A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry.

Background: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction.
Objective: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months.
Methods: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system.
Results: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%.
Conclusion: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.
Competing Interests: Disclosures Dr Garweg has received consultant/speaker fees and research grants from Abbott, Biotronik, and Medtronic. Dr Chinitz has received consulting fees from Medtronic, Boston Scientific, and Biosense Webster and speaking/teaching honorarium fees from Boston Scientific and Biotronik. Dr Marijon has received consulting fees from Medtronic, Abbott, and Boston Scientific. Dr Haeberlin has received travel fees/educational grants from Medtronic, Biotronik, Abbott, and Philips/Spectranetics without impact on personal remuneration and works as a proctor for Medtronic. Dr El-Chami serves as a consultant for Medtronic, Boston Scientific, and Biotronik. Dr Roberts has received honoraria from Medtronic, Boston Scientific, and Abbott and research funding from Boston Scientific. Dr Piccini has received clinical research grants from Abbott and Philips and serves as a consultant for Abbott, Boston Scientific, Medtronic, and Philips. Drs Stromberg and Fagan are employees/shareholders of Medtronic. Dr Clementy has received consulting fees from Medtronic. The remaining authors have nothing to disclose.
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