Procedure specifications for transapical transcatheter aortic valve replacement_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

SHI Jun ¹ , ZHAO Yuan ² ,  GUO Yingqiang ¹ , Writting Group of Procedure Specifications for TA-TAVR

1. Department of Cardiovascular Surgery, West China Hospital of Sichuan University, Chengdu, 610041, P. R. China;
2. Department of Cardiovascular Surgery, Xiangya Second Hospital of Central South University, Changsha, 350122, P. R. China;

Corresponding author：

GUO Yingqiang, Email: drguoyq@hotmail.com

Keywords：

Transcatheter aortic valve replacement; transapical; aortic regurgitation; surgical procedures

DOI：

10.7507/1007-4848.202302011

Video：

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Transcatheter aortic valve replacement (TAVR) techniques have been rapidly developed in recent years. Current guidelines and studies mainly focus on aortic stenosis patients treated by transfemoral approach, but they are not completely appropriate to patients with isolated aortic regurgitation or other patients who need transapical TAVR (TA-TAVR), which affects the standardized treatment of those patients. Therefore, our team pronounced the operational standards for TA-TAVR, based on fully reviewing the literatures worldwide, combined with the opinions of experts from 15 heart centers with rich experience in carrying out TA-TAVR in China. This standard aims to provide clinicians with standardized diagnosis and treatment principles of TA-TAVR and improve the quality of TA-TAVR in China.

Citation： SHI Jun, ZHAO Yuan, GUO Yingqiang, Writting Group of Procedure Specifications for TA-TAVR. Procedure specifications for transapical transcatheter aortic valve replacement. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(4): 491-500. doi: 10.7507/1007-4848.202302011 Copy

