Studies on psychological morbidity in patients with an implantable cardioverter-defibrillator (ICD) have focused on mean differences rather than intraindividual differences. Such an approach masks the chronicity of symptoms in individual patients and the potential differences in cardiac outcomes. We examined the prevalence and correlates of persistent depression using an intraindividual approach. Consecutive patients who had undergone ICD implantation (n = 386; 79.3% men) completed a set of validated questionnaires, including the Hospital Anxiety and Depression Scale (HADS), at baseline and 3 months after implantation. Information on ICD therapies was obtained by device interrogation. At 3 months after implantation, 52 (14%) of the 386 patients had persistent depression (HADS cutoff ≥8 before and 3 months after implantation). Heart failure (odds ratio [OR] 2.29; 95% confidence interval [CI] 1.26 to 4.15), cardiac resynchronization therapy (OR 1.92; 95% CI 1.05 to 3.52), New York Heart Association class III-IV (OR 2.47; 95% CI 1.36 to 4.48), diabetes (OR 2.09; 95% CI 1.01 to 4.29), Type D personality (OR 8.30; 95% CI 4.42 to 15.58), high levels of ICD concerns (OR 2.60; 95% CI 1.44 to 1.71), diuretics (OR 2.41; 95% CI 1.26 to 4.61), and psychotropic medication (OR 3.58; 95% CI 1.86 to 6.90) were all significant univariate correlates of persistent depression at 3 months. No effect was found for ICD shock during follow-up (OR 1.59; 95% CI 0.57 to 4.41). In adjusted analysis, New York Heart Association class III-IV (OR 2.95; 95% CI 1.47 to 5.89), Type D personality (OR 7.98; 95% CI 3.98 to 16.04), and the use of psychotropic medication (OR 2.73; 95% CI 1.27 to 5.84) were independent correlates of persistent depression. In conclusion, symptomatic heart failure, psychological status, and psychotropic medication use predicted persistent depression after ICD implantation.
The prevalence and correlates of psychological morbidity have received considerable attention in the published arrhythmia literature, but to date, studies have tended to focus on mean differences between groups rather than intraindividual symptom patterns over time or prevalence rates. Such an approach masks the chronicity of symptoms in individual patients and potential differences in cardiac outcomes. Moreover, in patients with an implantable cardioverter-defibrillator (ICD), the primary focus has been on anxiety, likely owing to the device being able to provide uncontrollable shocks, while depression has received less attention. However, identification of ICD patients with depression is important, because preliminary evidence from the Triggers of Ventricular Arrhythmias (TOVA) study indicated that depression might increase the risk of ventricular arrhythmias in these patients. The objective of the present study was to examine the prevalence and correlates of persistent depression (i.e., patients with clinically significant levels of depressive symptoms at baseline and at 3 months of follow-up) in patients with a first-time ICD, using an intraindividual approach.
Methods
The study cohort consisted of consecutive patients who had received a first-time ICD (n = 386; 79% men; mean age 58 ± 12 years) from August 2003 to March 2009 at the Erasmus Medical Center (Rotterdam, The Netherlands). All patients were enrolled in the Mood and personality as precipitants of arrhythmia in patients with an Implantable cardioverter Defibrillator: A prospective Study (MIDAS). Patients with a life expectancy of <1 year, who were on the waiting list for heart transplantation, with a history of psychiatric illness other than affective/anxiety disorders, or with insufficient knowledge of the Dutch language were excluded from the present study. The medical ethics committee of the Erasmus Medical Center approved the MIDAS study protocol. The study was conducted according to the ethical guidelines of the Declaration of Helsinki, as set out by the World Medical Association. All patients provided written informed consent.
Provided that patients fulfilled the inclusion criteria, they were approached by an ICD nurse for study participation and were asked to complete a set of standardized and validated psychological questionnaires at baseline (i.e., 1 day before ICD implantation) and at 3 months after implantation. Information on the demographic and clinical characteristics was also gathered at baseline.
The information on the demographic and clinical variables was obtained from the patients’ medical records or by purpose-designed questions in the questionnaire. The demographic variables included gender, age, marital status, and educational level. The clinical variables included the indication for ICD therapy (primary vs secondary), cardiac resynchronization therapy (CRT), QRS >120 ms, left ventricular ejection fraction of ≤35%, coronary artery disease, previous myocardial infarction, previous percutaneous coronary intervention, previous coronary artery bypass grafting, heart failure, atrial fibrillation, diabetes mellitus, smoking, and cardiac (i.e., amiodarone, β blockers, diuretics, angiotensin-converting enzyme inhibitors, statins, and digoxin) and psychotropic medication.
