Cath Lab Digest - October 2007 - (Page 34)

34 HEMOSTASIS OCTOBER 2007 Figure C. Catalyst System overall access time management was reduced by > 50% over manual compression in diagnostic subjects. Prairie Heart Institute’s Nilesh Goswami, MD, Director of Coronary Care Unit, and Sheryl Friedrich, RN, Cath Lab Manager. limb ischemia and sometimes leading to amputation.4 The Boomerang Catalyst™ System In order to protect the femoral artery from scarring that can complicate future vascular access procedures, hemostasis should be achieved with minimal trauma to the access site, leaving nothing behind in the artery when the patient is discharged. Physicians may choose from a variety of closure techniques for vascular access management, from manual and mechanical compression to active fixation devices. With manual compression, the site closure and recovery/ambulation is under the control of the post-care staff. With a VCD, the physician controls site closure and post-care staff supervise only the recovery/ambulation. Physicians hesitate to use VCDs in certain patient subsets, however, because of the higher incidence of vascular complications.1,12-16 “Acutely, I want reliable, quick and safe hemostasis,” Figure D. Catalyst System overall access time management was reduced by 40% over manual compression in interventional subjects. ured only acute endpoints. Although some trials exhibited an equivalent or lower rate of bleeding complications,9 results of two recent metaanalyses 10,11 show evidence of no reduction in overall vascular complications with VCD use. Some hospitals cite trials resulting in lower VCD complication rates as a rationale for attempting to decrease patient complications and staff injuries by employing VCDs.9 This strategy seems reasonable if the procedure’s endpoint is short-term arterial hemostasis. Viewed as a long-term continuum of care, however, arterial closure with VCDs, or “active fixation” devices, may result in complications during the recovery process, the post-discharge period, and beyond to the next procedure. VCDs always leave something behind, and these retained foreign materials induce an inflammatory response, leading to scarring and possible infection, and may impede future access. In addition, this inflammatory response may lead to severe implant-related complications, such as vessel thrombosis and Dr. Goswami commented. “Longterm, we wish to avoid potential complications.” The Boomerang Catalyst ™ System is designed to promote artery closure by working with the vessel’s natural elasticity. The Catalyst System works in conjunction with “gold standard” manual compression and the body’s own healing systems, leaving nothing behind in the artery to generate an inflammatory response or cause catastrophic implant-related complications. It employs a low-profile, intra-arterial nitinol disk attached to a coated tension wire to temporarily tamponade the arteriotomy while allowing natural elastic recoil (Figure B) of the vessel wall’s smooth muscle layer. The sheath-dilated arteriotomy is reduced to the 18-gauge profile of the coated wire, approximating the original needle stick. The Catalyst System, a “passive fixation” device, further promotes hemostasis through a proprietary hemostatic coating on the wire that Table 1. Complications — Interim data results from Prairie Heart Institute subjects enrolled (n=204) in the BOOMERANG II Trial.17 Diagnostic Boomerang Wire (108) 0 (0.0%) 2 (1.0%) 0 (0.0%) 1 (0.5%) 1 (0.5%) Manual Comp (26) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Interventional Boomerang Wire (57) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Manual Comp (12) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Major Complications Minor Complications Hematomas (> 4cm) Pseudoaneurysm w/ thrombin inj. DVT right iliac (non-device leg) *DVT: deep vein thrombosis

Table of Contents Feed for the Digital Edition of Cath Lab Digest - October 2007

Saints Medical Center Fibromuscular Dysplasia in Children and Adolescents Cerebral Vascular Accident Following a Pulmonary Embolism: Search for the Hidden Patent Foramen Ovale Contents Clinical Editor’s Corner Meetings Calendar CEU Education Center Radiation Tracking in the Cardiac Catheterization Lab Letter to the Editor Carotid Stenting: An update Release from Stent-jail: Beneficial Snow-Plowing? Patient Management Guidelines Searching for a Cardiovascular Position? Tips for Creating a ‘Stand-Out’ Resume Long-Term Implications of Short-Term Closure Decisions – The Evolution to Vascular Access Management and the Boomerang Catalyst System The Ten-Minute Interview with… Angie Bowles, RN, CCRN CMS Issues Final FY 2008 IPPS Rule ACVP• Membership Page Experience with a New Workhorse Guidewire Ask the Clinical Instructor: Q&A for Those New to Cath Lab A Glimpse of the Future of Clinical Education: Boston Scientific’s SimSuite Bus Visits Carnegie Institute 2007 Educational Fair Held at the Washington Hospital Center Research Update: Original Contribution Abstracts from The Journal of Invasive Cardiology What Do You Think? A Virtual Cath Lab Viewer (VCL): The Development of an Online 3D C-arm Simulator and Coronary Anatomy Viewer Clinical & Industry News Cost-Effectiveness of the Radial versus Femoral Artery Approach to Diagnostic Cardiac Catheterization

Cath Lab Digest - October 2007

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