3-years follow-up of a new upgradeable leadless pacemaker: steady electrical parameters and long battery life
F B Bokhari, M A Alshehri, C Chami, A G Grammatico, R S SweidanAbstract
Background
Leadless pacemakers (LP) offer an alternative to transvenous systems by reducing lead- and pocket-related complications. A newer generation of a new upgradeable LP introduced in 2022 features active fixation and pre-deployment parameter testing. While early feasibility and safety data have been reported, long-term real-world performances have not been described.
Purpose
To evaluate electrical performance and battery longevity of a new leadless pacemaker over a 3 years follow-up period.
Methods
Prospective registry of all-comer patients implanted with a new leadless pacemaker in two Saudi Arabian centers from December 2022 to October 2023. Electrical parameters (R-wave, impedance, capture threshold) and battery longevity were assessed at implant and at follow-up visits up to 36 months.
Results
Among 54 implanted patients, 42 had follow-up data extending beyond 12 months, with progressive data available up to 36 months. At implant, the mean R-wave amplitude was 8 ± 4 mV, impedance was 724 ± 335 Ω, and capture threshold was 1.0 ± 0.6 V @ 0.4 ms. Mean R-wave sensing improved in the first months of follow-up and then remained stable (11 mV at 12 months, 10 mV at 24 months and 11 mV at 36 months). Mean capture thresholds decreased in the first months of follow-up (0.50 V at 12 months, 0.75 V at 24 months, and 0.50 V at 36 months). Impedance values remained within physiological ranges during follow-up, ranging between 595 Ω and 615 Ω from 12 to 36 months. Battery longevity estimates confirmed long-term durability of the device. The total battery life was 17 ± 5 years at implant, 16 ± 2 years at 12 months, 16 ± 5 years at 24 months, and 15 ± 5 years at 36 months. The longest battery projections at 36 months reached up to 18.4 years, supporting sustained device reliability. No device-related complications or malfunctions were reported after 30 days post-implantation.
Conclusion
This cohort of patients demonstrates sustained electrical stability and good battery longevity for a new leadless pacemaker up to 36 months. Larger cohorts and extended follow-up are needed to confirm long-term performance and safety.