University of Washington, Seattle, WA 98104, USA.
J Vasc Surg. 2013 Aug;58(2):311-7. doi: 10.1016/j.jvs.2013.01.029. Epub 2013 May 3.
To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair.
A nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial was used. Data collected on patients treated with PMEG between April 2011 and August 2012 were analyzed. Subjects were followed with computed tomography, visceral duplex, and four-view X-ray at 30 days, 6 months, and 1 year. The protocol was designed to include follow-up to 5 years. The primary safety end point was the proportion of subjects who experienced a major adverse event (MAE) within 30 days of the procedure. The primary efficacy end point was the proportion of subjects experiencing treatment success.
During the 16-month study period, 28 patients were consented and 26 underwent endovascular repair using PMEGs. Anatomic, operative details, and length of stay were recorded and included aneurysm diameter (mean, 62.5 mm), proximal neck length (mean, 4.4 mm), graft manufacture time (mean, 59.7 minutes), procedure time (mean, 169 minutes), fluoroscopy time (mean, 42.8 minutes), total contrast usage (mean, 63 mL), estimated blood loss (mean, 221 mL), and length of hospital stay (mean, 4.9 days). There were 63 fenestrations created for 48 renal arteries and 15 superior mesenteric arteries. Renal artery fenestrations were stented whenever possible (96%) and superior mesenteric artery fenestrations were all left unstented. There were no unanticipated adverse device events, no MAEs, and only a single minor adverse device event treated with a successful reintervention. At 30 days, there were no type I or III endoleaks and only four type II endoleaks (15.4%). Two patients died during the study period, one at day 23 from respiratory failure (in-hospital and 30-day mortality = 3.8%) and one at day 210 from urosepsis and congestive heart failure. MAEs occurred in 11.5% of patients at 30 days. The primary efficacy end point was achieved in 87.5% of patients (technical success 100%, freedom from migration, rupture or conversion, type I or III endoleaks, or sac enlargement = 100%, 100%, 87.5%, and 87.5%, respectively).
These preliminary data suggest that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. Endovascular repair with PMEG has acceptable early rates of morbidity, mortality, and endoleak. This endovascular aortic strategy is particularly appealing for those patients presenting with symptomatic or ruptured aortic aneurysms until reliable off-the-shelf solutions become widely available.
确定医生改良的血管内移植物（PMEG）是否是治疗被认为不适合开放修复的肾周主动脉瘤患者的安全有效的方法。
使用非随机、前瞻性、连续纳入的器械豁免临床试验。分析了 2011 年 4 月至 2012 年 8 月期间接受 PMEG 治疗的患者的数据。对接受 PMEG 治疗的患者在 30 天、6 个月和 1 年时进行计算机断层扫描、内脏双工和四视图 X 射线检查。该方案设计包括 5 年的随访。主要安全性终点是 30 天内发生重大不良事件（MAE）的患者比例。主要疗效终点是治疗成功的患者比例。
在 16 个月的研究期间，28 名患者同意并接受了 PMEG 的血管内修复。记录了解剖学、手术细节和住院时间，包括动脉瘤直径（平均值，62.5mm）、近端颈部长度（平均值，4.4mm）、移植物制造时间（平均值，59.7 分钟）、手术时间（平均值，169 分钟）、透视时间（平均值，42.8 分钟）、总造影剂用量（平均值，63ml）、估计失血量（平均值，221ml）和住院时间（平均值，4.9 天）。为 48 条肾动脉和 15 条肠系膜上动脉创建了 63 个孔。只要有可能，就对肾动脉孔进行了支架置入（96%），肠系膜上动脉孔均未进行支架置入。没有意外的不良设备事件、重大不良设备事件，只有 1 例轻微不良设备事件通过成功的再次介入治疗得到治疗。30 天时，没有 I 型或 III 型内漏，只有 4 型 II 型内漏（15.4%）。两名患者在研究期间死亡，一名在第 23 天死于呼吸衰竭（院内和 30 天死亡率=3.8%），另一名在第 210 天死于尿路感染和充血性心力衰竭。30 天时，11.5%的患者发生 MAE。主要疗效终点在 87.5%的患者中达到（技术成功率 100%，无迁移、破裂或转换、I 型或 III 型内漏或囊腔增大=100%、100%、87.5%和 87.5%）。
这些初步数据表明，使用 PMEG 进行血管内修复治疗肾周主动脉瘤是安全有效的。PMEG 血管内修复的早期发病率、死亡率和内漏率可接受。这种血管内主动脉策略对于那些出现症状或破裂的主动脉瘤患者特别有吸引力，直到可靠的现货解决方案广泛可用。
