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International Journal of Cardiology 220 (2016) 360364

Contents lists available at ScienceDirect

International Journal of Cardiology

journal homepage: www.elsevier.com/locate/ijcard

Psychological correlates, allostatic overload and clinical course in


patients with implantable cardioverter debrillator (ICD)
Sara Gostoli a,,1,2, Matteo Bonomo a,1,2, Renzo Roncuzzi b,1,2, Mauro Bif c,1,2,
Giuseppe Boriani c,1,2, Chiara Rafanelli a,1,2
a
Department of Psychology, University of Bologna, Bologna, Italy
b
Division of Cardiology, Bellaria Hospital, Bologna, Italy
c
Division of Cardiology, Sant'Orsola-Malpighi Hospital, Bologna, Italy

a r t i c l e i n f o a b s t r a c t

Article history: Background: Implantable cardioverter debrillator (ICD) is a key treatment option for both primary and second-
Received 11 May 2016 ary prevention of sudden cardiac death. Despite this, there is a growing number of studies showing that ICD is
Accepted 26 June 2016 often associated with post-implantation deleterious psychosocial effects, even in the absence of medical
Available online 27 June 2016 complications. Knowledge about the predictive role of pre-ICD psychological prole is scant. The present research
aims to describe patients' pre-ICD psychological prole, focusing on acute and chronic distress, such as anxiety,
Keywords:
depression, type D personality, psychosomatic syndromes and allostatic overload (AO), and to evaluate if these
Allostatic overload
Anxiety
psychological variables could affect ICD outcomes and survival.
Diagnostic Criteria for Psychosomatic Research Methods: 117 consecutive patients (74.4% males; mean age = 63.1 13.7 years) underwent psychological
(DCPR) assessment prior to ICD implantation. Data on ICD-related complications and death were collected up to
Depression 26 months after the intervention.
Implantable cardioverter debrillator Results: At baseline, 36.8% of the sample had anxiety and 17.9% depression. Among psychosomatic syndromes,
Type D personality psychological factors affecting medical conditions were the most frequent (37.6%). 12.8% presented with type
D personality, whereas 16.2% showed moderate AO and 4.3% severe AO. 25.6% of the patients had post-ICD com-
plications and 6% died. Severe AO was the only predictor of survival.
Conclusion: Our ndings show that a reliable evaluation of stress and the inability to cope with it (allostatic over-
load) may help to identify patients at higher risk of post-ICD complications and death. Such sensitive index, more
than traditional psychiatric diagnostic criteria, may help the physician to identify easily manifestations of distress
and clinically relevant information, which could affect medical illness outcomes.
2016 Elsevier Ireland Ltd. All rights reserved.

1. Introduction infarction, with left ventricular ejection fraction (LVEF) of 35% or less,
NYHA Class II or III symptoms, on chronic guideline-directed medical
Implantable cardioverter debrillator (ICD) has emerged as an im- therapy, who have reasonable expectation of meaningful survival for
portant treatment option for patients who are at risk of sudden cardiac more than 1 year [5]. Secondary prevention by means of ICD is indicated
death (SCD) [1]. Randomized trials have consistently shown that ICD before discharge of patients who survive sustained ventricular tachycar-
implantation decreases mortality in patients with heart failure and re- dia or brillation, provided that arrhythmia is not due to transient or
duced left ventricular function, as well as patients who have suffered a reversible ischemia, re-infarction, or metabolic abnormalities [4].
cardiac arrest [2,3]. Recent guidelines recommend ICD for both primary Although the implantation is quite simple, medical complications
and secondary prevention of SCD [4,5]. Primary prevention consists in such as bleeding, infection, pneumothorax, cardiac perforation, lead
reducing total mortality of patients with non-ischemic dilated cardio- dislodgement, and death, have to be taken into account [6]. Among
myopathy or ischemic heart disease at least 40 days post-myocardial long term unwanted events, inappropriate shocks occur nowadays in
2 up to 6% ICD patients [7,8]. ICD implantation is often associated with
deleterious psychosocial effects, with about 50% of recipients reporting
Corresponding author at: Department of Psychology, University of Bologna, Viale Berti elevated levels of anxiety and depression resulting from the fear of ICD
Pichat 5, 40127 Bologna, Italy. discharge and device failure, decrease in physical activity, and negative
E-mail address: sara.gostoli2@unibo.it (S. Gostoli).
1
These authors contributed equally to this manuscript.
lifestyle changes (such as the inability to drive or return to work) [9]. In
2
This author takes responsibility for all aspects of the reliability and freedom from bias addition, some patients develop severe psychiatric problems, such as
of the data presented and their discussed interpretation. post-traumatic stress disorder (PTSD), after receiving inappropriate

