AVJ-514 Trial　― Baseline Characteristics and 30-Day Outcomes Following MitraClip<sup>®</sup> Treatment in a Japanese Cohort ―

Kentaro Hayashida(Keio University), Satoshi Yasuda(National Cerebral and Cardiovascular Center), Takashi Matsumoto(Sendai Kousei Hospital), Makoto Amaki(National Cerebral and Cardiovascular Center), Shingo Mizuno(Shonan Kamakura General Hospital), Tetsuya Tobaru(Sakakibara Hospital), Kentaro Jujo(Tokyo Women's Medical University Hospital), Tatsushi Ootomo(Sendai Kousei Hospital), Junichi Yamaguchi(Tokyo Women's Medical University Hospital), Keiichi Fukuda(Keio University), Shigeru Saito(Shonan Kamakura General Hospital), Elyse Foster(University of California, San Francisco), Atif Qasim(University of California, San Francisco), Masafumi Kitakaze(National Cerebral and Cardiovascular Center), Ryohei Yozu(Keio University), Morimasa Takayama(Sakakibara Hospital)
Circulation Journal
January 1, 2017
10.1253/circj.cj-17-0115
Cited by 41Open Access
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Abstract

BACKGROUND: system is a transcatheter-based therapeutic option for patients with chronic mitral regurgitation (MR) who are at high risk for surgery. A prospective, multicenter, single-arm study was initiated to confirm the transferability of this system to Japan. METHODS AND RESULTS: . At baseline, all patients had MR 3+/4+ with 53%/47% patients with degenerative/functional etiology with mean LVEF of 50.2±12.8%, and 37% of patients were NYHA class III/IV. APS was achieved in 86.7% with no occurrence of MAE. At 30 days, 86.7% of patients had MR ≤2+ and 96.7% were NYHA class I/II. CONCLUSIONS: procedure resulted in clinically meaningful improvements in MR severity, function and quality of life measures, and low MAE rates. These early results suggest the transferability of this therapy to appropriately selected Japanese patients. (Trial Registration: clinicaltrials.gov Identifier NCT02520310.).

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