Impact of the Duett sealing device on quality of life and hospitalization costs for coronary diagnostic and interventional procedures: Results from the Study of Economic and Quality of Life substudy of the SEAL trial

Abstract Background The Simple and Effective Arterial Closure (SEAL) trial examined the safety and effectiveness of the Duett vascular sealing device (Vascular Solutions, Minneapolis, Minn) versus manual compression after diagnostic and interventional coronary procedures. We compared quality of life and initial hospitalization costs among patients treated with the Duett device versus manual compression. Methods Functional status was assessed with the Duke Activity Status Index (DASI) at 7 and 30 days after intervention. General health status was assessed with the Short Form (SF-36) at 30 days after intervention. Hospitalization costs were derived from the UB92 formulation of the hospital bill. Results There was a strong trend toward higher functional status in patients receiving treatment with the Duett device at 7 days both before ( P = .04) and after ( P = .08) adjustment for significant covariates. This difference was significant in the diagnostic group but not in the interventional group. No significant differences in quality of life between the Duett device and manual compression at 30 days were found. There was no significant difference in total hospitalization costs between treatment arms ( P = .91). For interventional patients, mean total in-hospital costs were $10,167 in the Duett group and $10,225 in the manual compression group ( P = .82). For diagnostic patients, mean hospitalization costs were $7784 and $7996 for the Duett device and manual compression groups, respectively ( P = .72). Trends toward reduced recovery/observation room costs with the Duett device ( P = .06) were found; this difference was significant in the diagnostic group ($198 vs $279, P = .02). Conclusions The Duett sealing device was associated with significantly higher functional status at 7 days after the procedure in addition to shortened time to hemostasis and ambulation, with no associated increase in cost. (Am Heart J 2001; 142:982-8.)