Early Performance and Safety of the Micra Transcatheter Pacemaker in Pigs

BackgroundThe Micra (R) Transcatheter Pacing System (TPS; Medtronic Inc., Minneapolis, MN, USA) is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. In this study, the electrical performance was compared between the TPS and a traditional leaded pacemaker. In addition, the safety profile of the two systems was compared by thorough monitoring for a number of adverse events. MethodsThe TPS was implanted in the right ventricular apex of 10 Yucatan mini pigs and a Medtronic single-lead pacemaker (SLP) was implanted in the right ventricular apex of another 10 pigs and connected to a traditional pacemaker. The electrical performance of all devices was monitored for 12 weeks. The safety profile of each system was characterized using x-ray, computed tomography, ultrasound, blood work, and necropsy to monitor for a variety of adverse events. ResultsAt implant the mean pacing thresholds were 0.58 0.17 V @0.24 ms and 0.75 +/- 0.29 V @0.21 ms for the TPS and the SLP respectively. After 12 weeks, mean thresholds were 0.94 +/- 0.46 V and 1.85 +/- 0.75 V (P < 0.0001). There were two pulmonary emboli that were small and past the tertiary branch, and one occurred in each arm. There were also two infections with one in each arm. There were no dislodgements (macro or micro), tissue injury, tamponade, or valve injury. ConclusionsOverall, despite the 10-fold size reduction of the Micra TPS, it appears to perform similarly and have a similar safety profile to a traditional pacemaker system.