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).
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?
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.
Effect estimate: adj. HR 0.69 (95% CI 0.61-0.78)
Absolute Event Rate: 5.9% vs 8%
p-value: p=<0.001
Abstract 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, P0.001, Figure 1; reinterventions: adj. rates 4.9% vs. 7.7%, adj. HR 0.63, 95% CI 0.51-0.78, P0.001, 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, P0.001). 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.Figure 1 Figure 2
El-Chami et al. (Sat,) 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).