Safety and effectiveness of the SAPIEN 3 transcatheter heart valve in the treatment of severe aortic stenosis: Early clinical outcomes of a multicenter study in China_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

PAN Wenzhi ¹ , ZHANG Yuan ¹ , WU Yongjian ² , WANG Jian'an ³ , CHEN Mao ⁴ , FENG Yuan ⁴ , CHEN Shasha ¹ ,  ZHOU Daxin ¹ ,  GE Junbo ¹

1. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, P. R. China;
2. Department of Cardiology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, P. R. China;
3. Department of Cardiology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, 310003, P. R. China;
4. Department of Cardiology, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;

Corresponding author：

ZHOU Daxin, Email: zhou.daxin@zs-hospital.sh.cn; GE Junbo, Email: ge.junbo@zs-hospital.sh.cn

Keywords：

Transcatheter aortic valve replacement; aortic stenosis; balloon expandable valve

DOI：

10.7507/1007-4848.202112043

Video：

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Objective To evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 system. Methods This was a prospective, multicenter, single arm study in 4 centers in China. The clinical data of 50 patients with high-risk symptomatic severe aortic stenosis who underwent TAVR using the SAPIEN 3 system from June 2017 to June 2019 were analyzed, including 27 males and 23 females aged 76.8±6.1 years. Results The Society of Thoracic Surgeon score was 6.0%±2.8%. Totally, 20.0% of patients had severe bicuspid aortic stenosis. The operation time was 41.8±16.5 min and the hospital stay time was 8.5±5.0 d. At the postoperative 30-day follow-up, no all-cause mortality occurred and the device success rate was 89.5%. Major vascular complications occurred in one (2.0%) patient, stroke in one (2.0%) patient, new pacemaker implantation in one (2.0%) patient, as well as coronary artery obstruction in one (2.0%) patient. There was no moderate or moderate/severe paravalvular leak. The aortic pressure gradient was decreased from 49.2±16.2 mm Hg before the operation to 12.4±4.6 mm Hg at the postoperative 30-day follow-up, and the valvular area was increased from 0.6±0.3 cm² to 1.3±0.3 cm² (P<0.01). Moreover, the New York Heart Association classification in 83.7% of the patients was improved during the follow-up. Conclusion This pre-marketing multicenter study has demonstrated the safety and effectiveness of transfemoral TAVR with the SAPIEN 3 transcatheter valve system in Chinese aortic stenosis patients at high risk for surgery.

Citation： PAN Wenzhi, ZHANG Yuan, WU Yongjian, WANG Jian'an, CHEN Mao, FENG Yuan, CHEN Shasha, ZHOU Daxin, GE Junbo. Safety and effectiveness of the SAPIEN 3 transcatheter heart valve in the treatment of severe aortic stenosis: Early clinical outcomes of a multicenter study in China. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(5): 553-559. doi: 10.7507/1007-4848.202112043 Copy

1.	Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
2.	Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
3.	Wendler O, Schymik G, Treede H, et al. SOURCE 3 Registry: 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.
4.	Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet, 2016, 387(10034): 2218-2225.
5.	Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 Consensus document. J Am Coll Cardiol, 2012, 60(15): 1438-1454.
6.	Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med, 2010, 363(17): 1597-1607.
7.	Kodali S, Pibarot P, Douglas PS, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: Characterizing patients and impact on outcomes. Eur Heart J, 2015, 36(7): 449.
8.	Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol, 2014, 63(19): 1972-1981.
9.	Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med, 2011, 364(23): 2187-2198.
10.	Thyregod HG, Steinbrüchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol, 2015, 65(20): 2184-2194.
11.	Zhou D, Pan W, Wang J, et al. VitaFlow™ transcatheter valve system in the treatment of severe aortic stenosis: One-year results of a multicenter study. Catheter Cardiovasc Interv, 2020, 95(2): 332-338.
12.	Song GY, Wang MY, Wang Y, et al. Effect of transcatheter aortic valve replacement using Venus-A valve for treating patients with severe aortic stenosis. Zhonghua Xin Xue Guan Bing Za Zhi, 2017, 45(10): 843-847.
13.	Saia F, Gandolfo C, Palmerini T, et al. In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: The S3U registry. EuroIntervention, 2020, 15(14): 1240-1247.
14.	Ducrocq G, Francis F, Serfaty JM, et al. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: Incidence and impact on outcome. EuroIntervention, 2010, 5(6): 666-672.
15.	Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
16.	Herrmann HC, Thourani VH, Kodali SK, et al. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation, 2016, 134(2): 130-140.
17.	Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol, 2014, 64(21): 2235-2243.
18.	Pan W, Zhou D, Cheng L, et al. Candidates for transcatheter aortic valve implantation may be fewer in China. Int J Cardiol, 2013, 168(5): e133-e134.

1. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
2. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
3. Wendler O, Schymik G, Treede H, et al. SOURCE 3 Registry: 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.
4. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet, 2016, 387(10034): 2218-2225.
5. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 Consensus document. J Am Coll Cardiol, 2012, 60(15): 1438-1454.
6. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med, 2010, 363(17): 1597-1607.
7. Kodali S, Pibarot P, Douglas PS, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: Characterizing patients and impact on outcomes. Eur Heart J, 2015, 36(7): 449.
8. Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol, 2014, 63(19): 1972-1981.
9. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med, 2011, 364(23): 2187-2198.
10. Thyregod HG, Steinbrüchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol, 2015, 65(20): 2184-2194.
11. Zhou D, Pan W, Wang J, et al. VitaFlow™ transcatheter valve system in the treatment of severe aortic stenosis: One-year results of a multicenter study. Catheter Cardiovasc Interv, 2020, 95(2): 332-338.
12. Song GY, Wang MY, Wang Y, et al. Effect of transcatheter aortic valve replacement using Venus-A valve for treating patients with severe aortic stenosis. Zhonghua Xin Xue Guan Bing Za Zhi, 2017, 45(10): 843-847.
13. Saia F, Gandolfo C, Palmerini T, et al. In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: The S3U registry. EuroIntervention, 2020, 15(14): 1240-1247.
14. Ducrocq G, Francis F, Serfaty JM, et al. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: Incidence and impact on outcome. EuroIntervention, 2010, 5(6): 666-672.
15. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
16. Herrmann HC, Thourani VH, Kodali SK, et al. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation, 2016, 134(2): 130-140.
17. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol, 2014, 64(21): 2235-2243.
18. Pan W, Zhou D, Cheng L, et al. Candidates for transcatheter aortic valve implantation may be fewer in China. Int J Cardiol, 2013, 168(5): e133-e134.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Safety and effectiveness of the SAPIEN 3 transcatheter heart valve in the treatment of severe aortic stenosis: Early clinical outcomes of a multicenter study in China

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