Clinical feasibility of transfemoral transcatheter aortic valve replacement in the treatment of high-risk pure aortic valve regurgitation_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

CHE Bo ¹ , XU Chengyi ¹ , XU Wenjie ¹ , SUN Mengqi ¹ , HE Tongda ² , YAN Hua ¹ ,  SONG Dan ¹

1. Wuhan Asia Heart Hospital, Wuhan, 430022, P. R. China;
2. Wuhan Asia General Hospital, Wuhan, 430056, P. R. China;

Corresponding?author：

SONG Dan, Email: songdan8300@163.com

Keywords：

Transcatheter aortic valve replacement; transfemoral; transapical; pure aortic regurgitation

DOI：

10.7507/1007-4848.202303026

Video：

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Objective To assess early clinical safety and efficacy of transfemoral transcatheter aortic valve replacement (TF-TAVR) for pure aortic regurgitation (PAR). Methods The clinical data of PAR patients who underwent TAVR in Wuhan Asia Heart Hospital and Wuhan Asia General Hospital from January 2018 to October 2022 were retrospectively analyzed. Patients were divided into a TF-TAVR group and a transapical transcatheter aortic valve replacement (TA-TAVR) group. The clinical data of the patients were analyzed. Results A total of 54 patients were enrolled, including 34 males and 20 females with an average age of 74.43±6.87 years. The preoperative N-terminal pro-B-type natriuretic peptide level was lower [808.50 (143.50, 2 937.00) pg/mL vs. 2 245.00 (486.30, 7 177.50) pg/mL, P=0.015], and the left ventricular end-diastolic diameter (56.00±6.92 mm vs. 63.07±10.23 mm, P=0.005) and sinus junction diameter (32.47±4.41 mm vs. 37.65±8.08 mm, P=0.007) were smaller in the TF-TAVR group. There was no death in the two groups during the hospitalization. Only 1 new death within postoperative 1 month in the TF-TAVR group (cerebral hemorrhage). A total of 2 new deaths in the TF-TAVR group (1 patient of sudden cardiac death and 1 of multiple organ failure), and there was no death in the TA-TAVR group within postoperative 3 months. There was 1 new death in the TA-TAVR group (details unknown), and there was no death in the TF-TAVR group within postoperative 6 months. There was no statistical difference between the two groups in the all-cause mortality and the cumulative survival rate during the follow-up period (P>0.05). The incidence of high atrioventricular block was 36.0% in the TF-TAVR group and 10.3% in the TA-TAVR group (P=0.024). There were no significant differences between the two groups in the perivalvular leakage (≥moderate), valve in valve, a second valve implantation, valve migration, cerebrovascular events, major vascular complications, complete left bundle branch block, new permanent pacemaker implantation or transferring to surgery (P>0.05). However, the incidence rates of complete left bundle branch block and new permanent pacemaker implantation were higher in the TF-TAVR group, accounting for 56.0% and 40.0%, respectively. Conclusion TF-TAVR is a safe and feasible treatment for PAR patients, which is comparable to TA-TAVR in the early postoperative safety and efficacy.

Citation： CHE Bo, XU Chengyi, XU Wenjie, SUN Mengqi, HE Tongda, YAN Hua, SONG Dan. Clinical feasibility of transfemoral transcatheter aortic valve replacement in the treatment of high-risk pure aortic valve regurgitation. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(8): 1164-1173. doi: 10.7507/1007-4848.202303026 Copy

