Cath Lab Digest - December 2007 - (Page 22) 22 SPOTLIGHT DECEMBER 2007 Desert Cardiology Center Research Studies Involving the Cath Lab at Eisenhower Medical Center BROADWING Biological Waste Material and Outcomes Analysis of Lower Extremity Peripheral Disease Treated with the Silverhawk Plaque Excision System: A Tissue and Data Registery. (Temporarily on hold, revising protocol) Sponsor: FoxHollow Primary Investigator: P. Khanna Co-investigator: K. Le Collect waste plaque and blood to study peripheral and cardiovascular disease, correlate outcomes data with gene expression, protein and other data. Record demographics, risk factors, clinical presentation and other diagnostic and therapeutic info, document treatment strategies, collect outcomes data on patients undergoing plaque excision as well as info on repeat plaque excision procedures and other adjunct procedures. ARRIVE 2 (TAXUS) (Follow-up phase) Sponsor: Boston Scientific Primary Investigator: P. Khanna Co-investigator: K. Le, B. Hackshaw A multicenter safety surveillance program: Data registry with the TAXUS Express2 Paclitaxel-eluting Stent. LEAP Lower Extremity Atherosclerotic Plaque Excision (Closed May 2007) Sponsor: FoxHollow Primary Investigator: P. Khanna Co-investigator: K. Le Two-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of Simvastatin, Losartan and Pioglitazone on cardiovascular disease biomarkers in lower extremity atherosclerotic plaque excised from patients with peripheral arterial disease. OASIS A Clinical study of the Orbital Atherectomy System for the Treatment of Peripheral Vascular Stenosis (Closed January 2007) Sponsor: Cardiovascular Systems Inc. Primary Investigator: P. Khanna Co-investigator: K. Le At this point, there is no negative financial impact in applying extra diagnostic tools to confirm the physicians’ judgment with respect to a lesion. Our patients deserve the best diagnostic tools available prior to any lesion intervention. What measures has your cath lab implemented in order to cut or contain costs? One measure we have taken is to streamline supplies and do case-pack consolidation. The majority of our physicians agreed on the supplies in our basic case packs. They concur on the basic interventional supplies. This group consensus is a cost saver. Stocking fewer surpluses, consigning high-dollar supplies, consolidating supplies and continually working with vendors for better pricing saves money for our cost center. A second measure is in flex-off time during slow days. We work out among ourselves with respect to who will be off. So far we have not had to enforce a mandatory flex-off schedule. It seems to work out in a fair and equitable way. Our work schedule is staggered ten-hour shifts, four days a week, which covers the busiest time of day. With respect to our caseload versus hours of actual staffing, we have excellent productivity ratings when it comes to reporting statistics. Multicenter, prospective, single-arm study of de novo lesions. Establish patient safety and acute procedural effectiveness of the Orbital Atherectomy System in debulking and stenotic lesions in the treatment of symptomatic patients with occlusive peripheral arterial disease. MATRIX (Closed July 2004) Sponsor: Access Closure Primary Investigator: P. Khanna To evaluate the safety and effectiveness of the Matrix VSG System to achieve closure of femoral artery access sites in patients undergoing diagnostic or interventional vascular procedures. FIRE FilterWire During Transluminal Intervention of Saphenous Vein Grafts (Closed 2003) Sponsor: Access Closure Primary Investigator: P. Khanna Randomized, unblended trial of a temporary intra-arterial filtration system for use during PCI. REPLACE I Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Coronary Events, Part I (Closed) Sponsor: The Medicines Company Primary Investigator: K. Le Randomized, double-blind comparison of bivalirudin to heparin plus GP IIb/IIIa inhibitors during PCI. REPLACE II Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Coronary Events, Part II (Closed) Sponsor: The Medicines Company Primary Investigator: K. Le Demonstrate the efficacy of bivalirudin as the foundation anticoagulant in PCI when combined with glycoprotein IIb/IIIa inhibitors. Information supplied by Sharon Magnuson RN, Clinical Research Nurse, July 2007. What type of quality control/quality assurance measure is practiced in your cath lab? As noted, RTs perform x-ray machine QC/QA per California state law. They also attend required Radiation Safety Committee meetings. RNs perform QC/QA on lab machines (saturation & ACT) to meet the CLEA (laboratory accreditation) requirements and state certifications. Staff member Kathy Stevens, RN, is our self-appointed coordinator for the ACC-NCDR database. She does an outstanding job investigating and finding pertinent information. All RNs and the RCIS do the daily data input. The ACC-NCDR national database provides statistical and comparative analysis that depicts the performance of the participating cath labs. The cath lab also participates on the hospital acute myocardial infarction (AMI) committee. The committee focus is to improve optimal care for the acute heart attack patient, and to continually improve door-toballoon time. Statistics are submitted for core measure reporting. Cath lab staff member Mary Jacobs, RN, sits on this committee to represent a cath lab perspective. How does your cath lab compete for patients? Has your institution formed an alliance with others in the area?
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