A decade of leadless pacemaker implantation: technical performance, safety and device longevity

Background

Leadless pacemakers (L-PM) eliminate the need for transvenous leads and pacemaker pockets, reducing lead-related complications. After more than a decade of clinical use worldwide, real-world data on long-term performance and management of end-of-life devices remain limited. We report a 10-year single-center experience focusing on procedural practice evolution, long-term pacing parameters, safety and battery longevity.

Methods

Single-center prospective registry including all consecutive patients undergoing L-PM implantation from May 2015 to November 2025. Clinical characteristics, procedural data, pacing parameters and estimated battery longevity were collected at implant and at latest follow-up.

Results

The cohort included 447 patients (mean age 78±10 years; 66% male). Successful implantation occurred in 445 patients (99.6%). Main pacing indications were high-grade AV block (64%), atrial fibrillation with pauses (23%), and sinus node disease (7%). Notably, 8% of implants were performed after extraction of an infected conventional system and 17% following transcatheter structural heart procedures.

Procedural efficiency improved over the years, with current mean procedure and fluoroscopy times of 41.1±24.7 min and 4.4±3.8 min. Acute major complications were infrequent: pericardial effusion occurred in 1.2% (one tamponade), and 0.4% required conversion to a transvenous pacemaker (one due to acute L-PM dysfunction and the other due to a small RV cavity). Additionally, two lymphatic access-site complications were reported, one requiring surgical treatment. No device dislodgment occurred.

During a mean follow-up of 2.5 ± 2.3 years, pacing parameters remained stable (threshold: 0.64 to 0.60 mV; R-wave amplitude: 12.3 to 12.5mV). Mean ventricular pacing was 59±39%. Estimated battery longevity was >8 years in 84%. Among those with >5-year follow-up (N=60; mean 6.7±2.4 years), 80% maintained >5 years of predicted longevity. Three upgrades to CRT or LBBAP occurred due to pacing-induced LV dysfunction. One true end-of-life event occurred 6 years post-implant (100% VP, low thresholds), successfully managed with a second L-PM. There were 119 deaths (27%), none device-related.

Conclusion

Over 10 years of experience, L-PM implantation proved to be a robust and safe pacing modality in routine practice, maintaining stable electrical performance and excellent battery durability, with only one device reaching end-of-life. Ongoing follow-up will clarify long-term replacement strategies and lifetime device management in this growing population.