Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
Eur J Cardiothorac Surg. 2013 Jan;43(1):52-6; discussion 57. doi: 10.1093/ejcts/ezs139. Epub 2012 Apr 4.
The ACURATE TA(™) Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported.
The Symetis ACURATE TA(™) is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated.
The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA(™)). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the device's success rate was 92.5%, with a 30-day safety profile of 25%.
At the 6-month follow-up, the ACURATE TA(™) device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival.
ACURATE TA（™）主动脉生物瓣和输送系统（Symetis S.A.，埃库布伦，瑞士）是一种新的经导管主动脉瓣，设计用于经心尖植入。现将已完成的首例人体研究的 6 个月结果报告如下。
Symetis ACURATE TA（™）由附在自膨式镍钛诺支架上的猪生物组织瓣膜组成。它允许进行解剖定位，并便于直观植入，提供触觉反馈。自 2009 年 11 月以来，共有 40 名高危老年患者接受了治疗。
入选患者的平均年龄为 83.2±4.0 岁；60.0%为女性，平均 logistic EuroSCORE 为 21.2±10.8%，平均胸外科医师协会（STS）评分 9.0±4.7%。所有植入物均成功输送至瓣环内和冠状动脉下位置。1 例患者因冠状动脉受影响（在瓣膜内植入后）转为常规手术。另有 1 例患者接受瓣膜内植入治疗（SAPIEN THV TA（™））。30 天内 5 例患者死亡，6 个月随访期间另有 2 例患者因非瓣膜相关原因死亡，导致中期生存率为 82.5%。2 例患者发生中风，另有 3 例需要新植入起搏器。平均主动脉梯度显著改善，并在整个随访期间保持稳定（基线：51.9±14.3mmHg，30 天：12.3±5.1mmHg，6 个月：11.9±5.8mmHg）。6 个月随访时，96.7%的患者仅存在无/微量或轻度（1+/4）瓣周漏。根据瓣膜学术研究委员会（Valve Academic Research Council），该器械的成功率为 92.5%，30 天安全性为 25%。
在 6 个月的随访中，ACURATE TA（™）器械显示瓣膜功能稳定，瓣周漏发生率低。高危患者队列显示出良好的临床结果和 6 个月生存率。
