Shutze William, Suominen Velipekka, Jordan William, Cao Piergiorgio, Oweida Steven, Milner Ross
Texas Vascular Associates, Dallas, Tex; The Heart Hospital Baylor Plano, Plano, Tex.
Division of Vascular Surgery, Department of Surgery, Tampere University Hospital, Tampare, Finland.
J Vasc Surg. 2018 Dec;68(6):1714-1724. doi: 10.1016/j.jvs.2018.03.394. Epub 2018 May 24.
The Gore Global Registry for Endovascular Aortic Treatment (GREAT) was designed to evaluate real-world outcomes after treatment with Gore aortic endografts used in a real-world, global setting. We retrospectively analyzed the GREAT data to evaluate the incidence and effects of noncylindrical neck anatomy in patients undergoing endovascular aortic aneurysm repair.
The present analysis included patients with data in the GREAT who had been treated with the EXCLUDER endograft from August 2010 to October 2016. A noncylindrical neck was defined when the proximal aortic landing zone diameter had changed ≥2 mm over the first 15 mm of the proximal landing zone, indicating a tapered, conical, or hourglass morphology. Cox multivariate regression analyses were performed for any reintervention (including reinterventions on aortic branch vessels), device-related reinterventions, and reintervention specifically for endoleak. Independent binary (cylindrical vs noncylindrical necks) and continuous (percentage of neck diameter change) variables were assessed. The abdominal aortic aneurysm (AAA) diameter, proximal neck length, maximal infrarenal neck angle, gender, and use of aortic extender cuffs were also assessed.
Of 3077 GREAT patients with available proximal aortic landing zone diameter measurements available, 1765 were found to have cylindrical necks and 1312 had noncylindrical necks. The noncylindrical neck cohort had a significantly greater proportion of women (17.4% vs 12.6%; P < .001) and more severe infrarenal angulation (33.8° vs 28.4°; P < .001). A total 14.7% of noncylindrical neck patients and 11.2% cylindrical neck patients underwent implantation outside of the EXCLUDER instructions for use regarding the anatomic inclusion criteria (P = .004). The procedural characteristics were similar between the two cohorts; however, noncylindrical neck patients required significantly more aortic extender cuffs (P = .004). The average follow-up was 21.2 ± 17.5 months and 17.8 ± 15.8 months for the cylindrical and noncylindrical cohorts, respectively (P < .001). The Cox multivariate regression models demonstrated female gender and maximum AAA diameter were significant risk factors for subsequent reintervention (overall, device-related, and endoleak-specific). Women were 2.2 times as likely to require device-related intervention during the follow-up period compared with men (P < .001). Neck shape morphology was not a significant predictor, except for device-related intervention, for which cylindrical necks (binary definition) resulted in a slightly elevated risk (1.5 times; P = .03).
Noncylindrical neck morphology was more common in women and was associated with an increased use of aortic extender cuffs but did not increase the risk of intervention. Female gender and AAA diameter were associated with an increased need for reintervention.
戈尔全球血管内主动脉治疗注册研究(GREAT)旨在评估在真实世界的全球环境中使用戈尔主动脉腔内移植物治疗后的实际疗效。我们回顾性分析了GREAT数据,以评估接受血管内腹主动脉瘤修复术患者非圆柱形颈部解剖结构的发生率及其影响。
本分析纳入了2010年8月至2016年10月期间在GREAT中接受EXCLUDER腔内移植物治疗且有相关数据的患者。当近端主动脉锚定区直径在近端锚定区的前15mm内变化≥2mm时,定义为非圆柱形颈部,提示呈锥形、漏斗形或沙漏形。对任何再次干预(包括对主动脉分支血管的再次干预)、与器械相关的再次干预以及专门针对内漏的再次干预进行Cox多因素回归分析。评估独立的二元变量(圆柱形颈部与非圆柱形颈部)和连续变量(颈部直径变化百分比)。还评估了腹主动脉瘤(AAA)直径、近端颈部长度、肾下最大颈部角度、性别以及主动脉延长袖口的使用情况。
在3077例有可用近端主动脉锚定区直径测量值的GREAT患者中,1765例为圆柱形颈部,1312例为非圆柱形颈部。非圆柱形颈部队列中女性比例显著更高(17.4%对12.6%;P <.001),肾下角度更严重(33.8°对28.4°;P <.001)。共有14.7%的非圆柱形颈部患者和11.2%的圆柱形颈部患者在EXCLUDER使用说明书关于解剖纳入标准之外进行了植入(P =.004)。两组队列的手术特征相似;然而,非圆柱形颈部患者需要显著更多的主动脉延长袖口(P =.004)。圆柱形和非圆柱形队列的平均随访时间分别为21.2±17.5个月和17.8±15.8个月(P <.001)。Cox多因素回归模型显示,女性和最大AAA直径是后续再次干预(总体、与器械相关和特定于内漏)的显著危险因素。与男性相比,女性在随访期间需要器械相关干预的可能性是男性的2.2倍(P <.001)。颈部形状形态不是一个显著的预测因素,但对于与器械相关的干预,圆柱形颈部(二元定义)导致风险略有升高(1.5倍;P =.03)。
非圆柱形颈部形态在女性中更常见,与主动脉延长袖口使用增加相关,但并未增加干预风险。女性性别和AAA直径与再次干预需求增加相关。