Medtronic’s Micra TPS Compared With Traditional Transvenous Pacemakers in Real-World Study of Medicare Population

August 27, 2021—Medtronic announced new data from the Micra Coverage With Evidence Development (CED) Study, a large evaluation of the company’s leadless Micra transcatheter pacing system (TPS).

Micra CED is a continuously enrolling, observational, cohort study evaluating claims-based complications, utilization, and outcomes of Micra TPS in the United States’ Medicare fee-for-service population. The data were presented virtually in a late-breaking trials presentation at the European Society of Cardiology’s Congress 2021.

The study investigators evaluated 6,219 patients implanted with Micra VR TPS and 10,212 patients implanted with traditional transvenous (TV-VVI) pacemakers. They compared system reinterventions, chronic complications, and all-cause mortality at 2-years after implantation.

Overall, patients implanted with Micra TPS were sicker (with a greater comorbidity burden) than TV-VVI patients, with higher rates of end stage renal disease (12.0% vs 2.3%) and renal dysfunction (48.8% vs 42.1%), and a higher Charlson Comorbidity Index score (5.1 vs 4.6).

According to the company, the findings showed that the Medtronic Micra TPS was associated with a 38% reduction in reinterventions and a 31% reduction in chronic complications at 2-years compared with TV-VVI pacemakers.

The Micra CED study used Centers for Medicare & Medicaid Services administrative claims data to evaluate clinical outcomes of leadless pacing in the real-world setting and compare outcomes to a contemporaneous cohort of patients implanted with TV-VVI pacemakers. The CED study used statistical adjustment to account for differences in patient characteristics at baseline.

The company reported that although Micra patients had more comorbidities than TV-VVI patients, the adjusted results showed patients with Micra had significantly fewer reinterventions compared to patients with TV-VVI devices (Micra, 3.1% vs TV-VVI, 4.9%; adjusted P = .003) including significantly fewer system revisions, device removals, and upgrades to cardiac resynchronization therapy.

Micra TPS patients also had significantly fewer chronic complications at 2-years (Micra, 4.6% vs TV-VVI, 6.5%; adjusted hazard ratio [HR], 0.69; 95% CI. 0.6-0.81; P < .0001). Although Micra patients had more comorbidities than TV-VVI patients, there was no difference in adjusted all-cause mortality at 2-years compared to the transvenous comparator population (adjusted HR, 0.97; 95% CI, 0.91-1.04; P = .37).

The Micra TPS, which is available globally, is a leadless pacemaker option for patients who only require pacing in the right ventricle. Micra received European CE Mark approval in 2015 and FDA approval in the United States in 2016, advised Medtronic.