Affiliations 

  • 1 University Hospitals Leuven, Leuven, Belgium. Electronic address: christophe.garweg@uzleuven.be
  • 2 Northwell New Hyde Park, New Hyde Park, New York
  • 3 European Georges Pompidou Hospital, Paris, France
  • 4 Bern University Hospital, University of Bern, Bern, Switzerland
  • 5 Saint Vinzenz Hospital, Cologne, Germany
  • 6 Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy
  • 7 Spedali Civili Hospital, University of Brescia, Brescia, Italy
  • 8 University Hospital Zurich, Zurich, Switzerland
  • 9 Institut Jantung Negara, Kuala Lumpur, Malaysia
  • 10 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
  • 11 Emory University Medical School, Atlanta, Georgia
  • 12 University Hospital Southampton NHS Trust, Southampton, United Kingdom
  • 13 Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
  • 14 Medtronic, Inc., Mounds View, Minnesota
  • 15 Department of Cardiologic Medicine, Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau, Tours, France
Heart Rhythm, 2024 Jun 13.
PMID: 38878939 DOI: 10.1016/j.hrthm.2024.06.008

Abstract

BACKGROUND: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction.

OBJECTIVE: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months.

METHODS: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system.

RESULTS: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%.

CONCLUSION: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.

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