1.	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.
2.	中國醫師協會心血管內科醫師分會結構性心臟病專業委員會. 中國經導管主動脈瓣置換術臨床路徑專家共識(2021版). 中國循環雜志, 2022, 37(1): 12-23.Structural Heart Disease Professional Committee of the Cardiovascular Physicians Branch, Chinese Medical Doctor Association. 2021 expert consensus on clinical pathway for transcatheter aortic valve replacement in China. Chin Circ J, 2022, 37(1): 12-23.
3.	周達新, 潘文志, 吳永健, 等. 經導管主動脈瓣置換術中國專家共識(2020更新版). 中國介入心臟病學雜志, 2020, 28(6): 301-309.Zhou DX, Pan WZ, Wu YJ, et al. 2020 Chinese expert consensus on transcatheter aortic valve replacement. Chin J Interv Cardiol, 2020, 28(6): 301-309.
4.	Wernly B, Eder S, Navarese EP, et al. Transcatheter aortic valve replacement for pure aortic valve regurgitation: "On-label" versus "off-label" use of TAVR devices. Clin Res Cardiol, 2019, 108(8): 921-930.
5.	Rahhab Z, El Faquir N, Tchetche D, et al. Expanding the indications for transcatheter aortic valve implantation. Nat Rev Cardiol, 2020, 17(2): 75-84.
6.	車波, 徐承義, 徐文杰, 等. 經股動脈經導管主動脈瓣置換術治療單純主動脈瓣反流的研究進展. 中國介入心臟病學雜志, 2023, 31(3): 225-230.Che B, Xu CY, Xu WJ, et al. Clinical advances of transfemoral transcatheter aortic valve replacement in the treatment of pure aortic valve regurgitation. Chin J Interv Cardiol, 2023, 31(3): 225-230.
7.	Akinseye OA, Pathak A, Ibebuogu UN. Aortic valve regurgitation: A comprehensive review. Curr Probl Cardiol, 2018, 43(8): 315-334.
8.	Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro heart survey on valvular heart disease. Eur Heart J, 2003, 24(13): 1231-1243.
9.	Stachon P, Kaier K, Heidt T, et al. Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008-2015. Catheter Cardiovasc Interv, 2020, 95(4): 810-816.
10.	Tarantini G, Fabris T. Pure aortic valve regurgitation: SAVR is the gold standard, but TAVR is another gun. Catheter Cardiovasc Interv, 2020, 95(4): 817-818.
11.	Takagi H, Hari Y, Kawai N, et al. Meta-analysis and meta-regression of transcatheter aortic valve implantation for pure native aortic regurgitation. Heart Lung Circ, 2020, 29(5): 729-741.
12.	Auffret V, Puri R, Urena M, et al. Conduction disturbances after transcatheter aortic valve replacement: Current status and future perspectives. Circulation, 2017, 136(11): 1049-1069.
13.	Wang J, Liu S, Han X, et al. Prognostic outcome of new-onset left bundle branch block after transcatheter aortic valve replacement in patients with aortic stenosis: A systematic review and meta-analysis. Front Cardiovasc Med, 2022, 9: 842929.
14.	Ullah W, Zahid S, Zaidi SR, et al. Predictors of permanent pacemaker implantation in patients undergoing transcatheter aortic valve replacement: A systematic review and meta-analysis. J Am Heart Assoc, 2021, 10(14): e020906.
15.	De Torres-Alba F, Kaleschke G, Diller GP, et al. Changes in the pacemaker rate after transition from Edwards SAPIEN XT to SAPIEN 3 transcatheter aortic valve implantation: The critical role of valve implantation height. JACC Cardiovasc Interv, 2016, 9(8): 805-813.
16.	Alkhouli M, Sengupta P, Badhwar V. Toward precision in balloon-expandable TAVR: Oversizing tight versus just right. JACC Cardiovasc Interv, 2017, 10(8): 821-823.
17.	徐東輝, 羅新錦, 王旭, 等. 經股動脈經導管主動脈瓣置換術(TAVR)治療單純主動脈瓣關閉不全的臨床療效分析及術前評估. 中國胸心血管外科臨床雜志, 2021, 28(9): 1054-1060.Xu DH, Luo XJ, Wang X, et al. Outcomes and preoperative evaluation of transfemoral transcatheter aortic valve replacement (TAVR) in the treatment of pure native aortic valve regurgitation. Chin J Clin Thorac Cardiovasc Surg, 2021, 28(9): 1054-1060.
18.	Arias EA, Bhan A, Lim ZY, et al. TAVI for pure native aortic regurgitation: Are we there yet? Interv Cardiol, 2019, 14(1): 26-30.
19.	De Backer O, Pilgrim T, Simonato M, et al. Usefulness of transcatheter aortic valve implantation for treatment of pure native aortic valve regurgitation. Am J Cardiol, 2018, 122(6): 1028-1035.
20.	Chen S, Zheng F, Li M, et al. A study on correlation between preprocedural CT indexes and procedural success rate of transfemoral transcatheter aortic valve replacement with different self-expanding valves (VitaFlow or VenusA-Valve) in patients with pure native aortic regurgitation. Ann Transl Med, 2022, 10(11): 643.
21.	劉路路, 石峻, 錢宏, 等. 經導管主動脈瓣置換術治療單純主動脈瓣反流的研究進展. 中國胸心血管外科臨床雜志, 2019, 26(12): 1266-1270.Liu LL, Shi J, Qian H, et al. Advances in transcatheter aortic valve replacement for pure native aortic regurgitation. Chin J Clin Thorac Cardiovasc Surg, 2019, 26(12): 1266-1270.
22.	Fefer P, Bogdan A, Grossman Y, et al. Impact of rapid ventricular pacing on outcome after transcatheter aortic valve replacement. J Am Heart Assoc, 2018, 7(14): e009038.
23.	Kim WK, Renker M, Doerr O, et al. Impact of implantation depth on outcomes of new-generation balloon-expandable transcatheter heart valves. Clin Res Cardiol, 2021, 110(12): 1983-1992.
24.	Sammour Y, Banerjee K, Kumar A, et al. Systematic approach to high implantation of SAPIEN-3 valve achieves a lower rate of conduction abnormalities including pacemaker implantation. Circ Cardiovasc Interv, 2021, 14(1): e009407.
25.	Piayda K, Hellhammer K, Veulemans V, et al. Navigating the "optimal implantation depth" with a self-expandable TAVR device in daily clinical practice. JACC Cardiovasc Interv, 2020, 13(6): 679-688.
26.	Toggweiler S, Stortecky S, Holy E, et al. The electrocardiogram after transcatheter aortic valve replacement determines the risk for post-procedural high-degree AV block and the need for telemetry monitoring. JACC Cardiovasc Interv, 2016, 9(12): 1269-1276.
27.	Ream K, Sandhu A, Valle J, et al. Ambulatory rhythm monitoring to detect late high-grade atrioventricular block following transcatheter aortic valve replacement. J Am Coll Cardiol, 2019, 73(20): 2538-2547.

