Tina M. Morrison1, Clark A. Meyer1, Mark F. Fillinger2, Ron M. Fairman3, Marc H. Glickman4, Richard P. Cambria5, Mark A. Farber6, Thomas C. Naslund7, Peter S. Fail8, James R. Elmore9, Rodney A. White10; Carlo A. Dall’Olmo11; David M. Williams12
1Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD; 2Dartmouth Hitchcock Medical Center, Lebanon, NH; 3University of Pennsylvania Medical Center, Philadelphia, PA; 4Sentara Norfolk General Hospital, Norfolk, VA; 5Massachusetts General Hospital, Boston, MA; 6University of North Carolina Medical Center, Chapel Hill, NC; 7Vanderbilt Medical Center, Nashville, TN; 8Cardiovascular Institute of the South, Houma, LA; 9Geisinger Medical Center, Danville, PA; 10Harbor UCLA Medical Center; Los Angeles, CA; 11Michigan Vascular Center, Flint, MI; 12University of Michigan Medical Center, Ann Arbor, MI
OBJECTIVES: Using the CHAP database of nearly 10,000 patients nationwide, we examined eligibility for EVAR in patients with a short neck AAA (snAAA), where the neck length <10mm, and identified the anatomic parameters driving endograft (EVG) ineligibility.
METHODS: Pre-operative CT scans from 11 U.S. clinical sites were prospectively entered into a database from 7/96 to 11/12. A blinded third-party, M2S, recorded standardized measurements from the 3-D reconstructions. Two currently marketed EVG in the United States are labeled to treat snAAA, with neck angulation ≤45 degree and neck lengths ≥4mm (Cook Fenestrated) and >7mm (TriVascular Ovation). The EVAR criteria were analyzed in 2,245 men (M) and 1,079 women (W) with snAAA.
RESULTS: Of the 9,848 AAAs, 3,324 have snAAA (34%). Even if iliac and access criteria are excluded, EVAR eligibility for snAAA is at most 45%. In snAAA >5cm diameter, neck angulation is 48 degrees for women and 37 degrees for men (p<0.01). Women are more likely to have neck length <4mm and neck angulation >45 degrees (risk ratio is 90). Only 6% of patients are eligible for both EVG. Larger AAAs are not less likely to be eligible for fenestrated EVAR (Table 1, p=NS).
CONCLUSIONS: One-third of AAAs have a short neck, and less than half of these are eligible for current EVG, even with a fenestrated option. Neck angulation and length continue to challenge EVAR eligibility, especially for women. Eligibility for EVAR does not lessen as aneurysms enlarge, so there is no indication for early repair.
AUTHOR DISCLOSURES: R.P.Cambria: Nothing to disclose; C.A. Dall’Olmo: Nothing to disclose; J.R. Elmore: Nothing to disclose; P.S. Fail: Nothing to disclose; R.M. Fairmain: Nothing to disclose; M.A. Farber: Nothing to disclose; M. F. Fillinger: Nothing to disclose; M.H. Glickman: Nothing to disclose; C. A. Meyer: Nothing to disclose; T. M. Morrison: Nothing to disclose; T.C. Naslund: Paid consultant (Data Monitoring Committee) CVRx, Paid consultant (Clinical Events Committee) WL GORE, Paid educator COOK Medical; R.A. White: Nothing to disclose; D.M. Williams: Nothing to disclose.
Table 1: Eligibility for two marketed EVGs excluding iliac and access criteria; median (10th-90th percentile) values of anatomic parameters
Posted April 2013
|| M (512)
|Cook Fenestrated, %
|TriVascular Ovation, %
|Neck Length, mm
|| 6 (3-9)
||6 (2 9)
||5 (2 9)
|Neck Angulation, deg
||39 (19 64)
||43 (20 67)
|Neck Diameter, mm
||25 (21 38)
||26 (21 41)