Outcomes of thoracic endovascular aortic repair for complicated type B acute aortic dissection from a multicenter Japanese post-market surveillance study.
Yoshimasa Seike, Sophie B Green, Keita Mori, Kimberly Reid, Hitoshi Matsuda
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引用次数: 0
Abstract
Objectives: A primary goal of thoracic endovascular aortic repair (TEVAR) for type B acute aortic dissection (BAAD) is exclusion of the primary entry tear with a suitable stent graft (SG) to reestablish true lumen flow and promote aortic remodeling. This study aimed to determine the safety and efficacy of a conformable thoracic SG in a Japanese population with complicated BAAD.
Methods: Between 2016 and 2017, 43 patients with complicated BAAD were enrolled in this prospective, nonrandomized, multicenter post-market surveillance study at 27 sites in Japan. All patients underwent TEVAR using the Gore TAG Conformable Thoracic Endoprosthesis (CTAG) (W.L. Gore and Associates, Flagstaff, AZ).
Results: The most common TEVAR indication for complicated BAAD was malperfusion (41.9%; 24 out of 43) and aortic rupture was observed in 32.5% of patients (14 out of 43). All SG implants were successfully completed and there was no patient with surgical conversion. Thirty-day mortality was 7.0% (3 out of 43) and one patient (2.3%) experienced spinal cord ischemia during hospitalization. Entry tear exclusion was achieved in 91.3% of patients at 1 month, and 95.7% at 24 months. Through 24 months after TEVAR, no retrograde type A aortic dissection was observed and distal stent graft induced new entry was observed in two patients (4.7%).
Conclusion: TEVAR utilizing the CTAG device for complicated BAAD in Japan demonstrated a low incidence of perioperative mortality and complications. Complications directly attributed to the SG including RTAD and dSINE were uncommon and the midterm outcomes were deemed satisfactory.
目的:B型急性主动脉夹层(BAAD)的胸腔血管内主动脉修复(TEVAR)的主要目的是通过合适的支架移植(SG)来排除原发性入口撕裂,以重建真正的管腔流动并促进主动脉重塑。本研究旨在确定适形胸椎SG在日本复杂BAAD患者中的安全性和有效性。方法:在2016年至2017年期间,在日本27个地点招募了43名合并BAAD的患者参与这项前瞻性、非随机、多中心的上市后监测研究。所有患者均使用Gore TAG适形胸内假体(CTAG) (W.L. Gore and Associates, Flagstaff, AZ)进行TEVAR。结果:复杂BAAD最常见的TEVAR指征是灌注不良(41.9%;43例患者中有24例出现主动脉破裂,32.5%的患者(43例中有14例)出现主动脉破裂。所有SG植入物均成功完成,没有患者进行手术转换。30天死亡率为7.0%(3 / 43),1例(2.3%)患者在住院期间出现脊髓缺血。91.3%的患者在1个月时达到了进入性撕裂排除,而在24个月时达到了95.7%。TEVAR术后24个月,未观察到逆行性A型主动脉夹层,2例(4.7%)患者观察到远端支架移植诱导的新进入。结论:日本采用CTAG装置的TEVAR治疗复杂的BAAD,围手术期死亡率和并发症发生率低。直接由SG引起的并发症包括RTAD和dsin并不常见,中期结果令人满意。
期刊介绍:
The General Thoracic and Cardiovascular Surgery is the official publication of The Japanese Association for Thoracic Surgery and The Japanese Association for Chest Surgery, the affiliated journal of The Japanese Society for Cardiovascular Surgery, that publishes clinical and experimental studies in fields related to thoracic and cardiovascular surgery.