BackgroundThis study summarizes and analyzes data from patients suffering from symptomatic aortic stenosis who successfully underwent transcatheter aortic valve implantation (TAVI) using a novel, completely retrievable transcatheter heart valve.MethodsWe included patients who underwent a TAVI procedure with SinoCrown valves at our center between December 2021 and September 2022. We collected 1‐year follow‐up data on survival, complications, echocardiographic results, New York Heart Association functional class in heart failure, and patient‐reported health‐related quality of life outcomes.ResultsEight successive patients (73.3 ± 4.3 years) were included in the study, with a median Society of Thoracic Surgery risk score of 4.26%. The procedure had a 100% success rate. Median postoperative discharge time was 7 days, with no 30‐day hospital readmissions. Postoperative aortic valve hemodynamics improved, indicated by decreased transvalvular flow velocity compared with preoperative values (1.9 ± 0.2 vs. 4.9 ± 0.2 m/s, p < 0.0001). The median and maximum follow‐up times were 8 and 12 months, respectively. During the follow‐up period, there were no serious complications such as death, stroke, valve embolization, or high‐grade atrioventricular block.ConclusionsThe results from eight initial TAVI cases performed with the SinoCrown valve demonstrated promising safety and efficacy.

中文翻译：

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完全可回收的SinoCrown经导管心脏瓣膜治疗严重主动脉瓣狭窄的早期结果


背景本研究总结并分析了患有症状性主动脉瓣狭窄的患者的数据，这些患者使用一种新型的、完全可回收的经导管心脏瓣膜成功接受了经导管主动脉瓣植入术 (TAVI)。方法我们纳入了 2021 年 12 月期间在我们中心接受了使用SinoCrown 瓣膜进行 TAVI 手术的患者和 2022 年 9 月。我们收集了关于生存、并发症、超声心动图结果、纽约心脏协会心力衰竭功能分级以及患者报告的健康相关生活质量结果的 1 年随访数据。结果 8 名连续患者 (73.3 ± 4.3年）被纳入该研究，胸外科协会风险评分中位数为 4.26%。该手术的成功率是100%。术后中位出院时间为 7 天，没有 30 天再次入院。与术前相比，跨瓣膜流速降低表明术后主动脉瓣血流动力学得到改善（1.9 ± 0.2 vs. 4.9 ± 0.2 m/s，p < 0.0001）。中位随访时间和最长随访时间分别为 8 个月和 12 个月。随访期间，未出现死亡、中风、瓣膜栓塞或高度房室传导阻滞等严重并发症。 结论 8例使用SinoCrown瓣膜进行的初始TAVI病例的结果显示出良好的安全性和有效性。