Affiliations 

  • 1 Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. Electronic address: gduray@yahoo.com
  • 2 Department of Cardiac Pacing and Electrophysiology, CHU/Université de Bordeaux, Pessac, France
  • 3 Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, Georgia
  • 4 CARE Hospitals, CARE Foundation, Hyderabad, India
  • 5 Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia
  • 6 Hospital Clinic, Universitat de Barcelona, Barcelona, Spain
  • 7 Fuwai Hospital, Beijing, China
  • 8 Department of Cardiology, Kyorin University Hospital, Tokyo, Japan
  • 9 Department of Cardiology, Kepler University Hospital, Linz, Austria; Paracelsus Medical University Salzburg, Salzburg, Austria
  • 10 Medtronic, plc, Mounds View, Minnesota
  • 11 Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, Oklahoma
Heart Rhythm, 2017 05;14(5):702-709.
PMID: 28192207 DOI: 10.1016/j.hrthm.2017.01.035

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.