title: Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. Electronic address: gduray@yahoo.com.
authors.forename: Gabor Z
authors.initials: GZ
authors.lastname: Duray
authors.affiliation: Department of Cardiac Pacing and Electrophysiology, CHU/Université de Bordeaux, Pessac, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ritter
authors.affiliation: Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, Georgia.
authors.forename: Mikhael
authors.initials: M
authors.lastname: El-Chami
authors.affiliation: CARE Hospitals, CARE Foundation, Hyderabad, India.
authors.forename: Calambur
authors.initials: C
authors.lastname: Narasimhan
authors.affiliation: Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia.
authors.forename: Razali
authors.initials: R
authors.lastname: Omar
authors.affiliation: Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Tolosana
authors.affiliation: Fuwai Hospital, Beijing, China.
authors.forename: Shu
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, Kyorin University Hospital, Tokyo, Japan.
authors.forename: Kyoko
authors.initials: K
authors.lastname: Soejima
authors.affiliation: Department of Cardiology, Kepler University Hospital, Linz, Austria; Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Clemens
authors.initials: C
authors.lastname: Steinwender
authors.affiliation: Medtronic, plc, Mounds View, Minnesota.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Rapallini
authors.affiliation: Medtronic, plc, Mounds View, Minnesota.
authors.forename: Aida
authors.initials: A
authors.lastname: Cicic
authors.affiliation: Medtronic, plc, Mounds View, Minnesota.
authors.forename: Dedra H
authors.initials: DH
authors.lastname: Fagan
authors.affiliation: Medtronic, plc, Mounds View, Minnesota.
authors.forename: Shufeng
authors.initials: S
authors.lastname: Liu
authors.affiliation: Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, Oklahoma.
authors.forename: Dwight
authors.initials: D
authors.lastname: Reynolds
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D062906:Cardiac Catheters; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D061214:Patient Safety; D011446:Prospective Studies; D011475:Prosthesis Failure; D016896:Treatment Outcome
keywords: Leadless transcatheter pacing; Long-term performance; Transcatheter pacemaker