E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial.

UNLABELLED: 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 (ß = 0.35; p = .32), depression (ß = -0.01; p = .98) or health-related quality of life (Mental Component Scale: ß = 0.19; p = .86; Physical Component Scale: ß = 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 (ß = -0.37; p = .82), shock anxiety (ß = 0.21; p = .70), and ICD-related concerns (ß = -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. TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00895700.

Attrition and adherence in a WEB-Based Distress Management Program for Implantable Cardioverter defibrillator Patients (WEBCARE): randomized controlled trial.

BACKGROUND: WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence. OBJECTIVE: In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE. METHODS: Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group. RESULTS: The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support. CONCLUSIONS: Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz).

The magnetic navigation system allows safety and high efficacy for ablation of arrhythmias.

AIMS: We aimed to evaluate the safety and long-term efficacy of the magnetic navigation system (MNS) in a large number of patients. The MNS has the potential for improving safety and efficacy based on atraumatic catheter design and superior navigation capabilities. METHODS AND RESULTS: In this study, 610 consecutive patients underwent ablation. Patients were divided into two age- and sex-matched groups. Ablations were performed either using MNS (group MNS, 292) or conventional manual ablation [group manual navigation (MAN), 318]. The following parameters were analysed: acute success rate, fluoroscopy time, procedure time, complications [major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, and death; minor: minor bleeding and temporary AV block]. Recurrence rate was assessed during follow-up (15±9.5 months). Subgroup analysis was performed for the following groups: atrial fibrillation, isthmus dependent and atypical atrial flutter, atrial tachycardia, AV nodal re-entrant tachycardia, circus movement tachycardia, and ventricular tachycardia (VT). Magnetic navigation system was associated with less major complications (0.34 vs. 3.2%, P=0.01). The total numbers of complications were lower in group MNS (4.5 vs. 10%, P=0.005). Magnetic navigation system was equally effective as MAN in acute success rate for overall groups (92 vs. 94%, P=ns). Magnetic navigation system was more successful for VTs (93 vs. 72%, P<0.05). Less fluoroscopy was used in group MNS (30±20 vs. 35±25 min, P<0.01). There were no differences in procedure times and recurrence rates for the overall groups (168±67 vs. 159±75 min, P=ns; 14 vs. 11%, P=ns; respectively). CONCLUSIONS: Our data suggest that the use of MNS improves safety without compromising efficiency of ablations. Magnetic navigation system is more effective than manual ablation for VTs.

Insulation damage in a shock wire: an unexpected fluoroscopic image.

We report on a patient with a single-chamber implantable cardioverter defibrillator admitted with an increase in high-voltage lead impedance, detected with home-monitoring, and inappropriate shocks due to noise on the electrogram. Chest x-ray revealed no abnormalities. Fluoroscopy before the revision procedure showed insulation failure with migration of the shock wire in the heart. The lead was removed and replaced with a new shock lead. This is, as far as we know, the first report on such a particular insulation failure, detected with home-monitoring and inappropriate shocks.

Web-based distress management for implantable cardioverter defibrillator patients: A randomized controlled trial.

OBJECTIVE: 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. (PsycINFO Database Record

Clinical characteristics and acute results of catheter ablation for outflow tract ventricular tachycardia or premature beats.

PURPOSE: Contemporary outcome data of catheter ablation for outflow tract tachycardia (OTT) and ventricular premature beats (VPBs) are rare. The aim of this study was to describe the clinical characteristics, the acute procedure success rate, and the long-term survival of patients who underwent an ablation procedure for OTT or VPBs. METHODS: The study was a single-center retrospective cohort study. All 82 consecutive OTT and VPB first ablation procedures between 1999 and 2009 were included. Patients with structural heart disease were excluded. RESULTS: Mean age was 46 ± 13 years. Forty-three percent of the patients were male. All patients were alive after a median follow-up duration of 31 months (interquartile range, 14-65 months). Eighty-nine percent suffered from palpitations and 12 % had a history of syncope. Ventricular tachycardia was documented in 73 % and monomorphic VPBs in 99 %. Seventy-three percent of the patients were ablated in the right ventricular outflow tract, 15 % in the left ventricular outflow tract, and 12 % in the coronary cusps. Radiofrequency energy was used in 95 % of the patients, cryo energy in 9 %. Acute success was achieved in 78 %. Six patients (7 %) experienced a complication (five pericardial effusions, one pseudo-aneurysm of the femoral artery). Three patients needed pericardiocentesis (4 %). CONCLUSION: Ablation for OTT and VPB is successful in the vast majority of cases, with a low but still existing complication rate. Long-term survival was excellent, underscoring the benign nature of this arrhythmia.

