Advantages and related developments of self-expandable valves for transcatheter aortic valve replacement_West China Medical Journal

Authors：

MA Yunlong , WU Yue , YUAN Zuyi ,  HAN Ke

Department of Cardiology, the First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi 710061, P. R. China;

Corresponding author：

HAN Ke, Email: hanke630@sina.com

Keywords：

Transcatheter aortic valve replacement; self-expandable valves; balloon-expandable valves

DOI：

10.7507/1002-0179.202309205

Video：

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Transcatheter aortic valve replacement is an effective treatment for aortic stenosis currently, especially in elderly, surgical high-risk, and surgical procedures-intolerant patients with severe aortic stenosis. After several generations of updates in design and function, the self-expandable valves have shown significant efficacy in treating aortic stenosis patients with bicuspid aortic valve, bioprosthetic valve failure or small annulus, and superiority in terms of valve durability, and the favorable hemodynamic outcomes could translate into clinical endpoint benefit. This literature review summarizes the advantages and recent advances of the self-expandable valves in transcatheter aortic valve replacement.

Citation： MA Yunlong, WU Yue, YUAN Zuyi, HAN Ke. Advantages and related developments of self-expandable valves for transcatheter aortic valve replacement. West China Medical Journal, 2023, 38(12): 1914-1919. doi: 10.7507/1002-0179.202309205 Copy

