Greenberg Roy K, Sternbergh W Charles, Makaroun Michel, Ohki Takao, Chuter Timothy, Bharadwaj Priya, Saunders Alan
Department of Vascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
J Vasc Surg. 2009 Oct;50(4):730-737.e1. doi: 10.1016/j.jvs.2009.05.051.
This article reports the intermediate-term (24-month) outcomes of a prospective multicenter trial designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) for treating juxtarenal abdominal aortic aneurysms with short proximal necks. The study goals were to evaluate the safety and preliminary effectiveness of the device and refine patient selection criteria.
Five centers in the United States enrolled 30 patients with juxtarenal aortic aneurysms with >or=50-mm diameter and short proximal necks. Devices were custom-designed for each patient based on measurements from reconstructed computed tomography (CT) data. Follow-up studies included physical examinations, laboratory studies, CT imaging, mesenteric-renal duplex ultrasound imaging, and abdominal flat plate radiographs at hospital discharge, at 1, 6, and 12 months, and yearly thereafter up to 5 years.
During a 1-year period, 30 patients (80% men; mean age, 75 years) with a mean aneurysm size of 61.4 mm were enrolled. In these 30 patients, 77 visceral vessels were accommodated by fenestrations located within the sealing segment of the grafts. The most common design accommodated two renal arteries and the superior mesenteric artery (66.7%). All prostheses were implanted successfully. No visceral arteries were lost. Of the 30 patients treated, 27 were available for 12-month follow-up and 23 were available for 24-month follow-up. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed through 24 months of follow-up. No type I or type III endoleaks were observed. Type II endoleaks were noted in six (26.1%) at 12 months and four (20.0%) at 24 months. No patients had aneurysm growth >5 mm. Aneurysm size decreased in 16 of 23 (69.6%) and was stable in the remaining patients at 24 months. Eight patients experienced a renal event (4 renal artery stenoses, 2 renal artery occlusions, and 2 renal infarcts). Five underwent secondary interventions. No renal failure developed requiring dialysis.
The intermediate-term (24-month) results of the 30 patients in this multicenter study are concordant with previous single-center studies and support the concept that placement of fenestrated endovascular grafts is safe and effective at centers with experience in endovascular repair and renal/mesenteric stent placement.
本文报告一项前瞻性多中心试验的中期（24个月）结果，该试验旨在评估Zenith开窗型腹主动脉瘤腔内移植物（库克医疗公司，印第安纳州布卢明顿）治疗近端颈部较短的近肾腹主动脉瘤的效果。研究目标是评估该装置的安全性和初步有效性，并完善患者选择标准。
美国的五个中心招募了30例直径≥50 mm且近端颈部较短的近肾主动脉瘤患者。根据重建的计算机断层扫描（CT）数据测量结果为每位患者定制设计装置。随访研究包括出院时、1个月、6个月和12个月以及此后每年直至5年的体格检查、实验室检查、CT成像、肠系膜 - 肾双功超声成像和腹部平片。
在1年期间，纳入了30例患者（80%为男性；平均年龄75岁），平均动脉瘤大小为61.4 mm。在这30例患者中，77支内脏血管通过移植物密封段内的开窗得以保留。最常见的设计保留了两支肾动脉和肠系膜上动脉（66.7%）。所有假体均成功植入。无内脏动脉丢失。在接受治疗的30例患者中，27例可进行12个月随访，23例可进行24个月随访。随访24个月期间未观察到与动脉瘤相关的死亡、动脉瘤破裂或中转开腹。未观察到I型或III型内漏。12个月时6例（26.1%）出现II型内漏，24个月时4例（20.0%）出现II型内漏。无患者动脉瘤增大>5 mm。23例中有16例（69.6%）动脉瘤大小减小，其余患者在24个月时动脉瘤大小稳定。8例患者发生肾脏事件（4例肾动脉狭窄、2例肾动脉闭塞和2例肾梗死）。5例接受了二次干预。未发生需要透析的肾衰竭。
这项多中心研究中30例患者的中期（24个月）结果与先前的单中心研究一致，支持这样的观点，即在有血管腔内修复和肾/肠系膜支架置入经验的中心，放置开窗型血管腔内移植物是安全有效的。