Clinical experience with a novel subcutaneous implantable defibrillator system in a single center.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) reduce mortality in both primary and secondary prevention, but are associated with substantial short- and long-term morbidity. A totally subcutaneous ICD (S-ICD) system has been developed. We report the initial clinical experience of the first 31 patients implanted at our hospital. METHODS: All patients had an ICD indication according to the ACC/AHA/ESC guidelines. The first 11 patients were part of the reported CE trial. The implantation was performed without fluoroscopy. The device was implanted subcutaneously in the anterior axillary line, with a parasternal lead tunneled from the xiphoid to the manubrial-sternal junction. Ventricular fibrillation (VF) was induced to assess detection accuracy and defibrillation efficacy using 65 J shocks. RESULTS: Post-implant, 52 sustained episodes of VF were induced. Sensitivity was 100% and induced conversion efficacy was 100% (with standard polarity in 29 patients). Mean time to therapy was 13.9 ± 2.5 s (range 11-21.6 s). Late procedure-related complications were observed in 2 of the first 11 implantations (lead migration). During follow-up, spontaneous ventricular arrhythmias occurred in four patients, with accurate detection of all episodes. Inappropriate therapy was observed in five patients. Recurrences were prevented with reprogramming. CONCLUSIONS: The S-ICD system can be implanted without the use of fluoroscopy by using anatomical landmarks only. Episodes of VF were accurately detected using subcutaneous signals, and all induced and clinical episodes were successfully converted. The S-ICD system is a viable alternative to conventional ICD systems for selected patients.

Management of cardiogenic shock: focus on tissue perfusion.

Cardiogenic shock (CS) may result from ischemic heart disease, cardiomyopathy, valvular heart disease, inflammation, myocardial contusion, and cardiac surgery. CS is the leading cause of in-hospital death in patients with acute myocardial infarction. Although early revascularization strategies have resulted in a better prognosis, in-hospital mortality from CS remains exceptionally high. Notably, long-term annual mortality is similar in survivors of CS relative to patients with myocardial infarction without shock. This underlines the importance of aggressive support of the failing heart in the acute phase of CS. Because CS reflects a state of hypoperfusion induced by heart failure, management of CS should aim at improving cardiac function as well as at optimization of tissue perfusion. This review evaluates the current treatment of CS. In addition, novel approaches to monitor and modulate peripheral circulation at the bedside are highlighted. It is expected that these techniques will improve our understanding of the pathogenesis of CS and will offer new opportunities to guide therapy in CS patients to improve long-term prognosis.

Prognosis of patients undergoing cardiac surgery and treated with intra-aortic balloon pump counterpulsation prior to surgery: a long-term follow-up study.

The aim of this study was to evaluate short- and long-term outcome in patients undergoing coronary artery bypass grafting (CABG), who received an intra-aortic balloon pump (IABP) prior to surgery. Between January 1990 and June 2004, all patients (n=154) who received an IABP prior to on-pump CABG in our center were included. Patients received the IABP for vital indications (i.e. either unstable angina refractory to medical therapy or cardiogenic shock; group 1: n=99) or for prophylactic reasons (group 2: n=55). A Cox proportional hazards model was used to identify predictors of long-term all-cause mortality. Compared with the EuroSCORE predictive model, observed 30-day mortality in group 1 (15.2%) was slightly higher than predicted (10.3%). A decrease in 30-day mortality occurred in group 2 (median predicted mortality was 7.2% and observed was 0%). Cumulative 1-, 5-, and 6-year survival was 82.8+/-3.8%, 70.1+/-4.9%, and 67.3+/-5.1% for group 1 vs. 98.2+/-1.8%, 84.0+/-5.6% and 84.0+/-5.6% for group 2 (Log-rank: P=0.02). Logistic EuroSCORE (HR 1.03 [1.01-1.05], P=0.007) was an independent predictor of long-term all-cause mortality.

Usefulness of intra-aortic balloon pump counterpulsation in patients with cardiogenic shock from acute myocardial infarction.

Although intra-aortic balloon pump (IABP) counterpulsation is increasingly being used for the treatment of patients with cardiogenic shock from acute myocardial infarction, data on the long-term outcomes are lacking. The aim of the present study was to evaluate the 30-day and long-term mortality and to identify predictors for 30-day and long-term all-cause mortality of patients with acute myocardial infarction complicated by cardiogenic shock who were treated with IABP. From January 1990 to June 2004, 300 consecutive patients treated with IABP were included. The mean age of the study population was 61 +/- 11 years, and 79% of the patients were men. The survival rate until IABP removal after successful hemodynamic stabilization was 70% (n = 211). The overall cumulative 30-day survival rate was 58%. The 30-day mortality rate decreased over time from 52% in 1990 to 1994 to 36% in 2000 to 2004 (p for trend <0.05). Follow-up ranged from 0 to 15 years. In patients who survived until IABP removal, the cumulative 1-, 5-, and 10-year survival rate was 69%, 58%, and 36%, respectively. The adjusted predictors of long-term mortality were arrhythmias during the intensive cardiac care unit stay (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.2 to 2.9) and renal failure during the intensive cardiac care unit stay (HR 2.5, 95% CI 1.3 to 5.1). After adjustment, treatment with primary percutaneous coronary intervention (HR 0.5, 95% CI 0.3 to 0.9) and coronary artery bypass grafting (HR 0.4, 95% CI 0.2 to 0.8) were associated with lower long-term mortality. In conclusion, in patients with acute myocardial infarction complicated by cardiogenic shock treated with IABP, the 30-day survival improved with time and an encouraging number of patients survived in the long term.