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

Anxiety and risk of ventricular arrhythmias or mortality in patients with an implantable cardioverter defibrillator

Objective: A subgroup of patients with an implantable cardioverter defibrillator (ICD) experiences anxiety after device implantation. The purpose of the present study was to evaluate whether anxiety is predictive of ventricular arrhythmias and all-cause mortality 1 year post ICD implantation. Methods: A total of 1012 patients completed the state version of the State-Trait Anxiety Inventory at baseline. The end points were ventricular arrhythmias and mortality the first year after ICD implantation. Results: Within the first year after ICD implantation, 19% of patients experienced a ventricular arrhythmia, and 4% died. Anxiety was associated with an increased risk of ventricular arrhythmias (hazard ratio [HR] = 1.017; 95% confidence interval [CI] = 1.005-1.028; p = .005) and mortality (HR = 1.038; 95% CI = 1.014-1.063; p = .002) in adjusted analysis. Patients with anxiety (highest tertile) had a 1.9 increased risk for ventricular arrhythmias (95% CI = 1.329-2.753; p =.001) and a 2.9 increased risk for mortality (95% CI = 1.269-6.677; p = .01) compared with patients with low anxiety (lowest tertile). Among 257 patients with cardiac resynchronization therapy, anxiety was associated with mortality (HR = 5.381; 95% CI = 1.254-23.092; p = .02) after adjusting for demographic and clinical covariates. Conclusions: Anxiety was associated with an increased risk of ventricular arrhythmias and mortality 1 year after ICD implantation, independent of demographic and clinical covariates. Monitoring and treatment of anxiety may be warranted in a selected subgroup of high-risk patients with an ICD

Web-Based Distress Management for Implantable Cardioverter Defibrillator Patients:A Randomized Controlled Trial

textabstractObjective: Sudden cardiac arrest caused by cardiac arrhythmias is 1 of the leading causes of death worldwide. Implantable cardioverter defibrillators (ICDs) are considered as standard care for patients with increased risk of arrhythmias. However, 1 in 4 ICD patients experiences psychological distress post-ICD implantation. The WEB-based distress management program for ICD patients (WEBCARE) was developed to mitigate anxiety and depression and enhance health-related quality of life in ICD patients. This study investigates the 6- and 12-months outcomes. Method: A total of 289 consecutive ICD patients from 6 referral hospitals in the Netherlands were randomized to either the WEBCARE (n = 146) or usual care (n = 143) group. Patients in the WEBCARE group received an online, 12-weeks fixed, 6 lesson behavioral treatment based on problem solving therapy. Patients in the usual care group receive care as usual. Results: Current findings show no significant difference on anxiety, depression or quality of life between the WEBCARE and Usual Care group at 6- and 12-months postimplantation. Conclusions: In this clinical trial of a Web-based behavioral intervention for ICD patients, the Web-based treatment was not superior to usual care on the long-term regarding patient reported outcomes. Future studies are warranted to examine the applicability of blended-care models and focus on further personalizing the program in order to increase adherence and improve outcomes

E-Health to Manage Distress in Patients With an Implantable Cardioverter-Defibrillator:Primary Results of the WEBCARE Trial

The Web-based distress management program for patients with an implantable cardioverter-defibrillator (ICD; WEBCARE) was developed to mitigate distress and enhance health-related quality of life in ICD patients. This study investigated the treatment effectiveness at 3-month follow-up for generic and disease-specific outcome measures. Methods: Consecutive patients implanted with a first-time ICD from six hospitals in the Netherlands were randomized to either the “WEBCARE” or the “usual care” group. Patients in the WEBCARE group received a 12-week fixed, six-lesson behavioral treatment based on the problem-solving principles of cognitive behavioral therapy. Results: Two hundred eighty-nine patients (85% response rate) were randomized. The prevalence of anxiety and depression ranged between 11% and 30% and 13% and 21%, respectively. No significant intervention effects were observed for anxiety (β = 0.35; p = .32), depression (β = −0.01; p = .98) or health-related quality of life (Mental Component Scale: β = 0.19; p = .86; Physical Component Scale: β = 0.58; p = .60) at 3 months, with effect sizes (Cohen d) being small (range, 0.06-0.13). There were also no significant group differences as measured with the disease-specific measures device acceptance (β = −0.37; p = .82), shock anxiety (β = 0.21; p = .70), and ICD-related concerns (β = −0.08; p = .90). No differences between treatment completers and noncompleters were observed on any of the measures. Conclusions: In this Web-based intervention trial, no significant intervention effects on anxiety, depression, health-related quality of life, device acceptance, shock anxiety, or ICD-related concerns were observed. A more patient tailored approach targeting the needs of different subsets of ICD patients may be warranted