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

Tong Tan; Hongxiang WU; Bingqi FU; Nianjin Xie; Haijiang Guo; Xin Zang; Xiaoyi LI; Haozhong Liu; Ruobing Wang; Jian Liu; Huanlei Huang; Jimei Chen; Jian Zhuang; Huiming Guo

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

VernacularTitle:国产Renatus®球囊扩张式介入瓣膜治疗重度主动脉瓣狭窄早期临床疗效的前瞻性队列研究
Author: Tong TAN ^{1
,

2
,

3} ; Hongxiang WU ^{2
,

4} ; Bingqi FU ^{1
,

2
,

3} ; Nianjin XIE ^{2
,

4} ; Haijiang GUO ^{2
,

4} ; Xin ZANG ^{2
,

4} ; Xiaoyi LI ^{2
,

4} ; Haozhong LIU ^{2
,

4} ; Ruobing WANG ^{2
,

4} ; Jian LIU ^{2
,

4} ; Huanlei HUANG ^{2
,

4} ; Jimei CHEN ^{2
,

4} ; Jian ZHUANG ^{2
,

4} ; Huiming GUO ^{2
,

4}
Author Information

1. 1. Department of Cardiovascular Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People'
2. s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, P. R. China
3. 2. Shantou University Medical College, Shantou, 515041, Guangdong, P. R. China
4. Department of Cardiovascular Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People'
Publication Type:Journal Article
Keywords: Transcatheter aortic valve replacement; balloon-expandable valve; aortic stenosis; clinical outcomes; hemodynamics
From: Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(02):214-220
CountryChina
Language:Chinese
Abstract: 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.