Cath Lab Digest - November 2007 - (Page 20)

20 SINGLE-CENTER STUDY NOVEMBER 2007 Table 2. Comparison of BRMC results to those of the CLIP Trial (see also Figure 3). Procedure Type Diagnostic Interventional Total BRMC 96.5% 95.6% 96.3% CLIP 94.1% 86.8% 90.0% RCIS at BRMC between March 2006 and September 2006. Both diagnostic and interventional patients were included. Study Procedures. All operators underwent device training and a mandatory orientation period prior to performing access/closure procedures independently (see Background). Femoral angiograms were performed on each patient prior to close and the IFU for the StarClose device was strictly followed. Patients whose angiograms demonstrated anatomy or puncture locations unfavorable for VCD use received manual compression and were not included in the study. There was no allowance for a “lead-in” phase within this study, so final results incorporate and reflect the operators’ learning curve. Anticoagulation/antiplatelet therapy was administered per standard of care for BRMC. Device Use. Four clicks cue the operator to the sequence of steps for StarClose device use (Figure 1). The hub of the introducer sheath is modified to allow insertion of the clip applier. When the primary procedure is completed, the catheter is removed and the procedural sheath is exchanged for the StarClose introducer sheath. The clip applier is attached to the introducer sheath and the clip is then advanced down the inside of the sheath (click #1). Next, the vessel locator button is depressed (click #2). The device is then apposed against the arteriotomy with gentle traction, and an atraumatic “no-tension” position is assumed for device Figure 3. Physician vs. Non-Physician StarClose Deployments their preceptors to learn the science of common femoral artery anatomy and the art of successful access and closure. Once this probationary period is complete, the trainee begins attempting arterial puncture on his/her own and is introduced to the StarClose device under strict supervision of the mentor (it is assumed that manual compression techniques have already been mastered). This intensive hands-on training period generally lasts about 6 weeks, and a checklist of knowledge, skills, and abilities is provided as a structured guide. Once the preceptor is comfortable with the arteriotomy skills of the orientee, a physician is assigned to train on sheath insertion, and then observes 10 consecutive placements. If performance is satisfactory, the candidate will be ‘signed off’ with the understanding that their results will be monitored by a senior staff member over the next 23 months. A prolonged, direct observation period is also afforded to orientees requiring additional support. During this same time, the Abbott Vascular representative is contacted to perform a proficiency evaluation with regard to the StarClose vessel closure system (VCS), and once proper deployment techniques have been demonstrated, the nurse, tech or RCIS receives a formal training certificate. The entire orientation phase can last up to 8 months. Femoral artery access and closure for all patients at BRMC, even those at high risk for vascular complications (elderly, obese, diabetic, history of peripheral vascular disease, etc.) is generally 100% achieved by non-physician staff. As a result, a yearly re-evaluation of these skills is performed on all clinicians (via a one-week observation period), and a strict policy has been implemented whereby responsibility for the arteriotomy is handed over to the physician after two unsuccessful attempts by the nurse, tech or RCIS. Needless to say, this occurs very infrequently, and overall cardiologist satisfaction has been overwhelmingly positive. Though skeptical at first, interventionalists quickly came to realize that this unique paradigm was of a clear benefit to their patients, their cath lab flow and their overall time management. stabilization. The thumb advancer slides forward, which splits the sheath as the clip is advanced to the arteriotomy (click #3). While maintaining neutral tension or pressing down slightly, the trigger button is depressed (click #4), deploying the clip. Subsequently, the clip applier and introducer sheath are withdrawn. The nitinol clip provides a secure extravascular closure that does not invade the vessel lumen (Figure 2). The StarClose VCS has been approved for use by the FDA for diagnostic and interventional indications. Study Endpoints. The primary endpoint of this study was device success (efficacy) defined as achievement of hemostasis in the catheterization lab allowing transfer to cardiovascular holding unit. Patients who did not achieve immediate hemostasis with the StarClose device were considered failed closures, and converted to manual compression. Analysis. Patient procedural, angiographic, and demographic information was collected and recorded for the index procedure and then de-identified per HIPPA regulations prior to being transcribed onto a secure excel database within Michigan Cardiovas-cular Institute (MCVI). To protect privacy, each patient was given a specific study number and the stored data referenced only by the investigator. Data review and analysis was then completed to calculate rate of device success. Methods Study Design. This study was a single-center, retrospective evaluation of 1000 consecutive femoral artery punctures and subsequent arteriotomy closures using the StarClose device. Access and closure were performed by either a cath lab nurse, radiology technologist or Results Of the 1000 consecutive patients retrospectively analyzed, 749 (75%) were diagnostic catheterization procedures while 251 (25%) were interventional procedures. Overall device success rate for the combined population was 96.3% (963/1000). Diagnostic patients demonstrated a device success rate of 96.5% (723/ 749) while interventional patients were successfully closed with the StarClose device 95.6% (240/251) of the time. There were a total of 37 Table 1. Device Success Rates of Non-physician StarClose Closure by Procedure Type Procedure Type Diagnostic Interventional Total Enrollment 749 251 1000 Procedure Success 723/749 240/251 963/1000 Percentage 96.5% 95.6% 96.3%

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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