Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice. (15th October 2022)

• Record Type: Journal Article
• Authors: Palmisano, Pietro; Iacopino, Saverio; De Vivo, Stefano; D'Agostino, Carlo; Tomasi, Luca; Startari, Umberto; Ziacchi, Matteo; Pisanò, Ennio Carmine Luigi; Santobuono, Vincenzo Ezio; Caccavo, Vincenzo Paolo; Sgarito, Giuseppe; Rillo, Mariano; Nicosia, Antonino; Zucchelli, Giulio
• Is Part Of: International journal of cardiology. Volume 365(2022)
• Page Start: 49
• Page End: 56
• Publication Date: 2022-10-15
• Subjects: Leadless pacemaker -- Transvenous pacemaker -- Complications -- Lead-related complications -- Pocket-related complications -- Device infection; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2022.07.040
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: Safety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking. Methods: Consecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded. Results: A total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) ( n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient. Conclusions: In the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence. Highlights: Leadless pacemaker is often reserved for patients at high-risk of infection. Electrical parameters are optimal and remain stable during follow-up. The rate of major device-related complications is low. Peri-procedural management of OAT was consistent with available scientific evidence.