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The Unique effects of the implantable cardioverter defibrillator

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Title:
The Unique effects of the implantable cardioverter defibrillator : the female perspective
Creator:
Sowell, Lauren Vazquez ( Dissertant )
Sears, Samuel F. ( Thesis advisor )
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Gainesville, Fla.
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University of Florida
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2006
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English

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Subjects / Keywords:
Anxiety ( jstor )
Body image ( jstor )
Death ( jstor )
Defibrillators ( jstor )
Demography ( jstor )
Heart diseases ( jstor )
International Statistical Classification of Diseases ( jstor )
Psychological research ( jstor )
Psychosociology ( jstor )
Women ( jstor )
Clinical and Health Psychology thesis, M.S
Dissertations, Academic -- UF -- Clinical and Health Psychology
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bibliography ( marcgt )
theses ( marcgt )

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Abstract:
Abstract of Thesis Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science THE UNIQUE EFFECTS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: THE FEMALE PERSPECTIVE By Lauren Vazquez Sowell May 2006 Chair: Samuel F. Sears, Jr. Major Department: Clinical and Health Psychology Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are a particularly at-risk group for developing psychological distress secondary to cardiac disease. The aim of the study was to examine the intersex differences between women and men, and the intragroup differences among women, with implantable cardioverter defibrillators. One hundred thirty-two ICD patients were recruited at three medical centers: Shands Hospital at the University of Florida, Brigham and Women s Hospital in Boston, and Royal North Shore Hospital in Sydney, Australia. Seventy-one women and 61 men completed individual psychological assessment batteries, measuring the constructs of shock anxiety, death anxiety, body area satisfaction, and body image concerns. Medical record review was conducted for all patients regarding cardiac illnesses and ICD specific data. Results revealed significant differences between males and females in their reported levels of shock anxiety, such that women in the study reported higher rates of shock anxiety (F (2,128) = 3.552, p = 0.03, ?p2 = 0.053). The investigation of intrasex differences among females revealed that younger women (? 50 years of age) reported significantly higher rates of death anxiety than women over the age of 65 (F (2,68) = 3.681, p = 0.03, ?p2 = 0.098) and significantly lower body area satisfaction and greater body image concerns than women aged 51 to 64 (Pillai s trace = 0.133, p = 0.05, ?p2 = 0.067). The present study identifies a subgroup of female ICD patients at risk for the development of distress subsequent to device implantation. Young women appear to be highly at risk for the development of psychosocial maladjustments across the domains of shock anxiety, death anxiety, and body image. Results suggest that more rigorous assessment and research are indicated in female ICD recipients under the age of 50. Collectively, findings from this study suggest that ICD patients who report elevated feelings of death and shock anxiety, as well as body image dissatisfaction or concerns, warrant considerable attention by healthcare professionals in an effort to minimize adjustment difficulties and possible declines in quality of life after ICD implantation.
Subject:
arrhythmia, body, cardiac, cardioverter, death, defibrillator, device, gender, heart, implantable, shock, women
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Includes vita.
Thesis:
Thesis (M.S.)--University of Florida, 2006.
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Includes bibliographical references.
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Text (Electronic thesis) in PDF format.

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THE UNIQUE EFFECTS OF THE IMPLANTABLE CARDIOVERTER
DEFIBRILLATOR: THE FEMALE PERSPECTIVE















By

LAUREN VAZQUEZ SOWELL


A THESIS PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
MASTER OF SCIENCE

UNIVERSITY OF FLORIDA


2006

































Copyright 2006

by

Lauren Vazquez Sowell















ACKNOWLEDGMENTS

I am privileged to extend my appreciation to Dr. Samuel F. Sears, my mentor, for

his continued guidance and support in the pursuit of this project. I would also like to

thank Dr. Jamie B. Conti for her gracious involvement in this research. I am deeply

honored and grateful to have worked collaboratively with several colleagues, without

whom this project would not have been possible: Julie Bishop Shea, MS, RNCS, of

Brigham and Women's Hospital in Boston, Massachusetts, and Ann Kirkness, RN, CNS,

of Royal North Shore Hospital in Sydney, Australia.

I would also like to extend thanks to my parents, Paul and Teresa Vazquez, and my

husband, David Sowell, for their unbounded love and encouragement.
















TABLE OF CONTENTS

page

A C K N O W L E D G M E N T S ................................................................................................. iii

LIST OF TA BLES .............. .......................... ............ ...................... vi

ABSTRACT .............. ..................... ........... .............. vii

CHAPTER

1 IN TR O D U C TIO N ......................................................................... .... .. ........

2 L ITER A TU R E R E V IEW ............................................................................ ........ .4

S h o c k A n x iety ..............................................................................................................4
D death A anxiety ........................................................................ .. ...... ........ 4
B ody Im age ....................................................... .................... 6
H y p oth eses ..................................................... ......................... 7
Question 1: Intersex Differences ...................................... .................. ....... 7
Q question 2: Intrasex D differences .................................... .................................... 8

3 M E TH O D S .................................................................9

P ro c ed u re .................................................................................................... . 9
S am p le ............................................................................ . 9
M e a su re s .......................................................................................................1 5

4 R E S U L T S ........................................................................................................1 8

Intersex D ifferen ces ............................................................................... 18
Intrasex D ifferen ces ............................................................................... 2 0

5 D ISC U S SIO N ............................................................................... 22

Sum m ary of Results.............................................. 22
Strength s and L im itation s ...................................................................................... 24
C lin ical Im p licatio n s.............................................................................................. 2 6
Research Implications.............................................. 28
C conclusion ....................................................................................................... ........ 29

LIST O F R EFEREN CE S ........................................................................................... .......... 31









B IO G R A PH IC A L SK E T C H ...................................................................... ..................36
















LIST OF TABLES

Table pge

2-1 H hypothesis 1, A analysis 1 .................. .. .... .................... .... ....... ................ .7

2-2 H hypothesis 1, A analysis 2 ............................................................. ........................ 7

2-3 H hypothesis 2, A analysis 1 .............................................................. ....................... 8

2-4 H hypothesis 2, A analysis 2 ............................................................. ........................ 8

3-1 Dem graphic variables of total sample ........................................... ............... 10

3-2 D em graphic variables by gender .......................... ......................... ...... ......... 11

3-3 M medical variables of total sam ple........................................ ........................... 12

3-4 Demographic variables by gender ................... .. ......................... ............... 13

3-5 Recruitm ent locations of total sam ple ............................................. ............... 13

3-6 Demographic variables by recruitment site........................ ..... ...............14

3-7 M medical variables by recruitm ent site.................................... ......................... 15

4-1 Psychosocial m eans of total sam ple ........................................ ....................... 19

4-2 Psychosocial means of females by age group .............. .............................21















Abstract of Thesis Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Master of Science

THE UNIQUE EFFECTS OF THE IMPLANTABLE CARDIOVERTER
DEFIBRILLATOR: THE FEMALE PERSPECTIVE

By

Lauren Vazquez Sowell

May 2006

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

Significant rates of psychological distress occur in implantable cardioverter

defibrillator (ICD) patients. Research has demonstrated that women are a particularly at-

risk group for developing psychological distress secondary to cardiac disease. The aim of

the study was to examine the intersex differences between women and men, and the

intragroup differences among women, with implantable cardioverter defibrillators.

One hundred thirty-two ICD patients were recruited at three medical centers:

Shands Hospital at the University of Florida, Brigham and Women's Hospital in Boston,

and Royal North Shore Hospital in Sydney, Australia. Seventy-one women and 61 men

completed individual psychological assessment batteries, measuring the constructs of

shock anxiety, death anxiety, body area satisfaction, and body image concerns. Medical

record review was conducted for all patients regarding cardiac illnesses and ICD specific

data.









Results revealed significant differences between males and females in their

reported levels of shock anxiety, such that women in the study reported higher rates of

shock anxiety (F (2,128) = 3.552, p = 0.03, r2 = 0.053). The investigation of intrasex

differences among females revealed that younger women (< 50 years of age) reported

significantly higher rates of death anxiety than women over the age of 65 (F (2,68) =

3.681, p = 0.03, rp2= 0.098) and significantly lower body area satisfaction and greater

body image concerns than women aged 51 to 64 (Pillai's trace = 0.133, p = 0.05, r2 =

0.067).

The present study identifies a subgroup of female ICD patients at risk for the

development of distress subsequent to device implantation. Young women appear to be

highly at risk for the development of psychosocial maladjustments across the domains of

shock anxiety, death anxiety, and body image. Results suggest that more rigorous

assessment and research are indicated in female ICD recipients under the age of 50.

Collectively, findings from this study suggest that ICD patients who report elevated

feelings of death and shock anxiety, as well as body image dissatisfaction or concerns,

warrant considerable attention by healthcare professionals in an effort to minimize

adjustment difficulties and possible declines in quality of life after ICD implantation.














CHAPTER 1
INTRODUCTION

Sudden cardiac death (SCD) accounts for over 450,000 deaths per year in the

United States and is currently the highest ranked cause of mortality, claiming more lives

annually than stroke, lung cancer, breast cancer, and AIDS combined. Sudden cardiac

death is precipitated by the onset of life-threatening ventricular tachyarrhythmias,

resulting in death if not promptly defibrillated (e.g., within 10 minutes) (American Heart

Association, 2004). The implantable cardioverter defibrillator (ICD) is a biomedical

device designed to contravene potentially lethal arrhythmias by automatic delivery of an

electrical cardioverting shock to defibrillate the heart and restore normal sinus rhythm.

The ICD is now implanted in approximately 150,000 Americans each year and

randomized trials have demonstrated its superiority to pharmacological interventions in

reducing mortality in patients at-risk for SCD (Antiarrhythmics Versus Implantable

Defibrillators Trial Investigators, 1997; Bardy et al., 2005; Buxton, Lee, & Fisher, 1999;

Moss et al., 1996). The implant rate of the ICD is likely to continue to rise dramatically,

as its indications are broadened.

Despite the success of the ICD in preventing SCD, research indicates that the

psychological impact of living with a defibrillator can be significantly distressing for

recipients. Symptoms of fear and anxiety are considered the most common psychological

response of device recipients, with 24-87% of patients reporting symptoms of anxiety

(Sears & Conti, 2003), and 24-38% reporting elevated levels of depression (Sears et al.,

1999). Collectively, these rates are significantly higher than the general population and









have prompted current researchers to examine how symptoms of psychological distress

may affect the etiology of cardiac illness.

In patients with cardiac disease, the evidence that psychological distress can affect

both quality of life (QOL) and health outcomes has been described as "clear and

convincing" (Rozanski, Blumenthal, & Kaplan, 1999, p. 2192). Moreover, the impact of

psychological distress is thought to "strongly influence the course of cardiac disease"

(Rozanski et al., 2005, p. 637). Implantable cardioverter defibrillator patients are

vulnerable to the development of psychological distress due to many factors, including

ICD shock, the recognition of their potential mortality by cardiac disease, and the

perceived lack of control over their medical condition (Sears et al., 1999). As such, ICD

patients have been recognized as an appropriate population for the study of the

development of distress (Godeman et al., 2001).

Research has recognized females with cardiac illness as a particularly at-risk group

for the development of psychological distress secondary to their disease (Chin &

Goldman, 1998; Con et al., 1999; Frasure-Smith et al., 1999; Holahan et al., 1995;

Mendes de Leon et al., 2001; Vaccarino, Lin, & Kasl, 2003; Ziegelstein, 2001). Among

populations of patients with congestive heart failure (CHF), females have consistently

exhibited worse quality of life than males as well as increased rates of depression

(Gottlieb et al., 2004). Since CHF patients frequently require ICD implantation

congruent with their cardiac disease progression, this population of females is explicitly

at risk for adjustment difficulties (Holahan et al., 1995; Ziegelstein, 2001). Female

recipients face unique challenges with the ICD by its impact on their femininity,

sexuality, and body image satisfaction (Walker et al., 2004). Traditional ICD placement









often produces visible scarring and bulging around the implant site, presenting a

particularly sensitive problem for women, whose clothing often leaves this part of the

upper body exposed. Previous research examined quality of life among young ICD

patients (Dubin et al., 1996), the majority of which were female, revealing significant

patient concerns about the impact of the device on clothing fit (63%), socialization

(75%), and sexual activity (50%). Despite these data, there is a paucity of literature in

the examination of female-specific adjustment to living with an ICD. In epidemiological

studies examining sex differences in depression and anxiety among the general

population, women report clinical levels of depressive and anxious symptomatology with

nearly twice the frequency of men (APA, 1996; Kessler et al., 1994; Regier, 1994).

