Domestic self-expanding interventional pulmonary valve stent in transthoracic implantation for pulmonary valve regurgitation: A prospective cohort study_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

ZHOU Ziqin ^1,2 , HUANG Taoran ^1,3 , ABUDUREXITI Naijimuding ^1,2 , ZHANG Yong ^1,2 , YUAN Haiyun ^1,2 , XIE Nianjin ^1,4 , FEI Hongwen ^1,3 , LIU Hui ^1,5 , ZHUANG Jian ^1,2 , CHEN Jimei ^1,2 ,  WEN Shusheng ^1,2

1. Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, 510080, P. R. China;
2. Department of Cardiovascular Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, P. R. China;
3. Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, P. R. China;
4. Department of Adult Echocardiography, Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, P. R. China;
5. Department of Radiology, Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, P. R. China;

Corresponding?author：

WEN Shusheng, Email: wenshusheng@gdph.org.cn

Keywords：

Self-expanding pulmonary valve stent; pulmonary valve regurgitation; right ventricular outflow tract; right heart function

DOI：

10.7507/1007-4848.202312046

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Objective To analyze and summarize the early and medium-term outcomes of self-expanding interventional pulmonary valve stent (Salus^TM) for right ventricular outflow tract dysfunction with severe pulmonary valve regurgitation. Methods We established strict enrollment and follow-up criteria. Patients who received interventional pulmonary valve in transthoracic implantation in Guangdong Provincial People’s Hospital from September 2, 2021 to July 18, 2023 were prospectively included, and all clinical data of patients were collected and analyzed. Results A total of 38 patients with severe pulmonary regurgitation were included, with 23 (60.5%) males and 15 (39.5%) females. The mean age was 24.08±8.12 years, and the mean weight was 57.66±13.54 kg. The preoperative mean right ventricular end-diastolic volume index (RVEDVI) and right ventricular end-systolic volume index (RVESVI) were 151.83±42.84 mL/m² and 83.34±33.05 mL/m², respectively. All patients successfully underwent transcatheter self-expandable pulmonary valve implantation, with 3 (7.9%) patients experiencing valve stent displacement during the procedure. Perioperative complications included 1 (2.6%) patient of postoperative inferior wall myocardial infarction and 1 (2.6%) patient of poor wound healing. The median follow-up time was 12.00 (6.00, 17.50) months. During the follow-up period, there were no deaths or reinterventions, and no patients had recurrent severe pulmonary regurgitation. Three (7.9%) patients experienced chest tightness and chest pain, and 1 (2.6%) patient developed frequent ventricular premature beats. Compared with preoperative values, the right atrial diameter, right ventricular diameter, and tricuspid annular plane systolic excursion were significantly reduced at 6 months and 1 year postoperatively, with improvement in the degree of pulmonary regurgitation (P<0.01). Compared with preoperative values, RVEDVI and RVESVI decreased to 109.51±17.13 mL/m² and 55.88±15.66 mL/m², respectively, at 1 year postoperatively (P<0.01). Conclusion 　Self-expanding interventional pulmonary valve in transthoracic implantation is safe and effective for severe pulmonary valve regurgitation and shows good clinical and hemodynamic results in one-year outcome.

Citation： ZHOU Ziqin, HUANG Taoran, ABUDUREXITI Naijimuding, ZHANG Yong, YUAN Haiyun, XIE Nianjin, FEI Hongwen, LIU Hui, ZHUANG Jian, CHEN Jimei, WEN Shusheng. Domestic self-expanding interventional pulmonary valve stent in transthoracic implantation for pulmonary valve regurgitation: A prospective cohort study. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(9): 1305-1312. doi: 10.7507/1007-4848.202312046 Copy

