Li Jie, Sun Yinghao, Luo Songyuan, Zheng Shengneng, Chen Jiaohua, Fu Ming, Fang Zhenfei, Wang Yan, Li Guang, Fan Ruixin, Luo Jianfang
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong Cardiovascular Institute, Guangzhou, China.
Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China.
Front Cardiovasc Med. 2023 Aug 24;10:1169590. doi: 10.3389/fcvm.2023.1169590. eCollection 2023.
The outcomes of transcatheter aortic valve replacement (TAVR) employing the second-generation retrievable VenusA-Pro and VenusA-Plus delivery systems with the self-expanding VenusA-Valve have not been described yet. This study aims to report the outcomes of these two second-generation delivery systems.
From January 2022 to April 2023, we prospectively enrolled patients with severe aortic stenosis undergoing TAVR with VenusA-Pro from three centers across China in this first-in-man study and retrospectively identified those undergoing TAVR with VenusA-Plus. All outcomes were reported according to the Valve Academic Research Consortium 3 definition. The primary outcome was 30-day all-cause mortality.
A total of 156 patients were included, of which 46 underwent TAVR with VenusA-Pro and 110 underwent TAVR with VenusA-Plus. The Society of Thoracic Surgeons median score was 2.1%, bicuspid anatomy prevalence rate was 55.1%, and the mean aortic root calcification volume was 693 mm. The technical success rate was 91.7%, comparable between the VenusA-Pro and VenusA-Plus groups (87.0% vs. 93.6%, = 0.169). The 30-day all-cause mortality was 2.6%, similar between the VenusA-Pro and VenusA-Plus groups (2.2% vs. 2.7%, = 0.842). No myocardial infarction occurred. The incidences of stroke (0.6%), major bleeding (3.8%), major vascular complications (5.1%), acute kidney injury (9.0%), permanent pacemaker implantation (5.1%), new-onset atrial fibrillation (5.8%), and moderate-to-severe paravalvular aortic regurgitation (6.0%) were favorable and comparable between the two groups. The clinical outcomes were similar between the patients with bicuspid and tricuspid aortic valve, except that the incidence of permanent pacemaker implantation was lower in patients with bicuspid anatomy (1.2% vs. 10.6%, = 0.010).
The 30-day outcomes of TAVR with VenusA-Pro and VenusA-Plus were favorable and comparable.
使用第二代可回收VenusA-Pro和VenusA-Plus输送系统以及自膨胀VenusA瓣膜进行经导管主动脉瓣置换术（TAVR）的结果尚未见报道。本研究旨在报告这两种第二代输送系统的结果。
从2022年1月至2023年4月，在这项首例人体研究中，我们前瞻性纳入了来自中国三个中心的重度主动脉瓣狭窄患者，这些患者接受了使用VenusA-Pro的TAVR治疗，并回顾性确定了接受使用VenusA-Plus的TAVR治疗的患者。所有结果均根据瓣膜学术研究联盟3的定义进行报告。主要结局为30天全因死亡率。
共纳入156例患者，其中46例接受了使用VenusA-Pro的TAVR治疗，110例接受了使用VenusA-Plus的TAVR治疗。胸外科医师协会中位评分2.1%，二叶式解剖结构患病率55.1%，主动脉根部平均钙化体积693 mm。技术成功率为91.7%，VenusA-Pro组和VenusA-Plus组相当（87.0%对93.6%，P = 0.169）。30天全因死亡率为2.6%，VenusA-Pro组和VenusA-Plus组相似（2.2%对2.7%，P = 0.842）。未发生心肌梗死。两组的卒中发生率（0.6%）、大出血发生率（3.8%）、主要血管并发症发生率（5.1%）、急性肾损伤发生率（9.0%）、永久起搏器植入率（5.1%）、新发房颤发生率（5.8%）以及中重度瓣周主动脉反流发生率（6.0%）均良好且相当。二叶式和三叶式主动脉瓣患者的临床结局相似，只是二叶式解剖结构患者的永久起搏器植入率较低（1.2%对10.6%，P = 0.010）。
使用VenusA-Pro和VenusA-Plus进行TAVR的30天结局良好且相当。
