Oderich Gustavo S, Ribeiro Mauricio, Hofer Jan, Wigham Jean, Cha Stephen, Chini Julia, Macedo Thanila A, Gloviczki Peter
Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn; Division of Vascular and Endovascular Surgery, Department of Surgery and Anatomy, University of São Paulo School of Medicine of Ribeirão Preto, Ribeirão Preto, Brazil.
J Vasc Surg. 2017 May;65(5):1249-1259.e10. doi: 10.1016/j.jvs.2016.09.038. Epub 2016 Dec 13.
To investigate outcomes of manufactured fenestrated and branched endovascular aortic repair (F-BEVAR) endografts based on supraceliac sealing zones to treat pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs).
A total of 127 patients (91 male; mean age, 75 ± 10 years old) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (November 2013-March 2015). Stent design was based on supraceliac sealing zone in all patients with ≥ four vessels in 111 (89%). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by independent clinical event committee included mortality, major adverse events (any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss >1 L), freedom from reintervention, and branch-related instability (occlusion, stenosis, endoleak or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture.
There were 47 pararenal, 42 type IV, and 38 type I-III TAAAs with mean diameter of 59 ± 17 mm. A total of 496 renal-mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6% (n = 493/496). There were no 30-day or in-hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV, one type II TAAAs). Follow-up was >30 days in all patients, >6 months in 79, and >12 months in 34. No patients were lost to follow-up. After a mean follow-up of 9.2 ± 7 months, 23 patients (18%) had reinterventions (15 aortic, 8 nonaortic), 4 renal artery stents were occluded, five patients had type Ia or III endoleaks, and none had aneurysm sac enlargement. Primary and secondary target vessel patency was 96% ± 1% and 98% ± 0.7% at 1 year. Freedom from any branch instability and any reintervention was 93% ± 2% and 93% ± 2% at 1 year, respectively. Patient survival was 96% ± 2% at 1 year for the entire cohort.
Endovascular repair of pararenal aortic aneurysms and TAAAs, using manufactured F-BEVAR with supraceliac sealing zones, is safe and efficacious. Long-term follow-up is needed to assess the impact of four-vessel designs on device-related complications and progression of aortic disease.
探讨基于膈上密封区的定制开窗和分支型血管内主动脉修复术（F-BEVAR）治疗肾旁主动脉瘤和胸腹主动脉瘤（TAAA）的疗效。
采用定制的F-BEVAR（2013年11月至2015年3月），对127例患者（91例男性；平均年龄75±10岁）进行了一项前瞻性、非随机单中心研究。所有111例（89%）有≥4支血管的患者的支架设计均基于膈上密封区。随访包括临床检查、实验室检查、双功超声以及出院时、1个月、6个月和每年的计算机断层扫描成像。由独立临床事件委员会判定的终点包括死亡率、主要不良事件（任何死亡、心肌梗死、中风、截瘫、急性肾损伤、呼吸衰竭、肠缺血、失血>1L）、无需再次干预、分支相关不稳定（闭塞、狭窄、内漏或需要再次干预的断开连接）、靶血管通畅、瘤囊动脉瘤增大和动脉瘤破裂。
共有47例肾旁动脉瘤、42例IV型和38例I-III型TAAA，平均直径59±17mm。352个开窗、125个定向分支和19个腹腔扇贝形开口共纳入496条肾肠系膜动脉，平均每位患者3.9±0.5支血管。靶血管纳入的技术成功率为99.6%（n=493/496）。无30天或住院期间死亡、透析、破裂或转为开放手术修复。27例患者（21%）发生主要不良事件。2例患者发生截瘫（1例IV型，1例II型TAAA）。所有患者随访均>30天，79例>6个月，34例>12个月。无患者失访。平均随访9.2±7个月后，23例患者（18%）进行了再次干预（15例主动脉，8例非主动脉），4例肾动脉支架闭塞，5例患者发生Ia型或III型内漏，无瘤囊增大。1年时一级和二级靶血管通畅率分别为96%±1%和98%±0.7%。1年时无任何分支不稳定和无需任何再次干预分别为93%±2%和93%±2%。整个队列1年时患者生存率为96%±2%。
使用基于膈上密封区的定制F-BEVAR对肾旁主动脉瘤和TAAA进行血管内修复是安全有效的。需要长期随访以评估四支血管设计对器械相关并发症和主动脉疾病进展的影响。