http://dx.doi.org/10.1016/j.ijcard.2016.06.246
0167-5273/ 2016 Elsevier Ireland Ltd. All rights reserved.
S. Gostoli et al. / International Journal of Cardiology 220 (2016) 360364 361

shocks [10]. However, even in absence of medical complications and psychosomatic syndromes, highlighting the variety of somatic and mental responses
that individuals may have produced in various circumstances during life [36]. The DCPR
inappropriate shocks experience, 2533% of ICD patients report psycho-
allows translating into operational tools psychosocial variables resulting from psychoso-
logical problems following ICD implantation [11]. For these reasons, matic research. According to the psychosomatic approach, patient condition must be con-
most of research have focused on psychological problems risen after sidered holistically, as the psychological factors and the biological components interact
ICD implantation. The difculties in adaptation for both these patients during an organic disorder, affecting its course and the psychological response of the sub-
and their families [12] resulted in an increasing need to address psycho- ject [37]. Twelve psychosomatic syndromes were operationalized with a specic diagnos-
tic criterion, and divided into three clusters: abnormal illness behavior (nosophobia,
logical distress [13,14]. thanatophobia, health anxiety, illness denial), psychological factors affecting medical
Studies on the role of a previous history of psychiatric disorders are conditions (alexithymia, type A behavior, irritable mood, demoralization), and somati-
rare. Pedersen et al. [11] found that pre-ICD psychological impairments, zation (functional somatic symptoms secondary to a psychiatric disorder, persistent so-
such as specic personality traits, rather than ICD-related complications, matization, conversion, reaction to anniversaries). The DCPR is an observer rated, semi-
structured interview with closed questions, and dichotomous yes or no answers, referring
could be strongly associated with post-ICD emotional distress, such as
to the last twelve months. The instrument showed good psychometric properties [38].
anxiety. It has been found that a positive history of depression predicts
poor health status, such as impaired health-related quality of life [15, 2.2.3. Type D personality
16]. The manifestation of psychological distress such as anxiety and de- Type D personality is measured by 14-item Type D Scale (DS-14) [39]. The scale con-
pression prior to ICD implantation may be independent or attributed to sists in 14 items, divided into two scales (7 items each): negative affectivity and social in-
hibition. The answers are on a 5-point Likert scale, ranging from 0 (false) to 4 (true). Both
a combination of factors, including fear for ICD implantation or the un-
scales have a cut-off value 10, beyond which the presence of type D personality can be
derlying heart disease [1719]. Several studies also found high rates of assumed.
type D personality in pre-ICD patients [20,21] associated with the risk
for developing adverse health outcomes [22,23]. Thus, as highlighted 2.2.4. Sub-clinical symptoms of psychological distress
by Pedersen and colleagues [24], the identication and treatment of Symptom Questionnaire (SQ) [40] is a self-report measure, based on the Symptom
Rating Test by Kellner and Shefeld [41]. It consists of 92 dichotomous (yes/no, true/
subgroups of patients with stable high emotional distress levels is nec-
false) items that make the instrument easy to understand and fulll (those are important
essary, since chronic emotional distress and impaired health status features when the questionnaire is administered to people with poor verbal skills). The
may precipitate ventricular arrhythmias and mortality in patients with questionnaire consists in four scales (depression, anxiety, anger-hostility and somatic
ICD. Recent studies performed in medical settings have focused on the symptom) and the scoring is calculated by assigning one point for each positive response.
importance to detect allostatic overload (AO), which occurs when The maximum score is 23 and higher scores indicate higher psychological distress; if the
score exceeds one or two standard deviations (SD) from the average of general population,
cumulative interactions of life events and chronic stressors exceed
the distress is being considered as moderate, but if it exceeds two SD the presence of
individual resources [25,26]. In cardiology, it discriminated patients at severe psychological distress can be assumed [40]. Due to its sensitivity, SQ proved to be
high risk for psychological distress [27,28]. No studies, however, have a highly effective instrument in predicting the change in psychological and psychosomatic
been conducted among ICD patients. issues.
Other research revealed that psychosomatic syndromes, evaluated
2.2.5. Psychological well-being
by Diagnostic Criteria for Psychosomatic Research-DCPR [29,30], are
The Psychological Well-Being scale (PWB), short version (42 items), measures the
strictly associated to cardiac diseases [27,30]. To our knowledge, only presence of psychological well-being [42]. PWB is a self-rating and multidimensional
a small study [31] assessed DCPR syndromes among patients with ICD. questionnaire, which includes the six domains of Ryff's psychological well-being model:
