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 s...

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Bibliographic Details
Published in:The American heart journal 2002-04, Vol.143 (4), p.612-619
Main Author: The SEAL Trial Study Team
Format: Article
Language:English
Subjects:
Adult
Biological and medical sciences
Cardiac Catheterization
Diseases of the cardiovascular system
Early Ambulation
Female
Hemostasis, Surgical - instrumentation
Humans
Male
Medical sciences
Quality of Life
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Time Factors
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Summary: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
ISSN:0002-8703
1097-6744
DOI:10.1067/mhj.2002.121464