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

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 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 .