ClinicalSafety of leadless pacemaker implantation in the very elderly
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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Cited by (19)
Effects of atrial tachycardia and dehydration in an elderly patient with a leadless ventricular pacemaker implantation: A case report
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2022, HeartRhythm Case ReportsCitation Excerpt :The leadless pacemaker (LPM) has become an effective alternative to the traditional single-chamber ventricular transvenous pacemaker (PM) in selected patient populations.1 The LPM does not require a subcutaneous pocket or use of a transvenous lead, potentially mitigating many of the short- and long-term risks inherent to transvenous PMs, including infections, lead fractures, and venous occlusions.2 In patients who have a prosthetic tricuspid valve (TV), 5 options can be considered for the PM ventricular lead implantation: implant epicardial leads; implant a standard right ventricular transvenous lead; implant a para-Hisian lead; implant a coronary sinus (CS) lead for left ventricular (LV) pacing only; or implant an LPM.3
Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis
2022, Indian Pacing and Electrophysiology JournalCitation Excerpt :Additional analysis was performed by excluding cohort which had age restrictions. After review of the titles and abstracts from the studies retrieved from the search, a total of 18 studies were included [9,14–30]. ( Supplementary Fig. 1).
Efficacy and Safety of Leadless Pacemaker Implantation in Octogenarians
2023, Cardiology (Switzerland)
Funding sources: The authors have no funding sources to disclose.
Disclosures: The authors have no conflicts of interest to disclose.