Psacharopulo Daniele, Ferri Michelangelo, Ferrero Emanuele, Bahia Sandeep S, Viazzo Andrea, Pecchio Alberto, Ricceri Fulvio, Nessi Franco
Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
J Vasc Surg. 2017 Nov;66(5):1371-1378. doi: 10.1016/j.jvs.2017.03.444. Epub 2017 Jun 8.
The objective of this study was to evaluate the results of the off-label use of the Nellix endograft (Endologix, Irvine, Calif) for the treatment of short-neck aneurysms and juxtarenal aortic aneurysms (JAAs) compared with the outcomes of patients with infrarenal abdominal aortic aneurysms treated in accordance with the manufacturer's instructions for use.
Data available from patients treated with the Nellix endograft from September 2013 to January 2016 were reviewed to create a case-control analysis (1:2). Fourteen elective patients with a short-neck aneurysm or JAA (<10 mm) and mild aortic neck angulation (<35 degrees) were included. As a control group, 28 elective patients who had been treated in accordance with instructions for use were included. Patients were matched for age, sex, aortic diameter, and aortic neck angulation. The final cohort group included 42 patients: 14 in the JAA off-label group (5 with aortic neck length ≤4 mm and 9 with necks of 5 to 10 mm) and 28 in the control group. Technical and clinical success, freedom from any secondary intervention, any type of endoleak, and aneurysm-related death were evaluated.
There were no significant differences between the two groups in terms of comorbidity, intraoperative time, radiation time, contrast agent volume, and perioperative mortality and morbidity. Two patients of the JAA group subsequently underwent open repair (14%), both with aortic neck length <4 mm (2/5; 40%), for type Ia endoleak. Two of the control group also subsequently underwent open repair (7%). At a mean follow-up of 22 ± 3.9 months, freedom from any reintervention was 85% for the JAA off-label group vs 92% for the control group (log-rank test, P = .33).
The off-label use of the Nellix endograft for the treatment of JAA showed a higher rate of subsequent conversion to open repair for JAA patients (aortic neck length ≤4 mm), underlining the need for a proximal sealing zone. Longer term data are needed to verify the possible use of the Nellix endograft in selected short-neck aneurysms with aortic neck length >5 mm.
本研究的目的是评估 Nellix 腔内移植物(Endologix,加利福尼亚州欧文市)用于治疗短颈动脉瘤和近肾腹主动脉瘤(JAA)的标签外使用结果,并与按照制造商使用说明治疗的肾下腹主动脉瘤患者的结果进行比较。
回顾 2013 年 9 月至 2016 年 1 月接受 Nellix 腔内移植物治疗的患者的可用数据,以进行病例对照分析(1:2)。纳入 14 例患有短颈动脉瘤或 JAA(<10 mm)且主动脉颈部成角轻度(<35 度)的择期患者。作为对照组,纳入 28 例按照使用说明进行治疗的择期患者。对患者的年龄、性别、主动脉直径和主动脉颈部成角进行匹配。最终队列组包括 42 例患者:JAA 标签外使用组 14 例(主动脉颈部长度≤4 mm 的 5 例,颈部为 5 至 10 mm 的 9 例),对照组 28 例。评估技术和临床成功率、无需任何二次干预、任何类型的内漏以及与动脉瘤相关的死亡情况。
两组在合并症、手术时间、放射时间、造影剂用量以及围手术期死亡率和发病率方面无显著差异。JAA 组有 2 例患者随后接受了开放修复(14%),均为主动脉颈部长度<4 mm(2/5;40%),原因是 Ia 型内漏。对照组也有 2 例随后接受了开放修复(7%)。平均随访 22± 3.9 个月时,JAA 标签外使用组无需任何再次干预的比例为 85%,对照组为 92%(对数秩检验,P = 0.33)。
Nellix 腔内移植物用于治疗 JAA 的标签外使用显示,JAA 患者(主动脉颈部长度≤4 mm)随后转为开放修复的比例较高,突出了对近端密封区的需求。需要更长时间的数据来验证 Nellix 腔内移植物在选定的主动脉颈部长度>5 mm 的短颈动脉瘤中的可能应用。