Preliminary clinical outcomes of the domestic Renatus® balloon-expandable valve system for the treatment of severe aortic stenosis: A prospective cohort study_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

TAN Tong ^1,2 , WU Hongxiang ¹ , FU Bingqi ^1,2 , XIE Nianjin ¹ , GUO Haijiang ¹ , ZANG Xin ¹ , LI Xiaoyi ¹ , LIU Haozhong ¹ , WANG Ruobing ¹ ,  LIU Jian ¹ , HUANG Huanlei ¹ , CHEN Jimei ¹ , ZHUANG Jian ¹ ,  GUO Huiming ¹

1. Department of Cardiovascular Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, P. R. China;
2. Shantou University Medical College, Shantou, 515041, Guangdong, P. R. China;

Corresponding author：

LIU Jian, Email: Jameslau1984@sina.com; GUO Huiming, Email: guohuiming@gdph.org.cn

Keywords：

Transcatheter aortic valve replacement; balloon-expandable valve; aortic stenosis; clinical outcomes; hemodynamics

DOI：

10.7507/1007-4848.202207024

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the early clinical outcomes of the Renatus® balloon-expandable valve in the treatment of severe aortic stenosis. Methods From November 2021 to April 2022, a total of 38 patients who received Renatus® balloon-expandable valve for severe aortic stenosis in Guangdong Provincial People's Hospital were included. There were 22 males and 16 females, with an average age of 73.7±5.3 years. Mean aortic gradient and peak aortic jet velocity at baseline, post-procedure, and follow-up were compared. Clinical outcomes including all-cause mortality, perivalvular leakage, serious adverse cardiovascular events and the occurrence of permanent pacemaker implantation were assessed. Results All patients completed the procedure successfully without conversion to thoracotomy or perioperative death. The post-implant mean aortic pressure gradient was decreased from 41.5 (27.8, 58.8) mm Hg to 6.0 (3.0, 8.0) mm Hg, and the peak aortic jet velocity was also decreased from 4.1±0.9 m/s to 1.7±0.4 m/s (P<0.001). Pacemakers were required in 2 (5.3%) patients. The median follow-up time was 27.5 (23.0, 87.5) d, with a follow-up rate of 100.0%. The mean aortic gradient was 8.0 (7.0, 10.8) mm Hg and peak aortic jet velocity was 2.0±0.3 m/s, showing significant improvement compared with those in the preoperative period (P<0.001). No severe aortic regurgitation or paravalvular leak was observed. There was no serious cardiovascular adverse event or reoperative event during the study period. Conclusion Transcatheter aortic valve replacement with the domestic Renatus® balloon-expandable valve system is a safe and effective procedure for selected patients with severe aortic stenosis who are at high risk or not candidates for surgical aortic valve replacement.

Citation： TAN Tong, WU Hongxiang, FU Bingqi, XIE Nianjin, GUO Haijiang, ZANG Xin, LI Xiaoyi, LIU Haozhong, WANG Ruobing, LIU Jian, HUANG Huanlei, CHEN Jimei, ZHUANG Jian, GUO Huiming. Preliminary clinical outcomes of the domestic Renatus® balloon-expandable valve system for the treatment of severe aortic stenosis: A prospective cohort study. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(2): 214-220. doi: 10.7507/1007-4848.202207024 Copy

