The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair

• Published in: Journal of vascular surgery 2011-10, Vol.54 (4), p.931-937
• Main Authors: Sweet, Matthew P., MD, Fillinger, Mark F., MD, Morrison, Tina M., PhD, Abel, Dorothy, BSME
• Format: Article
• Language: English
• Subjects: Age Factors; Aged; Aged, 80 and over; Aortic Aneurysm, Abdominal - diagnostic imaging; Aortic Aneurysm, Abdominal - surgery; Aortography - methods; Biological and medical sciences; Blood and lymphatic vessels; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - instrumentation; Cardiology. Vascular system; Diseases of the aorta; Endovascular Procedures - instrumentation; Female; Humans; Imaging, Three-Dimensional; Linear Models; Logistic Models; Male; Medical sciences; Odds Ratio; Patient Selection; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Radiographic Image Interpretation, Computer-Assisted; Risk Assessment; Risk Factors; Sex Factors; Surgery; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Tomography, X-Ray Computed; Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2011.02.054

Objectives 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). Methods 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. Results 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 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. Conclusion 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 shoul