Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study

Micra Transcatheter Pacing Study Group, for the

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83 Citations (Scopus)

Abstract

Background Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months. Objective The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months. Methods The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates. Results The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%–97.2%; P <.0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35–0.77; P =.001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years. Conclusion Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.

Original languageEnglish
Pages (from-to)702-709
Number of pages8
JournalHeart Rhythm
Volume14
Issue number5
DOIs
Publication statusPublished - May 2017

Keywords

  • Leadless transcatheter pacing
  • Long-term performance
  • Transcatheter pacemaker

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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