Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms
Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms
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DOI：
10.1016/j.jvs.2016.07.123
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发表时间：
2017-02-01
影响因子：
4.3
通讯作者：
Tatum, Billi
中科院分区：
文献类型：
--
作者：
Starnes, Benjamin W.;Heneghan, Rachel E.;Tatum, Billi
目的：本研究的目的是报告正在进行的由医生发起的研究性装置豁免关键临床试验的中期结果，该试验使用医生改良的血管内移植物（PMEG）治疗被认为不适合开放修复的肾旁主动脉瘤患者。方法：使用来自非随机、前瞻性、连续入组研究性装置豁免临床试验的数据。数据收集于2011年4月1日开始，数据锁定于2015年5月31日进行，结果分析截至2015年12月31日。主要安全性和有效性终点用于衡量治疗成功。主要安全终点定义为手术后 30 天内经历重大不良事件的受试者比例。主要疗效终点是治疗成功的受试者比例。治疗成功需要 12 个月时满足以下条件： 技术成功，定义为成功输送和部署 PMEG，并保留那些打算保留的分支血管；且无 I 型和 III 型内漏、覆膜支架移位 > 10 mm、主动脉瘤囊扩大 > 5 mm、主动脉瘤破裂或开放性转化。 结果：在 50 个月的研究期间，入组了 64 名患者； 60 人开始植入手术，59 人接受 PMEG 植入。记录动脉瘤解剖结构、手术细节和住院时间，包括动脉瘤直径（平均，65.9毫米；范围，49-104毫米）、近端密封区长度（平均，40.8毫米；范围，18.9-72.2毫米）、移植物制造时间（平均，55.1分钟）、手术时间（平均，156.8分钟）、透视时间（平均，156.8分钟）。 39.6 分钟）、造影剂使用量（平均 75.3 mL）、估计失血量（平均 213 mL）、住院时间（平均 4.1 天）以及重症监护室住院时间（平均 2.2 天）。 110 根肾动脉和 38 根肠系膜上动脉 (SMA) 共进行了 145 个开窗。一名患者因严重狭窄而在手术前放置了 SMA 支架，一名受试者在手术期间放置了 SMA 支架。只要有可能就在肾动脉上安装支架（93%）。 58 名患者中有 102 根装有支架的肾动脉。没有公开的转换或移植。 30 天死亡率为 5.1% (3/59)。在再次干预成功的随访期间，Ia 型内漏 0 例，Ib 型内漏 1 例，III 型内漏 2 例。 30天主要不良事件总体发生率为11.9%。 94.1% 的患者实现了主要疗效终点。结论：这些中期结果是有利的，验证了我们的早期报告，即 PMEG 血管内修复对于治疗肾旁主动脉瘤患者是安全有效的。 PMEG 具有特殊的中期发病率、死亡率和内漏率，并且可能优于具有良好解剖结构的标准血管内动脉瘤修复术。对于患有有症状或破裂的肾旁主动脉瘤、不适合接受开放手术的患者，PMEG 仍然是一个极具吸引力的选择，因为可靠的现成解决方案尚未广泛使用。术前计划仍然是成功使用这些技术的关键因素。
Objective: The objective of this study was to report midterm results of an ongoing physician-sponsored investigational device exemption pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair.Methods: Data from a nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on May 31, 2015, with outcomes analysis through December 31, 2015. Primary safety and efficacy end points were used to measure treatment success. The primary safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The primary efficacy end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of those branch vessels intended to be preserved; and freedom from type I and III endoleak, stent graft migration > 10 mm, aortic aneurysm sack enlargement > 5 mm, and aortic aneurysm rupture or open conversion.Results: During the 50-month study period, 64 patients were enrolled; 60 began the implant procedure and 59 received the PMEG implant. Aneurysm anatomy, operative details, and lengths of stay were recorded and included aneurysm diameter (mean, 65.9 mm; range, 49-104 mm), proximal seal zone length (mean, 40.8 mm; range, 18.9-72.2 mm), graft manufacture time (mean, 55.1 minutes), procedure time (mean, 156.8 minutes), fluoroscopy time (mean, 39.6 minutes), contrast material use (mean, 75.3 mL), estimated blood loss (mean, 213 mL), and length of hospital stay (mean, 4.1 days) with intensive care unit length of stay (mean, 2.2 days). There were 145 fenestrations made for 110 renal arteries and 38 superior mesenteric arteries (SMAs). One patient had an SMA stent placed before the procedure for severe stenosis, and one subject had the SMA stented during the procedure. Renal arteries were stented whenever possible (93%). There were 102 stented renal arteries in 58 patients. There were no open conversions or explantations. Thirty-day mortality was 5.1% (3/59). There were zero type Ia, one type Ib, and two type III endoleaks during follow-up treated with successful reintervention. The overall rate of major adverse events at 30 days was 11.9%. The primary efficacy end points were achieved in 94.1% of patients.Conclusions: These midterm results are favorable and verify our early report that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. PMEG has exceptional midterm rates of morbidity, mortality, and endoleak and may outperform standard endovascular aneurysm repair with favorable anatomy. In patients who are poor open surgical candidates who present with symptomatic or ruptured juxtarenal aortic aneurysms, PMEG continues to be an extremely appealing option as reliable off-the-shelf solutions are not widely available. Preoperative planning remains the key ingredient for success with use of these techniques.