To date, no study has assessed the course of patient-reported health status in patients with an implantable cardioverter defibrillator (ICD). Studying health status trajectories and their baseline determinants would permit the identification of patients at risk for poor health outcomes after ICD implantation. A combined cohort of 1,222 patients with an ICD (79% men; age = 61.4 [11.2] years) completed the 12-Item Short-Form Health Survey at baseline and 2 to 3 months and 12 to 14 months after implantation. Latent class analyses were used to identify trajectories and predictors of health status over time. Most health status trajectories showed a stable pattern after short-term follow-up, with differences between trajectories being mainly related to differences in absolute levels of health status. Seven trajectories were identified for physical health status. Being unemployed, symptomatic heart failure, ICD shock, psychotropic medication, negative affectivity, and type D personality were identified as independent determinants of poorer physical health status. For mental health status, 6 trajectories were identified. Younger age, low educational level, symptomatic heart failure, renal failure, no use of ACE inhibitors, psychotropic medication, negative affectivity, and type D personality were identified as independent determinants of poorer mental health status. In conclusion, the population with an ICD seems to be heterogeneous in terms of patient-reported physical and mental health status. Patients with an ICD who present with poor health status and a distressed personality profile should be timely identified and monitored as they may benefit from cardiac rehabilitation in combination with behavioral intervention.
To our knowledge, no study to date has assessed the course of patient-reported health status in patients implanted with an implantable cardioverter defibrillator (ICD). Patient-reported health status is an important cardiovascular health outcome that includes 3 domains: symptom burden, functional status, and health-related quality of life. Recently, the American Heart Association and the European Society of Cardiology advocated the broader inclusion of patient-reported health status as a key measure of cardiovascular health in clinical research. Studying health status trajectories and their determinants in patients with an ICD would permit the identification of patients at risk for poor health status outcomes after implantation. This is very important because poor patient-reported health status has been associated with unfavorable prognosis in patients with an ICD and in patients with ischemic heart disease and heart failure independent of traditional biomedical risk factors. Therefore, the aims of the current study were to (1) identify trajectories of physical and mental health status in the first 12 to 14 months after implantation and (2) evaluate the determinants of class membership of these health status trajectories.
Methods
The study sample comprised patients implanted with a first-time ICD or ICD with cardiac resynchronization therapy (CRT-D) between May 2003 and August 2011 at 4 hospitals in the Netherlands. Three separate data sets were combined that included (1) patients from the Catharina Hospital Eindhoven and the Amphia Hospital Breda (n = 639), (2) patients who participated in the “Mood and personality as precipitants of arrhythmia in patients with an Implantable cardioverter Defibrillator: A prospective Study (MIDAS)” in the Erasmus Medical Center Rotterdam (n = 444), and (3) patients who were enrolled in “The influence of PSYchological factors on health outcomes in HEART failure patients treated with Cardiac Resynchronization Therapy” (PSYHEART-CRT) study from the University Medical Center Utrecht (n = 139). All patients were asked to complete a set of standardized and validated self-report questionnaires at the time of implantation, either 1 day before ICD or CRT-D implantation (MIDAS and PSYHEART-CRT cohorts) or between 1 day before and 3 weeks after implantation (Catharina Hospital and Amphia Hospital cohort). Patients completed a similar set of questionnaires at 2 to 3 months and at 12 to 14 months follow-up. The protocols of the aforementioned studies were approved by the medical ethics committees of the respective hospitals, and data collection was conducted in accordance with the Declaration of Helsinki, with every patient informed orally and in writing about the study and providing written informed consent.
Information on demographic and psychological characteristics was captured through purpose-designed questions in the questionnaires, whereas information on clinical data was obtained from the patients’ medical records. Demographic variables included age, sex, marital status (having a partner vs not having a partner), educational level (primary vs secondary education and higher), and working status (being employed vs being unemployed). Clinical variables included ICD indication (primary vs secondary prevention), ICD versus CRT-D, symptomatic heart failure (defined as New York Heart Association functional classes III to IV), ICD shock during the first year after implantation, coronary artery disease (CAD), diabetes, renal failure, smoking, and psychotropic and cardiac medications (i.e., amiodarone, angiotensin-converting enzyme [ACE] inhibitors, beta blockers, and statins).
