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

Bruce L. Wilkoff, James R. Cook, Andrew E. Epstein, Leon Greene, Alfred P. Hallstrom, Henry Hsia, Steven P. Kutalek, Arjun Sharma, Brian Blatt, Barry Karas, James Kirchhoffer, Deborah Warwick, Mary Duquette, Jean Provencher, Maureen Redmond, John M. Herre, Robert Bernstein, Linette R. Klevan, Kathleen D. Barackman, Jennine ZumbuhlMina K. Chung, Fredrick J. Jaeger, David Martin, Andrea Natale, Walid I. Saliba, Robert A. Schweikert, Mark J. Niebauer, Patrick Joseph Tchou, Raquel Rozich, Marc Roelke, Constantinos A. Costeas, Donald G. Rubenstein, Scott Ruffo, Kelly Kumar, Elizabeth McCarthy, Valerie Pastore, Mark S. Wathen, Jeffrey Rottman, Mark Anderson, John T. Lee, Katherine T. Murray, Dan M. Roden, Nancy Conners, Sandy Saunders, Gearoid P. O'Neill, Anne Skadsen, Shelley Allen, Ellie Vierra, Stephen Greer, Jeffrey Neuhauser, Pam Myers, Celeste Lee, Terri Moore, Richard C. Klein, Roger A. Freedman, Geri Wadsworth, Sharon M. Dailey, G. Neal Kay, Vance J. Plumb, Rosemary S. Bubien, Linda W. Kay, Candace M. Nasser, Jane E. Slabaugh, Robert Leman, Jenifer L. Lake, Julie Clark, Elizabeth Clarke, Laura Finklea, John C. Love, Charles M. Carpenter, Andrew Corsello, Joel E. Cutler, Susan BosworthFarrell, Gregory Michaud, Alfred E. Buxton, Kristin E. Ellison, Frederic Christian, Malcolm M. Kirk, Pamela L. Corcoran, Stephen Rothbart, Roy B. Sauberman, Jennifer McCarthy, Mary Ellen Page, Jonathan S. Steinberg, Frederick Ehlert, Bengt Herweg, Margot Vloka, Ammy Malinay, Edith Menchavez, Michael Rome, Kathy Marks, Alison Swarens, Maribel Hernandez, Roger Marinchak, Douglas Esberg, John Finkle, Glenn Harper, Peter R. Kowey, Colin Movsowitz

Research output: Contribution to journalArticle

Abstract

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 β-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.

Original languageEnglish (US)
Pages (from-to)3115-3123
Number of pages9
JournalJournal of the American Medical Association
Volume288
Issue number24
DOIs
StatePublished - Dec 25 2002
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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    Wilkoff, B. L., Cook, J. R., Epstein, A. E., Greene, L., Hallstrom, A. P., Hsia, H., Kutalek, S. P., Sharma, A., Blatt, B., Karas, B., Kirchhoffer, J., Warwick, D., Duquette, M., Provencher, J., Redmond, M., Herre, J. M., Bernstein, R., Klevan, L. R., Barackman, K. D., ... Movsowitz, C. (2002). Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. Journal of the American Medical Association, 288(24), 3115-3123. https://doi.org/10.1001/jama.288.24.3115