Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation: A prospective clinical study_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

HUANG Ying ¹ , ZHOU Ziqin ¹ , ZHANG Yong ¹ , LI Xiaohua ¹ , XIE Nianjin ² , FEI Hongwen ³ , LIU Hui ⁴ , ZHAO Junfei ¹ , ZHUANG Jian ¹ , CHEN Jimei ¹ ,  WEN Shusheng ¹

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

Transthoracic implantation; self-expanding pulmonary valve; pulmonary regurgitation; right ventricular outflow tract

DOI：

10.7507/1007-4848.202212049

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Objective To evaluate early outcomes of transthoracic pulmonary valve implantation for the treatment of moderate and severe pulmonary regurgitation by using homemade self-expanding valve (Salus^TM). Methods Patients with severe pulmonary regurgitation who underwent transthoracic pulmonary valve implantation in Guangdong Provincial People’s Hospital from September 2, 2021 to November 25, 2022 were prospectively enrolled. The early postoperative complications and improvement of valve and heart function were summarized and analyzed. Results A total of 25 patients were enrolled, including 16 males and 9 females, with an average age of 24.5±1.5 years and an average weight of 57.0±3.0 kg. The mean systolic diameters of the bifurcation near the main pulmonary artery, the stenosis of the middle segment of the aorta and near the valve of the right ventricular outflow tract of the patients were 31.8±7.4 mm, 30.6±5.9 mm and 38.4±8.0 mm, respectively. All patients were successfully implanted with valves, and there were no serious complications such as death, coronary compression, stent fracture, valve displacement and infective endocarditis in the early postoperative period. The indexed left atrial longitudinal diameter, indexed right atrial longitudinal diameter, and indexed right ventricular outflow tract anteroposterior diameter decreased significantly after the operation. The degree of tricuspid and pulmonary valve regurgitation and the indexed regurgitation area decreased significantly. The above differences were statistically significant (P<0.05). Conclusion The early outcomes of transthoracic pulmonary valve implantation with homemade self-expanding pulmonary valve (Salus^TM) in the treatment of severe pulmonary regurgitation is relatively good, and the long-term outcomes need to be verified by the long-term follow-up studies with large samples.

Citation： HUANG Ying, ZHOU Ziqin, ZHANG Yong, LI Xiaohua, XIE Nianjin, FEI Hongwen, LIU Hui, ZHAO Junfei, ZHUANG Jian, CHEN Jimei, WEN Shusheng. Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation: A prospective clinical study. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(6): 872-877. doi: 10.7507/1007-4848.202212049 Copy

1.	Park CS, Lee JR, Lim HG, et al. The long-term result of total repair for tetralogy of Fallot. Eur J Cardiothorac Surg, 2010, 38(3): 311-317.
2.	Frigiola A, Redington AN, Cullen S, et al. Pulmonary regurgitation is an important determinant of right ventricular contractile dysfunction in patients with surgically repaired tetralogy of Fallot. Circulation, 2004, 110(11 Suppl 1): Ⅱ153-Ⅱ157.
3.	Mikhail A, Labbio GD, Darwish A, et al. How pulmonary valve regurgitation after tetralogy of Fallot repair changes the flow dynamics in the right ventricle: An in vitro study. Med Eng Phys, 2020, 83: 48-55.
4.	Shahanavaz S, Qureshi AM, Levi DS, et al. Transcatheter pulmonary valve replacement with the melody valve in small diameter expandable right ventricular outflow tract conduits. JACC Cardiovasc Interv, 2018, 11(6): 554-564.
5.	Alkashkari W, Alsubei A, Hijazi ZM. Transcatheter pulmonary valve replacement: Current state of art. Curr Cardiol Rep, 2018, 20(4): 27.
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.	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.
8.	Lurz P, Kister T. Why we need another percutaneous pulmonary valve: If size matters. EuroIntervention, 2019, 14(13): 1347-1349.
9.	Jones TK, McElhinney DB, Vincent JA, et al. Long-term outcomes after melody transcatheter pulmonary valve replacement in the US investigational device exemption trial. Circ Cardiovasc Interv, 2022, 15(1): e010852.
10.	Kenny D, Rhodes JF, Fleming GA, et al. 3-year outcomes of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position from the COMPASSION multicenter clinical trial. JACC Cardiovasc Interv, 2018, 11(19): 1920-1929.
11.	Hribernik I, Thomson J, Ho A, et al. Comparative analysis of surgical and percutaneous pulmonary valve implants over a 20-year period. Eur J Cardiothorac Surg, 2022, 61(3): 572-579.
12.	Zahn EM, Hellenbrand WE, Lock JE, et al. Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the US clinical trial. J Am Coll Cardiol, 2009, 54(18): 1722-1729.
13.	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.
14.	Shang X, Dong N, Zhang C, et al. The clinical trial outcomes of Med-Zenith PT-Valve in the treatment of patients with severe pulmonary regurgitation. Front Cardiovasc Med, 2022, 9: 887886.
15.	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.
16.	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.
17.	Morray BH, McElhinney DB, Cheatham JP, et al. Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation: A multicenter experience. Circ Cardiovasc Interv, 2013, 6(5): 535-542.
18.	Cardoso R, Ansari M, Garcia D, et al. Prestenting for prevention of melody valve stent fractures: A systematic review and meta-analysis. Catheter Cardiovasc Interv, 2016, 87(3): 534-539.
19.	Lehner A, Haas NA, Dietl M, et al. The risk of infective endocarditis following interventional pulmonary valve implantation: A meta-analysis. J Cardiol, 2019, 74(3): 197-205.
20.	Abdelghani M, Nassif M, Blom NA, et al. Infective endocarditis after melody valve implantation in the pulmonary position: A systematic review. J Am Heart Assoc, 2018, 7(13): e008163.
21.	Jalal Z, Galmiche L, Beloin C, et al. Impact of percutaneous pulmonary valve implantation procedural steps on leaflets histology and mechanical behaviour: An in vitro study. Arch Cardiovasc Dis, 2016, 109(8-9): 465-475.

