ObjectiveTo compare the efficacy and safety of Venus A-Valve and other overseas devices in transcatheter aortic valve replacement (TAVR) for patients with severe aortic stenosis (AS).MethodsWe retrospectively analyzed the baseline characteristics, procedural details, and postprocedural outcomes of severe AS patients who underwent TAVR with Venus A-Valve or overseas devices between April 2012 and January 2019 in West China Hospital of Sichuan University.ResultsA total of 342 AS patients undergoing TAVR were finally included, 238 with Venus A-Valve and the other 104 with overseas devices (43 with CoreValve, 33 with Lotus, 21 with SAPIEN XT, and 7 with SAPIEN 3). Baseline characteristics were comparable between the two groups, and the proportion of patients with bicuspid aortic valve was around 50% in both groups. After successful valve implantation, all patients’ hemodynamics were significantly improved, with the median of maximum velocity decreased to 2.30 m/s (inter-quartile range: 0.60 m/s) and 2.50 m/s (inter-quartile range: 0.62 m/s), respectively (P=0.003). Postprocedural 30-day and 1-year all cause mortalities were similar (30-day: 5.9% vs. 1.9%, P=0.086; 1-year: 8.4% vs. 5.8%, P=0.307), while low incidence of procedure-related complications and improved life quality were achieved in both groups.ConclusionTAVR with the domestic Venus A-Valve is feasible, safe, and can produce favorable outcomes for AS patients, and especially for Chinese TAVR population with a high prevalence of bicuspid aortic valve.
Pure native aortic valve regurgitation (NAVR) is one of the common heart valve diseases, and the prognosis of symptomatic chronic NAVR is poor. Although transcatheter aortic valve replacement (TAVR) is currently an "off-label" procedure, it remains the option for patients with high risk for surgery. In this case, an 81-year-old man with multiple comorbidity and high Society of Thoracic Surgeons score, the risk for surgery is rather high. Through the preoperative evaluation by the multidisciplinary heart team, considering that the patient had calcification at the junction of annulus, as well as mild aortic stenosis, after careful consideration, 29# Venus A-Valve was chosen. After the procedure, the symptoms were obviously improved and the follow-up effect was good. Due to various causes of NAVR, great anatomical variation of annulus, little calcification of aortic valve, and lack of anchor point and other problems, the procedure to treat NAVR with TAVR is still difficult. At the same time, there are few valve systems developed for the anatomical characteristics of aortic regurgitation valve. TAVR in the treatment of patients with high risk for surgery still requires long-term practice and technical development.