Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice

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.