Safety of transcatheter aortic valve replacement through different approaches: A systematic review and meta-analysis_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

JIN Libo ¹ ,  WU Hao ² , FENG Weizhong ¹ , XU Peng ¹ , ZENG Yong ¹ , ZHOU Junqing ¹

1. Department of Cardiovascular Surgery, Shaoxing People's Hospital, Shaoxing, 312000, Zhejiang, P.R.China;
2. Department of Cardiothoracic Surgery, The Affiliated Hospital of Hangzhou Normal University, Hangzhou, 310015, P.R.China;

Corresponding author：

WU Hao, Email: xiaoleshui@163.com

Keywords：

Transcatheter aortic valve replacement (TAVR); transfemoral; transapical; transsubclavian; systematic review/meta-analysis

DOI：

10.7507/1007-4848.202010068

Video：

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Objective To evaluate the early and mid-term safety of transcatheter aortic valve replacement via transfemoral (TF), transapical (TAp) and transsubclavian (TSc) approaches by meta-analysis.Methods We systematically searched the clinical comparative trials published from inception to June 2019 from PubMed, Web of Science, EMbase and The Cochrane Library, to evaluate the safety of transcatheter aortic valve replacement through TF, TAp or TSc approaches. The information of all-cause mortality at 30 days, 1 year, 2 years and the incidence of common complications at 30 days after operation (including pacemaker-dependent block, major vascular complications, severe bleeding events, acute renal injury and stroke) were exacted, and a meta-analysis was conducted by RevMan 5.3 software.Results This study included 11 literatures, with a total of 7 833 patients, among whom 5 348 patients were treated by TF TAVR, 1 796 patients by TAp TAVR and 689 patients by TSc TAVR. The results of the meta-analysis were as follows: (1) at 30 days after operation, the mortality of TF and TSc approaches were lower than that of the TAp approach (TF vs. TAp: OR=0.57, 95%CI 0.39-0.84, P=0.004; TSc vs. TAp: OR=4.12, 95%CI 1.93-8.79, P=0.000 3). There was no statistical difference between the TF and TSc approaches (TF vs. TSc: OR=0.98, 95%CI 0.38-2.51, P=0.97); at 1 year, there was no statistical difference in mortality among the three approaches (P>0.05); at 2 years, there was no statistical difference between TSc and TF or TAp approaches (TF vs. TSc: OR=1.21, 95%CI 0.95-1.54, P=0.13; TSc vs. TAp: OR=1.02, 95%CI 0.76-1.36, P=0.91). (2) The incidence of acute kidney injury after TF approach was lower than that of the TAp approach (OR=0.30, 95%CI 0.22-0.41, P<0.000 01). (3) There was no statistical difference in major vascular complications between TSc and TF or TAp approaches (TF vs. TSc: OR=0.75, 95%CI 0.38-1.49, P=0.41; TSc vs. TAp: OR=1.37, 95%CI 0.56-3.32, P=0.49). (4) There was no statistical difference in severe bleeding events between TF and TSc (OR=0.97, 95%CI 0.53-1.76, P=0.92). (5) There was no statistical difference in the incidence of postoperative stroke, pacemaker dependent block among the three approaches (P>0.05).Conclusion TAp and TSc approaches are safe and effective. They are not only an alternative to TF approach, but also the first choice in some patients with poor condition of iliofemoral artery.

Citation： JIN Libo, WU Hao, FENG Weizhong, XU Peng, ZENG Yong, ZHOU Junqing. Safety of transcatheter aortic valve replacement through different approaches: A systematic review and meta-analysis. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2021, 28(7): 765-776. doi: 10.7507/1007-4848.202010068 Copy

1.	Arora S, Misenheimer JA, Ramaraj R. Transcatheter aortic valve replacement: Comprehensive review and present status. Tex Heart Inst J, 2017, 44(1): 29-38.
2.	Nguyen TC, Terwelp MD, Thourani VH, et al. Clinical trends in surgical, minimally invasive and transcatheter aortic valve replacement. Eur J Cardiothorac Surg, 2017, 51(6): 1086-1092.
3.	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.
4.	Durko AP, Osnabrugge RL, Kappetein AP. Long-term outlook for transcatheter aortic valve replacement. Trends Cardiovasc Med, 2018, 28(3): 174-183.
5.	Petronio AS, De Carlo M, Bedogni F, et al. 2-year results of CoreValve implantation through the subclavian access: A propensity-matched comparison with the femoral access. J Am Coll Cardiol, 2012, 60(6): 502-507.
6.	Fröhlich GM, Baxter PD, Malkin CJ, et al. Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry). Am J Cardiol, 2015, 116(10): 1555-1559.
7.	Moynagh AM, Scott DJ, Baumbach A, et al. CoreValve transcatheter aortic valve implantation via the subclavian artery: Comparison with the transfemoral approach. J Am Coll Cardiol, 2011, 57(5): 634-635.
8.	Ewe SH, Delgado V, Ng AC, et al. Outcomes after transcatheter aortic valve implantation: Transfemoral versus transapical approach. Ann Thorac Surg, 2011, 92(4): 1244-1251.
9.	Muensterer A, Mazzitelli D, Ruge H, et al. Safety and efficacy of the subclavian access route for TAVI in cases of missing transfemoral access. Clin Res Cardiol, 2013, 102(9): 627-636.
10.	Gleason TG, Schindler JT, Hagberg RC, et al. Subclavian/axillary access for self-expanding transcatheter aortic valve replacement renders equivalent outcomes as transfemoral. Ann Thorac Surg, 2018, 105(2): 477-483.
11.	Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation, 2010, 122(1): 62-69.
12.	Eltchaninoff H, Prat A, Gilard M, et al. Transcatheter aortic valve implantation: Early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J, 2011, 32(2): 191-197.
13.	Rodés-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: Acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol, 2010, 55(11): 1080-1090.
14.	Codner P, Pugliese D, Kouz R, et al. Transcatheter aortic valve replacement by a novel suprasternal approach. Ann Thorac Surg, 2018, 105(4): 1215-1222.
15.	Ciuca C, Tarantini G, Latib A, et al. Trans-subclavian versus transapical access for transcatheter aortic valve implantation: A multicenter study. Catheter Cardiovasc Interv, 2016, 87(2): 332-338.
16.	Bosmans JM, Kefer J, De Bruyne B, et al. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: Results of the Belgian national registry. Interact Cardiovasc Thorac Surg, 2011, 12(5): 762-767.
17.	Amat-Santos IJ, Rojas P, Gutiérrez H, et al. Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv, 2018, 92(5): 935-944.
18.	Garcia DC, Benjo A, Cardoso RN, et al. Device stratified comparison among transfemoral, transapical and transubclavian access for Transcatheter Aortic Valve Replacement (TAVR): A meta-analysis. Int J Cardiol, 2014, 172(2): e318-e321.
19.	Carabello BA. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. Curr Cardiol Rep, 2011, 13(3): 173-174.
20.	Murarka S, Lazkani M, Neihaus M, et al. Comparison of 30-day outcomes of transfemoral versus transapical approach for transcatheter aortic valve replacement: A single-center US experience. Ann Thorac Surg, 2015, 99(5): 1539-1544.
21.	Reents W, Barth S, Griese DP, et al. Transfemoral versus transapical transcatheter aortic valve implantation: A single-centre experience. Eur J Cardiothorac Surg, 2019, 55(4): 744-750.
22.	Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U. K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol, 2011, 58(20): 2130-2138.

