Background— The number of patients with longer follow-up after implantation of an implantable cardioverter-defibrillator is increasing continuously. Defibrillation lead failure is a typical long-term complication. Therefore, the long-term reliability of implantable cardioverter-defibrillator leads has become an increasing concern. The aim of the present study was to assess the annual rate of transvenous defibrillation lead defects related to follow-up time after lead implantation. Methods and Results— A total of 990 consecutive patients who underwent first implantation of an implantable cardioverter-defibrillator between 1992 and May 2005 were analyzed. Median follow-up time was 934 days (interquartile range, 368 to 1870). Overall, 148 defibrillation leads (15%) failed during the follow-up. The estimated lead survival rates at 5 and 8 years after implantation were 85% and 60%, respectively. The annual failure rate increased progressively with time after implantation and reached 20% in 10-year-old leads ( P <0.001). Lead defects affected newer as well as older models. Patients with lead defects were 3 years younger at implantation and more often female. Multiple lead implantation was associated with a trend to a higher rate of defibrillation lead defects ( P =0.06). The major lead complications were insulation defects (56%), lead fractures (12%), loss of ventricular capture (11%), abnormal lead impedance (10%), and sensing failure (10%). Conclusions— An increasing annual lead failure rate is noted primarily during long-term follow-up and reached 20% in 10-year-old leads. Patients with lead defects are younger and more often female.

Background: Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial. Methods: Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility. Results: Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%–11.9%) and in BMT patients by 7.3% (4.3%–10.3%; P =0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients. Conclusions: The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00652522.

Background-The maximal oxygen uptake (peak V O 2 ) is used in risk stratification of patients with chronic heart failure (CHF). Peak V O 2 might be lower than maximally possible if exercise is stopped early because of lack of patient motivation or premature cessation by the investigator. In contrast, the anaerobic threshold (V O 2 AT) and the ventilatory efficiency (V E versus V CO 2 slope) are less subject to these influences. Thus, we compared these parameters with peak V O 2 in identifying patients with CHF at increased risk for death within 6 months after evaluation. Methods and Results-We performed cardiopulmonary exercise tests with gas exchange measurements in 223 consecutive patients with CHF (114 coronary artery disease, 92 dilated cardiomyopathy, 17 others) at the Herzzentrum Ludwigshafen between 1995 and 1998. We measured peak V O 2 , V O 2 AT and V E versus V CO 2 slope. We selected peak V O 2 of Յ14 mL/kg per minute, V O 2 AT of Ͻ11 mL/kg per minute, and V E versus V CO 2 slope of Ͼ34 as threshold values for high risk of death. The median follow-up time was 644 days. Patients with peak V O 2 of Յ14 mL/kg per minute had a Ͼ3-fold-increased risk (ORϭ3.4; CI, 1.3 to 9.1), with V O 2 AT Ͻ11 mL/min per kg or V E versus V CO 2 slope Ͼ34 a 5-fold increased risk for early death (ORϭ5.3; CI, 1.5 to 19.0; ORϭ4.8; CI, 1.7 to 13.8, respectively). In patients with both V O 2 AT Ͻ11 mL/kg per minute and V E versus V CO 2 slope Ͼ34, the risk of early death was 10-fold higher (ORϭ9.6; CI, 2.1 to 44.7). After correction for age, sex, left ventricular ejection fraction, and New York Heart Association class in a multivariate analysis, the combination of V O 2 AT Ͻ11 mL/kg per minute and V E versus V CO 2 slope Ͼ34 was the best predictor of 6-month mortality (RRϭ5.1, Pϭ0.001). Conclusions-V O 2 AT of Ͻ11 mL/kg per minute and slope of V E versus V CO 2 Ͼ34, combined, better identified patients at high risk for early death from CHF than did peak V O 2 and should therefore be considered when prioritizing patients for heart transplantation. (Circulation. 2002;106:3079-3084.)

The Val-HeFT echocardiographic substudy of 5,010 patients with moderate heart failure demonstrated that valsartan therapy taken with either ACEI or BB reversed LV remodeling.