Elsevier

Heart Rhythm

Volume 17, Issue 12, December 2020, Pages 2023-2028
Heart Rhythm

Clinical
Safety of leadless pacemaker implantation in the very elderly

https://doi.org/10.1016/j.hrthm.2020.05.022Get rights and content

Background

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.

Objectives

The objectives of this study were to report the safety of the MLP and compare MPLs with TVPs in the very elderly.

Methods

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.

Results

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).

Conclusion

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.

Introduction

Permanent pacemakers (PPMs) have been the cornerstone of bradyarrhythmia management since the 1950s. Nearly 80% of pacemakers are implanted in an elderly patient population.1 Although PPM implantation is usually viewed as a low-risk procedure, complication rates have been reported to range between 3.8% and 12.4% and up to 7.4% in elderly patients.2 Many of these complications, such as infection, pneumothorax, lead dislodgment, and pocket hematoma are related to the presence of a transvenous lead and a subcutaneous generator pocket.1,3, 4, 5

The Micra transcatheter pacing system (Medtronic, Minneapolis, MN), a leadless pacemaker, has become an effective alternative to traditional single-chamber transvenous pacemakers (TVPs) in selected patient populations.6, 7, 8 Leadless pacemakers do not require a subcutaneous pocket or use of a transvenous lead, potentially mitigating many of the short- and long-term risks inherent to TVPs, including infection, lead fracture, and venous occlusion. The Micra leadless pacemaker (MLP) has been shown to have an ∼98% rate of freedom from major complications at 6 months from the time of implantation.6,9 However, limited data exist regarding use of the MLP in the very elderly population (85 years and older). For example, the mean age of patients in the landmark LEADLESS II trial and in the U.S. Food and Drug Administration investigational device exemption Micra transcatheter pacing system trial was 75 ± 8 and 75.9 ± 10.9 years, respectively.9,10 There has been concern about the use of the MLP in frail elderly patients because of the size of the implant sheath and the perceived risk of perforation. As the number of elderly patients in need of PPMs continues to grow, it becomes increasingly important to understand the safety of MLP implantation in this population. In this study, we report our experience in this population and compare the procedure-related complication rates between MLPs and TVPs in patients 85 years and older.

Section snippets

Methods

The study was approved by the Institutional Review Board of Northwell Health. Patients 85 years and older from 6 Northwell Health hospitals were included if they received an MLP or a single-chamber TVP between December 2015 and November 2019. Only patients implanted with a single-chamber right ventricular lead were included in the TVP group. Baseline demographic characteristics, antiplatelet and anticoagulant usage at the time of implantation, as well as procedural characteristics including the

Results

Over a 4-year period, 564 patients underwent MLP implantation by 23 electrophysiologists across 6 hospitals in the Northwell Health system. Of these, 183 (32.4%) were implanted in patients 85 years and older by the same electrophysiologists.

Discussion

The present study represents the largest detailed experience of MPLs in the very elderly (85 years and older). The main findings are as follows: (1) MLP implantation was successful in 98.4% of patients; (2) MLP implantation was safe with no difference in procedure-related complications as compared to a TVP group; and (3) implantation of the MLP resulted in significantly shorter procedure times.

There are concerns about using the MLP in frail elderly patients because of the size of the implant

Conclusion

The use of the MLP in patients 85 years and older is safe. We observed a low rate of procedure-related complications that was comparable to a similar cohort of patients who received a traditional TVP. Implanting a leadless pacemaker also resulted in a significantly shorter procedure time. Our results suggest that a leadless pacemaker is a viable alternative to a TVP in the very elderly.

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    Funding sources: The authors have no funding sources to disclose.

    Disclosures: The authors have no conflicts of interest to disclose.

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