Key result
Single-chamber leadless pacemakers are linked to ~31% fewer complications versus transvenous pacemakers at 5 years.
Why the study?
As single-chamber ventricular leadless pacemakers approach a decade on the market, long-term evidence comparing them to transvenous pacemakers is needed.
Does a single-chamber ventricular leadless pacemaker reduce complications, reinterventions, heart failure hospitalizations, and mortality compared to a transvenous pacemaker in Medicare patients?
Cohort (n=16,431)
Does a single-chamber ventricular leadless pacemaker reduce complications, reinterventions, heart failure hospitalizations, and mortality compared to a transvenous pacemaker in Medicare patients?
Effect estimate: adj. HR 0.69 (95% CI 0.61-0.78)
Absolute Event Rate: 5.9% vs 8%
p-value: p=<0.001
At 5-year follow-up in a Medicare population, single-chamber leadless pacemakers were associated with lower rates of complications, reinterventions, and heart failure hospitalizations compared to traditional transvenous pacemakers.
Adds 5-year Medicare data supporting leadless pacemakers; extends shorter-term findings but leaves practice change open pending RCTs.
Introduction Current evidence shows lower complications and reinterventions from leadless pacemakers compared to traditional transvenous pacemakers. However, as the first widely adopted single-chamber ventricular leadless pacemakers (LP-VVI) approach a decade in the market, there is a need for long-term evidence of leadless pacemakers. Purpose To compare complications, reinterventions, heart failure hospitalizations (HFH), and all-cause mortality at 5 years between LP-VVI and single-chamber ventricular transvenous pacemakers (TV-VVI). Methods This study follows the initial Micra CED Study cohort: Medicare fee-for-services patients implanted with LP-VVI or TV-VVI in 2017 and 2018 for 5 years after implantation. Medicare claims and enrollment data linked to manufacturer device registration information were used to identify de novo implants, patient characteristics, and pre-specified outcomes. Competing risk models adjusted for patient characteristics were used to compare outcomes between leadless and transvenous pacemaker patients. Results 6,219 LP-VVI and 10,212 TV-VVI patients were implanted during the study period. LP-VVI patients had significantly fewer complications and reinterventions compared to TV-VVI patients (complications: adj. rates 5.9% vs. 8.0%, adj. HR 0.69, 95% CI 0.61-0.78, P<0.001, Figure 1; reinterventions: adj. rates 4.9% vs. 7.7%, adj. HR 0.63, 95% CI 0.51-0.78, P<0.001, Figure 2). LP-VVI patients had significantly fewer HFH and upgrades to dual-chamber pacemakers or CRT devices than TV-VVI patients (HFH: adj. rates 24.7% vs. 27.0%, adj. HR 0.90 95% CI 0.84-0.97, P=0.004; upgrades to dual-chamber pacemakers: adj. rates 0.3% vs. 1.0%, adj. HR 0.65 95% CI 0.52-0.82, P=0.013; upgrades to CRT: adj. rates 2.1% vs. 3.1%, adj. HR 0.65 95% CI 0.52-0.82, P<0.001). At 5 years, 114 (4.1%) of surviving LP-VVI patients had their device inactivated. Adjusting for patient characteristics, LP-VVI patients had a lower all-cause mortality rate than TV-VVI patients (adj. rate 60.2% vs. 62.0%, adj. HR 0.95, 95% CI 0.91-1.00, P=0.042; unadj. HR 1.10, 95% CI 1.04-1.17, P=0.002). Conclusions The comparison of outcomes at a 5-year follow-up in a Medicare population shows that leadless pacemakers are associated with a lower rate of chronic complications and reinterventions as compared to single-chamber ventricular leadless pacemakers.
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El-Chami et al. (2025) conducted a cohort in Patients requiring single-chamber ventricular pacemakers (n=16,431). Single-chamber ventricular leadless pacemaker (LP-VVI) vs. Single-chamber ventricular transvenous pacemaker (TV-VVI) was evaluated on Complications (adj. HR 0.69, 95% CI 0.61-0.78, p=<0.001). Single-chamber ventricular leadless pacemakers were associated with significantly fewer complications compared to transvenous pacemakers at 5 years (adj. HR 0.69; 95% CI 0.61-0.78; P<0.001).
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