Therefore, the investigation of sex differences in psychological sequelae among ICD

recipients is largely warranted.














CHAPTER 2
LITERATURE REVIEW

The following sections review literature as it applies to patient adjustment to the

ICD. The female-specific adjustment issues for ICD patients are addressed across the

domains of shock anxiety, death anxiety, and body image.

Shock Anxiety

To prevent SCD in the event of an arrhythmia, the ICD delivers an electrical shock

to terminate the potentially lethal arrhythmia and restore normal heart rhythm. Within

the first year of implantation, approximately 40 to 42% of ICD patients will experience a

shock, 22% will receive 2 or more shocks, and 17% will sustain 3 or more shocks

(Credner et al., 1998). In short, shock is a common experience for many ICD patients.

Sears and Conti (2002) state that patients who have a history of ICD firings are at

particular risk for psychosocial difficulties. Recent research indicates that ICD patients

who receive shocks experience more depression and anxiety, and have poorer adjustment

to the device than patients who receive no shocks (Godeman et al., 2004; Kohn et al.,

2000). Even in the minority of ICD patients who do not experience shocks, shock

anxiety may result in increased avoidance behaviors and a perceived limitation in

performing everyday activities (Sears & Conti, 2003). As such, the examination of shock

anxiety in ICD populations is warranted.

Death Anxiety

Death anxiety is a multidimensional construct that is characterized by cognitive and

affective changes, physical alterations, stress, and even pain (Lonetto & Templer, 1986).









Death anxiety has been described as a dynamic factor that changes with an individual's

age, experiences, and health. Tomer and Eliason (2000) define death anxiety as the

anticipation of a state in which the self does not exist, which is variable in intensity over

time.

In the existing literature, gender is considered a moderating factor in the occurrence

of death anxiety. Research has established that women report higher levels of death

anxiety, on average (lammarino, 1975; Schulz, 1979; Templer, Ruff, & Franks, 1971).

Death anxiety research to date has traditionally used Templer's (1970) Death Anxiety

Scale (DAS), to reveal that female participants display higher levels of death anxiety than

do males, regardless of the sample population. However, more recently Neimeyer (1993)

found that even when controlling for emotional expressiveness among gender, female

participants endorsed greater death anxiety on the DAS compared to their male

counterparts. The differences in the incidence of death anxiety among gender have been

established in a variety of populations of men and women, including students, parents,

psychiatric patients, and hospital staff (Templer et al., 1971). Unfortunately, no studies

to date have examined this potential relationship in the context of cardiac disease.

The experience of death anxiety can be particularly salient in the presence of a life

threatening illness. As an individual is faced with a life-changing event such as diagnosis

of cardiac disease or the survival from sudden cardiac arrest, the frequency and intensity

of death anxiety is likely to increase. Despite the heuristic value of this phenomenon,

there is a notable absence of research devoted to examining death anxiety among cardiac

populations.









Body Image

Implantation of an ICD produces noticeable scarring that can affect body image in

recipients. Body image satisfaction is a prevalent issue in women's health research and

poses particular relevance for female ICD recipients. Socially visible scars, similar to

those created by implantation of an ICD, have been associated with poor self-ratings of

appearance, appearance satisfaction, and appearance-related anxiety (Dubin et al., 1996;

Lawrence et al., 2004). Several comparisons can be made between women who receive

ICDs and women who undergo surgical treatment for breast cancer. In a recent study by

Hoeller et al. (2003), women who had undergone breast conservation treatment rated the

presence of highly visible scars as the single most important determinant of their

perception of the cosmetic outcome of the surgery. Similarly, women have reported

significant displeasure with the cosmetic outcome of their surgery and the accompanying

sexual and body image sequelae, and continued to overestimate their risk of developing

future cancer (Payne et al., 2000). This scenario is strikingly similar to those women who

receive ICDs for primary prevention of future cardiac events. Despite their protection

from premature sudden cardiac death by the device, patients have a tendency to

overestimate their potential mortality by their heart condition (Sears, Shea, & Conti,

2005). Congruous with the breast cancer literature, the changes in physical appearance

that female ICD recipients experience may constitute difficulties in their perception of

body image. Research indicates that women in general are more concerned with body

image, possibly due to societal expectations that pressure women to strive for

attractiveness. This pressure regarding their physical appearance may affect a woman's

social experiences, mood, and overall quality of life (Wolszon, 1998).









Unfortunately, there has been little examination of the impact of cardiac surgery on

female body satisfaction (Allen & Wellard, 2001). Although several studies have

examined cardiac disease and body image in the context of perceived physical

functioning, there has been virtually no examination of the impact of defibrillators on

body image (Lichtenberger et al., 2003). The potential dissatisfaction of cosmetic

outcome of device placement and consequent body image sequelae may act as a catalyst

for psychological distress in female ICD patients.

Hypotheses

Question 1: Intersex Differences

Do female or male ICD patients experience different levels of shock anxiety, body

area satisfaction, and body image concerns?

Hypothesis. Female ICD patients will report more shock anxiety and body image
concerns, and less body area satisfaction than male patients.

Participants. All female and male ICD patients.

Analysis. An ANCOVA and a MANCOVA will be performed to determine if sex
affects shock anxiety, body area satisfaction, and body image concerns reported by
ICD patients.

Table 2-1 Hypothesis 1, Analysis 1
Variables Statistical analysis Participants

DV = Shock anxiety ANCOVA Females
Males
IV = Sex

Table 2-2 Hypothesis 1, Analysis 2
Variables Statistical analysis Participants

DV = Body satisfaction MANCOVA Females
Body image concerns Males

IV = Sex









Question 2: Intrasex Differences

Do young, middle-aged, or older female ICD patients experience different levels of

shock anxiety, death anxiety, body area satisfaction, and body image concerns?

Hypothesis. Younger women will report higher rates of shock anxiety, death
anxiety, and body image concerns, and less body area satisfaction.

Participants. Female ICD patients

Analysis. MANOVAs will be performed to determine if age affects shock anxiety,
death anxiety, body area satisfaction, and body image concerns reported by female
ICD patients.

Table 2-3 Hypothesis 2, Analysis 1
Variables Statistical analysis Participants

DV = Shock anxiety MANOVA Females
Death anxiety
IV = Age

Table 2-4 Hypothesis 2, Analysis 2
Variables Statistical analysis Participants

DV = Body satisfaction MANOVA Females
MANOVA Females
Body image concerns
IV = Age














CHAPTER 3
METHODS

Procedure

Female and male ICD patients were recruited during outpatient cardiac clinic

appointments at one of three enrollment sites: Shands Hospital at the University of

Florida, Brigham and Women's Hospital in Boston, or Royal North Shore Hospital in

Sydney, Australia. After an introduction of the study and gathering of informed consent,

patients were provided with individual psychological assessment batteries, and asked to

complete the questionnaires and return them to the researcher prior to leaving the clinic.

The assessment battery took approximately 15-25 minutes to complete. Upon completion

and submission of the assessment questionnaires, patients completed their participation in

the study. Medical record review was conducted for information regarding cardiac

illnesses and ICD specific data.

Sample

The mean age of the sample was 61.30 years (SD = 14.28) with a range of 23 to 92

years of age. Of the 132 individuals who participated in the study, 61 were male (46%)

and 71 were female (54%). Ethnically, 91% of participants self-rated as Caucasian, 6%

rated as African American, 2% rated as Asian/Pacific Islander, and 1% rated as

Hispanic/Latino. The majority of participants were married (73%), 8% reported being

separated or divorced, 8% reported being single, and 7% and 3% reported being widowed

and living with a partner, respectively. Of the total sample, 42% had earned a high

school diploma or less, 38% had earned a college degree, and 21% had completed a









graduate degree. Table 3-1 provides demographic information for the total sample of

ICD patients. Table 3-2 provides complete demographic information categorized by

gender.

Table 3-1 Demographic variables of total sample (N = 132)
Demographic n / %

Gender
Males 61 (46.2%)
Females 71 (53.8%)

Mean age 61.30 (SD = 14.28)

Ethnicity
Caucasian 90.9%
African American 6.1%
Asian/Pacific Islander 2.3%
Hispanic/Latino 0.8%

Marital status
Married, remarried 73.4%
Separated, divorced 8.1%
Single, never married 8.1%
Widowed 7.3%
Living with partner 3.2%

Education
High school degree or less 41.6%
College degree or less 37.5%
Graduate 20.9%

Employment
Retired 50%
Disability/ government 17.7%
Full time 16.2%
Part time 9.2%
Homemaker 6.2%
Unemployed 0.8%









Table 3-2 Demographic variables by gender

Demographic Males Females Test statistic p-value


Mean age* 67.36 56.08 F (1,130) = 24.07 p = 0.01

Ethnicity
x = 5.14, df 3 p = 0.16
Caucasian 96.7% 85.9%
African American 1.6% 9.9%
Asian/Pacific Islander 1.6% 2.8%
Hispanic/Latino 0.0% 1.4%


Marital status Z2 =5.62, df 3 p = 0.23
Married, remarried 80.7% 67.2%
Separated, divorced 8.8% 7.5%
Single, never married 3.5% 11.9%
Widowed 3.5% 10.4%
Living with partner 3.5% 3.0%



Education* X/ = 7.15, df= 2 p = 0.03
High school or less 38.9% 43.9%
College degree or less 29.7% 43.9%
Graduate 31.5% 12.1%


Employment* X2 = 21.11, df= 5 p = 0.01
Retired 68.3% 34.3%
Disability 10.0% 24.3%
Full time 16.7% 15.7%
Part time 5.0% 12.9%
Homemaker 0.0% 11.4%
Unemployed 0.0% 1.4%

*indicates significant difference

Patients' medical records were reviewed to obtain the following information.

Mean time since ICD implantation was 3.47 years (SD = 2.77). Fifty-one percent of

patients were diagnosed with an Ischemic Cardiomyopathy, while 49% were diagnosed









with a Nonischemic Cardiomyopathy. Of the entire sample, 33% had Coronary Artery

Disease and 29% met criteria for Congestive Heart Failure. This sample of ICD patients

had a mean ejection fraction of approximately 36% (SD = 17.32). Approximately 19% of

patients had experienced sudden cardiac arrest and received the ICD for secondary

prevention of any future cardiac events. Forty-two percent of patients had received shock

therapies prior to enrollment in the study; the mean number of shocks of the entire

sample was 3.44 (SD = 11.96). Table 3-3 provides information regarding medical

variables for patients. Table 3-4 provides medical variable information categorized by

gender.

Table 3-3 Medical variables of total sample (N = 132)

Medical Variable n / %


Mean length of time since implantation

Cardiac Diagnoses
Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Coronary Artery Disease
Congestive Heart Failure

Mean ejection fraction

History of sudden cardiac arrest

History of shocks
Yes
No

Mean number of shocks


3.47 years (SD = 2.77)


51.3%
48.7%
32.6%
28.8%

35.79% (SD = 17.32)

18.9%


42.4%
57.6%

3.44 (SD = 11.96)









Table 3-4 Demographic variables by gender
Males Females
Medical Variable Males Females Test statistic p-value
(n = 61) (n = 71)

Mean length of time since 3.83 3.14
implantation (SD = 2.69) (SD = 2.83) F (1,128) = 2.04 p = 0.16

Cardiac diagnoses
Ischemic Cardiomyopathy 77.4% 29.0%
Nonischemic Cardiomyopathy 22.6% 71.0%
CAD 49.2% 18.3%
CHF 27.9% 29.6%

32.3% 38.8%
Mean ejection fraction* (SD = 15.75) (SD = 18.10) F (1,109) = 4.04 p = 0.05

History of sudden cardiac
arrest x = 1.22, df = 1 p = 0.27
Yes 16.7% 25.0%
No 83.3% 75.0%

History of shocks* x2 = 4.68, df= 1 p = 0.03
Yes 52.5% 33.8%
No 47.5% 66.2%

3.78 3.15
Mean number of shocks (SD = 14.30) (SD = 9.65) F (1,129) = 0.09 p = 0.77

*indicates significant difference

Recruitment was conducted at three locations: 63 patients were recruited from

Shands Hospital at the University of Florida, 46 from Brigham and Women's Hospital,

and 23 from Royal North Shore Hospital in Australia. Table 3-5 presents relative

percentages of the total sample by recruitment site.

