cronbach’s = .77) and the LOT-R (Cronbach’s = .26) (Pedhazur, 1997). Results for the LVD-36 With the LVD-36 as the dependent variable, gradient, distress, or well-being factors did not significantly account for unique change in variance. However, the full model significantly predicted cardiac-specific QOL using the LVD-36 ( F [3,15] = 3.333, p = .048), without taking into account the Bonferroni alpha corrections ( p = .008). The full model explained 40.0% (Adjusted R2 = .280) of the variance in the LVD-36. Unique significant predictors of the LVD-36 were R-LVOT gradient ( = -.612, t = -2.601, p = .020) and depression ( = .695, t = 2.387, p = .031), indicating that higher gradient (more severe disease) and less depression pre-NSRT predicted better cardiac-specific QOL (lower scores indicate better QOL) at 3-month post-NSRT. However, these results were nonsignificant after Bonferroni correction. See Table 8 for summary of regression analysis. Table 8.Summary of hierarchical multiple regression analysis for predictors of CS-QOL using the LVD-36 bSE btp Step One R-LVOT gradient-.311.169-.409-1.846.082 Step Two R-LVOT gradient-.326.158-.428-2.061.056 Depression.736.402.3811.832.086 Step Three R-LVOT gradient-.466.179-.612-2.601.020 Depression1.343.563.6952.387.031 Life satisfaction1.5041.011.4641.488.157 Notes .Step one: R2 = .167, Adjusted R2 = .118, F (1, 17) = 3.408, p = .082. Step two: R2 change = .144, F change (1, 16) = 3.356, p = .086. Step three: R2 change = .152, F change (1, 15) = 2.214, p = .157. Total R2 = .400, Adjusted R2 = .280, F (3, 15) = 3.333, p = .048.

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58 Results for the MLHFQ Results were similar using scores on the MLHFQ as the dependent variable. RLVOT was significantly related to the MLHFQ, accounting for 22.1% (Adjusted R2 = .175) of the variance ( F [1, 17] = 4.827, p = .042). Entering depression into the model did not explain uniquely significant variance, but the overall model including R-LVOT gradient and CES-D was significant ( F [2, 16] = 4.070, p = .037). Satisfaction with life was not a significant addition to the model predicting MLHFQ. The full model was not significant ( F [3, 15] = 2.960, p = .066), explaining 37.2% (Adjusted R2 = .246) of the variance in the MLHFQ, but R-LVOT gradient at baseline was demonstrated as the only unique significant predictor of cardiac-specific QOL using the MLHFQ ( = -.603, t = -2.504, p = .024), suggesting that higher gradient (more severe disease) was associated with better cardiac-specific QOL post-NSRT (lower scores indicate better QOL) using the MLHFQ. See Table 9 for summary of multiple regression analysis. Taken together, these two analyses do not support the hypothesis. Baseline distress and well-being did not predict cardiac-sp ecific QOL at 3-months post-NSRT. Table 9.Summary of hierarchical multiple regression analysis for predictors of cardiac-specific QOL using the MLHFQ bSE btp Step one R-LVOT gradient-.317.144-.470-2.197.042 Step Two R-LVOT gradient-.329.138-.488-2.393.029 Depression.584.349.3411.674.114 Step three R-LVOT gradient-.407.163-.603-2.504.024 Depression.921.510.5381.806.091 Life satisfaction.834.917.290.910.377 Notes .Step one: R2 = .221, Adjusted R2 = .175, F (1, 17) = 4.827, p = .042. Step two: R2 change = .116, F change (1, 16) = 2.801, p = .114. Step three: R2 change = .035, F change (1, 15) = .829, p = .377. Total R2 = .372, Adjusted R2 = .246, F (3, 15) = 2.960, p = .066.

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59 Exploring the Relationship between Depression and Quality of Life Depression and QOL (both generic and cardiac-specific) were highly confounded in this study and demonstrated collinearity at pre-NSRT and at 3-months post-NSRT ( r > .70). However, across time these variables were not related to each other in either direction. In other words, depression at preNSRT was not significantly related to QOL at 3-months post-NSRT. Two out of three QOL measures (MLHFQ, PCS-12) at pre-NSRT were not significantly related to the CES-D at 3-months post-NSRT, but the LVD-36 preNSRT ( r = .545, p = .016) was significantly related to CES-D post NSRT. Depression Components Due to the confounded relationships between depression and QOL, the CES-D was divided into previously published factors to determine if there was a specific factor driving the relationship. Four factors were calculated: depressed affect (7 items), somatic activity (7 items), interpersonal problems (2 items), and positive affect (4 items) (Dikmen et al., 2004). Item 9, “I thought my life had been a failure” is an example of a depressed affect scale item. Item 7, “I felt that everything I did was an effort” is an example of a somatic activity scale item. Along with the CES-D factors, the MLHFQ physical dimension and emotional dimension were examined (Rector et al., 1987). Depressed affect of the CES-D and emotional scale of the MLHFQ were collinear preand postNSRT, as were somatic activity of the CES-D and the physical dimension of the MLHFQ were. An important relationship that evolved from these analyses was the significant, but non-collinear relationship between the CES-D depressed affect scale and the MLHFQ physical dimension at both pre-NSRT ( r = .590, p = < .001) and post-NSRT ( r = .654, p = .002). This relationship was not significant over time, in either direction. An

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60 additional notable finding was the significant, but non-collinear relationship between the CES-D depressed affect scale and the LVD-36 pre-NSRT ( r = .664, p < .001), suggesting that separating out “depressed affect” may be the most applicable for measuring depression in this sample, especially in relation to cardiac-specific QOL. See Table 10 for correlations between subscales of the CES-D and the QOL measures pre-NSRT. Along with attempts to separate out important components of depression and QOL, prevalence of depression was examined more closely. Prevalence of clinical depression (CES-D > 16) pre-NSRT was remarkably high, with overall prevalence rates reducing over time (55.8% to 35%), as did CES-D scores. Notably, despite the improvements over time, of those who reported significant levels of depression at baseline, 58.4% continued to report clinically significant depression. New Prediction Model Despite the significant relationships between depression and QOL, the hypothesized model did not capture their relationship. Changing the direction of the hypothesized model, depression at 3-month post-NSRT was significantly predicted by cardiac-specific QOL at baseline in a two-step hierarchical multiple regression analysis, performed post-hoc. The LVD-36 was used as the measure for cardiac-specific QOL because throughout the analyses of the study, it appeared to be a cleaner and more valid measure compared to the MLHFQ. Age and R-LVOT gradient at baseline were entered in step one, significantly explaining 37.7% (Adjusted R2 = .299) of the variance in the LVD-36 ( F [2, 16] = 4.848, p = .023), with worse disease severity pre-NSRT was associated with less depression at 3-months post-NSRT. The LVD-36 was entered on the second step and explained significant unique variance (32.5%) in 3-months post-NSRT

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61Table 10.Zero-order correlations between depression subscales and QOL measures pre-NSRT Variable234567891011 1CES-D total.969**.912**.645**-.660**.762**.646**.821**.746**-.287-.779** 2CES-D depressed affect.865**.619**-.571**.737**.590**.813**.664**-.229-.752** 3CES-D somatic activity-.411**.873**.780**.880**.784**-.458*-.720** 4CES-D interpersonal problems-.460**.318*.267.456**.363*-.033-.455* 5CES-D positive affect-.269-.318*-.378*-.505**.049.563** 6MLHFQ total.948**.924**.727**-.424*-.643** 7MLHFQ physical .800**.808**-.703**-.522** 8MLHFQ emotional .766**-.409*-.714** 9LVD total -.586**-.700** 10SF-12 physical health -.002 11SF-12 mental health ---

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62 depression scores. The full model significantly predicted depression at 3-months postNSRT, accounting for a total of 83.8% (Adjusted R2 = .702) in depression scores ( F [3, 15] = 11.772, p < .001). Worse disease severity ( = -.598, t = -4.221, p = .001) and better cardiac-specific QOL (lower scores indicate better QOL) ( = .573, t = 4.041, p = .001) pre-NSRT predicted less depression at 3-months post-NSRT. This post-hoc analysis seems to explain the relationship between depression and cardiac-specific QOL better than the previous hypothesized model.

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63 CHAPTER 5 DISCUSSION This study is the first comprehensive outcome study examining the relationships between psychological distress, well-be ing, and biomedical outcomes among HOCM patients. Further, while many have examined NSRT from a biomedical perspective, evaluating symptoms, outcome, and precision of the procedure in short and long-term studies (Firoozi et al., 2002; Lakkis et al., 2000; Nielsen et al., 2002; Nielsen & Spencer, 2002), this is the first evaluation of NSRT from the patient’s perspective and how psychosocial parameters change over time. There were three main overall findings. First, there was a high prevalence of clinical levels of depression in these pre-NSRT HOCM patients. Second, HOCM patients’ disease se verity, depression, and QOL improved over time and that disease severity at baseline was the primary determinant of change amongst the psychosocial variables. Thirdly, in the hypothesized prediction model, psychosocial variables tested here did not significantly impact health outcomes. Patient Pre-NSRT Characteristics Examining HOCM patients’ characteristics pre-NSRT, scores demonstrated that this group of patients is similar to other cardiac populations with NYHA class III or IV symptoms in demographic characteristics and in quality of life measures. Most notable in this study was the prevalence rate of depression appears to be higher than other heart disease groups, exemplifying the need for psychological attention in this group. Depression scores were comparable to other cardiac populations, but the proportion of

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64 patients reporting significant depression wa s higher than in other cardiac populations reported in the literature (Blumenthal et al., 2003). Patients in this study often suffered from cardiac symptoms and functional impair ments of significant duration before proper diagnosis and before presenting to the HOCM clinic for NSRT evaluation. NSRT has typically been the last line of defense in treating HOCM and patients are generally managed with medications prior to considering this procedure. Continuing to be symptomatic, patients present for NSRT evaluation, expressing frustration with symptoms (e.g., shortness of breath, fatigue, chest pain), medical treatment, and functional limitations (e.g., unable to walk a flight of stairs, care for children). Related to symptoms of depression that were expressed, patients’ noted poor satisfaction with life, which was significantly related to not only depression, but also QOL. This study included three separate measures of QOL, two cardiac specific, and one generic measure. All three demonstrated strong convergent validity amongst each other and indicated poor QOL in this sample of HOCM patients. Depending on comparison group and type of measure used, these HOCM patients reported comparable cardiac-specific QOL in some studies incl uding those with NYHA class III or IV heart failure patients (Rector et al., 1987). Yet, compared to other cardiac populations (e.g., chronic left ventricular dysfunction), me dical populations, and the general population, cardiac-specific QOL was worse in this sample of HOCM (Koenig, 1998; O’Leary & Jones, 2000). Using a generic measure of QOL (SF-12), this sample of HOCM patients reported worse QOL than CHF patients and other medical conditions, and therefore, was also worse than Cox and colleagues’ (1997) sample whose scores were akin to CHF patients. Cox and colleagues’ (1997) patient sample was comprised of HCM patients with or without obstruction; therefore, it is probable that the current sample was

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65 comprised of patients with more severe disease, and subsequently reported more/worse symptoms and more limitations. Depression and Quality of Life When examined cross-sectionally, depression and QOL were highly significantly related to each other both at baseline and at 3-month post-NSRT. Their relationship was so strong, that they could be considered collinear, measuring almost identical information when measured simultaneously. Findings suggest that depressive symptoms may be the main component of QOL in this sample of HOCM patients, rather than one of several components that comprise QOL, and therefore, they are highly confounded. When the CES-D was divided into four factors from previous research, collinear relationships between the four factors and QOL still existed in many of the correlations. The key relationship that was highlighted in these analyses was the relationships between the CES-D depressed affect scale, MLHFQ physi cal dimension scale, and the LVD-36 scale. Separating out depressed affect from ot her components of depression allowed the relationship to be significant while maintaining uniqueness, suggesting greater validity for measuring depression in this sample. This was also seen when separating the physical and emotional components of QOL. It is well known that depression and illness are often comorbid, and that depression includes somatic symptoms that can be misinterpreted as medical symptoms and vice versa. The findings with the subscales of the CES-D (particularly the depressed affect and somatic activity scales) support the intermingled relationship. The confounded relationship is difficult not only in terms of research measurement, but also in terms of clinical diagnosis and treatment. Patients a nd medical providers may misinterpret their depressive symptoms as cardiac symptoms or the opposite way around. This may result

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66 in either under or over reporting of cardiac symptoms and likewise with depressive symptoms, and subsequently patients may be misdiagnosed or mistreated, undermining outcome or treatment response. Patient Characteristic Conclusions Overall, the reported levels of depression, poor satisfaction with life, and QOL were worse than other cardiac and the general populations. Therefore, patients’ experience of physical and emotional symptoms was worse than hypothesized, highlighting the need for routine psychological assessment and intervention. Attention to the patients’ experience of disease and its impact can play a critical role in medical and psychological treatment of the patient and its outcome. A key treatment element for these patients is focus on enhancing QOL pre-NSRT, which may then subsequently reduce depression. Psychosocial treatments that are developed from a cognitive-behavioral approach can help patients cope with current symptoms, prepare for NSRT, and may also help with recovery. Changing perceptions (i.e., cognitive restructuring) of symptoms, disease, treatment would likely enhance QOL and decrease depression. Areas that cognitive-behavioral therapy can target are patients’ fear and worry of the procedure that involves creating a controlled heart attack. Another target area for therapy is expectations of the procedure, making sure they are realistic and that the patient is prepared for symptom reduction that may not meet expectations. Efficacy of Nonsurgical Septal Reduction Therapy Based on the repeated measures analyses, it appears that NSRT is an effective medical procedure in not only reducing LVOT gradient, consistent with the literature (Lakkis et al., 2000; Nielsen et al., 2002; Ralph-Edwards et al., 2005), but also in reducing levels of depression, anxiety, a nd improving cardiac-specific QOL in patients

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67 with HOCM. The latter findings are much needed additions to the current literature. It appears that even without a change in psychiatric treatment (i.e., psychotherapy, psychotropic medications), depression and QOL improved from preto post-NSRT. This suggests that favorable improvement in HOCM symptoms is associated with improvement in depressive symptoms and overall QOL or that they are highly confounded. While depression and QOL improved greatly over time, scores 3-month postNSRT were still only comparable to other cardiac populations, rather than reporting as good or as healthy as the general population. These patients were a highly select, highly symptomatic sample of cardiac disease. Therefore, while they made dramatic improvements, statistically and clinically, they are moving from outlier status to closer to the mean of the greater heart disease distribution. Importantly, while depression scores decreased from preto post-NSRT, prevalence rate was still considerable. Further, those who reported clinically significant depression pre-NSRT, a majority of them continued to report elevated levels of depression 3-months post-NSRT. Therefore, it is critical to recognize and treat these patients for depression beyond the NSRT procedure. Similar patterns of change emerged with the addition of baseline R-LVOT gradient as a covariate. There were improvements in depression and cardiac-specific QOL from pre-NSRT to 3-month post-NSRT, but they were dictated by disease severity pre-NSRT linearly. The findings are interesting by themselves; however, it was hypothesized that significant change in psychosocial and QOL variables would occur even after controlling for disease severity. Thus, the findings did not support the hypothesis. This relationship between disease severity, QOL and depression is also seen in previous studies (Ford et al., 1998; Ru msfeld et al., 2003; Vaccarino et al., 2001).

