Catheterization and Cardiovascular Interventions

ORIGINAL ARTICLE - CLINICAL SCIENCE

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

Qinchun Jin MD

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

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Yuliang Long MD,

Yuliang Long MD

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

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Gejun Zhang MD,

Gejun Zhang MD

National Clinical Research Center for Interventional Medicine, Shanghai, China

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Xin Pan MD,

Xin Pan MD

Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China

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Mao Chen MD,

Mao Chen MD

Department of Cardiology, West China Hospital of Sichuan University, Sichuan, China

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Yuan Feng MD,

Yuan Feng MD

Department of Cardiology, West China Hospital of Sichuan University, Sichuan, China

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Jinfen Liu MD,

Jinfen Liu MD

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China

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Shiqiang Yu MD,

Shiqiang Yu MD

Department of Cardiology, The First Affiliated Hospital of Air Force Medical University, Xi'an, China

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Wenzhi Pan MD,

Corresponding Author

Wenzhi Pan MD

[email protected]

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

Correspondence Wenzhi Pan, MD and Daxin Zhou, MD, Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Disease, Fudan University, 180 Fenglin Rd, Shanghai 200032, China.

Email: [email protected] and [email protected]

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Daxin Zhou MD,

Corresponding Author

Daxin Zhou MD

[email protected]

orcid.org/0000-0002-5709-4189

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

Email: [email protected] and [email protected]

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Junbo Ge MD,

Junbo Ge MD

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

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Qinchun Jin MD,

Qinchun Jin MD

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

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Yuliang Long MD,

Yuliang Long MD

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

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Gejun Zhang MD,

Gejun Zhang MD

National Clinical Research Center for Interventional Medicine, Shanghai, China

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Xin Pan MD,

Xin Pan MD

Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China

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Mao Chen MD,

Mao Chen MD

Department of Cardiology, West China Hospital of Sichuan University, Sichuan, China

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Yuan Feng MD,

Yuan Feng MD

Department of Cardiology, West China Hospital of Sichuan University, Sichuan, China

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Jinfen Liu MD,

Jinfen Liu MD

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China

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Shiqiang Yu MD,

Shiqiang Yu MD

Department of Cardiology, The First Affiliated Hospital of Air Force Medical University, Xi'an, China

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Wenzhi Pan MD,

Corresponding Author

Wenzhi Pan MD

[email protected]

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

Email: [email protected] and [email protected]

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Daxin Zhou MD,

Corresponding Author

Daxin Zhou MD

[email protected]

orcid.org/0000-0002-5709-4189

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

Email: [email protected] and [email protected]

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Junbo Ge MD,

Junbo Ge MD

Department of Cardiology, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, Fudan University, Shanghai, China

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First published: 06 December 2023

https://doi.org/10.1002/ccd.30916

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Abstract

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.

CONFLICT OF INTEREST STATEMENT

The authors declare no conflict of interest.

Open Research

DATA AVAILABILITY STATEMENT

The data reported in this study are available upon a valid request from the corresponding author.

