Very Low Ventricular Pacing Rates Can Be Achieved Safely in a Heterogeneous Pacemaker Population and Provide Clinical Benefits: The CANadian Multi-Centre Randomised Study-Spontaneous AtrioVEntricular Conduction pReservation (CAN-SAVE R) Trial

Bernard Thibault, Anique Ducharme, Adrian Baranchuk, Marc Dubuc, Katia Dyrda, Peter G Guerra, Laurent Macle, Blandine Mondésert, Léna Rivard, Denis Roy, Mario Talajic, Jason Andrade, Rémi Nitzsché, Paul Khairy, CAN‐SAVE R Study Investigators, Bernard Thibault, Anique Ducharme, Adrian Baranchuk, Marc Dubuc, Katia Dyrda, Peter G Guerra, Laurent Macle, Blandine Mondésert, Léna Rivard, Denis Roy, Mario Talajic, Jason Andrade, Rémi Nitzsché, Paul Khairy, CAN‐SAVE R Study Investigators

Abstract

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.

Keywords: adverse arrhythmic events; atrial fibrillation; dual‐chamber pacemaker; long atrioventricular delay; right ventricular pacing.

© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Figures

Figure 1
Figure 1
Flow chart of patients’ disposition. Inclusion, randomization, and follow-up of CAN-SAVE R patients. CAN-SAVE R indicates CANadian multi-centre randomised study–Spontaneous AtrioVEntricular conduction pReservation; DDD, intrinsic atrioventricular conduction and dual-chamber pacemaker.

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Source: PubMed

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