Table 3-5 Recruitment locations of total sample (N = 132)

Recruitment Site n

Shands Hospital at the University of Florida 47.7%
Brigham and Women's Hospital 34.8%
Royal North Shore Hospital 17.4%









Chi-square analyses and ANOVAs were conducted for all demographic and

medical variables to assess for any significant differences. Among the demographics,

significant differences were found in level of education attained and current work

situation; among the medical variables, a significant difference was found in mean

ejection fraction between the three sites, such that Brigham and Women's had a mean of

41%, followed by Shands with a mean of 34%, and lastly, Royal North Shore with the

lowest mean ejection fraction, at 20%. Table 3-6 provides information related to

significant demographic differences between recruitment sites. Table 3-7 provides

information related to cardiac diagnoses and mean ejection fraction by site.

Table 3-6 Demographic variables by recruitment site
Stands Brigham Royal Test
Shands Test
Demographic UF & North statistic p-value
UF statistic
Women's Shore
2
/ 16.19,
Education df= 4 p =0.01
High school or less 50.8% 20.0% 57.1%
College degree or less 33.9% 42.5% 38.1%
Graduate 15.3% 37.5% 4.8%

2
S= 20.28,
Employment* df= 10 p = 0.03
Retired 45.2% 52.2% 59.1%
Disability 29.0% 8.7% 4.5%
Full time 16.1% 21.7% 4.5%
Part time 6.5% 8.7% 18.2%
Homemaker 1.6% 8.7% 13.6%
Unemployed 1.6% 0.0% 0.0%

* indicates significant difference









Table 3-7 Medical variables by recruitment site
s Brigham Royal
Medical Variable & North Test statistic
UF value
Women's Shore

Cardiac diagnoses
Ischemic Cardiomyopathy 49.2% 51.1% 63.6%
Nonischemic Cardiomyopathy 50.8% 48.9% 36.4%

F(2,108)= p=
Ejection fraction* 6.26 0.01
Mean 33.9% 41.1% 20.1%
Standard Deviation 2.17 2.47 5.85

* indicates significant difference

Measures

Demographics. 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.

Shock anxiety. The Florida Shock Anxiety Survey (FSAS) is a 10-item measure used to

assess ICD-specific anxiety including the cognitive, behavioral, emotional and social

impacts of shock; alpha coefficients suggest good reliability (Cronbach's = .91, split-half

= .92) and moderate correlation (r = -.65) with death anxiety. Higher scores on the FSAS

indicate higher shock anxiety. Full psychometric information has been established (Kuhl

et al., in press).

Death anxiety. The Multidimensional Fear of Death Scale (MFODS) is a 42-item

assessment device with 5-point Likert response formatting (Neimeyer & Moore, 1994).

This scale is composed of eight factors: (1) Fear of the dying process, (2) Fear of the

dead, (3) Fear of being destroyed, (4) Fear for significant others, (5) Fear of the









Unknown, (6) Fear of conscious death, (7) Fear of the body after death, and (8) Fear of

premature death (Neimeyer & Moore, 1994). For this study only the Fear of the Dying

Process (6 items) and Fear of Premature Death (4 items) Scales will be used. The range

of scores for the whole measure is from 42 to 210, with lower scores indicating higher

death anxiety. Previous research has calculated the Cronbach's alpha of reliability at .85

(Neimeyer & Moore, 1994).

Body area satisfaction. The Body-Self Relations Questionnaire (BSRQ) is a widely

used, self-report measure of body image (Brown, Cash, & Mikulka, 1990). It has 10

subscales assessing patient satisfaction of appearance, fitness, health and illness, and

weight; Appearance Evaluation, Appearance Orientation, Fitness Evaluation, Fitness

Orientation, Health Evaluation, Health Orientation, Illness Orientation, Body Area

Satisfaction, Overweight Preoccupation, and Self-classified Weight. Participants respond

to questions on a scale of 1 ("definitely disagree") to 5 ("definitely agree"). Higher

scores reflect greater investment or satisfaction. The BSRQ has acceptable validity and

reliability; normal values are based on a large, national sample (Brown et al., 1990). For

the purposes of this study, we will only be using the Body Area Satisfaction subscale, on

which patients rate the extent to which they are satisfied with particular areas of their

body.

Body image concern. The Florida Patient Acceptance Survey (FPAS) is a valid and

reliable 18-item measure used to assess patient acceptance of cardiac device treatment

(Burns et al., 2005). Patient acceptance refers to achieving maximal benefit from a

biomedical device such as an ICD. The FPAS is composed of four factors: 1) Return to

Function, 2) Device-Related Distress, 3) Positive Appraisal, and 4) Body Image









Concerns. The FPAS total score and subscale scores demonstrated both convergent and

divergent validity with the SF-36, Atrial Fibrillation Symptom Severity Scale, CES-D,

STAI, and the Illness Intrusiveness Rating Scale (Burns et al., 2005). For this study, only

the Body Image Concerns scale will be used. Higher scores on the Body Image Concerns

subscale indicate higher levels of distress or concerns.

Medical variables. Data on the following medical variables was collected through

medical record review: left ventricular ejection fraction, cardiac diagnosis, ICD

placement duration, history of mental health problems or treatment, current medications,

cardiac risk factors, and shock history. Stored intracardiac electrograms allowed for

definitive identification of arrhythmias leading to the delivery of shock.














CHAPTER 4
RESULTS

The following statistical analyses were performed to evaluate the proposed

hypotheses for this research project. The Statistical Package for the Social Sciences

(SPSS) was utilized to perform all the analyses. In order to correct for violations of the

Box-M test and the Levene's test for the assumption of homogeneity of variance, the

relatively conservative Pillai's trace was used for the estimation of F-statistics in the

analyses that follow. Variables were examined on a list wise basis; therefore, participants

who did not complete all measures were not included in analyses. When appropriate,

Bonferroni corrections were applied to rectify the possibility of Type I error. Family

wise error rates are noted for each analysis. This method of correction was utilized in

order to provide a conservative and methodical analysis of the data.

Intersex Differences

Hypothesis 1: Female ICD patients will report more shock anxiety and body image

concerns, and less body area satisfaction than male patients.

Findings: The following analyses controlled for ejection fraction and shock

history as significant differences were found among men and women at study onset.

Data from all ICD patients were utilized in the following analyses. In all analyses,

Bonferroni corrections were applied. The first analysis was conducted to evaluate the

effects of participant group (male and female) on the amount of reported shock anxiety.

An ANCOVA was performed to evaluate the differences between male patients and

females. Results revealed a significant difference between males and females in reported









shock anxiety (F (2,128) = 3.552, p = 0.03, r = 0.053), such that female patients

reported higher rates of shock anxiety than their male counterparts. Despite using shock

history as a covariate, differences still remained between men and women enrolled in the

study in reported shock anxiety.

The second analysis was conducted to evaluate the effects of participant group on

reported body image concerns and body area satisfaction. A MANCOVA determined

that males and females did not significantly differ overall in their reported body area

satisfaction and body image concerns (Pillai's trace = 0.042, p = 0.10, rp2= 0.042). This

suggests that male and female ICD patients report similar levels of body area satisfaction

and body image concerns. Inspection of the mean values indicated that females did

report lower body area satisfaction and more body image concerns, on average, than did

men in the study, although these differences did not reach significance with this sample.

Table 4-1 provides means on psychosocial measures by the total sample.


Table 4-1 Psychosocial means of total sample
Male Female Male Female
M M n n

FSAS*:
15.53* 16.33*
Shock 60 71
Shock (SD = 6.77) (SD = 7.12)
anxiety


MBSRQ: 36.43 29.95
Body area (SD = 21.96) (SD = 6.87) 61 70
satisfaction


FPAS:
FPAS 9.63 16.72
Body 61 71
Body (SD = 21.33) (SD = 25.52) 61 71
image
concerns
*indicates significant difference









Intrasex Differences

Hypothesis 2: Younger women will report higher rates of shock anxiety, death anxiety,

and body image concerns, and less body area satisfaction.

Findings: Data from all female ICD patients were utilized in the following

analyses. In all analyses, Bonferroni corrections were applied. The first analysis was

conducted to evaluate the effects of participant group (young, middle-aged, or older

females) on the amount of reported shock anxiety and death anxiety. A MANOVA

determined that participant groups did not significantly differ overall in their reported

shock anxiety and death anxiety (Pillai's trace = 0.127, p = 0.06, r = 0.064). However,

upon examination of the univariate death anxiety ANOVA, it was evident that there was

a significant group difference in reported death anxiety (F (2,68) = 3.681, p = 0.03, r =

0.098) such that younger women reported significantly higher death anxiety than older

women (p = 0.025). This analysis suggests that young women may experience more

death anxiety than women over the age of 65.

The second analysis was conducted to evaluate the effects of age on reported

body area satisfaction and body image concerns. A MANOVA revealed that participant

groups did significantly differ overall in their reported body area satisfaction and body

image concerns (Pillai's trace = 0.133, p = 0.05, rP = 0.067). Multiple comparisons

determined that younger women reported significantly higher body image concerns than

their middle-aged cohorts (p = 0.03). Results suggest that female ICD recipients under

the age of 50 may experience more body image concerns than women between 51 and 64

years of age. Table 4-2 provides means on psychosocial measures by the three groups of

females.










Table 4-2 Psychosocial means of females by age group
Young Middle-Aged Older
(n = 28) (n = 21) (n = 22)


FSAS:
Shock
anxiety


MFODS*:
Death
anxiety


MBSRQ:
Body area
satisfaction


FPAS*:
Body
image
concerns


18.72
(SD = 8.23)



30.10*
(SD = 10.83)



30.32
(SD = 7.24)




26.78*
(SD = 29.01)


15.12
(SD = 7.10)



33.20
(SD = 9.17)



28.95
(SD = 5.59)




8.33*
(SD = 19.49)


14.45
(SD = 4.60)



37.83*
(SD = 9.70)



30.44
(SD = 7.70)




12.50
(SD = 22.70)


*indicates significant difference















CHAPTER 5
DISCUSSION

Summary of Results

The major objectives of the current study were to investigate the intersex and

intrasex differences among patients with ICDs. Specifically, this study investigated

through analyses of variance, the strength of the associations between sex, age, shock

anxiety, death anxiety, and body image, while controlling for left ventricular ejection

fraction, at a single time point.

Results from this study suggest that males and females exhibit significantly

different levels of shock anxiety. Recent literature has suggested that female ICD

patients may be at increased risk for psychological distress, although specific avenues for

distress have yet to be established (Walker et al., 2004). Fear of future shock may persist

as a particular area of concern for female patients. In the current study, women reported

higher rates of shock anxiety than did males. Based on our results, shock anxiety is an

area of highlighted concern for female patients and should be fully explored in future

research and acknowledged by clinicians.

Although rates of body area satisfaction and body image concerns were not

significantly different among males and females, an obvious trend was identified. On

average, women reported lower body area satisfaction and more body image concerns

than men in the study. There are several explanations why this trend may exist. Previous

research has established that women tend to report more body image disturbances after

physical scarring than men, on average (Lawrence et al., 2004). Therefore, it would seem









logical than this trend would persist even among cardiac populations. However, an even

more likely explanation of this phenomenon is the obvious imposition of the device on

the physiognomy of the female body. Standard placement can be challenging for women

due to their anatomy; the weight of the breast itself may pull and tear on incisions making

the scar larger still. The practical limitations of bra straps, purse straps, and seat belts

(Giudici, 2001) are side effects of standard device placement that have been

acknowledged. Davis and colleagues (2004) examined the body satisfaction of women

implanted with cardiac pacemakers. They reported that the visibility of their scar, how

their clothing fit with the device, and the impact their device had on wearing swimsuits,

were significant concerns of women, compared to their male cohorts. As an ICD is

significantly larger than a pacemaker, it is reasonable to assume that women who receive

ICDs may also experience considerable concerns related to the impact of the device on

body image.