1. 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.
2. 中國醫師協會心血管內科醫師分會結構性心臟病專業委員會. 中國經導管主動脈瓣置換術臨床路徑專家共識(2021版). 中國循環雜志, 2022, 37(1): 12-23.Structural Heart Disease Professional Committee of the Cardiovascular Physicians Branch, Chinese Medical Doctor Association. 2021 expert consensus on clinical pathway for transcatheter aortic valve replacement in China. Chin Circ J, 2022, 37(1): 12-23.
3. 周達新, 潘文志, 吳永健, 等. 經導管主動脈瓣置換術中國專家共識(2020更新版). 中國介入心臟病學雜志, 2020, 28(6): 301-309.Zhou DX, Pan WZ, Wu YJ, et al. 2020 Chinese expert consensus on transcatheter aortic valve replacement. Chin J Interv Cardiol, 2020, 28(6): 301-309.
4. Wernly B, Eder S, Navarese EP, et al. Transcatheter aortic valve replacement for pure aortic valve regurgitation: "On-label" versus "off-label" use of TAVR devices. Clin Res Cardiol, 2019, 108(8): 921-930.
5. Rahhab Z, El Faquir N, Tchetche D, et al. Expanding the indications for transcatheter aortic valve implantation. Nat Rev Cardiol, 2020, 17(2): 75-84.
6. 車波, 徐承義, 徐文杰, 等. 經股動脈經導管主動脈瓣置換術治療單純主動脈瓣反流的研究進展. 中國介入心臟病學雜志, 2023, 31(3): 225-230.Che B, Xu CY, Xu WJ, et al. Clinical advances of transfemoral transcatheter aortic valve replacement in the treatment of pure aortic valve regurgitation. Chin J Interv Cardiol, 2023, 31(3): 225-230.
7. Akinseye OA, Pathak A, Ibebuogu UN. Aortic valve regurgitation: A comprehensive review. Curr Probl Cardiol, 2018, 43(8): 315-334.
8. Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro heart survey on valvular heart disease. Eur Heart J, 2003, 24(13): 1231-1243.
9. Stachon P, Kaier K, Heidt T, et al. Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008-2015. Catheter Cardiovasc Interv, 2020, 95(4): 810-816.
10. Tarantini G, Fabris T. Pure aortic valve regurgitation: SAVR is the gold standard, but TAVR is another gun. Catheter Cardiovasc Interv, 2020, 95(4): 817-818.
11. Takagi H, Hari Y, Kawai N, et al. Meta-analysis and meta-regression of transcatheter aortic valve implantation for pure native aortic regurgitation. Heart Lung Circ, 2020, 29(5): 729-741.
12. Auffret V, Puri R, Urena M, et al. Conduction disturbances after transcatheter aortic valve replacement: Current status and future perspectives. Circulation, 2017, 136(11): 1049-1069.
13. Wang J, Liu S, Han X, et al. Prognostic outcome of new-onset left bundle branch block after transcatheter aortic valve replacement in patients with aortic stenosis: A systematic review and meta-analysis. Front Cardiovasc Med, 2022, 9: 842929.
14. Ullah W, Zahid S, Zaidi SR, et al. Predictors of permanent pacemaker implantation in patients undergoing transcatheter aortic valve replacement: A systematic review and meta-analysis. J Am Heart Assoc, 2021, 10(14): e020906.
15. De Torres-Alba F, Kaleschke G, Diller GP, et al. Changes in the pacemaker rate after transition from Edwards SAPIEN XT to SAPIEN 3 transcatheter aortic valve implantation: The critical role of valve implantation height. JACC Cardiovasc Interv, 2016, 9(8): 805-813.
