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Comparison of the boomerang wire vascular access management system versus manual compression alone during percutaneous diagnostic and interventional cardiovascular procedures: The boomerang™ wire vascular access management trial II
Author(s) -
Goswami Nilesh J.,
Smalling Ronnie G.,
Sinha Shantanu,
Gammon Roger S.,
Ramaiah Venkatesh G.
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25842
Subject(s) - medicine , percutaneous , hemostasis , randomized controlled trial , surgery , complication , femoral artery , adverse effect
Objectives To evaluate the use of the Boomerang™ Wire as an adjunct to manual compression (MC) in patients requiring diagnostic (Dx) or interventional (Ix) percutaneous procedures. Background MC remains the standard of care for closure of femoral artery access sites. Adjunctive use of a device to facilitate closure, reduce time to hemostasis (TTH) and ambulation (TTA) without increasing complication rates could reduce costs and hospital resource demands. Methods The Boomerang™ Trial was a prospective, multicenter, randomized, controlled trial comparing use of the Boomerang™ wire, (Cardiva Medical, Sunnyvale, CA) in conjunction with MC versus MC alone to achieve hemostasis in Dx and Ix patients undergoing percutaneous procedures requiring femoral artery access. Endpoints included TTH, TTA, major, and minor access‐site related complications. Subjects were randomized 3:1, Boomerang versus MC. Results No minor or major device‐related adverse events were reported. Nondevice related complication rates were 3 (0.9%) in the Boomerang arm ( n = 327) and 1 (0.8%) in MC arm ( n = 123). Mean TTH for Boomerang vs. MC was 11.2 ± 4.3 vs. 23.2 ± 11 min for Dx ( P < 0.0001) and 13.9 ± 5.4 vs. 38.4 ± 57.3 min for Ix patients ( P < 0.0001). Mean TTA for Boomerang vs. MC was 3.3 ± 3.0 vs. 4.5 ± 2.0 hr ( P < 0.0001)for Dx and 5.4 ± 3.3 vs. 6.8 ± 3.2 hr ( P < 0.0001) for Ix patients. Conclusions Boomerang™ use, in conjunction with MC, was associated with low rates of complications and demonstrated that Boomerang™ as an adjunct to MC can significantly decrease TTH and TTA after both Dx and Ix procedures. © 2015 Wiley Periodicals, Inc.