A decade of progress in transcatheter pulmonary valve replacement: From device innovation to precision assessment and individualized care_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

ZHOU Ziqin ^1,2 , CHEN Shuo ^1,2 , WANG Xin ^1,2 , ZHANG Yong ¹ , LI Xiaohua ¹ ,  WEN Shusheng ^1,2 ,  CHEN Jimei ^1,2

1. Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, 510010, P. R. China;
2. Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, 510100, P. R. China;

Corresponding?author：

WEN Shusheng, Email: wenshusheng0231@163.com; CHEN Jimei, Email: jimei_1965@outlook.com

Keywords：

Transcatheter pulmonary valve replacement; congenital heart disease; tetralogy of fallot; right ventricular outflow tract; interventional therapy; review

DOI：

10.7507/1007-4848.202509052

Video：

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Abstract Full text Figures/Tables Video References Cited by

Transcatheter pulmonary valve replacement (TPVR) has transitioned from an experimental technique to a standard of care over the last 10 years, with its application expanding from conduit-based right ventricular outflow tracts (RVOTs) to complex native or patch-repaired anatomies. Valve systems like Melody, Sapien, and Harmony have shown favorable safety and efficacy, achieving a 10-year freedom from reintervention of 60% (95%CI 55%-65%) and freedom from valve dysfunction of 53% (95%CI 47%-59%). For severely dilated RVOTs, innovations like the Alterra adaptive stent and physician-modified endografts offer new solutions. Patient selection is now a comprehensive process, evaluating RV function, coronary compression risk, and anatomy. Standardized perioperative management has markedly lowered major complication rates. Advanced technologies such as 3D printing, finite element analysis, and virtual reality are paving the way for precision medicine in TPVR. For pediatric patients, prospective technologies like growable valves and fetal interventions represent new frontiers. With maturing technology and broadening indications, TPVR is progressively extending to younger patients, underscoring the importance of multidisciplinary teams and long-term follow-up for safety. This review systematically outlines the technological evolution, current status, and future trajectory of TPVR.

