Research status of long-term durability in transcatheter aortic valve replacement_West China Medical Journal

Authors：

FANG Mingcheng ,  GUO Yansong , CHEN Xinjing , HONG Jingxuan

Third Department of Cardiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian 350000, P. R. China;

Corresponding author：

GUO Yansong, Email: ysguo1234@163.com

Keywords：

Transcatheter aortic valve replacement; structural valve degradation; durability

DOI：

10.7507/1002-0179.202203066

Video：

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The implantation of bioprosthetic heart valves have increased dramatically due to the aging population and the widespread application of transcatheter aortic valve replacement (TAVR). TAVR is increasingly being used in younger, lower-risk patients with a longer life expectancy, so it is important to overcome structural valve degeneration and ensure long-term TAVR durability. Although the mid-term durability results of the TAVR valve are encouraging, its long-term durability needs to be further explored. This article will mainly introduce the influencing factors of TAVR valve durability, evaluation criteria for structural valve degeneration, clinical research results related to TAVR valve durability, and problems to be solved.

Citation： FANG Mingcheng, GUO Yansong, CHEN Xinjing, HONG Jingxuan. Research status of long-term durability in transcatheter aortic valve replacement. West China Medical Journal, 2022, 37(4): 592-598. doi: 10.7507/1002-0179.202203066 Copy

