Implications of five-year outcomes of COMMENCE (SAVR) trial for aortic valve surgery in China_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

 WANG Chunsheng , LU Shuyang

Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, P.R.China;

Corresponding author：

WANG Chunsheng, Email: wang.chunsheng@zs-hospital.sh.cn

Keywords：

Surgical aortic valve replacement (SAVR); transcatheter aortic valve replacement (TAVR); structural valve deterioration; COMMENCE trial

DOI：

10.7507/1007-4848.202104039

Video：

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The advent of transcatheter aortic valve replacement (TAVR) has brought up a new treatment option for patients with severe aortic valve disease. However, with the continuous expansion of surgical indications, problems such as structural valve deterioration caused by biological prosthesis have become increasingly prominent. In the newly announced 5-year follow-up results of COMMENCE (SAVR) trial, the aortic bioprosthesis using the new RESILIA biotissue material demonstrated extraordinary clinical safety, efficacy and durability with zero structural valve deterioration and excellent hemodynamic evaluation results. As a result, patients with valvular heart disease have more diverse therapeutic options. However, the choice between surgical aortic valve replacement (SAVR) and TAVR, biological prosthesis and mechanical prosthesis, etc, has become more and more prominent, which brings more difficulties to clinicians. This paper reviews the research background, 5-year follow-up results of COMMENCE trial and the implications for aortic valve surgery in China.

Citation： WANG Chunsheng, LU Shuyang. Implications of five-year outcomes of COMMENCE (SAVR) trial for aortic valve surgery in China. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2021, 28(8): 877-883. doi: 10.7507/1007-4848.202104039 Copy

1.	Puskas JD, Bavaria JE, Svensson LG, et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg, 2017, 52(3): 432-439.
2.	Johnston DR, Griffith BP, Puskas JD, et al. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg, 2020, S0022-5223(20): 30474-30478.
3.	Bavaria J, Griffith B, Heimansohn DA, et al. Presented at the Society of Thoracic Surgeons Annual Meeting, January 2021.
4.	Akins CW, Miller DC, Turina MI, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg, 2008, 135(4): 732-738.
5.	Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J, 2012, 33(19): 2451-2496.
6.	Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart fisease: A report of the American College of Cardiology/American Heart AssociatioN Task Force on Practice Guidelines. Circulation, 2014, 129(23): e521-643.
7.	Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2017, 38(36): 2739-2791.
8.	Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 2017, 135(25): e1159-e1195.
9.	Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart fisease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2021, 143(5): e72-e227.
10.	Brown JM, O'Brien SM, Wu C, et al. Isolated aortic valve replacement in North America comprising 108, 687 patients in 10 years: Changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg, 2009, 137(1): 82-90.
11.	Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
12.	Leon MB, Mack MJ, Hahn RT, et al. Outcomes 2 years after transcatheter aortic valve replacement in patients at low surgical risk. J Am Coll Cardiol, 2021, 77(9): 1149-1161.
13.	Harken DE, Soroff HS, Taylor WJ, et al. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovasc Surg, 1960, 40: 744-762.
14.	Starr A, Edwards ML. Mitral replacement: Clinical experience with a ball-valve prosthesis. Ann Surg, 1961, 154(4): 726-740.
15.	Cimbollek M, Nies B, Wenz R, et al. Antibiotic-impregnated heart valve sewing rings for treatment and prophylaxis of bacterial endocarditis. Antimicrob Agents Chemother, 1996, 40(6): 1432-1437.
16.	Tsvelodub S, Pieper B, Stock S, et al. Long-term (up to 21 years) follow up after biological and mechanical aortic valve replacement in younger patients. J Heart Valve Dis, 2017, 26(5): 528-536.
17.	Celiento M, Ravenni G, Tomei L, et al. Excellent durability of the mosaic porcine aortic bioprosthesis at extended follow up. J Heart Valve Dis, 2018, 27(1): 97-103.
18.	Bourguignon T, Bouquiaux-Stablo AL, Candolfi P, et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg, 2015, 99(3): 831-837.
19.	Forcillo J, El Hamamsy I, Stevens LM, et al. The perimount valve in the aortic position: Twenty-year experience with patients under 60 years old. Ann Thorac Surg, 2014, 97(5): 1526-1532.
20.	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.
21.	Pan W, Zhou D, Wu Y, et al. First-in-human results of a novel user-friendly transcatheter edge-to-edge mitral valve repair device. JACC Cardiovasc Interv, 2019, 12(23): 2441-2443.
22.	Lu FL, Ma Y, An Z, et al. First-in-man experience of transcatheter tricuspid valve replacement withlux-valve in high-risk tricuspid regurgitation patients. JACC Cardiovasc Interv, 2020, 13(13): 1614-1616.

