PMID- 38054354
OWN - NLM
STAT- MEDLINE
DCOM- 20240131
LR  - 20240321
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Linking)
VI  - 103
IP  - 2
DP  - 2024 Feb
TI  - Five-year follow-up after percutaneous pulmonary valve implantation using the 
      Venus P-valve system for patients with pulmonary regurgitation and an enlarged 
      native right ventricular outflow tract.
PG  - 359-366
LID - 10.1002/ccd.30916 [doi]
AB  - BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) with the 
      self-expandable Venus P-valve system is a promising treatment for patients with 
      pulmonary regurgitation (PR) and a native right ventricular outflow tract (RVOT). 
      However, limited data is available regarding its midterm outcomes. This study 
      assessed the midterm clinical and echocardiographic outcomes following Venus 
      P-valve implantation. METHODS: From 2013 to 2018, 55 patients with moderate or 
      severe PR after surgical RVOT repair with a transannular or RVOT patch were 
      consecutively enrolled from six hospitals in China. Five-year clinical and 
      echocardiographic outcomes were collected and evaluated. The primary endpoint was 
      a freedom from all-cause mortality and reintervention. RESULTS: At 5 years, the 
      primary endpoint was met for 96% of patients, corresponding to a freedom from 
      all-cause mortality of 96% (95% confidence interval [CI]: 86%-99%) and freedom 
      from reintervention of 98% (95% CI: 87%-100%). Endocarditis was reported in five 
      patients (four patients within 1 year and one patient at 5 years) following PPVI. 
      Transpulmonary gradient and stent orifice diameter remained stable compared to at 
      discharge (p＞0.05). No paravalvular leak was reported while only 1 patient 
      gradually increased to moderate PR during follow-up. Significant improvement of 
      RV diameter and LVEF (p＜0.001) sustained over the 5-year follow-up, in consistent 
      with remarked improved New York Heart Association(NYHA) functional class 
      (p＜0.001). CONCLUSION: The 5-year results of the China VenusP Study demonstrated 
      the midterm benefits of Venus P-valve implantation in the management of patients 
      with severe PR with an enlarged native RVOT by providing sustained symptomatic 
      and hemodynamic improvement.
CI  - (c) 2023 Wiley Periodicals LLC.
FAU - Jin, Qinchun
AU  - Jin Q
AD  - Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, 
      Beijing, China.
AD  - Department of Cardiology, Zhongshan Hospital, Shanghai Institute of 
      Cardiovascular Diseases, Fudan University, Shanghai, China.
FAU - Long, Yuliang
AU  - Long Y
AD  - Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, 
      Beijing, China.
AD  - Department of Cardiology, Zhongshan Hospital, Shanghai Institute of 
      Cardiovascular Diseases, Fudan University, Shanghai, China.
FAU - Zhang, Gejun
AU  - Zhang G
AD  - National Clinical Research Center for Interventional Medicine, Shanghai, China.
FAU - Pan, Xin
AU  - Pan X
AD  - Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, 
      Shanghai, China.
FAU - Chen, Mao
AU  - Chen M
AD  - Department of Cardiology, West China Hospital of Sichuan University, Sichuan, 
      China.
FAU - Feng, Yuan
AU  - Feng Y
AD  - Department of Cardiology, West China Hospital of Sichuan University, Sichuan, 
      China.
FAU - Liu, Jinfen
AU  - Liu J
AD  - Shanghai Children's Medical Center, Shanghai Jiaotong University School of 
      Medicine, Shanghai, China.
FAU - Yu, Shiqiang
AU  - Yu S
AD  - Department of Cardiology, The First Affiliated Hospital of Air Force Medical 
      University, Xi'an, China.
FAU - Pan, Wenzhi
AU  - Pan W
AD  - Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, 
      Beijing, China.
AD  - Department of Cardiology, Zhongshan Hospital, Shanghai Institute of 
      Cardiovascular Diseases, Fudan University, Shanghai, China.
FAU - Zhou, Daxin
AU  - Zhou D
AUID- ORCID: 0000-0002-5709-4189
AD  - Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, 
      Beijing, China.
AD  - Department of Cardiology, Zhongshan Hospital, Shanghai Institute of 
      Cardiovascular Diseases, Fudan University, Shanghai, China.
FAU - Ge, Junbo
AU  - Ge J
AD  - Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, 
      Beijing, China.
AD  - Department of Cardiology, Zhongshan Hospital, Shanghai Institute of 
      Cardiovascular Diseases, Fudan University, Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20231206
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the 
      Society for Cardiac Angiography & Interventions
JID - 100884139
SB  - IM
MH  - Humans
MH  - *Pulmonary Valve Insufficiency/diagnostic imaging/etiology/surgery
MH  - *Pulmonary Valve/diagnostic imaging/surgery
MH  - *Heart Valve Prosthesis Implantation/adverse effects/methods
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis/adverse effects
MH  - Treatment Outcome
MH  - Prosthesis Design
MH  - Cardiac Catheterization/adverse effects/methods
MH  - *Ventricular Outflow Obstruction/diagnostic imaging/etiology/surgery
OTO - NOTNLM
OT  - clinical trials
OT  - pulmonary regurgitation
OT  - transcatheter
EDAT- 2023/12/06 06:42
MHDA- 2024/01/31 06:42
CRDT- 2023/12/06 05:29
PHST- 2023/11/07 00:00 [revised]
PHST- 2022/11/29 00:00 [received]
PHST- 2023/11/09 00:00 [accepted]
PHST- 2024/01/31 06:42 [medline]
PHST- 2023/12/06 06:42 [pubmed]
PHST- 2023/12/06 05:29 [entrez]
AID - 10.1002/ccd.30916 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2024 Feb;103(2):359-366. doi: 10.1002/ccd.30916. Epub 
      2023 Dec 6.