Key result
Micra AV leadless pacemakers are linked to ~58% fewer major complications than transvenous dual-chamber pacemakers.
Why the study?
Advances in leadless pacemaker technology have enabled accelerometer-based AV synchronous pacing, motivating evaluation of the real-world performance of the Micra AV leadless pacemaker through 12 months.
Does the Micra AV leadless pacemaker reduce major complications and system revisions compared to transvenous dual-chamber pacemakers in patients requiring pacing?
Does the Micra AV leadless pacemaker reduce major complications and system revisions compared to transvenous dual-chamber pacemakers in patients requiring pacing?
The Micra AV leadless pacemaker demonstrated a significantly lower rate of major complications and system revisions at 12 months compared to a historical cohort of transvenous dual-chamber pacemakers.
Micra AV linked to fewer complications than transvenous pacemakers; extends observational data but leaves open randomized confirmation.
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.
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Garweg et al. (2024) studied this question. The Micra AV leadless pacemaker significantly reduced 12-month major complications (3.7% vs 8.8%; HR 0.42) and system revisions (1.5% vs 5.5%) compared to transvenous dual-chamber pacemakers.
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