AVJ-514 trial: Baseline characteristics and 30-day outcomes following mitraclip® treatment in a Japanese cohort

Kentaro Hayashida, Satoshi Yasuda, Takashi Matsumoto, Makoto Amaki, Shingo Mizuno, Tetsuya Tobaru, Kentaro Jujo, Tatsushi Ootomo, Junichi Yamaguchi, Keiichi Fukuda, Shigeru Saito, Elyse Foster, Atif Qasim, Masafumi Kitakaze, Ryohei Yozu, Morimasa Takayama

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: The MitraClip® 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: Patients with symptomatic chronic moderate-to-severe (3+) or severe (4+) functional or degenerative MR with a Society of Thoracic Surgery (STS) score ≥8%, or the presence of 1 predefined risk factor were enrolled. Patients with left ventricular (LV) ejection fraction (EF) <30% were excluded. MR severity and LV function were assessed by an independent echocardiography core lab. Primary outcome included major adverse events (MAE) at 30 days and acute procedural success (APS). A total of 30 patients (age: 80±7 years; STS score: 10.3%±6.6%) were treated with the MitraClip®. 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: The MitraClip® 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.)

Original languageEnglish
Pages (from-to)1116-1122
Number of pages7
JournalCirculation Journal
Volume81
Issue number8
DOIs
Publication statusPublished - 2017

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Mitral Valve Insufficiency
Therapeutics
Thoracic Surgery
Left Ventricular Function
Stroke Volume
Echocardiography
Japan
Quality of Life

Keywords

  • 30-day outcomes
  • Japanese patients
  • Percutaneous mitral valve repair

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Hayashida, K., Yasuda, S., Matsumoto, T., Amaki, M., Mizuno, S., Tobaru, T., ... Takayama, M. (2017). AVJ-514 trial: Baseline characteristics and 30-day outcomes following mitraclip® treatment in a Japanese cohort. Circulation Journal, 81(8), 1116-1122. https://doi.org/10.1253/circj.CJ-17-0115

AVJ-514 trial : Baseline characteristics and 30-day outcomes following mitraclip® treatment in a Japanese cohort. / Hayashida, Kentaro; Yasuda, Satoshi; Matsumoto, Takashi; Amaki, Makoto; Mizuno, Shingo; Tobaru, Tetsuya; Jujo, Kentaro; Ootomo, Tatsushi; Yamaguchi, Junichi; Fukuda, Keiichi; Saito, Shigeru; Foster, Elyse; Qasim, Atif; Kitakaze, Masafumi; Yozu, Ryohei; Takayama, Morimasa.

In: Circulation Journal, Vol. 81, No. 8, 2017, p. 1116-1122.

Research output: Contribution to journalArticle

Hayashida, K, Yasuda, S, Matsumoto, T, Amaki, M, Mizuno, S, Tobaru, T, Jujo, K, Ootomo, T, Yamaguchi, J, Fukuda, K, Saito, S, Foster, E, Qasim, A, Kitakaze, M, Yozu, R & Takayama, M 2017, 'AVJ-514 trial: Baseline characteristics and 30-day outcomes following mitraclip® treatment in a Japanese cohort', Circulation Journal, vol. 81, no. 8, pp. 1116-1122. https://doi.org/10.1253/circj.CJ-17-0115
Hayashida, Kentaro ; Yasuda, Satoshi ; Matsumoto, Takashi ; Amaki, Makoto ; Mizuno, Shingo ; Tobaru, Tetsuya ; Jujo, Kentaro ; Ootomo, Tatsushi ; Yamaguchi, Junichi ; Fukuda, Keiichi ; Saito, Shigeru ; Foster, Elyse ; Qasim, Atif ; Kitakaze, Masafumi ; Yozu, Ryohei ; Takayama, Morimasa. / AVJ-514 trial : Baseline characteristics and 30-day outcomes following mitraclip® treatment in a Japanese cohort. In: Circulation Journal. 2017 ; Vol. 81, No. 8. pp. 1116-1122.
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AU - Mizuno, Shingo

AU - Tobaru, Tetsuya

AU - Jujo, Kentaro

AU - Ootomo, Tatsushi

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AU - Saito, Shigeru

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N2 - Background: The MitraClip® 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: Patients with symptomatic chronic moderate-to-severe (3+) or severe (4+) functional or degenerative MR with a Society of Thoracic Surgery (STS) score ≥8%, or the presence of 1 predefined risk factor were enrolled. Patients with left ventricular (LV) ejection fraction (EF) <30% were excluded. MR severity and LV function were assessed by an independent echocardiography core lab. Primary outcome included major adverse events (MAE) at 30 days and acute procedural success (APS). A total of 30 patients (age: 80±7 years; STS score: 10.3%±6.6%) were treated with the MitraClip®. 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: The MitraClip® 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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