The Dutch version of the 12-Item Short-Form Health Survey (SF-12) was administered at the time of implantation and at 2 to 3 months and 12 to 14 months after implantation to assess patient-perceived health status. The SF-12 consists of a subset of the items included in the SF-36 and provides an accurate reproduction of the validated SF-36 summary scores, as indicated by the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12) score. Items contributing to the PCS and MCS subscales are through an algorithm changed into a score range from 0 to 100 (0 = poorest possible health status; 100 = best possible health status). Both PCS and MCS combine the 12 items in such a way that they compare with a national norm with a mean score of 50.0 and an SD of 10.0. In the Netherlands, the mean scores are 52.0 (7.6) and 49.8 (8.8) for the PCS and 52.5 (8.5) and 50.1 (8.8) for the MCS in male and female subjects between 60 and 69 years, respectively. The SF-12 is a reliable and valid instrument.
The 14-item Type D Scale (DS14) was administered at the time of implantation to assess the potential role of personality as a predictor of health status trajectories. The “distressed” (type D) personality is defined as the tendency to experience negative emotions across time and situations paired with the tendency to inhibit self-expression in social interaction. The DS14 comprises 2 subscales, “negative affectivity” (e.g., “I often feel unhappy”) and “social inhibition” (e.g., “I am a closed kind of person”), each consisting of 7 items. Items are answered on a 5-point Likert scale ranging from 0 (false) to 4 (true), with total scores ranging from 0 to 28 for both subscales. The DS14 is a valid and reliable scale. In the present study, patients were classified into personality categories to compare the separate and combined effects of high and low negative affectivity and social inhibition. The previously established cutoff score (≥10) on the subscales of the DS14 was used to define 4 categories: (1) “low negative affectivity and low social inhibition,” (2) “low negative affectivity and high social inhibition,” (3) “high negative affectivity and low social inhibition,” and (4) “high negative affectivity and high social inhibition” (i.e., type D personality).
LatentGOLD 5.0 was used to fit a number of latent class regression models to determine how many latent classes (i.e., physical and mental health status trajectories) could be identified. Time was entered as a nominal predictor (1 = time of implantation, 2 = 2 to 3 months after implantation, 3 = 12 to 14 months after implantation). For each dependent variable (physical and mental health status), 8 models were compared with an increasing number of trajectories (1 to 8 trajectories). To determine the optimal number of trajectories, the Bayesian information criterion (BIC) was used. A lower BIC indicates a better fit. In case of a small difference between 2 models, the least complex model was preferred. After trajectory determination, the new Step3 submodule in LatentGOLD 5.0 (which corrects for classification error to prevent bias) was used for multivariable analyses in which external variables predicted health status class membership (“Step3-Covariate”). The trajectory with the highest value on the dependent variable (patients experiencing the best possible physical or mental health status) was used as a reference category. In case of <10% membership in the reference trajectory, this trajectory was merged with the second best trajectory, such that the reference group would be large enough for comparisons. SPSS 20.0 for Windows (SPSS Inc., Chicago, Illinois) was used to determine which external variables were predicted by class membership, whereas the corresponding p values were obtained using adjusted Step3 analysis procedures (“Step3-Dependent”). The Wald test was used to evaluate statistical significance. The tests were 2 tailed, and p <0.05 was used to indicate significance.
Results
The mean age of the patient sample was 61.4 years, 79% of the patients were men, and 70% were implanted with an ICD, whereas 30% received a CRT-D. Baseline characteristics for the total sample and stratified by physical and mental health status class are presented in Tables 1 and 2 .
