BackgroundAs implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers.Methods and ResultsWe evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up.ConclusionsCurrently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
Heart failure (HF) is responsible for an immense burden on our healthcare system. The prevalence of this disease continues to increase as a result of an aging population, successful treatment of acute coronary syndrome, and the use of new pharmacotherapies. Although pharmacotherapy with angiotensin converting enzyme inhibitors and beta-blockers shows improvement in morbidity and mortality, the overall prognosis of these patients remains poor. Cardiac transplant has limited applicability. Conduction disturbances are frequent in patients with advanced heart failure and may cause worsening systolic function and ventricular dyssynchrony. Biventricular pacing to achieve cardiac resynchronization is a recent and promising therapy for HF patients with an intraventricular conduction defect. Randomized clinical trials have substantiated that cardiac resynchronization therapy (CRT) through biventricular pacing offers significant benefit in morbidity and mortality in a select group of HF patients. Because of the high incidence of sudden cardiac death in patients with severe HF, the combination biventricular pacing with implantable cardioverter defibrillator therapy will provide additional benefit. This article provides an overview of CRT with the intent of describing ventricular dyssynchrony, the benefits of CRT, and the implications for advanced practice nurses.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.