Brunkwall Jan, Vaquero Puerta Carlos, Heckenkamp Joerg, Egaña Barrenechea Jose Maria, Szopinski Piotr, Mertikian Gerard, Seifert Sven, Rümenapf Gerhard, Buz Semih, Assadian Afshin, Majd Payman, Mylonas Spyridon, Revilla Calavia Alvaro, Theis Thorsten, de Blas Bravo Mariano, Pleban Eliza, Schupp Jasper, Esche Mirko, Kocaer Cetin, Hirsch Kornelia, Oberhuber Alexander, Schäfer Jost-Philipp
1 Clinic of Vascular and Endovascular Surgery, University Clinic of Cologne, Cologne, Germany.
2 Vascular Surgery Department, University Hospital of Valladolid, Valladolid, Spain.
Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.
To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms.
A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality.
Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter.
The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.
研究E-liac覆膜支架系统在主动脉/髂动脉瘤患者中的安全性和可行性。
开展一项针对接受E-liac覆膜支架系统的患者的前瞻性多中心欧洲注册研究。研究终点包括技术成功率、围手术期事件、30天内漏、再次干预、髂内和髂外动脉通畅情况及死亡率。
2014年7月至2016年6月期间，四个欧洲国家的11个研究点共纳入45例患者（男性占93%，平均年龄72岁，范围53 - 90岁）。5例患者接受单纯髂动脉治疗。37例患者接受腹主动脉覆膜支架与单侧E-liac联合治疗，3例接受双侧E-liac联合治疗。所有48枚E-liac覆膜支架均成功植入预定位置，髂内动脉成功桥接。2例患者未获得临床成功，原因是主动脉覆膜支架出现Ia型内漏。30天随访时，临床成功率为96%。在30天随访期内进行了3次成功的血管腔内再次干预：1次因髂总动脉Ia型内漏，1次因主动脉覆膜支架Ia型内漏，1次因覆膜支架肢体狭窄引发双侧下肢间歇性跛行。30天时，报告生存率为100%，盆腔或臀部无缺血/间歇性跛行。30天时，髂内动脉的原发性通畅率为100%，髂外动脉为98%，后者的辅助通畅率为100%。
高临床成功率、低器械相关再次干预率（2%）和出色的通畅率证明了E-liac覆膜支架系统的安全性和可行性。有待长期结果来阐明其有效性和耐久性。ClinicalTrials.gov标识符：NCT02209194。