1.	中国心血管健康与疾病报告编写组. 中国心血管健康与疾病报告2020概要. 中国循环杂志, 2021, 36(6): 521-545.
2.	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.
3.	经导管主动脉瓣置换术流程优化共识专家组. 经导管主动脉瓣置换术(TAVR)流程优化专家共识2022版. 中华急诊医学杂志, 2022, 31(2): 154-160.
4.	Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation, 2021, 143(5): e35-e71.
5.	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.
6.	中国医师协会心血管内科医师分会结构性心脏病专业委员会. 中国经导管主动脉瓣置换术临床路径专家共识(2021版). 中国循环杂志, 2022, 37(1): 12-23.
7.	Flameng W, Rega F, Vercalsteren M, et al. Antimineralization treatment and patient-prosthesis mismatch are major determinants of the onset and incidence of structural valve degeneration in bioprosthetic heart valves. J Thorac Cardiovasc Surg, 2014, 147(4): 1219-1224.
8.	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 J Cardiothorac Surg, 2017, 52(3): 408-417.
9.	Rodriguez-Gabella T, Voisine P, Puri R, et al. Aortic bioprosthetic valve durability: incidence, mechanisms, predictors, and management of surgical and transcatheter valve degeneration. J Am Coll Cardiol, 2017, 70(8): 1013-1028.
10.	Yerasi C, Rogers T, Forrestal BJ, et al. Transcatheter versus surgical aortic valve replacement in young, low-risk patients with severe aortic stenosis. JACC Cardiovasc Interv, 2021, 14(11): 1169-1180.
11.	Mehilli J. Lessons learned from in vitro durability testing of transcatheter heart valves. JACC Cardiovasc Interv, 2020, 13(2): 250-252.
12.	Bre LP, McCarthy R, Wang W. Prevention of bioprosthetic heart valve calcification: strategies and outcomes. Curr Med Chem, 2014, 21(22): 2553-2564.
13.	Manji RA, Zhu LF, Nijjar NK, et al. Glutaraldehyde-fixed bioprosthetic heart valve conduits calcify and fail from xenograft rejection. Circulation, 2006, 114(4): 318-327.
14.	Puri R, Auffret V, Rodés-Cabau J. Bioprosthetic valve thrombosis. J Am Coll Cardiol, 2017, 69(17): 2193-2211.
15.	Mangione FM, Jatene T, Gonçalves A, et al. Leaflet thrombosis in surgically explanted or post-mortem TAVR valves. JACC Cardiovasc Imaging, 2017, 10(1): 82-85.
16.	Blackman DJ, Saraf S, MacCarthy PA, et al. Long-term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol, 2019, 73(5): 537-545.
17.	Martin C, Sun W. Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: a fatigue simulation study. J Biomech, 2015, 48(12): 3026-3034.
18.	Lancellotti P, Pibarot P, Chambers J, et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging, 2016, 17(6): 589-590.
19.	曾咏, 朱齐丰, 陈俊, 等. 主动脉瓣生物瓣长期耐久性的研究进展. 中国循环杂志, 2021, 36(10): 1031-1035.
20.	Zoghbi WA, Chambers JB, Dumesnil JG, et al. Recommendations for evaluation of prosthetic valves with echocardiography and doppler ultrasound: a report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, developed in conjunction with the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, the European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography and the Canadian Society of Echocardiography, endorsed by the American College of Cardiology Foundation, American Heart Association, European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography, and Canadian Society of Echocardiography. J Am Soc Echocardiogr, 2009, 22(9): 975-1014.
21.	Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol, 2012, 60(15): 1438-1454.
22.	Dvir D, Bourguignon T, Otto CM, et al. Standardized definition of structural valve degeneration for surgical and transcatheter bioprosthetic aortic valves. Circulation, 2018, 137(4): 388-399.
23.	VARC-3 WRITING COMMITTEE, Généreux P, Piazza N, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J, 2021, 42(19): 1825-1857.
24.	Coylewright M, Forrest JK, McCabe JM, et al. TAVR in low-risk patients: FDA approval, the new NCD, and shared decision-making. J Am Coll Cardiol, 2020, 75(10): 1208-1211.
