Comparison of the Boomerang Wire Vascular Access Management System Versus Manual Compression Alone During Percutaneous Diagnostic and Interventional Cardiovascular Procedures: The Boomerang (TM) Wire Vascular Access Management Trial II

摘要

Objectives: To evaluate the use of the Boomerang (TM) 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 (TM) Trial was a prospective, multicenter, randomized, controlled trial comparing use of the Boomerang (TM) 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 (TM) use, in conjunction with MC, was associated with low rates of complications and demonstrated that Boomerang (TM) as an adjunct to MC can significantly decrease TTH and TTA after both Dx and Ix procedures. (C) 2015 Wiley Periodicals, Inc.