Pacemaker mode selection: the evidence from randomized trials.
The evidence base for pacing, specifically with regards to outcome-based randomized trials, is only beginning to emerge. At present, the guidelines for pacing in sinus node dysfunction (SND), atrioventricular block (AVB), and vasovagal syncope are largely based on observational, not randomized studies. The findings from observational studies that physiological pacing was associated with reduced mortality, fewer strokes, less heart failure, and less AF when compared with ventricular pacing, were not uniformly supported by the early randomized trials of a relatively small sample size. Thus, it has become increasingly clear that large scale randomized trials are necessary to measure reliably the benefit, if any, of progressively more expensive and complex pacemakers. To provide reliable answers to these important questions, three large multicenter randomized trials in Canada, the United Kingdom, and the United States have been designed and conducted. The present review analyzed the results of completed randomized trials on pacemaker mode selection. To date, > 6,000 patients requiring permanent pacing to prevent bradycardia have been randomized; among these, dual chamber pacing did not prevent stroke or improve survival when compared with ventricular pacing. However, dual chamber pacing led to a moderate reduction of incident and chronic AF, reduced symptoms of heart failure in patients with SND, prevented pacemaker syndrome, and modestly improved quality-of-life. Further, a 5-10% reduction in mortality by atrial-based pacing cannot be excluded based on the results of the analyzed trials. The availability of data from ongoing randomized trials and their meta analysis should complete the totality of evidence during the next several years.
Montanez
Alicia
A
Division of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida 33140, USA.
Hennekens
Charles H
CH
Zebede
Joseph
J
Lamas
Gervasio A
GA
D002304:Cardiac Pacing, Artificial / Q000379:methods*; D006331:Heart Diseases / Q000628:therapy*; D006801:Humans; D010138:Pacemaker, Artificial; D016032:Randomized Controlled Trials as Topic