Key result
Leadless pacemakers yield 100% freedom from major complications at 6 months in young adults.
Why the study?
Leadless pacing is an alternative to conventional pacemakers but its use in young adults remains controversial due to limited experience in this population.
Is the implantation of a leadless single chamber pacemaker safe and effective in young adults (18-40 years)?
Observational (n=35)
Yes
Is the implantation of a leadless single chamber pacemaker safe and effective in young adults (18-40 years)?
Leadless pacemakers demonstrate favorable short- and intermediate-term safety and effectiveness in young adults aged 18-40 years.
Supports short-term safety of leadless pacemakers in young adults; leaves open long-term durability and replacement needs.
AIMS: Leadless pacing has emerged as an alternative to conventional transvenous pacemakers to mitigate the risks of pocket- and lead-related complications but its use remains controversial in young adults mostly because experience in this patient population is limited. We sought to examine the feasibility and safety of implanting leadless single chamber pacemakers in young adults. METHODS: This multicenter, retrospective, observational study sought to evaluate the safety, efficacy, and electrical performance of the Micra VR Transcatheter Pacemaker System (Medtronic) in patients between 18 and 40 years who underwent implantation of a leadless pacemaker for any indication at the university medical centers of Bordeaux, Clermont-Ferrand, Toulouse, and Tours (France), between 2015 and 2021. The primary safety endpoint was freedom from system-related or procedure-related major complications at 6 months. The primary efficacy endpoint was the combination of a low (≤2 V) and stable (increase within 1.5 V) pacing capture threshold at 6 months. RESULTS: Leadless pacemaker implantation was successful in all 35 patients. At 6 months, safety endpoint was met for 35 (100%) and efficacy endpoint for 34 (97%) patients. During a follow-up of 26 ± 15 months (range: 6-60 months), Safety endpoint remained 100% and efficacy endpoint was 94%. Leadless pacemaker retrieval was not required in any patient. Approximately one-third of patients (n = 13, 37%) had >40% ventricular pacing burdens at 1 year, including all 10 patients with a complete AV block but also 3 patients with normal AV conduction during implantation. One patient reported symptoms of pacemaker syndrome which was confirmed using Holter recording and successfully treated using reprogramming. CONCLUSION: In this observational study, leadless pacemakers demonstrated favorable short- and intermediate-term safety and effectiveness in young adults.
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Strik et al. (2022) conducted an observational in Pacemaker indication (n=35). Micra VR Transcatheter Pacemaker System was evaluated on Freedom from system-related or procedure-related major complications at 6 months. Implantation of a leadless pacemaker in young adults achieved 100% freedom from major complications and 97% stable pacing capture thresholds at 6 months.
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