PMID- 34719559
OWN - NLM
STAT- MEDLINE
DCOM- 20220414
LR  - 20220414
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 86
IP  - 3
DP  - 2022 Feb 25
TI  - MitraClip Treatment of Moderate-to-Severe and Severe Mitral Regurgitation in High 
      Surgical Risk Patients　- Real-World 1-Year Outcomes From Japan.
PG  - 402-411
LID - 10.1253/circj.CJ-21-0309 [doi]
AB  - BACKGROUND: The MitraClip NT System was approved for marketing in Japan on 
      October 31, 2017, and a prospective, multi-center, single-arm Post-Marketing use 
      Surveillance (PMS) study was launched in 2018. This is the first report of the 
      Japan PMS study with 1-year subject outcomes.Methods and Results:A total of 500 
      patients were registered between April 2018 and January 2019. Patients with 
      symptomatic chronic moderate-to-severe (3+) or severe mitral regurgitation (MR; 
      4+), MR with a Society of Thoracic Surgery (STS) replacement score of >/=8%, or 
      presence of 1 pre-defined risk factor were enrolled. Primary outcome measures 
      included acute procedural success (APS), and rate of Single Leaflet Device 
      Attachment (SLDA) at 30 days. The overall cohort was elderly (77.9+/-9.48 years) 
      with functional MR etiology in 71.6% of the subjects. The majority of subjects 
      were New York Heart Association (NYHA) class III/IV (68.9%), with mean STS 
      replacement score of 11.95+/-9.66%. The APS rate was 91.13% and the 30-day SLDA 
      rate was 1.21%. Durable MR reduction was achieved with 88.1% of subjects at MR 
      </=2+ at 1 year. Significant improvement in the functional capacity was observed, 
      with 93% of subjects at NYHA class I/II at 1 year. CONCLUSIONS: In the Japan PMS 
      experience, the MitraClip procedure resulted in improvements in MR severity, with 
      significantly improved functional outcomes. These results demonstrate safety and 
      efficacy of MitraClip therapy in the eligible Japanese population.
FAU - Matsumoto, Takashi
AU  - Matsumoto T
AD  - Department of Cardiology, Sendai Kousei Hospital.
AD  - Department of Cardiology and Catheterization Laboratories, Shonan Kamakura 
      General Hospital.
FAU - Kubo, Shunsuke
AU  - Kubo S
AD  - Department of Cardiology, Kurashiki Central Hospital.
FAU - Izumo, Masaki
AU  - Izumo M
AD  - Division of Cardiology, Department of Internal Medicine, St. Marianna University 
      School of Medicine.
FAU - Mizuno, Shingo
AU  - Mizuno S
AD  - Department of Cardiology and Catheterization Laboratories, Shonan Kamakura 
      General Hospital.
FAU - Shirai, Shinichi
AU  - Shirai S
AD  - Department of Cardiology, Kokura Memorial Hospital.
CN  - MitraClip Japan PMS Investigators
LA  - eng
PT  - Journal Article
DEP - 20211029
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
SB  - IM
CIN - Circ J. 2022 Feb 25;86(3):412-414. PMID: 34866124
MH  - Aged
MH  - Cardiac Catheterization
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Japan
MH  - *Mitral Valve Insufficiency
MH  - Prospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Mitral regurgitation
OT  - Mitral valve
OT  - Valvular diseases
EDAT- 2021/11/02 06:00
MHDA- 2022/04/15 06:00
CRDT- 2021/11/01 05:59
PHST- 2021/11/02 06:00 [pubmed]
PHST- 2022/04/15 06:00 [medline]
PHST- 2021/11/01 05:59 [entrez]
AID - 10.1253/circj.CJ-21-0309 [doi]
PST - ppublish
SO  - Circ J. 2022 Feb 25;86(3):402-411. doi: 10.1253/circj.CJ-21-0309. Epub 2021 Oct 
      29.