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

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Garg, A; Koneru, JN; Fagan, DH; Stromberg, K; Padala, SK; El-Chami, MF; Roberts, PR; Piccini, JP; Cheng, A; Ellenbogen, KA

Published Date

  • December 2020

Published In

Volume / Issue

  • 17 / 12

Start / End Page

  • 2056 - 2063

PubMed ID

  • 32763431

Electronic International Standard Serial Number (EISSN)

  • 1556-3871

Digital Object Identifier (DOI)

  • 10.1016/j.hrthm.2020.07.035

Language

  • eng

Conference Location

  • United States