1.	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.
2.	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.
3.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease: Developed by the Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Rev Esp Cardiol (Engl Ed), 2022, 75(6): 524.
4.	潘文志, 周达新, 葛均波. 最新经导管主动脉瓣置换器械的研发与创新. 中国医刊, 2020, 55(1): 8-11.
5.	Rotman OM, Bianchi M, Ghosh RP, et al. Principles of TAVR valve design, modelling, and testing. Expert Rev Med Devices, 2018, 15(11): 771-791.
6.	Shi J, Wei L, Chen Y, et al. Transcatheter aortic valve implantation with J-valve: 2-year outcomes from a multicenter study. Ann Thorac Surg, 2021, 111(5): 1530-1536.
7.	Jayasuriya C, Moss RR, Munt B. Transcatheter aortic valve implantation in aortic stenosis: The role of echocardiography. J Am Soc Echocardiogr, 2011, 24(1): 15-27.
8.	Fernandes P, Cleland A, Bainbridge D, et al. Development of our TAVI protocol for emergency initiation of cardiopulmonary bypass. Perfusion, 2015, 30(1): 34-39.
9.	Bavaria JE, Tommaso CL, Brindis RG, et al. 2018 AATS/ACC/SCAI/STS expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement: A joint report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol, 2019, 73(3): 340-374.
10.	周达新, 潘文志, 吴永健, 等. 经导管主动脉瓣置换术中国专家共识(2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
11.	"心尖入路经导管主动脉瓣植入术麻醉管理规范"工作组. 心尖入路经导管主动脉瓣植入术麻醉管理规范. 中华麻醉学杂志, 2021, 41(2): 133-137.
12.	Sullivan BL, Bartels K, Hamilton N. Insertion and management of temporary pacemakers. Semin Cardiothorac Vasc Anesth, 2016, 20(1): 52-62.
13.	Rodés-Cabau J, Ellenbogen KA, Krahn AD, et al. Management of conduction disturbances associated with transcatheter aortic valve replacement: JACC Scientific Expert Panel. J Am Coll Cardiol, 2019, 74(8): 1086-1106.
14.	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.
15.	Banks A, Gaca J, Kiefer T. Review of alternative access in transcatheter aortic valve replacement. Cardiovasc Diagn Ther, 2020, 10(1): 72-82.
16.	McInerney A, Vera-Urquiza R, Tirado-Conte G, et al. Pre-dilation and post-dilation in transcatheter aortic valve replacement: Indications, benefits and risks. Interv Cardiol, 2021, 16: e28.
17.	Thourani VH, Jensen HA, Babaliaros V, et al. Transapical and transaortic transcatheter aortic valve replacement in the United States. Ann Thorac Surg, 2015, 100(5): 1718-1726.
18.	Fassa AA, Himbert D, Vahanian A. Mechanisms and management of TAVR-related complications. Nat Rev Cardiol, 2013, 10(12): 685-695.
19.	Gerckens U, Tamburino C, Bleiziffer S, et al. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J, 2017, 38(36): 2729-2738.
20.	Wendler O, Schymik G, Treede H, et al. SOURCE 3registry: Design and 30-day results of the european postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation, 2017, 135(12): 1123-1132.
21.	Sinning JM, Vasa-Nicotera M, Chin D, et al. Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement. J Am Coll Cardiol, 2013, 62(1): 11-20.
22.	Eleid MF, Cabalka AK, Malouf JF, et al. Techniques and outcomes for the treatment of paravalvular leak. Circ Cardiovasc Interv, 2015, 8(8): e001945.
23.	Pollari F, Dell’Aquila AM, Söhn C, et al. Risk factors for paravalvular leak after transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2019, 157(4): 1406-1415.