1.	李喆, 郭帅, 叶蕴青, 等. 中国中重度主动脉瓣疾病患者的临床特点及预后: 来自China-VHD研究的分析. 中国循环杂志, 2022, 37(4): 322-328.
2.	Otto CM, Burwash IG, Legget ME, et al. Prospective study of asymptomatic valvular aortic stenosis. Clinical, echocardiographic, and exercise predictors of outcome. Circulation, 1997, 95(9): 2262-2270.
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.	Gertz ZM, Pibarot P, Douglas PS, et al. Implications of left ventricular geometry in low-flow aortic stenosis: A PARTNER 2 trial subanalysis. JACC Cardiovasc Imaging, 2019, 12(2): 367-368.
5.	Reardon MJ, van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
6.	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.
7.	中国结构性心脏病介入治疗进展报告编写组. 中国结构性心脏病介入治疗进展报告2020. 中国循环杂志, 2021, 36(9): 833-840.
8.	齐喜玲, 许海燕, 刘庆荣, 等. 中国老年退行性心脏瓣膜病住院患者诊疗现状分析. 中国循环杂志, 2019, 34(8): 771-776.
9.	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.
10.	中国医师协会心血管内科医师分会结构性心脏病专业委员会. 中国经导管主动脉瓣置换术临床路径专家共识 (2021版). 中国循环杂志, 2022, 37(1): 12-23.
11.	Herre HD, Falkenthal S, Lenz P. The tolbutamide effect in normal pregnancy. Z Geburtshilfe Gynakol, 1968, 169(3): 310-320.
12.	Popma JJ, Reardon MJ, Khabbaz K, et al. Early clinical outcomes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic stenosis who are suboptimal for surgery: Results of the Evolut R U. S. Study. JACC Cardiovasc Interv, 2017, 10(3): 268-275.
13.	Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transcatheter aortic valve replacement: The CHOICE randomized clinical trial. JAMA, 2014, 311(15): 1503-1514.
14.	Abdel-Wahab M, Landt M, Neumann FJ, et al. 5-year outcomes after tavr with balloon-expandable versus self-expanding valves: Results from the CHOICE randomized clinical trial. JACC Cardiovasc Interv, 2020, 13(9): 1071-1082.
15.	Vlastra W, Chandrasekhar J, Muñoz-Garcia AJ, et al. Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration. Eur Heart J, 2019, 40(5): 456-465.
16.	Van Belle E, Vincent F, Labreuche J, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement: A propensity-matched comparison from the FRANCE-TAVI Registry. Circulation, 2020, 141(4): 243-259.
17.	Thiele H, Kurz T, Feistritzer HJ, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: The randomized SOLVE-TAVI trial. Eur Heart J, 2020, 41(20): 1890-1899.
18.	Witberg G, Landes U, Talmor-Barkan Y, et al. Center valve preference and outcomes of transcatheter aortic valve replacement: Insights from the AMTRAC Registry. JACC Cardiovasc Interv, 2022, 15(12): 1266-1274.
19.	Carroll JD, Vemulapalli S, Dai D, et al. Procedural experience for transcatheter aortic valve replacement and relation to outcomes: The STS/ACC TVT Registry. J Am Coll Cardiol, 2017, 70(1): 29-41.
20.	Russo MJ, McCabe JM, Thourani VH, et al. Case volume and outcomes after TAVR with balloon-expandable prostheses: Insights from TVT Registry. J Am Coll Cardiol, 2019, 73(4): 427-440.
21.	魏家富, 杨皓然, 彭勇, 等. 球扩式瓣膜Prizvalve经导管主动脉瓣膜系统治疗重度主动脉瓣狭窄的初步研究. 中华心血管病杂志, 2022, 50(2): 137-141.
22.	潘文志, 张源, 吴永健, 等. SAPIEN3经导管主动脉瓣膜系统中国上市前研究的早期临床结果. 中国胸心血管外科临床杂志, 2022, 29(5): 553-559.
23.	宋光远, 王墨扬, 王媛, 等. Venus-A主动脉瓣膜介入治疗重度主动脉瓣狭窄的效果. 中华心血管病杂志, 2017, 45(10): 843-847.
24.	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.
25.	Miyasaka M, Tada N, Taguri M, et al. Incidence, predictors, and clinical impact of prosthesis-patient mismatch following transcatheter aortic valve replacement in Asian patients: The OCEAN-TAVI Registry. JACC Cardiovasc Interv, 2018, 11(8): 771-780.
26.	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.
27.	Jilaihawi H, Wu Y, Yang Y, et al. Morphological characteristics of severe aortic stenosis in China: Imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv, 2015, 85 Suppl 1: 752-761.
28.	Binder RK, Webb JG, Willson AB, et al. The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: A prospective, multicenter, controlled trial. J Am Coll Cardiol, 2013, 62(5): 431-438.