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68 Increasing disease severity, impacts physical, social, emotional functioning, which can also be associated with depression and epitomizes the biopsychosocial model of health and wellness. Change across time, contingent on disease severity was shown, and the next step was to determine a model of prediction, or direction of these relationships. Thus, the biopsychosocial model was tested to examine direction over time. Biopsychosocial Model and Prediction Literature has shown that patients who are more distressed report greater physical symptoms and/or disease and worse QOL (C arels, 2004; Duits et al., 1997; Rector, 2005; Zvolensky et al., 2003). It was predicted th at pre-NSRT psychological distress and wellbeing would be related to post-NSRT cardi ac-specific QOL. This was not found in the current study. Using the LVD-36 as the m easure for cardiac-specific QOL, depression pre-NSRT was associated with LVD-36 scores at 3-months post-NSRT. But the results with the MLHFQ indicated that baseline psychosocial characteristics did not predict cardiac-specific QOL 3-months following NS RT procedure. Further evaluating the hypothesis with the subscales of the CES-D and the MLHFQ also did not lead to a significant prediction model. In the present analyses, pre-NSRT reported psychological health did not predict future patient-reported symptom experience (cardiac-specific QOL). While the model was theoretically sound, it was not statistically significant. This could be due to several reasons. It may be that in this sample, the relationships exist and were not able to be captured due to sample size. Had the study only used the LVD-36 to measure cardiac-specific QOL, the data woul d have supported the hypothesis; however, two measures were used to increase sensitivity of cardiac-specific QOL and to compare validity amongst the two. It also may be that the relationships exist, but in the opposite

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69 direction. Seen in the post-hoc analyses, cardiac-specific QOL pre-NSRT was associated with future psychological distress and well-bei ng. It is highly probable that clinically the relationship is bi-directional, but cannot be seen statistically in this sample. Extending the Findings The mechanism yielding a change in depression needs to be considered. Over time, from preto post-NSRT, disease severity, depression, and QOL improve. Among pre-NSRT variables, R-LVOT gradient was not significantly related to either depression or QOL at baseline. Yet, according to the findings, it appears that disease severity has a strong impact on these two constructs over time. In fact, pre-NSRT R-LVOT gradient was inversely related to depression and QOL at 3-months follow-up. There are several possible reasons for the improvements in depression and QOL, as well as the inverse relationship between baseline disease severity and the patients’ reported experience over time. It may be that patients who start out with worse disease severity have more room for improvement over time. Their condition may have been so severe and disruptive that any reduction in symptoms is perceived as an improvement, and subsequently QOL and depression improved as well. Patients experiencing a reduction in symptoms are able to engage in more activities, have less limitations or impairments, and enjoy their life more fully, at least relative to before NSRT. Another plausible explanation is that patients accept their condition and symptoms over time, and therefore, were less negatively impacted as they continue to live their lives. Finally, applying cognitive dissonance theory (Festinger, 1957), patients experiencing severe disease pre-NSRT, and then choosing to undergo a relatively new and controversial procedure will perceive their post-NSRT health status favorably so that it is congruent with all that they have suffered through (i.e., disease severity, procedure). All these

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70 mechanisms would likely lead to improved depression and QOL. Furthermore, the relationship between symptoms and depression may be moderated by QOL and/or cognitive appraisals. The model of QOL moderating the relationship between symptoms and future depression was seen in the post-hoc multiple regression analysis, and it appeared to fit the relationship better than the hypothesized model. Baseline disease severity and cardiac-specific QOL predicted depression at 3-months post-NSRT, which is still consistent with current literature among medical illness populations, including CHF (Rumsfeld et al., 2003). Based on this last analysis, it appears that HOCM patients who are doing poorly pre-NSRT have more opportunity for improvement, and thus, when symptoms improve drastically, they report improved mood 3-months post-NSRT. Thus, intervening with psychosocial treatment targeted at improving cardiac-specific QOL preNSRT may improve later depression after NSRT. Limitations While this study is groundbreaking in the HOCM and NSRT literature, there are also areas for improvement in design, acquisition of data, and in statistical analyses. This study was simple in its quasi-experimental design and limited in scope of size and follow-up durations, which limits study conclusions. As with any longitudinal study, attrition can be a problem, and was the most significant limitation to the study. This study had a 55.6% attrition rate, mostly due to patients not returning to their cardiology clinic follow-up appointment. Because of the high attrition rate, the sample size was smaller than anticipated, and therefore, constrained planned statistical analyses. Future studies should consider design revisions. For example, mailing questionnaire packets to participants or having questionnaires on a secure Internet website may resolve some

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71 attrition issues, at least in terms of psychosocial data. Another solution would be to add additional centers for participant recruitment. In terms of statistical analyses, sample size was determined, during study development, based on medical variables (i.e., R-LVOT gradient) and QOL as a guideline for power analyses. Examining the current data, analyses with these variables, with the current sample size, have large effect sizes and more than sufficient power to detect true change. In contrast, examining psychosocial constructs (e.g., depression, anxiety, optimism), the current sample size did not allow for adequate power to detect change and indicated that the study would need hundreds of more participants (i.e., N > 150) to reach an adequate power of .80. Critical variables were confounded in this study, and variables that may contribute information to this population and treatment were not included because of the project’s simplicity. Lastly, it is believed that this sample is representative of HOCM patients undergoing NSRT because patients were recruited from two independent institutions. However, the sample may not be representative of all HOCM patients, or HOCM patients choosing other treatment options. All patients in this study were severely ill and symptomatic, seeking out a relatively new treatment done by a few interventionalists. More research is needed in this area, with larger sample sizes and with patients utilizing different treatments and with a range of disease severity. Clinical and Research Implications This study has positive implications for the fields of cardiac psychology and interventional cardiology. The study provide d a well-rounded description of HOCM patients, medically, symptomatically, and psychologically, incorporating both objective and subjective indices. These findings can be used in development and implementation of

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72 psychosocial treatments, particularly those based in a cognitive-behavioral framework. HOCM patients present to the cardiology clinics with cardiac and psychologic symptoms that are difficult to distinguish and would lik ely be better addressed by the inclusion of a health psychologist as part of the treatment team. Collectively, findings indicate the need for multidisciplinary care of HOCM patients, regardless of NSRT as a treatment choice. The prevalence rate of depression, along with a majority of those whose depression did not improve, was a compelling finding, one that needs utmost attention. Knowing that these patients pre-NSRT may be at particularly high risk for depression and its maintenance, members of the medical team can be trained to discern symptoms of depression from cardiac symptoms and then request appropriate consult from and referral to a health psychologist. A key treatment element for these patients is focus on both cognitive and behavioral techniques, enhanc ing QOL and cognitive appraisals, both preand post-NSRT, which may then subsequently reduce depression. Psychosocial and QOL outcomes were overshadowed by disease severity, as measured by a biomedical marker. Baseline disease severity was inversely related to outcomes at 3-months post-NSRT, such that starting with worse severity and symptoms was associated with less depression and better QOL after NSRT. These data provide preliminary, short-term data, and are the starting point of development of clinical outcome trials, multidisciplinary care, and highly specialized treatment aimed at symptom reduction and QOL enhancement. To fully understand the relationship between these three constructs more powerful studies are needed and evaluating outcomes over a longer period of time. Taking this study one more step would be to develop identification methods of depression, enabling prediction of those who are depressed prior to intervention and does not improve over time. Examining psychological distress, well-

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73 being, and QOL in patients receiving myectomy vs. NSRT, and in patients who may have undergone both procedures, would also be beneficial to the literature and in patients’ treatment and outcomes. Other beneficial studies would be evaluating patients recently diagnosed with HOCM, as well as patients who choose not to undergo NSRT. Critical to NSRT efficacy trials are longer-term studies evaluating outcomes from a biopsychosocial perspective. Conclusions There are two critical conclusions from this project. The first is the psychosocial status of these HOCM patients pre-NSRT. They reported clinically significant levels of depression and depression was more prevalent compared to patients with other cardiac diseases and to the general population. These patients also reported poor QOL compared to other medical populations, including those with cardiac disease. Literature has established that baseline psychosocial status can impact treatment outcomes and recovery; therefore, these patients are prime candidates for psychological intervention pre-NSRT. The second conclusion from this study is that NSRT is an effective procedure in reducing R-LVOT gradient, depression and QOL over the first three months after NSRT. Despite no changes in psychiatric treatment, patients reported dramatic improvements in mood and QOL. These improvements appeared to be dictated by disease severity at baseline. It is hypothesized that the relationship between medical health and depression is moderated by QOL. Future research is needed to test this model and to look at long-term effectiveness of NSRT on depression and QOL.

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86 BIOGRAPHICAL SKETCH Eva R. Serber was born December 15, 1975, to Mary Lynn Serber and Russell Paul Serber. She was born and raised in Newport Beach, California, with her older sister Carolyn. She graduated from Corona Del Mar high school in 1994, after which she moved to San Diego, California. Eva earned a bachelor’s degree in psychology, with a minor in speech communications, from the University of San Diego in 1998. She earned a master’s degree in preclinical psychology from San Diego State University in 2001. Since 2001, Eva has been a doctoral student at University of Florida in the Department of Clinical and Health Psychology, specializing in clinical health psychology. Eva’s predoctoral internship will be at the Medical University of South Carolina, in Charleston, from 2005-2006, after which she will have fulfilled all requirements for her doctorate. Eva’s career goals are to continue integration of patient care and research. Her ultimate goal is to be a psychologist in a heart center or other medical institution, providing consultative, assessment, and treatment services to cardiac patients, alongside conducting research on treatment outcomes and quality of life.


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Title: Psychological Distress, Well-Being, and Cardiac-Specific Quality of Life among Patients with Hypertrophic Obstructive Cardiomyopathy Undergoing Nonsurgical Septal Reduction Therapy
Physical Description: Mixed Material
Copyright Date: 2008

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Source Institution: University of Florida
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PSYCHOLOGICAL DISTRESS, WELL-BEING, AND CARDIAC-SPECIFIC
QUALITY OF LIFE AMONG PATIENTS WITH HYPERTROPHIC
OBSTRUCTIVE CARDIOMYOPATHY UNDERGOING NONSURGICAL
SEPTAL REDUCTION THERAPY













By

EVA RUSSELL SERBER


A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
DOCTOR OF PHILOSOPHY

UNIVERSITY OF FLORIDA


2006

































Copyright 2005

By

Eva Russell Serber



















"Consider it pure joy, my brothers, whenever you face trials of many kinds,
because you know that the testing of your faith develops perseverance.
Perseverance must finish its work so that you may be mature and complete,
not lacking anything." -James 1:2-4















ACKNOWLEDGMENTS

I thank God every day for giving me Samuel F. Sears, Ph.D., my advisor, chair,

and, most of all, my mentor. He has been a mentor in every way-professionally,

demonstrating a balance between patient care, research, and academia; and personally,

modeling a balance between work and family. Sam had high expectations and pushed

me, but allowed me to be independent and develop and mature in my own way. He

provided me with countless opportunities that allowed me to excel and experience

different aspects of our profession. I have been truly blessed to be able to work with Sam.

Karen M. Smith, M.D., was my mentor in the medical world. She took me under

her wing and taught me alongside her cardiology fellows in clinic and in the cath lab. I

appreciate all that she brought to this project, and I am grateful for her initial ideas,

collaboration, and mentorship.

I also would like to thank the members of my dissertation committee, James

Rodrigue, Ph.D., Duane Dede, Ph.D, and James Jessup, Ph.D. They have watched me

progress through my education and research, challenging, guiding, and encouraging me

to think more critically. With their help, my dissertation project became stronger.

I also want to thank my friends and family who were with me every step along the

way, and it has been a very long way. The support from my Sears Lab colleagues over

the past 4 years has been invaluable. Most importantly, I could not have accomplished

any of this without the love, encouragement, and prayers from my family. They have

always been there for me, and I know they always will.















TABLE OF CONTENTS

Page

ACKNOW LEDGM ENTS ................................................ iv

LIST OF TABLES ......... ............................... ........ vii

FIG U R E ................................. . .......... .. .......... viii

ABSTRACT .......... .................................. ......... ix

CHAPTER

1 INTRODUCTION .............................................. 1

2 LITERATURE REVIEW .............................................. 3

M medical B background . ....... ...................................... 3
Quality of Life ........ ........................................... 11
Psychological D stress ................................ .... . 17
Psychological W ell-B eing . ....... .. .............................. 23
Psychosocial Evaluation of Medical Treatment ............................ 27
Statem ent of Purpose ........... ...................................... 31

3 METHODS .................................................. 33

Participants ........... ....................................... 33
Procedure .......... ................................. ......... 33
Measures ............................................ ........ 34

4 STATISTICAL ANALYSES .................................. . 41

Power and Sample Size Calculations ............................. 41
Aim 1: Describe HOCM Patients Pre-NSRT ....................... 42
Aim 2: Change Pre- Post-N SRT ................................ 50
Aim 3: Prediction Model ......................................... 56
Exploring the Relationship between Depression and Quality of Life ............ 59










5 DISCUSSION ................................................ 63

Patient Pre-N SRT Characteristics ............................... 63
Efficacy ofNonsurgical Septal Reduction Therapy ................... 66
Biopsychosocial M odel and Prediction ........................... 68
Extending the Findings . ..... .................................... 69
Limitations .......................................... ......... 70
Clinical and Research Implications .............................. 71
Conclusions .......... ........................................ 73

REFERENCES .................................................. 74

BIOGRAPHICAL SKETCH . ...... ................................. .. 86















LIST OF TABLES


Table page

1 Prevalence rates of depression and anxiety in the published cardiac literature ..... 19

2 Descriptive statistics on demographic, medical, and psychosocial variables in pre-
NSRT HOCM patients ....... .................................. 44

3 CES-D depression severity cut-off scores and HOCM prevalence rates .......... 47

4 Zero-order correlations of relevant pre-NSRT variables ................. 49

5 Summary of psychiatric history of patients pre- and 3-months post-NSRT ....... 51

6 Normative comparisons (t tests) with pre-NSRT and 3-month post-NSRT scores .. 52

7 Mean scores across time from pre- to 3-month post-NSRT (n = 20) ............ 54

8 Summary of hierarchical multiple regression analysis for predictors of CS-QOL
using the LVD-36 ...... ..................................... 57

9 Summary of hierarchical multiple regression analysis for predictors of cardiac-
specific QOL using the M LHFQ ................................ 58

10 Zero-order correlations between depression subscales and QOL measures pre-
NSRT ...................................................... 61















FIGURE

Figure page

1 D iagram of constructs tested ........................................... 41















Abstract of Dissertation Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Doctor of Philosophy

PSYCHOLOGICAL DISTRESS, WELL-BEING, AND CARDIAC-SPECIFIC
QUALITY OF LIFE AMONG PATIENTS WITH HYPERTROPHIC
OBSTRUCTIVE CARDIOMYOPATHY UNDERGOING NONSURGICAL
SEPTAL REDUCTION THERAPY

By

Eva Russell Serber

August 2006

Chair: Samuel F. Sears
Major Department: Clinical and Health Psychology

Patients with hypertrophic obstructive cardiomyopathy (HOCM) are presumed to

have poor quality of life (QOL) and distress related to their cardiac symptoms and

functional limitations. Nonsurgical septal reduction therapy (NSRT) is a rapidly emerging

treatment for HOCM, designed to improve heart function and reduce cardiac symptoms.

The purpose of this study was to evaluate psychological distress, well-being, and cardiac-

specific QOL among HOCM patients pre- and post-NSRT. There were 45 adult

participants (Mage = 54.3, SD = 15.62; 59.1% female; 97.6% Caucasian; 65.9% married)

who were recruited during their initial evaluation or index hospitalization for NSRT.

Psychological and medical measures were collected pre- and 3-month post-NSRT,

including the Center for Epidemiological Studies-Depression (CES-D) Scale and the

Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess depression and

cardiac-specific QOL, respectively. Results indicated that prior to NSRT, 55.8% reported









clinically relevant levels of depression (CES-D > 16), a higher prevalence than cardiac

disease and general populations. Pre-NSRT HOCM patients also reported poor cardiac-

specific QOL (MMLHFQ = 49.86, SD = 29.83) and satisfaction with life (M= 21.02, SD

= 8.42). Repeated measures analyses of variance (n = 20) revealed that NSRT is an

effective procedure in reducing resting left ventricular outflow tract (R-LVOT) gradient

(M= 59.26 vs. 20.79,p < .001), depression (M= 23.95 vs. 14.37,p = .005), and cardiac-

specific QOL (MMLHFQ = 58.16 vs. 30.32, p < .001). However, when including R-

LVOT gradient as a covariate, change in depression and cardiac-specific QOL were

dependent on disease severity pre-NSRT. Contrary to the hypothesis, baseline depression

did not predict 3-month post-NSRT cardiac-specific QOL. Notably, post-hoc analyses

revealed that baseline R-LVOT gradient and cardiac-specific QOL predicted 3-month

post-NSRT depression, explaining 62.7% of the variance (F [3,15] = 11.093, p < .001).

This study was the first comprehensive, longitudinal outcome study examining HOCM

patients and NSRT from a biopsychosocial model. Findings suggest that before

intervention, patients may benefit from multidisciplinary care. Greater precision in

depressive symptom identification independent of cardiac symptoms and QOL may point

to a subset of depressed HOCM patients whose depression does not improve over time.















CHAPTER 1
INTRODUCTION

Cardiovascular disease (CVD) has been the number one killer in the United States

every year since 1900, with the exception of 1918 (World War I). Nearly 2,600 Americans

die of CVD every day, claiming more lives each year than the next five leading causes of

death combined (American Heart Association, 2003). One in five adult males and females

have some form of CVD. One type of CVD is cardiomyopathy (CM), which is defined as

a structural abnormality limited to the myocardium. The computed mortality rate (actual

confirmed occurrence) for cardiomyopathy in the year 2001 was 26,863, while the total

mention mortality (predicted or assumed) for 2000 was 55,300 (American Heart

Association, 2003). Further, hypertrophic cardiomyopathy (HCM) is the leading cause of

sudden cardiac death in young athletes, estimated at about 36% of cases (American Heart

Association, 2003). Mortality rates of HCM in the general population are between 1 to 6%

annually (Cannan, Reeder, Bailey, Melton, & Gersh, 1995; Maron et al., 1999). With the

high prevalence and mortality rates of CVD in general and specific types of disease (e.g.,

HCM), it is critical to examine its risk factors, resilience factors, and treatments from both

a biomedical and a psychological standpoint.

The incidence of CVD has climbed due to poor health behaviors and individuals

living longer lives. Now is an era of expanding therapies for these disease states, which

further leads to an increase in an aging population living with CVD and other comorbid

conditions. With advances in treatment regimens (e.g., polypharmacy, interventional







2

procedures, devices), there is a need for robust mechanisms to quantify the impact of new

treatment on patients, their survival, their symptoms, and their quality of life (QOL). In

addition to the patients, payers, practitioners and regulatory agencies are increasingly

relying upon patient-centered outcomes to monitor and improve quality of care (Green,

Porter, Bresnahan, & Spertus, 2000). There are several ways researchers may examine

quality of care and QOL with the goal of improvement. The examination of predictors of

QOL, physical well-being, psychological well-being, and most recently spiritual well-

being provide information for potential intervention targets.

The current study examined physical and psychological functioning among

patients diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), using

biomedical and self-report data. Further, this study examined the biopsychosocial status

of HOCM patients before and after a cutting edge treatment procedure (Nonsurgical

Septal Reduction Therapy; NSRT), which was designed to relieve the obstruction of the

left ventricular outflow tract (LVOT), and, in turn, alleviate cardiovascular symptoms.















CHAPTER 2
LITERATURE REVIEW

This paper begins by briefly describing HOCM and its treatment. However, the

focus is on the anticipated QOL and psychosocial implications that correspond with this

disease and its ensuing treatment. Due to the paucity of psychosocial literature regarding

HOCM, the majority of our knowledge stems from general cardiac populations.

Medical Background

Cardiomyopathies

The cardiomyopathies are a group of heart disorders in which there is a structural

abnormality limited to the myocardium. This group of disorders often results in

symptoms of heart failure with the underlying cause sometimes identifiable; however, the

etiology is often unknown (Chen, Dec, & Lilly, 2003). There are three broad

classifications of cardiomyopathy: dilated, restrictive, and hypertrophic, with the latter

being the focus of this study.

Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a primary, often familial disorder of

heart muscle caused by mutation of one or more of the genes coding for sarcomeric

proteins (Marian & Roberts, 2001). It is characterized by heterogeneous expression

between genotypes and within the same family, unique pathophysiology and clinical

course (Yoerger & Weyman, 2003). It results in an abnormally thickened ventricular wall

with an abnormal diastolic relaxation but usually normal systolic (contraction) function.







