Cardiovascular Surgery Department, Federal University of São Paulo, São Paulo, Brazil.
EuroIntervention. 2015 Oct;11(6):682-9. doi: 10.4244/EIJV11I6A136.
Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage.
Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred.
Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.
经导管主动脉瓣置换术已成为高危患者传统主动脉瓣置换术的替代方法。目前正在研究多种假体。本研究的目的是评估 Braile Inovare 经导管主动脉瓣假体使用的临床、安全性和疗效。
90 例高危或不能手术的患者接受了经导管主动脉瓣植入术。平均逻辑 EuroSCORE 为 39.3%。所有患者均有钙化性主动脉瓣狭窄。手术在透视和超声心动图引导下进行。假体通过经心尖途径在快速心室起搏下植入。包括超声心动图和血管造影检查。87 例手术可行。只有 1 例手术死亡，30 天死亡率为 13.3%。跨瓣主动脉梯度从 44.8±15.3mmHg 降至 14.1±8.0mmHg。左心室功能在术后 7 天内得到改善。瓣周主动脉瓣反流发生率为 29.7%，大多为微量。1 例发生主要血管并发症，2 例植入永久性起搏器。发生 2 例主要卒中。
使用 Braile Inovare 假体进行经导管主动脉瓣置换术能够提供令人鼓舞的结果，显著改善心功能和结构。必须继续随访，以衡量该器械的益处，并改进患者的选择标准。
