PMID- 30398963
OWN - NLM
STAT- MEDLINE
DCOM- 20190730
LR  - 20190730
IS  - 1969-6213 (Electronic)
IS  - 1774-024X (Linking)
VI  - 14
IP  - 13
DP  - 2019 Jan 20
TI  - A self-expanding percutaneous valve for patients with pulmonary regurgitation and 
      an enlarged native right ventricular outflow tract: one-year results.
PG  - 1371-1377
LID - EIJ-D-18-00715 [pii]
LID - 10.4244/EIJ-D-18-00715 [doi]
AB  - AIMS: The aim of the study was to evaluate the midterm safety and efficacy of a 
      self-expanding valve (Venus P-valve) in the treatment of patients with pulmonary 
      regurgitation and a native right ventricular outflow tract (RVOT) in China. 
      METHODS AND RESULTS: Patients who had moderate or severe pulmonary regurgitation 
      after surgical repair of the RVOT with a transannular or RVOT patch were included 
      in the study. Fifty-five patients (67% female; average age 28.7+/-12.4 years) from 
      six different hospitals in China were enrolled. The procedure success rate was 
      98.2%. In the one failure, the patient experienced valve dislodgement two days 
      after the procedure. During the 12-month follow-up, two patients died, one due to 
      infective endocarditis. Three other patients developed infective endocarditis. 
      Two patients developed atrial flutter, and one patient had a pulmonary embolism. 
      Echocardiography examinations at 12 months showed that two patients had mild 
      pulmonary regurgitation, and 19 patients had trace pulmonary regurgitation. No 
      paravalvular regurgitation occurred. The mean peak pulmonary gradient was 
      16.3+/-7.4 (range 4-38) mmHg. Compared with the baseline data, the right 
      ventricular end-diastolic volume index (RVEDVI) was reduced from 137.6+/-15.8 mL/m2 
      to 83.9+/-16.0 mL/m2 (p<0.001), and the New York Heart Association (NYHA) class was 
      significantly improved (p<0.01). CONCLUSIONS: The one-year results of the China 
      Venus P-valve study show considerable promise for a hitherto unmet need in 
      patients with pulmonary regurgitation and an enlarged native RVOT.
FAU - Zhou, Daxin
AU  - Zhou D
AD  - Zhongshan Hospital of Fudan University, Shanghai, China.
FAU - Pan, Wenzhi
AU  - Pan W
FAU - Jilaihawi, Hasan
AU  - Jilaihawi H
FAU - Zhang, Gejun
AU  - Zhang G
FAU - Feng, Yuan
AU  - Feng Y
FAU - Pan, Xin
AU  - Pan X
FAU - Liu, Jinfen
AU  - Liu J
FAU - Yu, Shiqiang
AU  - Yu S
FAU - Cao, Qiling
AU  - Cao Q
FAU - Ge, Junbo
AU  - Ge J
LA  - eng
PT  - Journal Article
PL  - France
TA  - EuroIntervention
JT  - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on 
      Interventional Cardiology of the European Society of Cardiology
JID - 101251040
MH  - Adolescent
MH  - Adult
MH  - China
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Male
MH  - *Pulmonary Valve
MH  - *Pulmonary Valve Insufficiency
MH  - Treatment Outcome
MH  - *Ventricular Outflow Obstruction
MH  - Young Adult
EDAT- 2018/11/07 06:00
MHDA- 2019/07/31 06:00
CRDT- 2018/11/07 06:00
PHST- 2018/11/07 06:00 [pubmed]
PHST- 2019/07/31 06:00 [medline]
PHST- 2018/11/07 06:00 [entrez]
AID - EIJ-D-18-00715 [pii]
AID - 10.4244/EIJ-D-18-00715 [doi]
PST - ppublish
SO  - EuroIntervention. 2019 Jan 20;14(13):1371-1377. doi: 10.4244/EIJ-D-18-00715.