Key result
Early-phase leadless pacemaker implantation linked to ~175% higher six-month mortality versus recent-phase.
Why the study?
With more recent leadless pacemakers offering VDD/DDD functionality widening clinical indications, it was unknown how patient characteristics and mid-term outcomes changed over time.
How do patient profiles and six-month mortality differ between early and recent experiences with leadless pacemaker implantation?
Cohort (n=174)
No
How do patient profiles and six-month mortality differ between early and recent experiences with leadless pacemaker implantation?
The evolution of leadless pacemaker technology to include VDD functionality has broadened its use to younger patients and those with AV block, accompanied by improved six-month survival.
Early-cohort implantation associated with higher mortality; leaves open whether experience or selection bias drives outcomes.
Background Leadless pacemakers (LLPM) obtained regulatory approval in Japan in 2017. Initially used in a limited population (VVI-only), more recent devices with VDD/DDD functionality have widened the indication. We examined the change in patient background and outcomes for LLPM implantation in our institution over time. Purpose To compare patient characteristics and mid-term outcomes of LLPM recipients in our institution in the early-introduction phase versus the current phase. Methods Between February 2018 and March 2025, 174 patients underwent LLPM implantation at our center. We divided them into an early cohort (February 2018–December 2021; n = 72) and a recent cohort (January 2022–March 2025; n = 100). We compared baseline age, indication for implantation, procedure time, and six-month post-implant mortality between groups. Results Mean age was significantly higher in the early cohort (87.8 ± 11.5 years) than in the recent cohort (84.2 ± 10.0 years; p = 0.034). The implantation indications were: atrial fibrillation with bradycardia in 23 patients (32 %) in the early cohort vs 19 patients (19 %) in the recent cohort; atrioventricular (AV) block in 33 (46 %) vs 55 (55 %); sick sinus syndrome in 29 (40 %) vs 37 (37 %) respectively. Procedure time was 75.6 ± 24.7 minutes in the early cohort vs 80.1 ± 24.1 minutes in the recent cohort (p = 0.28). Six-month mortality after implantation was 16 in the early cohort vs 10 in the recent cohort (odds ratio 2.75; 95 % CI, 1.09–6.06; p = 0.046). Implantation in patients aged ≤ 60 was rare (early 1 patient; recent 3 patients). Conclusion In our center, LLPM implantation in the early phase was performed in an older patient population, whereas in the recent phase there has been a shift toward increased use for AV block and broader patient profiles. This change may reflect growing evidence for the efficacy of LLPM in less advanced age groups and the availability of VDD-capable LLPM since 2022. As pacing device technology continues to evolve, the eligible patient population will keep changing — proactive engagement with new technologies remains essential for optimal patient care.
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Kajiwara et al. (2026) conducted a cohort in Bradycardia, atrioventricular block, or sick sinus syndrome requiring pacing (n=174). Early-phase leadless pacemaker implantation (2018-2021) vs. Recent-phase leadless pacemaker implantation (2022-2025) was evaluated on Six-month mortality after implantation (OR 2.75, 95% CI 1.09-6.06, p=0.046). Early-phase leadless pacemaker implantation was associated with higher six-month mortality compared to recent-phase implantation (22.2% vs 10.0%; OR 2.75; 95% CI 1.09-6.06; p=0.046).
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