The freedom from major complications at 6-month postimplant among the 725 patients with a TPS implant attempt was 96.0%. The percentage of patients with a low and stable pacing capture threshold measured at 6 months post-implant was 98.3%. Similarly, through the 12 months post-implant, the freedom from major complications rate was 96.0% and pacing thresholds remained low and stable throughout the follow-up period. 5 No significant interregional differences have been reported in traditional leaded pacing therapy, but the TPS is a novel device and requires a new implant procedure. The purpose of this study was to compare outcomes in the global study results P ermanent cardiac pacing is the only effective treatment for symptomatic bradycardia, and over 50,000 patients receive pacemakers in Japan annually. 1 Traditional pacemakers consist of an electrical generator and one or more transvenous leads and have a history of over half a century; however, 1 in 8 patients experiences a complication. 2,3 Complications include lead-related complications (2.4-5.5%), pocket-related complications (0.4-4.8%), pneumothorax (0.9-2.2%), or device infection (0.3-0.8%). 2,3 Recently, the Transcatheter Pacing System (TPS, Medtronic plc, MN, USA) was introduced to overcome these lead-and pocket-associated problems. In a prospective global clinical study, including Japanese centers, the TPS was successfully implanted in 99.2% of 725 patients, and met prespecified safety and efficacy criteria. Background: A global study designed to demonstrate the safety and efficacy of a transcatheter pacing system included 38 Japanese patients enrolled at 4 sites. Subgroup analysis to evaluate the performance of the leadless intracardiac transcatheter pacing system in Japanese patients was performed.
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