Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker

Aatish Garg, Jayanthi N. Koneru, Dedra H. Fagan, Kurt Stromberg, Santosh K. Padala, Mikhael F. El-Chami, Paul R. Roberts, Jonathan P. Piccini, Alan Cheng, Kenneth A. Ellenbogen

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. Objective: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. Methods: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. Results: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). Conclusion: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. Clinical Trial Registration: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.

Original languageEnglish (US)
Pages (from-to)2056-2063
Number of pages8
JournalHeart Rhythm
Volume17
Issue number12
DOIs
StatePublished - Dec 2020

Keywords

  • Clinical trials
  • Leadless pacemaker
  • Micra VR
  • Pacemaker complications
  • Transvenous pacemaker

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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