Symptoms of depression were measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire consisting of two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D). The items are scored on a 4-point Likert scale, ranging from 0 to 3, with a score range of 0 to 21 for both subscales. A cutoff score of ≥8 on the HADS-A and HADS-D indicates clinically significant levels of anxiety and depression, respectively. The HADS is a valid and internally consistent measure, with a mean Cronbach’s α of 0.83 and 0.82 for the HADS-A and HADS-D, respectively, and a sensitivity score of 0.80 for both subscales. The test–retest reliability is high, as shown by a Pearson’s r of 0.89 and 0.86 for the HADS-A and HADS-D, respectively. In the present study, we defined persistent depression as a cutoff ≥8 on the HADS-D at baseline and 3 months after implantation.
Type D personality—a dual personality construct defined by the tendency to experience negative affectivity and the tendency to inhibit these negative feelings in social situations—was assessed at baseline using The Type D Scale. The items are rated on a 5-point Likert scale from 0 to 4. The Type D Scale consists of two 7-item subscales, both with a score range of 0 to 28, measuring negative affectivity (e.g., “I often feel unhappy”) and social inhibition (e.g., “I am a closed kind of person”). A standardized cutoff score of ≥10 was used to define Type D caseness. The Type D Scale has proved to be a valid and internally consistent measure, as indicated by Cronbach’s α of 0.88 and 0.86 for the negative affectivity and social inhibition subscales, respectively, and to be stable over time, as indicated by a 3-month test–retest reliability of r = 0.72 and r = 0.82, respectively. A Type D personality is not confounded by indicators of disease severity, such as left ventricular ejection fraction, making it an ideal measure to use in cardiac and other somatic disease populations.
Device-related concerns were measured with the ICD Patient Concerns Questionnaire, an 8-item scale that taps into concerns about the ICD giving a shock (e.g., “I am worried about my ICD firing” and “I am worried about symptoms/pain associated with my ICD firing”). The items are answered using a 5-point Likert scale from 0 (not at all) to 4 (very much so), with a score range of 0 to 32. Higher scores indicate greater device-related concerns. The psychometric properties of the ICD Patient Concerns Questionnaire are good, with a Cronbach’s α of 0.94 for the original scale and of 0.91 for the Dutch translation of the ICD Patient Concerns Questionnaire, indicating high internal consistency. In the present study, the highest tertile (cutoff of ≥13) was used to indicate high levels of ICD concerns.
Information on ICD therapy during follow-up was obtained by device interrogation. From the time of ICD implantation, information on delivered ICD therapy was recorded in our institutional database. All patients were followed up at 3-month intervals and were also advised to contact our outpatient clinic as soon as possible after a symptomatic event. Two experienced electrophysiologists from the electrophysiology staff of the Erasmus Medical Center reviewed and categorized all spontaneous episodes with stored electrograms that resulted in ventricular therapies. In the event of disagreement between the 2 reviewers, a third reviewer was consulted, and a consensus was reached. The arrhythmias were classified as (1) ventricular tachyarrhythmia or (2) atrial tachyarrhythmia without a coexistent ventricular arrhythmia. Therapy triggered by ventricular tachyarrhythmias was considered appropriate, and therapy delivered for atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, atrial tachycardia, sinus tachycardia) or T-wave oversensing and noise was considered inappropriate.
The chi-square test (or Fisher’s exact test, when appropriate) was used to compare patients with and without persistent depression at 3 months for the nominal variables, and Student’s t test for independent samples was used to compare the continuous variables. Logistic regression analysis was performed to identify univariate and multivariate correlates of persistent depression at 3 months. A priori, based on the literature, we decided to enter age >65 years, diabetes, New York Heart Association class III-IV (symptomatic heart failure), the use of psychotropic medication, Type D personality, and ICD concerns as covariates in the multivariate analysis. For the results of logistic regression analysis, the odds ratio (OR) and corresponding 95% confidence interval (CI) are reported. All data were analyzed using the Statistical Package for Social Sciences, version 17.0, for Windows (SPSS, Chicago, Illinois). All tests were 2-tailed, and p <0.05 was used to indicate statistical significance.
