MARVEL 2: AV Synchronous Pacing Using a Leadless Ventricular Pacemaker

New findings from the MARVEL 2 study presented at AHA 2019 and published Nov. 11 in JACC: Clinical Electrophysiology suggest that accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved atrioventricular (AV) synchrony in patients with sinus rhythm and AV block implanted with a leadless ventricular pacemaker.

The multi-center study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to five hours in 75 patients with AV block implanted with a Micra leadless pacemaker. According to Clemens Steinwender, MD, and colleagues, the primary efficacy objective was to demonstrate the superiority of the algorithm to provide AV synchronous (VDD) pacing versus VVI-50 pacing in patients with sinus rhythm and complete AV block. The primary safety objective was to demonstrate that the algorithm did not result in pauses or heart rates >100 bpm.

Results found that of the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70 percent AV synchrony at rest was significantly greater with VDD pacing (95 percent) compared with VVI pacing (0 percent). The mean percent AV synchrony increased from 26.8 percent during VVI pacing to 89.2 percent during VDD pacing. In terms of the primary safety objective, researchers noted no pauses or episodes of pacing-induced tachycardia were reported in any of the patients, regardless of predominant heart rhythm.

"If implemented in clinical practice, this new technology will further expand the spectrum of patients who will be eligible for leadless pacing," concluded Steinwender, et al.

In a related editorial, E. Kevin Heist, MD, PhD, FACC, agreed, calling the findings "the next big advancement for leadless pacemakers." "It is clearly the beginning and not the end of the evolution of leadless pacing," he writes. "The future of leadless pacing is bright, and the journey has just begun."

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: AHA19, AHA Annual Scientific Sessions, Atrioventricular Block, Heart Rate, Atrial Fibrillation, Pacemaker, Artificial, Tachycardia, Algorithms, Electrophysiology, Accelerometry

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