CI-452768-4 THE MICRA AV LEADLESS PACEMAKER IN THE REAL-WORLD MEDICARE POPULATION: EARLY RESULTS FROM THE MICRA AV COVERAGE WITH EVIDENCE DEVELOPMENT (CED) STUDY

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The Micra AV CED study is a novel analysis of utilization, safety, and outcomes associated with the Micra AV leadless pacemaker in the US Medicare population. To describe the initial cohort of AV CED patients implanted in 2020 and compare them to patients implanted with Micra VR leadless or a traditional dual chamber transvenous (DC TV) pacemaker. Patients implanted with a Micra AV leadless pacemaker (N=2,668), a Micra VR leadless pacemaker (N=4,785), or a DC TV pacemaker (N=46,531) were identified using device registry-linked Medicare administrative claims data. Univariate logistic regression was used to compare unadjusted and propensity score overlap weight–adjusted 30-day acute complication rates. Compared with Micra VR and DC TV patients, Micra AV patients were more likely to have end-stage renal disease (17.8% AV vs. 8.8% VR vs. 2.2% DC, P<0.0001), higher overall comorbidity burden (mean Charlson Comorbidity Index 5.2 AV vs. 5.0 VR vs. 4.0 DC TV, P<0.0001), and were more likely to be admitted for their implant procedure through the emergency department (17.1% AV vs. 10.4% VR vs. 11.0% DC TV, P<0.0001) (figure). An estimated 23% of Micra AV patients were likely to have been precluded from TV pacing. Despite these differences, there was no difference in the unadjusted rate of complications at 30 days between Micra AV and DC TV patients (9.8% vs. 8.8%, P=0.25), and Micra AV patients had significantly lower complications after adjustment for measured baseline characteristics (adj. 9.2% vs. 11.1%, P=0.01). Micra AV patients had higher rates of perforation (adj. 1.4% vs. 0.8%, P=0.003), but lower rates of device complications (adj. 1.9% vs. 4.2%, P<0.0001). Compared to VR patients, Micra AV patients had a higher unadjusted rate of overall complications at 30 days (9.8% vs. 7.2%, P=0.0004); however, these differences were not significant following adjustment (adj. overall complications 9.3% vs. 9.6%, P=0.74). Micra AV and Micra VR patients had similar adjusted rates of perforation (adj. 1.4% vs. 1.1%, P=0.32) and device complications (adj. 1.9% vs. 1.5%, P=0.36). In a real-world study of US Medicare patients, patients implanted with Micra AV leadless pacemaker were significantly sicker and more complex than patients implanted with either a Micra VR leadless or a traditional DC TV pacemaker. Despite these differences, similar rates of overall complications were observed at 30 days.