Leadless pacing using the transcatheter pacing system (Micra TPS) in the real world: initial Swiss experience from the Romandie region—Authors’ reply

Leadless pacemakers are implanted in Switzerland since June 2015. Large worldwide registries have shown high implant success, low complication rates, and good electrical parameters up to 12 months' follow-up. However, data are scarce outside the investigational setting. The purpose of this study is to assess the real-world experience regarding clinical safety and efficacy of Micra TPS (transcatheter pacing system) leadless pacemakers. Retrospective observational, multi-centre study designed to assess initial safety and efficacy of the Micra TPS in the Swiss Romande region. A total of 92 patients were included from four different centres with an implantation success rate of 97.8% (90 of 92). Thresholds were overall low at implantation (median 0.38 V/0.24 ms, ranging from 0.13 to 2.88 V/0.24 ms) and remained stable over 1-year follow-up. The perioperative serious adverse event rate was 6.5% in six patients which lead to prolonged hospitalization in five patients and death in one patient. In addition, three further major events (3.3%) occurred during an average follow-up of 1 year, requiring implantation of a standard transvenous pacemaker in two patients, and surgical explantation of the Micra TPS in one patient due to intractable ventricular tachycardia. Leadless pacemakers are a valuable adjunct for treating selected patients requiring single-chamber pacing. However, in this initial experience, major complication rates were high (9.8%). The implant procedure requires proper training and should be performed in an adequate setting.