Cath Lab Digest - February 2008 - (Page 22)

22 SPOTLIGHT FEBRUARY 2008 Cath lab staff. Left to right: Johnathan McLead RT, Chandra Rasmussen RN, and Bob Beyerlein RCIS. operated by the interventional cardiologist, so RT attendance not essential. What are some of the new equipment, devices, and products introduced at your cath lab lately? New devices include Xience V drug-eluting stent (Abbott Vascular, Redwood City, CA) which is currently used within the guidelines of SPIRIT IV, various cutting balloons, ® SilverHawk peripheral atherectomy catheter (Fox Hollow, Redwood City, CA), PolarCath cryoplasty balloon (Boston Scientific, Natick, MA) and the StarClose® Vessel Closure System (Abbott Vascular) for hemostasis. New equipment includes the Boston Scientific iLab with a tableside intravascular ultrasound (IVUS) and the PressureWire (Radi Medical Systems, Inc., Wilmington, MA), which measures flow across a lesion. Can you describe the main systems you utilize? Currently the systems are split between Philips and another manufacturer, but effective in March, Philips (flat panel detectors) will have the majority. Within the next three years, we will implement the Philips FD 10 in remaining rooms. We are replacing our current hemodynamic monitoring systems with Philips Xper Information Management systems. The system is a personalized cardiovascular workflow solution with a user-centric, role-based navigation that facilitates the collection and reporting of patient information along with scheduling and inventory. The best part is that it will allow patients’ families to be updated every 15 seconds while in the waiting room. Bay Regional will soon become a beta testing site for Philips. What modalities do you utilize to verify stenosis? Cardiologists eyeball (gold standard) the angiogram, and IVUS or the PressureWire are used on questionable lesions. How do you handle vendors that visit your lab? Vendors are rotated such that each primary company is allowed one day a week. In April 2008, the department will have a mandatory badge entry system. Basically, without an approved badge, the doors will remain closed. The vendor will need to first come to the administrative area for his/her badge. They must sign in and out, and they must wear scrubs. Is your lab involved in clinical research? Yes. Following are some ongoing studies: AMEthyst: The Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System (distal protection in saphenous vein grafts). Study completed. ASCEND HF: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure. COGENT-1: A randomized, double-blind, double-dummy, parallel group, phase 3 efficacy and safety study of cgt-2168 compared with clopidogrel to reduce upper gastrointestinal events including bleeding and symptomatic ulcer disease. FREEDOM: A Frequent Optimization Study Using the QuickOpt™ Method. The purpose of the FREEDOM Study is to demonstrate that frequent AV/PV and V-V delay optimization using QuickOpt in Cath lab staff. Left to right: Kim Smith RCIS, Melissa Birch RN, Barb Nowicki RT and Kristen Bator RT patients with CRT-F device results in improved clinical response over standard of care (i.e., empiric programming or one-time optimization using any non-IEGM optimization methods). INNOCOLL: A Randomized, Controlled, Phase 3 Study of GentamicinCollagen Sponge (Collatamp G) in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection. MEND CABG II: A randomized, double-blind, placebo-controlled, multi-center study to evaluate the cardioprotective effects of mc-1 in patients undergoing high-risk coronary artery bypass graft (CABG) surgery. PROOF: A compendium registry of St. Jude Medical devices. RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System. A Prospective, Multi-Center, Registry to Evaluate Safety and Efficacy of the StarClose Vascular Closure System in Patients Who Are Ambulated Early Post Diagnostic Catheterization. (Study completed.) SAPPHIRE Worldwide: Carotid stenting and angioplasty with protection in patients at high risk for endarterectomy. SATURN: Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN. SPIRIT IV: A Clinical Evaluation of the Xience™ V Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects with de novo Native Coronary Artery Lesions. TRACER: Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome. Following are some upcoming studies in which Bay Regional will be participating: RESOLUTE: Looking at the nextgeneration Medtronic (Santa Rosa, CA) Endeavor® Resolute drug-eluting stent system with the new BioLinx™ polymer. RACER: Looking at renal stent protocol and the Medtronic Racer stent. How do you handle sponsored clinical trials in your lab? Who is the quarterback/coordinator? Michigan Cardiovascular Institute (MCVI, www.mcvi.com) has a research team that operates studies across 4 local, affiliate hospitals. The Director of Research, Katie Mostek, handles most of the coordination for sponsored research. How does your lab handle hemostasis? The nurses, techologists, and RCISs at Bay Regional Medical Center have been independently performing femoral artery access and closure procedures for more than 10 years. Access and closure for all patients, even those at high risk for vascular complications (elderly, obese, diabetic, history of peripheral vascular disease, etc.) is generally 100% achieved by nonphysician staff, and though not mandatory or even a requirement of the job, nearly 90% of the cath lab staff chose to undergo and complete the training necessary for certification and independent operation. Femoral http://www.mcvi.com

Table of Contents Feed for the Digital Edition of Cath Lab Digest - February 2008

Cath Lab Digest - February 2008 Bay Regional Medical Center ENDEAVOR IV: A Zotarolimus-Eluting Stent Versus a Paclitaxel-Eluting Stent in a Randomized Clinical Trial A 3D CT Vessel “Roadmap” Over Live Fluoroscopy for Chronic Total Occlusions Contents Clinical Editor’s Corner An Evaluation of Cath Lab Turnaround Time Commentary: An Evaluation of Cath Lab Turnaround Time Excerpts from Chapter 19. STEMI Interventions – Future Perspectives The Potential Clinical Utility of Intravascular Ultrasound Guidance in Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents The Ten-Minute Interview with…Debbie Charlton, RN The Society of Invasive Cardiovascular Professionals (SICP) at Transcatheter Cardiovascular Therapeutics (TCT) 2007 The Cath Lab is a Business: Do You Have the Knowledge to Stay Afloat? Incidence and Predictors of Vascular Complications after Invasive Coronary Procedures: A Prospective Analysis Ask the Clinical Instructor: A Q&A Column for those New to the Cath Lab Volunteer Survey SICP* Section Meetings Calendar What Do You Think? CEU Education Center Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - February 2008

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