Although intrasex differences in shock anxiety were not found, highly significant

differences in death anxiety were reported among female patients enrolled in the current

study. Results suggest that women under the age of 50 experience clinically significant

levels of death anxiety, largely in excess of their older-aged cohorts. Many of these

women have experienced sudden cardiac death and have been faced with the prospect of

dying. Younger women often experience a rapid onset of cardiac disease, such as non-

ischemic cardiomyopathy, giving them little time to adjust with the life-altering events

they have recently experienced. While the ICD has been widely established as a life-

saving device, some patients appear to have significant anxiety related to the device and

fears of death (Pauli et al., 1999). Death anxiety appears to be a particularly relevant









construct to this population of young female patients, which may be due to the rapid

onset of their cardiac disease coupled with the implantation of an ICD as a constant

reminder of their potential mortality.

In the current study, results revealed highly significant differences in reported body

image issues between women under the age of 50 and women between the ages of 51 and

64. This suggests that middle- and older-aged women who have undergone implantation

of an ICD experience similar rates of body area satisfaction and body image concerns,

while younger women experience highly clinically significant symptoms of distress

associated with body image. The visibility of a defibrillator and the accompanying

socially visible scar may likely contribute to body dissatisfaction among younger women

with ICDs. Martin, Leary, and Rejeski (2000) described a variety of psychological

implications accompanying disease- and age-related changes that resulted in a perceived

decrease in physical attractiveness. Notably, low self-esteem, depression, social

isolation, and symptoms of hypochondriasis were associated with negative self-ratings of

appearance. Previous research examined quality of life among younger ICD patients

(Dubin et al., 1996) and revealed significant patient concerns about the impact of device

placement on clothing fit (63%), socializing problems due to their device (75%), and

worries about sexual activity with an implantable device (50%), suggesting body image

and quality of life are highly related. As such, the imposition of the device on a woman's

body in terms of visibility and scarring warrants increased attention to body image issues

surrounding ICD implantation and subsequent adjustment in younger female recipients.

Strengths and Limitations

When interpreting results from this study, there are several strengths and

limitations that should be taken into consideration. In an attempt to recruit an unbiased









sample, we enrolled participants from three distinct medical centers with a considerably

wide geographical area. Analyses evaluating this sample found participants to be

relatively equivalent to each other in regards to demographic and medical variables, with

the exception of education and vocational status, and ejection fraction. Despite extending

recruitment to multiple locations, our sample size may be considered relatively limited in

the number of patients participating in data collection. This limitation may have resulted

in reduced significant findings regarding the stated hypotheses. We attempted to

minimize the effect of this limitation through the use of Bonferroni corrections to control

for Type I errors. It should also be noted that this study examined data from a single time

point, and may not accurately represent comprehensive psychosocial functioning over

time. In order to rectify this methodological limitation, future research should include

repeated measurement over time with a randomized controlled design.

For purposes of investigating intrasex differences among female participants in the

study, women were stratified according to age. We divided the women into three age

groups; < 50, 51-64, and > 65 years of age. Despite the potential limitations of grouping

women by age, and thus splitting a continuous variable into a categorical variable, we felt

we were justified in doing so for several reasons. First, previous cardiac research has

utilized this methodology, categorizing females as young women (under 50), middle aged

women (51 to 64), and older women (over the age of 65). Second, research within breast

cancer has often organized women into similar groupings by age to examine differences

between younger and older females in their experience with breast cancer and subsequent

treatment. Third, the experience of heart disease may be very different across the

lifespan. Younger women more typically have a rapid onset of a more non-ischemic









cardiac disease and often receive an ICD for secondary prevention after they have already

experienced a sudden cardiac arrest. Older women more typically have experienced

years of coronary risk factors, suffer from a more ischemic form of cardiac disease, and

receive the device for primary prevention of future cardiac events. Therefore, women

across the lifespan may experience different forms of cardiac disease and may also

present with different indications for receiving an ICD, which makes clinical sense to

separate them by age in research.

As with all research, consideration of self-report measures should be made; self-

report measures may be influenced by patient demand characteristics, such as participant

perception of how they should respond or would like themselves to be perceived. The

measures used in assessing psychosocial functioning in patients were restricted to the use

of standardized and validated measures that were chosen for their established reliability

and validity in measuring the constructs of interest. We also attempted to minimize the

influence of demand characteristics by allowing patients to complete the measures in

privacy in outpatient clinics and by assuring confidentiality of responses and anonymity

after data collection.

Clinical Implications

Collectively, results from this study highlight the growing need for

comprehensive psychological care for women with ICDs. The lack of research in the

female-specific adjustment to the ICD represents absence of innovation in the area of

comprehensive care for women. Without such innovation, healthcare professionals fail to

provide universal comprehensive care to the female ICD recipients. Only with

appropriate facilitative care can female ICD patients return to previous levels of physical

and psychosocial functioning. The study emphasizes the need for healthcare providers to









recognize and acknowledge symptoms of distress among female patients in an attempt to

identify those women most at risk for the development of psychosocial maladjustments

secondary to cardiac disease. Clinicians can utilize this information to improve outcomes

in ICD recipients by providing patients with increased attention to their psychological

needs and referrals for psycho-educational interventions when indicated.

Implantable cardioverter defibrillator patients may experience improved health

outcomes through a combination of optimal medical treatment and tailored psychosocial

care, including pre- and post-implant psychological consultation, support groups with

other recipients, or individual psychotherapy. This process can be facilitated by the

integration of cardiac psychologists as an essential component of the electrophysiology

team.

The changes in physical appearance that female ICD recipients experience may

constitute differences in their perception of body image. Traditional ICD placement

involves creating an incision in the left chest wall wherein the device is implanted. This

procedure produces both visible scarring and bulging around the implant site due to the

placement of the device underneath the skin. This protocol presents a particularly

sensitive problem for women, whose clothing often leaves this part of the upper body

exposed. Female ICD recipients would likely benefit from well-developed treatment

protocols that include a variety of implant options, pre-operative education, and plastic

surgery consultation. As therapies continue to advance, female ICD patients, particularly

those under the age of 50, may benefit from well-established guidelines that take into

consideration the unique issues women face with the implantation of a cardiac device.









Research Implications

The review of the relevant literature to date suggests that the female-specific

adjustment to the ICD has not been thoroughly assessed. The current study substantially

adds to this body of literature, in the exploration of the unique experience female patients

face in living with an ICD. Given that women with cardiac disease experience more

psychological morbidity than men, it is reasonable to predict that female ICD patients

demonstrate different patterns of adjustment relative to males; this hypothesis in part was

supported by our results. The investigation of the unique issues women face in living

with an ICD is noteworthy, as it could largely improve quality of life, adjustment, and

psychological fitness of female ICD recipients.

Given the findings of the current study and other research documenting

psychological maladjustment to the ICD, future research needs to next address the

potential differences in psychological functioning among age groups of device recipients.

Results from the current study revealed several intrasex differences among females,

including the reported frequencies of clinically significant death anxiety and body image

concerns; further exploration of these constructs is largely warranted.

Future research focused on tailored psychological care for female patients is also

indicated, including the investigation of psychosocial interventions and their effects on

health outcomes of ICD patients post-implant. To date, however, there have been very

few studies that have examined the impact of such interventions on ICD patient

adjustment and psychosocial functioning (Kohn et al., 2000). Additionally, given the

paucity of research that has been conducted to date examining individual differences

influencing the adjustment of females to the ICD, future studies would be beneficial in

providing useful information to clinicians about the potential differences between male









and female ICD recipients. Finally, additional research identifying and further

scrutinizing potential risk factors for psychological maladjustment to the ICD is

indicated. While the current study provides useful information in this regard, future

studies could more specifically address the independent value of each of the

aforementioned variables by determining the differential risk associated with each of

these factors. While this type of analysis was beyond the original scope of the current

study, it is clearly an extension that is implicated from the findings and should be

incorporated in future research endeavors. This data emphasizes the importance of a

multidisciplinary approach in the investigation and treatment of ICD patients.

Conclusion

In summary, the ICD is a life-saving device whose use is increasing annually.

Although the effectiveness of its life-saving utility is well established, quality of life and

adjustment issues persist. Women in particular appear to be a vulnerable subpopulation

for developing subsequent distress after implantation. Shock anxiety, death anxiety, and

body image issues are possible avenues of distress for female recipients. Given these

considerations, this study offers new information regarding the female-specific

experience in living with an ICD.

In closing, the findings from this study suggest that ICD patients who report

elevated feelings of death and shock anxiety, as well as body image dissatisfaction or

concerns, should be evaluated for psychological intervention to minimize adjustment

difficulties and possible declines in quality of life after ICD implantation. Subsequent to

implant, young women appear to be highly at risk for the development of psychosocial

distress associated with shock anxiety, death anxiety, and body image. More

considerable attention is warranted in women under the age of 50 by researchers and






30


clinicians alike, as this population has been identified to be increasingly more likely to

receive an ICD as the indications for implantation continue to grow exponentially

(Wolbrette et al., 2002).















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J.B. (2004). Women and the implantable cardioverter defibrillator: A lifespan
perspective on key psychosocial issues. Clinical Cardiology, 27, 543-546.

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BIOGRAPHICAL SKETCH

Lauren Vazquez Sowell was born in Farmington Hills, Michigan, on March 11th,

1982, to Dr. and Mrs. Paul and Teresa Vazquez. She has one younger sister, Andrea, and

a younger brother, Paul Evan. Lauren graduated cum laude from the University of

Florida in May 2004 with a Bachelor of Health Science degree in health science and a

Bachelor of Science in psychology. She married David Sowell on May 6t, 2005. Lauren

and her husband, David, currently reside in Gainesville, Florida, where she is pursuing

her Ph.D. in clinical and health psychology at the University of Florida. Her clinical and

research interests lie in medical and health psychology, with a focus on cardiovascular

disease and cardiac device therapy.




Full Text

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THE UNIQUE EFFECTS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: THE FEMALE PERSPECTIVE By LAUREN VAZQUEZ SOWELL A THESIS PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLOR IDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE UNIVERSITY OF FLORIDA 2006

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Copyright 2006 by Lauren Vazquez Sowell

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iii ACKNOWLEDGMENTS I am privileged to extend my appreciation to Dr. Samuel F. Sears, my mentor, for his continued guidance and support in the pursuit of this project. I would also like to thank Dr. Jamie B. Conti for her gracious i nvolvement in this research. I am deeply honored and grateful to have worked collabo ratively with several colleagues, without whom this project would not have been po ssible: Julie Bishop Shea, MS, RNCS, of Brigham and Womens Hospital in Boston, Ma ssachusetts, and Ann Kirkness, RN, CNS, of Royal North Shore Hospita l in Sydney, Australia. I would also like to extend th anks to my parents, Paul and Teresa Vazquez, and my husband, David Sowell, for their unbounded love and encouragement.

