Transcatheter aortic valve replacement via vascular access for pure aortic regurgitation: Operational specification for dedicated devices_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LIU Lulu , SHI Jun ,  GUO Yingqiang , Writing Group for the Operation Standard of Dedicated Transvascular TAVR Devices for Pure Aortic Regurgitation

Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, 610045, P. R. China;

Corresponding?author：

GUO Yingqiang, Email: drguoyq@wchscu.cn

Keywords：

Aortic regurgitation; transcatheter aortic valve replacement; dedicated devices; complications management; operational specification

DOI：

10.7507/1007-4848.202511028

Video：

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This operational specification provides a systematic operational framework for the use of dedicated transvascular devices in transcatheter aortic valve replacement (TAVR) for patients with pure aortic regurgitation (AR). Unlike conventional systems designed for aortic stenosis, AR-specific devices incorporate specialized positioning and anchoring mechanisms that engage the native valve apparatus, effectively addressing the challenge created by the lack of annular calcification. The operational specification outlines indications and patient selection criteria, preprocedural assessment requirements, device design principles and characteristics, step-by-step procedural techniques, and strategies for preventing and managing complications associated with transvascular TAVR using these dedicated systems. The overarching aim is to improve procedural safety and reproducibility, promote broader clinical adoption of AR-specific transvascular TAVR devices, and support the optimization of long-term patient outcomes.

1.	Praz F, Borger MA, Lanz J, et al. 2025 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2025.
2.	Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet, 2006, 368(9540): 1005-1011.
3.	Yang Y, Wang Z, Chen Z, et al. Current status and etiology of valvular heart disease in China: a population-based survey. BMC Cardiovasc Disord, 2021, 21(1): 339.
4.	De Meester C, Gerber BL, Vancraeynest D, et al. Do guideline-based indications result in an outcome penalty for patients with severe aortic regurgitation? JACC Cardiovasc Imaging, 2019, 12(11 Pt 1): 2126-2138.
5.	Messika-Zeitoun D, Baumgartner H, Burwash IG, et al. Unmet needs in valvular heart disease. Eur Heart J, 2023, 44(21): 1862-1873.
6.	Xu H, Liu Q, Cao K, et al. Distribution, characteristics, and management of older patients with valvular heart disease in China: China-DVD study. JACC Asia, 2022, 2(3): 354-365.
7.	Noble S, Mauler-Wittwer S. TAVR as an alternative to SAVR for pure native aortic regurgitation. Can J Cardiol, 2024, 40(2): 316-325.
8.	Markham R, Ghodsian M, Sharma R. TAVR in patients with pure aortic regurgitation: ready to use? Curr Cardiol Rep, 2020, 22(9): 98.
9.	Samimi S, Hatab T, Kharsa C, et al. Meta-analysis of dedicated vs off-label transcatheter devices for native aortic regurgitation. JACC Cardiovasc Interv, 2025, 18(1): 44-57.
10.	Wang Y, Wei L, Liu L, et al. A multicenter prospective clinical study on transcatheter aortic valve implantation for aortic stenosis or pure aortic regurgitation: 5-year outcomes. J Thorac Cardiovasc Surg, 2025.
11.	Silaschi M, Conradi L, Wendler O, et al. The JUPITER registry: one-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv, 2018, 91(7): 1345-1351.
12.	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.
13.	Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet, 2024, 403(10435): 1451-1459.
