Safety of leadless pacemaker implantation in the very elderly

Abstract

The Micra leadless pacemaker (MLP) has proven to be an effective alternative to a traditional transvenous pacemaker (TVP). However, there has been concern about using the MLP in frail elderly patients because of the size of the implant sheath and perceived risk of perforation. The objectives of this study were to report the safety of the MLP and compare MPLs with TVPs in the very elderly. All patients 85 years and older who received an MLP or a single-chamber TVP across 6 hospitals in the Northwell Health system from December 2015 to November 2019 were included. Demographic characteristics, procedural details, and procedure-related complications were reviewed. Over 4 years, 564 patients underwent MLP implantation. During this time, 183 MLPs and 119 TVPs were implanted in patients 85 years and older. The mean age was 89.7 ± 3.4 years, and 47.4% were men. MLP implantation was successful in all but 3 patients (98.4% success rate). There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276). Complications included 5 (2.7%) access site hematomas in the MLP group, 3 (2.5%) in the TVP group, 1 (0.5 vs 0.8%) pericardial effusion in each group, and 3 (2.5%) acute lead dislodgments (<24 hours) in the TVP group. MLP implantation resulted in a significantly shorter mean procedure time (35.7 ± 23.0 minutes vs 62.3 ± 31.5 minutes, P < .001). In a large multicenter study of patients 85 years and older, MLP implantation (1) was successful in 98.4% of patients, (2) was safe with no difference in procedure-related complications compared to the TVP group, and (3) resulted in significantly shorter procedure times.