Bosiers Michel, Kölbel Tilo, Resch Timothy, Tsilimparis Nikolaos, Torsello Giovanni, Austermann Martin
Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany.
University Heart and Vascular Center, Hamburg, Germany.
J Vasc Surg. 2021 Oct;74(4):1081-1089.e3. doi: 10.1016/j.jvs.2021.01.070. Epub 2021 Mar 5.
We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study.
Patients who had been treated with the t-Branch device from September 2012 to November 2017 at three European centers were either prospectively or retrospectively enrolled in the present study. Device implantation and postprocedural follow-up were performed according to the standard of care at each center. The primary objectives of the present study were to assess the procedure-related mortality and morbidity at 30 days and 1 year and to assess the presence of endoleaks, device integrity, and stent-graft and branch vessel patency.
A total of 80 patients were included in the present study (mean age, 71.0 ± 7.4 years; 70.0% male). Most (n = 77) had been treated for thoracoabdominal aortic aneurysms (TAAAs) and the rest for dissection (n = 3). Most TAAAs were stable (72.7%; 56 of 77). The remaining TAAAs were symptomatic (7.8%; 6 of 77) or had a contained rupture (19.5%; 15 of 77). The t-Branch device was successfully deployed in 79 patients. In one patient, the delivery system of the device could not be advanced through the iliac artery. Within 30 days, one patient had died (1.3%). At 1 year, seven patients had died (8.8%), and no aortic rupture or conversion to open surgery had been reported. The 30-day neurologic events included stroke in three patients (3.8%), paraplegia in one (1.3%), and paraparesis in six patients (7.5%). Secondary interventions were required in nine patients (11.3%) during follow-up. Postoperative endoleaks were observed in 37 of 72 patients (51.4%), including type II endoleak in 30, type Ia in 4, and type III endoleak in 6 patients. At 1 year, endoleaks had been reported in 20 patients (16 with type II and 4 with type III). The t-Branch main body graft patency was 100% throughout the 1-year follow-up period. At 30 days after the procedure, all celiac and superior mesenteric artery branches were patent and one left renal and one right renal branch were occluded. At 1 year, occlusion had developed in three bridging stent-grafts for the celiac artery, one for the left renal artery, and two for the right renal artery.
The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and symptomatic cases.
我们在一项上市后多中心研究中报告了现成的Zenith t型分支胸腹主动脉覆膜支架移植物（威廉库克欧洲公司，丹麦比耶沃斯考夫）安全性的短期结果。
2012年9月至2017年11月期间在三个欧洲中心接受t型分支装置治疗的患者，前瞻性或回顾性纳入本研究。根据各中心的护理标准进行装置植入和术后随访。本研究的主要目的是评估30天和1年时与手术相关的死亡率和发病率，并评估内漏的存在、装置完整性以及覆膜支架和分支血管的通畅情况。
本研究共纳入80例患者（平均年龄71.0±7.4岁；70.0%为男性）。大多数患者（n = 77）接受了胸腹主动脉瘤（TAAA）治疗，其余患者（n = 3）接受了夹层治疗。大多数TAAA病情稳定（72.7%；77例中的56例）。其余TAAA有症状（7.8%；77例中的6例）或有局限性破裂（19.5%；77例中的15例）。t型分支装置成功植入79例患者。1例患者中，装置输送系统无法通过髂动脉推进。30天内，1例患者死亡（1.3%）。1年时，7例患者死亡（8.8%），未报告主动脉破裂或转为开放手术情况。30天的神经系统事件包括3例患者发生中风（3.8%）、1例截瘫（1.3%）和6例患者轻截瘫（7.5%）。随访期间9例患者（11.3%）需要进行二次干预。72例患者中有37例（51.4%）观察到术后内漏，其中30例为Ⅱ型内漏，4例为Ⅰa型内漏，6例为Ⅲ型内漏。1年时，20例患者报告有内漏（16例为Ⅱ型，4例为Ⅲ型）。在1年的随访期内，t型分支主体移植物通畅率为100%。术后30天，所有腹腔干和肠系膜上动脉分支通畅，1例左肾分支和1例右肾分支闭塞。1年时，腹腔干的3个桥接支架移植物、左肾动脉的1个桥接支架移植物和右肾动脉的2个桥接支架移植物发生闭塞。
在本研究中，包括稳定和有症状的病例，t型分支装置似乎是安全的，30天和1年的死亡率和发病率良好。