1. Puskas JD, Bavaria JE, Svensson LG, et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg, 2017, 52(3): 432-439.
2. Johnston DR, Griffith BP, Puskas JD, et al. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg, 2020, S0022-5223(20): 30474-30478.
3. Bavaria J, Griffith B, Heimansohn DA, et al. Presented at the Society of Thoracic Surgeons Annual Meeting, January 2021.
4. Akins CW, Miller DC, Turina MI, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg, 2008, 135(4): 732-738.
5. Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J, 2012, 33(19): 2451-2496.
6. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart fisease: A report of the American College of Cardiology/American Heart AssociatioN Task Force on Practice Guidelines. Circulation, 2014, 129(23): e521-643.
7. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2017, 38(36): 2739-2791.
8. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 2017, 135(25): e1159-e1195.
9. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart fisease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2021, 143(5): e72-e227.
10. Brown JM, O'Brien SM, Wu C, et al. Isolated aortic valve replacement in North America comprising 108, 687 patients in 10 years: Changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg, 2009, 137(1): 82-90.
11. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
12. Leon MB, Mack MJ, Hahn RT, et al. Outcomes 2 years after transcatheter aortic valve replacement in patients at low surgical risk. J Am Coll Cardiol, 2021, 77(9): 1149-1161.
13. Harken DE, Soroff HS, Taylor WJ, et al. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovasc Surg, 1960, 40: 744-762.
14. Starr A, Edwards ML. Mitral replacement: Clinical experience with a ball-valve prosthesis. Ann Surg, 1961, 154(4): 726-740.
15. Cimbollek M, Nies B, Wenz R, et al. Antibiotic-impregnated heart valve sewing rings for treatment and prophylaxis of bacterial endocarditis. Antimicrob Agents Chemother, 1996, 40(6): 1432-1437.
16. Tsvelodub S, Pieper B, Stock S, et al. Long-term (up to 21 years) follow up after biological and mechanical aortic valve replacement in younger patients. J Heart Valve Dis, 2017, 26(5): 528-536.
17. Celiento M, Ravenni G, Tomei L, et al. Excellent durability of the mosaic porcine aortic bioprosthesis at extended follow up. J Heart Valve Dis, 2018, 27(1): 97-103.
18. Bourguignon T, Bouquiaux-Stablo AL, Candolfi P, et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg, 2015, 99(3): 831-837.
19. Forcillo J, El Hamamsy I, Stevens LM, et al. The perimount valve in the aortic position: Twenty-year experience with patients under 60 years old. Ann Thorac Surg, 2014, 97(5): 1526-1532.
20. 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.
21. Pan W, Zhou D, Wu Y, et al. First-in-human results of a novel user-friendly transcatheter edge-to-edge mitral valve repair device. JACC Cardiovasc Interv, 2019, 12(23): 2441-2443.
22. Lu FL, Ma Y, An Z, et al. First-in-man experience of transcatheter tricuspid valve replacement withlux-valve in high-risk tricuspid regurgitation patients. JACC Cardiovasc Interv, 2020, 13(13): 1614-1616.

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Implications of five-year outcomes of COMMENCE (SAVR) trial for aortic valve surgery in China

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