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The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial
Author(s) -
Wilkoff Bruce L.
Publication year - 2003
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1046/j.1460-9592.2003.t01-2-00231_5.x
Subject(s) - medicine , bradycardia , single chamber , cardiology , heart failure , ejection fraction , clinical endpoint , ventricular rate , randomized controlled trial , anesthesia , heart rate , blood pressure
The devices used to prove the benefit of ICD therapy had only VVI pacing but most current ICD devices provide dual chamber pacing therapy. The DAVID trial sought to measure the impact of dual chamber pacing at 70 bpm (DDDR‐70) vs. ventricular backup pacing at 40 bpm (VVI‐40) in patients with standard indications for ICD implantation but without indications for bradycardia pacing. Methods: This single‐blind, multicenter, parallel‐group, randomized clinical trial enrolled 506 patients with indications for ICD therapy between 10/2000 and 9/2002. All patients had an LVEF ≤0.40, no indication for pacemaker therapy and no persistent atrial arrhythmias. ICDs with dual chamber, rate‐responsive pacing capability were implanted and programmed to VVI‐40 or DDDR‐70. Results: The combined endpoint of mortality or hospitalization for congestive heart failure (CHF) at one year was 16.1% (VVI‐40) vs. 26.7% (DDDR‐70), (p ∼ 0.03), mortality 6.5% vs. 10.1% (p ∼ 0.15) and CHF hospitalization 13.3% vs. 22.5% (p ∼ 0.07). Conclusion: For ICD patients, DDDR‐70 pacing exhibits no clinical advantage over VVI‐40 pacing and may increase CHF and mortality.