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DAVID II: Atrial pacing safe alternative to ventricular pacing
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The effects of atrial pacing on survival and quality of life were essentially equivalent to backup only ventricular pacing, researchers found.
The DAVID and DAVID II trials evaluated whether active pacing in both cardiac chambers (DAVID) or only in the atrium (DAVID II), as compared with minimal pacing, would permit more aggressive drug treatment of HF, and result in improved clinical outcomes in the patient population. The results from the original DAVID trial suggested that dual-chamber rate-responsive pacing worsened mortality and HF hospitalization compared with ventricular backup pacing. To determine whether the original intent of the DAVID trial might still be fulfilled by promoting atrial pacing but not ventricular pacing, the researchers for DAVID II enrolled 600 patients with impaired ventricular function and assigned half to an atrial pacing (AAI) group and the other half to a ventricular backup (VVI) pacing group.
The researchers reported no differences between treatment arms for the primary combined endpoints of HF hospitalization or death at one year (11.1%), two years (16.9%) and three years (24.6%). There were no differences between treatment arms for the time to death and HF hospitalization endpoints. There was no difference in secondary endpoints, including the incidence of atrial fibrillation syncope, or measures of quality of life.
“Although implantable defibrillator recipients with LV dysfunction had no clinical indication for pacing, the effect of atrial pacing on event-free survival and quality of life was not substantially worse, and was likely equivalent to, backup-only ventricular pacing,” the researchers wrote in the conclusion.
Necessity of DAVID II?
In an accompanying editorial, Brian Olshansky, MD, a cardiologist at the University of Iowa Hospital in Iowa City, Iowa, and colleagues, acknowledged the study’s results, but questioned whether the trial needed to be conducted.
“Whereas the DAVID trial cast the first stone against dual-chamber ICD programming, its brother, the DAVID II trial, appears to have missed the shot at conquering the substantial challenges, the proverbial Goliath, that remain in our understanding of the best method for programming ICDs to protest against brachycardia and to ultimately optimize outcomes for our patients.”
Wilkoff B. J Am Coll Cardiol. 2009;53:872-880.