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iv TABLE OF CONTENTS page ACKNOWLEDGMENTS.................................................................................................iii LIST OF TABLES.............................................................................................................vi ABSTRACT......................................................................................................................vii CHAPTER 1 INTRODUCTION........................................................................................................1 2 LITERATURE REVIEW.............................................................................................4 Shock Anxiety..............................................................................................................4 Death Anxiety...............................................................................................................4 Body Image...................................................................................................................6 Hypotheses....................................................................................................................7 Question 1: Intersex Differences...........................................................................7 Question 2: Intrasex Differences...........................................................................8 3 METHODS...................................................................................................................9 Procedure......................................................................................................................9 Sample......................................................................................................................... .9 Measures.....................................................................................................................15 4 RESULTS...................................................................................................................18 Intersex Differences....................................................................................................18 Intrasex Differences....................................................................................................20 5 DISCUSSION.............................................................................................................22 Summary of Results....................................................................................................22 Strengths and Limitations...........................................................................................24 Clinical Implications...................................................................................................26 Research Implications.................................................................................................28 Conclusion..................................................................................................................29 LIST OF REFERENCES...................................................................................................31

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v BIOGRAPHICAL SKETCH.............................................................................................36

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vi LIST OF TABLES Table page 2-1 Hypothesis 1, Analysis 1..............................................................................................7 2-2 Hypothesis 1, Analysis 2..............................................................................................7 2-3 Hypothesis 2, Analysis 1..............................................................................................8 2-4 Hypothesis 2, Analysis 2..............................................................................................8 3-1 Demographic variables of total sample......................................................................10 3-2 Demographic variables by gender..............................................................................11 3-3 Medical variables of total sample...............................................................................12 3-4 Demographic variables by gender..............................................................................13 3-5 Recruitment locations of total sample........................................................................13 3-6 Demographic variables by recruitment site................................................................14 3-7 Medical variables by recruitment site.........................................................................15 4-1 Psychosocial means of total sample...........................................................................19 4-2 Psychosocial means of females by age group.............................................................21

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vii Abstract of Thesis Presen ted to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science THE UNIQUE EFFECTS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: THE FEMALE PERSPECTIVE By Lauren Vazquez Sowell May 2006 Chair: Samuel F. Sears, Jr. Major Department: Clini cal and Health Psychology Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are a particularly atrisk group for developing psychological distre ss secondary to cardiac disease. The aim of the study was to examine the intersex differences betw een women and men, and the intragroup differences among women, with im plantable cardioverter defibrillators. One hundred thirty-two ICD patients were recruited at three medical centers: Shands Hospital at the University of Flor ida, Brigham and Womens Hospital in Boston, and Royal North Shore Hospital in Sydney, Australia. Seventy-one women and 61 men completed individual psychological assessment batteries, measuring the constructs of shock anxiety, death anxiety, body area satisf action, and body image concerns. Medical record review was conducted for all patients regarding cardiac illn esses and ICD specific data.

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viii Results revealed significant differences between males and females in their reported levels of shock anxi ety, such that women in the study reported higher rates of shock anxiety ( F (2,128) = 3.552, p = 0.03, p 2 = 0.053). The investig ation of intrasex differences among females re vealed that younger women ( 50 years of age) reported significantly higher rates of death anxiety than women over the age of 65 ( F (2,68) = 3.681, p = 0.03, p 2 = 0.098) and significantly lower body area satisfaction and greater body image concerns than women aged 51 to 64 ( Pillais trace = 0.133, p = 0.05, p 2 = 0.067). The present study identifies a subgroup of female ICD patients at risk for the development of distress subsequent to devi ce implantation. Young wo men appear to be highly at risk for the development of psychos ocial maladjustments across the domains of shock anxiety, death anxiety, and body image. Results suggest that more rigorous assessment and research are indicated in fe male ICD recipients under the age of 50. Collectively, findings from this study suggest that ICD patients who report elevated feelings of death and shock anxiety, as we ll as body image dissatisfaction or concerns, warrant considerable attention by healthcare professionals in an effort to minimize adjustment difficulties and possible declines in quality of life after ICD implantation.

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1 CHAPTER 1 INTRODUCTION Sudden cardiac death (SCD) accounts for over 450,000 deaths per year in the United States and is currently the highest ra nked cause of mortalit y, claiming more lives annually than stroke, lung cancer, breast ca ncer, and AIDS combined. Sudden cardiac death is precipitated by the onset of life -threatening ventricular tachyarrhythmias, resulting in death if not promptly defibril lated (e.g., within 10 minutes) (American Heart Association, 2004). The implantable cardiover ter defibrillator (ICD) is a biomedical device designed to contravene potentially leth al arrhythmias by automatic delivery of an electrical cardioverting shock to defibrillate the heart and restore normal sinus rhythm. The ICD is now implanted in approximately 150,000 Americans each year and randomized trials have demonstrated its supe riority to pharmacological interventions in reducing mortality in patients at-risk fo r SCD (Antiarrhythmics Versus Implantable Defibrillators Trial Investigators, 1997; Ba rdy et al., 2005; Buxton, Lee, & Fisher, 1999; Moss et al., 1996). The implant rate of the ICD is likely to continue to rise dramatically, as its indications are broadened. Despite the success of the ICD in preven ting SCD, research indicates that the psychological impact of living with a defibr illator can be significantly distressing for recipients. Symptoms of fear and anxiety are considered the most common psychological response of device recipients, with 24-87% of patients repo rting symptoms of anxiety (Sears & Conti, 2003), and 24-38% reporting elevated levels of depression (Sears et al., 1999). Collectively, these rates are significan tly higher than the ge neral population and

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2 have prompted current researchers to exam ine how symptoms of psychological distress may affect the etiol ogy of cardiac illness. In patients with cardiac disease, the evid ence that psychological distress can affect both quality of life (QOL) a nd health outcomes has been described as clear and convincing (Rozanski, Blumenthal, & Kapl an, 1999, p. 2192). Moreover, the impact of psychological distress is thought to strongly influence the course of cardiac disease (Rozanski et al., 2005, p. 637). Implantabl e cardioverter defibrillator patients are vulnerable to the development of psychologica l distress due to many factors, including ICD shock, the recognition of their potentia l mortality by cardiac disease, and the perceived lack of control over their medical condition (Sears et al., 1999). As such, ICD patients have been recognized as an appropriate population for the study of the development of distress (Godeman et al., 2001). Research has recognized females with cardi ac illness as a particularly at-risk group for the development of psychological dist ress secondary to their disease (Chin & Goldman, 1998; Con et al., 1999; Frasure-Smith et al., 1999; Holahan et al., 1995; Mendes de Leon et al., 2001; Vaccarino, Lin, & Kasl, 2003; Ziegel stein, 2001). Among populations of patients with congestive heart failure (CHF), females have consistently exhibited worse quality of life than males as well as increased rates of depression (Gottlieb et al., 2004). Since CHF patient s frequently require ICD implantation congruent with their cardiac disease progressi on, this population of females is explicitly at risk for adjustment difficulties (Holah an et al., 1995; Ziegelstein, 2001). Female recipients face unique challenges with th e ICD by its impact on their femininity, sexuality, and body image satisfaction (Walke r et al., 2004). Traditional ICD placement

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3 often produces visible scarring and bulgi ng around the implant site, presenting a particularly sensitive proble m for women, whose clothing ofte n leaves this part of the upper body exposed. Previous research ex amined quality of life among young ICD patients (Dubin et al., 1996), the majority of which were female, revealing significant patient concerns about the impact of the device on clothing fit (63%), socialization (75%), and sexual activity (50%). Despite these data, there is a paucity of literature in the examination of female-specific adjustment to living with an ICD. In epidemiological studies examining sex differences in de pression and anxiety among the general population, women report clinical levels of depressive and anxious symptomatology with nearly twice the frequency of men (APA 1996; Kessler et al ., 1994; Regier, 1994). Therefore, the investigation of sex diffe rences in psychological sequelae among ICD recipients is largely warranted.

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4 CHAPTER 2 LITERATURE REVIEW The following sections review literature as it applies to patient adjustment to the ICD. The female-specific adjustment issu es for ICD patients are addressed across the domains of shock anxiety, death anxiety, and body image. Shock Anxiety To prevent SCD in the event of an arrhythm ia, the ICD delivers an electrical shock to terminate the potentially lethal arrhythmia and restore normal heart rhythm. Within the first year of implantation, approximately 40 to 42% of ICD patients will experience a shock, 22% will receive 2 or more shocks, and 17% will sustain 3 or more shocks (Credner et al., 1998). In short, shock is a common experience for many ICD patients. Sears and Conti (2002) state that patients w ho have a history of ICD firings are at particular risk for psychosocial difficulties. Recent research indicat es that ICD patients who receive shocks experience more depressi on and anxiety, and have poorer adjustment to the device than patients who receive no shocks (Godeman et al., 2004; Kohn et al., 2000). Even in the minority of ICD patients who do not experience shocks, shock anxiety may result in incr eased avoidance behaviors a nd a perceived limitation in performing everyday activities (Sears & Conti, 2003). As such, the examination of shock anxiety in ICD populations is warranted. Death Anxiety Death anxiety is a multidimensional construc t that is characterized by cognitive and affective changes, physical alte rations, stress, and even pa in (Lonetto & Templer, 1986).

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5 Death anxiety has been described as a dynamic factor that changes w ith an individuals age, experiences, and health. Tomer and E liason (2000) define death anxiety as the anticipation of a state in which the self does not exist, which is variable in intensity over time. In the existing literature, ge nder is considered a moderati ng factor in the occurrence of death anxiety. Research has establishe d that women report higher levels of death anxiety, on average (Iammarino, 1975; Schulz, 1979; Templer, Ruff, & Franks, 1971). Death anxiety research to date has traditio nally used Templers (1970) Death Anxiety Scale (DAS), to reveal that female participants display higher levels of death anxiety than do males, regardless of the sample populati on. However, more recently Neimeyer (1993) found that even when controlling for emo tional expressiveness among gender, female participants endorsed greater death anxiety on the DAS compared to their male counterparts. The differences in the incide nce of death anxiety among gender have been established in a variety of populations of men and women, including students, parents, psychiatric patients, and hospital staff (Templ er et al., 1971). Unfortunately, no studies to date have examined this potential relations hip in the context of cardiac disease. The experience of death anxiety can be partic ularly salient in th e presence of a life threatening illness. As an i ndividual is faced with a life-ch anging event such as diagnosis of cardiac disease or the survival from sudde n cardiac arrest, the fr equency and intensity of death anxiety is likely to increase. Despite the heuris tic value of this phenomenon, there is a notable absence of research devoted to examin ing death anxiety among cardiac populations.

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6 Body Image Implantation of an ICD produces noticeable scarring that can affect body image in recipients. Body image satisfac tion is a prevalent issue in womens health research and poses particular relevance for female ICD reci pients. Socially visible scars, similar to those created by implantation of an ICD, have been associated with poor self-ratings of appearance, appearance satisfaction, and app earance-related anxiety (Dubin et al., 1996; Lawrence et al., 2004). Several comparisons can be made between women who receive ICDs and women who undergo surgical treatm ent for breast cancer. In a recent study by Hoeller et al. (2003), women who had undergone breast conservation treatment rated the presence of highly visible scars as the si ngle most important determinant of their perception of the cosmetic outcome of the surgery. Similarly, women have reported significant displeasure with the cosmetic outcome of their surgery and the accompanying sexual and body image sequelae, and continued to overestimate their risk of developing future cancer (Payne et al., 2000). This scenar io is strikingly sim ilar to those women who receive ICDs for primary prevention of futu re cardiac events. Despite their protection from premature sudden cardiac death by the device, patients have a tendency to overestimate their potential mortality by th eir heart condition (Sear s, Shea, & Conti, 2005). Congruous with the breast cancer litera ture, the changes in physical appearance that female ICD recipients experience may constitute difficulties in their perception of body image. Research indicates that women in general are more concerned with body image, possibly due to societal expectati ons that pressure women to strive for attractiveness. This pressure regarding th eir physical appearance may affect a womans social experiences, mood, and overall quality of life (Wolszon, 1998).

