Interpretation of 7-year follow-up outcomes of PERIGON trial_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LI Jun , ZUO Zheng ,  WANG Chunsheng

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

Corresponding?author：

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

Keywords：

PERIGON trial; bioprosthetic valve; aortic valve disease; surgical aortic valve replacement; structural durability; hemodynamic performance; valve-related adverse events; structural valve deterioration

DOI：

10.7507/1007-4848.202512016

Video：

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With the progressive aging of the population and the evolving spectrum of aortic valve disease, bioprosthetic valve has gained widespread clinical adoption owing to their reduced requirement for lifelong anticoagulation and impact on patients’ postoperative quality of life. Consequently, the long-term durability of bioprosthetic valve has become a central focus in contemporary valvular research. The Avalus valve, representing a new generation stented bovine pericardial valve, incorporates optimized leaflet configuration, stent geometry, and anti-calcification treatment to achieve a balance between superior hemodynamic performance and structural durability. The recently reported 7-year outcomes of the PERIGON trial demonstrated excellent mid- and long-term outcomes, a remarkably low incidence of valve-related adverse events and sustained hemodynamic stability throughout follow-up. Importantly, no cases required reintervention for structural valve deterioration, underscoring the outstanding durability profile of the Avalus valve in surgical aortic valve replacement. This article reviews PERIGON trial clinical outcomes and discusses significance of the Avalus valve, as well as the future directions for bioprosthetic valve therapy in Chinese patients.

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7.	Klautz RJM, Dagenais F, Reardon MJ, et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg, 2022, 62(3): ezac374.
8.	Sabik JF 3rd, Rao V, Dagenais F, et al. Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1 100 patients: a prospective multicentre analysis. Eur J Cardiothorac Surg, 2024, 67(1): ezae414.
9.	Kiaii BB, Moront MG, Patel HJ, et al. Outcomes of surgical bioprosthetic aortic valve replacement in patients aged ≤65 and >65 years. Ann Thorac Surg, 2023, 116(3): 483-490.
10.	Zoghbi WA, Jone PN, Chamsi-Pasha MA, et al. Guidelines for the evaluation of prosthetic valve function with cardiovascular imaging: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society of Cardiovascular Computed Tomography. J Am Soc Echocardiogr, 2024, 37(1): 2-63.
11.	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.
12.	Hahn RT, Pibarot P. Prosthesis-patient mismatch in transcatheter and surgical aortic valve replacement. Ann Cardiothorac Surg, 2024, 13(3): 211-223.
13.	Nishimura RA, Otto CM, Bonow RO, et al. 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 Practice Guidelines. Circulation, 2014, 129(23): e521-e643.
14.	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. Circulation, 2021, 143(5): e72-e227.
15.	Lee G, Chikwe J, Milojevic M, et al. ESC/EACTS vs. ACC/AHA guidelines for the management of severe aortic stenosis. Eur Heart J, 2023, 44(10): 796-812.
16.	Tchétché D, Chevalier B, Holzhey D, et al. TAVR for failed surgical aortic bioprostheses using a self-expanding device: 1-year results from the prospective VIVA postmarket study. JACC Cardiovasc Interv, 2019, 12(10): 923-932.
17.	Danesh S, Tam V, Lee A, et al. Influence of effective orifice area on long-term survival in bioprosthetic versus mechanical aortic valves. J Thorac Cardiovasc Surg, 2025.
18.	Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg, 2024, 168(3): 781-791.
19.	Onorati F, Geisler D, Theron A, et al. Five-year results of aortic valve replacement with a novel bioprosthesis: real-world data from a large multicenter registry. Ann Thorac Surg, 2025.
20.	Weber PA, Jouan J, Matsunaga A, et al. Evidence of mitigated calcification of the Mosaic versus Hancock Standard valve xenograft in the mitral position of young sheep. J Thorac Cardiovasc Surg, 2006, 132(5): 1137-1143.
21.	Duarte IG, MacDonald MJ, Cooper WA, et al. In vivo hemodynamic, histologic, and antimineralization characteristics of the Mosaic bioprosthesis. Ann Thorac Surg, 2001, 71(1): 92-99.
22.	Rie? FC, Fradet G, Lavoie A, et al. Long-term outcomes of the Mosaic bioprosthesis. Ann Thorac Surg, 2018, 105(3): 763-769.
23.	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, 2021, 162(5): 1478-1485.
24.	Krishnaswamy A, Abbas AE, Babaliaros VC, et al. Mid-term outcomes of balloon-expandable aortic valve-in-valve replacement in the United States. JACC Cardiovasc Interv, 2025, 18(16): 1989-2000.
25.	Han QQ, Xu ZY, Zhang BR, et al. Primary triple valve surgery for advanced rheumatic heart disease in Mainland China: a single-center experience with 871 clinical cases. Eur J Cardiothorac Surg, 2007, 31(5): 845-850.
26.	Wei L, Wang B, Yang Y, et al. Transcatheter aortic valve replacement in China: a review of the available evidence. AsiaIntervention, 2024, 10(2): 110-118.
27.	Lin M, Gan N, Chen J, et al. A single-center 14-year follow-up study of the BalMedic bovine pericardial bioprosthetic valve. Ann Transl Med, 2020, 8(11): 692.
28.	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.
29.	Simonato M, Whisenant B, Ribeiro HB, et al. Transcatheter mitral valve replacement after surgical repair or replacement: comprehensive midterm evaluation of valve-in-valve and valve-in-ring implantation from the VIVID registry. Circulation, 2021, 143(2): 104-116.
30.	Beerkens FJ, Tang GHL, Kini AS, et al. Transcatheter aortic valve replacement beyond severe aortic stenosis: JACC state-of-the-art review. J Am Coll Cardiol, 2025, 85(9): 944-964.

