Relevance of the ADAM and UK Small Aneurysm trial data in the age of endovascular aneurysm repair.
OBJECTIVE
Neither the ADAM nor the UK Small Aneurysm trials showed an advantage for early open surgical repair of abdominal aortic aneurysms (AAAs) smaller than 5.5 cm in diameter. The rigorous exclusion criteria of these studies, however, limited surgery to low-risk patients. We tested the hypothesis that endovascular aneurysm repair (EVAR) has been successfully used for higher-risk patients, thus questioning the utility of the ADAM and UK Small Aneurysm trials exclusion criteria in EVAR patient selection.


METHODS
Retrospective case review.


METHODS
An urban Veterans Affairs Medical Center.


METHODS
Forty-four consecutive cases of patients with AAA who received EVAR.


METHODS
Electronic medical records were accessed for 11 high-risk conditions that would have excluded patients from the open surgery trials, and 30-day interventional morbidity and mortality data were collected.


RESULTS
The mean (SD) age of patients who underwent EVAR was 73.2 (10.3) years, with a mean (SD) AAA diameter of 5.8 (1.6) cm. Of 44 patients, 19 (43%) met at least 1 exclusion criterion that would have prevented randomization in the small AAA trials. Significant perioperative complications occurred in 14 patients (32%) and 1 death occurred at home within 30 days of the procedure.


CONCLUSIONS
Patients receiving EVAR at an urban Veterans Affairs Medical Center had a greater prevalence of high-risk conditions than patients included in the ADAM and UK Small Aneurysm trials, and overall perioperative morbidity and mortality were lower. Endovascular aneurysm repair has extended aneurysm repair to a higher-risk population with greater safety.
Department of Surgery, University of California, Irvine Medical Center, Orange, CA 92868, USA.
Madhukar S
MS
Patel
David A
DA
Brown
Samuel E
SE
Wilson
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D002986:Clinical Trials as Topic; D006787:Hospitals, Veterans; D006801:Humans; D008875:Middle Aged; D012189:Retrospective Studies; D014505:Urban Population