Only few studies have examined the role of baseline psychological autonomy, environmental mastery, personal growth, positive relations with others, pur-
pose in life and self-acceptance [43]. The higher the score, the higher psychological well-
characteristics such as anxiety [31], type D personality and self-
being is. Patients must indicate their level of agreement or disagreement with the items
reported health-related quality of life [10,24,32,33] as risk factors for using a 7-point Likert scale, ranging from 0 (not my case) to 6 (that is exactly my case).
ventricular arrhythmias and death in ICD patients.
The present study aims to describe the baseline psychological and 2.2.6. Health-related quality of life
psychosomatic prole of patients undergoing the implantation of ICD, The 36-item Short Form Health Survey (SF-36) [44] is a self-rated test, accurate and
focusing on acute and chronic distress, and evaluate if these psycholog- fast to be administered. Usually, it is used for medical population and it is very sensible
in valuating health status changes [45]. The 36 questions refer to eight subscales: physical
ical variables could affect the clinical course of ICD patients. Specically, activity (10 items), role limitations due to physical health (4 items), role limitations due to
the goal and novelty of this study is to verify if pre-existing psycholog- emotional problems (3 items), physical pain (2 items), perception of general health status
ical correlates could predict ICD outcomes and survival. (5 items), vitality (4 items), social activities (2 items), mental health (5 items), and a single
question about the change in health status. The different dimensions are included in three
2. Methods main domains: physical quality of life, mental quality of life, overall quality of life. All SF-36
questions are referred to the four weeks prior the assessment, except for the question
2.1. Sample about the change of the health status, which considers the last year. The test includes
both dichotomous (yes/no) and on a Likert scale answers.
The study includes a sample of 117 consecutive patients (74.4% males; mean age =
63.1 13.7 years, range from 26 to 86 years) undergoing ICD implantation from July 2.2.7. Allostatic overload
2012 to November 2015 at the Department of Cardiology of the Policlinico S. Orsola- The operationalization of the concept of allostatic overload is based on specic
Malpighi, Bologna. Patients underwent the psychological assessment before the interven- clinimetric criteria developed by Fava and colleagues [26]. Since the assessment of life
tion and at multiple follow-up, up to 24 months after the implantation. Written informed events by a detailed interview method, such as the Interview for Recent Life Events [46]
consent was obtained from all the participants. The study protocol conforms to the ethical is unlikely to be endorsed in practice, even if certainly the gold standard, the Psychosocial
guidelines of the 1975 Declaration of Helsinki as reected in a priori approval by the Local Index (PSI) [47] has been chosen as a reliable compromise. PSI is a short clinimetric index,
Ethic Committee. tailored to a busy clinical setting, for the assessment of stress and related psychological
distress (allostatic load). It offers a synthesis of previously validated instruments: the
2.2. Assessment Screening List for Psychosocial Problems [48], the Stress Prole [49], the Psychological
Well-Being scales [50,51] and the Illness Attitude Scales [52]. All this information may
2.2.1. Anxiety and depression help formulate a global clinical judgment of an individual's assets and coping skills in deal-
Structured Clinical Interview for DSM-IV-TR Disorders (SCID) [34,35], Axis I, was ad- ing with his/her current life situation. AO Criterion A requires the presence and identiable
ministered in order to identify anxiety and depressive diagnoses. SCID is an excellent stressor, either as a recent life event or as prolonged exposure; the stressor must be judged
tool that meets the needs of both clinician and investigator. The SCID can be applied to as exceeding or taxing the individual's coping skills when evaluated. The presence of an
any person thanks to his easy understanding, except to people with severe cognitive im- acute or chronic stressor was established on patient's reporting of at least one chronic
pairment. Time of administration varies from 45 to 90 min, depending on the complexity stressor or life event comprised in the Psychosocial Index [47] stress subscale, as assessed
of patient medical history and psychological status. by items 3240 and 4754. The perceived feeling of inability to cope prociently with the
situation was identied through at least one positive answer to items 43 and/or 44. Both
2.2.2. Psychosomatic syndromes conditions were deemed necessary to satisfy criterion A requirements. Criterion B requires
The Diagnostic Criteria for Psychosomatic Research (DCPR) [29,30] integrate somatic the stressor to be associated with at least 1 manifestation among psychiatric symptoms
disorders with the DSM-IV and International Classication of Disease (ICD-10) in a multi- (B1), psychosomatic symptoms (B2), impaired functioning (B3) or compromised well-
axial approach. The basic idea of this new classication system is to think in terms of being (B4). Furthermore, the manifestations must occur within 6 months after the onset
362 S. Gostoli et al. / International Journal of Cardiology 220 (2016) 360364

