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75. Health-related Quality of Life in the ADAM Study, a Randomized Trial of Surgery vs. Surveillance for Small Abdominal Aortic Aneurysm

FA Lederle, Minneapolis VA Medical Center; GR Johnson, West Haven VA Medical Center; SE Wilson, Long Beach VA Medical Center; and the ADAM VA Cooperative Study Investigators

Objectives: Determining the diameter at which abdominal aortic aneurysms (AAA) should undergo elective surgical repair is the major question of AAA management. In the Aneurysm Detection and Management (ADAM) Study (VA Cooperative Study #379), patients with small AAA, 4.0-5.4 cm in diameter, were randomized to surgery vs. periodic imaging surveillance with surgery reserved for AAA that expanded to 5.5 cm or developed symptoms. The purpose of this report is to compare long-term changes in health-related quality of life with these two strategies.

Methods: Patients were recruited over 5 years at 16 VA medical centers and randomized by telephone call to the statistical center. Study nurses collected questionnaire data at randomization and at clinic visits every 6 months thereafter during the 8 years of the study. Telephone interviews replaced clinic visits when necessary. Analysis was by intent-to-treat.

Results: 1136 patients were randomized. AAA repair was performed in 92% of the surgery group (87% by 6 months), and in 61% (uncensored) of the surveillance group (3% at 6 months, 12% at 1 year, 25% at 2 years). All AAA were asymptomatic at baseline and at all follow-up visits. The mean SF-36 Physical and Mental Component Scores (PCS and MCS) were low at baseline (42 and 52) and declined significantly from baseline over time in both groups. There were no significant mean differences at baseline between the two randomized groups in PCS, MCS, or in any of the eight individual scales. There were no significant differences in mean PCS or MCS between treatment groups at any time period, but PCS favored Surgery at 12 and 18 months (p < 0.01) when compared as change from baseline. The Surgery group scored significantly better (p < 0.01) in the General Health scale at 6 and 12 months, and in Health Transition at 6, 12, 18, and 24 months, with similar results obtained by comparing change in these scales from baseline. Impotence was reported in 37%, 39%, and 45% of the Surgery group at baseline, 6 months and 12 months, compared with 36%, 36%, and 40% of the Surveillance group (NS). Thereafter, the Surgery group had significantly more impotence at most time periods. 63% of patients reported maximum activity level of "moderate" or "vigorous" at baseline and 3% reported being "sedentary". Maximum activity level did not differ significantly at baseline or at any subsequent time between treatment groups. Following surgery in all operated patients, the proportion reporting "moderate" or "vigorous" activity declined from 60% to 48%, whereas those reporting "sedentary" increased from 6% to 8%.

Conclusions: Surprisingly, surgery for asymptomatic AAA resulted in improvements in physical and general health scores compared with surveillance. Contrary to previous assertions, AAA repair was not associated with a substantial increase in the reported rate of impotence in the first year after surgery, nor was maximum activity level reduced in most patients.

Impact: Despite its being a major procedure for an asymptomatic condition, elective AAA repair carried out in major academic VA medical centers does not appear to reduce health-related quality of life.