Outcomes of Patients Implanted with an Atrioventricular Synchronous Leadless Ventricular Pacemaker in the Medicare Population

The Micra AV Coverage with Evidence Development (CED) study is a novel analysis of utilization and outcomes associated with Micra AV leadless pacing among US Medicare patients.To describe patient characteristics, complications, and outcomes of patients implanted with a Micra AV leadless pacemaker compared to a contemporaneous cohort of dual chamber transvenous pacemaker patients.Patients implanted with Micra AV (N=7,471) or a dual chamber transvenous pacemaker (N=107,800) from February 5, 2020 - December 1, 2021 were identified using device registry-linked Medicare claims data. Acute complications were assessed at 30 days and chronic complications, reinterventions, and all-cause mortality were assessed at 6 months.Micra AV patients had higher rates of end-stage renal disease (14.9% vs. 2.0%, P<0.0001) and overall comorbidity burden (mean Charlson Comorbidity Index 4.9 vs. 3.8, P<0.0001). There was no difference in the unadjusted rate of complications at 30 days (9.1% vs. 8.7%, P=0.61), and Micra AV patients had a significantly lower adjusted rate of complications (8.6% vs. 11.0%, P<0.0001). At 6 months, Micra AV patients had significantly lower rates of complications (adj. HR 0.50, 95% CI 0.43-0.57, P<0.0001) and reinterventions (adj. HR 0.46, 95% CI 0.36-0.58, P<0.0001). Micra AV patients had higher all-cause mortality at 30 days and 6 months, likely due to differences in underlying risk for mortality.Patients implanted with Micra AV had similar rates of complications at 30 days and significantly lower rates of complications and reintervention at 6 months, despite being sicker than patients implanted with a transvenous pacemaker.