Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.
J Vasc Surg. 2011 Oct;54(4):931-7. doi: 10.1016/j.jvs.2011.02.054. Epub 2011 Jun 12.
The purpose of this study was to compare the eligibility of men and women with infrarenal abdominal aortic aneurysms (AAAs) for on-label endovascular aneurysm repair (EVAR) as part of the clinician-Food & Drug Administration (FDA) collaborative effort, the Characterization of Human Aortic Anatomy Project (CHAP).
Computed tomography (CT) scans with 3D reconstruction from a single institution obtained between July 1996 and December 2009, including standardized measurements by a blinded third-party (M2S, West Lebanon, NH) were examined. For inclusion, abdominal aortic aneurysm (AAA) had to be infrarenal, unrepaired, and >5 cm, or 4 cm to 5 cm if the orthogonal sac diameter was more than twice the aortic diameter at the renal level. Scans were included regardless of subsequent EVAR, open repair, or lack of treatment. One thousand sixty-three unique, unrepaired AAAs were analyzed.
Neck length, diameter, and angulation differ for women (P < .001) even after adjustment for patient age and AAA size. EVAR eligibility based on device Instructions for Use (IFU) criterion is affected by gender. Neck length <15 mm was found in 47% of men and 63% of women. Neck angulation exceeding 60 degrees was found in 12% of men and 26% of women. Minimum iliac diameter of 6 mm was found in 35% of men and 55% of women. Only 32% of men and 12% of women met all three neck criterion and had iliac lumen diameters >6 mm. Logistic regression modeling shows that older patient age (odds ratio [OR], 0.84 per decade), increased aneurysm diameter (OR, 0.70 per cm), and female gender (OR, 0.4) are each independently associated with decreased odds of meeting all device IFU neck criterion (P < .05). EVAR eligibility by neck criterion does not decline significantly until AAA size exceeds 5.5 cm in women and 6.5 cm in men.
Women are significantly less likely to meet device IFU criterion for EVAR. Aortic neck criteria and iliac access are important for men and women, but more women than men fail to meet IFU criterion. Devices that accommodate shorter infrarenal AAA neck length will have the greatest impact on expanding on-label EVAR regardless of gender. Lower profile devices and those that accommodate higher neck angulation are expected to expand EVAR eligibility further for women. EVAR eligibility is unlikely to be lost as AAAs enlarge to 5.5 cm in women and 6.5 cm in men. Observation of small AAAs until they reach the standard threshold size for repair should not compromise EVAR eligibility.
本研究旨在比较男性和女性的肾下腹部主动脉瘤（AAA）在标签外腔内修复（EVAR）的适应证，这是临床医生-食品和药物管理局（FDA）合作努力的一部分，即人体主动脉解剖特征项目（CHAP）。
对 1996 年 7 月至 2009 年 12 月期间在单一机构获得的 CT 扫描进行 3D 重建，由第三方（新罕布什尔州 West Lebanon 的 M2S）进行标准化测量。纳入标准为：AAA 必须是肾下、未修复、>5cm，如果垂直囊直径大于肾水平主动脉直径的两倍，则为 4cm 至 5cm。无论是否随后进行 EVAR、开放修复或未治疗，均纳入扫描。共分析了 1063 个独特的、未修复的 AAA。
即使在调整了患者年龄和 AAA 大小后，女性的颈部长度、直径和角度仍存在差异（P<0.001）。基于器械使用说明书（IFU）标准的 EVAR 适应证受到性别影响。发现男性中有 47%，女性中有 63%的颈部长度<15mm。男性中发现颈部角度超过 60 度的占 12%，女性中占 26%。最小髂内直径为 6mm 的男性占 35%，女性占 55%。只有 32%的男性和 12%的女性同时符合所有三个颈部标准，且髂内管腔直径>6mm。Logistic 回归模型显示，患者年龄较大（每十年降低 0.84 倍）、AAA 直径增大（每厘米降低 0.70 倍）和女性（降低 0.4 倍）均与符合所有器械 IFU 颈部标准的几率降低独立相关（P<0.05）。直到女性的 AAA 直径超过 5.5cm，男性超过 6.5cm，EVAR 适应证才会因颈部标准而显著下降。
女性更不可能符合 EVAR 器械 IFU 标准。主动脉颈部标准和髂内通道对男性和女性都很重要，但不符合 IFU 标准的女性多于男性。适应较短肾下 AAA 颈部长度的器械将对扩大标签内 EVAR 产生最大影响，无论性别如何。预计更低轮廓的器械和适应更高颈部角度的器械将进一步扩大女性 EVAR 的适应证。随着女性的 AAA 直径增大到 5.5cm，男性增大到 6.5cm，EVAR 适应证不太可能丢失。观察到较小的 AAA 直到它们达到修复的标准阈值大小，不应该影响 EVAR 的适应证。