of the stressor. Based on the available information from the PSI, the degree of psycholog- Table 1
ical distress was determined by reaching a score above 11.5 (75th percentile) on the PSI Relationship among baseline variables and survival in ICD patients.
psychological distress subscale (items 13 to 27). Similarly, the presence of impaired psy-
chological well-being was determined by reporting a cumulative score equal or lower Socio-demographic and N (%) Mean SD Hazard ratio (95% p
than 7 (25th percentile) on items 41, 42, 45, 46, 55. The presence of AO was thus deter- clinical variables CI)
mined by satisfying both criteria A and B. Age 63.1 13.7 1 (0.981.03) NS
Gender
2.3. Statistical analysis Male 87 (74.4)
Female 30 (25.6) 1.52 (0.773.01) NS
The SPSS software, version 20.0, was used in order to run the statistical analyses. Sta- Psychiatric and psychosomatic
tistical signicance was set to p = 0.05, two tailed. Descriptive analyses were run in order diagnoses
to describe the study population at baseline in terms of socio-demographic variables, psy- DSM depression 21 (17.9) 2.83 (0.879.2) NS
chological questionnaires (SQ, PWB, DS-14 and SF-36) mean scores, type D personality, DSM anxiety 43 (36.8) 1.39 (0.692.8) NS
DSM and DCPR clusters frequencies. DCPR abnormal illness 34 (29.1) 1.45 (0.693.08) NS
AO has been calculated on the basis of the clinimetric criteria mentioned above. Two behavior
categories have been identied: moderate AO (criterion A + criterion B, dened as high DCPR somatization 7 (6.0) 2.99 (0.4121.82) NS
psychological distress OR low psychological well-being) and severe AO (criterion DCPR psychological factors 44 (37.6) 1.39 (0.72.75) NS
A + criterion B, dened as high psychological distress AND low psychological well-being). affecting medical conditions
Cox model hazard-ratio was derived. To select appropriate covariates for statistical Type D personality 15 (12.8) 1.14 (0.43.21) NS
control, baseline psychological mean scores (SQ, PWB, DS-14 and SF-36) and diagnoses Allostatic overload
(DSM depression/anxiety, DCPR, type D personality and moderate/severe AO) were tested Moderate AO 19 (16.2) 0.65 (0.291.49) NS
in univariate Cox regression analysis. Those variables signicantly related to post-ICD Severe AO 5 (4.3) 0.18 (0.060.51) 0.001
complications in univariate analysis were also entered into the multivariate Cox regres- Psychological questionnaires
sion analysis, adjusted for sex and age. We used the KaplanMeier method and Logarith- Symptom Questionnaire
mic Rang (Log Rank) to estimate survival curves. Anxiety 6.5 4.9 1.06 (11.13) 0.049
Among post-ICD complications, heart failure, hospitalizations due to cardiac prob- Depression 5.9 4.1 1.03 (0.951.11) NS
lems, supraventricular tachycardia, ICD extraction due to an infection, coronary arteries Somatization 7.7 5.2 1 (0.941.07) NS
surgery, ICD re-evaluation, deep vein thrombosis, atrial tachycardia, dyspnea and all- Hostility 3.6 3.6 1.04 (0.951.13) NS
cause mortality were included. The mean period of survival was 14.8 11.2 months. Psychological Well-Being scales
Autonomy 35.1 5.1 1.05 (0.981.13) NS
Environmental mastery 33.5 5.7 1.03 (0.971.09) NS
3. Results
Personal growth 31.3 5.9 1 (0.951.06) NS
Positive relations 36.2 5.6 0.99 (0.941.05) NS
63.2% of patients were married, whereas 17.1% were single, 6% Purpose in life 29.2 6.5 1.01 (0.961.06) NS
common-law wife/husband, 6% widow/widower, 4.3% divorced, and Self-acceptance 32.8 6.2 0.99 (0.941.04) NS
3.4% separated. 32.5% had a junior high school degree, 29.1% a high 14-item Type D scale
Negative affectivity 8 6.7 0.99 (0.91.09) NS
school degree, 22.2% primary school certicate, and 16.2% master de-
Social inhibition 7.3 6.5 0.95 (0.851.07) NS
gree or higher level of education. One third had retired from employ- Psychosocial Index
ment (53%). Psychological distress 7.9 6.0 1 (0.951.06) NS
With regard to the medical prole, 66.7% of patients had congestive Psychological well-being 8.6 1.5 1.01 (0.811.26) NS
Stress 2.3 1.9 0.99 (0.841.17) NS
heart failure: 5.1% NYHA class I, 28.2% NYHA class II, 19.7% NYHA class
Abnormal illness behavior 0.7 1.1 1.04 (0.781.4) NS
III, and 1.7% NYHA class IV. 50.4% of the patients had a history of coro- 36-item Short Form Health Survey
nary artery disease; 19.7% atrial brillation and 20.5% a family history Physical health-related quality of life 54.2 21.0 1 (0.981.01) NS
of heart diseases. Among medical comorbidities, 48.7% of the patients Mental health-related quality of life 58.4 18.9 1 (0.981.01) NS
had hypertension, 25.6% diabetes, 17.9% chronic kidney failure, 15.4% Total health-related quality of life 58.1 19.4 0.99 (0.981.01) NS

