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.

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