25.	Toggweiler S, Humphries KH, Lee M, et al. 5-year outcome after transcatheter aortic valve implantation. J Am Coll Cardiol, 2013, 61(4): 413-419.
26.	Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2477-2484.
27.	Kovac J, Schuler G, Gerckens U, et al. Four-year experience with the CoreValve transcatheter heart valve. EuroIntervention, 2016, 12(8): e1039-e1046.
28.	Barbanti M, Costa G, Zappulla P, et al. Incidence of long-term structural valve dysfunction and bioprosthetic valve failure after transcatheter aortic valve replacement. J Am Heart Assoc, 2018, 7(15): e008440.
29.	Panico RA, Giannini C, De Carlo M, et al. Long-term results and durability of the CoreValve transcatheter aortic bioprosthesis: outcomes beyond five years. EuroIntervention, 2019, 14(16): 1639-1647.
30.	Testa L, Latib A, Brambilla N, et al. Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis. Eur Heart J, 2020, 41(20): 1876-1886.
31.	Murray MI, Hofmann E, De Rosa R, et al. Hemodynamic outcome and valve durability beyond five years after transcatheter aortic valve replacement. J Invasive Cardiol, 2020, 32(3): 82-87.
32.	Durand E, Sokoloff A, Urena-Alcazar M, et al. Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves using the new european definition. Circ Cardiovasc Interv, 2019, 12(4): e007597.
33.	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.
34.	Sathananthan J, Lauck S, Polderman J, et al. Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement. Catheter Cardiovasc Interv, 2021, 97(3): E431-E437.
35.	Holy EW, Kebernik J, Abdelghani M, et al. Long-term durability and haemodynamic performance of a self-expanding transcatheter heart valve beyond five years after implantation: a prospective observational study applying the standardised definitions of structural deterioration and valve failure. EuroIntervention, 2018, 14(4): e390-e396.
36.	Deutsch MA, Erlebach M, Burri M, et al. Beyond the five-year horizon: long-term outcome of high-risk and inoperable patients undergoing TAVR with first-generation devices. EuroIntervention, 2018, 14(1): 41-49.
37.	Siqueira DA, Simonato M, Ramos AA, et al. Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system. Catheter Cardiovasc Interv, 2021, 97(1): 167-174.
38.	Butchart EG, Chambers J, Borer JS, et al. Long-term durability of transcatheter valves: the importance of accurate data. JACC Cardiovasc Interv, 2020, 13(2): 253-256.
39.	Martín M, Cuevas J, Cigarrán H, et al. Transcatheter aortic valve implantation and subclinical and clinical leaflet thrombosis: multimodality imaging for diagnosis and risk stratification. Eur Cardiol, 2021, 16: e35.
40.	Jose J, Sulimov DS, El-Mawardy M, et al. Clinical bioprosthetic heart valve thrombosis after transcatheter aortic valve replacement: incidence, characteristics, and treatment outcomes. JACC Cardiovasc Interv, 2017, 10(7): 686-697.
41.	Barbanti M, Webb JG, Tamburino C, et al. Outcomes of redo transcatheter aortic valve replacement for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter valve failure. Circ Cardiovasc Interv, 2016, 9(9): e003930.
42.	Sá MPBO, Van den Eynde J, Simonato M, et al. Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement: an updated meta-analysis. JACC Cardiovasc Interv, 2021, 14(2): 211-220.
43.	Testa L, Agnifili M, Van Mieghem NM, et al. Transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT international project. Circ Cardiovasc Interv, 2021, 14(6): e010440.
44.	Khan JM, Greenbaum AB, Babaliaros VC, et al. BASILICA trial: one-year outcomes of transcatheter electrosurgical leaflet laceration to prevent TAVR coronary obstruction. Circ Cardiovasc Interv, 2021, 14(5): e010238.
45.	Simionescu DT. Prevention of calcification in bioprosthetic heart valves: challenges and perspectives. Expert Opin Biol Ther, 2004, 4(12): 1971-1985.