1. Park CS, Lee JR, Lim HG, et al. The long-term result of total repair for tetralogy of Fallot. Eur J Cardiothorac Surg, 2010, 38(3): 311-317.
2. Frigiola A, Redington AN, Cullen S, et al. Pulmonary regurgitation is an important determinant of right ventricular contractile dysfunction in patients with surgically repaired tetralogy of Fallot. Circulation, 2004, 110(11 Suppl 1): Ⅱ153-Ⅱ157.
3. Mikhail A, Labbio GD, Darwish A, et al. How pulmonary valve regurgitation after tetralogy of Fallot repair changes the flow dynamics in the right ventricle: An in vitro study. Med Eng Phys, 2020, 83: 48-55.
4. Shahanavaz S, Qureshi AM, Levi DS, et al. Transcatheter pulmonary valve replacement with the melody valve in small diameter expandable right ventricular outflow tract conduits. JACC Cardiovasc Interv, 2018, 11(6): 554-564.
5. Alkashkari W, Alsubei A, Hijazi ZM. Transcatheter pulmonary valve replacement: Current state of art. Curr Cardiol Rep, 2018, 20(4): 27.
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. 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.
8. Lurz P, Kister T. Why we need another percutaneous pulmonary valve: If size matters. EuroIntervention, 2019, 14(13): 1347-1349.
9. Jones TK, McElhinney DB, Vincent JA, et al. Long-term outcomes after melody transcatheter pulmonary valve replacement in the US investigational device exemption trial. Circ Cardiovasc Interv, 2022, 15(1): e010852.
10. Kenny D, Rhodes JF, Fleming GA, et al. 3-year outcomes of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position from the COMPASSION multicenter clinical trial. JACC Cardiovasc Interv, 2018, 11(19): 1920-1929.
11. Hribernik I, Thomson J, Ho A, et al. Comparative analysis of surgical and percutaneous pulmonary valve implants over a 20-year period. Eur J Cardiothorac Surg, 2022, 61(3): 572-579.
12. Zahn EM, Hellenbrand WE, Lock JE, et al. Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the US clinical trial. J Am Coll Cardiol, 2009, 54(18): 1722-1729.
13. 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.
14. Shang X, Dong N, Zhang C, et al. The clinical trial outcomes of Med-Zenith PT-Valve in the treatment of patients with severe pulmonary regurgitation. Front Cardiovasc Med, 2022, 9: 887886.
15. 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.
16. 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.
17. Morray BH, McElhinney DB, Cheatham JP, et al. Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation: A multicenter experience. Circ Cardiovasc Interv, 2013, 6(5): 535-542.
18. Cardoso R, Ansari M, Garcia D, et al. Prestenting for prevention of melody valve stent fractures: A systematic review and meta-analysis. Catheter Cardiovasc Interv, 2016, 87(3): 534-539.
19. Lehner A, Haas NA, Dietl M, et al. The risk of infective endocarditis following interventional pulmonary valve implantation: A meta-analysis. J Cardiol, 2019, 74(3): 197-205.
20. Abdelghani M, Nassif M, Blom NA, et al. Infective endocarditis after melody valve implantation in the pulmonary position: A systematic review. J Am Heart Assoc, 2018, 7(13): e008163.
21. Jalal Z, Galmiche L, Beloin C, et al. Impact of percutaneous pulmonary valve implantation procedural steps on leaflets histology and mechanical behaviour: An in vitro study. Arch Cardiovasc Dis, 2016, 109(8-9): 465-475.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation: A prospective clinical study

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