1.	Cuypers JA, Menting ME, Konings EE, et al. Unnatural history of tetralogy of Fallot: Prospective follow-up of 40 years after surgical correction. Circulation, 2014, 130(22): 1944-1953.
2.	Ali LA, Gentili F, Festa P, et al. Long-term assessment of clinical outcomes and disease progression in patients with corrected tetralogy of Fallot. Eur Rev Med Pharmacol Sci, 2021, 25(20): 6300-6310.
3.	Ansari MM, Cardoso R, Garcia D, et al. Percutaneous pulmonary valve implantation: Present status and evolving future. J Am Coll Cardiol, 2015, 66(20): 2246-2455.
4.	潘文志, 周達新, 葛均波. 經皮肺動脈瓣植入術的研究進展. 中國醫學前沿雜志(電子版), 2013, 5(6): 24-28.Pan WZ, Zhou DX, Ge JB. Research progress on percutaneous pulmonary valve implantation. Chin J Front Med Sci (Electronic Version), 2013, 5(6): 24-28.
5.	陳峰, 李紅梅, 沈立. 法洛四聯癥根治術后肺動脈瓣置換術研究進展. 中華小兒外科雜志, 2020, 41(1): 5.Chen F, Li HM, Shen L. Research progress on pulmonary valve replacement after radical surgery for tetralogy of Fallot. Chin J Pediatr Surg, 2020, 41(1): 5.
6.	Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: Early phase 1 results from an international multicenter clinical trial. J Am Coll Cardiol, 2011, 58(21): 2248-2256.
7.	Priromprintr B, Silka MJ, Rhodes J, et al. A prospective 5-year study of exercise performance following Melody valve implant. Am Heart J, 2019, 209: 47-53.
8.	Martin MH, Meadows J, McElhinney DB, et al. Safety and feasibility of melody transcatheter pulmonary valve replacement in the native right ventricular outflow tract: A multicenter pediatric heart network scholar study. JACC Cardiovasc Interv, 2018, 11(16): 1642-1650.
9.	Lurz P, Kister T. Why we need another percutaneous pulmonary valve: If size matters. EuroIntervention, 2019, 14(13): 1347-1349.
10.	黃穎, 周子秦, 張勇, 等. 自膨式介入肺動脈瓣經胸植入術的早期結果. 中國胸心血管外科臨床雜志, 2024, 31(6): 872-877.Huang Y, Zhou ZQ, Zhang Y, et al. Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation. Chin J Clin Thorac Cardiovasc Surg, 2024, 31(6): 872-877.
11.	Zoghbi WA, Jone PN, Chamsi-pasha MA, et al. Guidelines for the evaluation of prosthetic valve function with cardiovascular imaging: A report From the American Society of Echocardiography Developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society of Cardiovascular Computed Tomography. J Am Soc Echocardiogr, 2024, 37(1): 2-63.
12.	Lee C, Choi ES, Lee CH. Long-term outcomes of pulmonary valve replacement in patients with repaired tetralogy of Fallot. Eur J Cardiothorac Surg, 2020, 58(2): 246-252.
13.	Gillespie MJ, McElhinney DB, Jones TK, et al. 1-year outcomes in a pooled cohort of harmony transcatheter pulmonary valve clinical trial participants. JACC Cardiovasc Interv, 2023, 16(15): 1917-1928.
14.	Qureshi AM, Bansal N, McElhinney DB, et al. Branch pulmonary artery valve implantation reduces pulmonary regurgitation and improves right ventricular size/function in patients with large right ventricular outflow tracts. JACC Cardiovasc Interv, 2018, 11(6): 541-550.
15.	Kim GB, Song MK, Bae EJ, et al. Successful feasibility human trial of a new self-expandable percutaneous pulmonary valve (Pulsta valve) implantation using knitted nitinol wire backbone and trileaflet α-gal-free porcine pericardial valve in the native right ventricular outflow tract. Circ Cardiovasc Interv, 2018, 11(6): e006494.
16.	Zhou 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.
17.	Morgan 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.
18.	Virk SA, Liou K, Chandrakumar D, et al. Percutaneous pulmonary valve implantation: A systematic review of clinical outcomes. Int J Cardiol, 2015, 201: 487-489.
19.	McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: Patient-related and procedural risk factors in the US Melody valve tial. Circ Cardiovasc Interv, 2011, 4(6): 602-614.
20.	McElhinney DB, Sondergaard L, Armstrong AK, et al. Endocarditis after transcatheter pulmonary valve replacement. J Am Coll Cardiol, 2018, 72(22): 2717-2728.
21.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
22.	Fraisse A, Aldebert P, Malekzadeh-Milani S, et al. Melody? transcatheter pulmonary valve implantation: Results from a French registry. Arch Cardiovasc Dis, 2014, 107(11): 607-614.

