PMID- 36773041
OWN - NLM
STAT- MEDLINE
DCOM- 20230526
LR  - 20230527
IS  - 1615-2573 (Electronic)
IS  - 0910-8327 (Print)
IS  - 0910-8327 (Linking)
VI  - 38
IP  - 7
DP  - 2023 Jul
TI  - 1-year outcomes of patients implanted with the Perceval sutureless valve: the 
      Japanese post-marketing surveillance study.
PG  - 949-956
LID - 10.1007/s00380-023-02240-1 [doi]
AB  - Sutureless offers an alternative to standard valves in surgical aortic valve 
      replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval 
      sutureless valve in Japanese patients. Prospective observational study of 204 
      patients who underwent SAVR with Perceval at 19 sites in Japan between March and 
      December 2019. The primary outcomes were 30-day mortality and postoperative 
      complications; the secondary outcome was all-cause mortality at 1 year. Efficacy 
      outcomes were changed in New York Heart Association (NYHA) class, pressure 
      gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) 
      and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. 
      Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary 
      bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 
      (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late 
      mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation 
      rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 
      11.0 mmHg at 1 year; while the mean EOA was 1.5 cm(2) at discharge remaining 
      stable up to 1 year. No moderate or severe leakages were present at discharge or 
      at 1 year. NYHA class improved by >/= 1 level in 55.1% of the patients at discharge 
      and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval 
      sutureless valve in Japanese patients were favorable. This valve offers a 
      promising alternative to conventional biological AVR in this Japanese population.
CI  - (c) 2023. The Author(s).
FAU - Niinami, Hiroshi
AU  - Niinami H
AUID- ORCID: 0000-0002-3713-7372
AD  - Department of Cardiovascular Surgery, The Heart Institute of Japan, Tokyo Women's 
      Medical University Tokyo, Tokyo, Japan. hniinami@twmu.ac.jp.
FAU - Sawa, Yoshiki
AU  - Sawa Y
AD  - Cardiovascular Surgery, Osaka University, Suita, Japan.
FAU - Shimokawa, Tomoki
AU  - Shimokawa T
AD  - Cardiovascular Surgery, Sakakibara Heart Institute Tokyo/Teikyo University, 
      Fuchu, Japan.
FAU - Domoto, Satoru
AU  - Domoto S
AD  - Department of Cardiovascular Surgery, The Heart Institute of Japan, Tokyo Women's 
      Medical University Tokyo, Tokyo, Japan.
FAU - Nakamura, Yoshitsugu
AU  - Nakamura Y
AD  - Cardiovascular Surgery, Chiba-Nishi General Hospital, Matsudo, Japan.
FAU - Sakaguchi, Taichi
AU  - Sakaguchi T
AD  - Cardiovascular Surgery, The Sakakibara Heart Institute of Okayama, Okayama, 
      Japan.
FAU - Ito, Toshiaki
AU  - Ito T
AD  - Cardiovascular Surgery, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, 
      Japan.
FAU - Toda, Koichi
AU  - Toda K
AD  - Cardiovascular Surgery, Osaka University, Suita, Japan.
FAU - Amano, Atsushi
AU  - Amano A
AD  - Cardiovascular Surgery, Juntendo University Hospital, Tokyo, Japan.
FAU - Gersak, Borut
AU  - Gersak B
AD  - Medical Faculty/Nisteri, Medicine and Research, University of Ljubljana, Phoenix, 
      AZ, USA.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20230211
PL  - Japan
TA  - Heart Vessels
JT  - Heart and vessels
JID - 8511258
SB  - IM
MH  - Humans
MH  - Female
MH  - Aged
MH  - Male
MH  - *Heart Valve Prosthesis Implantation/adverse effects
MH  - *Aortic Valve Stenosis/surgery/etiology
MH  - East Asian People
MH  - *Bioprosthesis
MH  - Prosthesis Design
MH  - Aortic Valve/diagnostic imaging/surgery
MH  - *Heart Valve Prosthesis/adverse effects
MH  - *Sutureless Surgical Procedures/adverse effects
MH  - Product Surveillance, Postmarketing
MH  - Treatment Outcome
PMC - PMC10209299
OTO - NOTNLM
OT  - Clinical and hemodynamic outcomes
OT  - Japan
OT  - Sutureless aortic valve
COIS- Hiroshi Niinami, Tomoki Shimokawa, Yoshitsugu Nakamura, Taichi Sakaguchi and 
      Koichi Toda are proctors for CORCYM. Borut Gersak is consultant for CORCYM.
EDAT- 2023/02/12 06:00
MHDA- 2023/05/26 06:42
PMCR- 2023/02/11
CRDT- 2023/02/11 11:12
PHST- 2022/09/11 00:00 [received]
PHST- 2023/01/18 00:00 [accepted]
PHST- 2023/05/26 06:42 [medline]
PHST- 2023/02/12 06:00 [pubmed]
PHST- 2023/02/11 11:12 [entrez]
PHST- 2023/02/11 00:00 [pmc-release]
AID - 10.1007/s00380-023-02240-1 [pii]
AID - 2240 [pii]
AID - 10.1007/s00380-023-02240-1 [doi]
PST - ppublish
SO  - Heart Vessels. 2023 Jul;38(7):949-956. doi: 10.1007/s00380-023-02240-1. Epub 2023 
      Feb 11.