St. Thomas' Hospital, London, United Kingdom.
Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, Germany.
JACC Cardiovasc Interv. 2016 Sep 12;9(17):1815-22. doi: 10.1016/j.jcin.2016.06.031.
The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).
TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.
ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.
A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.
TAo access for TAVR seems to be a safe alternative to the transapical procedure.
利用 Edwards SAPIEN 瓣膜的经主动脉（TAo）入路注册登记研究（ROUTE）旨在评估经导管主动脉瓣置换术（TAVR）中使用经主动脉（TAo）入路的有效性和安全性（NCT01991431）。
TAVR 是高危患者进行瓣膜置换术的一种替代方法。经股动脉入路通常作为首选方法，而经心尖入路是不适合经股动脉治疗的患者的一种选择，主要是由于解剖条件的原因。TAo-TAVR 已被证明是一种可行的替代手术入路；然而，关于其有效性和安全性的数据有限。
ROUTE 是一项多中心、国际性、前瞻性、观察性登记研究；从 2013 年 2 月开始，在欧洲的 18 个中心收集数据。如果患者有严重的主动脉瓣钙化狭窄，计划使用 Edwards SAPIEN XT 或 SAPIEN 3 瓣膜进行 TAo-TAVR，则记录患者资料。主要终点是 30 天死亡率。次要终点包括术中或住院期间和 30 天并发症发生率。
共纳入 301 例患者，平均年龄为 81.7 ± 5.9 岁，胸外科医生协会评分（STS）为 9.0 ± 7.6%。记录到瓣膜成功率为 96.7%。30 天死亡率为 6.1%（18/293）（与手术相关的死亡率：3.1%；293 例中的 9 例）。瓣膜学术研究联合会 2 型定义的并发症包括心肌梗死（1.0%）、中风（1.0%）、短暂性脑缺血发作（0.3%）、大血管并发症（3.4%）、威胁生命的出血（3.4%）和急性肾损伤（9.5%）。在 3.3%的患者中，瓣周漏被分类为中度或重度（300 例中的 10 例）。26 例（8.8%）患者需要植入永久性起搏器。
TAo 入路用于 TAVR 似乎是经心尖手术的一种安全替代方法。