1. 李喆, 郭帅, 叶蕴青, 等. 中国中重度主动脉瓣疾病患者的临床特点及预后: 来自China-VHD研究的分析. 中国循环杂志, 2022, 37(4): 322-328.
2. Otto CM, Burwash IG, Legget ME, et al. Prospective study of asymptomatic valvular aortic stenosis. Clinical, echocardiographic, and exercise predictors of outcome. Circulation, 1997, 95(9): 2262-2270.
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. Gertz ZM, Pibarot P, Douglas PS, et al. Implications of left ventricular geometry in low-flow aortic stenosis: A PARTNER 2 trial subanalysis. JACC Cardiovasc Imaging, 2019, 12(2): 367-368.
5. Reardon MJ, van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
6. 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.
7. 中国结构性心脏病介入治疗进展报告编写组. 中国结构性心脏病介入治疗进展报告2020. 中国循环杂志, 2021, 36(9): 833-840.
8. 齐喜玲, 许海燕, 刘庆荣, 等. 中国老年退行性心脏瓣膜病住院患者诊疗现状分析. 中国循环杂志, 2019, 34(8): 771-776.
9. 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.
10. 中国医师协会心血管内科医师分会结构性心脏病专业委员会. 中国经导管主动脉瓣置换术临床路径专家共识 (2021版). 中国循环杂志, 2022, 37(1): 12-23.
11. Herre HD, Falkenthal S, Lenz P. The tolbutamide effect in normal pregnancy. Z Geburtshilfe Gynakol, 1968, 169(3): 310-320.
12. Popma JJ, Reardon MJ, Khabbaz K, et al. Early clinical outcomes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic stenosis who are suboptimal for surgery: Results of the Evolut R U. S. Study. JACC Cardiovasc Interv, 2017, 10(3): 268-275.
13. Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transcatheter aortic valve replacement: The CHOICE randomized clinical trial. JAMA, 2014, 311(15): 1503-1514.
14. Abdel-Wahab M, Landt M, Neumann FJ, et al. 5-year outcomes after tavr with balloon-expandable versus self-expanding valves: Results from the CHOICE randomized clinical trial. JACC Cardiovasc Interv, 2020, 13(9): 1071-1082.
15. Vlastra W, Chandrasekhar J, Muñoz-Garcia AJ, et al. Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration. Eur Heart J, 2019, 40(5): 456-465.
16. Van Belle E, Vincent F, Labreuche J, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement: A propensity-matched comparison from the FRANCE-TAVI Registry. Circulation, 2020, 141(4): 243-259.
17. Thiele H, Kurz T, Feistritzer HJ, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: The randomized SOLVE-TAVI trial. Eur Heart J, 2020, 41(20): 1890-1899.
18. Witberg G, Landes U, Talmor-Barkan Y, et al. Center valve preference and outcomes of transcatheter aortic valve replacement: Insights from the AMTRAC Registry. JACC Cardiovasc Interv, 2022, 15(12): 1266-1274.
19. Carroll JD, Vemulapalli S, Dai D, et al. Procedural experience for transcatheter aortic valve replacement and relation to outcomes: The STS/ACC TVT Registry. J Am Coll Cardiol, 2017, 70(1): 29-41.
20. Russo MJ, McCabe JM, Thourani VH, et al. Case volume and outcomes after TAVR with balloon-expandable prostheses: Insights from TVT Registry. J Am Coll Cardiol, 2019, 73(4): 427-440.
21. 魏家富, 杨皓然, 彭勇, 等. 球扩式瓣膜Prizvalve经导管主动脉瓣膜系统治疗重度主动脉瓣狭窄的初步研究. 中华心血管病杂志, 2022, 50(2): 137-141.
22. 潘文志, 张源, 吴永健, 等. SAPIEN3经导管主动脉瓣膜系统中国上市前研究的早期临床结果. 中国胸心血管外科临床杂志, 2022, 29(5): 553-559.
23. 宋光远, 王墨扬, 王媛, 等. Venus-A主动脉瓣膜介入治疗重度主动脉瓣狭窄的效果. 中华心血管病杂志, 2017, 45(10): 843-847.
24. 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.
25. Miyasaka M, Tada N, Taguri M, et al. Incidence, predictors, and clinical impact of prosthesis-patient mismatch following transcatheter aortic valve replacement in Asian patients: The OCEAN-TAVI Registry. JACC Cardiovasc Interv, 2018, 11(8): 771-780.
26. 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.
27. Jilaihawi H, Wu Y, Yang Y, et al. Morphological characteristics of severe aortic stenosis in China: Imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv, 2015, 85 Suppl 1: 752-761.
28. Binder RK, Webb JG, Willson AB, et al. The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: A prospective, multicenter, controlled trial. J Am Coll Cardiol, 2013, 62(5): 431-438.

Previous Article
肝圆韧带修补下腔静脉治疗复杂肝泡型包虫病1例报道
Next Article
肝圆韧带修补下腔静脉治疗复杂肝泡型包虫病1例报道

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Preliminary clinical outcomes of the domestic Renatus® balloon-expandable valve system for the treatment of severe aortic stenosis: A prospective cohort study

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content