AVJ-514 Trial　- Baseline Characteristics and 30-Day Outcomes Following MitraClip®Treatment in a Japanese Cohort.
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.



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.



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.).
Keio University School of Medicine.
Kentaro
K
Hayashida
National Cerebral and Cardiovascular Center.
Satoshi
S
Yasuda
Sendai Kousei Hospital.
Takashi
T
Matsumoto
National Cerebral and Cardiovascular Center.
Makoto
M
Amaki
Shonan Kamakura General Hospital.
Shingo
S
Mizuno
Sakakibara Heart Institute.
Tetsuya
T
Tobaru
Tokyo Women's Medical University Hospital.
Kentaro
K
Jujo
Sendai Kousei Hospital.
Tatsushi
T
Ootomo
Tokyo Women's Medical University Hospital.
Junichi
J
Yamaguchi
Keio University School of Medicine.
Keiichi
K
Fukuda
Shonan Kamakura General Hospital.
Shigeru
S
Saito
University of California at San Francisco.
Elyse
E
Foster
University of California at San Francisco.
Atif
A
Qasim
National Cerebral and Cardiovascular Center.
Masafumi
M
Kitakaze
Keio University School of Medicine.
Ryohei
R
Yozu
Sakakibara Heart Institute.
Morimasa
M
Takayama
D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods*; D002908:Chronic Disease; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008944:Mitral Valve Insufficiency / Q000503:physiopathology* / Q000601:surgery*; D011446:Prospective Studies; D012307:Risk Factors; D016277:Ventricular Function, Left
30-day outcomes; Japanese patients; Percutaneous mitral valve repair