4

The septal or left ventricular (LV) thickening is not due to chronic pressure overload; that

is, it is not associated with hypertension or aortic stenosis, which are the most frequent

antecedents to congestive heart failure (CHF). Severity of symptoms can vary greatly,

with some patients having minimal or no symptoms, and other patients experiencing

severe symptoms including sudden cardiac arrest and/or death. Signs and symptoms

include fatigue, exercise intolerance, shortness of breath dyspneaa) at rest and with

exertion, chest pain (angina), dizziness, pre-syncope or syncope, palpitations, and

arrhythmias. The most frequent symptom is dyspnea due to elevated diastolic LV

pressures, which is further exacerbated by high systolic LV pressure and mitral

regurgitation (Chen et al., 2003). Arrhythmias occurring with HCM, which may be due to

the disarray of myocardial fibers, are the most concerning because they exacerbate

symptoms. For example, atrial fibrillation further impairs diastolic filling and can worsen

pulmonary congestion. Ventricular fibrillation is of greatest concern, and sometimes is

the first clinical manifestation of HCM, resulting in sudden cardiac death (Chen et al.,

2003).

In some patients, a diagnosis is made only after they, or an affected family

member, experiences) sudden cardiac death. HCM affects approximately 0.2% (1:500)

of the adult general population and is the most common genetic (familial) cardiovascular

disease (Maron, 2002). Although HOCM affects individuals of all ages, sudden death in

young people is its most devastating effect and is the most common cause of sudden

cardiac death in young people (Chen et al., 2003; Maron, 2002; Roberts & Sigwart,

2001).

Hypertrophic obstructive cardiomyopathy (HOCM) is considered a more severe

condition in terms of anatomical and functional impairments compared to other









nonobstructive conditions in the HCM disease classification (Chen et al., 2003). It is

characterized by abnormal enlargement of the cardiac interventricular septum

(asymmetric hypertrophy) which interferes with mitral valve function and creates an

obstruction to outflow of blood from the left ventricle (LVOT obstruction) into the aorta.

LVOT obstruction contributes to and may result in systolic anterior motion (SAM),

commonly present with HOCM. SAM is the abnormal movement of the anterior mitral

valve leaflet into the LVOT, due to the turbulence of the blood flow through the

obstructed LVOT (Venturi Effect) (Yoerger & Weyman, 2003). This then causes greater

obstruction because the anterior mitral valve leaflet makes contact with the septum

during systole (Chen et al., 2003).

Medical Management of HOCM

The aim of medical therapy for HOCM is to decrease LVOT obstruction, improve

diastolic function, and improve symptoms (Nielsen, Killip, & Spencer, 2002).

Historically, there have been three types of treatment available for HOCM: medications,

pacemaker, and surgery (Maron, 2002). Surgery is the only treatment designed to be

curative in focus rather than to just reduce symptom burden. Medications (i.e., beta-

blockers, calcium channel blockers, other negative inotropic medications) are used in

attempts to "relax" the heart, decrease left ventricular wall tension, reduce obstruction,

and alleviate symptoms. However, they frequently have limited effectiveness even in

high doses. Implantation of a permanent pacemaker is thought to change the pattern of

the contraction of the heart and may help improve left ventricular outflow, but there is

considerable debate regarding the effectiveness of this treatment (Nishimura et al., 1997).

Surgical excision of the thickened interventricular septal muscle (myectomy,

myomectomy) and/or mitral valve replacement has been the gold standard of treatment of









drug-refractory HOCM, although operative cases represent only 5% of the overall

HOCM population (Maron, 2002).

The newest treatment for HOCM is nonsurgical septal reduction therapy (NSRT;

also termed alcohol septal ablation), in which absolute ethanol is injected into the area of

hypertrophied muscle to induce infarction in the targeted area. As healing occurs, the

thickened muscle is replaced with thinner, noncontractile scar tissue and the mechanical

obstruction of the left ventricular outflow tract (LVOT) is relieved. NSRT has been

shown to improve diastolic function, decrease left ventricular hypertrophy and mass, and

cause changes at the cellular and molecular level, thereby improving myocardial function

(Nielsen & Spencer, 2002).

Maron (2002; Maron et al., 2003) has repeatedly criticized NSRT for lack of

direct comparison to surgical therapy in randomized, controlled, clinical trials. However,

studies have compared the two procedures in nonrandomized trials, and researchers have

made comparisons through literature reviews. NSRT compares favorably to surgical

myectomy in terms of LVOT gradient reduction, septal wall thickness, symptomatic

improvements, and QOL improvements (Firoozi et al., 2002; Ruzyllo et al., 2000).

Improvement in exercise capacity (i.e., peak oxygen consumption, exercise time) has

been inconsistent, with some research demonstrating that NSRT is inferior to myectomy

(Firoozi et al., 2002); yet, the majority of research demonstrates equivalent benefit

between the two procedures (Ruzyllo et al., 2000), as well as analogous improvements in

exercise blood pressure (Kim et al., 1999).

In general, NSRT compares favorably to other treatments for HOCM and appears

to provide greater symptom reduction (Lakkis, Nagueh, Dunn, Killip, & Spencer, 2000;

Nagueh et al., 2001). While it is equally as effective as myectomy in regards to









symptomatic improvements, NSRT has demonstrated superiority over surgery with

respect to complications (Kuhn et al., 2000). NSRT is less invasive than open-heart

surgery, therefore reducing surgical risk (Ruzyllo et al., 2000). For example pre- and

post-operative mortality rates of myectomy range from 1-10% (Mayes et al., 2002).

Because the procedure is less invasive, recovery time and rehabilitation are substantially

shorter in patients undergoing NSRT than myectomy, and improvements continue status

post procedure up to six months (Nielsen et al., 2002).

Nonsurgical Septal Reduction Therapy

Patients evaluated for NSRT are symptomatic despite medical treatment. To be

considered an appropriate candidate for NSRT, patients must have asymmetrical septal

hypertrophy (ASH) with septal wall thickness > 1.6 cm or a septal to posterior wall ratio

of 1.3; SAM of the mitral valve contributing to the obstruction; and a resting LVOT

gradient of > 30 mmHg or a provoked gradient of > 50 mmHg (Nielsen et al., 2002). In

addition, many investigational studies include a criteria of NYHA > 3 functional

classification (Chang, Lakkis, Franklin, Spencer, & Nagueh, 2004).

Similar to myectomy and other interventional procedures, such as coronary artery

bypass graft (CABG) surgery, the goals of NSRT are to bring symptom relief to the

patients and to improve QOL. The procedure continues to be refined and perfected as

more procedures are performed and the specialized interventional cardiologists determine

the most effective strategies and approaches (Nagueh et al., 2001; Ruzyllo et al., 2000).

Two-dimensional, Doppler, and contrast echocardiography are used throughout the

NSRT procedure, as well as x-ray fluoroscopy (Mayes et al., 2002). Resting LVOT

gradient is determined at rest and sometimes with provocative maneuvers such as during

and after Valsalva and after extrasystole. Other methods that may reveal an LVOT









gradient include exercise, administration of intravenous Dobutamine, and inhalation of

amyl nitrite (Ommen & Nishimura, 2000).

The ostium of the left coronary artery is cannulated with a guiding catheter and

radiographic contrast is injected into the coronary artery under fluoroscopic observation.

Septal perforator branches of the left anterior descending (LAD) coronary artery are

identified on the coronary angiogram, determining the appropriate septal branches) that

supply the hypertrophied septum, and allow for angioplasty techniques to administer the

ethanol (Mayes et al., 2002). A small angioplasty balloon catheter is introduced over the

guidewire into the proximal portion of the target artery. The balloon is inflated and

appropriate positioning is confirmed by angiography. Radiographic contrast injected

through the balloon is used to confirm that there is no leak of contrast (and therefore,

alcohol) retrograde around the balloon into the LAD artery; and that there is no

communication of this septal perforator with other arteries or cardiac structures (Karen

Smith, M.D., personal communication, July 19, 2004; Mayes et al., 2002). Then,

echocardiographic contrast medium is injected through the lumen of the balloon catheter

and the septum is observed under echocardiography. This contrast "lights up" the area of

the septum supplied by the artery, confirming that the selected septal perforator supplies

the area of the hypertrophied septum responsible for the LVOT obstruction. Confident of

anatomy and positioning, the interventional cardiologist then infuses absolute ethanol

through this septal perforator artery into the basal septal myocardium. Depending on the

size of the vascular territory, 1 to 4 mL of ethanol is instilled through the inflated balloon

catheter over five to ten minutes at a slow injection rate of approximately 0.25-0.5

mL/minute (Karen Smith, M.D., personal communication, July 19, 2004). The ethanol

also gives the basal septum a white or bright appearance under echocardiographic









observation, allowing the area of infusion to be visible to the cardiologist. The total

amount of ethanol infused is judged by the interventional cardiologist based on area of

brightness of the septum, contractility of the septum, resolution of the gradient,

electrocardiographic and hemodynamic changes, and experience (Karen Smith, M.D.,

personal communication, July 19, 2004). Upon completion of the ethanol infusion, the

balloon is deflated and removed. Morphological results of the NSRT are examined by

coronary angiography and the LVOT gradient measurements are repeated.

The alcohol injected into the septum is directly toxic to the myocardium and kills

the cells. Immediately, the effected septum becomes akinetic and therefore no longer

bulges into the LVOT during systole, thus producing an immediate reduction in gradient

(Ommen & Nishimura, 2000). Over ensuing weeks and months, the injured myocardial

tissue is replaced, through the normal healing process, by much thinner scar tissue; thus

reducing the obstruction, enlarging the effective LV chamber, improving blood flow out

of the LV, reducing the turbulence of the ejected blood, and reducing the LV pressure

gradient. Through improvement in flow characteristics, SAM and mitral regurgitation are

also improved or completely alleviated (Karen Smith, M.D., personal communication,

July 19, 2004).

Following the procedure, patients are hospitalized for three to five days for close

cardiac monitoring. Most patients notice improvement in symptoms such as shortness of

breath, chest discomfort, paroxysmal nocturnal dyspnea, and orthopnea almost

immediately. As healing occurs and the septum thins over the next several weeks and

months, they report further improvements especially in fatigue and exercise tolerance

(Karen Smith, M.D., personal communication, January 7, 2004). Interventional

cardiologists and primary care providers follow patients for the next several years.









Generally, echocardiograms are performed three months post-NSRT and then yearly to

evaluate septal thickness and contractility, LV gradient, and the mitral valve (Karen

Smith, M.D., personal communication, January 7, 2004).

The most common side effect of NSRT is an arrhythmia (irregular heart beat)

called complete heart block (also called atrioventricular block). This occurs because the

site of the ablation is located near the conduction system. Damage to this conduction

system causes interruption of the electrical communication and synchronization between

the atria and ventricles resulting in (sometimes profound) bradycardia, which may

require implantation of a permanent cardiac pacemaker (Gietzen et al., 1999). The

incidence of complete heart block is steadily declining with experience of the

interventional cardiologists (Kuhn et al., 2000). Neither surgical myomectomy nor NSRT

appears to significantly alter the risk of sudden cardiac death in patients with HCM.

Some cardiologists have postulated that the scar tissue created by the alcohol ablation

procedure might become a focus for development of arrhythmias, but this has not been

confirmed (Kuhn et al., 2000; Ommen & Nishimura, 2000). Other noted complications

include requirement of a second NSRT procedure to further relieve the obstruction, and

death (< 1%) (Seggewiss, 2000).

NSRT may be considered analogous to implantable cardioverter defibrillators

(ICD) in the 1980s. For the past three decades, ICD implantation has increased

exponentially. For example, approximately 20,000 devices were implanted in 1995 and

as many as 125,000 were implanted in 2002 (Medtronic, Inc., personal communication,

June 2, 2004). Today, ICDs are considered the first line of treatment for ventricular

tachycardia/fibrillation, sudden death, ejection fraction (EF) < 30%, and it is even used

prophylactically in many other cardiac conditions (Sears & Conti, 2003). With further







11

refinement, modifications, better technology, and more experience, NSRT may prove to

be the "gold standard" of treatment for HOCM. Currently, only a select few

interventional cardiologists are trained in the procedure, but with increased patient

demand and more refined procedures, better outcomes are expected. For example,

Nagueh and colleagues (2001) modified their NSRT technique with the addition of

contrast echocardiography after 7 procedures and demonstrated dramatic improvement in

outcomes (heart block requiring permanent pacing in 22% vs. 8.6%) after the

modification. In just a few years, outcomes of NSRT have improved substantially with

the use of echocardiographic contrast agents, thereby enabling the precision of the

delivered alcohol into the septum (Firoozi et al., 2002). NSRT procedures will never be

as common as ICD implantation rates due to the fewer numbers of candidate patients, but

it is reasonable to project that their rates will continue to rise as it establishes itself as an

effective intervention for HOCM. Therefore, the examination of QOL and psychosocial

factors along with biomedical indices of the condition and of the procedure are now

indicated.

Quality of Life

At its heart, QOL is a nebulous subjective construct that may be assessed and

determined in a number of ways. QOL implicitly focuses on the quality, value, meaning,

or worth of life beyond that of number of years alive. The QOL construct strives to

describe the components of "living" including emotional well-being or distress, social

relationships or functioning, financial concerns, physical functioning or limitations,

health status, and/or spiritual well-being (Swenson & Clinch, 2000).

Health-Related Quality of Life

Health-related QOL, irrespective of disease specificity or generality, combines

physical, cognitive, emotional, and social functioning experienced and reported by the









patient. It can be considered the appreciation of the pervasive and adverse effects of

illness on the patient as perceived by the patient (Swenson & Clinch, 2000). In other

words, it is the "illness experience as opposed to the disease" (Swenson & Clinch, 2000,

p. 406). Aligned with that definition, Wenger, Mattson, Furgerg, and Elinson (1984)

depict health-related QOL as comprised of three aspects: functional capacity, perceptions

or patients' personal judgments, and symptoms and their consequences.

Health-related QOL instruments may either be generic measures of health status

or disease-specific measures. Generic measures of health-related QOL incorporate a

broad spectrum of function, health perceptions, and symptoms, which can be used in

different patient populations including those without disease. This enables direct

comparison of QOL across different disease states and conditions. The inherent

limitation of generic measures is that they may overlook important aspects or changes

that are of particular value for a specific medical condition (Swenson & Clinch, 2000).

Disease-specific measures quantify more clinically relevant domains for a specific

disease state than a generic measure. They are often more responsive to changes in

health-related QOL and are more sensitive in discriminating the range of impairment in

health-related QOL because their focus is on the most relevant aspects for the problem or

condition assessed (Guyatt, Feeny, & Patrick, 1993; Swenson & Clinch, 2000). Given the

breadth and complexity of QOL, it is important to include and assess multiple domains of

QOL from a variety of perspectives usually incorporating both generic and disease-

specific measures. It is these reasons as to why the proposed study utilizes cardiac-

specific QOL as the primary outcome and generic health-related QOL as the secondary

outcome.









Quality of Life Among Patients with Cardiac Disease

The Medical Outcomes Study demonstrated that across nine chronic medical

conditions, cardiac disease (e.g., myocardial infarction [MI], CHF) had the greatest

adverse impact on broad domains of functioning and well-being (Stewart et al., 1989).

Stewart and colleagues (1989) found that QOL is more severely impaired in heart failure

patients compared to other common chronic conditions, such as angina, diabetes,

arthritis, and lung disease. Since then, investigators have consistently demonstrated that

QOL is impacted in a variety of cardiac conditions, ranging from patients with CHF,

angina, coronary artery disease (CAD), to arrhythmias and electrical desychronization

(Dougherty, Dewhurst, Nichol, & Spertus, 1998; Dracup, Walden, Stevenson, & Brecht,

1992; Kamphuis, De Leeuw, Derksen, Hauer, & Winnubst, 2002). In addition, QOL is

impacted among patients who have undergone treatment and/or procedures such as

percutaneous transluminal coronary angioplasty (PTCA) and CABG (Konstam et al.,

1996; Majani et al., 1999). Not only are a variety of QOL domains influenced, but also

they, in turn, can lead to declining health and/or death. For example, QOL components

including emotional distress, social functioning, physical functioning, perceived health,

and life satisfaction were predictors of all-cause mortality in a sample of CHF patients

(Konstam et al., 1996). Impairments in QOL are frequently evidenced in sleep

disturbance, financial difficulties, dysfunctional eating patterns, and decreased sexual

activity and sexual dysfunction (Majani et al., 1999).

Quality of Life Among Patients with Cardiomyopathy

QOL among patients with cardiomyopathy (CM) has received minimal empirical

investigation, thus the value of the proposed study. There are two studies that provide

some QOL information specific to HCM and dilated CM (DCM) (Cox, O'Donoghue,







14

McKenna, & Steptoe, 1997; Steptoe, Mohabir, Mahon, & McKenna, 2000). Both studies

were identical in procedure to enable comparison between samples of CM. Each study

was a cross-sectional design with two aims: (1) to evaluate the level of health-related

QOL and psychological well-being among CM patients, and to compare them to the

general population and patients with other serious cardiac conditions, and (2) to identify

the clinical, demographic, and psychosocial factors that predicted limitations in QOL in

patients. The researchers used standardized measures: Health Survey Short Form

(SF-36), Hospital Anxiety and Depression Scale (HADS), MOS sleep quality, questions

on adjustment, and biomedical data to answer their questions.

