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

OBJECTIVE
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.


BACKGROUND
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.


METHODS
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.


RESULTS
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, 400, 1120 minutes) in the standard compression group (P <.001). Major complications occurred in 3.6% of the DUETT group and 1.7% of the standard compression group (P =.22), with a diminishing risk of complications in the DUETT group as experience was accrued. Similar benefits from DUETT use were seen in patients who underwent both diagnostic and interventional procedures.


CONCLUSION
The DUETT sealing device allows immediate arterial sheath removal after both diagnostic and interventional procedures, dramatically reducing time to hemostasis and patient ambulation without compromising patient safety in comparison with standard compression techniques.