14.	Pan W, Chen S, Li W, et al. Early results of multicenter trial of a novel balloon-expandable valve with anchor for aortic regurgitation. JACC Cardiovasc Interv, 2025, 18(6): 752-764.
15.	Wang Y, Cao T, Liu X, et al. A new benchmark for modern management of valvular heart disease: the whole-life cycle management system. JACC Asia, 2025, 5(5): 609-632.
16.	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.
17.	Michelena HI, Enriquez-Sarano M. Corrigan's pulse and Quincke's pulse. N Engl J Med, 2018, 379(5): e9.
18.	Yang LT, Pellikka PA, Enriquez-Sarano M, et al. Diastolic blood pressure and heart rate are independently associated with mortality in chronic aortic regurgitation. J Am Coll Cardiol, 2020, 75(1): 29-39.
19.	Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr, 2017, 30(4): 303-371.
20.	Blanke P, Weir-McCall JR, Achenbach S, et al. Computed tomography imaging in the context of transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR): an expert consensus document of the Society of Cardiovascular Computed Tomography. JACC Cardiovasc Imaging, 2019, 12(1): 1-24.
21.	Ranard LS, Bonow RO, Nishimura R, et al. Imaging methods for evaluation of chronic aortic regurgitation in adults: JACC state-of-the-art review. J Am Coll Cardiol, 2023, 82(20): 1953-1966.
22.	Ad N, Holmes SD, Patel J, et al. Comparison of EuroSCORE II, original EuroSCORE, and The Society of Thoracic Surgeons risk score in cardiac surgery patients. Ann Thorac Surg, 2016, 102(2): 573-579.
23.	Garcia S, Ye J, Webb J, et al. Transcatheter treatment of native aortic valve regurgitation: the North American experience with a novel device. JACC Cardiovasc Interv, 2023, 16(16): 1953-1960.
24.	Liu L, Qin C, Shi J, et al. A novel designed TAVR system for pure aortic regurgitation: first-in-human experience. JACC Cardiovasc Interv, 2023, 16(21): 2690-2691.
25.	Barrett C, Sandhu A, Tzou W. Electrophysiologic implications of transcatheter aortic valve replacement: incidence, outcomes, and current management strategies. Curr Cardiol Rep, 2021, 23(11): 167.
26.	Moreno R, Dobarro D, López de Sá E, et al. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation, 2009, 120(5): e29-e30.
27.	Lilly SM, Deshmukh AJ, Epstein AE, et al. 2020 ACC expert consensus decision pathway on management of conduction disturbances in patients undergoing transcatheter aortic valve replacement: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol, 2020, 76(20): 2391-2411.
28.	石峻, 趙元, 郭應強, TA-TAVR手術技術規范編寫組. 心尖入路經導管主動脈瓣植入手術操作規范. 中國胸心血管外科臨床雜志, 2023, 30(4): 491-500.Shi J, Zhao Y, Guo YQ, Writting Group of Procedure Specifications for TA-TAVR. Surgical operation standard for transapical transcatheter aortic valve replacement. Chin J Clin Thorac Cardiovasc Surg, 2023, 30(4): 491-500.
29.	Lederman RJ, Babaliaros VC, Rogers T, et al. Preventing coronary obstruction during transcatheter aortic valve replacement: from computed tomography to BASILICA. JACC Cardiovasc Interv, 2019, 12(13): 1197-1216.
30.	Toggweiler S, Leipsic J, Binder RK, et al. Management of vascular access in transcatheter aortic valve replacement: part 2: vascular complications. JACC Cardiovasc Interv, 2013, 6(8): 767-776.
31.	Franzone A, Piccolo R, Siontis GCM, et al. Transcatheter aortic valve replacement for the treatment of pure native aortic valve regurgitation: a systematic review. JACC Cardiovasc Interv, 2016, 9(22): 2308-2317.
32.	Levi A, Linder M, Seiffert M, et al. The impact of cerebral embolic protection devices on characteristics and outcomes of stroke complicating TAVR. JACC Cardiovasc Interv, 2024, 17(5): 666-677.