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7 Unfortunately, there has been little examin ation of the impact of cardiac surgery on female body satisfaction (Allen & Wellar d, 2001). Although several studies have examined cardiac disease and body image in the context of perceived physical functioning, there has been virtually no examin ation of the impact of defibrillators on body image (Lichtenberger et al., 2003). Th e potential dissatisfaction of cosmetic outcome of device placement and consequent body image sequelae may act as a catalyst for psychological distress in female ICD patients. Hypotheses Question 1: Intersex Differences Do female or male ICD patients experien ce different levels of shock anxiety, body area satisfaction, and body image concerns? Hypothesis Female ICD patients will report more shock anxiety and body image concerns, and less body area satisf action than male patients. Participants. All female and male ICD patients. Analysis. An ANCOVA and a MANCOVA will be performed to determine if sex affects shock anxiety, body area satisfac tion, and body image concerns reported by ICD patients. Table 2-1 Hypothesis 1, Analysis 1 Table 2-2 Hypothesis 1, Analysis 2 Variables Statistical analysis Participants DV = Body satisfaction Body image concerns MANCOVA Females Males IV = Sex Variables Statistical analysis Participants DV = Shock anxiety ANCOVA Females Males IV = Sex

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8 Question 2: Intrasex Differences Do young, middle-aged, or older female ICD pa tients experience different levels of shock anxiety, death anxiety, body area satisfaction, and body image concerns? Hypothesis. Younger women will report higher rates of shock anxiety, death anxiety, and body image concerns, and less body area satisfaction. Participants Female ICD patients Analysis MANOVAs will be performed to determine if age affects shock anxiety, death anxiety, body area satisfaction, a nd body image concerns reported by female ICD patients. Table 2-3 Hypothesis 2, Analysis 1 Variables Statistical analysis Participants DV = Shock anxiety Death anxiety MANOVA Females IV = Age Table 2-4 Hypothesis 2, Analysis 2 Variables Statistical analysis Participants DV = Body satisfaction Body image concerns MANOVA Females IV = Age

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9 CHAPTER 3 METHODS Procedure Female and male ICD patients were r ecruited during outpatient cardiac clinic appointments at one of three enrollment sites: Shands Hospital at the University of Florida, Brigham and Womens Hospital in Boston, or Royal North Shore Hospital in Sydney, Australia. After an introduction of the study and gathering of informed consent, patients were provided with i ndividual psychological assess ment batteries, and asked to complete the questionnaires and re turn them to the researcher prior to leaving the clinic. The assessment battery took approximately 1525 minutes to complete. Upon completion and submission of the assessment questionnaires, patients completed their participation in the study. Medical record review was c onducted for information regarding cardiac illnesses and ICD specific data. Sample The mean age of the sample was 61.30 years (SD = 14.28) with a range of 23 to 92 years of age. Of the 132 i ndividuals who partic ipated in the study, 61 were male (46%) and 71 were female (54%). Ethnically, 91% of participants self-rated as Caucasian, 6% rated as African American, 2% rated as Asian/Pacific Islander, and 1% rated as Hispanic/Latino. The majority of participan ts were married (73%), 8% reported being separated or divorced, 8% repor ted being single, and 7% an d 3% reported being widowed and living with a part ner, respectively. Of the tota l sample, 42% had earned a high school diploma or less, 38% had earned a college degree, and 21% had completed a

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10 graduate degree. Table 3-1 provides demographic information for the total sample of ICD patients. Table 3-2 provides complete demographic information categorized by gender. Table 3-1 Demographic variable s of total sample (N = 132) Demographic n / % Gender Males 61 (46.2%) Females 71 (53.8%) Mean age 61.30 (SD = 14.28) Ethnicity Caucasian 90.9% African American 6.1% Asian/Pacific Islander 2.3% Hispanic/Latino 0.8% Marital status Married, remarried 73.4% Separated, divorced 8.1% Single, never married 8.1% Widowed 7.3% Living with partner 3.2% Education High school degree or less 41.6% College degree or less 37.5% Graduate 20.9% Employment Retired 50% Disability/ government 17.7% Full time 16.2% Part time 9.2% Homemaker 6.2% Unemployed 0.8%

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11 *indicates significant difference Patients medical records were reviewed to obtain the following information. Mean time since ICD implantation was 3.47 years (SD = 2.77). Fifty-one percent of patients were diagnosed with an Ischemic Cardiomyopathy, while 49% were diagnosed Table 3-2 Demographic variables by gender Demographic Males Females Test statistic p -value Mean age* 67.36 56.08 F (1,130) = 24.07 p = 0.01 Ethnicity 2 = 5.14, df = 3 p = 0.16 Caucasian 96.7% 85.9% African American 1.6% 9.9% Asian/Pacific Islander 1.6% 2.8% Hispanic/Latino 0.0% 1.4% Marital status 2 = 5.62, df = 3 p = 0.23 Married, remarried 80.7% 67.2% Separated, divorced 8.8% 7.5% Single, never married 3.5% 11.9% Widowed 3.5% 10.4% Living with partner 3.5% 3.0% Education* 2 = 7.15, df = 2 p = 0.03 High school or less 38.9% 43.9% College degree or less 29.7% 43.9% Graduate 31.5% 12.1% Employment* 2 = 21.11, df = 5 p = 0.01 Retired 68.3% 34.3% Disability 10.0% 24.3% Full time 16.7% 15.7% Part time 5.0% 12.9% Homemaker 0.0% 11.4% Unemployed 0.0% 1.4%

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12 with a Nonischemic Cardiomyopathy. Of th e entire sample, 33% had Coronary Artery Disease and 29% met criteria for Congestive H eart Failure. This sample of ICD patients had a mean ejection fraction of approximately 36% (SD = 17.32). Approximately 19% of patients had experienced sudden cardiac arre st and received the ICD for secondary prevention of any future cardiac events. Fort y-two percent of patients had received shock therapies prior to enrollment in the study; the mean number of shocks of the entire sample was 3.44 (SD = 11.96). Table 3-3 pr ovides information regarding medical variables for patients. Table 3-4 provides medical variable information categorized by gender. Table 3-3 Medical variables of total sample (N = 132) Medical Variable n / % Mean length of time since implantation 3.47 years (SD = 2.77) Cardiac Diagnoses Ischemic Cardiomyopathy 51.3% Nonischemic Cardiomyopathy 48.7% Coronary Artery Disease 32.6% Congestive Heart Failure 28.8% Mean ejection fraction 35.79% (SD = 17.32) History of sudden cardiac arrest 18.9% History of shocks Yes 42.4% No 57.6% Mean number of shocks 3.44 (SD = 11.96)

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13 *indicates significant difference Recruitment was conducted at three loca tions: 63 patients were recruited from Shands Hospital at the University of Florid a, 46 from Brigham and Womens Hospital, and 23 from Royal North Shore Hospital in Australia. Table 3-5 presents relative percentages of the total samp le by recruitment site. Table 3-5 Recruitment locations of total sample (N = 132) Recruitment Site n Shands Hospital at the University of Florida 47.7% Brigham and Womens Hospital 34.8% Royal North Shore Hospital 17.4% Table 3-4 Demographic variables by gender Medical Variable Males (n = 61) Females (n = 71) Test statistic p -value Mean length of time since implantation 3.83 (SD = 2.69) 3.14 (SD = 2.83) F (1,128) = 2.04 p = 0.16 Cardiac diagnoses Ischemic Cardiomyopathy 77.4% 29.0% Nonischemic Cardiomyopathy 22.6% 71.0% CAD 49.2% 18.3% CHF 27.9% 29.6% Mean ejection fraction* 32.3% (SD = 15.75) 38.8% (SD = 18.10) F (1,109) = 4.04 p = 0.05 History of sudden cardiac arrest 2 = 1.22, df = 1 p = 0.27 Yes 16.7% 25.0% No 83.3% 75.0% History of shocks* 2 = 4.68, df = 1 p = 0.03 Yes 52.5% 33.8% No 47.5% 66.2% Mean number of shocks 3.78 (SD = 14.30) 3.15 (SD = 9.65) F (1,129) = 0.09 p = 0.77

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14 Chi-square analyses and ANOVAs were conducted for all demographic and medical variables to assess for any signifi cant differences. Among the demographics, significant differences were found in level of education attained and current work situation; among the medical variables, a significant difference was found in mean ejection fraction between the th ree sites, such that Brigha m and Womens had a mean of 41%, followed by Shands with a mean of 34%, and lastly, Royal North Shore with the lowest mean ejection fraction, at 20%. Table 3-6 provides information related to significant demographic differences between recruitment sites. Table 3-7 provides information related to cardiac diagno ses and mean ejection fraction by site. *indicates significant difference Table 3-6 Demographic variables by recruitment site Demographic Shands UF Brigham & Womens Royal North Shore Test statistic p -value Education* 2 = 16.19, df = 4 p = 0.01 High school or less 50.8% 20.0% 57.1% College degree or less 33.9% 42.5% 38.1% Graduate 15.3% 37.5% 4.8% Employment* 2 = 20.28, df = 10 p = 0.03 Retired 45.2% 52.2% 59.1% Disability 29.0% 8.7% 4.5% Full time 16.1% 21.7% 4.5% Part time 6.5% 8.7% 18.2% Homemaker 1.6% 8.7% 13.6% Unemployed 1.6% 0.0% 0.0%

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15 *indicates significant difference Measures Demographics. This measure is a brief self-report tool to facilitat e collection of demographic information. It includes informa tion such as age, gender, education, work status, income, marital status, religion, and use of past and/or present psychological treatment. Shock anxiety The Florida Shock Anxiety Survey (FSAS) is a 10-item measure used to assess ICD-specific anxiety including the c ognitive, behavioral, emotional and social impacts of shock; alpha coefficients suggest good reliability (Cronb achs = .91, split-half = .92) and moderate correlation (r = -.65) with death anxiety. Higher scores on the FSAS indicate higher shock anxiety. Full psychom etric information has been established (Kuhl et al., in press). Death anxiety The Multidimensional Fear of Death Scale (MFODS) is a 42-item assessment device with 5-point Likert res ponse formatting (Neimeyer & Moore, 1994). This scale is composed of eight factors: (1 ) Fear of the dying pro cess, (2) Fear of the dead, (3) Fear of being destroyed, (4) Fear for significant others, (5) Fear of the Table 3-7 Medical vari ables by recruitment site Medical Variable Shands UF Brigham & Womens Royal North Shore Test statistic p value Cardiac diagnoses Ischemic Cardiomyopathy 49.2% 51.1% 63.6% Nonischemic Cardiomyopathy50.8% 48.9% 36.4% Ejection fraction* F (2,108) = 6.26 p = 0.01 Mean 33.9% 41.1% 20.1% Standard Deviation 2.17 2.47 5.85

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16 Unknown, (6) Fear of conscious death, (7) Fear of the body af ter death, and (8) Fear of premature death (Neimeyer & Moore, 1994). For this study only the Fear of the Dying Process (6 items) and Fear of Premature Deat h (4 items) Scales will be used. The range of scores for the whole measure is from 42 to 210, with lower scores indicating higher death anxiety. Previous research has calculate d the Cronbachs alpha of reliability at .85 (Neimeyer & Moore, 1994). Body area satisfaction. The Body-Self Relations Questionnaire (BSRQ) is a widely used, self-report measure of body image (B rown, Cash, & Mikulka, 1990). It has 10 subscales assessing patient sati sfaction of appearance, fitne ss, health and illness, and weight; Appearance Evaluation, Appearance Orientation, Fitne ss Evaluation, Fitness Orientation, Health Evaluation, Health Or ientation, Illness Or ientation, Body Area Satisfaction, Overweight Preoccupation, and Se lf-classified Weight. Participants respond to questions on a scale of 1 (definitely disa gree) to 5 (definite ly agree). Higher scores reflect greater investment or satisfa ction. The BSRQ has acceptable validity and reliability; normal values are based on a larg e, national sample (Brown et al., 1990). For the purposes of this study, we will only be using the Body Area Satisfaction subscale, on which patients rate the extent to which they are satisfied with part icular areas of their body. Body image concern The Florida Patient Acceptance Survey (FPAS) is a valid and reliable 18-item measure used to assess pa tient acceptance of car diac device treatment (Burns et al., 2005). Patient acceptance re fers to achieving maximal benefit from a biomedical device such as an ICD. The FPAS is composed of four factors: 1) Return to Function, 2) Device-Related Distress, 3) Positive Appraisal, and 4) Body Image

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17 Concerns. The FPAS total score and subscal e scores demonstrated both convergent and divergent validity with the SF-36, Atrial Fibr illation Symptom Severity Scale, CES-D, STAI, and the Illness Intrusiveness Rating S cale (Burns et al., 2005). For this study, only the Body Image Concerns scale will be used. Higher scores on the Body Image Concerns subscale indicate higher levels of distress or concerns. Medical variables Data on the following medical variables was collected through medical record review: left ventricula r ejection fraction, car diac diagnosis, ICD placement duration, history of mental health problems or treatment, current medications, cardiac risk factors, and shoc k history. Stored intracardi ac electrograms allowed for definitive identification of arrhythmias leading to the delivery of shock.

