Fridley, Minn.-based Medtronic’s Micra Coverage with Evidence Development (CED) study, which it labeled the largest evaluation of leadless pacemakers to date, showed that the Micra transcatheter pacing system (TPS) was associated with a 38% reduction in reinterventions and a 31% reduction in chronic complications at two years when compared with traditional transvenous pacemakers.
The company presented data virtually in a late-breaking trials presentation at the European Society of Cardiology (ESC) Congress 2021, according to a news release.
Micra TPS, a leadless pacemaker option for patients who only require pacing in the right ventricle, is the size of a large vitamin — one-tenth the size of traditional pacemakers. The device is attached to the heart with small tines and delivers electrical impulses that pace the heart without requiring leads or a surgical “pocket” under the skin. (Read about the challenges Medtronic overcame to create the device.)
Medtronic’s Micra CED study — a continuously enrolling, observational cohort study — evaluates claims-based complications, utilization and outcomes of Micra TPS in the U.S. Medicare fee-for-service population. The company said it is the first study to use CMS 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 transvenous-VVI pacemakers.
Researchers evaluated 6,219 patients implanted with Micra VR PTS and 10,212 patients implanted with traditional TV-VVI pacemakers. While reinterventions and chronic complications were reduced, Micra patients did present more comorbidities than transvenous-VVI patients, although there was no difference in adjusted all-cause mortality at two years.
“As part of our commitment to improving outcomes for patients needing pacing therapy, we embraced the opportunity to evaluate our devices in a real-world setting,” CMO of Medtronic’s cardiac rhythm management business Dr. Rob Kowal said in the release. “The results presented at ESC further reinforce the significant advantages of leadless pacemakers and support earlier findings that show a reduced risk of complications with Micra TPS. These data should assist physicians and patients to select the most appropriate, individualized pacing option to meet their goals.”