Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial

Autor: Colin Movsowitz, James R. Cook, Mark S. Wathen, Alfred P. Hallstrom, Elizabeth McCarthy, Mina K. Chung, Steven P. Kutalek, Charles M. Carpenter, Arjun Sharma, Laura Finklea, Barry Karas, Geri Wadsworth, Malcolm Kirk, Celeste Lee, Alfred E. Buxton, Walid Saliba, Brian Blatt, Jennine Zumbuhl, Andrea Natale, Pam Myers, Sharon M. Dailey, Nancy Conners, John T. Lee, Rosemary S. Bubien, Andrew Corsello, Robert S. Bernstein, Jennifer McCarthy, David O. Martin, Donald G. Rubenstein, John M. Herre, Mary Ellen Page, Glenn Harper, Douglas Esberg, Linette R. Klevan, Candace M. Nasser, Ellie Vierra, Jeffrey Neuhauser, Ammy Malinay, Pamela L. Corcoran, Anne Skadsen, Andrew E. Epstein, Stephen Greer, Roy B. Sauberman, Gearoid P. O'Neill, Kathleen D. Barackman, Raquel Rozich, Shelley Allen, Marc Roelke, Valerie Pastore, John Finkle, Alison Swarens, Deborah Warwick, Kelly Kumar, Elizabeth Clarke, Bruce L. Wilkoff, Margot Vloka, Constantinos A. Costeas, Peter R. Kowey, Edith Menchavez, Henry H. Hsia, Linda W. Kay, Roger A. Marinchak, Stephen T. Rothbart, Jonathan S. Steinberg, Robert A. Schweikert, John C. Love, Patrick J. Tchou, Maribel Hernandez, Joel E. Cutler, James Kirchhoffer, Julie Clark, Jenifer L. Lake, Mark Niebauer, Robert B. Leman, Susan BosworthFarrell, Scott Ruffo, Katherine T. Murray, Terri Moore, Leon Greene, Bengt Herweg, Maureen Redmond, Kristin E. Ellison, Jane E. Slabaugh, Vance J. Plumb, Frederick Ehlert, G. Neal Kay, Dan M. Roden, Jean Provencher, Kathy Marks, Roger A. Freedman, Fredrick J. Jaeger, Mary Duquette, Frederic Christian, Jeffrey N. Rottman, Michael Rome, Gregory Michaud, Sandy Saunders, Richard C. Klein, Mark Anderson
Rok vydání: 2003
Předmět:
Zdroj: JAMA. 288(24)
ISSN: 0098-7484
Popis: CONTEXT: Implantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid cause for mortality in this population is congestive heart failure. OBJECTIVE: To determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation but without indications for antibradycardia pacing. DESIGN: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial. SETTING AND PARTICIPANTS: A total of 506 patients with indications for ICD therapy were enrolled between October 2000 and September 2002 at 37 US centers. All patients had a left ventricular ejection fraction (LVEF) of 40% or less, no indication for antibradycardia pacemaker therapy, and no persistent atrial arrhythmias. INTERVENTIONS: All patients had an ICD with dual-chamber, rate-responsive pacing capability implanted. Patients were randomly assigned to have the ICDs programmed to ventricular backup pacing at 40/min (VVI-40; n = 256) or dual-chamber rate-responsive pacing at 70/min (DDDR-70; n = 250). Maximal tolerated medical therapy for left ventricular dysfunction, including angiotensin-converting enzyme inhibitors and beta-blockers, was prescribed to all patients. MAIN OUTCOME MEASURE: Composite end point of time to death or first hospitalization for congestive heart failure. RESULTS: One-year survival free of the composite end point was 83.9% for patients treated with VVI-40 compared with 73.3% for patients treated with DDDR-70 (relative hazard, 1.61; 95% confidence interval [CI], 1.06-2.44). The components of the composite end point, mortality of 6.5% for VVI-40 vs 10.1% for DDDR-70 (relative hazard, 1.61; 95% CI, 0.84-3.09) and hospitalization for congestive heart failure of 13.3% for VVI-40 vs 22.6% for DDDR-70 (relative hazard, 1.54; 95% CI, 0.97-2.46), also trended in favor of VVI-40 programming. CONCLUSION: For patients with standard indications for ICD therapy, no indication for cardiac pacing, and an LVEF of 40% or less, dual-chamber pacing offers no clinical advantage over ventricular backup pacing and may be detrimental by increasing the combined end point of death or hospitalization for heart failure.
Databáze: OpenAIRE