Vaislic Claude D, Fabiani Jean Noël, Chocron Sidney, Robin Jacques, Costache Victor S, Villemot Jean-Pierre, Alsac Jean Marc, Leprince Pascal N, Unterseeh Thierry, Portocarrero Eric, Glock Yves, Rousseau Hervé
Department of Cardiac, Vascular, and Thoracic Surgery, Centre Hospitalier Privé Parly 2, Le Chesnay, France
Department of Cardiovascular Surgery, Hôpital Européen Georges-Pompidou, Paris, France.
J Endovasc Ther. 2016 Oct;23(5):762-72. doi: 10.1177/1526602816653095. Epub 2016 Jun 8.
To evaluate midterm outcomes of endovascular repair of types II and III thoracoabdominal aortic aneurysms (TAAA) using the Multilayer Flow Modulator (MFM) in patients unsuitable for open surgery or fenestrated stent-grafts.
In the prospective, multicenter, nonrandomized STRATO trial (EudraCT registration: 2009-013678-42; ClinicalTrials.gov identifier NCT01756911), 23 patients (mean age 75.8 years; 19 men) with Crawford type II and III TAAA (mean diameter 6.5 cm) were implanted between April 2010 and February 2011. Outcomes included all-cause mortality and stable aneurysm thrombosis with associated branch vessel patency.
Through 36 months, there were 7 deaths (none confirmed as aneurysm-related), and no cases of spinal cord injury, device migration or fracture, or respiratory, renal, or peripheral complications. Three patients were lost to follow-up and 2 devices were explanted. The device was patent in the 11 remaining patients at 3 years. Stable aneurysm thrombosis was achieved for 15 of 20 patients at 12 months, 12 of 13 at 24 months, and 10 of 11 at 36 months. The rate of branch patency was 96% at 12 months (primary patency), 100% at 24 months, and 97% at 36 months. Nine patients suffered from endoleaks (attachment site or device overlap); 9 patients underwent 11 reinterventions (3 surgical). Maximum aneurysm diameter was stable for 18 of 20 patients at 12 months, 11 of 13 at 24 months, and 9 of 11 at 36 months. For 10 patients with computed tomography at 36 months, the mean ratio of aneurysm flow volume to total volume had decreased by 83%; the mean ratio of thrombus volume to total volume increased by 159%.
Through 3 years, endovascular repair with the MFM appears to be safe and effective while successfully maintaining branch vessel patency.
评估在不适宜接受开放手术或开窗支架型人工血管治疗的患者中，使用多层血流调节器（MFM）对Ⅱ型和Ⅲ型胸腹主动脉瘤（TAAA）进行血管腔内修复的中期疗效。
在一项前瞻性、多中心、非随机的STRATO试验（欧洲临床试验数据库注册编号：2009-013678-42；美国国立医学图书馆临床试验注册中心标识符：NCT01756911）中，2010年4月至2011年2月期间为23例患者（平均年龄75.8岁；19例男性）植入了CrawfordⅡ型和Ⅲ型TAAA（平均直径6.5 cm）。观察指标包括全因死亡率、动脉瘤稳定血栓形成及相关分支血管通畅情况。
随访36个月时，有7例死亡（均未证实与动脉瘤相关），无脊髓损伤、器械移位或断裂，以及呼吸、肾脏或周围血管并发症的病例。3例患者失访，2例器械被取出。3年时，其余11例患者的器械保持通畅。20例患者中，15例在12个月时实现了动脉瘤稳定血栓形成，13例中的12例在24个月时实现，11例中的10例在36个月时实现。分支血管通畅率在12个月时为96%（初始通畅率），24个月时为100%，36个月时为97%。9例患者发生内漏（附着部位或器械重叠处）；9例患者接受了11次再次干预（3次手术干预）。20例患者中，18例在12个月时动脉瘤最大直径稳定，13例中的11例在24个月时稳定，11例中的9例在36个月时稳定。10例患者在36个月时进行了计算机断层扫描，动脉瘤血流体积与总体积的平均比值下降了83%；血栓体积与总体积的平均比值增加了159%。
随访3年，使用MFM进行血管腔内修复似乎安全有效，同时成功维持了分支血管通畅。