peripheral vascular diseases, and 8.5% hyperthyroidism or hypothyroid-


ism. All patients regularly received multiple drug therapy: 89.7% -
blockers, 80.3% ACE inhibitors, 79.5% diuretics, 40.2% anticoagulants,
30.8% antithrombotic agents and 2.6% antiarrhythmics. At baseline,
DSM anxiety disorders were more frequent than depressive disorders complications or death. No one of the remaining psychological variables
(36.8% versus 17.9%) (Table 1). Concerning DCPR syndromes, the most resulted to be predictive of survival. In multivariate analysis (controlled
represented cluster including psychological factors affecting medical for age and sex), however, anxiety (SQ) lost its signicance, whereas se-
conditions (37.6%), followed by abnormal illness behavior (29.1%) and vere AO did not (HR: 4.57 [95% condence interval {CI}: 1.5713.29];
somatization (6%) clusters (Table 1). 12.8% of the total sample showed p = 0.005). KaplanMeier survival curves for post-ICD complications
type D personality (Table 1). 16.2% of the sample (N = 19) presented by severe AO are presented in Fig. 1 (Log Rank(1) = 13.27; p b 0.001).
with AO of middle entity (high psychological distress OR well-being im-
pairment), while 4.3% (N = 5) showed a severe AO (high psychological
distress AND well-being impairment) (Table 1). 4. Discussion
Of the total sample, 37 (31.6%) showed negative outcomes after ICD
implantation. 7 (6%) patients died (most of them for cardiac causes) and In this study, the psychological prole of patients undergoing ICD
30 (25.6%) had at least one post-ICD complication. Among post-ICD implantation is quite in line with literature. Indeed, a systematic review
complications, 20% were related to ICD implantation (3.4% hospitaliza- [18] conducted on 45 studies from 1996 to 2009, showed that the prev-
tion for ICD re-evaluation, 0.9% pending skin erosion of the ICD pocket, alence of anxiety ranged from 27% to 63%, whereas the prevalence of de-
and 0.9% inappropriate shock) and 80% to cardiac illness (6.8% atrial - pression from 10% to 36%. Our results conrm the high prevalence of
brillation, 4.3% ventricular tachycardia, 3.4% hospitalizations for cardiac these psychiatric disorders among ICD patients. Concerning DCPR syn-
disease such as heart failure, cardiac shock, coronaropathy and venous dromes, as easily conceivable, the most represented cluster was that
thrombosis, 2.6% supraventricular tachycardia, 1.7% cardiac surgery, of psychological factors affecting medical conditions, due to its strong
and 1.7% paroxysmal ventricular tachycardia). Among the variables ex- association with cardiac illness [27,30,53,54]. On the same line,
amined as potential risk factors for post-ICD complications, only base- Banihashemian and colleagues [31] found greater percentages of such
line score of anxiety (SQ) and severe, but not moderate, AO attained DCPR diagnoses (27.3% type A behavior, 22.7% irritable mood and
statistical signicance (p b 0.05) in univariate analysis (Table 1). In par- 18.2% demoralization) than those of DSM diagnoses in 36 ICD patients.
ticular, 80% of the patients with severe AO experienced ICD-related The higher rates of DCPR syndromes, rather than DSM psychiatric
S. Gostoli et al. / International Journal of Cardiology 220 (2016) 360364 363

