title: Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Cleveland Clinic Foundation, 9500 Euclid Ave, Desk F-15, Cleveland, OH 44195, USA. wilkofb@ccf.org
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Wilkoff
authors.forename: James R
authors.initials: JR
authors.lastname: Cook
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Epstein
authors.forename: H Leon
authors.initials: HL
authors.lastname: Greene
authors.forename: Alfred P
authors.initials: AP
authors.lastname: Hallstrom
authors.forename: Henry
authors.initials: H
authors.lastname: Hsia
authors.forename: Steven P
authors.initials: SP
authors.lastname: Kutalek
authors.forename: Arjun
authors.initials: A
authors.lastname: Sharma
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000368:Aged; D000638:Amiodarone / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D000925:Anticoagulants / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000150:complications / Q000628:therapy*; D002304:Cardiac Pacing, Artificial; D002317:Cardiovascular Agents / Q000627:therapeutic use; D017115:Catheter Ablation; D017147:Defibrillators, Implantable; D004077:Digoxin / Q000627:therapeutic use; D004232:Diuretics / Q000627:therapeutic use; D005260:Female; D006333:Heart Failure / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D016037:Single-Blind Method; D016019:Survival Analysis; D017180:Tachycardia, Ventricular / Q000628:therapy; D018487:Ventricular Dysfunction, Left / Q000150:complications / Q000628:therapy*; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000889:Anti-Arrhythmia Agents; D000925:Anticoagulants; D002317:Cardiovascular Agents; D004232:Diuretics; D014859:Warfarin; D004077:Digoxin; D000638:Amiodarone