Clinical Evidence

Research the latest ground-breaking studies and peer-reviewed articles that set the standard of best practices for physicians treating heart failure patients.

Long-Term Outcome after Implantation of a Cardioverter Defibrillator

Abstract

The Multicenter Automatic Defibrillator Trial II (MADIT-II) showed a significant reduction in the risk of death with an implantable cardioverter defibrillator (ICD) during a mean follow-up period of 20 months. However, the long-term benefit of defibrillator implantation is unknown.

Authors

Ilan Goldenberg M.D., Arthur J. Moss M.D., Mary Brown MS, John Gillespie M.D., Iwona Cygankiewicz M.D., Helmut Klein M.D., Scott McNitt MS, Mark L. Andrews BBA, Wojciech Zareba M.D., PhD, and the Executive Committee of the Multicenter Automatic Defibrillator Implantation Trial-II

Citation

Heart Rhythm Society Scientific Sessions Abstract 2009.

Amiodarone or an Implantable Cardioverter-Defibrillator for Congestive Heart Failure (SCH-HeFT)

Abstract

Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter–defibrillator (ICD) has been proposed to improve the prognosis in such patients.

In patients with NYHA class II or III CHF and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent.

Methods

We randomly assigned 2521 patients with New York Heart Association (NYHA) class II or III CHF and a left ventricular ejection fraction (LVEF) of 35 percent or less to conventional therapy for CHF plus placebo (847 patients), conventional therapy plus amiodarone (845 patients), or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients). Placebo and amiodarone were administered in a double-blind fashion. The primary end point was death from any cause.

Authors

Gust H. Bardy, M.D., Kerry L. Lee, Ph.D., Daniel B. Mark, M.D., Jeanne E. Poole, M.D., Douglas L. Packer, M.D., Robin Boineau, M.D., Michael Domanski, M.D., Charles Troutman, R.N., Jill Anderson, R.N., George Johnson, B.S.E.E., Steven E. McNulty, M.S., Nancy Clapp-Channing, R.N., M.P.H., Linda D. Davidson-Ray, M.A., Elizabeth S. Fraulo, R.N., Daniel P. Fishbein, M.D., Richard M. Luceri, M.D., John H. Ip, M.D., for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators

Citation

New England Journal of Medicine 2005. 352(3):225-37.

Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction (MADIT-II)

Abstract

Patients with reduced left ventricular function after myocardial infarction are at risk for life-threatening ventricular arrhythmias. This randomized trial was designed to evaluate the effect of an implantable defibrillator on survival in such patients.

In patients with a prior myocardial infarction and advanced left ventricular dysfunction, prophylactic implantation of a defibrillator improves survival and should be considered as a recommended therapy.

Methods

Over the course of four years, we enrolled 1232 patients with a prior myocardial infarction and a left ventricular ejection fraction of 0.30 or less. Patients were randomly assigned in a 3:2 ratio to receive an implantable defibrillator (742 patients) or conventional medical therapy (490 patients). Invasive electrophysiological testing for risk stratification was not required. Death from any cause was the end point.

Authors

Arthur J. Moss, M.D., Wojciech Zareba, M.D., Ph.D., W. Jackson Hall, Ph.D., Helmut Klein, M.D., David J. Wilber, M.D., David S. Cannom, M.D., James P. Daubert, M.D., Steven L. Higgins, M.D., Mary W. Brown, M.S., Mark L. Andrews, B.B.S.

Citation

New England Journal of Medicine 2002. 346(12):877-83.

Multi-center Automatic Defibrillator Implantation (MADIT) Trial

Abstract

The MADIT-I study was a proof-of-principle study, and this randomized trial showed that the implantable cardioverter defibrillator (ICD) saves lives in high-risk patients with coronary heart disease. The MADIT-II study showed that prophylactic ICD therapy was associated with significantly improved survival in patients with ischemic cardiomyopathy, as defined by documented coronary heart disease and advanced left ventricular dysfunction, without requiring screening for ventricular arrhythmias or inducibility by electrophysiologic testing. Taken together, these two trials, as well as the results from several other randomized ICD trials, indicate that ICD therapy is indicated in coronary patients who meet MADIT-I or MADIT-II eligibility criteria and are not excluded by major noncardiac comorbidity. (J Cardiovasc Electrophysiol, Vol. 14, pp. S96-S98, September 2003, Suppl.)

Authors

ARTHUR J. MOSS, M.D. , et al

 

Citation

Multicenter Automatic Defibrillator Implantation Trial (MADIT): design and clinical protocol. PACE 1991, 14:920-927.

Effect of Chronic Amiodarone Therapy on Defibrillation Energy Requirements in Humans

Abstract

Amiodarone is commonly prescribed for patients with an implantable defibrillator who receive frequent shocks for atrial or ventricular arrhythmias. The effect of oral amiodarone therapy on defibrillation energy requirements in patients with an implantable defibrillator has not been established. The purpose of this study was to determine prospectively the effect of chronic amiodarone therapy on the defibrillation energy requirement in patients with an implantable defibrillator.

Authors

Frank Pelosi, Jr., M.D., Hakan Oral, M.D., Michael H. Kim, M.D., Christian Sticherling, M.D., Laura Horwood, RN, Bradley P. Knight, M.D., Gregory F. Michaud, M.D., Fred Morady, M.D. and S. Adam Strickberger, M.D.

Citation

Journal of Cardiovascular Electrophysiology. July 2000;11:736-74.