1.	Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation, 2002, 106(24): 3006-3008.
2.	Van BE, Vincent F, Labreuche J, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement: a propensity-matched comparison from the FRANCE-TAVI Registry. Circulation, 2020, 141(4): 243-259.
3.	Mosleh W, Amer MR, Joshi S, et al. Comparative outcomes of balloon-expandable S3 versus self-expanding Evolut bioprostheses for transcatheter aortic valve implantation. Am J Cardiol, 2019, 124(10): 1621-1629.
4.	Schmidt S, Fortmeier V, Ludwig S, et al. Hemodynamics of self-expanding versus balloon-expandable transcatheter heart valves in relation to native aortic annulus anatomy. Clin Res Cardiol, 2022, 111(12): 1336-1347.
5.	Rodés-Cabau J, Abbas AE, Serra V, et al. Balloon- vs self-expanding valve systems for failed small surgical aortic valve bioprostheses. J Am Coll Cardiol, 2022, 80(7): 681-693.
6.	Xiong TY, Ali WB, Feng Y, et al. Transcatheter aortic valve implantation in patients with bicuspid valve morphology: a roadmap towards standardization. Nat Rev Cardiol, 2023, 20(1): 52-67.
7.	Kusner JJ, Brown JY, Gleason TG, et al. The natural history of bicuspid aortic valve disease. Struct Heart, 2022, 7(2): 100119.
8.	Elbadawi A, Saad M, Elgendy IY, et al. Temporal trends and outcomes of transcatheter versus surgical aortic valve replacement for bicuspid aortic valve stenosis. JACC Cardiovasc Interv, 2019, 12(18): 1811-1822.
9.	Forrest JK, Ramlawi B, Deeb GM, et al. Transcatheter aortic valve replacement in low-risk patients with bicuspid aortic valve stenosis. JAMA Cardiol, 2021, 6(1): 50-57.
10.	Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(21): 2492-2516.
11.	Saeed Al-Asad K, Martinez Salazar A, Radwan Y, et al. Transcatheter aortic valve replacement in bicuspid versus tricuspid aortic valve stenosis: meta-analysis and systemic review. Am J Cardiol, 2023, 203: 105-112.
12.	Hong N, Pan W, Liu X, et al. Transcatheter aortic valve replacement for bicuspid vs. tricuspid aortic stenosis among patients at low surgical risk in China: from the Multicenter National NTCVR Database. J Clin Med, 2023, 12(1): 387.
13.	Liu X, He Y, Zhu Q, et al. Supra-annular structure assessment for self-expanding transcatheter heart valve size selection in patients with bicuspid aortic valve. Catheter Cardiovasc Interv, 2018, 91(5): 986-994.
14.	Petronio AS, Angelillis M, De Backer O, et al. Bicuspid aortic valve sizing for transcatheter aortic valve implantation: development and validation of an algorithm based on multi-slice computed tomography. J Cardiovasc Comput Tomogr, 2020, 14(5): 452-461.
15.	Makkar RR, Yoon SH, Chakravarty T, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke among patients at low surgical risk. JAMA, 2021, 326(11): 1034-1044.
16.	Freitas-Ferraz AB, Tirado-Conte G, Dagenais F, et al. Aortic stenosis and small aortic annulus. Circulation, 2019, 139(23): 2685-2702.
17.	Joury A, Duran A, Stewart M, et al. Prosthesis-patient mismatch following aortic and mitral valves replacement - a comprehensive review. Prog Cardiovasc Dis, 2022, 72: 84-92.
18.	Ortoleva JP, Gonzalez-Ciccarelli LF, Kawabori M, et al. Prosthesis-patient mismatch after transcatheter aortic valve replacement: a new technology with an old problem. J Cardiothorac Vasc Anesth, 2021, 35(8): 2253-2255.
19.	Mangieri A, Tchetchè D, Kim WK, et al. Balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis: insights from the BEAT International Collaborative Registrys. Circ Cardiovasc Interv, 2020, 13(7): e008714.
20.	Kornyeva A, Burri M, Lange R, et al. Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli. Front Cardiovasc Med, 2023, 10: 1175246.
21.	Deharo P, Leroux L, Theron A, et al. Long-term prognosis value of paravalvular leak and patient-prosthesis mismatch following transcatheter aortic valve implantation: insight from the France-TAVI Registry. J Clin Med, 2022, 11(20): 6117.
22.	Lee YJ, Lee SJ, Hong SJ, et al. Comparison of transcatheter aortic valve replacement between self-expanding versus balloon-expandable valves in patients with small aortic annulus. Korean Circ J, 2021, 51(3): 222-231.
23.	Meguro K, Kumamaru H, Kohsaka S, et al. Transcatheter aortic valve replacement in patients with a small annulus - from the Japanese Nationwide Registry (J-TVT). Circ J, 2021, 85(7): 967-976.
24.	Herrmann HC, Abdel-Wahab M, Attizzani GF, et al. Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). Am Heart J, 2022, 243: 92-102.
25.	Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J, 2017, 38(45): 3382-3390.
26.	Jørgensen TH, Thyregod HGH, Ihlemann N, et al. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J, 2021, 42(30): 2912-2919.
27.	O’Hair D, Yakubov SJ, Grubb KJ, et al. Structural valve deterioration after self-expanding transcatheter or surgical aortic valve implantation in patients at intermediate or high risk. JAMA Cardiol, 2023, 8(2): 111-119.
28.	Abdel-Wahab M, Landt M, Neumann FJ, et al. 5-year outcomes after TAVR with balloon-expandable versus self-expanding valves: results from the CHOICE randomized clinical trial. JACC Cardiovasc Interv, 2020, 13(9): 1071-1082.
29.	Ueyama H, Kuno T, Takagi H, et al. Meta-analysis comparing valve durability among different transcatheter and surgical aortic valve bioprosthesis. Am J Cardiol, 2021, 158: 104-111.
30.	Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med, 2015, 373(21): 2015-2024.
31.	Fukui M, Bapat VN, Garcia S, et al. Deformation of transcatheter aortic valve prostheses: implications for hypoattenuating leaflet thickening and clinical outcomes. Circulation, 2022, 146(6): 480-493.
32.	Bansal A, Agarwal S, Braghieri L, et al. Subclinical leaflet thrombosis after balloon versus self-expandable transcatheter aortic valve implantation. Am J Cardiol, 2023, 192: 88-97.
33.	Rashid HN, Rajani R, Leipsic J, et al. Computed tomography imaging for subclinical leaflet thrombosis following surgical and transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr, 2023, 17(1): 2-10.
34.	Hirji SA, Percy ED, Zogg CK, et al. Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs. reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes. Eur Heart J, 2020, 41(29): 2747-2755.
35.	Gallo M, Fovino LN, Blitzer D, et al. Transcatheter aortic valve replacement for structural degeneration of previously implanted transcatheter valves (TAVR-in-TAVR): a systematic review. Eur J Cardiothorac Surg, 2022, 61(5): 967-976.
36.	Kornowski R, Chevalier B, Verhoye JP, et al. Transcatheter aortic valve implantation for failed surgical aortic bioprostheses using a self-expanding device (from the prospective VIVA post market study). Am J Cardiol, 2021, 144: 118-124.
37.	Abbas AE, Mando R, Hanzel G, et al. Hemodynamic principles of prosthetic aortic valve evaluation in the transcatheter aortic valve replacement era. Echocardiography, 2020, 37(5): 738-757.
38.	Abbas AE, Hanzel G, Shannon F, et al. Post-TAVR trans-aortic valve gradients: echocardiographic versus invasive measurements. Structural Heart, 2019, 3(4): 348-350.
39.	Abdelghani M, Mankerious N, Allali A, et al. Bioprosthetic valve performance after transcatheter aortic valve replacement with self-expanding versus balloon-expandable valves in large versus small aortic valve annuli: insights from the CHOICE trial and the CHOICE-extend registry. JACC Cardiovasc Interv, 2018, 11(24): 2507-2518.
40.	Nuis RJ, van Belle E, Teles R, et al. BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial. Am Heart J, 2023, 256: 139-147.

