Sleep disturbance in patients with an implantable cardioverter defibrillator:Prevalence, predictors and impact on health status

Background:  Sleep disturbances are highly prevalent in patients with cardiac diseases and associated with poor health outcomes. However, little is known about sleep disturbance in patients with an implantable cardioverter defibrillator. Aims:  We examined the prevalence and predictors of sleep disturbance and the impact on perceived health status in a Dutch cohort of implantable cardioverter defibrillator patients. Methods:  Patients ( n=195) enrolled in the Web-based distress program for implantable cardioverter defibrillator patients (WEBCARE) trial completed questionnaires at the time of implantable cardioverter defibrillator implantation, three, six and 12 months afterwards. Sleep disturbance was assessed with the corresponding item #3 of the Patient Health Questionnaire 9. Results:  At baseline, 67% ( n=130) reported sleep disturbance (cut off ≥1). One year later, the prevalence was 57% ( n=112). Younger age (odds ratio=0.96, 95% confidence interval 0.92-0.99; p=0.012) and high negative affectivity/low social inhibition (odds ratio=4.47, 95% confidence interval 1.52-13.17; p=0.007) were associated with sleep disturbance at 12 months in adjusted analyses. Sleep disturbance was not associated with health status at 12 months. Charlson Comorbidity Index, anxiety, Type D personality and high negative affectivity/low social inhibition were associated with impaired health status at follow-up. Conclusions:  Sleep disturbance was highly prevalent in patients with an implantable cardioverter defibrillator. Younger age and high negative affectivity predicted sleep disturbance 12 months post-implantation independent of other demographic, clinical, intervention and psychological covariates. Sleep disturbance was not associated with impaired health status at the 12-month follow-up

Poor health status and distress in cardiac patients: The role of device therapy vs. underlying heart disease

AimsImplantable cardioverter defibrillator (ICD) therapy, which includes the risk of shocks, is considered the primary culprit of reductions in patient reported outcomes (PROs; e.g. health status and distress), thereby negating the role of underlying disease severity. We examined the relative influence of living with an ICD vs. congestive heart failure (CHF) on PROs and compared (i) ICD patients without CHF (ICD only), (ii) CHF patients without an ICD (CHF-only), and (iii) CHF patients with an ICD (ICD + CHF).Methods and resultsSeparate cohorts of ICD and CHF patients (N = 435; 75% men) completed PROs at baseline, 6 and 12 months. Groups differed on physical health status only at baseline (F(2,415) = 7.15, P = 0.001) and on anxiety at 12 months (F(2,415) = 4.04, P = 0.01); ICD + CHF patients had the most impaired physical health status but the lowest anxiety level followed by the ICD only and CHF only patients. Congestive heart failure only patients had the most impaired mental health status and reported the highest level of anxiety as compared to the ICD only (P < 0.001) and ICD + CHF groups (P = 0.009), while the two latter groups did not differ. The effect sizes ranged from very small (0.03) to moderate-large (0.69). Groups did not differ in depression scores.ConclusionCongestive heart failure patients reported worse PROs as compared to ICD patients, although the magnitude of the differences was relatively small. This suggests that the well being of patients is not necessarily negatively influenced by the implantation of an ICD, and that underlying heart disease may have at least an equal if not greater influence on PROs

Personality traits, ventricular tachyarrhythmias, and mortality in patients with an implantable cardioverter defibrillator: 6 years follow-up of the WEBCARE cohort

Objective: Risk stratification within the ICD population warrants the examining of the role of protective- and risk factors. Current study examines the association between Type D personality, pessimism, and optimism and risk of ventricular tachyarrhythmias (VTa's) and mortality in patients with a first-time ICD 6 years post implantation. Methods: A total of 221 first-implant ICD patients completed questionnaires on optimism and pessimism (Life Orientation Test) and Type D personality (Type D scale DS14) 10 to 14 days after implantation. VTa's and all-cause mortality 6 years post implant comprised the study endpoints. Results: Ninety (40.7%) patients had experienced VTa's and 37 (16.7%) patients died, 12 (5.4%) due to a cardiac cause. Adjusted logistic regression analysis showed that pessimism was significantly associated with increased risk of VTa's (OR = 1.09; 95% CI = 1.00–1.19; p =.05). Type D personality (OR = 1.05; 95% CI = 0.47–2.32; p =.91) and optimism (OR = 1.00; 95% CI = 0.90–1.12; p =.98) were not associated with VTa's. None of the personality types were associated with mortality. Conclusion: Pessimism was associated with VTa's but not with mortality. No significant association with either of the endpoints was observed for Type D personality and optimism. Future research should focus on the coexistent psychosocial factors that possibly lead to adverse cardiac prognosis in this patient population

Posttraumatic stress and anxiety in patients with an implantable cardioverter defibrillator: Trajectories and vulnerability factors

