Leadless pacemaker implantation as an alternative to generator replacement in very elderly patients

Background Japan's aging population and the increasing number of pacemaker recipients have led to a rise in pacemaker replacements for the very elderly. However, skin fragility and dementia increase the risk of infection after generator replacement. Leadless pacemakers offer a lower risk of device-related infection; however, evidence on their performance as a substitute for conventional pacemaker generator replacement remains limited. Purpose This study aimed to evaluate the efficacy and safety of leadless pacemaker implantation as a substitute for generator replacement in very elderly patients. Methods From September 2017 to May 2025, 71 consecutive patients underwent leadless pacemaker implantation instead of generator exchange. Baseline characteristics, procedural details, and outcomes were retrospectively analyzed. Results The mean age was 89.6±6.9 years, with 48 females (67.6%) and a mean body mass index of 19.7±3.3 kg/m2. Comorbidities included dialysis in 4 (5.6%), chronic obstructive pulmonary disease in 14 (19.7%), and dementia in 67 (94%). Indications were sick sinus syndrome in 11 (15.5%), bradycardic atrial fibrillation in 27 (38.0%), and atrioventricular block in 33 (46.5%). Devices used were Micra™ in 61 patients and Aveir™ in 10. Mean procedure time was 16.9±6.6 minutes. Paced QRS duration remained essentially unchanged, from 155.7±24.1 ms before LP implantation to 154.5±18.2 ms afterward. Complications occurred in 2 patients (2.8%): one cardiac tamponade managed by pericardiocentesis and one threshold elevation requiring re-implantation. No infections or major vascular complications were observed. Mean hospital stay following implantation was 3.1±1.8 days. Conclusion Leadless pacemaker implantation is a safe and effective alternative to generator replacement in very elderly patients at high risk of infection, while ensuring favorable procedural and clinical outcomes. Furthermore, LP implantation was associated with a shorter time to discharge compared with conventional generator replacement.