1. Arora S, Misenheimer JA, Ramaraj R. Transcatheter aortic valve replacement: Comprehensive review and present status. Tex Heart Inst J, 2017, 44(1): 29-38.
2. Nguyen TC, Terwelp MD, Thourani VH, et al. Clinical trends in surgical, minimally invasive and transcatheter aortic valve replacement. Eur J Cardiothorac Surg, 2017, 51(6): 1086-1092.
3. 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.
4. Durko AP, Osnabrugge RL, Kappetein AP. Long-term outlook for transcatheter aortic valve replacement. Trends Cardiovasc Med, 2018, 28(3): 174-183.
5. Petronio AS, De Carlo M, Bedogni F, et al. 2-year results of CoreValve implantation through the subclavian access: A propensity-matched comparison with the femoral access. J Am Coll Cardiol, 2012, 60(6): 502-507.
6. Fröhlich GM, Baxter PD, Malkin CJ, et al. Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry). Am J Cardiol, 2015, 116(10): 1555-1559.
7. Moynagh AM, Scott DJ, Baumbach A, et al. CoreValve transcatheter aortic valve implantation via the subclavian artery: Comparison with the transfemoral approach. J Am Coll Cardiol, 2011, 57(5): 634-635.
8. Ewe SH, Delgado V, Ng AC, et al. Outcomes after transcatheter aortic valve implantation: Transfemoral versus transapical approach. Ann Thorac Surg, 2011, 92(4): 1244-1251.
9. Muensterer A, Mazzitelli D, Ruge H, et al. Safety and efficacy of the subclavian access route for TAVI in cases of missing transfemoral access. Clin Res Cardiol, 2013, 102(9): 627-636.
10. Gleason TG, Schindler JT, Hagberg RC, et al. Subclavian/axillary access for self-expanding transcatheter aortic valve replacement renders equivalent outcomes as transfemoral. Ann Thorac Surg, 2018, 105(2): 477-483.
11. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation, 2010, 122(1): 62-69.
12. Eltchaninoff H, Prat A, Gilard M, et al. Transcatheter aortic valve implantation: Early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J, 2011, 32(2): 191-197.
13. Rodés-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: Acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol, 2010, 55(11): 1080-1090.
14. Codner P, Pugliese D, Kouz R, et al. Transcatheter aortic valve replacement by a novel suprasternal approach. Ann Thorac Surg, 2018, 105(4): 1215-1222.
15. Ciuca C, Tarantini G, Latib A, et al. Trans-subclavian versus transapical access for transcatheter aortic valve implantation: A multicenter study. Catheter Cardiovasc Interv, 2016, 87(2): 332-338.
16. Bosmans JM, Kefer J, De Bruyne B, et al. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: Results of the Belgian national registry. Interact Cardiovasc Thorac Surg, 2011, 12(5): 762-767.
17. Amat-Santos IJ, Rojas P, Gutiérrez H, et al. Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv, 2018, 92(5): 935-944.
18. Garcia DC, Benjo A, Cardoso RN, et al. Device stratified comparison among transfemoral, transapical and transubclavian access for Transcatheter Aortic Valve Replacement (TAVR): A meta-analysis. Int J Cardiol, 2014, 172(2): e318-e321.
19. Carabello BA. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. Curr Cardiol Rep, 2011, 13(3): 173-174.
20. Murarka S, Lazkani M, Neihaus M, et al. Comparison of 30-day outcomes of transfemoral versus transapical approach for transcatheter aortic valve replacement: A single-center US experience. Ann Thorac Surg, 2015, 99(5): 1539-1544.
21. Reents W, Barth S, Griese DP, et al. Transfemoral versus transapical transcatheter aortic valve implantation: A single-centre experience. Eur J Cardiothorac Surg, 2019, 55(4): 744-750.
22. Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U. K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol, 2011, 58(20): 2130-2138.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Safety of transcatheter aortic valve replacement through different approaches: A systematic review and meta-analysis

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