Key result
Micra AV leadless pacemakers were associated with a significantly lower rate of complications at 6 months compared to transvenous pacemakers (adjusted HR 0.50; 95% CI 0.43-0.57; P<.0001).
Why the study?
Real-world utilization, patient characteristics, complications, and outcomes associated with Micra AV leadless pacing compared with dual chamber transvenous pacemakers in US Medicare patients needed description.
Does the Micra AV leadless pacemaker reduce complications and reinterventions compared to a dual chamber transvenous pacemaker in US Medicare patients?
Cohort (n=115,271)
Yes
Does the Micra AV leadless pacemaker reduce complications and reinterventions compared to a dual chamber transvenous pacemaker in US Medicare patients?
Hazard Ratio: 0.5 (95% CI 0.43–0.57)
p-value: p=<.0001
In a Medicare population, the Micra AV leadless pacemaker was associated with significantly lower adjusted rates of complications and reinterventions at 6 months compared to dual-chamber transvenous pacemakers, despite being used in sicker patients.
Lower complications with Micra AV in sicker Medicare patients warrant randomized trials; leaves open mortality differences versus transvenous pacing.
BACKGROUND: The Micra AV Coverage with Evidence Development study is a novel analysis of utilization and outcomes associated with Micra AV leadless pacing in US Medicare patients. OBJECTIVE: The purpose of this study was to describe patient characteristics, complications, and outcomes of patients implanted with a Micra AV leadless pacemaker compared with a contemporaneous cohort of patients implanted with a dual chamber transvenous pacemaker. METHODS: Patients implanted with Micra AV (n = 7471) or a dual chamber transvenous pacemaker (n = 107,800) from February 5, 2020, through 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. RESULTS: Patients implanted with Micra AV had higher rates of end-stage renal disease (14.9% vs 2.0%; P < .0001) and overall comorbidity burden (mean Charlson Comorbidity Index 4.9 vs 3.8; P < .0001). There was no difference in the unadjusted rate of complications at 30 days (9.1% vs 8.7%; P = .61), and patients implanted with Micra AV had a significantly lower adjusted rate of complications (8.6% vs 11.0%; P < .0001). At 6 months, patients implanted with Micra AV had significantly lower rates of complications (adjusted hazard ratio 0.50; 95% confidence interval 0.43-0.57; P < .0001) and reinterventions (adjusted hazard ratio 0.46; 95% confidence interval 0.36-0.58; P < .0001). Patients implanted with Micra AV had higher all-cause mortality at 30 days and 6 months, likely because of differences in the underlying risk of mortality. CONCLUSION: Patients implanted with Micra AV had similar rates of complications at 30 days and significantly lower rates of complications and reinterventions at 6 months, despite being sicker than patients implanted with a transvenous pacemaker.
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Crossley et al. (2023) conducted a cohort in Pacemaker indication (n=115,271). Micra AV leadless pacemaker vs. Dual chamber transvenous pacemaker was evaluated on Complications at 6 months (HR 0.50, 95% CI 0.43-0.57, p=<.0001). Micra AV leadless pacemakers were associated with a significantly lower rate of complications at 6 months compared to transvenous pacemakers (adjusted HR 0.50; 95% CI 0.43-0.57; P<.0001).
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