Safety profile, longevity and electrical performances of a novel leadless pacemaker. First results from real-world clinical practice in Italy

Abstract Background Leadless pacemakers (LP) are a promising, safe alternative to transvenous pacemakers (TVP), reducing lead and pocket related complications. LP may improve patient outcomes and comfort. A new LP system became available in 2023 in Europe; it features active fixation with helix, permitting measurement of sensing/pacing parameters before LP deployment and it is upgradable to a dual chamber LP system. Aim Evaluate safety, longevity, electrical performances and clinical outcomes associated with LP implants in Italy. Methods We performed a prospective evaluation of patients who received LP in Italy. Clinical and electrical data were collected at implant and follow-up. A questionnaire on the implant preferences was completed by the physicians. Results 141 patients (67% male, age 74±13 years) were implanted between September 2023 and September 2024 at 10 Italian sites. Pacemaker implant indications were AV-block in the 37%, atrial fibrillation with slow ventricular response in 31%, sinus node disease in the 23% and neurally-mediated syncope in 9% of the subjects. Implant was successful in all attempted cases. Final device position was mid-septum in 52 %, apical septum in the 37%, low septum in the 10%, and RVOT in the 1% of the cases. Mean skin-to-skin procedure time was 40±20 minutes. Mean fluoroscopic time was 7±3 minutes. The final device position was the first fixation site in 92% of the cases; and the first or second fixation site in 99%. No procedure or device-related complications occurred during implants. Median longevity, estimated at implant, was 21 years (interquartile range:15-23 years). At implant, mean R wave sensing was 9±4mV, mean impedance was 722±268Ohm, mean threshold was 0,7±0,3V at 0,4ms. The compression methods were figure of eight in 68%, suture closure system in 25% and simple compression in 7% of cases. Patients were ambulating after 20±6 hours; mean hospitalization time was 4±5 days. Most physicians (73%) choose to implant LP instead of TVP due to patient conditions (high risk of infection in 36%, old age in 14%, post-extraction in 12%, previous infections in 3% and other reasons in 35% of cases) and the remaining 27% choose LP as preferred standard of care. Physicians chose this LP instead of other LP available in the market for upgradability to DR in 57%, for increased battery longevity in 33% and for the possibility of extraction/repositioning in 10% of cases. In a mean follow-up of 28 days, there were no procedure or device-related complications, only one clinical event was reported (new-onset atrial fibrillation treated with anticoagulation therapy), all implanted devices performed as expected, and electrical parameters showed acceptable values. Conclusion First real-world experience of a novel LP in Italy shows optimal feasibility, safety, longevity and electrical performances. Most of the physicians chose to implant this innovative LP due to the upgradability to DR system.Reasons to implant LP instead of TVP.