16. Alkhouli M, Sengupta P, Badhwar V. Toward precision in balloon-expandable TAVR: Oversizing tight versus just right. JACC Cardiovasc Interv, 2017, 10(8): 821-823.
17. 徐東輝, 羅新錦, 王旭, 等. 經股動脈經導管主動脈瓣置換術(TAVR)治療單純主動脈瓣關閉不全的臨床療效分析及術前評估. 中國胸心血管外科臨床雜志, 2021, 28(9): 1054-1060.Xu DH, Luo XJ, Wang X, et al. Outcomes and preoperative evaluation of transfemoral transcatheter aortic valve replacement (TAVR) in the treatment of pure native aortic valve regurgitation. Chin J Clin Thorac Cardiovasc Surg, 2021, 28(9): 1054-1060.
18. Arias EA, Bhan A, Lim ZY, et al. TAVI for pure native aortic regurgitation: Are we there yet? Interv Cardiol, 2019, 14(1): 26-30.
19. De Backer O, Pilgrim T, Simonato M, et al. Usefulness of transcatheter aortic valve implantation for treatment of pure native aortic valve regurgitation. Am J Cardiol, 2018, 122(6): 1028-1035.
20. Chen S, Zheng F, Li M, et al. A study on correlation between preprocedural CT indexes and procedural success rate of transfemoral transcatheter aortic valve replacement with different self-expanding valves (VitaFlow or VenusA-Valve) in patients with pure native aortic regurgitation. Ann Transl Med, 2022, 10(11): 643.
21. 劉路路, 石峻, 錢宏, 等. 經導管主動脈瓣置換術治療單純主動脈瓣反流的研究進展. 中國胸心血管外科臨床雜志, 2019, 26(12): 1266-1270.Liu LL, Shi J, Qian H, et al. Advances in transcatheter aortic valve replacement for pure native aortic regurgitation. Chin J Clin Thorac Cardiovasc Surg, 2019, 26(12): 1266-1270.
22. Fefer P, Bogdan A, Grossman Y, et al. Impact of rapid ventricular pacing on outcome after transcatheter aortic valve replacement. J Am Heart Assoc, 2018, 7(14): e009038.
23. Kim WK, Renker M, Doerr O, et al. Impact of implantation depth on outcomes of new-generation balloon-expandable transcatheter heart valves. Clin Res Cardiol, 2021, 110(12): 1983-1992.
24. Sammour Y, Banerjee K, Kumar A, et al. Systematic approach to high implantation of SAPIEN-3 valve achieves a lower rate of conduction abnormalities including pacemaker implantation. Circ Cardiovasc Interv, 2021, 14(1): e009407.
25. Piayda K, Hellhammer K, Veulemans V, et al. Navigating the "optimal implantation depth" with a self-expandable TAVR device in daily clinical practice. JACC Cardiovasc Interv, 2020, 13(6): 679-688.
26. Toggweiler S, Stortecky S, Holy E, et al. The electrocardiogram after transcatheter aortic valve replacement determines the risk for post-procedural high-degree AV block and the need for telemetry monitoring. JACC Cardiovasc Interv, 2016, 9(12): 1269-1276.
27. Ream K, Sandhu A, Valle J, et al. Ambulatory rhythm monitoring to detect late high-grade atrioventricular block following transcatheter aortic valve replacement. J Am Coll Cardiol, 2019, 73(20): 2538-2547.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Clinical feasibility of transfemoral transcatheter aortic valve replacement in the treatment of high-risk pure aortic valve regurgitation

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