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18 CHAPTER 4 RESULTS The following statistical analyses were performed to evaluate the proposed hypotheses for this research project. The St atistical Package for the Social Sciences (SPSS) was utilized to perform all the analyses. In order to correct for violations of the Box-M test and the Levenes test for the assumption of homogeneity of variance, the relatively conservative Pillais trace was used for the estimation of F-statistics in the analyses that follow. Variables were examined on a list wise basis; therefore, participants who did not complete all measures were not included in analyses. When appropriate, Bonferroni corrections were ap plied to rectify the possibility of Type I error. Family wise error rates are noted for each analysis. This method of correc tion was utilized in order to provide a conservative a nd methodical analysis of the data. Intersex Differences Hypothesis 1: Female ICD patients will report more shock anxiety and body image concerns, and less body area satisf action than male patients. Findings: The following analyses controlled for ejection fraction and shock history as significant differences were found among men and women at study onset. Data from all ICD patients were utilized in the following analyses. In all analyses, Bonferroni corrections were applied. The fi rst analysis was conduc ted to evaluate the effects of participant group (male and fema le) on the amount of reported shock anxiety. An ANCOVA was performed to evaluate th e differences between male patients and females. Results revealed a significant difference between males and females in reported

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19 shock anxiety ( F (2,128) = 3.552, p = 0.03, p 2 = 0.053), such that female patients reported higher rates of shock anxiety than th eir male counterparts. Despite using shock history as a covariate, differences still rema ined between men and women enrolled in the study in reported shock anxiety. The second analysis was conducted to eval uate the effects of participant group on reported body image concerns and body ar ea satisfaction. A MANCOVA determined that males and females did not significan tly differ overall in their reported body area satisfaction and body image concerns ( Pillais trace = 0.042, p = 0.10, p 2 = 0.042). This suggests that male and female ICD patients report similar levels of body area satisfaction and body image concerns. Inspection of the mean values indicated that females did report lower body area satisfaction and more body image concerns, on average, than did men in the study, although these differences did not reach significance with this sample. Table 4-1 provides means on psychosocial measures by the total sample. *indicates significant difference Table 4-1 Psychosocial means of total sample Male M Female M Male n Female n FSAS*: Shock anxiety 15.53* (SD = 6.77) 16.33* (SD = 7.12) 60 71 MBSRQ: Body area satisfaction 36.43 (SD = 21.96) 29.95 (SD = 6.87) 61 70 FPAS: Body image concerns 9.63 (SD = 21.33) 16.72 (SD = 25.52) 61 71

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20 Intrasex Differences Hypothesis 2: Younger women will report higher rates of shock anxiety, death anxiety, and body image concerns, and less body area satisfaction. Findings: Data from all female ICD patients were utilized in the following analyses. In all analyses, B onferroni corrections were appl ied. The first analysis was conducted to evaluate the e ffects of participant group ( young, middle-aged, or older females) on the amount of reported shoc k anxiety and death anxiety. A MANOVA determined that participant groups did not si gnificantly differ overa ll in their reported shock anxiety and death anxiety ( Pillais trace = 0.127, p = 0.06, p 2 = 0.064). However, upon examination of the univariate death anxi ety ANOVA, it was evident that there was a significant group difference in reported death anxiety ( F (2,68) = 3.681, p = 0.03, p 2 = 0.098) such that younger women reported significantly higher death anxiety than older women ( p = 0.025). This analysis suggests that young women may experience more death anxiety than women over the age of 65. The second analysis was conducted to eval uate the effects of age on reported body area satisfaction and body image concerns. A MANOVA revealed that participant groups did significantly differ overall in their reported body area satisfaction and body image concerns ( Pillais trace = 0.133, p = 0.05, p 2 = 0.067). Multiple comparisons determined that younger women reported signi ficantly higher body image concerns than their middle-aged cohorts ( p = 0.03). Results suggest that female ICD recipients under the age of 50 may experience more body imag e concerns than women between 51 and 64 years of age. Table 4-2 provides means on ps ychosocial measures by the three groups of females.

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21 Young (n = 28) Middle-Aged (n = 21) Older (n = 22) FSAS: Shock anxiety 18.72 (SD = 8.23) 15.12 (SD = 7.10) 14.45 (SD = 4.60) MFODS*: Death anxiety 30.10* (SD = 10.83) 33.20 (SD = 9.17) 37.83* (SD = 9.70) MBSRQ: Body area satisfaction 30.32 (SD = 7.24) 28.95 (SD = 5.59) 30.44 (SD = 7.70) FPAS*: Body image concerns 26.78* (SD = 29.01) 8.33* (SD = 19.49) 12.50 (SD = 22.70) *indicates significant difference Table 4-2 Psychosocial means of females by age group

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22 CHAPTER 5 DISCUSSION Summary of Results The major objectives of the current study were to investigate the intersex and intrasex differences among patients with IC Ds. Specifically, this study investigated through analyses of variance, the strength of the associations between sex, age, shock anxiety, death anxiety, and body image, while controlling for left ventricular ejection fraction, at a single time point. Results from this study suggest that males and females exhibit significantly different levels of shock anxiety. Recent literature has suggested that female ICD patients may be at increased risk for psychol ogical distress, although specific avenues for distress have yet to be established (Walker et al., 2004). Fear of future shock may persist as a particular area of concern for female patients. In the current study, women reported higher rates of shock anxiety th an did males. Based on our results, shock anxiety is an area of highlighted concern for female patien ts and should be fully explored in future research and acknowledged by clinicians. Although rates of body area satisfaction and body image concerns were not significantly different among males and female s, an obvious trend was identified. On average, women reported lower body area sa tisfaction and more body image concerns than men in the study. There are several explan ations why this trend may exist. Previous research has established that women tend to report more body image disturbances after physical scarring than men, on average (Lawrenc e et al., 2004). Therefore, it would seem

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23 logical than this trend would persist even among cardiac populations. However, an even more likely explanation of this phenomenon is the obvious imposition of the device on the physiognomy of the female body. Standard placement can be challenging for women due to their anatomy; the weight of the breas t itself may pull and tear on incisions making the scar larger still. The pr actical limitations of bra stra ps, purse straps, and seat belts (Giudici, 2001) are side effects of sta ndard device placement that have been acknowledged. Davis and colleagues (2004) examined the body satisfaction of women implanted with cardiac pacemakers. They repor ted that the visibility of their scar, how their clothing fit with the device, and the impact their device had on wearing swimsuits, were significant concerns of women, compared to their male cohorts. As an ICD is significantly larger than a pacemaker, it is re asonable to assume that women who receive ICDs may also experience considerable conc erns related to the impact of the device on body image. Although intrasex differences in shock a nxiety were not found, highly significant differences in death anxiety were reported am ong female patients enrolled in the current study. Results suggest that women under the ag e of 50 experience clinically significant levels of death anxiety, largely in excess of their older-aged cohorts. Many of these women have experienced sudden cardiac death an d have been faced with the prospect of dying. Younger women often experience a rapid onset of cardiac disease, such as nonischemic cardiomyopathy, giving them little time to adjust with the life-altering events they have recently experienced. While the IC D has been widely established as a lifesaving device, some patients appear to have si gnificant anxiety relate d to the device and fears of death (Pauli et al., 1999) Death anxiety appears to be a particularly relevant

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24 construct to this population of young female patients, which may be due to the rapid onset of their cardiac disease coupled with the implantation of an ICD as a constant reminder of their potential mortality. In the current study, results revealed highl y significant differences in reported body image issues between women under the age of 50 and women between the ages of 51 and 64. This suggests that middleand olderaged women who have undergone implantation of an ICD experience similar rates of body area satisfaction and body image concerns, while younger women experience highly clinic ally significant symp toms of distress associated with body image. The visibili ty of a defibrillator and the accompanying socially visible scar may likely contribut e to body dissatisfaction among younger women with ICDs. Martin, Leary, and Rejeski ( 2000) described a variety of psychological implications accompanying diseaseand age-rela ted changes that resulted in a perceived decrease in physical attrac tiveness. Notably, low self -esteem, depression, social isolation, and symptoms of hypochondriasis were associated with nega tive self-ratings of appearance. Previous research examined quality of life among younger ICD patients (Dubin et al., 1996) and revealed significant patient concerns about the impact of device placement on clothing fit (63%), socializing pr oblems due to their device (75%), and worries about sexual activity with an impl antable device (50%), suggesting body image and quality of life are highly related. As such, the imposition of the device on a womans body in terms of visibility and scarring warrants increased atte ntion to body image issues surrounding ICD implantation and subsequent ad justment in younger female recipients. Strengths and Limitations When interpreting results from this study, there are several strengths and limitations that should be taken into considerat ion. In an attempt to recruit an unbiased

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25 sample, we enrolled participants from three distinct medical centers with a considerably wide geographical area. Anal yses evaluating this sample found participants to be relatively equivalent to each other in regards to demographi c and medical variables, with the exception of education and vocational status, and ejection fraction. Despite extending recruitment to multiple locations, our sample size may be considered relatively limited in the number of patients participating in data co llection. This limitati on may have resulted in reduced significant findings regarding the stated hypotheses. We attempted to minimize the effect of this limitation through th e use of Bonferroni co rrections to control for Type I errors. It should also be noted that this study examined data from a single time point, and may not accurately represent comp rehensive psychosocial functioning over time. In order to rectify this methodologica l limitation, future research should include repeated measurement over time with a randomized controlled design. For purposes of investigating intrasex diffe rences among female participants in the study, women were stratified according to age. We divided the women into three age groups; 50, 51-64, and 65 years of age. Despite th e potential limita tions of grouping women by age, and thus splitting a continuous variable into a categorical variable, we felt we were justified in doing so for several r easons. First, previous cardiac research has utilized this methodology, categorizing fema les as young women (under 50), middle aged women (51 to 64), and older women (over the ag e of 65). Second, research within breast cancer has often organized women into sim ilar groupings by age to examine differences between younger and older females in their e xperience with breast cancer and subsequent treatment. Third, the experi ence of heart disease may be very different across the lifespan. Younger women more typically have a rapid onset of a more non-ischemic

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26 cardiac disease and often receiv e an ICD for secondary preven tion after they have already experienced a sudden cardiac arrest. Olde r women more typically have experienced years of coronary risk factors, suffer from a more ischemic form of cardiac disease, and receive the device for primary prevention of future cardiac events. Therefore, women across the lifespan may experience different forms of cardiac disease and may also present with different indicati ons for receiving an ICD, wh ich makes clinical sense to separate them by age in research. As with all research, consideration of se lf-report measures s hould be made; selfreport measures may be influenced by patient demand characteristics, such as participant perception of how they should respond or w ould like themselves to be perceived. The measures used in assessing psychosocial function ing in patients were restricted to the use of standardized and validated measures that were chosen for their established reliability and validity in measuring the c onstructs of interest. We al so attempted to minimize the influence of demand characteristics by allo wing patients to complete the measures in privacy in outpatient clinics and by assuri ng confidentiality of responses and anonymity after data collection. Clinical Implications Collectively, results from this st udy highlight the growing need for comprehensive psychological care for women w ith ICDs. The lack of research in the female-specific adjustment to the ICD repres ents absence of innova tion in the area of comprehensive care for women. Without such innovation, healthcare pr ofessionals fail to provide universal comprehens ive care to the female ICD recipients. Only with appropriate facilitative care can female ICD pa tients return to previ ous levels of physical and psychosocial functioning. The study emphasi zes the need for healthcare providers to

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27 recognize and acknowledge symptoms of distress among female patients in an attempt to identify those women most at risk for the development of psychosocial maladjustments secondary to cardiac disease. Clinicians can utilize this in formation to improve outcomes in ICD recipients by providing patients with increased attention to their psychological needs and referrals for psycho-educat ional interventions when indicated. Implantable cardioverter defibrillator patients may experience improved health outcomes through a combination of optimal me dical treatment and tailored psychosocial care, including preand post-implant ps ychological consultati on, support groups with other recipients, or individual psychothera py. This process can be facilitated by the integration of cardiac psychologists as an e ssential component of the electrophysiology team. The changes in physical appearance that female ICD recipients experience may constitute differences in their percepti on of body image. Traditional ICD placement involves creating an incision in the left chest wall wherein th e device is implanted. This procedure produces both visible scarring and bulging around the implant site due to the placement of the device underneath the skin. This protocol presents a particularly sensitive problem for women, whose clothing often leaves this part of the upper body exposed. Female ICD recipients would lik ely benefit from well-developed treatment protocols that include a vari ety of implant options, pre-ope rative education, and plastic surgery consultation. As therap ies continue to advance, fema le ICD patients, particularly those under the age of 50, may benefit from well-established guideli nes that take into consideration the unique issues women face w ith the implantation of a cardiac device.