Background: Implantable cardioverter defibrillator (ICD) therapy is first-line treatment for the primary and secondary prevention of sudden cardiac death. Despite the unequivocal medical benefits, living with an ICD may affect patients' psychological functioning and general well-being. We examined the trajectories of symptoms of posttraumatic stress disorder (PTSD) and anxiety in patients with an ICD and the vulnerability factors associated with an increased risk of symptoms of PTSD and anxiety. Methods: A total of 249 patients were included as part of the WEB-based distress program for implantable CARdioverter dEfibrillator patients (WEBCARE) study. Data were analyzed using Latent class analyses, with trajectories of PTSD symptomatology and anxiety examined between baseline and 12 months follow-up. Results: The mean age of the sample was 58.9±9.8, with the majority being male (82%). Latent Class analyses (LatentGOLD) revealed four classes with respect to PTSD symptomatology, and three classes of patients with respect to anxiety. Younger age, increased depression score at baseline, and Type D personality were all associated with increased vulnerability for posttraumatic stress and anxiety symptoms. Conclusion: Comparable trajectories were found for symptoms of PTSD and anxiety over time. Patients with a younger age, increased depression score at baseline, and Type D personality were especially prone to experience PTSD and anxiety symptomatology at 12 months follow up. Due to the negative association between PTSD, anxiety, and health outcomes, it is paramount to timely identify the subset of patients who are vulnerable to experience these symptoms and provide them with personalized support

Optimism as predictor of patient-reported outcomes in patients with an implantable cardioverter defibrillator (data from the WEBCARE study)

Objective:  The implantable cardioverter defibrillator (ICD) is the treatment of choice for prevention of sudden cardiac death. However, a subgroup of ICD patients experiences psychological adjustment problems post implant. To date, positive psychological constructs (e.g. optimism) have been understudied in this population. Hence, we examined the association between optimism and anxiety, depression, and health status at 12-months post implant. Methods:  Patients (N=171) enrolled in the WEB-based distress management study for ICD patients were included in the analyses. Optimism and pessimism (LOT), and Type D personality (DS14) were administered at baseline, while anxiety (GAD-7), depression (PHQ-9), and health status (SF-12) were assessed at 12-months. Results:  The mean age was 59.6±10.06 with 81% being male. After controlling for demographic, personality, and clinical variables, baseline optimism was associated with lower anxiety (β=-0.210; p=0.011) and depression (β=-0.222; p=0.005), and better physical (β=0.227; p=0.004) and mental health status (β=0.350; p=0.000) at follow-up. Optimism was also associated with change in mental health status (β=0.195; p=0.007) but not with change in anxiety, depression, and physical health status at follow-up. Conclusions:  Our findings indicate that optimism is associated with less distress and possibly helps safeguard mental health in ICD patients. Increase optimism might be the way forward to reduce long-term distress and impaired health status

Enhancing lifestyle change in cardiac patients through the do change system ("Do cardiac health: Advanced new generation ecosystem"): Randomized controlled trial protocol

BACKGROUND: Promoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality. OBJECTIVE: The current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life. METHODS: Cardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients' progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application. RESULTS: The Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why. CONCLUSIONS: The Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change. TRIAL REGISTRATION: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU)

Sleep disturbance in patients with an implantable cardioverter defibrillator: Prevalence, predictors and impact on health status

Background:  Sleep disturbances are highly prevalent in patients with cardiac diseases and associated with poor health outcomes. However, little is known about sleep disturbance in patients with an implantable cardioverter defibrillator. Aims:  We examined the prevalence and predictors of sleep disturbance and the impact on perceived health status in a Dutch cohort of implantable cardioverter defibrillator patients. Methods:  Patients ( n=195) enrolled in the Web-based distress program for implantable cardioverter defibrillator patients (WEBCARE) trial completed questionnaires at the time of implantable cardioverter defibrillator implantation, three, six and 12 months afterwards. Sleep disturbance was assessed with the corresponding item #3 of the Patient Health Questionnaire 9. Results:  At baseline, 67% ( n=130) reported sleep disturbance (cut off ≥1). One year later, the prevalence was 57% ( n=112). Younger age (odds ratio=0.96, 95% confidence interval 0.92-0.99; p=0.012) and high negative affectivity/low social inhibition (odds ratio=4.47, 95% confidence interval 1.52-13.17; p=0.007) were associated with sleep disturbance at 12 months in adjusted analyses. Sleep disturbance was not associated with health status at 12 months. Charlson Comorbidity Index, anxiety, Type D personality and high negative affectivity/low social inhibition were associated with impaired health status at follow-up. Conclusions:  Sleep disturbance was highly prevalent in patients with an implantable cardioverter defibrillator. Younger age and high negative affectivity predicted sleep disturbance 12 months post-implantation independent of other demographic, clinical, intervention and psychological covariates. Sleep disturbance was not associated with impaired health status at the 12-month follow-up