Examining QOL in HCM patients, Cox and colleagues (1997) found that these

patients had significant impairments on all 8 scales of the SF-36 (i.e., physical

functioning, physical role limitations, emotional role limitations, social functioning,

mental well-being, general health perceptions, vitality, and bodily pain). The sample

consisted of 171 patients diagnosed within the broad HCM disease spectrum (Cox et al.,

1997). In other words, not all patients had an obstructed LVOT, but were rather

characterized because of their enlarged heart muscle, which typically occurs in the left

ventricle and the interventricular septum. Patients were divided into three groups: no

known family history of HCM, those with family history, and those with family history

and one or more with premature sudden death. There were no significant differences

among family history groups on demographic or clinical data, QOL, psychological well-

being, or adjustment. As a whole, HCM patients reported impairments similar to patients

with CHF, hypertension with CHF, complicated diabetes, MI, regular angina, and severe

autonomic neuropathy (p <.01). They also found that HCM patients reported

significantly poorer QOL in terms of role limitations attributable to emotional problems,









social functioning, and mental health compared to the general and cardiac populations.

This suggests that QOL is severely affected among patients with HCM, particularly in

mental health functioning, and even in comparison to known severe disease.

Similarly, Steptoe, Mohabir, Mahon, and McKenna (2000) demonstrated that

patients with DCM (N = 99) reported poor QOL in areas of physical functioning,

activities of daily living, emotional and social functioning, vitality, and general

perceptions of health, and sleep quality compared to the general population (p < .025).

However, DCM patients reported greater restrictions in social functioning and pain

compared to HCM patients (p < .003). DCM patients reported similar depression rates

but greater anxiety levels and social functioning restrictions, compared to other cardiac

disease populations. In addition to describing poor QOL among these patients, predictive

relationships were also shown between physical role limitations and depression. Those

who reported poorer QOL among the HCM patients were associated with experiencing

chest pain and dyspnea (Cox et al., 1997). This finding suggests that physical symptoms

lead to functional limitations and therefore reduced QOL, which may in turn lead to

psychological distress.

These two studies also examined predictors of QOL among CM patients.

Adjustment to HCM was the most consistent correlate of QOL and psychological well-

being dimensions, predicting a range of difficulties across physical, social, and emotional

domains, independent of demographic and clinical variables (Cox et al., 1997). The

researchers hypothesized that patients with familial cardiomyopathy (e.g., DCM, HCM)

might experience greater psychological distress since they have knowledge that their

cardiac condition can be inherited or passed on to offspring. While this potential origin of

distress would not be impacted by medical treatment, it is an area that may be addressed







16

with psychosocial treatment, and currently, these patients are often neglected in terms of

psychosocial care. Other significant relationships seen in these CM studies were between

physical functioning and patients with comorbid CHF, lower left ventricular shortening

fractions, and higher left ventricular end diastolic diameters. Poor social functioning was

seen in CM patients with moderate to severe mitral regurgitation. The most notable

finding was that poor adjustment to CM predicted poor physical function, mental health,

and emotional distress.

Summary and Implications of Quality of Life Literature

The familial origin of HCM and its potential reason for distress may be one of the

main differences in the development of psychological distress when comparing HCM

patients to other cardiac populations. While QOL may be impacted in all cardiac

populations, development and progression of disease and/or psychological problems may

be vastly different. For example, HOCM is a structural abnormality caused by mutations

on the genes encoding proteins of the muscle fibers (Marian & Roberts, 2001; Mayes et

al., 2002). In other words, patients with HOCM did nothing themselves to cause the

disease, whereas a significant proportion of CHD (i.e., CAD) develops from poor

lifestyle and health behaviors (e.g., diet, physical activity) and is the leading preventable

disease. Therefore, reported QOL and rates of psychological distress may be similar

across cardiac disease; yet, worse than the general population, but emerging from

different factors. These QOL impairments may then lead to further physical and

emotional problems, including death.

These CM studies provide rationale for the current study. They indicate the need

for an increased understanding of psychosocial concerns and QOL, of which is pervasive

and poorly understood. These studies also emphasize the importance of further









examination of QOL among CM patients. Gaining this knowledge, we can better

optimize both emotional and physical outcomes with CM patients. These specific CM

studies also emphasize weaknesses and/or gaps in the literature. For example, these

studies were only cross-sectional, and only longitudinal studies can attempt to determine

how impairments in QOL develop and progress. While there is ample QOL research in

other areas, it is extremely sparse among HCM patients, particularly HOCM patients.

Further, psychosocial examination of treatments for HOCM is even more limited.

Researchers not only need to study HOCM, but also its treatments from a physiological

perspective, but also from a psychosocial perspective, the latter being the focus of this

study.

Psychological Distress

Related to and independent of QOL, negative emotions play a role in

psychological and physical health, particularly in cardiac disease. The experience of

negative emotions such as anger, anxiety, and depression are probable risk factors for

coronary heart disease (CHD) and may substantially account for poor cardiac disease

outcomes (Kubzansky & Kawachi, 2000). Emotions may influence cardiovascular health

through a number of pathways, including excessive activation of the sympathetic nervous

system or the hypothalamus-pituitary-adrenal (HPA) axis, or altered autonomic

regulation of the heart (Kubzansky & Kawachi, 2000). For example, anxiety may

provoke electrical instability in the heart, promote increased atherosclerotic processes,

and trigger myocardial infarction (Kubzansky, Kawachi, Weiss, & Sparrow, 1998).

Depression may impact cardiac outcomes by altering neuroendocrine functioning,

increasing sympathetic tone and decreasing vagal tone, and by increasing platelet

aggregation (Carney, Freedland, Rich, & Jaffe, 1995).







18

In addition to the influence of emotions on physiology, psychological distress can

impact social and behavioral components of health. Anxiety and depression experienced

before and during a recovery period from a procedure (e.g., CABG, PTCA) are as

important as physical limitations and comorbidities in influencing outcomes such as

length of hospital stay, ability to function, and QOL (Pirraglia, Peterson, Williams-

Russo, Gorkin, & Charlson, 1999). Negative emotional states have also been associated

with reduced adherence to prescribed medical regimens (i.e., increasing self-care and

decreasing health compromising behaviors) known to be important in cardiac

rehabilitation (Januzzi, Stern, Pasternak, & DeSanctis, 2000; Ziegelstein et al., 2000).

Mood and affective disorders appear to be common in cardiac patients, ranging

from diagnoses of panic disorder, agoraphobia, generalized anxiety disorder, and social

phobia, to dysthymia, major depressive disorder, and alcohol abuse (Griez et al., 2000).

Panic disorder is evident in patients with CAD, mitral valve prolapse, and it is also

suggested in those with idiopathic cardiomyopathy (Kahn et al., 1987). See Table 1 for

prevalence rates of depression and anxiety among cardiac samples.

Depression Among Patients with Cardiac Disease

Emotional distress and depression have been suggested as new risk factors for

CAD (Rozanski, Blumenthal, & Kaplan, 1999). Rates of depression among cardiac

patients range from 14% to 87%, among patients with CAD, ischemic heart disease,

nonischemic heart disease, arrhythmias, and patients with ICDs (Blumenthal et al., 2003;

Musselman, Evans, & Nemeroff, 1998; Sears, Todaro, Saia, Sotile, & Conti, 1999).

Higher rates are more often seen in patients awaiting CABG, those with unstable angina,

and those with ICDs (Blumenthal et al., 2003; Sears et al., 1999). Clearly, the wide range

in depression rates depends, in part, on the method of measurement used as well as the







19

specific condition examined. Despite the variation of rates, it is evident that depression is

highly prevalent in cardiac populations and may predict psychosocial and physical health

status, and therefore, warrants examination and treatment.

Table 1. Prevalence rates of depression and anxiety in the published cardiac literature
Sample/Population Depression Anxiety Investigator
General population 2-9% 1-3% American Psychiatric
Association, 1994

CAD 14-47% Blumenthal et al., 2003
6-34% Jeejeebhoy et al., 2000

CHF 30.2% Rumsfeld et al., 2003
36.5% Koenig, 1998
Idiopathic CM 51% Kahn et al., 1987

Idiopathic DCMa 19% 19% Griez et al., 2000

DCMa 22% 52% Steptoe et al., 2000

HCMa,b Cox et al., 1997
Possible 13.1% 21.2%
Probable 9.5% 28.5%

ICD 24-87% 13-38% Sears et al., 1999

CABG 12-76% Blumenthal et al., 2003
Pre 32% 55% Rymaszewska et al.,
3-months post 26% 32% 2003

Angioplasty 15% 26% Lenzen et al., 2002

Heart transplant Fisher et al., 1995
0-4 months pre >49%
5 year post 11%
Note. a Comparable to other cardiac populations, but greater than the general
population.
b Greater than a cancer sample (p < .0001).

In addition to the high prevalence, depression holds predictive value. For

example, among coronary revascularization studies, preoperative depression affects

postoperative QOL and psychosocial functioning (Duits, Boeke, Taams, Passachier, &

Erdman, 1997). Depression also influences morbidity and mortality, independent of









cardiac disease severity, including left ventricular dysfunction (Burg, Benedetto,

Rosenberg, & Soufer, 2003). It is associated with elevated cardiac mortality risk, similar

to its impact on patients' prognosis with unstable angina and post MI (Frasure-Smith &

Lesperance, 2003; Zellweger, Osterwalder, Langewitz, & Pfisterer, 2004).

Depressive symptoms are common in patients with CHF, which subsequently

may be an important determinant of health status (Vaccarino, Kasl, Abramson, &

Krumholz, 2001). Patients with CHF suffer with moderate to severe depression and

moderate anxiety and appear to have higher levels of depressive disorders (36.5% vs.

17.0%, p = .002) compared to other cardiac patients, but no significant differences with

Major Depression, specifically (Dracup, Walden, Stevenson, & Brecht, 1992; Koenig,

1998). Rumsfeld and colleagues (2003) found that depressed CHF patients reported

markedly worse baseline health status compared to nondepressed patients (p < .001).

Further, after adjusting for baseline health status, demographic, cardiac, and treatment

variables, depressive symptoms were a strong predictor of worsening heart failure

symptoms, functional status, and QOL over a 6-week period. Not only were depressive

symptoms a predictor, but also seen in multivariable models of change in QOL scores,

symptoms scores, and social functioning scores, depressive symptoms had the largest

magnitude of association with the outcome. Rumsfeld and colleagues' (2003) study was

the first to demonstrate the unique impact of depressive symptoms on heart failure

specific health status and indicate that patient-centered outcomes for heart failure patients

may be improved with the recognition and treatment of depression.

A large body of research provides evidence for a strong relationship between

depression and cardiac disease, particularly after a MI. While, there is inconsistent

evidence regarding the causative role of depression in CHD, the bulk of the evidence









supports depression's causal role in CHD. In the National Health Examination Follow-

Up Study, self-reported depression was associated with an increased risk of fatal and

nonfatal ischemic heart disease (RR = 1.5 and 1.6, respectively) (Anda et al., 1993). A

prospective, longitudinal study found that men with psychiatric diagnoses of clinical

depression were at a significant risk of subsequent CHD (RR = 2.12) (Ford et al., 1998).

Other follow-up studies have failed to show a relationship between depression and

increased risk of CHD (e.g., ischemic heart disease, MI) (Vogt, Pope, Mullooly, &

Hollis, 1994; Wassertheil-Smoller et al., 1996). Regardless of the unknown or unproven

direction of the relationship between depression and CHD, there is notably a strong

relationship between the two and that the relationship has critical clinical relevance and

implications for outcomes and QOL in all examinations of cardiac disease, including

HOCM.

Anxiety Among Patients with Cardiac Disease

Anxiety is another negative emotional state that is experienced in a large number

of cardiac patients, and is more strongly associated with CHD than depression or anger

(Kubzansky & Kawachi, 2000). Symptoms of anxiety and symptoms of cardiac disease

can often times mimic each other. For example, chest pain, shortness of breath, heart

palpitations, and racing heart are all symptoms of both anxiety disorders and heart

disease (including HOCM) (Jeejeebhoy, Dorian, & Newman, 2000). Patients with known

heart disease, may be more susceptible to hypervigilance in monitoring their symptoms,

have an increased somatic concern and body awareness, fear and worry about chest and

heart sensations, along with avoiding activities that may elicit cardiac symptoms or

activity (Jeejeebhoy et al., 2000; Lebovitz, Shekelle, Ostfeld, & Paul, 1967; Zvolensky,

Eifert, Feldner, & Feldner, 2003). According to Zvolensky and colleagues (2003) heart-









focused anxiety is the fear of cardiac-related stimuli and sensations grounded in their

perceived negative meaning. Therefore, cardiac symptoms and anxiety may perpetuate

each other in a constant cycle. Further, the experience of health-related anxiety during the

course of illness may occur as the patient engages in persistent worry about their

condition, and not just their manifest symptoms (Zvolensky et al., 2003). Therefore,

anxiety is not an uncommon condition among cardiac patients.

The majority of researchers have reported associations between anxiety and CHD.

For example, the Northwick Park Heart Study as well as the Health Professionals Follow-

Up Study found that phobic anxiety had relative risks of fatal CHD of 3.77 and 2.45,

respectively, compared to men reporting low or no anxiety (Haines, Imeson, & Meade,

1987; Kawachi, Colditz, et al., 1994). In the Normative Aging Study, men reporting

symptoms of anxiety had elevated risks of fatal CHD, particularly that of sudden cardiac

death (Kawachi, Sparrow, Vokonas, & Weiss, 1994). In the Framingham Heart Study,

anxiety symptoms were significantly related with MI and coronary death among

homemakers but not among employed women (Eaker, Pinsky, & Castelli, 1992). Further,

anxiety may cause acute cardiac events such as MI by stimulating the release of

catecholamines that increase the heart rate, blood pressure, and cardiac output (Mittleman

et al., 1995). Therefore, it may cause myocardial ischemia and electrocardiogram

changes in those with already established heart disease (Tofiler et al., 1990).

Summary and Implications of Psychological Distress Literature

This review has highlighted that not only do cardiac patients experience

significant psychological distress, but also their distress can predict outcomes both

psychologically and medically. Symptoms of cardiac disease (e.g., shortness of breath,

fatigue, dizziness, chest pain) tend to lead to functional limitations in those who







23

experience them, with greater limitations the more severe the symptoms. Along with the

distressing symptoms, patients may be even more distressed by the limitations and

impairments that are caused by these symptoms. Patients with HOCM who are evaluated

for NSRT are usually at their last line of defense in terms of treatment, and consequently

have been suffering for years with unrelenting symptoms of increasing severity. In

addition, they report significant functional limitations in a variety of areas, and thus,

report poor QOL.

The current study evaluated these emotional states because it was assumed that

symptoms of depression and anxiety would occur in HOCM patients due to their physical

symptoms and functional limitations; however, it has not been evaluated in a systematic

fashion. Further, congruent with the literature, it was expected that the symptoms of

depression and anxiety would impact these patients' QOL, physical health, and the

effectiveness of and/or recovery from NSRT.

Psychological Well-Being

With psychological distress now an accepted risk factor for poor overall health, it

is worthwhile to also examine positive emotions, resilience factors, and their relationship

with cardiac conditions. Resilience factors are those that enhance one's ability to recover

quickly from distress or illness. Research indicates that positive emotions such as

optimism, positive expectations, satisfaction, and spirituality may enhance one's ability

to cope with illness, treatment, and other related stressors.

Optimism Among Patients with Cardiac Disease

In the general population, optimism and satisfaction with life has been shown to

be a mental health factor that positively influences both psychological and physical well-

being (Taylor, Kemeny, Reed, Bower, & Gruenewald, 2000). Optimism may allow









individuals to mobilize effective coping strategies and resources when faced with stress

or adversity (Scheier et al., 1999). Optimistic individuals may believe that their attitudes

or actions will positively influence their health outcomes.

Initial optimism research among cardiac patients has yielded promising results.

Positive expectations and an optimistic disposition predict fewer symptoms, lower levels

of cardiovascular reactivity, and better health outcomes in CABG and cardiac patients

(Cohen, de Moor, & Amato, 2001; Leedham, Meyerowitz, Muirhead, & Frist, 1995;

Scheier & Carver, 1987, 1992). The prospective Veterans Affairs Normative Aging

Study examined optimistic versus pessimistic explanatory style, revealing that a more

optimistic explanatory style lowered the risk of CHD in that particular sample of older

men, independent of health behaviors (i.e., tobacco or alcohol consumption) (Kubzansky,

Sparrow, Vokonas, & Kawachi, 2001).

A recent study supported the existence of resilience factors in a prospective study

of ICD patients (Sears et al., 2004). Results suggested that optimism and positive health

expectations differentially relate to specific health outcomes from baseline to a 14-month

follow-up. Positive health expectations were more closely associated with general

physical health, while optimism was more closely associated with mental health

outcomes. Collectively, these resilience factors appear to hold some value in promoting

future intervention studies in terms of QOL for the ICD patient (Sears et al., 2004).

Positive health expectations and/or optimism may be beneficial by facilitating healthy

behavioral practices, enhancing treatment adherence, and increasing motivation to

engage in appropriate health behaviors such as exercise and healthy dietary choices

(Salovey, Rothman, Detwieler, & Steward, 2000).









Spiritual Well-Being Among Patients with Cardiac Disease

Along with optimism, spirituality or spiritual well-being has been seen as a

resilience factor. In health promotion literature, spiritual health has been defined as, "a

high level of faith, hope, and commitment in relation to a well-defined worldview or

belief system that provides a sense of meaning and purpose to existence in general and

that offers an ethical path to personal connectedness with self, others, and a higher power

or larger reality" (Hawks et al., 1995, p. 373). Accordingly, overall wellness may be

conceived to include not only emotional and physical health, but also spiritual health.

Researchers have begun to focus on the relationship between spirituality and

health, providing ample data to suggest that there is a relationship between spirituality

and physical and psychological health (Brady, Peterson, Fitchett, Mo, & Cella, 1999;

Mytko & Knight, 1999). The relationship between spirituality and enhanced quality of

life has been demonstrated in many populations, such as healthy individuals (Kaye &

Robinson, 1994), HIV patients (Ironson et al., 2002), cancer patients (Brady et al., 1999;

Cotton, Levine, Fitzpatrick, Dold, & Targ, 1999), and cardiac patients (Morris, 2001;

Sears, Rodrigue, Greene, Fauerbach, Mills, 1997). Individuals with a strong sense of

spirituality tend to have less symptomatology compared to those without a sense of

spiritual well-being. They are also found to have less pain, anxiety, and isolation, as well

as higher life satisfaction, better psychological adjustment, and lower mortality rates

(Brady et al., 1999; Cotton et al., 1999; Levin & Schiller, 1987).