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28 Research Implications The review of the relevant literature to date suggests that the female-specific adjustment to the ICD has not been thoroughl y assessed. The current study substantially adds to this body of literature, in the explora tion of the unique experience female patients face in living with an ICD. Given that women with cardiac disease experience more psychological morbidity than men, it is reasona ble to predict that female ICD patients demonstrate different patterns of adjustment re lative to males; this hypothesis in part was supported by our results. The investigation of the unique issues women face in living with an ICD is noteworthy, as it could largel y improve quality of life, adjustment, and psychological fitness of female ICD recipients. Given the findings of the current study and other research documenting psychological maladjustment to the ICD, futu re research needs to next address the potential differences in psychological functi oning among age groups of device recipients. Results from the current study revealed seve ral intrasex differences among females, including the reported frequenc ies of clinically significan t death anxiety and body image concerns; further exploration of thes e constructs is largely warranted. Future research focused on tailored psyc hological care for female patients is also indicated, including the investig ation of psychosocial interv entions and their effects on health outcomes of ICD patients post-implant. To date, however, there have been very few studies that have examined the impact of such interventions on ICD patient adjustment and psychosocial functioning (Kohn et al., 2000). Additionally, given the paucity of research that has been conducte d to date examining i ndividual differences influencing the adjustment of females to the ICD, future studies w ould be beneficial in providing useful information to clinicians about the potential differences between male

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29 and female ICD recipients. Finally, a dditional research id entifying and further scrutinizing potential risk factors for psychological maladjustment to the ICD is indicated. While the current study provides useful information in this regard, future studies could more specifically address the independent value of each of the aforementioned variables by determining the diff erential risk associated with each of these factors. While this t ype of analysis was beyond the original scope of the current study, it is clearly an extension that is imp licated from the findings and should be incorporated in future research endeavors. This data emphasizes the importance of a multidisciplinary approach in the investigation and treatment of ICD patients. Conclusion In summary, the ICD is a life-saving de vice whose use is increasing annually. Although the effectiveness of its life-saving utility is well es tablished, quality of life and adjustment issues persist. Women in part icular appear to be a vulnerable subpopulation for developing subsequent dist ress after implantation. Shoc k anxiety, death anxiety, and body image issues are possible avenues of dist ress for female recipients. Given these considerations, this study offers new in formation regarding the female-specific experience in living with an ICD. In closing, the findings from this study suggest that ICD patients who report elevated feelings of death and shock anxi ety, as well as body image dissatisfaction or concerns, should be evaluated for psychologi cal intervention to minimize adjustment difficulties and possible declines in quality of life after ICD implantation. Subsequent to implant, young women appear to be highly at risk for the development of psychosocial distress associated with shock anxiety, death anxiety, and body image. More considerable attention is warranted in wo men under the age of 50 by researchers and

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30 clinicians alike, as this popul ation has been identified to be increasingly more likely to receive an ICD as the indications for im plantation continue to grow exponentially (Wolbrette et al., 2002).

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31 LIST OF REFERENCES Allen K. & Wellard S. (2001). Older wo men's experiences with sternotomy. International Journal of Nursing Practice, 7, 274-279. American Heart Association. (2004). Sudden death from cardiac arrest-statistics. Retrieved September 1, 2005, from http:// www.americanheart.org. American Psychological Association. (1996). Research agenda for psychosocial and behavioral factors in women's health. Washington, DC: Women's Programs Office. Antiarrhythmics Versus Implantable Defibrill ators Trial Investigators. (1997). A comparison of anti-arrhythmic-drug thera py with implantable defibrillators in patients resuscitated from near-f atal ventricular arrhythmias. New England Journal of Medi cine, 337(22), 1576-1583. Bardy G.H., Lee K.L., Mark D.B., Poole, J.E., Packer, D.L., Boineau, R., Domanski, M., Troutman, C., Anderson, J., Johnson, G., McNulty, S.E., Clapp-Channing, N., Davidson-Ray, L.D., Fraulo, E.S., Fishbe in, D.P., Luceri, R.M., & Ip, J.H.; Sudden Cardiac Death in Heart Failure Tr ial (SCD-HeFT) Investigators. (2005). Amiodarone or an implantable cardiovert er-defibrillator for congestive heart failure. New England Journal of Medicine, 352, 225-237. Brown, T.A., Cash, T.F., & Mikulka, P.J. (1990). Attitudinal body-image assessment: factor analysis of the Body-Self Relations Questionnaire. Journal of Personality Assessment, 55(1-2), 135-144. Burns J.L., Serber E.R., Keim S., & Sears S.F. (2005). Measuring patient acceptance of implantable cardiac device therapy: Initial psychometric investigation of the Florida patient acceptance survey. Journal of Cardiovascul ar Electrophysiology, 16(4), 384-390. Buxton, A.E., Lee, K.L., & Fisher, J.D. (1999) A randomized study of the prevention of sudden death in patients with coronary artery disease. New England Journal of Medicine, 341, 1882-1890. Chin M. & Goldman L. (1998). Gender differences in 1-year survival and quality of life among patients with congestive heart failure. Medical Care, 36, 1033-1046.

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33 Iammarino, N.K. (1975). Relationship between d eath anxiety and demographic variables. Psychological Reports, 37(1), 262. Kessler, R., McGonagle, K., Zhao, S., Nelson, C.B., Hughes, M., Eshelman, S., Wittchen, H.U., & Kendler, K.S. (1994).Lifetime and 12 month prevalence of DSM-III psychiatric disorders in the United States: Results from the National Comorbidity Study. Archives of General Psychiatry, 51, 8-19. Kohn, C.S., Petrucci, R.J., Baessler, C., Soto, D.M., & Movsowitz, C. (2000). The effect of psychological intervention on patients long-term adjustment to the ICD: A prospective study. Pacing and Clinical Electrophysiology, 23, 450-456. Kuhl, E.A., Dixit, N.K., Conti, J.B., & Sears, S.F. (in press). Measurement of patient fears about implantable cardi overter defibrillator shock: An initial evaluation of the Florida Shock Anxiety Scale. Pacing and Clinical Electrophysiology. Lawrence, J., Fauerbach, J., Heinberg, L., & Do ctor, M. (2004). Visible vs. hidden scars and their relation to body esteem. Journal of Burn Care and Rehabilitation, 25, 25-32. Lichtenberger, C., Ginis, K ., MacKenzie, C., & McCartney, N. (2003). Body image and depressive symptoms as correlates of se lf-reported versus clinician-reported physiologic function. Journal of Cardiopulmonary Rehabilitation, 23, 53-59. Lonetto, R. & Templer, D.I. (1986). Death Anxiety. Washington: Hemisphere Publishing Corporation. Martin, K., Leary, M., & Rejeski, J. (2000). Self -presentational concerns in older adults: Implications for health and well-being. Basic and Applied Social Psychology, 22, 169-179. Mendes de Leon, C., DiLillo, V., Czajkowski, S., Norten, J., Schaefer, J., Catellier, D., & Blumenthal, J. (2001). Psychosocial char acteristics after acute myocardial infarction: The ENRICHD pilot study. Journal of Cardiopulmonary Rehabilitation, 21, 353-362. Moss, A.J., Hall, W.J., Cannom, D.S., Daubert J.P., Higgins, S.L., Klien, H., Levine, J.H.,Saksena, S., Waldo, A.L., Wilber D., Brown, M.W., & Moonseong, H. (1996). Improved survival with an impla nted defibrillator in patients with coronary disease at high risk for vent ricular arrhythmia. Multicenter Automatic Defibrillator Implantation Tr ial (MADIT) Investigators. New England Journal of Medicine, 335, 1933-1940. Neimeyer, R.A. (1993). Death anxiety handbook: Research, instrumentation, and application. Washington, DC: Tayl or Francis Publishing.

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34 Neimeyer, R.A. & Moore, M.K. (1994). Validity and reliability of the multidimensional fear of death scale. In R. Neimeyer (ed.) Death anxiety handbook: Research, instrumentation, and application. Washington, DC: Taylor Francis Publishing. Pauli, P., Wiedemann, G., Dengler, W., Be nninghoff, G.B., & Kuhlkamp, V. (1999). Anxiety in patients with an automatic implantable cardioverter defibrillator: What differentiates them from panic patients? Psychosomatic Medicine, 61, 6976. Payne, D.K., Biggs, C., Tran, K.N., Borgi n, P.I., & Massie, M.J. (2000). Womens regrets after bilateral prophylactic mastectomy. Annals of Surgical Oncology, 7(1), 150-154. Regier, DA. (1994). The NIMH epidemiologi c catchment area program: Historical context, major objectives, and study population characteristics. Archives in General Psychiatry, 41(10), 934-941. Rozanski, A., Blumenthal, J., & Kaplan, J. (1999 ). Impact of psychological factors on the pathogenesis of cardiovascular dise ase and implications for therapy. Circulation, 99, 2192-2217. Rozanski, A., Blumenthal, J., Davidson, K., Saab, P., & Kubzansky, L. (2005). The epidemiology, pathophysiology, and management of psychosocial risk factors in cardiac practice. Journal of the American College of Cardiology, 45, 637-651. Schulz, R. (1979). Death anxiety: Intuitive empi rical perspectives. In L.A. Bugen (ed.) Death and Dying: Theory, Research, and Practice. Sears S.F., & Conti J.B. (2002). Current views on the quality of life and psychological functioning of implantable cardi overter defibrillator patients. Heart, 87, 488-493. Sears, S.F., & Conti, J.B. (2003). Understand ing ICD shocks and storms: Medical and psychosocial considerations for research and clinical care. Clinical Cardiology, 26, 107-111. Sears, S. F., Conti, J. B., Curtis, A., Saia, T. L., Foote, R., & Wen, F. (1999). Affective distress and implantable cardioverter defi brillators: Cases for psychological and behavioral interventions. Pacing and Clinical Electrophysiology, 22, 1831-1834. Sears S.F., Shea J.B., & Conti J.B. (2005). Th e cardiology patient page: How to respond to an ICD shock. Circulation, 111, e380-e382. Sears, S.F., Todaro, J.F., Saia, T.L., Sotile, W., & Conti, J.B. (1999). Examining the psychosocial impact of implantable car dioverter defibrillators: A literature review. Clinical Cardiology, 22, 481-489.

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36 BIOGRAPHICAL SKETCH Lauren Vazquez Sowell was born in Farmington Hills, Michigan, on March 11th, 1982, to Dr. and Mrs. Paul and Teresa Vazqu ez. She has one younger sister, Andrea, and a younger brother, Paul Evan. Lauren gra duated cum laude from the University of Florida in May 2004 with a Bachelor of Health Science degree in health science and a Bachelor of Science in psychology. She married David Sowell on May 6th, 2005. Lauren and her husband, David, currently reside in Ga inesville, Florida, where she is pursuing her Ph.D. in clinical and health psychology at the University of Florida. Her clinical and research interests lie in me dical and health psychology, w ith a focus on cardiovascular disease and cardiac device therapy.