February 24, 2005

Health-Related Quality Of Life In Patients Participating In the AneuRx Phase II Trial

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Abstract 02

Robert B. McLafferty, M.D., April Jackson, M.D., Don E. Ramsey, M.D., Aamir M. Zakaria, M.D., Kim J. Hodgson, M.D..
Southern Illinois University, Springfield, IL, USA.

Objective:
To report the health-related quality of life (QOL) of patients participating in a prospective study of endovascular aneurysm repair (EVAR) compared to open repair (OR).
Methods:
QOL data was prospectively obtained from patients participating in the AneuRx Phase II trial. EVAR and OR groups completed a self-administered survey utilizing the Medical Outcomes Study Short Form-36 (SF-36) at baseline, discharge, 1, 6, and 12 months follow-up. Summed scores were transformed to a 0 - 100 scale with higher scores more favorable.
Results:
427 patients had QOL data (398 EVAR, 29 OR). 84% of EVAR patients and 58% of OR patients had surveys at baseline, discharge, and 1 month. Baseline demographics and clinical risk factors between EVAR and OR were similar. At discharge, EVAR had more favorable scores than OR for physical functioning (p<0.05), vitality, mental health, and general health. At one month, QOL scores for EVAR were still substantially more favorable than OR for physical functioning, role limitation, social function, and mental health. For EVAR at 1 month, 7 of 8 QOL parameters returned to near baseline compared to 4 of 8 for OR. By 6 months, differences in QOL scores resolved between EVAR and OR. Scores for pain were similar between the two groups for all time periods.


Mean QOL Scores: AneuRx/Surgery	Physical Functioning	Role - Limitation	Pain	General Health	Vitality	Social Function	Role - Emotional	Mental Health
Baseline	55.5 / 53.8	50.3 / 37.5	71.9 / 63.3	61.3 / 61.4	51.2 / 53.4	77.8 / 68.4	75.6 / 72.5	74.5 / 69.9
Discharge	46.7 / 25.9*	-- / --	47.7 / 44.2	58.9 / 57.3	43.5 / 37.0	-- / --	-- / --	71.4 / 66.2
Month 1	55.1 / 49.4	40.7 / 28.8	68.8 / 70.5	62.8 / 66.7	48.8 / 48.2	76.4 / 64.4	70.9 / 70.0	76.2 / 71.3
Month 6	58.6 / 63.5	56.6 / 65.4	69.9 / 78.5	63.3 / 58.8	52.1 / 63.5*	82.0 / 86.5	77.8 / 94.9	77.5 / 73.7
Month 12	62.5 / 55.5	58.5 / 42.5	67.6 / 73.2	62.8 / 51.3	56.3 / 46.5	82.4 / 81.3	74.8 / 80.0	78.2 / 72.0
* p<0.05 for difference between treatment groups for same scale at same timepoint

Conclusions:
Patients undergoing EVAR experience a faster return to normal functioning compared to OR. These differences resolve by 6 months follow-up. Although the number of patients in the OR group is small for comparison, this prospective QOL data set remains vital for comparison to other studies examining QOL for EVAR and OR.