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CLINICAL RESEARCH: HEART RHYTHM DISORDER

The DAVID (Dual Chamber and VVI Implantable Defibrillator) II Trial

Bruce L. Wilkoff, MD, FACC^_*, Peter J. Kudenchuk, MD, FACC^,_*, Alfred E. Buxton, MD, FACC, Arjun Sharma, MD, James R. Cook, MD, FACC^||, Anil K. Bhandari, MD, FACC^¶, Michael Biehl, MD, FACC^#, Gery Tomassoni, MD^_**, Anna Leonen, MS, Linette R. Klevan, RN, Alfred P. Hallstrom, PhD for the DAVID II Investigators

^_* Cleveland Clinic, Cleveland, Ohio
University of Washington, Seattle, Washington
Brown University Medical School, Providence, Rhode Island
Boston Scientific Cardiac Rhythm Management, St. Paul, Minnesota
^|| Baystate Medical Center, Springfield, Massachusetts
^¶ Hospital of the Good Samaritan, Los Angeles, California
^# St. Joseph's Hospital and Medical Center, Paterson, New Jersey
^_** Central Baptist Hospital, Lexington, Kentucky
Sentara Norfolk General Hospital, Norfolk, Virginia

Manuscript received August 30, 2008; revised manuscript received October 15, 2008, accepted October 21, 2008.

^_* Reprint requests and correspondence: Dr. Peter J. Kudenchuk, Division of Cardiology, Box 356422, University of Washington, Seattle, Washington 98195-6422 (Email: kudenchu{at}u.washington.edu).

Objectives: The purpose of this study was to determine whether atrial pacing is a safe alternative to minimal (backup-only) ventricular pacing in defibrillator recipients with impaired ventricular function.

Background: The DAVID (Dual Chamber and VVI Implantable Defibrillator) trial demonstrated that dual chamber rate responsive pacing as compared with ventricular backup-only pacing worsens the combined end point of mortality and heart failure hospitalization. Although altered ventricular activation from right ventricular pacing was presumed to be the likely cause for these maladaptive effects, this supposition is unproven.

Methods: In all, 600 patients with impaired ventricular function from 29 North American sites, who required an implanted defibrillator for primary or secondary prevention, with no clinical indication for pacing, were randomly assigned to atrial pacing (at 70 beats/min) versus minimal ventricular pacing (at 40 beats/min) and followed up for a mean of 2.7 years.

Results: There were no significant differences between pacing arms in patients' baseline characteristics, use of heart failure medications, and combined primary end point of time to death or heart failure hospitalization during follow-up, with an overall incidence of 11.1%, 16.9%, and 24.6% at 1, 2, and 3 years, respectively. Similarly, the incidence of atrial fibrillation, syncope, appropriate or inappropriate shocks, and quality of life measures did not significantly differ between treatment groups.

Conclusions: The effect of atrial pacing on event-free survival and quality of life was not substantially worse than, and was likely equivalent to, backup-only ventricular pacing. Atrial pacing may be considered a "safe alternative" when pacing is desired in defibrillator recipients, but affords no clear advantage or disadvantage over a ventricular pacing mode that minimizes pacing altogether. (Dual Chamber and VVI Implantable Defibrillator [DAVID] Trial II; NCT00187187 [ClinicalTrials.gov] )

Key Words: implantable defibrillator • heart failure • pacing

Abbreviations and Acronyms   AAI-70 = atrial pacing at a rate of 70 beats/min   AV = atrioventricular   DDDR-70 = dual chamber rate responsive pacing at 70 beats/min   MLHF = Minnesota Living with Heart Failure Questionnaire   NYHA = New York Heart Association   VVI-40 = ventricular backup pacing at a rate of 40 beats/min

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