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| 胸部闭合性胸主动脉损伤的腔内修复术- 更新从刺穿的研究结果 Endovascular Repair of Blunt Thoracic Aortic Injuries With the Zenith Alpha Thoracic Device- Updated Outcomes From the TRANSFIX Study
OBJECTIVE: The objective of this study was to report 30-day results from a prospective, nonrandomized, multicenter trial that evaluated the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injuries (BTAIs). 摘要 目的： 本研究的目的是报告30天结果来自一项前瞻性、非随机、多中心临床试验，评估了有效性的α胸腔内隔绝术的安全性和有效性（Cook Medical, Bloomington, Ind）闭合性胸主动脉损伤的治疗（BTAIs） METHODS: Eligible patients with BTAIs (grade II to grade IV) in the descending thoracic aorta were treated with the Zenith Alpha device, which is available in smaller graft diameters (starting at 18 mm) and lower profile delivery systems (starting at 16F) than currently available thoracic endografts. The device (nitinol stents and polyester graft material) accommodates a tighter aortic curvature (radius of 20 mm) than the predicate Zenith TX2 Pro-Form. Follow-up clinical and imaging evaluations were performed at 30 days, at 6 and 12 months, and annually thereafter through 5 years. The primary end point was 30-day mortality. 方法: 符合条件的患者btais（IV级II级）在胸降主动脉与天顶α装置处理，这在小移植物直径是可用的（从18毫米）和低调输送系统（从16F）比目前可用的胸endografts。该装置（镍钛合金支架和聚酯接枝材料）有严格的主动脉曲率（半径为20毫米）比谓词天顶TX2亲形式。随访30天，6个月和12个月，并每年随访5个月，随访的临床和影像学评价。主要终点为30天死亡率 RESULTS: Between January 2013 and May 2014, 50 patients (44 men; mean age, 43 ± 19 years; range, 18-89 years) were treated with the Zenith Alpha device at 17 U.S. sites. The mean Injury Severity Score was 31 ± 14 (range, 3-66). Technical success was achieved in 100% of patients, with 0% intraoperative mortality. Device access was entirely percutaneous in 22 patients (44%). Smaller size grafts (18-24 mm) were used in 15 patients (30%). The mean procedure time was 85 ± 44 minutes (range, 34-278 minutes), and mean blood loss was 103 ± 145 mL (range, 0-1000 mL). The 30-day mortality rate was 2%; one patient died 24 days after the procedure of respiratory failure related to associated injuries and not to the device or procedure as adjudicated by an independent Clinical Events Committee (CEC). One patient experienced a stroke 7 days after the procedure (cause undetermined by the CEC), and one patient underwent reintervention for a site-reported proximal type I endoleak (core laboratory reported unknown endoleak type) at 30 days after the procedure. There have been no conversions to open surgical repair, paraplegia, or aortic rupture within 30 days. 结果: 在2013年一月和2014年，50例患者（44名男性；平均年龄19岁，43±；范围18-89岁）与天顶α装置处理后，在美国的17个。平均损伤严重度评分为31±14（范围3-66）。技术成功实现了100%的患者，有0%的术中死亡率。设备访问是完全经皮在22例（44%）。小尺寸的移植（18-24毫米）用于15例（30%）。平均手术时间为85±44分钟（范围，34-278分钟），平均出血量103±145毫升（范围0-1000毫升）。30天的死亡率为2%；一个病人死于呼吸衰竭相关的合并伤术后24天并不是由一个独立的临床事件委员会裁定的设备或程序（CEC）。一个病人经历了手术后的7天（原因不明的卒中由CEC），一个病人接受再次手术的一个网站报道近端I型内漏（核心实验室报道未知的内漏型）手术后30天。30天内无中转开放手术修复，截瘫或主动脉破裂。 CONCLUSIONS: Short-term results indicate that the Zenith Alpha thoracic endovascular graft appears safe and effective for the treatment of BTAIs. This low-profile device enables complete percutaneous repair in a large percentage of patients and can achieve high rates of technical success and very low rates of aortic injury-related mortality within 30 days. 结论： 短期结果表明天顶α胸腔内隔绝术中出现btais治疗安全有效。这种低配置设备，使完整的经皮修复，在很大比例的患者，可以实现高利率的技术成功率和非常低的主动脉损伤相关的死亡率在30天内 原文：http://www.dxye.com/thread-24303-1-1.html |
