Cath Lab Digest - November 2007 - (Page 19)

NOVEMBER 2007 SINGLE-CENTER STUDY 19 Cath Lab Nurse/Tech Vascular Access and Closure Using the StarClose® Device 1 Daniel T. Lee, MD 1 Matthew T. Lee, Research Assistant 1 Patrick C. Rim, Research Assistant 1 Thomas E. Tomczak Jr., NP 2 Karen DiDonato RN, MSN, Clinical Affairs Manager 1 Bay Regional Medical Center, Bay City, Michigan; 2Abbott Vascular, Redwood City, California Figure 1. The StarClose® Vascular Closure System. Abstract Background. Standard of care at most hospitals is for the physician to perform the femoral artery puncture required for vascular access, with the arteriotomy then being closed with manual compression or a vessel closure device (VCD). Clinical trials demonstrating safety and efficacy of VCDs have been mandated by the FDA, with participation restricted to interventional cardiologists. Little to no data has been published regarding the utilization of non-physician cath lab staff for providing vascular access and closure. Methods. This study was a singlecenter, retrospective evaluation of 1000 consecutive femoral artery punctures and closures using the Abbott Vascular (Redwood City, CA) StarClose® device between March 2006 and September 2006. The population included both diagnostic and interventional patients, with arterial access and closure performed exclusively by non-physician cath lab personnel. Primary endpoint (device success) was defined as achievement of hemostasis in the catheterization lab allowing transfer to the cardiovascular holding unit. Results. Overall device success rate was 96.3%; 96.5% for diagnostic and 95.6% for interventional. There were a total of 37 failed closures; 26 diagnostic and 11 interventional. Conclusion. Successful femoral artery access and closure performed by trained cath lab staff is feasible and safe. Additional, prospective studies with non-physician deployment of VCDs are ongoing. A B C D Introduction Standard of care at most hospitals and interventional cardiology practices is for the attending physician (or fellow) to perform the femoral artery puncture required for vascular access. The advent of vascular closure Daniel T. Lee, MD devices has also dictated that interventionalists invest additional time and energy at the end of the catheterization procedure to ensure safe and effective deployment of these devices prior to patient transfer to the recovery area. 1 Manufacturer labeling and Instructions For Use (IFU) have traditionally targeted “trained hospital staff” as the end user of VCDs, but randomized, pivotal trials conducted for FDA approval of these devices have exclusively engaged well-known interventional cardiologists for demonstration of initial safety and efficacy.2-5 As a result, very little research has been published regarding the utilization of non-physician cath lab staff for performing the initial arteriotomy and subsequent closure. The primary objective of this retrospective, observational study was to evaluate the safety and efficacy of the Figure 2. Mechanism of circumferential clip closure. A. The Vessel Locator Wings are positioned against the arteriotomy; B. The Clip Delivery Tube delivers the Clip to the arteriotomy, passing through the Introducer Sheath; C. The Trigger is depressed and the Clip is released; D. The tines of the Clip grasp the tissue and close the arteriotomy in a purse-string fashion. StarClose device in achieving hemostasis following diagnostic and percutaneous coronary interventional (PCI) procedures, where femoral arterial access and closure was obtained by a trained cath lab nurse, radiology technologist or registered cardiovascular invasive specialist (RCIS). Background The non-physician cath lab staff at Bay Regional Medical Center (BRMC) in Bay City, Michigan has been independently performing femoral artery access and closure procedures for more than 10 years. Though not mandatory or even a requirement of the job, nearly 90% of the nurses, techs and RCISs chose to undergo and complete the training necessary for certification and independent operation. Orientation for this type of advanced practice does not begin until the practitioner has been competently functioning in their current position for at least 6 months. Once identified as a training program candidate, the orientee is assigned a like-licensed mentor/preceptor and enters into a three-month observation period. During this time they are completely “hands off” and spend their days scrubbed into cases and aggressively shadowing

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

Henry Ford Heart and Vascular Institute Treating Patients with Complex Vascular Disease with a Multi-Disciplinary Approach Improving Patient Compliance with Antiplatelet Medications Clinical Editor’s Corner Cath Lab Nurse/Tech Vascular Access and Closure Using the StarClose® Device The Clinical and Economic Impact of Measuring Fractional Flow Reserve FFR and Choosing an Optimal Revascularization Strategy Finally! The New Registered Cardiac Electrophysiology Specialist (RCES) Credential Use of a Mobile Lab to ‘Test the Waters’ at a Rural Hospital Remembering a Cardiac Cath Lab History ACVP• Membership Page What Do You Think? The Ten-Minute Interview with… Ernie Livingston, RN, BSN SICP* Chapter Updates Who’s in Charge? Working to Eliminate Bottlenecks: Florida Hospital’s Cardiac Cath Lab Achieves Greater Efficiency and Higher Satisfaction Preserving Left Ventricular Function during Percutaneous Coronary Intervention Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Making the Most of Your First Impression: Interviewing Tips and Techniques CEU Education Center Clinical & Industry News Meetings Calendar

Cath Lab Digest - November 2007

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