Clinical and Industry News

Heartlab Customers Now Can Electronically Harvest and Submit Data to the ACC-NCDR® Quality Measurement Program Heartlab, Inc. announced that its Encompass® Cardiac Network has achieved certified vendor status from the American College of Cardiology (ACC) for the ACC’s National Cardiovascular Data Registry (ACC-NCDR). Encompass users now have the option of electronically collecting and submitting data to the ACC-NCDR, enabling them to participate more easily in this national quality measurement program for cardiovascular specialists, hospitals and cath labs. All ACC-NCDR-certified software vendors must meet strict standards of the Core Data Elements published by the ACC and undergo a certification review, which Heartlab completed in October 2003. Participants in the ACC-NCDR submit complete data on all adult patients who have undergone percutaneous cardiovascular intervention (PCI) or cardiac catheterization. Data is submitted quarterly. The ACC then provides quarterly comparisons of each participant’s practice patterns and outcomes to national and peer group results. Participants use this information for improving patient care, supporting quality improvement programs and communicating with regulatory and contracting organizations. The ACC-NCDR program is voluntary; participants must, however, acquire and use ACC-certified software. The ACC-NCDR functionality is available as an option to customers using Heartlab’s Cardiac Catheterization Results Management (CCRM) reporting system. PunctSURE® Offers Hands-Free Solution New Ultrasonic Vascular Access Imaging System Provides Capabilities for Vessel Cannulation Inceptio Medical Technologies introduced their new ultrasonic vascular access imaging system, PunctSURE®. PunctSURE is a patented, portable ultrasound device designed to help clinicians visually locate and identify veins and arteries for precise needle placement before attempting vessel cannulation. The PunctSURE system features real-time procedure monitoring and offers hands-free operation and dual-view imaging. PunctSURE provides a large dual-image display screen and is battery- and AC-operated. Additionally, PunctSURE offers sterile, disposable procedure kits. PunctSURE® is available to purchase through Inceptio Medical Technologies at 801.593.6300. For more information on PunctSURE, visit www.punctsure.com. i-STAT Receives FDA 510(k) Clearance for 10-Minute Cardiac Troponin I Test i-STAT Corporation, a manufacturer of point-of-care diagnostic systems for blood analysis, announced it has received U.S. Food and Drug Administration clearance to market its 10-minute i-STAT System Cardiac Troponin I (cTnI) test. The i-STAT System Troponin I test offers central laboratory-grade performance at the patient's bedside. Data from the clinical trials showed the i-STAT Troponin I test to have the sensitivity necessary to pick up even the slightest elevation, as any troponin is indicative of heart damage. The American College of Cardiology’s preferred protocol for assessing patients with chest pain includes a Troponin I measurement within 30 minutes of patient presentation at the Emergency Department. With i-STAT, it is as easy as a single drop of blood and 10 minutes. Prior to the i-STAT Troponin I test, emergency physicians and cardiologists often waited over an hour for these critical test results. Two medical studies underscore the advantages of point of care testing (POCT) and troponin markers. According to an American Heart Association study in 2002, hospitals that did follow the 30-minute treatment guideline improved heart attack patients’ survival by one-third, compared with hospitals who did not achieve rapid turnaround time. An April 2003 study reported that turnaround time for cardiac troponin and other cardiac marker tests improved by 84.5 percent with POCT (17 minutes) compared with a central laboratory (110 minutes). In addition to diagnosing patients faster and more easily, the i-STAT Troponin I test is also expected to save hospitals money by rapidly identifying the 10-15% of patients who are admitted with chest pain but aren’t suffering a heart attack, and often undergo unnecessary testing and hospitalization. Siemens Speed4D Improves Evaluation of the Beating Heart and Other Internal Organs Siemens Medical Solutions announces advancements in Computed Tomography (CT) that will provide significant performance enhancements for advanced imaging and workflow requirements. First outcomes of the new technology, called Speed4D, will be presented at the annual meeting of the American Heart Association (Nov. 9 - 12 in Orlando, Fla.) and the technology will officially be unveiled at the Radiological Society of North America conference (Nov. 30-Dec. 5 in Chicago). Speed4D technology includes Straton, a new X-ray tube, WorkStream4D for workflow optimization and data handling, syngo InSpace4D for evaluation of the moving heart, and CARE Dose4D(TM) for automated real-time dose adaptation. These components enable utilization of multi-slice CT technology and integration of imaging applications in daily clinical practice. The Straton X-ray Tube. Straton an X-ray tube that routinely enables a gantry speed of 0.37 seconds per rotation in both cardiac and whole-body applications, and can complete a procedure in 20 seconds due to sub-millimeter scanning with 500 milliampere (mA). Straton also provides direct cooling of the anode because all bearings are located outside the vacuum. This enables cooling rates of five Million Heat Units (MHU) per minute, and eliminates with close to zero Mega Heat Units, the need for large heat storage capacities. Even at maximum load, the new tube cools down within much less time than needed for initiating the next procedure. In addition, the anode and inner tube assembly of Straton are smaller than in conventional X-ray tubes, and the system’s longer tube life is essential for reduced life-cycle cost. WorkStream4D. The four-dimensional (4D) workflow design of WorkStream4D eliminates the need for manual reconstruction steps. The standardized imaging protocols allow the user to plan the image planes that are needed for diagnosis, and the software will do the rest, with an image-reconstruction speed up to ten images per second in real-time mode and up to five images per second with full cone reconstruction. Instant oblique and double-oblique reconstructions enable faster diagnosis even for more complex anatomy. WorkStream4D also reduces the amount of data produced per case. The diagnostic information in up to 2000 slices that are acquired from a high-resolution scan can be captured in a pre-defined series of image planes using direct 3D reconstruction of the raw scan data. This translates to a reduction of data volume. CARE Dose4D. An additional feature of Speed4D technology is enhanced CARE (Combined Applications to Reduce Exposure) Siemens initiative to reduce radiation exposure in CT examinations. The new CARE Dose4D analyzes the cross-sectional anatomy of each individual patient in real-time and adjusts the emitted X-ray dose accordingly, without need for user interaction or an additional topogram to determine the patient attenuation. The system automatically provides the best possible exposure parameters for every patient individually without the need for user interaction. Initial clinical experience using CARE Dose4D demonstrates dose savings up to 66 percent. Solucient’s Market Impact Modeler: Drug-Eluting Stents to Have Significant Effect on Cardio Admissions in U.S. Hospitals Drug-eluting stents are projected to have a significant effect in decreasing inpatient cardiovascular admissions in U.S. hospitals over the next few years. However, U.S. population changes, particularly after 2010, are likely to dramatically reverse this trend as the growth and aging of the population could be a far more powerful force than some studies have indicated. This finding comes from a report generated by Solucient’s® Market Impact Modeler, an online market forecasting application. Solucient’s Market Impact Modeler helps hospitals make intelligent, cost-effective planning and marketing decisions based on the impact that new and emerging medical technologies are projected to have on their customer base. The tool helps enable hospitals to determine when specific medical technologies will be available, how quickly they are likely to be adopted, and future utilization and resource requirements. Hospitals can use this information to: Improve their long-term budgeting process by properly planning for investments in technology; avoid overinvestment in technologies by understanding which new and emerging technologies have the greatest potential; plan for consumer demand for treatments based on new technologies by forecasting patient resource and use rates in hospitals. Reports can be tailored to show what effect a particular technology might have on inpatient discharges, length of stay, outpatient visits, emergency department visits, and physician office visits. The Market Impact Modeler is now available for U.S. hospitals. For more information, call 1-800-366-7526 or e-mail mim_info@solucient.com.

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