Abstract

Introduction: Medicare Advantage (MA) patients are typically healthier and report better outcomes compared to fee-for-service (FFS) Medicare patients. While the benefits of leadless pacing have been demonstrated in the FFS population, no study has evaluated leadless pacemakers in the 100% MA population. Hypothesis: The benefits of leadless pacing extend to the MA patient population. Aims: To compare patient characteristics and outcomes between Micra VR and single-chamber transvenous pacing among MA patients vs. FFS patients. Methods: MA Encounter data was used to identify patients implanted with a Micra VR leadless pacemaker (N=4,970), or a single-chamber transvenous pacemaker (N=6,615) from 2017-2019. Logistic regression was used to compare unadjusted and propensity score overlap weight-adjusted 30-day complication rates. Cox models were used to compare 2-year chronic complications and reinterventions between groups. MA results were compared to results of the Micra Coverage with Evidence Development (CED) study of FFS patients. Results: MA Micra VR patients had a higher comorbidity burden (mean Charlson Comorbidity Index (CCI) 5.3 vs. 4.9, P<0.001) and higher rates of end-stage renal disease (ESRD) (7.3% vs. 1.5%, P<0.001) compared to transvenous patients. After adjusting for patient differences, Micra VR patients had similar rates of acute complications at 30 days (adj. 7.0% vs. 6.8%, P=0.76). At 2 years, Micra VR patients had significantly lower adjusted rates of chronic complications (adj. HR 0.75, 95% CI: 0.61-0.91, P<0.001) and reinterventions (adj. HR 0.57, 95% CI: 0.44-0.75, P<0.001) and there was no difference in adjusted all-cause mortality (adj. HR 1.05, 95% CI: 0.97, 1.14, P=0.26). Compared to FFS patients, MA patients had lower rates of ESRD (7.3% vs. 12.0%) and lower rates of emergency admission (5.4% vs. 12.0%), though their overall comorbidity burden was similar (mean CCI 5.3 vs. 5.1). The comparative benefits compared to transvenous were similar in magnitude in the MA vs. FFS populations. Conclusion: Compared to transvenous pacing, MA patients treated with a Micra VR leadless pacemaker had reductions in chronic complications and reinterventions at 2 years of similar magnitude to those observed in the Medicare FFS population.

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