Key result
The SafeR pacing algorithm reduced ventricular-paced beats at 1 year compared to DDD pacing, but did not reduce atrial fibrillation burden at 3 years.
Why the study?
Does the SafeR pacing algorithm reduce ventricular paced beats and atrial fibrillation burden compared to DDD pacing with a long AV delay in patients with indications for dual chamber pacemakers?
RCT (n=373)
double-blinded
1:1
Yes
Does the SafeR pacing algorithm reduce ventricular paced beats and atrial fibrillation burden compared to DDD pacing with a long AV delay in patients with indications for dual chamber pacemakers?
The SafeR pacing algorithm significantly reduces ventricular pacing compared to DDD pacing with a long AV delay, but this does not translate into a reduction in atrial fibrillation burden at 3 years.
Answers are grounded in this paper and cite their sources.
SafeR reduces ventricular pacing without lowering AF burden; challenges assumption that VP minimization prevents AF in dual-chamber pacemaker patients.
BACKGROUND: It is well recognized that right ventricular apical pacing can have deleterious effects on ventricular function. We performed a head-to-head comparison of the SafeR pacing algorithm versus DDD pacing with a long atrioventricular delay in a heterogeneous population of patients with dual-chamber pacemakers. METHODS AND RESULTS: In a multicenter prospective double-blinded randomized trial conducted at 10 centers in Canada, 373 patients, age 71±11 years, with indications for dual chamber DC pacemakers were randomized 1:1 to SafeR or DDD pacing with a long atrioventricular delay (250 ms). The primary objective was twofold: (1) reduction in the proportion of ventricular paced beats at 1 year; and (2) impact on atrial fibrillation burden at 3 years, defined as the ratio between cumulative duration of mode-switches divided by follow-up time. Statistical significance of both co-primary end points was required for the trial to be considered positive. At 1 year of follow-up, the median proportion of ventricular-paced beats was 4.0% with DDD versus 0% with SafeR (P<0.001). At 3 years of follow-up, the atrial fibrillation burden was not significantly reduced with SafeR versus DDD (median 0.00%, interquartile range [0.00% to 0.23%] versus median 0.01%, interquartile range [0.00% to 0.44%], respectively, P=0.178]), despite a persistent reduction in the median proportion of ventricular-paced beats (10% with DDD compared to 0% with SafeR). CONCLUSIONS: A ventricular-paced rate <1% was safely achieved with SafeR in a population with a wide spectrum of indications for dual-chamber pacing. However, the lower percentage of ventricular pacing did not translate into a significant reduction in atrial fibrillation burden. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ Unique identifier: NCT01219621.
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Thibault et al. (2015) conducted an RCT in indications for dual chamber pacemakers (n=373). SafeR pacing algorithm vs. DDD pacing with a long atrioventricular delay (250 ms) was evaluated on co-primary: proportion of ventricular paced beats at 1 year and atrial fibrillation burden at 3 years (p=<0.001). The SafeR pacing algorithm reduced ventricular-paced beats at 1 year compared to DDD pacing, but did not reduce atrial fibrillation burden at 3 years.
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