An interpretation of the 2-year follow-up results of Evolut Low Risk research_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YANG Haoran , XIONG Tianyuan ,  CHEN Mao

Department of Cardiology, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

CHEN Mao, Email: hmaochen@vip.sina.com

Keywords：

Aortic stenosis; transcatheter aortic valve replacement (TAVR); low risk

DOI：

10.7507/1007-4848.202106043

Video：

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Transcatheter aortic valve replacement (TAVR) has become a well-established treatment for patients with severe aortic stenosis. At present, TAVR has already shown noninferiority and even superiority to surgical aortic valve replacement (SAVR) in patients deemed at high or intermediate risk for SAVR. However, the long-term follow-up results of the randomized controlled trials comparing the efficacy and safety between TAVR and SAVR are still lacking in those patients who are at low risk for SAVR. This paper gives an overview and reviews results of the Evolut Low Risk trial and interprets its implications for transcatheter therapy in aortic valve diseases.

Citation： YANG Haoran, XIONG Tianyuan, CHEN Mao. An interpretation of the 2-year follow-up results of Evolut Low Risk research. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2021, 28(8): 884-887. doi: 10.7507/1007-4848.202106043 Copy

1.	Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
2.	Thyregod HG, Sondergaard L, Ihlemann N, et al. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: Study protocol for a randomised controlled trial. Trials, 2013, 14: 11.
3.	hyregod HGH, Ihlemann N, Jørgensen TH, et al. Five-year clinical and echocardiographic outcomes from the Nordic Aortic Valve Intervention (NOTION) randomized clinical trial in lower surgical risk patients. Circulation, 2019. [Epub ahead of print].
4.	Mack M J, Leon M B, Thourani V H, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
5.	Thiele H, Kurz T, Feistritzer H J, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: The randomized SOLVE-TAVI trial. Eur Heart J, 2020, 41(20): 1890-1899.
6.	Webb J, Wood D, Sathananthan J, et al. Balloon-expandable or self-expandable transcatheter heart valves. Which are best? Eur Heart J, 2020, 41(20): 1900-1902.
7.	Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol, 2021, 77(4): e25-e197.
8.	Braghiroli J, Kapoor K, Thielhelm TP, et al. Transcatheter aortic valve replacement in low risk patients: A review of PARTNER 3 and Evolut Low Risk trials. Cardiovasc Diagn Ther, 2020, 10(1): 59-71.
9.	Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet, 2015, 385(9986): 2485-2491.
10.	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.
11.	Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprostheses in the PARTNER-2 trial. J Am Coll Cardiol, 2020, 76(16): 1830-1843.
12.	Roberts WC, Ko JM. Frequency by decades of unicuspid, bicuspid, and tricuspid aortic valves in adults having isolated aortic valve replacement for aortic stenosis, with or without associated aortic regurgitation. Circulation, 2005, 111(7): 920-925.
13.	Li Y, Wei X, Zhao Z, et al. Prevalence and complications of bicuspid aortic valve in Chinese according to echocardiographic database. Am J Cardiol, 2017, 120(2): 287-291.
14.	Vincent F, Ternacle J, Denimal T, et al. Transcatheter aortic valve replacement in bicuspid aortic valve stenosis. Circulation, 2021, 143(10): 1043-1061.
15.	Sa M, Simonato M, Van den Eynde J, et al. Asymptomatic severe aortic stenosis, bicuspid aortic valves and moderate aortic stenosis in heart failure: New indications for transcatheter aortic valve implantation. Trends Cardiovasc Med, 2020. [Epub ahead of print].
16.	中华医学会心血管病学分会结构性心脏病学组. 经导管主动脉瓣置换术治疗二叶式主动脉瓣狭窄的中国专家建议. 中华心血管病杂志, 2020, 48(8): 634-640.
17.	Goel SS, Ige M, Tuzcu EM, et al. Severe aortic stenosis and coronary artery disease-implications for management in the transcatheter aortic valve replacement era: A comprehensive review. J Am Coll Cardiol, 2013, 62(1): 1-10.
18.	Kvidal P, Bergström PR, Hörte LG, et al. Observed and relative survival after aortic valve replacement. J Am Coll Cardiol, 2000, 35(3): 747-756.
19.	Abdelghani M, Landt M, Traboulsi H, et al. Coronary access after TAVR with a self-expanding bioprosthesis: Insights from computed tomography. JACC Cardiovasc Interv, 2020, 13(6): 709-722.
20.	Arshi A, Yakubov SJ, Stiver KL, et al. Overcoming the transcatheter aortic valve replacement Achilles heel: Coronary re-access. Ann Cardiothorac Surg, 2020, 9(6): 468-477.
21.	Faroux L, Lhermusier T, Vincent F, et al. ST-segment elevation myocardial infarction following transcatheter aortic valve replacement. J Am Coll Cardiol, 2021, 77(17): 2187-2199.
22.	Tang GHL, Zaid S, Fuchs A, et al. Alignment of transcatheter aortic-valve neo-commissures (ALIGN TAVR): Impact on final valve orientation and coronary artery overlap. JACC Cardiovasc Interv, 2020, 13(9): 1030-1042.

1. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
2. Thyregod HG, Sondergaard L, Ihlemann N, et al. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: Study protocol for a randomised controlled trial. Trials, 2013, 14: 11.
3. hyregod HGH, Ihlemann N, Jørgensen TH, et al. Five-year clinical and echocardiographic outcomes from the Nordic Aortic Valve Intervention (NOTION) randomized clinical trial in lower surgical risk patients. Circulation, 2019. [Epub ahead of print].
4. Mack M J, Leon M B, Thourani V H, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
5. Thiele H, Kurz T, Feistritzer H J, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: The randomized SOLVE-TAVI trial. Eur Heart J, 2020, 41(20): 1890-1899.
6. Webb J, Wood D, Sathananthan J, et al. Balloon-expandable or self-expandable transcatheter heart valves. Which are best? Eur Heart J, 2020, 41(20): 1900-1902.
7. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol, 2021, 77(4): e25-e197.
8. Braghiroli J, Kapoor K, Thielhelm TP, et al. Transcatheter aortic valve replacement in low risk patients: A review of PARTNER 3 and Evolut Low Risk trials. Cardiovasc Diagn Ther, 2020, 10(1): 59-71.
9. Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet, 2015, 385(9986): 2485-2491.
10. 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.
11. Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprostheses in the PARTNER-2 trial. J Am Coll Cardiol, 2020, 76(16): 1830-1843.
12. Roberts WC, Ko JM. Frequency by decades of unicuspid, bicuspid, and tricuspid aortic valves in adults having isolated aortic valve replacement for aortic stenosis, with or without associated aortic regurgitation. Circulation, 2005, 111(7): 920-925.
13. Li Y, Wei X, Zhao Z, et al. Prevalence and complications of bicuspid aortic valve in Chinese according to echocardiographic database. Am J Cardiol, 2017, 120(2): 287-291.
14. Vincent F, Ternacle J, Denimal T, et al. Transcatheter aortic valve replacement in bicuspid aortic valve stenosis. Circulation, 2021, 143(10): 1043-1061.
15. Sa M, Simonato M, Van den Eynde J, et al. Asymptomatic severe aortic stenosis, bicuspid aortic valves and moderate aortic stenosis in heart failure: New indications for transcatheter aortic valve implantation. Trends Cardiovasc Med, 2020. [Epub ahead of print].
16. 中华医学会心血管病学分会结构性心脏病学组. 经导管主动脉瓣置换术治疗二叶式主动脉瓣狭窄的中国专家建议. 中华心血管病杂志, 2020, 48(8): 634-640.
17. Goel SS, Ige M, Tuzcu EM, et al. Severe aortic stenosis and coronary artery disease-implications for management in the transcatheter aortic valve replacement era: A comprehensive review. J Am Coll Cardiol, 2013, 62(1): 1-10.
18. Kvidal P, Bergström PR, Hörte LG, et al. Observed and relative survival after aortic valve replacement. J Am Coll Cardiol, 2000, 35(3): 747-756.
19. Abdelghani M, Landt M, Traboulsi H, et al. Coronary access after TAVR with a self-expanding bioprosthesis: Insights from computed tomography. JACC Cardiovasc Interv, 2020, 13(6): 709-722.
20. Arshi A, Yakubov SJ, Stiver KL, et al. Overcoming the transcatheter aortic valve replacement Achilles heel: Coronary re-access. Ann Cardiothorac Surg, 2020, 9(6): 468-477.
21. Faroux L, Lhermusier T, Vincent F, et al. ST-segment elevation myocardial infarction following transcatheter aortic valve replacement. J Am Coll Cardiol, 2021, 77(17): 2187-2199.
22. Tang GHL, Zaid S, Fuchs A, et al. Alignment of transcatheter aortic-valve neo-commissures (ALIGN TAVR): Impact on final valve orientation and coronary artery overlap. JACC Cardiovasc Interv, 2020, 13(9): 1030-1042.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

An interpretation of the 2-year follow-up results of Evolut Low Risk research

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