1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation, 2002, 106(24): 3006-3008.
2. Van BE, Vincent F, Labreuche J, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement: a propensity-matched comparison from the FRANCE-TAVI Registry. Circulation, 2020, 141(4): 243-259.
3. Mosleh W, Amer MR, Joshi S, et al. Comparative outcomes of balloon-expandable S3 versus self-expanding Evolut bioprostheses for transcatheter aortic valve implantation. Am J Cardiol, 2019, 124(10): 1621-1629.
4. Schmidt S, Fortmeier V, Ludwig S, et al. Hemodynamics of self-expanding versus balloon-expandable transcatheter heart valves in relation to native aortic annulus anatomy. Clin Res Cardiol, 2022, 111(12): 1336-1347.
5. Rodés-Cabau J, Abbas AE, Serra V, et al. Balloon- vs self-expanding valve systems for failed small surgical aortic valve bioprostheses. J Am Coll Cardiol, 2022, 80(7): 681-693.
6. Xiong TY, Ali WB, Feng Y, et al. Transcatheter aortic valve implantation in patients with bicuspid valve morphology: a roadmap towards standardization. Nat Rev Cardiol, 2023, 20(1): 52-67.
7. Kusner JJ, Brown JY, Gleason TG, et al. The natural history of bicuspid aortic valve disease. Struct Heart, 2022, 7(2): 100119.
8. Elbadawi A, Saad M, Elgendy IY, et al. Temporal trends and outcomes of transcatheter versus surgical aortic valve replacement for bicuspid aortic valve stenosis. JACC Cardiovasc Interv, 2019, 12(18): 1811-1822.
9. Forrest JK, Ramlawi B, Deeb GM, et al. Transcatheter aortic valve replacement in low-risk patients with bicuspid aortic valve stenosis. JAMA Cardiol, 2021, 6(1): 50-57.
10. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(21): 2492-2516.
11. Saeed Al-Asad K, Martinez Salazar A, Radwan Y, et al. Transcatheter aortic valve replacement in bicuspid versus tricuspid aortic valve stenosis: meta-analysis and systemic review. Am J Cardiol, 2023, 203: 105-112.
12. Hong N, Pan W, Liu X, et al. Transcatheter aortic valve replacement for bicuspid vs. tricuspid aortic stenosis among patients at low surgical risk in China: from the Multicenter National NTCVR Database. J Clin Med, 2023, 12(1): 387.
13. Liu X, He Y, Zhu Q, et al. Supra-annular structure assessment for self-expanding transcatheter heart valve size selection in patients with bicuspid aortic valve. Catheter Cardiovasc Interv, 2018, 91(5): 986-994.
14. Petronio AS, Angelillis M, De Backer O, et al. Bicuspid aortic valve sizing for transcatheter aortic valve implantation: development and validation of an algorithm based on multi-slice computed tomography. J Cardiovasc Comput Tomogr, 2020, 14(5): 452-461.
15. Makkar RR, Yoon SH, Chakravarty T, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke among patients at low surgical risk. JAMA, 2021, 326(11): 1034-1044.
16. Freitas-Ferraz AB, Tirado-Conte G, Dagenais F, et al. Aortic stenosis and small aortic annulus. Circulation, 2019, 139(23): 2685-2702.
17. Joury A, Duran A, Stewart M, et al. Prosthesis-patient mismatch following aortic and mitral valves replacement - a comprehensive review. Prog Cardiovasc Dis, 2022, 72: 84-92.
18. Ortoleva JP, Gonzalez-Ciccarelli LF, Kawabori M, et al. Prosthesis-patient mismatch after transcatheter aortic valve replacement: a new technology with an old problem. J Cardiothorac Vasc Anesth, 2021, 35(8): 2253-2255.
19. Mangieri A, Tchetchè D, Kim WK, et al. Balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis: insights from the BEAT International Collaborative Registrys. Circ Cardiovasc Interv, 2020, 13(7): e008714.
20. Kornyeva A, Burri M, Lange R, et al. Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli. Front Cardiovasc Med, 2023, 10: 1175246.
21. Deharo P, Leroux L, Theron A, et al. Long-term prognosis value of paravalvular leak and patient-prosthesis mismatch following transcatheter aortic valve implantation: insight from the France-TAVI Registry. J Clin Med, 2022, 11(20): 6117.
