Implantable cardioverter defibrillators and cardiac resynchronization therapy in patients with left ventricular dysfunction: randomized trial evidence through 2004.
Although many studies have shown that implantable cardioverter defibrillator (ICD) therapy improves the survival of patients with significant left ventricular dysfunction, the magnitude of effectiveness of ICD therapy in clinically defined subgroups remains uncertain. Similarly, although studies have shown an improvement in patients' hemodynamics and quality of life with cardiac resynchronization therapy (CRT), there is a continuing uncertainty about the effect of CRT on patients' survival and the magnitude of improvement in quality of life with this therapy. On August 24, 2004, an ad hoc group of experts representing clinical cardiovascular medicine, biostatistics, economics, and health policy were joined by representatives of the Food and Drug Administration, Centers for Medicare and Medicaid Services (Baltimore, Md), Agency for Healthcare Research and Quality (Rockville, Md), and the device industry for a 1-day round table to review the available clinical trial evidence on the effect of ICD therapy in the primary prevention of sudden cardiac death and the effect of CRT in patients with congestive heart failure. The meeting was organized by the Duke Clinical Research Institute, Durham, NC, and funded in part by the Agency for Healthcare Research and Quality. This document summarizes the evidence reviewed at that meeting and the discussions of that evidence.
Al-Khatib
Sana M
SM
The Duke Clinical Research Institute, Durham, NC 27715, USA. alkha001@mc.duke.edu
Sanders
Gillian D
GD
Mark
Daniel B
DB
Lee
Kerry L
KL
Bardy
Gust H
GH
Bigger
J Thomas
JT
Buxton
Alfred E
AE
Connolly
Stuart
S
Kadish
Alan
A
Moss
Arthur
A
Feldman
Arthur M
AM
Ellenbogen
Kenneth A
KA
Singh
Steven
S
Califf
Robert M
RM
D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control; D017147:Defibrillators, Implantable; D006333:Heart Failure / Q000150:complications; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D018487:Ventricular Dysfunction, Left / Q000209:etiology / Q000628:therapy*