Cath Lab Digest - November 2007 - (Page 21)

21 results of the study included and reflected the learning curve of (investigator) physicians. Successful femoral artery access and closure when performed by trained, non-physician cath lab staff is feasible and appears to be safe and effective, based on this preliminary observational study. failed closures; 26 of which occurred in the diagnostic population, and 11 in the interventional population. The CLIP Study was the pivotal trial for U.S. approval of the StarClose device and provides an interesting, though not exact, comparison population. A total of 17 sites enrolled 483 subjects randomized at a 2:1 ratio to receive either StarClose or manual compression after the percutaneous procedure. The study included diagnostic (n = 208) and interventional (n = 275) arms with all deployments being performed by trained interventional cardiologists. The primary safety endpoint was major vascular complications through 30 days, with a primary efficacy endpoint of post-procedure time to hemostasis.5 Device success for this study was defined as achievement of hemostasis via the StarClose alone or with ≤ 5 minutes of adjunctive compression and freedom from major vascular complications. The diagnostic cohort had a device success rate of 94.1% (128/136), while 86.8% (160/184) of the interventional subjects were successfully closed in less than 5 minutes. Though the definition of “device success” varied between the two studies, Figure 3 provides a rough comparison of physician versus non-physician deployments. The CLIP trial confirmed the device was a safe and effective means of establishing circumferential clip-based closure, but the overall, protocoldefined success rate (90% for both populations) fell short of what we observed in the cath lab at BRMC (96.3%). As acknowledged, one possible explanation for this discrepancy could be that the FDAmandated definition for device success in CLIP was much more rigorous than the one applied for the BRMC study. Additionally, the design and mechanism of action of the StarClose device was still experimental and brand new to operators during the enrollment phase of the trial. As a result, and as one might expect, the final safety and efficacy Conclusion Successful femoral artery access and closure when performed by trained, non-physician cath lab staff is feasible and appears to be safe and effective based on this preliminary observational study in patients who underwent diagnostic and interventional catheterization procedures. Additional, prospective studies with the StarClose device utilizing a more formalized hypothesis testing should now be attempted. ■ Discussion Careful and proper sheath placement, confirmed by femoral angiography, is the cornerstone of a successful endovascular procedure. Vascular complications at the femoral artery access site remain one of the most common and significant detriments to diagnostic and interventional catheterizations. Recent studies have observed femoral access site complications of 2% for diagnostic and up to 10% for PCI, depending on the definition used.6 Puncture sites located above the most inferior aspect of the inferior epigastric artery are associated with retroperitoneal hematoma, while those below the bifurcation of the common femoral artery are correlated with an increased incidence of pseudoaneurysm, AV fistula and dissection.7 Training programs developed and implemented by the medical device industry have primarily focused on the end user with regard to safe deployment of VCDs, but very little emphasis has been placed on techniques to ensure optimal access. This dichotomy has contributed to a persistent and significant rate of vascular complications. Bay Regional Medical Center has operationalized a paradigm whereby the cath lab nurses, technologists, and RCISs not only perform the femoral puncture, but also complete the close utilizing either the StarClose VCD or manual compression. This model provides consistency for the patient and affords the operator a great deal of experience upon which to establish and develop his or her arteriotomy skill set. Results of this retrospective analysis suggest that with the proper training and support, non-physician cath lab staff can have success rates for femoral artery puncture and closure that are comparable to or potentially exceed those of cardiologists. The authors can be contacted at: karen.didonato@abbott.com Additional information about the policies and procedures behind BRMC staff arterial access can be found in a Cath Lab Digest October 2003 Email Discussion Group, on the web at: www.cathlabdigest.com/ article/2180 (See the final response, titled “Policy and procedures provided.”) Note: This article underwent double-blind peer review by members of the Cath Lab Digest Editorial Board. References 1. Tavris DR, Gallauresi, BA, Lin B, et al. Risk of Local Adverse Events Following Cardiac Catheterization by Hemostasis Device Use and Gender. J Invas Cardiol 2004;16:459–464. 2. Kussmaul W, Buchbinder M, Whitlow P, et al. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. Journal of the American College of Cardiology 1995;25: 1685–1692. 3. Baim D, Knopf W, Hinohara T, et al. Suture-Mediated Closure of the Femoral Access Site After Cardiac Catheterization: Results of the Suture To Ambulate aNd Discharge (STAND I and STAND II) Trials. American Journal of Cardiology 2000;85:864–869. 4. Ansel G, Yakubov S, Neilsen C, et al. Safety and efficacy of staple-mediated femoral arteriotomy closure: Results from a randomized multicenter study. Catheterization and Cardiovascular Interventions 2006;67: 546–553. 5. Hermiller JB, Simonton C, Hinohara T, et al. A Randomized Trial of a Novel Femoral Closure Device: The StarClose™ VCS in the CLIP Study. Catheterization and Cardiovascular Interventions 2006 Nov;68: 677–683. 6. Schnyder G, Sawhney N, Whisenant B, et al. Common femoral artery anatomy is influenced by demographics and comorbidity: Implications for cardiac and peripheral invasive studies. Catheterization and Cardiovascular Interventions 2001;53: 289–29 7. Sherev D, Shaw R, Brent B. Angiographic predictors of femoral access site complications: Implication for planned percutaneous coronary intervention. Catheterization and Cardiovascular Interventions 2005;65: 196–202. http://www.cathlabdigest.com/article/2180

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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