In contrast with previous research, we did not nd any of the tradi-


tional psychological risk factors, such as anxiety, depression and type D
personality [6166] to predict survival. We found that the only predic-
tive factor was severe allostatic overload (AO). Findings from previous
studies suggest that AO is associated with worse health conditions and
plays a signicant role in the susceptibility (exacerbating disease pro-
cesses depending on the type of stressor involved and/or the duration
of its inuence on an organism), course, and outcome of cardiovascular
diseases, such as hypertension, atherosclerosis, coronary artery disease
and myocardial infarction [67]. Mental and psychosocial stressors
through the sympathetic nervous system have been found to have del-
eterious inuences on the cardiovascular system [67].
Our study includes obvious limitations due to its preliminary nature
such as limited sample size and lack of assessment of stress biomarkers
(e.g. erythrocytes, leukocytes, triglycerides, cholesterol, cortisol, C-
reactive protein, glucose, and insulin) relevant for both ICD clinical
course and AO. Nonetheless, our ndings show that a reliable evaluation
of AO, merging different clinical information otherwise assessed by sev-
eral instruments, may help to identify those patients at higher risk of
Fig. 1. Survival curves of patients with and without severe allostatic overload (AO).
post-ICD complications and death. AO criteria may thus be considered
a global clinimetric index for detecting conditions that might adversely
inuence course and progression of the medical illness [57]. Hence, such
diagnoses, sustain once more the importance of introducing the DCPR clinimetric index regarding stress and the ability to cope with it, more
evaluation in a multidimensional assessment, since it offers the possibil- than the traditional psychiatric diagnostic criteria, may help the physi-
ity to obtain a wider characterization of these patients in comparison cian to identify distress manifestations and clinically relevant informa-
with traditional nosography [29,55]. In the present study, the frequency tion easily. Indeed, the ultimate goal in treating patients with long-
of type D personality (12.8%) is lower than that found in Starrenburg course illnesses should be to prevent or decrease the negative impact
et al. [20] and Mastenbroek et al. [21] research, where it ranged from of excessive distress on individuals' health and quality of life.
21% to 23%. This may be due to the smaller size of our sample than
those of the mentioned studies. Conicts of interest
Concerning self-rated questionnaires, patients of the present study
reported mean scores of health-related quality of life similar to those The authors report no relationships that could be construed as a con-
of the same kind of patients found in literature [20]. Regarding subclin- ict of interest.
ical psychological symptoms (SQ) and psychological well-being (PWB),
there are no studies in literature using the same measures to assess ICD
Funding source
patients. However, if compared with similar population with chronic
cardiac conditions, such as atrial brillation, ICD patients reported sim-
None.
ilar mean scores on both SQ and PWB [56]. Moderate AO has been diag-
nosed in 16.2% of the total sample, severe AO in 4.3%. The frequency of
moderate AO is quite in line with that found by Porcelli and colleagues References
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