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BACKGROUND: The leadless pacemaking transcatheter system, Micra, is a miniaturized, single-chamber pacemaker system. We report herein our experience with implantation of the Micra TPS system. OBJECTIVE: The current study was conducted to evaluate the safety and efficacy of the leadless Micra Transcatheter Pacemaker System (Medtronic). RESEARCH DESIGN AND METHODS: This was a prospective single centre nonrandomized study without controls. A transcatheter pacemaker was implanted in patients who had guideline based indications for ventricular pacing. 28 subjects were screened based on the selection criteria. Mica TPS was implanted. Parameters assessed were: duration of procedure (from femoral vein puncture to venous access closure), fluoroscopy time, number of device repositions, periprocedural electrical measurements (sensing, threshold and impedance) and in-hospital, intermediate to long term adverse events related to procedure. RESULT AND CONCLUSION: s: The device was successfully implanted in 28 subjects. The mean intraoperative sensing value was 9.04 ± 1.5 mV and the impedance was 766.89 ± 213.9 Ω. At discharge from hospital, those values were 13.2 ± 15.83 mV and 855 ± 111.7, respectively. The recommended pacing threshold value as achieved in all subjects was 0.78 V, i.e. ≤ 1 V at 0.24 ms. There was no adverse event or complications reported for any of the subjects. Mean time from hospitalization to discharge was 1.5 days. Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system.
Kumar et al. (Tue,) studied this question.