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2.	Gebauer R, Chaloupecky V, Hu?ín B, et al. Survival and freedom from reinterventions in patients with repaired tetralogy of Fallot: up to 42-year follow-up of 917 patients. J Am Heart Assoc, 2023, 12(20): e024771.
3.	季巍, 莫瑩, 羅毅. 法洛四聯癥根治術后遠期主要并發癥及其微創化手術治療. 中國臨床醫生雜志, 2021, 49(9): 1011-1016.Ji W, Mo Y, Luo Y. Long-term major complications after radical repair of tetralogy of Fallot and minimally invasive surgical treatment. Chin J Clinicians, 2021, 49(9): 1011-1016.
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7.	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.
8.	Stefanescu Schmidt AC, Armstrong AK, Aboulhosn JA, et al. Transcatheter pulmonary valve replacement with balloon-expandable valves: utilization and procedural outcomes from the IMPACT registry. JACC Cardiovasc Interv, 2024, 17(2): 231-244.
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12.	Morray BH, Gillespie MJ, Cheatham JP, et al. Midterm outcomes in a pooled cohort of Harmony transcatheter pulmonary valve recipients. Circ Cardiovasc Interv, 2025: e015196.
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.
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20.	Agwu N, Chau D, Kelley GS, et al. Preclinical evaluation of a growth-accommodating transcatheter pulmonary valve system for young children. J Am Heart Assoc, 2025, 14(13): e041932.
21.	Thompson EW, Bhattacharya A, Hu F, et al. Pulmonary artery shear stress and oscillatory shear index are associated with right ventricular remodeling in repaired tetralogy of Fallot. Ann Biomed Eng, 2025, 53(9): 2206-2222.
22.	Loke YH, Capuano F, Cleveland V, et al. Moving beyond size: vorticity and energy loss are correlated with right ventricular dysfunction and exercise intolerance in repaired Tetralogy of Fallot. J Cardiovasc Magn Reson, 2021, 23(1): 98.
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1. Flores-Umanzor E, Alshehri B, Keshvara R, et al. Transcatheter-based interventions for tetralogy of Fallot across all age groups. JACC Cardiovasc Interv, 2024, 17(9): 1079-1090.
2. Gebauer R, Chaloupecky V, Hu?ín B, et al. Survival and freedom from reinterventions in patients with repaired tetralogy of Fallot: up to 42-year follow-up of 917 patients. J Am Heart Assoc, 2023, 12(20): e024771.
3. 季巍, 莫瑩, 羅毅. 法洛四聯癥根治術后遠期主要并發癥及其微創化手術治療. 中國臨床醫生雜志, 2021, 49(9): 1011-1016.Ji W, Mo Y, Luo Y. Long-term major complications after radical repair of tetralogy of Fallot and minimally invasive surgical treatment. Chin J Clinicians, 2021, 49(9): 1011-1016.
4. Latus H, Stammermann J, Voges I, et al. Impact of right ventricular pressure load after repair of tetralogy of Fallot. J Am Heart Assoc, 2022, 11(7): e022694.
5. Havers-Borgersen E, Butt JH, Smerup M, et al. Incidence of infective endocarditis among patients with tetralogy of Fallot. J Am Heart Assoc, 2021, 10(22): e022445.
6. Gr?ning M, Smerup MH, Munk K, et al. Pulmonary valve replacement in tetralogy of Fallot: procedural volume and durability of bioprosthetic pulmonary valves. JACC Cardiovasc Interv, 2024, 17(2): 217-227.
7. 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.
8. Stefanescu Schmidt AC, Armstrong AK, Aboulhosn JA, et al. Transcatheter pulmonary valve replacement with balloon-expandable valves: utilization and procedural outcomes from the IMPACT registry. JACC Cardiovasc Interv, 2024, 17(2): 231-244.
9. 中國醫師協會心血管內科醫師分會結構性心臟病學組, 亞洲心臟病學會, 國家放射與治療臨床醫學研究中心. 經導管肺動脈瓣置換術亞洲專家共識. 中國介入心臟病學雜志, 2023, 31(6): 404-412.Committee of Cardiovascular Physicians Branch of Chinese Medical Doctor Association, Asian Society of Cardiology, National Clinical Research Center for Interventional Medicine. Asian expert consensus on transcatheter pulmonary valve replacement. Chin J Interv Cardiol, 2023, 31(6): 404-412.
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. 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.
12. Morray BH, Gillespie MJ, Cheatham JP, et al. Midterm outcomes in a pooled cohort of Harmony transcatheter pulmonary valve recipients. Circ Cardiovasc Interv, 2025: e015196.
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. Shahanavaz S, Balzer D, Babaliaros V, et al. Alterra adaptive prestent and SAPIEN 3 THV for congenital pulmonic valve dysfunction: an early feasibility study. JACC Cardiovasc Interv, 2020, 13(21): 2510-2524.
15. Jalal Z, Valdeolmillos E, Malekzadeh-Milani S, et al. Mid-term outcomes following percutaneous pulmonary valve implantation using the "folded Melody valve" technique. Circ Cardiovasc Interv, 2021, 14(4): e009707.
16. Shahanavaz S, Berger F, Jones TK, et al. Outcomes after transcatheter reintervention for dysfunction of a previously implanted transcatheter pulmonary valve. JACC Cardiovasc Interv, 2020, 13(13): 1529-1540.
17. Samayoa JC, Boucek D, Mccarthy E, et al. Echocardiographic assessment of Melody versus Sapien valves following transcatheter pulmonary valve replacement. JACC Cardiovasc Interv, 2022, 15(2): 165-175.
18. Dimas VV, Babaliaros V, Kim D, et al. Multicenter pivotal study of the Alterra adaptive prestent for the treatment of pulmonary regurgitation. JACC Cardiovasc Interv, 2024, 17(19): 2287-2297.
19. Pérez-Cualtán CE, Castro-Páez C, Guerrero-Chalela CE, et al. The role of 3D printing and finite element-based computational simulations in transcatheter pulmonary valve replacement. Prog Biomed Eng (Bristol), 2025, 7(4).
20. Agwu N, Chau D, Kelley GS, et al. Preclinical evaluation of a growth-accommodating transcatheter pulmonary valve system for young children. J Am Heart Assoc, 2025, 14(13): e041932.