1. 中国心血管健康与疾病报告编写组. 中国心血管健康与疾病报告2020概要. 中国循环杂志, 2021, 36(6): 521-545.
2. 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.
3. 经导管主动脉瓣置换术流程优化共识专家组. 经导管主动脉瓣置换术(TAVR)流程优化专家共识2022版. 中华急诊医学杂志, 2022, 31(2): 154-160.
4. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation, 2021, 143(5): e35-e71.
5. 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.
6. 中国医师协会心血管内科医师分会结构性心脏病专业委员会. 中国经导管主动脉瓣置换术临床路径专家共识(2021版). 中国循环杂志, 2022, 37(1): 12-23.
7. Flameng W, Rega F, Vercalsteren M, et al. Antimineralization treatment and patient-prosthesis mismatch are major determinants of the onset and incidence of structural valve degeneration in bioprosthetic heart valves. J Thorac Cardiovasc Surg, 2014, 147(4): 1219-1224.
8. 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 J Cardiothorac Surg, 2017, 52(3): 408-417.
9. Rodriguez-Gabella T, Voisine P, Puri R, et al. Aortic bioprosthetic valve durability: incidence, mechanisms, predictors, and management of surgical and transcatheter valve degeneration. J Am Coll Cardiol, 2017, 70(8): 1013-1028.
10. Yerasi C, Rogers T, Forrestal BJ, et al. Transcatheter versus surgical aortic valve replacement in young, low-risk patients with severe aortic stenosis. JACC Cardiovasc Interv, 2021, 14(11): 1169-1180.
11. Mehilli J. Lessons learned from in vitro durability testing of transcatheter heart valves. JACC Cardiovasc Interv, 2020, 13(2): 250-252.
12. Bre LP, McCarthy R, Wang W. Prevention of bioprosthetic heart valve calcification: strategies and outcomes. Curr Med Chem, 2014, 21(22): 2553-2564.
13. Manji RA, Zhu LF, Nijjar NK, et al. Glutaraldehyde-fixed bioprosthetic heart valve conduits calcify and fail from xenograft rejection. Circulation, 2006, 114(4): 318-327.
14. Puri R, Auffret V, Rodés-Cabau J. Bioprosthetic valve thrombosis. J Am Coll Cardiol, 2017, 69(17): 2193-2211.
15. Mangione FM, Jatene T, Gonçalves A, et al. Leaflet thrombosis in surgically explanted or post-mortem TAVR valves. JACC Cardiovasc Imaging, 2017, 10(1): 82-85.
16. Blackman DJ, Saraf S, MacCarthy PA, et al. Long-term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol, 2019, 73(5): 537-545.
17. Martin C, Sun W. Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: a fatigue simulation study. J Biomech, 2015, 48(12): 3026-3034.
18. Lancellotti P, Pibarot P, Chambers J, et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging, 2016, 17(6): 589-590.
19. 曾咏, 朱齐丰, 陈俊, 等. 主动脉瓣生物瓣长期耐久性的研究进展. 中国循环杂志, 2021, 36(10): 1031-1035.
20. Zoghbi WA, Chambers JB, Dumesnil JG, et al. Recommendations for evaluation of prosthetic valves with echocardiography and doppler ultrasound: a report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, developed in conjunction with the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, the European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography and the Canadian Society of Echocardiography, endorsed by the American College of Cardiology Foundation, American Heart Association, European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography, and Canadian Society of Echocardiography. J Am Soc Echocardiogr, 2009, 22(9): 975-1014.
21. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol, 2012, 60(15): 1438-1454.
22. Dvir D, Bourguignon T, Otto CM, et al. Standardized definition of structural valve degeneration for surgical and transcatheter bioprosthetic aortic valves. Circulation, 2018, 137(4): 388-399.
23. VARC-3 WRITING COMMITTEE, Généreux P, Piazza N, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J, 2021, 42(19): 1825-1857.
24. Coylewright M, Forrest JK, McCabe JM, et al. TAVR in low-risk patients: FDA approval, the new NCD, and shared decision-making. J Am Coll Cardiol, 2020, 75(10): 1208-1211.
25. Toggweiler S, Humphries KH, Lee M, et al. 5-year outcome after transcatheter aortic valve implantation. J Am Coll Cardiol, 2013, 61(4): 413-419.
26. Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2477-2484.
27. Kovac J, Schuler G, Gerckens U, et al. Four-year experience with the CoreValve transcatheter heart valve. EuroIntervention, 2016, 12(8): e1039-e1046.
28. Barbanti M, Costa G, Zappulla P, et al. Incidence of long-term structural valve dysfunction and bioprosthetic valve failure after transcatheter aortic valve replacement. J Am Heart Assoc, 2018, 7(15): e008440.
29. Panico RA, Giannini C, De Carlo M, et al. Long-term results and durability of the CoreValve transcatheter aortic bioprosthesis: outcomes beyond five years. EuroIntervention, 2019, 14(16): 1639-1647.
30. Testa L, Latib A, Brambilla N, et al. Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis. Eur Heart J, 2020, 41(20): 1876-1886.
31. Murray MI, Hofmann E, De Rosa R, et al. Hemodynamic outcome and valve durability beyond five years after transcatheter aortic valve replacement. J Invasive Cardiol, 2020, 32(3): 82-87.
32. Durand E, Sokoloff A, Urena-Alcazar M, et al. Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves using the new european definition. Circ Cardiovasc Interv, 2019, 12(4): e007597.
33. 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.
34. Sathananthan J, Lauck S, Polderman J, et al. Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement. Catheter Cardiovasc Interv, 2021, 97(3): E431-E437.
35. Holy EW, Kebernik J, Abdelghani M, et al. Long-term durability and haemodynamic performance of a self-expanding transcatheter heart valve beyond five years after implantation: a prospective observational study applying the standardised definitions of structural deterioration and valve failure. EuroIntervention, 2018, 14(4): e390-e396.
36. Deutsch MA, Erlebach M, Burri M, et al. Beyond the five-year horizon: long-term outcome of high-risk and inoperable patients undergoing TAVR with first-generation devices. EuroIntervention, 2018, 14(1): 41-49.
37. Siqueira DA, Simonato M, Ramos AA, et al. Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system. Catheter Cardiovasc Interv, 2021, 97(1): 167-174.
38. Butchart EG, Chambers J, Borer JS, et al. Long-term durability of transcatheter valves: the importance of accurate data. JACC Cardiovasc Interv, 2020, 13(2): 253-256.
39. Martín M, Cuevas J, Cigarrán H, et al. Transcatheter aortic valve implantation and subclinical and clinical leaflet thrombosis: multimodality imaging for diagnosis and risk stratification. Eur Cardiol, 2021, 16: e35.
40. Jose J, Sulimov DS, El-Mawardy M, et al. Clinical bioprosthetic heart valve thrombosis after transcatheter aortic valve replacement: incidence, characteristics, and treatment outcomes. JACC Cardiovasc Interv, 2017, 10(7): 686-697.
41. Barbanti M, Webb JG, Tamburino C, et al. Outcomes of redo transcatheter aortic valve replacement for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter valve failure. Circ Cardiovasc Interv, 2016, 9(9): e003930.
42. Sá MPBO, Van den Eynde J, Simonato M, et al. Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement: an updated meta-analysis. JACC Cardiovasc Interv, 2021, 14(2): 211-220.
43. Testa L, Agnifili M, Van Mieghem NM, et al. Transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT international project. Circ Cardiovasc Interv, 2021, 14(6): e010440.
44. Khan JM, Greenbaum AB, Babaliaros VC, et al. BASILICA trial: one-year outcomes of transcatheter electrosurgical leaflet laceration to prevent TAVR coronary obstruction. Circ Cardiovasc Interv, 2021, 14(5): e010238.
45. Simionescu DT. Prevention of calcification in bioprosthetic heart valves: challenges and perspectives. Expert Opin Biol Ther, 2004, 4(12): 1971-1985.

West China Medical Journal

Research status of long-term durability in transcatheter aortic valve replacement

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