Results
Of 446 eligible patients, 18 did not complete the questionnaire at baseline (96% response rate). Of the remaining 428 patients, 3 patients died during the 3-month follow-up period, and 39 did not complete the questionnaire at 3 months, leaving 386 patients for statistical analysis.
Patients excluded from analyses (13%; 60 of 446) did not differ systematically from patients included in the analyses (87%; 386 of 446) on demographic and clinical baseline characteristics, except for patients excluded from analyses being more likely to have a low educational level (74% vs 57%; p = 0.036) and atrial fibrillation (35% vs 22%; p = 0.033) but less likely to have a QRS >120 ms (37% vs 51%; p = 0.049).
Of all 386 patients, 52 (14%) displayed persistent depression at 3 months, defined as a HADS-D score of ≥8 at baseline and at 3 months after implantation.
The demographic, clinical, and psychological baseline characteristics for the total patient sample and stratified by persistent depression at 3 months after implantation are presented in Table 1 . Patients with persistent depression were older and more likely to have a CRT device, to have heart failure, to be in New York Heart Association class III and IV, to have undergone previous coronary artery bypass grafting, to be prescribed diuretics and psychotropic medication, to have a Type D personality, and to report high levels of ICD concerns. No other systematic differences were found between patients with persistent depression and those without persistent depression on the baseline characteristics.
| Characteristic | Total (n = 386) | Persistent Depression | p Value | |
|---|---|---|---|---|
| Yes (n = 52) | No (n = 334) | |||
| Men | 80 (21%) | 15 (29%) | 65 (20%) | 0.17 |
| Age (years) | 58.1 ± 12.1 | 61.0 ± 11.4 | 57.6 ± 12.1 | 0.058 |
| Single/no partner ⁎ | 22 (5.7%) | 3 (5.8%) | 19 (5.7%) | 1.00 |
| Lower education ⁎ † | 306 (79%) | 37 (71%) | 269 (91%) | 0.11 |
| Primary prevention indication | 253 (66%) | 37 (71%) | 216 (65%) | 0.45 |
| Cardiac resynchronization therapy | 108 (28%) | 21 (40%) | 87 (26%) | 0.048 |
| QRS >120 ms | 198 (51%) | 29 (56%) | 169 (51%) | 0.59 |
| Left ventricular ejection fraction ≤35% ‡ | 291 (87%) | 44 (90%) | 247 (86%) | 0.63 |
| Coronary artery disease | 227 (59%) | 35 (67%) | 192 (58%) | 0.24 |
| Previous myocardial infarction | 193 (50%) | 28 (54%) | 165 (49%) | 0.66 |
| Previous percutaneous coronary intervention | 102 (27%) | 18 (35%) | 84 (25%) | 0.21 |
| Previous coronary artery bypass grafting | 82 (21%) | 17 (33%) | 65 (20%) | 0.048 |
| Heart failure | 162 (42%) | 31 (60%) | 131 (39%) | 0.009 |
| New York Heart Association functional class III-IV § | 116 (30%) | 25 (48%) | 91 (27%) | 0.004 |
| Atrial fibrillation | 83 (22%) | 14 (27%) | 69 (21%) | 0.40 |
| Diabetes mellitus | 54 (14%) | 12 (23%) | 42 (13%) | 0.07 |
| Smoking ⁎ | 39 (10%) | 9 (17%) | 30 (9.0%) | 0.11 |
| Amiodarone | 72 (19%) | 9 (17%) | 63 (19%) | 0.94 |
| β Blockers | 307 (80%) | 42 (81%) | 265 (79%) | 0.96 |
| Diuretics | 215 (56%) | 38 (73%) | 177 (53%) | 0.01 |
| Angiotensin-converting enzyme inhibitors | 275 (71%) | 41 (79%) | 234 (70%) | 0.26 |
| Statins | 231 (60%) | 33 (64%) | 198 (59%) | 0.68 |
| digoxin | 58 (15%) | 10 (19%) | 48 (14%) | 0.48 |
| Psychotropic medication ⁎ | 62 (16%) | 18 (35%) | 44 (13%) | <0.0001 |
| Type D personality | 86 (22%) | 32 (62%) | 54 (16%) | <0.001 |
| Preimplantation implantable cardioverter-defibrillator concerns ⁎ ¶ | 137 (36%) | 29 (56%) | 108 (33%) | 0.002 |
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