A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry

Paul R. Roberts*, Nicolas Clementy, Faisal Al Samadi, Christophe Garweg, Jose Luis Martinez-Sande, Saverio Iacopino, Jens Brock Johansen, Xavier Vinolas Prat, Robert C. Kowal, Didier Klug, Lluis Mont, Jan Steffel, Shelby Li, Dirk Van Osch, Mikhael F. El-Chami

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

Background First-in-man studies of leadless pacemakers have demonstrated high rates of implant success, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are concerns, particularly over cardiac effusion and perforation, device dislodgement, infection, telemetry, and battery issues. Objective The acute performance of the Micra transcatheter pacemaker from a worldwide Post-Approval Registry is reported. Methods The registry is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra in the post-approval setting. The safety end point was system- or procedure-related major complications at 30 days post implant. We compared the major complication rate with that of the 726 patients from the investigational study. Electrical performance was also characterized. Results The device was successfully implanted in 792 of 795 registry patients (99.6%) by 149 implanters at 96 centers in 20 countries. Through 30 days post implant, a total of 13 major complications occurred in 12 patients, for a major complication rate of 1.51% (95% confidence interval, 0.78%–2.62%). Major complications included cardiac effusion/perforation (1, 0.13%), device dislodgement (1, 0.13%), and sepsis (1, 0.13%). After adjusting for baseline differences, the rate of major complications in the registry trended lower than the investigational trial (odds ratio, 0.58, 95% confidence interval, 0.27–1.25; P =.16). Early pacing capture thresholds were low and stable. Conclusion Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high rate (99.6%) of implant success and low rate (1.51%) of major complications through 30 days post implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.

Original languageEnglish
JournalHeart Rhythm
Volume14
Issue number9
Pages (from-to)1375-1379
ISSN1547-5271
DOIs
Publication statusPublished - 2017

Keywords

  • Acute performance
  • Leadless pacemaker
  • Real-world performance

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