Assessment of the safety and efficacy of the DUETT vascular hemostasis device: final results of the safe and effective vascular hemostasis (SEAL) trial

American Heart Journal
SEAL Trial Study Team

Abstract

We sought to determine the safety and efficacy of the novel DUETT vascular hemostasis device in comparison with standard manual compression after diagnostic and interventional coronary procedures. Vascular hemostasis devices are increasingly used to improve patient comfort and speed mobilization after coronary and peripheral vascular procedures. Currently available devices have certain limitations, however. At 16 clinical sites, 630 patients who underwent diagnostic or interventional coronary procedures were randomized 5:3 to the DUETT sealing device or standard manual compression. The primary study end points were time to hemostasis and ambulation and the incidence of major vascular complications at 30 days. Time to hemostasis from the completion of the procedure (catheter removal; median) was 14 minutes (interquartile range [IQR], 10, 17 minutes) in the DUETT group and 195 minutes (IQR, 46, 351 minutes) in the standard compression group (P <.001), and time from sheath removal (median) was 7 minutes (IQR, 6, 8 minutes) and 20 minutes (IQR, 15, 30 minutes) for the 2 groups, respectively (P <.001). Time to ambulation from catheter removal (median) was 338 minutes (IQR, 223, 526 minutes) in the DUETT group and 705 minutes (IQR, 4...Continue Reading

Citations

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