Rationale and design of WEBCARE: A randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life

Background: The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial.Methods: WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing level

Implantable cardioverter defibrillator stored ECGs: clinical management and case reports

B

Prevention of inappropriate therapy in implantable defibrillators: a meta-analysis of clinical trials comparing single-chamber and dual-chamber arrhythmia discrimination algorithms

Introduction: A proposed benefit of dual-chamber arrhythmia discrimination is a reduction in inappropriate therapy in implantable cardioverter-defibrillators (ICDs). The aim of this meta-analysis was to establish whether dual-chamber arrhythmia discrimination algorithms reduce inappropriate device therapy. Methods and results: Public domain databases, MEDLINE, EMBASE, and Cochrane Register of Controlled Trials, were searched from 1996 to 2006. Two investigators abstracted data independently. Pooled estimates were calculated using both fixed-effects and random-effects models. We retrieved 5 prospective studies comparing dual-chamber with single-chamber arrhythmia discrimination, accumulating data on 748 patients. Pooled per-patient based analysis demonstrated that the number of patients receiving inappropriate ICD therapy was not different between single- and dual-chamber devices (odds ratio [OR] 1.23; 95% CI, 0.83 to 1.81; p=0.31). Per-episode based analysis demonstrated a favoring benefit for dual-chamber arrhythmia discrimination (ORO.64; 95% CI, 0.52 to 0.78; p < 0.001). A mean reduction of 1.1 inappropriately treated atrial episodes per patient was observed with dual-chamber arrhythmia discrimination (p < 0.001). Conclusions: Dual-chamber arrhythmia discrimination is associated with a reduction in the number of inappropriate treated episodes. The number of patients who experience inappropriate therapy is not reduced by dual-chamber discrimination. (c) 2007 Elsevier Ireland Ltd. All rights reserved

Pre implantation psychological functioning preserved in majority of implantable cardioverter defibrillator patients 12 months post implantation

Background The impact of ICD therapy on patient well being has typically focused on mean differences between groups, thereby neglecting changes within individuals. Using an intra-individual approach, we examined (i) the prevalence of implantable cardioverter defibrillator (ICD) patients maintaining their pre implantation level of psychological functioning at 12 months, and (ii) factors associated with deterioration in functioning. Methods Consecutively implanted ICD patients (n = 332) completed a set of standardized and validated patient reported measures at baseline and at 12 months post implantation. Results The majority of patients (72.8% to 81.7%) preserved their pre implantation level of psychological functioning 12 months post implantation. In adjusted analysis, ICD shock (all ps < .001) and Type D personality (all ps < .05) were independent predictors of deterioration in psychological functioning at 12 months across all domains, while baseline psychological status was associated with an improvement (all ps < .05). Patients with a primary prevention indication experienced a decrease in ICD concerns (p = .03) and anxiety (p = .006), and older patients (p = .04) a decrease in anxiety symptoms during the follow-up period. By contrast, patients with left ventricular dysfunction (p = .007) and atrial fibrillation (p = .02) were more likely to experience an increase in anxiety. Conclusions The majority of ICD patients maintained their pre implantation level of psychological functioning at 12 months. A subset of patients was at risk of poor psychological adaptation, attributable to ICD shocks, Type D personality, atrial fibrillation, and left ventricular dysfunction, while primary prevention indication and older age had a protective effect against deterioration in functioning

Pre implantation psychological functioning preserved in majority of implantable cardioverter defibrillator patients 12 months post implantation

Background The impact of ICD therapy on patient well being has typically focused on mean differences between groups, thereby neglecting changes within individuals. Using an intra-individual approach, we examined (i) the prevalence of implantable cardioverter defibrillator (ICD) patients maintaining their pre implantation level of psychological functioning at 12 months, and (ii) factors associated with deterioration in functioning. Methods Consecutively implanted ICD patients (n = 332) completed a set of standardized and validated patient reported measures at baseline and at 12 months post implantation. Results The majority of patients (72.8% to 81.7%) preserved their pre implantation level of psychological functioning 12 months post implantation. In adjusted analysis, ICD shock (all ps < .001) and Type D personality (all ps < .05) were independent predictors of deterioration in psychological functioning at 12 months across all domains, while baseline psychological status was associated with an improvement (all ps < .05). Patients with a primary prevention indication experienced a decrease in ICD concerns (p = .03) and anxiety (p = .006), and older patients (p = .04) a decrease in anxiety symptoms during the follow-up period. By contrast, patients with left ventricular dysfunction (p = .007) and atrial fibrillation (p = .02) were more likely to experience an increase in anxiety. Conclusions The majority of ICD patients maintained their pre implantation level of psychological functioning at 12 months. A subset of patients was at risk of poor psychological adaptation, attributable to ICD shocks, Type D personality, atrial fibrillation, and left ventricular dysfunction, while primary prevention indication and older age had a protective effect against deterioration in functioning

Clustering of device-related concerns and Type D personality predicts increased distress in ICD patients independent of shocks

Background: This study examined the impact of clustering of device-related concerns and Type D personality on anxiety and depressive symptoms during a six-month period and the clinical relevance of shocks, implantable cardioverter defibrillator (ICD) concerns, and Type D. Methods: Consecutively implanted ICD patients (n=176) completed questionnaires at baseline and six months and were divided into four risk groups: (1) No riskfactors (neither ICD concerns nor Type D); (2) ICD concerns only; (3) Type D only; (4) Clustering (both ICD concerns and Type D). Results: The prevalence of Type D and concerns were 21.6% and 34.7%. Analysis of variance for repeated measures showed a reduction in anxiety over time (P = 0.8) compared to negligible to moderate for shocks (0.0 - 0.6). Conclusions: ICD patients with psychosocial risk factor clustering had the highest level of anxiety, whereas the pattern for depression was less consistent. Shocks influenced outcomes, but the impact was smaller compared to ICD concerns and Type D personality. It may be timely to expand the focus beyond shocks when seeking to identify ICD patients at risk for adverse clinical outcome due to their psychological profile

Sudden death of unknown origin

A