1. Cuypers JA, Menting ME, Konings EE, et al. Unnatural history of tetralogy of Fallot: Prospective follow-up of 40 years after surgical correction. Circulation, 2014, 130(22): 1944-1953.
2. Ali LA, Gentili F, Festa P, et al. Long-term assessment of clinical outcomes and disease progression in patients with corrected tetralogy of Fallot. Eur Rev Med Pharmacol Sci, 2021, 25(20): 6300-6310.
3. Ansari MM, Cardoso R, Garcia D, et al. Percutaneous pulmonary valve implantation: Present status and evolving future. J Am Coll Cardiol, 2015, 66(20): 2246-2455.
4. 潘文志, 周達新, 葛均波. 經皮肺動脈瓣植入術的研究進展. 中國醫學前沿雜志(電子版), 2013, 5(6): 24-28.Pan WZ, Zhou DX, Ge JB. Research progress on percutaneous pulmonary valve implantation. Chin J Front Med Sci (Electronic Version), 2013, 5(6): 24-28.
5. 陳峰, 李紅梅, 沈立. 法洛四聯癥根治術后肺動脈瓣置換術研究進展. 中華小兒外科雜志, 2020, 41(1): 5.Chen F, Li HM, Shen L. Research progress on pulmonary valve replacement after radical surgery for tetralogy of Fallot. Chin J Pediatr Surg, 2020, 41(1): 5.
6. Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: Early phase 1 results from an international multicenter clinical trial. J Am Coll Cardiol, 2011, 58(21): 2248-2256.
7. Priromprintr B, Silka MJ, Rhodes J, et al. A prospective 5-year study of exercise performance following Melody valve implant. Am Heart J, 2019, 209: 47-53.
8. Martin MH, Meadows J, McElhinney DB, et al. Safety and feasibility of melody transcatheter pulmonary valve replacement in the native right ventricular outflow tract: A multicenter pediatric heart network scholar study. JACC Cardiovasc Interv, 2018, 11(16): 1642-1650.
9. Lurz P, Kister T. Why we need another percutaneous pulmonary valve: If size matters. EuroIntervention, 2019, 14(13): 1347-1349.
10. 黃穎, 周子秦, 張勇, 等. 自膨式介入肺動脈瓣經胸植入術的早期結果. 中國胸心血管外科臨床雜志, 2024, 31(6): 872-877.Huang Y, Zhou ZQ, Zhang Y, et al. Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation. Chin J Clin Thorac Cardiovasc Surg, 2024, 31(6): 872-877.
11. Zoghbi WA, Jone PN, Chamsi-pasha MA, et al. Guidelines for the evaluation of prosthetic valve function with cardiovascular imaging: A report From the American Society of Echocardiography Developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society of Cardiovascular Computed Tomography. J Am Soc Echocardiogr, 2024, 37(1): 2-63.
12. Lee C, Choi ES, Lee CH. Long-term outcomes of pulmonary valve replacement in patients with repaired tetralogy of Fallot. Eur J Cardiothorac Surg, 2020, 58(2): 246-252.
13. Gillespie MJ, McElhinney DB, Jones TK, et al. 1-year outcomes in a pooled cohort of harmony transcatheter pulmonary valve clinical trial participants. JACC Cardiovasc Interv, 2023, 16(15): 1917-1928.
14. Qureshi AM, Bansal N, McElhinney DB, et al. Branch pulmonary artery valve implantation reduces pulmonary regurgitation and improves right ventricular size/function in patients with large right ventricular outflow tracts. JACC Cardiovasc Interv, 2018, 11(6): 541-550.
15. Kim GB, Song MK, Bae EJ, et al. Successful feasibility human trial of a new self-expandable percutaneous pulmonary valve (Pulsta valve) implantation using knitted nitinol wire backbone and trileaflet α-gal-free porcine pericardial valve in the native right ventricular outflow tract. Circ Cardiovasc Interv, 2018, 11(6): e006494.
16. Zhou 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.
17. Morgan 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.
18. Virk SA, Liou K, Chandrakumar D, et al. Percutaneous pulmonary valve implantation: A systematic review of clinical outcomes. Int J Cardiol, 2015, 201: 487-489.
19. McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: Patient-related and procedural risk factors in the US Melody valve tial. Circ Cardiovasc Interv, 2011, 4(6): 602-614.
20. McElhinney DB, Sondergaard L, Armstrong AK, et al. Endocarditis after transcatheter pulmonary valve replacement. J Am Coll Cardiol, 2018, 72(22): 2717-2728.
21. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
22. Fraisse A, Aldebert P, Malekzadeh-Milani S, et al. Melody? transcatheter pulmonary valve implantation: Results from a French registry. Arch Cardiovasc Dis, 2014, 107(11): 607-614.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Domestic self-expanding interventional pulmonary valve stent in transthoracic implantation for pulmonary valve regurgitation: A prospective cohort study

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