1. Praz F, Borger MA, Lanz J, et al. 2025 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2025.
2. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet, 2006, 368(9540): 1005-1011.
3. Yang Y, Wang Z, Chen Z, et al. Current status and etiology of valvular heart disease in China: a population-based survey. BMC Cardiovasc Disord, 2021, 21(1): 339.
4. De Meester C, Gerber BL, Vancraeynest D, et al. Do guideline-based indications result in an outcome penalty for patients with severe aortic regurgitation? JACC Cardiovasc Imaging, 2019, 12(11 Pt 1): 2126-2138.
5. Messika-Zeitoun D, Baumgartner H, Burwash IG, et al. Unmet needs in valvular heart disease. Eur Heart J, 2023, 44(21): 1862-1873.
6. Xu H, Liu Q, Cao K, et al. Distribution, characteristics, and management of older patients with valvular heart disease in China: China-DVD study. JACC Asia, 2022, 2(3): 354-365.
7. Noble S, Mauler-Wittwer S. TAVR as an alternative to SAVR for pure native aortic regurgitation. Can J Cardiol, 2024, 40(2): 316-325.
8. Markham R, Ghodsian M, Sharma R. TAVR in patients with pure aortic regurgitation: ready to use? Curr Cardiol Rep, 2020, 22(9): 98.
9. Samimi S, Hatab T, Kharsa C, et al. Meta-analysis of dedicated vs off-label transcatheter devices for native aortic regurgitation. JACC Cardiovasc Interv, 2025, 18(1): 44-57.
10. Wang Y, Wei L, Liu L, et al. A multicenter prospective clinical study on transcatheter aortic valve implantation for aortic stenosis or pure aortic regurgitation: 5-year outcomes. J Thorac Cardiovasc Surg, 2025.
11. Silaschi M, Conradi L, Wendler O, et al. The JUPITER registry: one-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv, 2018, 91(7): 1345-1351.
12. 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.
13. Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet, 2024, 403(10435): 1451-1459.
14. Pan W, Chen S, Li W, et al. Early results of multicenter trial of a novel balloon-expandable valve with anchor for aortic regurgitation. JACC Cardiovasc Interv, 2025, 18(6): 752-764.
15. Wang Y, Cao T, Liu X, et al. A new benchmark for modern management of valvular heart disease: the whole-life cycle management system. JACC Asia, 2025, 5(5): 609-632.
16. 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.
17. Michelena HI, Enriquez-Sarano M. Corrigan's pulse and Quincke's pulse. N Engl J Med, 2018, 379(5): e9.
18. Yang LT, Pellikka PA, Enriquez-Sarano M, et al. Diastolic blood pressure and heart rate are independently associated with mortality in chronic aortic regurgitation. J Am Coll Cardiol, 2020, 75(1): 29-39.
19. Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr, 2017, 30(4): 303-371.
20. Blanke P, Weir-McCall JR, Achenbach S, et al. Computed tomography imaging in the context of transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR): an expert consensus document of the Society of Cardiovascular Computed Tomography. JACC Cardiovasc Imaging, 2019, 12(1): 1-24.
21. Ranard LS, Bonow RO, Nishimura R, et al. Imaging methods for evaluation of chronic aortic regurgitation in adults: JACC state-of-the-art review. J Am Coll Cardiol, 2023, 82(20): 1953-1966.
22. Ad N, Holmes SD, Patel J, et al. Comparison of EuroSCORE II, original EuroSCORE, and The Society of Thoracic Surgeons risk score in cardiac surgery patients. Ann Thorac Surg, 2016, 102(2): 573-579.
23. Garcia S, Ye J, Webb J, et al. Transcatheter treatment of native aortic valve regurgitation: the North American experience with a novel device. JACC Cardiovasc Interv, 2023, 16(16): 1953-1960.
24. Liu L, Qin C, Shi J, et al. A novel designed TAVR system for pure aortic regurgitation: first-in-human experience. JACC Cardiovasc Interv, 2023, 16(21): 2690-2691.
25. Barrett C, Sandhu A, Tzou W. Electrophysiologic implications of transcatheter aortic valve replacement: incidence, outcomes, and current management strategies. Curr Cardiol Rep, 2021, 23(11): 167.
26. Moreno R, Dobarro D, López de Sá E, et al. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation, 2009, 120(5): e29-e30.
27. Lilly SM, Deshmukh AJ, Epstein AE, et al. 2020 ACC expert consensus decision pathway on management of conduction disturbances in patients undergoing transcatheter aortic valve replacement: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol, 2020, 76(20): 2391-2411.
28. 石峻, 趙元, 郭應強, TA-TAVR手術技術規范編寫組. 心尖入路經導管主動脈瓣植入手術操作規范. 中國胸心血管外科臨床雜志, 2023, 30(4): 491-500.Shi J, Zhao Y, Guo YQ, Writting Group of Procedure Specifications for TA-TAVR. Surgical operation standard for transapical transcatheter aortic valve replacement. Chin J Clin Thorac Cardiovasc Surg, 2023, 30(4): 491-500.
29. Lederman RJ, Babaliaros VC, Rogers T, et al. Preventing coronary obstruction during transcatheter aortic valve replacement: from computed tomography to BASILICA. JACC Cardiovasc Interv, 2019, 12(13): 1197-1216.
30. Toggweiler S, Leipsic J, Binder RK, et al. Management of vascular access in transcatheter aortic valve replacement: part 2: vascular complications. JACC Cardiovasc Interv, 2013, 6(8): 767-776.
31. Franzone A, Piccolo R, Siontis GCM, et al. Transcatheter aortic valve replacement for the treatment of pure native aortic valve regurgitation: a systematic review. JACC Cardiovasc Interv, 2016, 9(22): 2308-2317.
32. Levi A, Linder M, Seiffert M, et al. The impact of cerebral embolic protection devices on characteristics and outcomes of stroke complicating TAVR. JACC Cardiovasc Interv, 2024, 17(5): 666-677.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

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