In the Lifestyle Heart Trial, researchers assessed sense of spiritual well-being

four-years after the completion of an intervention to promote heart healthy behaviors

(Morris, 2001). The intervention compared a group following a vegetarian diet, regular

aerobic exercise, and practiced meditation daily for one hour to a group provided with









standard medical care. The primary endpoint was computerized cardiac catheterization

data, measuring disease progression or regression of coronary obstruction. The

experimental group scored higher on spiritual well-being than the control group and

spirituality was correlated with disease progression or regression. Participants with low

spirituality scores tended to have progression of their disease, and participants with high

spirituality scores tended to have regression of their coronary obstruction. In addition to

demonstrating a significant relationship between spirituality and health, this study

indicates that sense of spirituality influences objective health. It is the first to suggest a

definable relationship between spirituality and documented physical data (Morris, 2001).

A small amount of research exists examining relationships between spirituality

and/or religiousness with both physical and psychological health among cardiac patients.

Researchers have studied patients in the coronary care unit, awaiting cardiac surgery, and

those with cardiac arrest and near death experiences. Among these studies, researchers

have operationalized spirituality by measuring different components of spirituality such

as, prayer, spirituality as a coping strategy, optimism, meaning of life, and love and

acceptance of others (Ai, Peterson, Bolling, & Koenig, 2002; Byrd, 1988; Harris et al.,

1999; van Lommel, van Wees, Meyers, & Elfferich, 2001). In studies examining

intercessory prayer (someone praying on another's behalf) and patients on the coronary

care unit, using a severity-adjusted outcome score, they found a trend of lower overall

adverse outcomes for coronary care unit patients randomized to a prayer group compared

to those in a usual care group; however, results were not statistically significant (Byrd,

1988; Harris et al., 1999). Optimistic patients awaiting cardiac surgery tended to be

individuals who used private prayer for coping, and were less depressed and less anxious

than those who were not considered optimistic (Ai et al., 2002). van Lommel and









colleagues (2001) concluded that medical factors could not account for near death

experiences. Instead, they reported that patients with near death experiences had

significantly decreased fear of death, increased belief in an afterlife, and rated themselves

higher on spiritual items, such as meaning of life, love, and acceptance of others, and

were more religious than before their near death experience.

Summary and Implications of Psychological Well-being Literature

Collectively, research on optimism and spirituality indicate that patients reporting

higher levels of these traits report less symptomatology in both medical and

psychological indices. Also, QOL appears to be enhanced in patients with an optimistic

disposition, positive expectations, or spiritual well-being. It may be that these resilience

factors lead individuals to engage in better health behaviors. While it is important to

examine risk factors and disease, it is equally important to examine resilience factors and

disease. Positive psychology has only recently been receiving a great deal of attention,

and the promising research and outcomes explain why (Seligman & Csikszentmihalyi,

2000). Evaluating QOL cannot be complete unless examining both risk factors and

resilience factors together. Thus, psychological well-being was incorporated in the

current study of HOCM patients. This study's overarching aim was to capture the essence

of HOCM patients, which includes negative and positive characteristics, QOL, and

health.

Psychosocial Evaluation of Medical Treatment

Assessing QOL and other psychosocial components in cardiac patients can be

especially useful in comparing differential treatment options, considering adverse

treatment effects, and comparing mild mood symptom change (Wenger et al., 1984).

First, QOL measurement is beneficial when examining a treatment that has the potential









of showing a major improvement in survival over another clinical investigation or

treatment option (e.g., NSRT in HOCM). Second, if a treatment is effective in reducing

mortality but may have toxic or unacceptable side effects for some patients, including

QOL measurement can help patients and physicians weigh out costs and benefits

(e.g., ICD shocks, chemotherapy). Third, QOL measurement is helpful when a mildly

symptomatic or asymptomatic patient is on long-term treatment to ensure QOL is not

diminished, thereby creating a risk of poor compliance to treatment (e.g., antihypertensive

medication). A particular application of psychosocial evaluation is to be able to provide

information about the patients to the medical team or vice versa to the patients from the

medical team in order to optimize treatment outcome.

CABG and PTCA are the two most common cardiac procedures and the most

well known in the general population. CABG surgery has been described as the most

thoroughly studied operation in the history of surgery, with angina relief and QOL

improvement as the primary goals of CABG (American College of Cardiology/American

Heart Association Task Force, 1991; Burg et al., 2003). Studies demonstrate that changes

in emotional functioning and satisfaction following CABG and PTCA are generally

favorable for most patients relative to their preoperative emotional status. However,

patients reporting high levels of anxiety and depression prior to interventional procedures

often do not feel satisfied with their life, have more complaints about their health,

disregard positive effects of surgery, and are less apt to return to work after procedure;

thus, impacting social functioning and occupational functioning, and may lead to

continued and worse anxiety and depression (Duits et al., 1999; Rymaszewska et al.,

2003; Swenson & Clinch, 2000; Timberlake et al., 1997).









Advances have been made in the medical management of CABG; however,

attention to the psychological management is warranted because of its prognostic

importance. Blumenthal and colleagues (2003) examined the relationship between

depression and mortality among 817 patients pre- and six-months post CABG.

Participants were also followed for up to 12 years following data collection (mean

follow-up time = 5.2 years). Results indicated that moderate to severe depression before

CABG, or persistent depression (> 6 months) predicted increased risk of death over the

course of 12 years. Patients with moderate to severe depression had a greater than two-

fold higher risk of death compared to nondepressed patients during the follow-up period.

Further, depression was significantly associated with mortality after controlling for other

risk factors, such as age, sex, number of grafts, smoking history, diabetes, ejection

fraction, and previous MI (Blumenthal et al., 2003).

Anxiety has also been seen among patients undergoing CABG and PTCA

(Lenzen et al., 2002; McCrone, Lenz, Tarzian, & Perkins, 2001; Sirois, Sears, & Bertolet,

2003). Preoperative anxiety has been well documented in CABG patients, such that high,

moderate, and even low anticipatory anxiety levels at baseline were maintained up to six

months postoperatively (Fitzsimons, Parahoo, Richardson, & Stringer, 2003;

Vingerhoets, 1998). In addition, preoperative trait anxiety has shown significant

contribution to patient's postoperative state anxiety in patients undergoing CABG or

PTCA (Lenzen, Gamel, & Immink, 2002; McCrone et al., 2001; Vingerhoets, 1998).

Five impacts of anxiety emerged from the data analyzed by Fitzsimons and colleagues

(2003): (a) chest pain, (b) procedure uncertainty, (c) forthcoming operation, (d) physical

incapacity, and (e) dissatisfaction with health service. Both the quantitative and









qualitative analyses of anxiety revealed that anxiety is a pervasive feature of the

experience of waiting for CABG (Fitzsimons et al., 2003).

In addition to predicting future anxiety, baseline levels have been used to predict

cardiac symptoms and clinical outcomes. Fitzsimons and colleagues (2003) found

significant differences in both state and trait anxiety levels by angina severity (grades 1-

4). Among patients undergoing PTCA, a factor of negative emotions (i.e., depression and

anxiety) predicted anginal frequency at 6-months and 1-year post-PTCA, more than

demographic and biomedical variables (Sirois et al., 2003). Negative emotions were also

the strongest predictor of anginal frequency at 6-months and 1-year post-PTCA,

evidenced by the standardized beta weight (-0.35 and -0.42, respectively). Baseline

symptom report was also found to be a significant predictor at all time periods (6-weeks,

6-months, and 1-year post PTCA). These studies suggest that not only is anxiety

prevalent in cardiac patients with differing diagnoses and awaiting different procedures,

but that it should be included in interventions to help allay distress and promote physical

health.

In contrast to risk factors in cardiac procedures, such as preoperative anxiety or

depression, resilience factors such as higher preoperative levels of positive expectations

demonstrate a faster recovery rate after CABG (Scheier et al., 1989). In a similar study,

patients with positive expectations undergoing CABG were half as likely to be

rehospitalized six months later for complications or other cardiac symptoms (Scheier et

al., 1999). Spirituality has also been associated with enhanced quality of life, as well as

promoting adjustment to trauma, treatments, and recovery (Brady et al., 1999; Cotton et

al., 1999; Morris, 2001).









Summary and Implications of Psychosocial Management of Medical Treatment

Research demonstrates that physical symptoms, medical procedures, and

outcomes can impact psychological distress and well-being and likewise, distress and

well-being can impact symptoms, procedures, and outcomes. NSRT is a new treatment of

HOCM, and therefore, evaluating the procedure from a biopsychosocial perspective is

beneficial and aids in determining whether NSRT is an effective treatment, not only from

a medical standpoint, but also from the patients' views. The current study took a

biopsychosocial approach in examining this new medical procedure, which has already

been shown to have good biomedical outcomes.

Statement of Purpose

The current study combined the cardiac psychosocial literature, and of particular

relevance, are the two studies of CM patients and the use of psychological variables

when studying CABG and PTCA. Findings demonstrate the critical importance of the

inclusion of psychosocial components of QOL in the treatment of cardiac disease.

Building upon the CM studies, this study also addressed limitations in this area. It

focused on patients with HOCM, and was longitudinal in design to enable examination of

progression and/or changes of QOL. Further, the current study took an additional step,

not only examining patients longitudinally, but also evaluating the QOL impact for a

specific treatment of HOCM (i.e., NSRT). The study aimed to provide descriptive

information about HOCM patients and NSRT, but also to provide longitudinal and

clinically relevant data, which may aid in future biomedical and psychological

treatments. Therefore, the purpose was threefold:

1. Descriptive: To describe HOCM patient characteristics, including the rates of
psychological distress, well-being, and cardiac-specific QOL pre-NSRT.







32

2. Change Over Time: To determine if there were changes in distress, well-being,
and cardiac-specific QOL in HOCM patients pre- and post-NSRT.

3. Predictive: To determine if psychological distress and well-being pre-NSRT
predicted post-NSRT cardiac-specific QOL.















CHAPTER 3
METHODS

Participants

There were 45 adult participants with HOCM from two sites: the Shands

Teaching Hospital at the University of Florida (UF) (n = 25) and the Medical University

of South Carolina (MUSC) (n = 20). Participants were recruited during their initial

outpatient clinic evaluation or index hospitalization for NSRT. Patients were excluded

from the study if they were younger than 18 years of age, or not able to read and write

English.

Procedure

After checking into their outpatient medical clinic and completing their standard

medical forms, a member of the medical team approached the patient with informed

consent for the current study. The patient was informed that his/her responses to research

questionnaires would not influence psychological or medical care that is part of standard

clinical care, and vice versa. The physician, or a member from the cardiac psychology

team, was available to answer any of the patient's questions. After providing signed

informed consent, the participants completed the packet of research questionnaires

examining QOL and psychological factors (baseline). At the time of standard clinical

care, the same research questionnaires were re-administered three-months post-NSRT.

The battery of questionnaires took approximately 30 to 45 minutes to complete. In

addition to self-report questionnaires, information was obtained from medical and/or







34

psychological records available through their residing institution of care (i.e., University

of Florida/Shands Teaching Hospital or MUSC). During standard clinical care or the

research protocol, if a patient needed or requested psychological services, an appropriate

referral was made. Completed questionnaire packets were returned to a member of the

medical or cardiac psychology team, which were then given to the project coordinator

(ERS). To control for treatment effects, throughout the study, participants were asked if

they have or are currently receiving psychotherapy or other forms of psychiatric

treatment.

Measures

Demographic Information

The BackgroundInformation Questionnaire was included at each of the patients'

assessments. This measure is a brief self-report tool to facilitate collection of

demographic information. It includes information such as, age, gender, education, work

status, income, marital status, religion, and use of past and/or present psychological

treatment.

Biomedical Information

Resting left ventricular outflow tract (R-LVOT) Gradient is the biomedical

marker that was used as an outcome measure, collected at baseline and the 3-month

follow-up, obtained from the patient's echocardiogram. The gradient is the difference

between the left ventricle (LV) systolic pressure and the aortic systolic pressure due to

obstruction of the LVOT. Normal values for both resting and provoked gradient are less

than 30 mm Hg.









General Health-Related Quality of Life

The SF-12 Health Survey (SF-12; Ware, Kosinski, & Keller, 1995) is a generic

measure of health status and was used to measure general QOL. The 12 items that

comprise this measure are a subset from the SF-36. The scale measures eight

components: physical functioning, role limitations due to physical health problems,

bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations

due to emotional problems, and mental health (psychological distress and well being)

(Ware et al., 1995). The SF-12 can be separated into two components: physical

component summary (PCS-12) and mental component summary (MCS-12). All scores of

the SF-12 are comparable and highly correlated with SF-36 scores (ranging from .63-.97)

(Ware et al., 1995; Ware, Kosinski, & Keller, 1996). The SF-12 reproduced 90% of the

variance in the SF-36 PCS and MCS measures in the United States and on cross-

validation in the MOS (Ware et al., 1996). Test-retest reliability for the PCS-12 scale in

the United States was .89, and for the MCS-12 scale was .77 (Ware et al., 1996). Internal

consistency has been demonstrated for the PCS-12 (.77) and the MSC-12 (.80) (Luo et

al., 2003). In the current study, the PCS-12 demonstrated poor three-month test-retest

reliability (r, = -.018), and therefore results were interpreted cautiously. This may be

because our sample reported improvements over time.

Cardiac-Specific Quality of Life

The Left Ventricular Dysfunction Questionnaire (LVD-36; O'Leary & Jones,

2000) was designed to measure the impact of left ventricular dysfunction on daily life

and well-being. This 36-item questionnaire measured cardiac-specific QOL. Responses

are dichotomous (true or false). True responses are summed, which are then calculated as









a percentage; higher scores indicate worse functioning (i.e., 0 = best possible score).

Analyses have also revealed that for this measure significant differences were found

between all NYHA classes, except between classes III and IV (O'Leary & Jones, 2000).

The measure demonstrated high internal consistency in a sample with chronic left

ventricular dysfunction (Kuder-Richardson coefficient = .95) (O'Leary & Jones, 2000).

In the current sample, high internal consistency was found (Cronbach's a = .95). Test-

retest reliability in this sample was moderate (r, = .594).

The Minnesota Living n ith Heart Failure Questionnaire (MLHFQ; Rector, Kubo,

& Cohn, 1987) was used to measure cardiac-specific QOL, including components of

symptom distress and function (Harrison et al., 2002). The 21 items that comprise the

MLHFQ originate from the Sickness Impact Profile. Patients with congestive heart

failure were asked to select items that they experienced and attributed to their CHF. Items

are rated on a 6-point Likert-type scale from 0 to 5; scores range from 0-105. Lower

scores indicate less disability from symptoms, or in other words, better QOL. A physical

dimension and an emotional dimension can also be calculated from this scale. In this

study, the primary variable used was the total score. Research demonstrates that the

MLHFQ is more sensitive to changes across a six and twelve week period among CHF

patients (Harrison et al., 2002). Analyses have also revealed that for this measure

significant differences were found between all NYHA classes, except between classes III

and IV (O'Leary & Jones, 2000). The scale has demonstrated strong internal consistency,

yielding a Kuder-Richardson coefficient of .95 among patients with chronic left

ventricular dysfunction (O'Leary & Jones, 2000). Internal consistency in the present

sample was established (Cronbach's a = .96), and moderate three month test-retest

reliability was found (r = .537).









Depression

The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff,

1977) is a 20-item self-report measure that assesses depressive symptomatology.

Respondents indicate how frequently they have experienced each symptom in the past

week. Responses range from 0 (less than one day) to 3 (5-7 days). The total score can

range from 0 to 60 and reflects both the number of depressive symptoms and their

duration. In the general population, a standard cut-off score of 16 can be used to indicate

clinically significant symptoms of depression (Radloff, 1977). Heart disease and primary

care literature has demonstrated that CES-D scores can be grouped into three depression

classifications: mild/ subclinical symptoms (0-15), moderate symptoms (16-26), and

severe symptoms (>26) (Blumenthal et al., 2003; Zich, Attkinsson, & Greenfield, 1990).

Previous research has demonstrated that the CES-D is highly sensitive and specific and

exhibits a high internal reliability coefficient of .85. It has been reported as a more

generally useful self-report measure of depression than the Beck Depression Inventory,

the MMPI Depression Scale, and the Zung Self Rating Scale of Depression (Turk &

Okifuji, 1994). In the current sample of HOCM patients, the CES-D demonstrated to

have strong internal consistency (Cronbach's c = .87) and moderate three month test-

retest reliability (rp = .530).

Anxiety

The Revised State Trait Personality Inventory-Trait Scale (STPI; Spielberger et

al., 1979) is a 40-item self-report measure used to assess dispositional anxiety. The full

trait scale is comprised of 4 subscales (10 items each): anxiety, anger, depression, and

curiosity. In the current study, only the first three subscales (anxiety, anger, and









depression) were used; therefore the current measure consists of 30 items. Respondents

rate how strongly they agree with each item on a 4-point Likert-type scale ranging from 1

to 4, with total scores ranging from 30-120. The scoring procedure for the STPI is the

same as that used in the STAI and STAXI, with higher scores indicating greater presence

of dispositional anxiety, anger, and depression (Spielberger & Reheiser, 2003). The

current study utilized a total score only, which is a summation of the 30 items. In the

current HOCM sample, strong internal consistency was seen (Cronbach's a = .77) and

strong three month test-retest reliability (r = .777).