24.	Fanous EJ, Mukku RB, Dave P, et al. Paravalvular leak assessment: Challenges in assessing severity and interventional approaches. Curr Cardiol Rep, 2020, 22(12): 166.
25.	Aguirre J, Waskowski R, Poddar K, et al. Transcatheter aortic valve replacement: Experience with the transapical approach, alternate access sites, and concomitant cardiac repairs. J Thorac Cardiovasc Surg, 2014, 148(4): 1417-1422.
26.	Tabata M. Transapical approach in transcatheter cardiovascular interventions. Gen Thorac Cardiovasc Surg, 2018, 66(4): 185-191.
27.	Mach M, Okutucu S, Kerbel T, et al. Vascular complications in TAVR: Incidence, clinical impact, and management. J Clin Med, 2021, 10(21): 5046.
28.	Heitkemper M, Hatoum H, Azimian A, et al. Modeling risk of coronary obstruction during transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2020, 159(3): 829-838.
29.	Palmerini T, Chakravarty T, Saia F, et al. Coronary protection to prevent coronary obstruction during TAVR: A multicenter international registry. JACC Cardiovasc Interv, 2020, 13(6): 739-747.
30.	Qian H, Chen Y, Cheng Z, et al. An alternative solution for patient with high risk of coronary obstruction underwent TAVI procedure using a novel second-generation device—A case series. J Cardiothorac Surgy, 2019, 14: 1-3.
31.	Ye J, Lee A J, Blanke P, et al. The first transapical transcatheter aortic valve‐in‐valve implantation using the J‐valve system into a failed biophysio aortic prosthesis in a patient with high risk of coronary obstruction. Catheter Cardiovasc Interv, 2018, 92(6): 1209-1214.
32.	Valvo R, Costa G, Barbanti M. How to avoid coronary occlusion during TAVR valve-in-valve procedures. Front Cardiovasc Med, 2019, 6: 168.
33.	Tchetche D, Farah B, Misuraca L, et al. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: A FRANCE-2 registry substudy. JACC Cardiovasc Interv, 2014, 7(10): 1138-1145.
34.	Ghatak A, Bavishi C, Cardoso RN, et al. Complications and mortality in patients undergoing transcatheter aortic valve replacement with Edwards SAPIEN & SAPIEN XT valves: A meta‐analysis of world‐wide studies and registries comparing the transapical and transfemoral accesses. J Interv Cardiol, 2015, 28(3): 266-278.
35.	Lowenstern A, Hung A, Manandhar P, et al. Association of transcatheter aortic valve replacement reimbursement, new technology add-on payment, and procedure volumes with embolic protection device use. JAMA Cardiol, 2022, 7(9): 945-952.
36.	Rubín JM, Avanzas P, del Valle R, et al. Atrioventricular conduction disturbance characterization in transcatheter aortic valve implantation with the CoreValve prosthesis. Circ Cardiovasc Interv, 2011, 4(3): 280-286.
37.	Aljabbary T, Qiu F, Masih S, et al. Association of clinical and economic outcomes with permanent pacemaker implantation after transcatheter aortic valve replacement. JAMA Netw Open, 2018, 1(1): e180088.
38.	Tung M, Wang X, Li F, et al. A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system. J Cardiol, 2018, 72(5): 377-384.
39.	Vallabhajosyula S, Patlolla SH, Sandhyavenu H, et al. Periprocedural cardiopulmonary bypass or venoarterial extracorporeal membrane oxygenation during transcatheter aortic valve replacement: A systematic review. J Am Heart Assoc, 2018, 7(14): e009608.

