Impact of leadless pacemakers on long-term quality of life: a controlled cohort study

Background Leadless pacemakers (LesPM) have emerged as an alternative to conventional transvenous systems for right ventricular pacing. Although their procedural safety is well documented, much less is known about how these devices influence patients’ day-to-day well-being and overall quality of life (QoL). Objective To examine differences in QoL between individuals implanted with LesPM compared with those receiving traditional single-chamber transvenous pacemakers (ConvPM). Methods Patients undergoing single-chamber pacemaker implantation from December 2020 through May 2025 were prospectively studied. QoL was assessed using the SF-36 instrument at baseline and again at 12 and 36 months. A customized 10-item survey addressing procedure-related sensations, emotional reactions, and functional limitations was also administered. Results The study included 108 patients (54 LesPM; 54 ConvPM). Baseline characteristics were largely similar, aside from age (45.5 vs. 56.6 years; P = 0.023) and diabetes rates (29% vs. 23%; P = 0.021). Initial SF-36 profiles were comparable. By 6 months, the LesPM group showed substantially higher scores for physical functioning (48 vs. 33; P < 0.001), physical role (52 vs. 36; P = 0.004), and mental health (66 vs. 54; P = 0.017), a pattern that persisted after adjustment for covariates. Patients with LesPM also reported less post-procedural discomfort, reduced anxiety, and fewer physical restrictions. Conclusion Compared with conventional pacemakers, leadless systems were associated with more favorable quality-of-life outcomes, reflecting improvements in both physical capability and mental well-being. The reduced procedural discomfort and lower activity limitations observed among LesPM recipients support broader clinical adoption of leadless pacing technology.