Well-Being

The Satisfaction i/ ilh Life Scale (SWLS; Diener, Emmons, Larson, & Griffin,

1985) was designed to assess overall satisfaction with life. It is a 5 item measure that

respondents are asked to rate their agreement with each item using a 7-point Likert-type

scale, ranging from 1 ("strongly disagree) to 7 ("strongly agree"). Possible scores range

from 5 to 35, with higher scores indicating higher satisfaction with life. Strong reliability

has been demonstrated, yielding a Cronbach's alpha of .87 and a two-month test-retest

reliability of .82. Adequate levels of convergent validity with the Life Satisfaction Index

were also seen (Diener et al., 1985). The SWLS did not correlate with the Marlowe-

Crowne measure (r = .02), indicating that it is not evoking a social desirability response

pattern. In addition, it appears that individuals who are satisfied with their lives are

generally well adjusted and free from emotional distress or psychopathology (Diener et

al., 1985). The scale demonstrated high internal consistency (Cronbach's a = .91) and

strong three month test-retest reliability (rp = .818) in the current sample of HOCM

patients.







39

The Life Orientation Test-Revised (LOT-R; Scheier, Carver, & Bridges, 1994) is

a 6-item, self-report questionnaire (with 4 additional filler items) that assesses

generalized expectancies for positive versus negative outcomes. Respondents rate the

items on a 5-point Likert-type scale from 0 ("strongly disagree") to 4 ("strongly agree").

Half of the items are phrased in the positive direction (items 1, 4, 10). The scores for the

negative items (items 3, 7, 9) are reversed, and then all items are summed to yield an

overall dispositional optimism score. Range of scores is 0-24, with higher scores

indicating a more positive disposition. The LOT-R has an acceptable reported reliability

alpha of 0.78. Test-retest reliability of the LOT-R has been shown across 4 to 28 months

to range between .56 and .79 (Scheier et al., 1994). The authors conclude that overall, the

LOT-R has good predictive validity, and dispositional optimism (as measured by the

LOT) is quite distinguishable as an independent construct, as compared to the constructs

of neuroticism and negative affectivity (Scheier et al., 1994). In the current sample,

internal consistency was poor (Cronbach's uc = .26), but three month test-retest reliability

was excellent (r, = .769).

The Spiritual Well-Being Scale (SWBS; Paloutzian & Ellison, 1982) is a self-

report measure comprised of 20 items assessing sense of well-being in the relationship

with God and sense of purpose in and satisfaction with life (Paloutzian & Ellison, 1982).

Ten items assess existential well-being (EWB) and 10 items assess religious well-being

(RWB). Half of the items from each subscale are positively-valenced, and the other half

are negatively-valenced. Responses to items are on a 6-point scale from 1 (strongly

agree) to 6 (strongly disagree). The SWBS yields three scores: (1) a total score; (2) a

summed score for religious well-being items; and (3) a summed score for existential









well-being items. Higher scores indicate greater well-being. The subscales have

demonstrated both high reliability and internal consistency. Test-retest reliabilities were

0.93 (SWB), 0.96 (RWB), and 0.86 (EWB) (Paloutzian & Ellison, 1982). Internal

consistency has been demonstrated for the three scores: 0.89 (SWB), 0.87 (RWB), and

0.78 (EWB) (Paloutzian & Ellison, 1982).

This study intended to use the total score for spiritual well-being. However, in the

current sample, the total score demonstrated poor internal consistency (Cronbach's c =

.38) and low three-month test-retest reliability (r, = .432). Due to the scale's

demonstration of poor consistency, reliability, and validity, it was dropped from all

analyses in the current project.















CHAPTER 4
STATISTICAL ANALYSES

Analyses were conducted to evaluate psychological distress, well-being, and

health related QOL among HOCM patients pre- and post-NSRT, with cardiac-specific

QOL as the primary outcome. See Figure 1 for a diagram of constructs tested. General

QOL (SF-12) was also examined as a secondary outcome, but only for normative

comparisons to other general and cardiac populations. The Bonferroni alpha correction

procedure was used to control familywise error (Tabachnick & Fidell, 2001). This

procedure was used to reduce the probability of making a Type 1 error due to the

multiple analyses conducted.


DISTRESS


STPI CARDIAC-
SPECIFIC QOL

LVD-36, MLHFQ

WELL-BEING

SWLS
LOT-R


Figure 1. Diagram of constructs tested

Power and Sample Size Calculations

In the original proposal, a rationale for a sample size of 30 participants for pre-

and 3-month post-NSRT was presented. Significant challenges in patient recruitment

were encountered indicating the need to review progress with n = 20 pairs of pre- post-







42

NSRT data. There were two notable findings with the current data related to sample size.

First, the data on which power analyses were calculated (i.e., pre- post- LVOT gradient,

QOL) demonstrated very large effect sizes (Cohen's d> 1.00) and more than satisfactory

power (> .85). These findings supported the decision of sufficient data to stop data

collection. Secondly, to examine other psychosocial constructs (e.g., distress, well-being)

while controlling for disease severity, it would take more than 4 years and be cost

prohibitive to recruit a sample size (N> 150) that would yield adequate power and effect

sizes. For example, in the repeated measures analysis, controlling for disease severity,

depression yielded a rqp2 = .020, with observed power = .086.

Aim 1: Describe HOCM Patients Pre-NSRT

The first aim of the study was to describe HOCM patient characteristics,

including the rates of psychological distress, well-being, and cardiac-specific QOL, pre-

NSRT. Descriptive analyses (i.e., means, one-sample t tests) were used to describe

HOCM patients at baseline, examining pre-NSRT HOCM patients on demographic,

medical, and psychosocial variables. It was predicted that pre-NSRT HOCM patients

would be comparable to other cardiac populations, but worse than the general population

on measures of distress (CES-D, STPI), well-being (SWLS, LOT-R) and QOL (LVD-36,

MLHFQ, SF-12). To correct familywise error, Bonferroni alpha corrections were applied

to the descriptive analyses based on the eight psychosocial variables of interest (CES-D,

STPI, SWLS, LOT-R, LVD-36, MLHFQ, PCS-12, MCS-12), yielding significance at

alpha = .006 (.05/8).

Patient Characteristics Pre-NSRT

Descriptive analyses were conducted on the 45 participants (M age = 54.3, SD =

15.62) who completed questionnaires during their evaluation for NSRT or at index









hospitalization at time of NSRT. Patients also received an echocardiogram as part of

standard medical evaluation.

Participants were predominantly female (59.1%), Caucasian (97.6%), and married

(65.9%). Fifty percent reported that they were retired or receiving disability or other

financial assistance and 38.1% were working full-time. Majority of the sample reported

having spiritual beliefs of a Judeo-Christian religious background (78.9%). Based on

self-report, 8.6% reported that they were currently receiving psychotherapy and 17.1%

reported currently taking psychotropic medications. Combining antidepressant or

anxiolytic prescriptions from their medical record, 36.4% of the sample was taking a

psychotropic medication. The percentage of HOCM patients who were receiving some

kind of psychiatric treatment (i.e., self-report or medical chart review) was 45.9%.

Patients' biomedical parameters were comparable to the NSRT research (Chang

et al., 2004; Ralph-Edwards et al., 2005). Average R-LVOT gradient was 60.36 mm Hg

(SD = 35.74), and average provoked LVOT gradient was 101.12 mm Hg (SD = 52.57).

See Table 2 for complete descriptive data of demographic, medical, and psychosocial

variables at pre-NSRT. All variables, except demographic variables, were normally

distributed and reflected the full ranges of scores, without ceiling or floor effects.

Comparisons for differences between sites

There were no significant differences in demographic variables between UF and

MUSC participants. There were significant differences between sites on both pre-NSRT

resting (p = .001) and provoked (p = .002) LVOT gradient, with MUSC scores being

worse. However, the differences did not exist at 3-month post-NSRT (p = .213, andp =

.348, respectively). It is assumed that MUSC may have initiated the procedure on sicker

patients; but, procedurally, the sites did not differ, evidenced by comparable outcomes.









Table 2. Descriptive statistics on demographic, medical, and psychosocial variables in
pre-NSRT HOCM patients
Variable n Mean/ % SD Minimum Maximum


Demographic variables
Age
Sex (male)
Race
Caucasian
African-American

Marital status
Single
Separated/Divorced
Widowed
Married/Remarried
Living with partner

Have children (Yes)
Number of children

Religion
Not religious/None
Catholic
Protestant
Jewish
Other
Employment status
Full-time
Homemaker
Unemployed
Disability/ Financial asst.
Retired


Income
< $14,000
$15,000 29,999
$30,000 44,999
$45,000 59,999
$60,000 74,999
$75,000 89,999
> $90,000


Medical Variables
Heart rate
Normal range:
Systolic blood pressure
Normal range:


54.3 15.62
40.9% 0.50


0.62


97.6%
2.4%


12.2%
9.8%
7.3%
65.9%
4.9%

81.0%
2.58


2.6%
23.7%
52.6%
2.6%
18.4%


38.1%
7.1%
4.8%
21.4%
28.6%


2.8%
38.9%
13.9%
13.9%
19.4%
2.8%
8.3%


1.14


0.40
1.48

1.06


2.19


1.68


44 70.70 13.63

45 131.20 24.12


110
100
200
140









Table 2. Continued


Variable n Mean/ % SD Minimum Maximum
Diastolic blood pressure 45 66.84 11.45 44 94
Normal range: 50 90
Ejection fraction (%) 42 70.95 7.05 55 85
Normal range: >55
Ventricular septal thickness 42 19.21 6.21 7 36
Normal range: 8 10
Ventricular posterior wall 42 13.12 3.89 7 24
thickness
Normal range: 7 9
Resting LVOT gradient 44 60.36 35.74 0 150
Normal range: <30
Provoked LVOT gradient 33 101.12 52.57 10 210
Normal range: <30

Psychosocial variables
Depression 43 20.53 14.01 1 54
Anxiety 43 57.05 19.34 31 107
Satisfaction with life 42 21.02 8.42 6 34
Optimism 41 14.82 6.20 0 24
Cardiac-specific QOL (LVD) 43 59.50 27.06 0 94.44
Cardiac-specific QOL (MLHFQ) 43 49.86 29.83 0 104
Median score = 50.00
Physical health (SF-12) 28 31.47 8.68 19.29 53.78
Mental health (SF-12) 28 45.00 12.72 24.23 66.76


Comparisons for differences between completers and noncompleters

Examining participants, at baseline, who completed 3-month post-NSRT vs. those

who did not, revealed no significant differences in demographic variables. There were

also no differences between completers and noncompleters on medical variables.

Significant differences were found between completers and noncompleters on QOL

measures, with completers reporting worse QOL. Differences were seen in MLHFQ

scores (M= 62.70 [SD = 19.81] vs. M= 32.71 [SD = 32.74], respectively); higher scores

indicate worse QOL (F [1, 25] = 8.122, p = .009). Differences were also seen in the PCS-

12 scores, completers (M= 28.07 [SD = 5.02]) vs. noncompleters (M= 35.05 [SD =







46

10.24]), with lower scores indicating worse QOL (F [1, 25] = 4.923, p = .036). However,

after Bonferroni alpha correction (c = .006) was taken into account, neither of these

differences maintained significance.

Normative Comparisons Pre-NSRT

Examining HOCM patients at evaluation for NSRT, patients reported significant

psychological distress, and poor QOL. Comparisons were made between the current

HOCM sample pre-NSRT and other populations with previously published norms. It was

predicted that scores would be comparable to other cardiac populations but worse than

the general population.

Psychosocial normative comparisons

Depression scores were comparable to other cardiac populations. Notably, more

than half the HOCM sample expressed, at minimum, mild levels of depression (MCES-

D = 20.53, SD = 14.01). This sample was not statistically different from CHF patients

(MCES-D = 16.9, SD = 11.9) (Koenig, 1998) (t score [42] = 1.701, p = .096). But scores

were significantly worse compared to a sample of patients with other types of heart

disease (MCES-D = 12.2, SD = 11.9) (t score [42] = 3.901, p < .001), and from other

medical diseases (MCES-D = 15.8, SD = 12.2) (t score [42] = 2.216,p = .034) (Koenig,

1998).

While ratings of depression may be similar to other cardiac populations, the point

prevalence rate of depression in this sample of HOCM patients appears to be higher than

other cardiac populations. Based on the three-group severity classification system

(Table 3), 44.2% of pre-NSRT HOCM patients reported mild (subclinical) symptoms of

depression, 20.9% reported moderate symptoms, and 34.9% reported severe symptoms of

depression. Among patients pre-CABG, Blumenthal and colleagues' (2003) found 26%







47

scored moderate symptoms and 12% scored severe symptoms; thus, prevalence rates for

meeting criteria for depression were 55.8% (HOCM) vs. 38% (CABG). Of the 55.8% of

HOCM patients reporting clinically significant depression (CES-D score > 16), 47.6%

were receiving some sort of psychiatric care (i.e., psychotherapy or psychotropic

medication).

Normative comparisons for other psychosocial constructs that could be made with

this sample were with the SWLS and the LOT-R. These pre-NSRT HOCM patients

reported significantly less satisfaction with life compared to a general elderly population

referenced in the scale's validation analyses (M= 21.02 vs. M= 25.8) (t score [41] = -

3.675, p = .001). Regarding optimism scores, there were not significant differences

between these HOCM patients compared to patients awaiting CABG surgery (M= 14.83

vs. M= 15.16) (t score [40] = -.341,p = .735) or to college students (M= 14.33) (t score

[40] = .515,p = .609).

Table 3. CES-D depression severity cut-off scores and HOCM prevalence rates
HOCM prevalence HOCM prevalence
CES-D score Depression severity rates pre-NSRT rates post-NSRT
0- 15 Mild/subclinical symptoms 44.2% 65.0%
16 -26 Moderate symptoms 20.9% 25.0%
> 26 Severe symptoms 34.9% 10.0%
Note. Blumenthal et al., 2003; Zich, Attkinsson, & Greenfield, 1990

Quality of life normative comparisons

Results of comparisons depended on normative data and measure used. QOL

scores were commensurate to other cardiac populations with NYHA class III heart failure

(Rector et al., 1987). However, when compared to a population with chronic left

ventricular dysfunction (validation sample of the LVD-36), the current sample of pre-

NSRT HOCM patients reported significantly worse cardiac-specific QOL on both the

LVD-36 and the MLHFQ (O'Leary & Jones, 2000). On both the LVD-36 and the







48

MLHFQ, lower scores indicate better QOL. HOCM patients scored aMLVD-36 = 59.50

(SD = 27.06) compared to a normative sample M= 39.0 (SD = 28.9) (t score [42] =

4.968,p < .001). Using the MLHFQ, HOCM patients' M= 49.86 (SD= 29.83) compared

to the same normative sample for the LVD-36, M MLHFQ = 29.7 (SD =22.7) (t score

[42] = 4.432, p < .001).

While the cardiac-specific QOL scales did not indicate differences with CHF

patients, the SF-12, measuring generic QOL did capture significant differences between

the current HOCM sample and a CHF population on physical health (PCS-12)

(M= 31.47 vs. M= 40.02) (t score [27] = -5.217, p < .001) and on mental health

(MCS-12) (M= 45.00 vs. M= 51.12) (t score [27] = -2.548,p = .017). HOCM SF-12

scores were also significantly worse than scores from a population of minor medical

conditions for both PCS-12 and MCS-12 (p < .001) (Ware et al., 1995). Collectively,

these results indicate that QOL in these pre-NSRT HOCM patients is worse than the

general population and worse than other cardiac populations.

Relationships pre-NSRT

Zero-order correlations with pre-NSRT data were examined to evaluate

relationships of interest. Seen in Table 4, age, sex, and R-LVOT gradient were not

significantly related to any of the psychological distress, well-being, or QOL variables,

except for the relationship between sex and the MLHFQ (p < .05). Depression was highly

correlated with all the psychological and QOL variables, and exceeded the collinearity

cutoff of r = .70 (Kleinbaum, Kupper, Muller, & Nizam, 1998) in its relationship with the

STPI (r = .856) and all QOL scales: LVD-36 (r = .746), MLHFQ (r = .762), and the PCS-

12 (r = -.779). All depression and QOL correlations indicated inverse relationships, such

that as depression increased, QOL decreased. However, in this sample, depression and

QOL were seemingly too highly related or confounded at pre-NSRT. The measures used












Table 4. Zero-order correlations of relevant pre-NSRT variables
Variable 2 3 4 5 6 7 8 9 10 11
1 Age .166 .043 .014 -.137 .213 .180 -.031 -.115 -.093 .211
2 Sex .297 .142 .034 .043 -.057 .213 .319* -.146 .242
3 R-LVOT gradient .171 .098 .107 .066 .201 .264 -.218 .031
4 Depression .856** -.489** -.519** .746** .762** -.287 -.779**
5 Anxiety -.593** -.585** .597** .600** -.130 -.750**
6 Life satisfaction .710** -.433** -.246 .088 .496**
7 Optimism -.338 -.197 .019 .451*
8 Cardiac-specific QOL (LVD-36) .727** -.586** -.700**
9 Cardiac-specific QOL (MLHFQ) -.424** -.643**
10 Mental health (SF-12) -.002
11 Physical health (SF-12)
Note. *p < .05; **p < .001. Sample size for all correlations ranged 41-43, except correlations with SF-12, n = 28.







50

to assess these constructs appear to be tapping into shared components of the indices, and

thus, may not be independent or unique when evaluated at the same point in time in this

study.

In addition to showing problematic collinear relationships, the correlation

analyses also demonstrated good convergent validity between measures. Satisfaction

with life and optimism were collinear (r = .710), but also demonstrated convergent

validity between the two well-being measures. The QOL measures also demonstrated

good convergent validity. For example, the LVD-36 and MLHFQ (r = .727) were highly

related, as were the LVD-36 and the PCS-12 (r = -.700), and the MLHFQ and the PCS-

12 (r = -.643).

Aim 2: Change Pre- Post-NSRT

The second aim of the study was to determine if there were changes in

psychological distress (CES-D, STPI), well-being (SWLS, LOT-R), and cardiac-specific

QOL (LVD-36, MLHFQ) in HOCM patients across time, from pre- to post-NSRT. First,

descriptive analyses (e.g., means, one-sample t tests) were conducted to compare 3-

month post-NSRT HOCM patients to other cardiac populations as well as the general

population (c = .006). This was performed so that both (a) change and (b) how

post-NSRT patients compared to cardiac and general populations were evaluated over

time. Repeated measure analyses of variance (RM-ANOVA) were conducted to evaluate

change from pre- to 3-month post-NSRT.