1. 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.
2. 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.
3. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease: Developed by the Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Rev Esp Cardiol (Engl Ed), 2022, 75(6): 524.
4. 潘文志, 周达新, 葛均波. 最新经导管主动脉瓣置换器械的研发与创新. 中国医刊, 2020, 55(1): 8-11.
5. Rotman OM, Bianchi M, Ghosh RP, et al. Principles of TAVR valve design, modelling, and testing. Expert Rev Med Devices, 2018, 15(11): 771-791.
6. Shi J, Wei L, Chen Y, et al. Transcatheter aortic valve implantation with J-valve: 2-year outcomes from a multicenter study. Ann Thorac Surg, 2021, 111(5): 1530-1536.
7. Jayasuriya C, Moss RR, Munt B. Transcatheter aortic valve implantation in aortic stenosis: The role of echocardiography. J Am Soc Echocardiogr, 2011, 24(1): 15-27.
8. Fernandes P, Cleland A, Bainbridge D, et al. Development of our TAVI protocol for emergency initiation of cardiopulmonary bypass. Perfusion, 2015, 30(1): 34-39.
9. Bavaria JE, Tommaso CL, Brindis RG, et al. 2018 AATS/ACC/SCAI/STS expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement: A joint report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol, 2019, 73(3): 340-374.
10. 周达新, 潘文志, 吴永健, 等. 经导管主动脉瓣置换术中国专家共识(2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
11. "心尖入路经导管主动脉瓣植入术麻醉管理规范"工作组. 心尖入路经导管主动脉瓣植入术麻醉管理规范. 中华麻醉学杂志, 2021, 41(2): 133-137.
12. Sullivan BL, Bartels K, Hamilton N. Insertion and management of temporary pacemakers. Semin Cardiothorac Vasc Anesth, 2016, 20(1): 52-62.
13. Rodés-Cabau J, Ellenbogen KA, Krahn AD, et al. Management of conduction disturbances associated with transcatheter aortic valve replacement: JACC Scientific Expert Panel. J Am Coll Cardiol, 2019, 74(8): 1086-1106.
14. 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.
15. Banks A, Gaca J, Kiefer T. Review of alternative access in transcatheter aortic valve replacement. Cardiovasc Diagn Ther, 2020, 10(1): 72-82.
16. McInerney A, Vera-Urquiza R, Tirado-Conte G, et al. Pre-dilation and post-dilation in transcatheter aortic valve replacement: Indications, benefits and risks. Interv Cardiol, 2021, 16: e28.
17. Thourani VH, Jensen HA, Babaliaros V, et al. Transapical and transaortic transcatheter aortic valve replacement in the United States. Ann Thorac Surg, 2015, 100(5): 1718-1726.
18. Fassa AA, Himbert D, Vahanian A. Mechanisms and management of TAVR-related complications. Nat Rev Cardiol, 2013, 10(12): 685-695.
19. Gerckens U, Tamburino C, Bleiziffer S, et al. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J, 2017, 38(36): 2729-2738.
20. Wendler O, Schymik G, Treede H, et al. SOURCE 3registry: Design and 30-day results of the european postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation, 2017, 135(12): 1123-1132.
21. Sinning JM, Vasa-Nicotera M, Chin D, et al. Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement. J Am Coll Cardiol, 2013, 62(1): 11-20.
22. Eleid MF, Cabalka AK, Malouf JF, et al. Techniques and outcomes for the treatment of paravalvular leak. Circ Cardiovasc Interv, 2015, 8(8): e001945.
23. Pollari F, Dell’Aquila AM, Söhn C, et al. Risk factors for paravalvular leak after transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2019, 157(4): 1406-1415.
24. Fanous EJ, Mukku RB, Dave P, et al. Paravalvular leak assessment: Challenges in assessing severity and interventional approaches. Curr Cardiol Rep, 2020, 22(12): 166.
25. Aguirre J, Waskowski R, Poddar K, et al. Transcatheter aortic valve replacement: Experience with the transapical approach, alternate access sites, and concomitant cardiac repairs. J Thorac Cardiovasc Surg, 2014, 148(4): 1417-1422.
26. Tabata M. Transapical approach in transcatheter cardiovascular interventions. Gen Thorac Cardiovasc Surg, 2018, 66(4): 185-191.
27. Mach M, Okutucu S, Kerbel T, et al. Vascular complications in TAVR: Incidence, clinical impact, and management. J Clin Med, 2021, 10(21): 5046.
28. Heitkemper M, Hatoum H, Azimian A, et al. Modeling risk of coronary obstruction during transcatheter aortic valve replacement. J Thorac Cardiovasc Surg, 2020, 159(3): 829-838.
29. Palmerini T, Chakravarty T, Saia F, et al. Coronary protection to prevent coronary obstruction during TAVR: A multicenter international registry. JACC Cardiovasc Interv, 2020, 13(6): 739-747.
30. Qian H, Chen Y, Cheng Z, et al. An alternative solution for patient with high risk of coronary obstruction underwent TAVI procedure using a novel second-generation device—A case series. J Cardiothorac Surgy, 2019, 14: 1-3.
31. Ye J, Lee A J, Blanke P, et al. The first transapical transcatheter aortic valve‐in‐valve implantation using the J‐valve system into a failed biophysio aortic prosthesis in a patient with high risk of coronary obstruction. Catheter Cardiovasc Interv, 2018, 92(6): 1209-1214.
32. Valvo R, Costa G, Barbanti M. How to avoid coronary occlusion during TAVR valve-in-valve procedures. Front Cardiovasc Med, 2019, 6: 168.
33. Tchetche D, Farah B, Misuraca L, et al. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: A FRANCE-2 registry substudy. JACC Cardiovasc Interv, 2014, 7(10): 1138-1145.
34. Ghatak A, Bavishi C, Cardoso RN, et al. Complications and mortality in patients undergoing transcatheter aortic valve replacement with Edwards SAPIEN & SAPIEN XT valves: A meta‐analysis of world‐wide studies and registries comparing the transapical and transfemoral accesses. J Interv Cardiol, 2015, 28(3): 266-278.
35. Lowenstern A, Hung A, Manandhar P, et al. Association of transcatheter aortic valve replacement reimbursement, new technology add-on payment, and procedure volumes with embolic protection device use. JAMA Cardiol, 2022, 7(9): 945-952.
36. Rubín JM, Avanzas P, del Valle R, et al. Atrioventricular conduction disturbance characterization in transcatheter aortic valve implantation with the CoreValve prosthesis. Circ Cardiovasc Interv, 2011, 4(3): 280-286.
37. Aljabbary T, Qiu F, Masih S, et al. Association of clinical and economic outcomes with permanent pacemaker implantation after transcatheter aortic valve replacement. JAMA Netw Open, 2018, 1(1): e180088.
38. Tung M, Wang X, Li F, et al. A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system. J Cardiol, 2018, 72(5): 377-384.
39. Vallabhajosyula S, Patlolla SH, Sandhyavenu H, et al. Periprocedural cardiopulmonary bypass or venoarterial extracorporeal membrane oxygenation during transcatheter aortic valve replacement: A systematic review. J Am Heart Assoc, 2018, 7(14): e009608.

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