Objective This study evaluated the safety and efficacy of the Renatus transcatheter aortic valve system in treating severe aortic stenosis. Methods This prospective, multicenter, single-arm clinical trial employed a target-value approach.The primary endpoint was the all-cause mortality rate at one year postoperatively, while secondary endpoints included assessments of safety and effectiveness. Safety was measured by the all-cause mortality rate at 30 days, the incidence of major adverse cardiovascular events within one year, and the device success rate. Effectiveness was assessed using transvalvular pressure gradient measurements, the incidence of paravalvular leaks, improvements in New York Heart Association (NYHA) cardiac function classification, and quality of life assessments. Results The study enrolled 166 patients across 14 national centers between July 2021 and April 2022, with a mean age of 73.9 +/- 6.0 years and a median STS risk score of 7.7% (IQR 4.1-8.8). Notably, 58.4% of participants had a bicuspid aortic valve (BAV). Baseline comparisons revealed that BAV patients were marginally younger than tricuspid aortic valve (TAV) patients (median age 73 [IQR 69-77] vs. 74 [IQR 71-79], p = 0.055), with larger annular diameters, greater calcification, and more transverse aortic anatomy. All-cause mortality rates at 30 days and one year postoperatively were 2.5% and 3.7%, while cardiac mortality rates were 1.8% and 3.0%, respectively. Rates of permanent pacemaker implantation at 30 days and one year were 1.8% and 3.0%, respectively. Moderate-to-severe paravalvular leaks were present in 2.5% of patients at 30 days, increasing to 6.6% after one year. Stroke, coronary obstruction, and myocardial infarction incidences remained low, at 0.6%. EuroQol-5 Dimension scores significantly improved from 67.7 +/- 18.4 at baseline to 80.0 +/- 11.6 and 83.7 +/- 10.1 at 30 days and one year, respectively. Patients with NYHA classes I and II rose dramatically from 18.7% at baseline to 99.3% postoperatively. Conclusion Among selected patients, the Renatus balloon-expandable transcatheter valve system was associated with favorable safety and efficacy outcomes at 1-year post-procedure, regardless of aortic valve leaflet morphology.
[1]Capital Med Univ, Beijing Anzhen Hosp, Dept Valvular, Surg Ctr, Beijing 100029, Peoples R China.
[2]Fudan Univ, Zhongshan Hosp, Dept Cardiovasc Surg, Shanghai 200032, Peoples R China.
[3]Sichuan Univ, West China Hosp, Dept Cardiovasc Surg, Chengdu 610041, Sichuan, Peoples R China.
[4]Zhejiang Univ, Affiliated Hosp 1, Dept Cardiovasc Surg, Sch Med, Hangzhou 310003, Peoples R China.
[5]Chinese Acad Med Sci & Peking Union Med Coll, Natl Clin Res Ctr Cardiovasc Dis, Dept Struct Heart Dis, Fuwai Hosp,Natl Hlth Commiss,Key Lab Cardiovasc Re, Beijing 100037, Peoples R China.
[6]Chinese Acad Med Sci & Peking Union Med Coll, Natl Clin Res Ctr Cardiovasc Dis, Key Lab Innovat Cardiovasc Devices, Natl Ctr Cardiovasc Dis,Natl Hlth Commiss Key Lab, Beijing 100037, Peoples R China.
[7]Nanjing Univ, Nanjing Drum Tower Hosp, Dept Cardiothorac Surg, Affiliated Hosp,Med Sch, Nanjing 210008, Peoples R China.
[8]Cent South Univ, Xiangya Hosp, Dept Cardiac Surg, Changsha 410008, Peoples R China.
[9]Zhejiang Univ, State Key Lab Transvasc Implantat Devices, Dept Cardiol, Affiliated Hosp 2,Sch Med, Hangzhou 310009, Peoples R China.
(8.0+极速模式)