22. Lee YJ, Lee SJ, Hong SJ, et al. Comparison of transcatheter aortic valve replacement between self-expanding versus balloon-expandable valves in patients with small aortic annulus. Korean Circ J, 2021, 51(3): 222-231.
23. Meguro K, Kumamaru H, Kohsaka S, et al. Transcatheter aortic valve replacement in patients with a small annulus - from the Japanese Nationwide Registry (J-TVT). Circ J, 2021, 85(7): 967-976.
24. Herrmann HC, Abdel-Wahab M, Attizzani GF, et al. Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). Am Heart J, 2022, 243: 92-102.
25. Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J, 2017, 38(45): 3382-3390.
26. Jørgensen TH, Thyregod HGH, Ihlemann N, et al. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J, 2021, 42(30): 2912-2919.
27. O’Hair D, Yakubov SJ, Grubb KJ, et al. Structural valve deterioration after self-expanding transcatheter or surgical aortic valve implantation in patients at intermediate or high risk. JAMA Cardiol, 2023, 8(2): 111-119.
28. Abdel-Wahab M, Landt M, Neumann FJ, et al. 5-year outcomes after TAVR with balloon-expandable versus self-expanding valves: results from the CHOICE randomized clinical trial. JACC Cardiovasc Interv, 2020, 13(9): 1071-1082.
29. Ueyama H, Kuno T, Takagi H, et al. Meta-analysis comparing valve durability among different transcatheter and surgical aortic valve bioprosthesis. Am J Cardiol, 2021, 158: 104-111.
30. Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med, 2015, 373(21): 2015-2024.
31. Fukui M, Bapat VN, Garcia S, et al. Deformation of transcatheter aortic valve prostheses: implications for hypoattenuating leaflet thickening and clinical outcomes. Circulation, 2022, 146(6): 480-493.
32. Bansal A, Agarwal S, Braghieri L, et al. Subclinical leaflet thrombosis after balloon versus self-expandable transcatheter aortic valve implantation. Am J Cardiol, 2023, 192: 88-97.
33. Rashid HN, Rajani R, Leipsic J, et al. Computed tomography imaging for subclinical leaflet thrombosis following surgical and transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr, 2023, 17(1): 2-10.
34. Hirji SA, Percy ED, Zogg CK, et al. Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs. reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes. Eur Heart J, 2020, 41(29): 2747-2755.
35. Gallo M, Fovino LN, Blitzer D, et al. Transcatheter aortic valve replacement for structural degeneration of previously implanted transcatheter valves (TAVR-in-TAVR): a systematic review. Eur J Cardiothorac Surg, 2022, 61(5): 967-976.
36. Kornowski R, Chevalier B, Verhoye JP, et al. Transcatheter aortic valve implantation for failed surgical aortic bioprostheses using a self-expanding device (from the prospective VIVA post market study). Am J Cardiol, 2021, 144: 118-124.
37. Abbas AE, Mando R, Hanzel G, et al. Hemodynamic principles of prosthetic aortic valve evaluation in the transcatheter aortic valve replacement era. Echocardiography, 2020, 37(5): 738-757.
38. Abbas AE, Hanzel G, Shannon F, et al. Post-TAVR trans-aortic valve gradients: echocardiographic versus invasive measurements. Structural Heart, 2019, 3(4): 348-350.
39. Abdelghani M, Mankerious N, Allali A, et al. Bioprosthetic valve performance after transcatheter aortic valve replacement with self-expanding versus balloon-expandable valves in large versus small aortic valve annuli: insights from the CHOICE trial and the CHOICE-extend registry. JACC Cardiovasc Interv, 2018, 11(24): 2507-2518.
40. Nuis RJ, van Belle E, Teles R, et al. BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial. Am Heart J, 2023, 256: 139-147.

West China Medical Journal

Advantages and related developments of self-expandable valves for transcatheter aortic valve replacement

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