Patient Characteristics at 3-Months Post-NSRT

Of the 45 participants pre-NSRT, there were 20 participants (44.4%) who

completed 3-month post-NSRT data (UF, n = 9; MUSC, n = 11). The average follow-up

time was 3.55 months (SD= .880), congruent with the design of the study, corresponding

to standard clinical care. Participants (n = 25) were lost to follow-up because they did not









return to the clinic for their standard cardiology clinic follow-up appointment, and

therefore did not receive and complete the packet of questionnaires nor did they have an

echocardiogram taken. As seen by the completers vs. noncompleters analysis, those who

completed 3-month post-NSRT data reported worse QOL at baseline. It is unknown if

completers would still report worse QOL 3-months post compared to noncompleters,

because data was not collected. It is presumed that the noncompleters did not attend their

follow-up appointment because their health status had improved dramatically, and

therefore, felt no need to see the cardiologist. See Table 5 for prevalence of past and

current history of psychiatric treatment at baseline and post-NSRT.

Table 5. Summary of psychiatric history of patients pre- and 3-months post-NSRT
3-month post-
Pre-NSRT N
NSRT
Variable (no/yes) n % n %

Past psychotherapy (SR) 34 11.8% 18 16.7%
Past psychotropic medications (SR) 33 27.3% 18 6.3%
Current psychotherapy (SR) 35 8.6% 18 5.6%
Current psychotropic medications (SR) 35 17.1% 18 22.2%
Antidepressant prescription (CR) 44 27.3% 20 30.0%
Anxiolytic prescription (CR) 44 15.9% 20 25.0%
Total currently treated (SR) 35 17.1% 18 22.2%
Total with prescription (CR)a 44 36.4% 20 35.4%
Overall treatment (SR or CR) 37 45.9% 18 55.6%
CES-D > 16, overall treatment (SR or CR) 21 45.7% 7 57.1%
Notes. SR = Self-Report, CR = Chart Review. There were no significant changes over
time (p values ranged .082 1.000).
a Prescription includes only antidepressant or anxiolytic medication.

Normative Comparisons Post-NSRT

Normative comparisons of psychosocial status at 3-months post-NSRT, along

with pre-NSRT findings are seen in Table 6. Notable findings were that scores had

significantly changed over time, such that at pre-NSRT, HOCM patients reported worse

scores (e.g., more depression, lower life satisfaction, poorer QOL) on a majority of the












Table 6. Normative comparisons (t tests) with pre-NSRT and 3-month post-NSRT scores
Norm Pre-NSRT
Measure M Comparison population HOCMM
CES-D 16.9 CHF 20.53
12.2 Other heart diseases 20.53
15.8 Other medical diseases 20.53
SWLS 25.8 Elderly 21.02
LOT-R 15.16 Awaiting CABG 14.83
14.33 College students 14.83
LVD-36 39.0 Chronic left ventricular dysfunction 59.50
MLHFQ 29.7 Chronic left ventricular dysfunction 49.86
PCS-12 40.02 CHF 31.47
47.10 Minor medical conditions 31.47
MCS-12 51.12 CHF 45.00
53.62 Minor medical conditions 45.00


.096
< .001
.032
.001
.735
.609
< .001
<.001
<.001
< .001
.017
.001


Post-NSRT
HOCMM
14.1
14.1
14.1
21.4
16.3
16.3
35.83
30.1
38.03
38.03
47.61
47.61


.277
.457
.505
.030
.411
.163
.622
.943
.540
.012
.325
.102









measures than the normative samples (i.e., both cardiac populations and the general

population), and later, post-NSRT, HOCM patients report comparable scores to the

normative samples. Similarly to depression findings pre-NSRT, scores of depression

post-NSRT were not significantly different from normative samples; however,

prevalence rate of depression (CES-D scores > 16) continued to be noteworthy (35%).

Thus, while these patients reported dramatic improvements, three-months post-NSRT,

they were still comparable to other sick cardiac populations. Three-month post-NSRT,

the only significant findings when comparing HOCM to other populations were in

satisfaction with life (p = .030) and the PCS-12 (p = .012). Thus, HOCM patients, post-

NSRT, reported worse life satisfaction compared to an elderly population. They also

reported worse QOL compared to a population of minor medical conditions; however,

they report equivalent scores to a CHF population. After Bonferroni correction (Uc = .006,

based on the 8 measures for normative comparisons), these significant differences

disappear.

Repeated Measures Results

It was predicted that HOCM patients would rate improvements on post-NSRT

scores of distress, well-being, and cardiac-specific QOL compared to their ratings pre-

NSRT. Several significant time effects were found from pre-NSRT to 3-month post-

NSRT (See Table 7 for means and standard deviations across time). Bonferroni alpha

corrections were applied to the repeated measures analyses based on the six psychosocial

variables of interest (CES-D, STPI, SWLS, LOT-R, LVD-36, MLHFQ), yielding

significance at alpha = .008 (.05/6).









Table 7. Mean scores across time from pre- to 3-month post-NSRT (n = 20)
3-month post-
Pre-NSRT NSRT
NSRT
Variable Mean SD Mean SD
R-LVOT gradient** 59.26 41.45 20.79 23.7
P-LVOT gradient** 100.21 56.31 30.71 28.09
Depression** 23.95 14.81 14.37 11.44
Anxiety* 62.21 21.93 54.95 16.94
Life satisfaction 21.68 8.83 21.63 8.53
Optimism 15.61 5.96 16.67 6.07
Cardiac-specific QOL (LVD-36)* 67.11 23.72 34.80 28.63
Cardiac-specific QOL (MLHFQ)* 58.16 25.03 30.32 25.38
Note. *p <.05; ** p< .01.

Biomedical variables

As expected, the medical outcome of both resting and provoked LVOT gradient

decreased dramatically and demonstrated a large effect size (Cohen's d, adjusted with

Hedges' g = 1.12 and 1.52, respectively). R-LVOT gradient improved from M= 59.26

(SD = 41.45) to M= 20.79 (SD = 23.70) (p < .001, n = 19). Provoked gradient improved

fromM= 100.21 (SD = 56.31) toM= 30.71 (SD = 28.09) (p < .001, n = 14). Calculating

power from differences in pre- to post-NSRT, R-LVOT gradient yielded power of .92,

and provoked LVOT gradient yielded power of .99.

Psychosocial variables

Among the psychosocial variables, there were significant time effects for

depression (Pillai's Trace F [1, 18] = 10.226, p = .005) and anxiety (Pillai's Trace F

[1,18] = 5.251, p = .034). Depression demonstrated a strong medium effect size (Cohen's

d, adjusted with Hedges' g = .71) and power = .58. Anxiety demonstrated a small but

strong effect size (Cohen's d, adjusted with Hedges' g = .36). After Bonferroni

corrections, the time effect for anxiety was no longer significant. There were no

significant time effects for the constructs of satisfaction with life, and optimism.









Quality of life variables

Similarly to medical outcome, cardiac-specific QOL demonstrated highly

significant improvements from pre-NSRT to 3-month post-NSRT, as well as very large

effect sizes. Examining scores on the LVD-36, Cohen's d, adjusted with Hedges' g=

1.20 (Pillai's Trace F [1,18] = 34.468, p < .001). Power for the LVD-36 was .96.

Additionally, examining scores on the MLHFQ, Cohen's d, adjusted with Hedges' g=

1.08 (Pillai's Trace F [1,18] = 25.05, p <.001), and power was .85.

Repeated Measures Results: Controlling for Disease Severity

Repeated measures analyses of covariance (RM-ANCOVA) were conducted

using pre-NSRT R-LVOT gradient as a covariate, to control for disease severity. It was

predicted that HOCM patients would report improvements across time on scores of

distress, well-being, and cardiac-specific QOL and would maintain significance, even

after controlling for disease severity at baseline.

Psychosocial variables

There was no significant change in depression after controlling for disease severity,

contrary to the hypothesis. However, the analysis revealed a negligible effect size

indicated by rIp2 = .020 and poor observed power (.086). There was a significant

depression by covariate (pre-NSRT R-LVOT gradient) interaction effect (Pillai's Trace F

[1,17] = 7.613, p = .013, rp2 = .31, observed power = .74), indicating that change in

depression was dependent on disease severity at baseline. There were no significant

effects for anxiety (main effect p = .809, rqp2 = .004; interaction effect p = .124, rqp2 =

.133). Similar to previous RM-ANOVAs, the addition of the covariate did not yield

significant results with satisfaction with life and optimism.









Quality of life variables

Similar to the findings for depression, examining cardiac-specific QOL revealed

no significant main effects of time. Both cardiac-specific QOL measures significantly

interacted with the covariate. Scores on the LVD-36 significantly varied by pre-NSRT R-

LVOT gradient (Pillai's Trace F [1,17] = 7.668, p = .013, qp2 = .311, observed power =

.742). In addition, scores on the MLHFQ significantly varied by gradient (Pillai's Trace

F [1,17] = 25.719, p < .001, q2 = .602, observed power = .998). Thus, change in cardiac-

specific QOL was dependent on disease severity at baseline, and therefore, the hypothesis

was not supported. After Bonferroni alpha corrections were made, the only significant

time effect with gradient as the covariate was cardiac-specific QOL using the MLHFQ.

Aim 3: Prediction Model

To determine whether psychological distress and well-being pre-NSRT predicted

3-month post-NSRT cardiac specific QOL two hierarchical multiple regression analyses

were conducted with the LVD-36 and MLHFQ at 3-month follow-up as the dependent

variables. Disease severity (R-LVOT gradient) was entered on the first step. Depression

(CES-D) was entered on the second step and satisfaction with life (SWLS) was entered

on the third step. It was predicted that after controlling for pre-NSRT disease severity,

patient's baseline level of clinical distress and well-being would uniquely predict post-

NSRT cardiac-specific QOL.

Initially, it was planned that both the CES-D and the STPI would be used to

measure distress and SWLS and LOT-R would be used to measure well-being. After

examining the zero-order correlations at baseline, both the STPI and LOT-R were

eliminated from the hierarchical regression analyses because of their collinearity with

CES-D and SWLS, respectively. The CES-D and SWLS were retained in the analyses









because, in the current sample, they demonstrated not only good but also stronger

reliability (Cronbach's a = .87 and .91, respectively) than the STPI (Cronbach's a = .77)

and the LOT-R (Cronbach's a = .26) (Pedhazur, 1997).

Results for the LVD-36

With the LVD-36 as the dependent variable, gradient, distress, or well-being

factors did not significantly account for unique change in variance. However, the full

model significantly predicted cardiac-specific QOL using the LVD-36 (F [3,15] = 3.333,

p = .048), without taking into account the Bonferroni alpha corrections (p = .008). The

full model explained 40.0% (Adjusted R2 = .280) of the variance in the LVD-36. Unique

significant predictors of the LVD-36 were R-LVOT gradient (/8= -.612, t = -2.601, p =

.020) and depression (/ = .695, t = 2.387, p = .031), indicating that higher gradient (more

severe disease) and less depression pre-NSRT predicted better cardiac-specific QOL

(lower scores indicate better QOL) at 3-month post-NSRT. However, these results were

nonsignificant after Bonferroni correction. See Table 8 for summary of regression

analysis.

Table 8. Summary of hierarchical multiple regression analysis for predictors of
CS-QOL using the LVD-36
b SEb P t p


Step One
R-LVOT gradient -.311 .169 -.409 -1.846

Step Two
R-LVOT gradient -.326 .158 -.428 -2.061
Depression .736 .402 .381 1.832

Step Three
R-LVOT gradient -.466 .179 -.612 -2.601
Depression 1.343 .563 .695 2.387
Life satisfaction 1.504 1.011 .464 1.488
Notes. Step one: R2 .167, Adjusted R2 = .118, F (1, 17) = 3.408, p = .082.
Step two: R2 change = .144, F change (1, 16) = 3.356, p = .086.
Step three: R2 change = .152, F change (1, 15) = 2.214, p = .157.
Total R2 =.400, Adjusted R2 = .280, F (3, 15) = 3.333, p = .048.


.082


.056
.086


.020
.031
.157









Results for the MLHFQ

Results were similar using scores on the MLHFQ as the dependent variable. R-

LVOT was significantly related to the MLHFQ, accounting for 22.1% (Adjusted R2 =

.175) of the variance (F [1, 17] = 4.827, p = .042). Entering depression into the model did

not explain uniquely significant variance, but the overall model including R-LVOT

gradient and CES-D was significant (F [2, 16] = 4.070, p = .037). Satisfaction with life

was not a significant addition to the model predicting MLHFQ. The full model was not

significant (F [3, 15] = 2.960, p = .066), explaining 37.2% (Adjusted R = .246) of the

variance in the MLHFQ, but R-LVOT gradient at baseline was demonstrated as the only

unique significant predictor of cardiac-specific QOL using the MLHFQ (/f= -.603,

t = -2.504, p = .024), suggesting that higher gradient (more severe disease) was

associated with better cardiac-specific QOL post-NSRT (lower scores indicate better

QOL) using the MLHFQ. See Table 9 for summary of multiple regression analysis.

Taken together, these two analyses do not support the hypothesis. Baseline distress and

well-being did not predict cardiac-specific QOL at 3-months post-NSRT.

Table 9. Summary of hierarchical multiple regression analysis for predictors of
cardiac-specific QOL using the MLHFQ
b SEb fP t p
Step one
R-LVOT gradient -.317 .144 -.470 -2.197 .042
Step Two
R-LVOT gradient -.329 .138 -.488 -2.393 .029
Depression .584 .349 .341 1.674 .114

Step three
R-LVOT gradient -.407 .163 -.603 -2.504 .024
Depression .921 .510 .538 1.806 .091
Life satisfaction .834 .917 .290 .910 .377
Notes. Step one: R = .221, Adjusted R2 =. 175, F (1, 17) = 4.827, p = .042.
Step two: R2 change = .116, F change (1, 16) = 2.801, p =. 114.
Step three: R2 change = .035, F change (1, 15) = .829, p = .377.
Total R2 = .372, Adjusted R2 = .246, F (3, 15) = 2.960, p = .066.









Exploring the Relationship between Depression and Quality of Life

Depression and QOL (both generic and cardiac-specific) were highly confounded

in this study and demonstrated collinearity at pre-NSRT and at 3-months post-NSRT (r >

.70). However, across time these variables were not related to each other in either

direction. In other words, depression at pre-NSRT was not significantly related to QOL at

3-months post-NSRT. Two out of three QOL measures (MLHFQ, PCS-12) at pre-NSRT

were not significantly related to the CES-D at 3-months post-NSRT, but the LVD-36 pre-

NSRT (r = .545, p = .016) was significantly related to CES-D post NSRT.

Depression Components

Due to the confounded relationships between depression and QOL, the CES-D

was divided into previously published factors to determine if there was a specific factor

driving the relationship. Four factors were calculated: depressed affect (7 items), somatic

activity (7 items), interpersonal problems (2 items), and positive affect (4 items) (Dikmen

et al., 2004). Item 9, "I thought my life had been a failure" is an example of a depressed

affect scale item. Item 7, "I felt that everything I did was an effort" is an example of a

somatic activity scale item. Along with the CES-D factors, the MLHFQ physical

dimension and emotional dimension were examined (Rector et al., 1987). Depressed

affect of the CES-D and emotional scale of the MLHFQ were collinear pre- and post-

NSRT, as were somatic activity of the CES-D and the physical dimension of the MLHFQ

were. An important relationship that evolved from these analyses was the significant, but

non-collinear relationship between the CES-D depressed affect scale and the MLHFQ

physical dimension at both pre-NSRT (r = .590, p = < .001) and post-NSRT (r = .654,

p = .002). This relationship was not significant over time, in either direction. An







60

additional notable finding was the significant, but non-collinear relationship between the

CES-D depressed affect scale and the LVD-36 pre-NSRT (r = .664, p < .001), suggesting

that separating out "depressed affect" may be the most applicable for measuring

depression in this sample, especially in relation to cardiac-specific QOL. See Table 10

for correlations between subscales of the CES-D and the QOL measures pre-NSRT.

Along with attempts to separate out important components of depression and

QOL, prevalence of depression was examined more closely. Prevalence of clinical

depression (CES-D > 16) pre-NSRT was remarkably high, with overall prevalence rates

reducing over time (55.8% to 35%), as did CES-D scores. Notably, despite the

improvements over time, of those who reported significant levels of depression at

baseline, 58.4% continued to report clinically significant depression.

New Prediction Model

Despite the significant relationships between depression and QOL, the

hypothesized model did not capture their relationship. Changing the direction of the

hypothesized model, depression at 3-month post-NSRT was significantly predicted by

cardiac-specific QOL at baseline in a two-step hierarchical multiple regression analysis,

performed post-hoc. The LVD-36 was used as the measure for cardiac-specific QOL

because throughout the analyses of the study, it appeared to be a cleaner and more valid

measure compared to the MLHFQ. Age and R-LVOT gradient at baseline were entered

in step one, significantly explaining 37.7% (Adjusted R2 = .299) of the variance in the

LVD-36 (F [2, 16] = 4.848, p = .023), with worse disease severity pre-NSRT was

associated with less depression at 3-months post-NSRT. The LVD-36 was entered on the

second step and explained significant unique variance (32.5%) in 3-months post-NSRT












Table 10. Zero-order correlations between depression subscales and QOL measures pre-NSRT
Variable 2 3 4 5 6 7 8 9 10 11
1 CES-D total .969** .912** .645** -.660** .762** .646** .821** .746** -.287 -.779**
2 CES-D depressed affect .865** .619** -.571** .737** .590** .813** .664** -.229 -.752**
3 CES-D somatic activity -.411** .873** .780** .880** .784** -.458* -.720**
4 CES-D interpersonal problems -.460** .318* .267 .456** .363* -.033 -.455*
5 CES-D positive affect -.269 -.318* -.378* -.505** .049 .563**
6 MLHFQ total .948** .924** .727** -.424* -.643**
7 MLHFQ physical .800** .808** -.703** -.522**
8 MLHFQ emotional .766** -.409* -.714**
9 LVD total -.586** -.700**
10 SF-12 physical health -.002
11 SF-12 mental health ---







62

depression scores. The full model significantly predicted depression at 3-months post-

NSRT, accounting for a total of 83.8% (Adjusted R2 = .702) in depression scores (F [3,

15] = 11.772,p < .001). Worse disease severity (/8= -.598, t= -4.221,p = .001) and

better cardiac-specific QOL (lower scores indicate better QOL) (/8= .573, t = 4.041, p =

.001) pre-NSRT predicted less depression at 3-months post-NSRT. This post-hoc

analysis seems to explain the relationship between depression and cardiac-specific QOL

better than the previous hypothesized model.