| Baseline variable | Missing | Total | Excellent | Fairly good – Excellent | Good | Adequate – Good | Adequate | Moderate | Poor | p-value † |
|---|---|---|---|---|---|---|---|---|---|---|
| (n = 1222) | (n = 124) | (n = 57) | (n = 193) | (n = 119) | (n = 481) | (n = 216) | (n = 32) | |||
| Mean age (SD) | 0 (0%) | 61.4 (11.2) | 59.2 (13.2) | 61.7 (11.0) | 61.0 (12.0) | 61.2 (10.7) | 61.5 (11.0) | 62.4 (10.0) | 64.0 (10.1) | .36 |
| Men | 0 (0%) | 962 (79%) | 104 (84%) | 49 (86%) | 160 (83%) | 95 (80%) | 374 (78%) | 156 (72%) | 24 (75%) | .034 |
| Having a partner | 15 (1%) | 1063 (88%) | 112 (94%) | 49 (86%) | 173 (91%) | 102 (86%) | 413 (87%) | 188 (87%) | 26 (81%) | .23 |
| Low education ‡ | 29 (2%) | 263 (22%) | 14 (12%) | 13 (23%) | 35 (18%) | 21 (18%) | 111 (24%) | 57 (27%) | 12 (38%) | .006 |
| Being employed | 20 (2%) | 318 (27%) | 43 (36%) | 20 (35%) | 64 (34%) | 39 (34%) | 117 (25%) | 33 (15%) | 2 (6%) | <.001 |
| Secondary prevention | 3 (0%) | 415 (34%) | 48 (39%) | 22 (39%) | 79 (41%) | 38 (32%) | 162 (34%) | 51 (24%) | 15 (47%) | .022 |
| Cardiac resynchronization therapy | 28 (2%) | 359 (30%) | 20 (17%) | 15 (27%) | 45 (24%) | 39 (33%) | 151 (32%) | 83 (39%) | 6 (19%) | .004 |
| Symptomatic heart failure § | 170 (14%) | 414 (39%) | 9 (9%) | 11 (22%) | 31 (19%) | 47 (47%) | 181 (43%) | 120 (63%) | 15 (56%) | <.001 |
| ICD shock | 56 (5%) | 160 (14%) | 7 (6%) | 6 (11%) | 27 (14%) | 11 (10%) | 77 (17%) | 27 (14%) | 5 (16%) | .06 |
| Coronary artery disease | 1 (0%) | 782 (64%) | 75 (61%) | 35 (61%) | 121 (63%) | 65 (55%) | 323 (67%) | 135 (63%) | 28 (88%) | .028 |
| Diabetes mellitus | 17 (1%) | 213 (18%) | 9 (7%) | 9 (16%) | 21 (11%) | 19 (17%) | 103 (22%) | 46 (22%) | 6 (19%) | .002 |
| Renal failure | 66 (5%) | 202 (18%) | 9 (8%) | 10 (19%) | 25 (14%) | 22 (20%) | 91 (20%) | 38 (19%) | 7 (22%) | .038 |
| Smoking | 19 (2%) | 178 (15%) | 9 (8%) | 4 (7%) | 32 (17%) | 17 (15%) | 77 (16%) | 35 (16%) | 4 (13%) | .15 |
| Amiodarone | 4 (0%) | 216 (18%) | 18 (15%) | 8 (14%) | 40 (21%) | 20 (17%) | 87 (18%) | 36 (17%) | 7 (22%) | .59 |
| ACE inhibitors | 4 (0%) | 852 (70%) | 81 (65%) | 42 (74%) | 128 (67%) | 90 (76%) | 334 (70%) | 154 (71%) | 23 (72%) | .47 |
| Beta blockers | 4 (0%) | 979 (80%) | 94 (76%) | 47 (83%) | 147 (77%) | 97 (82%) | 392 (82%) | 176 (82%) | 26 (81%) | .69 |
| Statins | 4 (0%) | 791 (65%) | 77 (62%) | 31 (54%) | 122 (64%) | 71 (60%) | 325 (68%) | 140 (65%) | 25 (78%) | .06 |
| Psychotropic medication | 23 (2%) | 212 (18%) | 7 (6%) | 3 (5%) | 24 (13%) | 12 (10%) | 91 (19%) | 64 (30%) | 11 (34%) | <.001 |
| No SI, no NA | 27 (2%) | 528 (44%) | 82 (68%) | 35 (63%) | 99 (52%) | 62 (52%) | 174 (37%) | 69 (33%) | 7 (23%) | <.001 ¶ |
| Only social inhibition | 27 (2%) | 239 (20%) | 29 (24%) | 9 (16%) | 42 (22%) | 23 (19%) | 109 (23%) | 24 (11%) | 3 (10%) | |
| Only negative affectivity | 27 (2%) | 159 (13%) | 3 (3%) | 2 (4%) | 19 (10%) | 13 (11%) | 72 (15%) | 40 (19%) | 10 (32%) | |
| Type D personality | 27 (2%) | 269 (23%) | 6 (5%) | 10 (18%) | 29 (15%) | 21 (18%) | 114 (24%) | 78 (37%) | 11 (36%) |
∗ Results are presented as n (%), unless otherwise indicated. Significant results are printed in bold.
† P-values were obtained using adjusted Step3- Dependent analysis procedures in LatentGOLD 5.0. All other values were observed values obtained using SPSS.
‡ Defined as primary education versus secondary education and higher.