1. 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.
2. 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.
3. Praz F, Borger MA, Lanz J, et al. 2025 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2025, 46(44):4635-4736.
4. Leviner DB, Abraham D, Ronai T, et al. Mechanical valves: past, present, and future-a review. J Clin Med, 2024, 13(13): 3768.
5. Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J, 2021, 42(19): 1825-1857.
6. Dagenais F, Moront MG, Brown WM, et al. Safety, efficacy, and hemodynamic performance of a stented bovine pericardial aortic valve bioprosthesis: two-year analysis. J Thorac Cardiovasc Surg, 2020, 160(2): 371-381. e374.
7. Klautz RJM, Dagenais F, Reardon MJ, et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg, 2022, 62(3): ezac374.
8. Sabik JF 3rd, Rao V, Dagenais F, et al. Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1 100 patients: a prospective multicentre analysis. Eur J Cardiothorac Surg, 2024, 67(1): ezae414.
9. Kiaii BB, Moront MG, Patel HJ, et al. Outcomes of surgical bioprosthetic aortic valve replacement in patients aged ≤65 and >65 years. Ann Thorac Surg, 2023, 116(3): 483-490.
10. Zoghbi WA, Jone PN, Chamsi-Pasha MA, et al. Guidelines for the evaluation of prosthetic valve function with cardiovascular imaging: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society of Cardiovascular Computed Tomography. J Am Soc Echocardiogr, 2024, 37(1): 2-63.
11. 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.
12. Hahn RT, Pibarot P. Prosthesis-patient mismatch in transcatheter and surgical aortic valve replacement. Ann Cardiothorac Surg, 2024, 13(3): 211-223.
13. Nishimura RA, Otto CM, Bonow RO, et al. 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 Practice Guidelines. Circulation, 2014, 129(23): e521-e643.
14. 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. Circulation, 2021, 143(5): e72-e227.
15. Lee G, Chikwe J, Milojevic M, et al. ESC/EACTS vs. ACC/AHA guidelines for the management of severe aortic stenosis. Eur Heart J, 2023, 44(10): 796-812.
16. Tchétché D, Chevalier B, Holzhey D, et al. TAVR for failed surgical aortic bioprostheses using a self-expanding device: 1-year results from the prospective VIVA postmarket study. JACC Cardiovasc Interv, 2019, 12(10): 923-932.
17. Danesh S, Tam V, Lee A, et al. Influence of effective orifice area on long-term survival in bioprosthetic versus mechanical aortic valves. J Thorac Cardiovasc Surg, 2025.
18. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg, 2024, 168(3): 781-791.
19. Onorati F, Geisler D, Theron A, et al. Five-year results of aortic valve replacement with a novel bioprosthesis: real-world data from a large multicenter registry. Ann Thorac Surg, 2025.
20. Weber PA, Jouan J, Matsunaga A, et al. Evidence of mitigated calcification of the Mosaic versus Hancock Standard valve xenograft in the mitral position of young sheep. J Thorac Cardiovasc Surg, 2006, 132(5): 1137-1143.
21. Duarte IG, MacDonald MJ, Cooper WA, et al. In vivo hemodynamic, histologic, and antimineralization characteristics of the Mosaic bioprosthesis. Ann Thorac Surg, 2001, 71(1): 92-99.
22. Rie? FC, Fradet G, Lavoie A, et al. Long-term outcomes of the Mosaic bioprosthesis. Ann Thorac Surg, 2018, 105(3): 763-769.
23. 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, 2021, 162(5): 1478-1485.
24. Krishnaswamy A, Abbas AE, Babaliaros VC, et al. Mid-term outcomes of balloon-expandable aortic valve-in-valve replacement in the United States. JACC Cardiovasc Interv, 2025, 18(16): 1989-2000.
25. Han QQ, Xu ZY, Zhang BR, et al. Primary triple valve surgery for advanced rheumatic heart disease in Mainland China: a single-center experience with 871 clinical cases. Eur J Cardiothorac Surg, 2007, 31(5): 845-850.
26. Wei L, Wang B, Yang Y, et al. Transcatheter aortic valve replacement in China: a review of the available evidence. AsiaIntervention, 2024, 10(2): 110-118.
27. Lin M, Gan N, Chen J, et al. A single-center 14-year follow-up study of the BalMedic bovine pericardial bioprosthetic valve. Ann Transl Med, 2020, 8(11): 692.
28. 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.
29. Simonato M, Whisenant B, Ribeiro HB, et al. Transcatheter mitral valve replacement after surgical repair or replacement: comprehensive midterm evaluation of valve-in-valve and valve-in-ring implantation from the VIVID registry. Circulation, 2021, 143(2): 104-116.
30. Beerkens FJ, Tang GHL, Kini AS, et al. Transcatheter aortic valve replacement beyond severe aortic stenosis: JACC state-of-the-art review. J Am Coll Cardiol, 2025, 85(9): 944-964.

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