CHAPTER 5
DISCUSSION

This study is the first comprehensive outcome study examining the relationships

between psychological distress, well-being, and biomedical outcomes among HOCM

patients. Further, while many have examined NSRT from a biomedical perspective,

evaluating symptoms, outcome, and precision of the procedure in short and long-term

studies (Firoozi et al., 2002; Lakkis et al., 2000; Nielsen et al., 2002; Nielsen & Spencer,

2002), this is the first evaluation of NSRT from the patient's perspective and how

psychosocial parameters change over time. There were three main overall findings. First,

there was a high prevalence of clinical levels of depression in these pre-NSRT HOCM

patients. Second, HOCM patients' disease severity, depression, and QOL improved over

time and that disease severity at baseline was the primary determinant of change amongst

the psychosocial variables. Thirdly, in the hypothesized prediction model, psychosocial

variables tested here did not significantly impact health outcomes.

Patient Pre-NSRT Characteristics

Examining HOCM patients' characteristics pre-NSRT, scores demonstrated that

this group of patients is similar to other cardiac populations with NYHA class III or IV

symptoms in demographic characteristics and in quality of life measures. Most notable in

this study was the prevalence rate of depression appears to be higher than other heart

disease groups, exemplifying the need for psychological attention in this group.

Depression scores were comparable to other cardiac populations, but the proportion of









patients reporting significant depression was higher than in other cardiac populations

reported in the literature (Blumenthal et al., 2003). Patients in this study often suffered

from cardiac symptoms and functional impairments of significant duration before proper

diagnosis and before presenting to the HOCM clinic for NSRT evaluation. NSRT has

typically been the last line of defense in treating HOCM and patients are generally

managed with medications prior to considering this procedure. Continuing to be

symptomatic, patients present for NSRT evaluation, expressing frustration with

symptoms (e.g., shortness of breath, fatigue, chest pain), medical treatment, and

functional limitations (e.g., unable to walk a flight of stairs, care for children). Related to

symptoms of depression that were expressed, patients' noted poor satisfaction with life,

which was significantly related to not only depression, but also QOL.

This study included three separate measures of QOL, two cardiac specific, and

one generic measure. All three demonstrated strong convergent validity amongst each

other and indicated poor QOL in this sample of HOCM patients. Depending on

comparison group and type of measure used, these HOCM patients reported comparable

cardiac-specific QOL in some studies including those with NYHA class III or IV heart

failure patients (Rector et al., 1987). Yet, compared to other cardiac populations (e.g.,

chronic left ventricular dysfunction), medical populations, and the general population,

cardiac-specific QOL was worse in this sample of HOCM (Koenig, 1998; O'Leary &

Jones, 2000). Using a generic measure of QOL (SF-12), this sample of HOCM patients

reported worse QOL than CHF patients and other medical conditions, and therefore, was

also worse than Cox and colleagues' (1997) sample whose scores were akin to CHF

patients. Cox and colleagues' (1997) patient sample was comprised of HCM patients

with or without obstruction; therefore, it is probable that the current sample was









comprised of patients with more severe disease, and subsequently reported more/worse

symptoms and more limitations.

Depression and Quality of Life

When examined cross-sectionally, depression and QOL were highly significantly

related to each other both at baseline and at 3-month post-NSRT. Their relationship was

so strong, that they could be considered collinear, measuring almost identical information

when measured simultaneously. Findings suggest that depressive symptoms may be the

main component of QOL in this sample of HOCM patients, rather than one of several

components that comprise QOL, and therefore, they are highly confounded. When the

CES-D was divided into four factors from previous research, collinear relationships

between the four factors and QOL still existed in many of the correlations. The key

relationship that was highlighted in these analyses was the relationships between the

CES-D depressed affect scale, MLHFQ physical dimension scale, and the LVD-36 scale.

Separating out depressed affect from other components of depression allowed the

relationship to be significant while maintaining uniqueness, suggesting greater validity

for measuring depression in this sample. This was also seen when separating the physical

and emotional components of QOL.

It is well known that depression and illness are often comorbid, and that

depression includes somatic symptoms that can be misinterpreted as medical symptoms

and vice versa. The findings with the subscales of the CES-D (particularly the depressed

affect and somatic activity scales) support the intermingled relationship. The confounded

relationship is difficult not only in terms of research measurement, but also in terms of

clinical diagnosis and treatment. Patients and medical providers may misinterpret their

depressive symptoms as cardiac symptoms or the opposite way around. This may result









in either under or over reporting of cardiac symptoms and likewise with depressive

symptoms, and subsequently patients may be misdiagnosed or mistreated, undermining

outcome or treatment response.

Patient Characteristic Conclusions

Overall, the reported levels of depression, poor satisfaction with life, and QOL

were worse than other cardiac and the general populations. Therefore, patients'

experience of physical and emotional symptoms was worse than hypothesized,

highlighting the need for routine psychological assessment and intervention. Attention to

the patients' experience of disease and its impact can play a critical role in medical and

psychological treatment of the patient and its outcome.

A key treatment element for these patients is focus on enhancing QOL pre-NSRT,

which may then subsequently reduce depression. Psychosocial treatments that are

developed from a cognitive-behavioral approach can help patients cope with current

symptoms, prepare for NSRT, and may also help with recovery. Changing perceptions

(i.e., cognitive restructuring) of symptoms, disease, treatment would likely enhance QOL

and decrease depression. Areas that cognitive-behavioral therapy can target are patients'

fear and worry of the procedure that involves creating a controlled heart attack. Another

target area for therapy is expectations of the procedure, making sure they are realistic and

that the patient is prepared for symptom reduction that may not meet expectations.

Efficacy of Nonsurgical Septal Reduction Therapy

Based on the repeated measures analyses, it appears that NSRT is an effective

medical procedure in not only reducing LVOT gradient, consistent with the literature

(Lakkis et al., 2000; Nielsen et al., 2002; Ralph-Edwards et al., 2005), but also in

reducing levels of depression, anxiety, and improving cardiac-specific QOL in patients









with HOCM. The latter findings are much needed additions to the current literature. It

appears that even without a change in psychiatric treatment (i.e., psychotherapy,

psychotropic medications), depression and QOL improved from pre- to post-NSRT. This

suggests that favorable improvement in HOCM symptoms is associated with

improvement in depressive symptoms and overall QOL or that they are highly

confounded.

While depression and QOL improved greatly over time, scores 3-month post-

NSRT were still only comparable to other cardiac populations, rather than reporting as

good or as healthy as the general population. These patients were a highly select, highly

symptomatic sample of cardiac disease. Therefore, while they made dramatic

improvements, statistically and clinically, they are moving from outlier status to closer to

the mean of the greater heart disease distribution. Importantly, while depression scores

decreased from pre- to post-NSRT, prevalence rate was still considerable. Further, those

who reported clinically significant depression pre-NSRT, a majority of them continued to

report elevated levels of depression 3-months post-NSRT. Therefore, it is critical to

recognize and treat these patients for depression beyond the NSRT procedure.

Similar patterns of change emerged with the addition of baseline R-LVOT

gradient as a covariate. There were improvements in depression and cardiac-specific

QOL from pre-NSRT to 3-month post-NSRT, but they were dictated by disease severity

pre-NSRT linearly. The findings are interesting by themselves; however, it was

hypothesized that significant change in psychosocial and QOL variables would occur

even after controlling for disease severity. Thus, the findings did not support the

hypothesis. This relationship between disease severity, QOL and depression is also seen

in previous studies (Ford et al., 1998; Rumsfeld et al., 2003; Vaccarino et al., 2001).









Increasing disease severity, impacts physical, social, emotional functioning, which can

also be associated with depression and epitomizes the biopsychosocial model of health

and wellness. Change across time, contingent on disease severity was shown, and the

next step was to determine a model of prediction, or direction of these relationships.

Thus, the biopsychosocial model was tested to examine direction over time.

Biopsychosocial Model and Prediction

Literature has shown that patients who are more distressed report greater physical

symptoms and/or disease and worse QOL (Carels, 2004; Duits et al., 1997; Rector, 2005;

Zvolensky et al., 2003). It was predicted that pre-NSRT psychological distress and well-

being would be related to post-NSRT cardiac-specific QOL. This was not found in the

current study. Using the LVD-36 as the measure for cardiac-specific QOL, depression

pre-NSRT was associated with LVD-36 scores at 3-months post-NSRT. But the results

with the MLHFQ indicated that baseline psychosocial characteristics did not predict

cardiac-specific QOL 3-months following NSRT procedure. Further evaluating the

hypothesis with the subscales of the CES-D and the MLHFQ also did not lead to a

significant prediction model. In the present analyses, pre-NSRT reported psychological

health did not predict future patient-reported symptom experience (cardiac-specific

QOL).

While the model was theoretically sound, it was not statistically significant. This

could be due to several reasons. It may be that in this sample, the relationships exist and

were not able to be captured due to sample size. Had the study only used the LVD-36 to

measure cardiac-specific QOL, the data would have supported the hypothesis; however,

two measures were used to increase sensitivity of cardiac-specific QOL and to compare

validity amongst the two. It also may be that the relationships exist, but in the opposite







69

direction. Seen in the post-hoc analyses, cardiac-specific QOL pre-NSRT was associated

with future psychological distress and well-being. It is highly probable that clinically the

relationship is bi-directional, but cannot be seen statistically in this sample.

Extending the Findings

The mechanism yielding a change in depression needs to be considered. Over

time, from pre- to post-NSRT, disease severity, depression, and QOL improve. Among

pre-NSRT variables, R-LVOT gradient was not significantly related to either depression

or QOL at baseline. Yet, according to the findings, it appears that disease severity has a

strong impact on these two constructs over time. In fact, pre-NSRT R-LVOT gradient

was inversely related to depression and QOL at 3-months follow-up.

There are several possible reasons for the improvements in depression and QOL,

as well as the inverse relationship between baseline disease severity and the patients'

reported experience over time. It may be that patients who start out with worse disease

severity have more room for improvement over time. Their condition may have been so

severe and disruptive that any reduction in symptoms is perceived as an improvement,

and subsequently QOL and depression improved as well. Patients experiencing a

reduction in symptoms are able to engage in more activities, have less limitations or

impairments, and enjoy their life more fully, at least relative to before NSRT. Another

plausible explanation is that patients accept their condition and symptoms over time, and

therefore, were less negatively impacted as they continue to live their lives. Finally,

applying cognitive dissonance theory (Festinger, 1957), patients experiencing severe

disease pre-NSRT, and then choosing to undergo a relatively new and controversial

procedure will perceive their post-NSRT health status favorably so that it is congruent

with all that they have suffered through (i.e., disease severity, procedure). All these









mechanisms would likely lead to improved depression and QOL. Furthermore, the

relationship between symptoms and depression may be moderated by QOL and/or

cognitive appraisals.

The model of QOL moderating the relationship between symptoms and future

depression was seen in the post-hoc multiple regression analysis, and it appeared to fit

the relationship better than the hypothesized model. Baseline disease severity and

cardiac-specific QOL predicted depression at 3-months post-NSRT, which is still

consistent with current literature among medical illness populations, including CHF

(Rumsfeld et al., 2003). Based on this last analysis, it appears that HOCM patients who

are doing poorly pre-NSRT have more opportunity for improvement, and thus, when

symptoms improve drastically, they report improved mood 3-months post-NSRT. Thus,

intervening with psychosocial treatment targeted at improving cardiac-specific QOL pre-

NSRT may improve later depression after NSRT.

Limitations

While this study is groundbreaking in the HOCM and NSRT literature, there are

also areas for improvement in design, acquisition of data, and in statistical analyses. This

study was simple in its quasi-experimental design and limited in scope of size and

follow-up durations, which limits study conclusions. As with any longitudinal study,

attrition can be a problem, and was the most significant limitation to the study. This study

had a 55.6% attrition rate, mostly due to patients not returning to their cardiology clinic

follow-up appointment. Because of the high attrition rate, the sample size was smaller

than anticipated, and therefore, constrained planned statistical analyses. Future studies

should consider design revisions. For example, mailing questionnaire packets to

participants or having questionnaires on a secure Internet website may resolve some









attrition issues, at least in terms of psychosocial data. Another solution would be to add

additional centers for participant recruitment.

In terms of statistical analyses, sample size was determined, during study

development, based on medical variables (i.e., R-LVOT gradient) and QOL as a

guideline for power analyses. Examining the current data, analyses with these variables,

with the current sample size, have large effect sizes and more than sufficient power to

detect true change. In contrast, examining psychosocial constructs (e.g., depression,

anxiety, optimism), the current sample size did not allow for adequate power to detect

change and indicated that the study would need hundreds of more participants (i.e., N>

150) to reach an adequate power of .80. Critical variables were confounded in this study,

and variables that may contribute information to this population and treatment were not

included because of the project's simplicity.

Lastly, it is believed that this sample is representative of HOCM patients

undergoing NSRT because patients were recruited from two independent institutions.

However, the sample may not be representative of all HOCM patients, or HOCM patients

choosing other treatment options. All patients in this study were severely ill and

symptomatic, seeking out a relatively new treatment done by a few interventionalists.

More research is needed in this area, with larger sample sizes and with patients utilizing

different treatments and with a range of disease severity.

Clinical and Research Implications

This study has positive implications for the fields of cardiac psychology and

interventional cardiology. The study provided a well-rounded description of HOCM

patients, medically, symptomatically, and psychologically, incorporating both objective

and subjective indices. These findings can be used in development and implementation of









psychosocial treatments, particularly those based in a cognitive-behavioral framework.

HOCM patients present to the cardiology clinics with cardiac and psychologic symptoms

that are difficult to distinguish and would likely be better addressed by the inclusion of a

health psychologist as part of the treatment team. Collectively, findings indicate the need

for multidisciplinary care of HOCM patients, regardless of NSRT as a treatment choice.

The prevalence rate of depression, along with a majority of those whose

depression did not improve, was a compelling finding, one that needs utmost attention.

Knowing that these patients pre-NSRT may be at particularly high risk for depression

and its maintenance, members of the medical team can be trained to discern symptoms of

depression from cardiac symptoms and then request appropriate consult from and referral

to a health psychologist. A key treatment element for these patients is focus on both

cognitive and behavioral techniques, enhancing QOL and cognitive appraisals, both pre-

and post-NSRT, which may then subsequently reduce depression.

Psychosocial and QOL outcomes were overshadowed by disease severity, as

measured by a biomedical marker. Baseline disease severity was inversely related to

outcomes at 3-months post-NSRT, such that starting with worse severity and symptoms

was associated with less depression and better QOL after NSRT. These data provide

preliminary, short-term data, and are the starting point of development of clinical

outcome trials, multidisciplinary care, and highly specialized treatment aimed at

symptom reduction and QOL enhancement. To fully understand the relationship between

these three constructs more powerful studies are needed and evaluating outcomes over a

longer period of time. Taking this study one more step would be to develop identification

methods of depression, enabling prediction of those who are depressed prior to

intervention and does not improve over time. Examining psychological distress, well-







73

being, and QOL in patients receiving myectomy vs. NSRT, and in patients who may have

undergone both procedures, would also be beneficial to the literature and in patients'

treatment and outcomes. Other beneficial studies would be evaluating patients recently

diagnosed with HOCM, as well as patients who choose not to undergo NSRT. Critical to

NSRT efficacy trials are longer-term studies evaluating outcomes from a biopsychosocial

perspective.

Conclusions

There are two critical conclusions from this project. The first is the psychosocial

status of these HOCM patients pre-NSRT. They reported clinically significant levels of

depression and depression was more prevalent compared to patients with other cardiac

diseases and to the general population. These patients also reported poor QOL compared

to other medical populations, including those with cardiac disease. Literature has

established that baseline psychosocial status can impact treatment outcomes and

recovery; therefore, these patients are prime candidates for psychological intervention

pre-NSRT.

The second conclusion from this study is that NSRT is an effective procedure in

reducing R-LVOT gradient, depression and QOL, over the first three months after NSRT.

Despite no changes in psychiatric treatment, patients reported dramatic improvements in

mood and QOL. These improvements appeared to be dictated by disease severity at

baseline. It is hypothesized that the relationship between medical health and depression is

moderated by QOL. Future research is needed to test this model and to look at long-term

effectiveness of NSRT on depression and QOL.















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BIOGRAPHICAL SKETCH

Eva R. Serber was born December 15, 1975, to Mary Lynn Serber and Russell

Paul Serber. She was born and raised in Newport Beach, California, with her older sister

Carolyn. She graduated from Corona Del Mar high school in 1994, after which she

moved to San Diego, California. Eva earned a bachelor's degree in psychology, with a

minor in speech communications, from the University of San Diego in 1998. She earned

a master's degree in preclinical psychology from San Diego State University in 2001.

Since 2001, Eva has been a doctoral student at University of Florida in the

Department of Clinical and Health Psychology, specializing in clinical health

psychology. Eva's predoctoral internship will be at the Medical University of South

Carolina, in Charleston, from 2005-2006, after which she will have fulfilled all

requirements for her doctorate. Eva's career goals are to continue integration of patient

care and research. Her ultimate goal is to be a psychologist in a heart center or other

medical institution, providing consultative, assessment, and treatment services to cardiac

patients, alongside conducting research on treatment outcomes and quality of life.