§ Defined as NYHA class III and IV.
| Baseline Variable | Missing | Total | Excellent | Good | Adequate | Moderate – Adequate | Adequate | Poor | p-value † |
|---|---|---|---|---|---|---|---|---|---|
| (n = 1222) | (n = 25) | (n = 153) | (n = 348) | (n = 112) | (n = 466) | (n = 118) | |||
| Mean age (SD) | 0 (0%) | 61.4 (11.2) | 62.2 (8.9) | 61.5 (11.2) | 62.1 (11.4) | 61.1 (11.2) | 60.8 (11.4) | 61.4 (10.5) | .97 |
| Men | 0 (0%) | 962 (79%) | 22 (88%) | 121 (79%) | 284 (82%) | 86 (77%) | 358 (77%) | 91 (77%) | .29 |
| Having a partner | 15 (1%) | 1063 (88%) | 23 (96%) | 137 (91%) | 310 (90%) | 94 (85%) | 395 (85%) | 104 (90%) | .14 |
| Low education ‡ | 29 (2%) | 263 (22%) | 2 (9%) | 22 (15%) | 51 (15%) | 21 (19%) | 134 (30%) | 33 (29%) | <.001 |
| Being employed | 20 (2%) | 318 (27%) | 5 (21%) | 45 (30%) | 101 (29%) | 36 (33%) | 111 (24%) | 20 (17%) | .014 |
| Secondary prevention | 3 (0%) | 415 (34%) | 5 (20%) | 54 (36%) | 115 (33%) | 39 (35%) | 164 (35%) | 38 (32%) | .74 |
| Cardiac resynchronization therapy | 28 (2%) | 359 (30%) | 2 (8%) | 49 (33%) | 102 (30%) | 33 (30%) | 140 (31%) | 33 (28%) | .38 |
| Symptomatic heart failure § | 170 (14%) | 414 (39%) | 3 (14%) | 31 (24%) | 105 (35%) | 45 (47%) | 176 (43%) | 54 (55%) | .001 |
| ICD shock | 56 (5%) | 160 (14%) | 2 (8%) | 14 (10%) | 41 (12%) | 9 (8%) | 79 (18%) | 15 (14%) | .016 |
| Coronary artery disease | 1 (0%) | 782 (64%) | 20 (80%) | 86 (56%) | 217 (63%) | 71 (63%) | 304 (65%) | 84 (71%) | .025 |
| Diabetes mellitus | 17 (1%) | 213 (18%) | 5 (20%) | 21 (14%) | 52 (15%) | 20 (18%) | 92 (20%) | 23 (20%) | .08 |
| Renal failure | 66 (5%) | 202 (18%) | 2 (8%) | 22 (15%) | 66 (20%) | 24 (22%) | 72 (16%) | 16 (15%) | .30 |
| Smoking | 19 (2%) | 178 (15%) | 4 (17%) | 14 (9%) | 40 (12%) | 15 (14%) | 80 (17%) | 25 (22%) | .032 |
| Amiodarone | 4 (0%) | 216 (18%) | 3 (12%) | 25 (16%) | 66 (19%) | 19 (17%) | 83 (18%) | 20 (17%) | .66 |
| ACE inhibitors | 4 (0%) | 852 (70%) | 21 (84%) | 111 (73%) | 241 (70%) | 82 (73%) | 315 (68%) | 82 (70%) | .30 |
| Beta blockers | 4 (0%) | 979 (80%) | 21 (84%) | 118 (77%) | 279 (81%) | 88 (79%) | 376 (81%) | 97 (82%) | .47 |
| Statins | 4 (0%) | 791 (65%) | 19 (76%) | 91 (60%) | 277 (66%) | 63 (56%) | 307 (66%) | 84 (71%) | .018 |
| Psychotropic medication | 23 (2%) | 212 (18%) | 2 (8%) | 12 (8%) | 33 (10%) | 19 (18%) | 106 (23%) | 40 (35%) | <.001 |
| No SI, no NA | 27 (2%) | 528 (44%) | 19 (79%) | 103 (68%) | 192 (57%) | 44 (39%) | 154 (34%) | 16 (14%) | <.001 ¶ |
| Only social inhibition | 27 (2%) | 239 (20%) | 5 (21%) | 38 (25%) | 91 (27%) | 26 (23%) | 70 (15%) | 9 (8%) | |
| Only negative affectivity | 27 (2%) | 159 (13%) | 0 (0%) | 6 (4%) | 18 (5%) | 15 (13%) | 95 (21%) | 25 (22%) | |
| Type D personality | 27 (2%) | 269 (23%) | 0 (0%) | 4 (3%) | 38 (11%) | 27 (24%) | 137 (30%) | 63 (56%) |
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