Key result
Micra AV linked to ~52% lower rate of major complications vs transvenous dual-chamber pacemakers.
Why the study?
Longer-term performance of leadless atrioventricular synchronous pacemakers in real-world clinical practice had not been assessed.
Does the Micra AV leadless pacemaker reduce major complications and system revisions compared to transvenous dual chamber pacemakers?
Observational (n=3,468)
Yes
Does the Micra AV leadless pacemaker reduce major complications and system revisions compared to transvenous dual chamber pacemakers?
Hazard Ratio: 0.48
Absolute Event Rate: 4.2% vs 8.8%
p-value: p=<0.001
In a real-world post-approval registry, the Micra AV leadless pacemaker achieved high implant success and maintained a significantly lower rate of major complications and system revisions at 12 months compared to a historical transvenous dual-chamber pacemaker cohort.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“By enabling AV synchronous pacing, the second generation device could be potentially implanted in patients who need ventricular pacing due to high degree AV block with preserved sinus rhythm, therefore increasing the targeted population”
Real-world registry data associate Micra AV with fewer complications and revisions than historical transvenous controls; leaves open need for randomized confirmation.
Introduction Advances in leadless pacemaker technology have enabled accelerometer based atrioventricular synchronous (AVS) pacing by sensing atrial mechanical contraction. However, longer-term performance of these devices in real-world clinical practice has not been assessed. Objectives To report the performance of the Micra AV transcatheter pacemaker from the worldwide Micra AV post-approval registry (PAR) through 1-year post-implant. Methods The Micra AV PAR is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of the Micra AV system in the real-world setting. Patients enrolled in the Micra AV PAR will be followed for 3 years. For the present interim analysis, baseline characteristics, total AV synchrony index (sum of %AM-VP, %AM-VS, and AV conduction mode switch percentage), major complications, and system revisions through 12-months of implant were summarized and compared to a historical cohort of 2,667 transvenous dual chamber (TV-DC) pacing patients. Results The device was successfully implanted in 797 of 801 patients (99.4%) at 98 centers in 19 countries between February 2020 and April 2022. Mean age was 74.1±15.1 years, 42.2% were female, and 31.3% were precluded from transvenous device therapy. Micra AV patients were on average older (74.1 vs. 71.1 yrs, P<0.0001) and had a significantly higher incidence of renal disease (22.3% vs. 9.8%, P<0.0001) compared with TV-DC patients. Mean follow-up was 7.7±6.4 months. Through 12-months, the major complication rate was 4.2% in Micra AV patients compared to 8.8% TV-DC patients (HR: 0.48, P<0.001, Figure). At 12-months, the system revision rate was 1.9% in Micra AV patients compared to 5.5% for TV-DC patients (HR: 0.28, P<0.001). The reduction in system revisions was largely driven by the absence of lead dislodgements requiring revision. Of the 397 patients with device interrogation files available for analysis, 315 (79.4%) were programmed to VDD mode at last follow-up and had a median AV synchrony index of 86.4% (IQR: 68.8% - 97.4%). Conclusions The Micra AV leadless pacemaker was implanted with a high rate of success in patients with a high co-morbidity burden, with a significantly lower rate of complications and system revisions through 12-months compared to dual-chamber transvenous pacemakers despite patients being older and having a higher incidence of renal disease. Longer-term performance will continue to be assessed in this ongoing trial.
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Garweg et al. (2023) conducted an observational in Atrioventricular synchronous pacing indication (n=3,468). Micra AV transcatheter pacemaker vs. Transvenous dual-chamber (TV-DC) pacing was evaluated on Major complications through 12-months (HR 0.48, p=<0.001). The Micra AV leadless pacemaker was associated with a significantly lower rate of major complications at 12 months compared to transvenous dual-chamber pacemakers (4.2% vs 8.8%; HR 0.48, P<0.001).
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