21. Thompson EW, Bhattacharya A, Hu F, et al. Pulmonary artery shear stress and oscillatory shear index are associated with right ventricular remodeling in repaired tetralogy of Fallot. Ann Biomed Eng, 2025, 53(9): 2206-2222.
22. Loke YH, Capuano F, Cleveland V, et al. Moving beyond size: vorticity and energy loss are correlated with right ventricular dysfunction and exercise intolerance in repaired Tetralogy of Fallot. J Cardiovasc Magn Reson, 2021, 23(1): 98.
23. Zablah JE, Than J, Browne LP, et al. Patient screening for self-expanding percutaneous pulmonary valves using virtual reality. J Am Heart Assoc, 2024, 13(6): e033239.
24. Plessis J, Hasco?t S, Baruteau A, et al. Edwards SAPIEN transcatheter pulmonary valve implantation: results from a French registry. JACC Cardiovasc Interv, 2018, 11(19): 1909-1916.
25. Qureshi SA, Jones MI, Pushparajah K, et al. Transcatheter pulmonary valve implantation using self-expandable percutaneous pulmonary valve system: 3-year CE study results. JACC Cardiovasc Interv, 2025, 18(8): 1045-1056.
26. 周子秦, 黃陶然, 乃吉木丁·阿布都熱西提, 等. 國產自膨式介入肺動脈瓣支架經胸植入術治療肺動脈瓣反流的前瞻性隊列研究. 中國胸心血管外科臨床雜志, 2024, 31(9): 1305-1312.Zhou ZQ, Huang TR, Najmudin Abudurexiti, et al. Prospective cohort study of domestic self-expanding interventional pulmonary valve stent implantation via transthoracic approach for pulmonary regurgitation. Chin J Clin Thorac Cardiovasc Surg, 2024, 31(9): 1305-1312.
27. Ueyama HA, Greenbaum AB, Leshnower BG, et al. Physician-modified endograft-facilitated transcatheter pulmonary valve replacement in large right ventricular outflow tract. Circ Cardiovasc Interv, 2023, 16(9): e013123.
28. Kamioka N, Babaliaros VC, Lisko JC, et al. Single-barrel, double-barrel, and fenestrated endografts to facilitate transcatheter pulmonary valve replacement in large RVOT. JACC Cardiovasc Interv, 2020, 13(23): 2755-2765.
29. Carr K, Nijres BM, Windsor JJ, et al. Single-center experience of hybrid pulmonary valve replacement using left anterior thoracotomy with pulmonary artery plication in patients with large right ventricular outflow tract. J Am Heart Assoc, 2022, 11(14): e026517.
30. He F, Feng Z, Chen Q, et al. Whether pulmonary valve replacement in asymptomatic patients with moderate or severe regurgitation after tetralogy of Fallot repair is appropriate: a case-control study. J Am Heart Assoc, 2019, 8(1): e010689.
31. Grbac AJ, Naimo PS, Russo JJ, et al. High variability in reporting of right ventricle contouring technique and body surface area methodology in cardiac magnetic resonance studies of patients with repaired Tetralogy of Fallot: a systematic review. J Cardiovasc Magn Reson, 2025: 101942.
32. Fogel MA, Faerber JA, Mahmood A, et al. Clinical outcome prediction model in tetralogy of Fallot without pulmonary valve replacement using contraction fraction from the SCOUT-TOF registry. J Am Heart Assoc, 2025, 14(10): e037983.
33. Wald RM, Tomlinson G, Caldarone CA, et al. Outcome prediction after tetralogy of Fallot repair: a prospective clinical and cardiovascular magnetic resonance study. J Am Heart Assoc, 2025, 14(8): e039006.
34. Crabb BT, Chandrupatla RS, Masutani EM, et al. Characteristics of left ventricular dysfunction in repaired tetralogy of Fallot: a multi-institutional deep learning analysis of regional strain and dyssynchrony. J Cardiovasc Magn Reson, 2025, 27(1): 101886.
35. Thomas SK, R DS, Hanneman K, et al. Prognostic value of myocardial deformation parameters for outcome prediction in tetralogy of Fallot. J Cardiovasc Magn Reson, 2024, 26(2): 101054.
36. Lindholm A, Kjellstr?m B, R?degran G, et al. Right ventricular dyssynchrony predicts outcome in pulmonary arterial hypertension when assessed in multiple cardiac magnetic resonance views. J Cardiovasc Magn Reson, 2024, 26(2): 101103.
37. Lumens J, Fan CS, Walmsley J, et al. Relative impact of right ventricular electromechanical dyssynchrony versus pulmonary regurgitation on right ventricular dysfunction and exercise intolerance in patients after repair of tetralogy of Fallot. J Am Heart Assoc, 2019, 8(2): e010903.
38. Romans RA, Lu JC, Balasubramanian S, et al. Cardiac magnetic resonance to predict coronary artery compression in transcatheter pulmonary valve implantation into conduits. JACC Cardiovasc Interv, 2022, 15(9): 979-988.
39. Batlivala SP, Goldstein BH. A new concern: persistent coronary artery compression after balloon testing during transcatheter pulmonary valve replacement. JACC Cardiovasc Interv, 2019, 12(3): e17-e20.
40. Yang JK, Wattenbarger L, Taylor AC, et al. Extended rhythm monitoring to assess for ventricular arrhythmias after transcatheter pulmonary valve replacement with the Harmony valve. Circ Cardiovasc Interv, 2025, 18(1): e014381.
41. Stammnitz C, Huscher D, Bauer UMM, et al. Nationwide registry-based analysis of infective endocarditis risk after pulmonary valve replacement. J Am Heart Assoc, 2022, 11(5): e022231.
42. 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).
43. Shahanavaz S, Asnes JD, Grohmann J, et al. Intentional fracture of bioprosthetic valve frames in patients undergoing valve-in-valve transcatheter pulmonary valve replacement. Circ Cardiovasc Interv, 2018, 11(8): e006453.
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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Latest ArticlesA decade of progress in transcatheter pulmonary valve replacement: From device innovation to precision assessment and individualized care

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