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The anatomy characteristics of 7000 inferior abdominal aortic aneurysms, CHAP patient cohort (percentiles) by gender

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posted on 2016-09-08, 02:24 authored by Tina MorrisonTina Morrison

CHAP, the Characterization of Human Aortic Anatomy Project, which started in 2009 by the Food and Drug Administration (FDA) and practicing clinicians in the community, is a collaboration to gather and analyze anatomic data from patients with aortic aneurysms.  One of CHAP’s first goals is to characterize the anatomy of unrepaired infrarenal AAA (iAAA) from a large subset of the patient population, with the hope of elucidating pertinent anatomical differences between men and women that might lead to treatment disparities, and to expand patient eligibility for EVAR by identifying criteria for augmenting endovascular design and evaluation.  The CHAP database contains data from centers that consecutively submit[1] their pre-operative CT scans of unrepaired aneurysm cases to M2S for analysis and surgical planning.  M2S, Inc. (Lebanon, NH) is a third party core lab that independently reviews each scan and records anatomic measurements that define the geometry and shape of aneurysms and other vascular pathologies. 

 

The following studies have been conducted under CHAP with approval from the FDA and center specific Institutional Review Boards: (i) Single center anatomical study [1], (ii) 3-center anatomical study [2], (iii) 11-center anatomical study, current study.  For these studies, the measurements (as listed in the Table below) of the iAAA anatomy were determined in conjunction with SVS reporting standards [3]. The table below are the data from the CHAP database for infrarenal AAA binned by gender.

 

 

[1] Sweet MP, Fillinger MF, Morrison TM, and Abel DB. J Vasc Surg 2011;54(4):931-7.

[2] Morrison, T.M., Yan, X., Abel, D.B., Fairman, R.M., Glickman, M.H., and Fillinger, M.F.,  J of Vasc Surg, 55(6):30S 2012

[3] Chaikof EL, Blankensteijn JD, Harris PL, et al. J Vasc Surg 2002;35:1048-60.



[1] Two sites consecutively submitted cases that were considered for EVAR only.  We tested for heterogeneity and there were no statistical differences between those sites and the 9 remaining center.  Therefore, we determined that it was acceptable to keep data from all 11 centers.

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FDA Critical Path Project

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