REFERENCES

1Baumgartner H, De Backer J, Babu-Narayan SV, et al. 2020 ESC guidelines for the management of adult congenital heart disease. Eur Heart J. 2021; 42(6): 563-645.
10.1093/eurheartj/ehaa554
CAS PubMed Web of Science® Google Scholar
2Chatterjee A, Bajaj NS, McMahon WS, et al. Transcatheter pulmonary valve implantation: A comprehensive systematic review and Meta-Analyses of observational studies. J Am Heart Assoc. 2017; 6(8):e006432.
10.1161/JAHA.117.006432
PubMed Web of Science® Google Scholar
3Martin MH, Meadows J, McElhinney DB, et al. Safety and feasibility of melody transcatheter pulmonary valve replacement in the native right ventricular outflow tract. JACC Cardiovas Interventions. 2018; 11(16): 1642-1650.
10.1016/j.jcin.2018.05.051
PubMed Web of Science® Google Scholar
4Zhou D, Pan W, Jilaihawi H, et al. A self-expanding percutaneous valve for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract: one-year results. EuroIntervention. 2019; 14(13): 1371-1377.
10.4244/EIJ-D-18-00715
PubMed Web of Science® Google Scholar
5Cao QL, Kenny D, Zhou D, et al. Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract. Catheter Cardiovasc Interv. 2014; 84(7): 1131-1137.
10.1002/ccd.25544
PubMed Web of Science® Google Scholar
6Morgan GJ, Sivakumar K, Promphan W, Goreczny S, Prachasilchai P, Qureshi S. Early clinical experience with the straight design of Venus p-valve in dysfunctional right ventricular outflow tracts. Catheter Cardiovasc Interv. 2020; 96(6): E653-E659.
10.1002/ccd.28819
PubMed Web of Science® Google Scholar
7Promphan W, Prachasilchai P, Siripornpitak S, Qureshi SA, Layangool T. Percutaneous pulmonary valve implantation with the Venus P-valve: clinical experience and early results. Cardiol Young. 2016; 26(4): 698-710.
10.1017/S1047951115001067
PubMed Web of Science® Google Scholar
8Houeijeh A, Batteux C, Karsenty C, et al. Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves. Int J Cardiol. 2023; 370: 156-166.
10.1016/j.ijcard.2022.10.141
PubMed Web of Science® Google Scholar
9Shahanavaz S, Zahn EM, Levi DS, et al. Transcatheter pulmonary valve replacement with the sapien prosthesis. J Am Coll Cardiol. 2020; 76(24): 2847-2858.
10.1016/j.jacc.2020.10.041
PubMed Web of Science® Google Scholar
10Jones TK, McElhinney DB, Vincent JA, et al. Long-Term outcomes after melody transcatheter pulmonary valve replacement in the US investigational device exemption trial. Circ Cardiovas Intervent. 2022; 15(1):e010852.
10.1161/CIRCINTERVENTIONS.121.010852
PubMed Web of Science® Google Scholar
11Sinha S, Aboulhosn J, Asnes J, et al. Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: a multi-institutional experience. Catheter Cardiovasc Interv. 2019; 93(3): 455-463.
10.1002/ccd.27973
PubMed Web of Science® Google Scholar
12Morgan G, Prachasilchai P, Promphan W, et al. Medium-term results of percutaneous pulmonary valve implantation using the Venus p-valve: international experience. EuroIntervention. 2019; 14(13): 1363-1370.
10.4244/EIJ-D-18-00299
PubMed Web of Science® Google Scholar
13Gillespie MJ, Bergersen L, Benson LN, Weng S, Cheatham JP. 5-Year outcomes from the harmony native outflow tract early feasibility study. JACC Cardiovas Intervent. 2021; 14(7): 816-817.
10.1016/j.jcin.2021.01.046
PubMed Web of Science® Google Scholar
14Takajo D, Forbes TJ, Kobayashi D. Impact of patient prosthesis mismatch on the outcome of transcatheter pulmonic valve implantation. Am J Cardiol. 2021; 151: 93-99.
10.1016/j.amjcard.2021.04.022
PubMed Web of Science® Google Scholar
15Baddour LM, Cahill TJ, Prendergast BD. Infective endocarditis complicating transcatheter pulmonary valve replacement. J Am Coll Cardiol. 2021; 78(6): 590-593.
10.1016/j.jacc.2021.05.043
PubMed Web of Science® Google Scholar
16Li YJ, Pan X, Wang C, He B. Case report: transcatheter pulmonary valve-in-valve implantation in a deteriorated self-expandable valve caused by infective endocarditis. Front Cardiovasc Med. 2022; 9:939297.
10.3389/fcvm.2022.939297
PubMed Web of Science® Google Scholar
17Cools B, Brown S, Budts W, et al. Up to 11 years of experience with the melody valved stent in the right ventricular outflow tract. EuroIntervention. 2018; 14(9): e988-e994.
10.4244/EIJ-D-18-00054
PubMed Web of Science® Google Scholar

Volume103, Issue2

February 1, 2024

Pages 359-366

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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

Abstract

Background

Methods

Results

Conclusion

CONFLICT OF INTEREST STATEMENT

Open Research

DATA AVAILABILITY STATEMENT

REFERENCES

References

Information

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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

Abstract

Background

Methods

Results

Conclusion

CONFLICT OF INTEREST STATEMENT

Open Research

DATA AVAILABILITY STATEMENT

REFERENCES

References

Related

Information