Safety of leadless pacemaker implantation in centers with and without on-site cardiac surgery: a real-world multicenter experience

Background Guidelines and regulatory agencies often recommend that leadless pacemaker (LP) implantation is performed in centers with on-site cardiac surgery, due to concerns regarding potential cardiac perforation and tamponade. However, real-world data suggest that the risk of major complications is low, and that appropriately trained teams, with a predefined protocol for the management of tamponade, may safely perform LP implantations even in centers without surgical backup. Aims To compare procedural safety and management of pericardial tamponade in patients undergoing LP (Micra™ Transcatheter Pacing System) implantation in centers with and without cardiac surgery. Methods We analyzed 2,612 consecutive patients implanted with a Micra device across 30 Italian centers participating in the One Hospital Clinical Service project. Fifteen centers had on-site cardiac surgery (CS group, n =1570, 60.1%), while fifteen did not (non-CS group, n = 1042, 39,9%). Baseline characteristics were comparable between groups (mean age = 75.9 ± 9 years; 66.7% male; 27.5% with diabetes, 71,9 with history of hypertension). Procedural success and acute complications were recorded and adjudicated by the local implanting teams. Results Procedural success was achieved in 99.8% of cases. A total of 8 pericardial tamponades/effusion (0.31%) occurred: 4 (0.32%) in the CS group and 4 (0.38%) in the non-CS group, p=0.56. In CS centers, three out of four tamponades were managed with pericardiocentesis, and one patient required surgical repair of a right ventricular breach. The fourth patient was hemodynamically stable, thus managed with echocardiographic monitoring, and fully recovered. In non-CS centers, three patients were successfully treated with pericardiocentesis and on-site hemodynamic stabilization, while one patient was transferred to a surgical facility after stabilization, in accordance with the local protocol for tamponade management. The last patient was clinically asymptomatic and therefore managed conservatively, although a small effusion was visible under fluoroscopy. Patients experiencing tamponade had a mean age of 83.5 ± 7 years, were predominantly female (75%) and had an average of 1.7 comorbidities (mainly hypertension and diabetes). No deaths were reported. Conclusion This large, real-world multicenter experience demonstrates that LP implantation can be performed safely both in centers with and without cardiac surgery. The presence of structured training programs and a clearly defined protocol for tamponade management, are key to ensuring procedural safety even in non-surgical centers. The incidence of tamponade (0.3%) aligns with that reported in contemporary clinical trials, supporting the extension of LP implantation to qualified centers without surgical backup