Cath Lab Digest - April 2008 - (Page 54)

54 CLINICAL AND INDUSTRY NEWS APRIL 2008 ACIST Receives Prestigious Frost & Sullivan Technology Innovation Award A CIST Medical Systems, offering variable-rate contrast injection systems for cardiac and vascular angiography, is pleased to be the recipient of the Frost & Sullivan Technology Innovation Award. According to Frost and Sullivan, “ACIST Medical Systems’ ability to provide innovative, variable-rate contrast injection solutions for cardiovascular angiography applications has endeared the company to its customers. ACIST offers flexible system configurations to meet the specific needs of the customer, lab workflow and patient. For these reasons, Frost and Sullivan recognize ACIST Medical Systems for its ongoing commitment to excellence in medical technology.” “This award from Frost & Sullivan is quite an honor. It further validates ACIST’s focus on innovation — especially innovation developed with the purpose of making things better and easier for physicians and their patients around the world,” states Fulvio Renoldi Bracco, CEO of ACIST. “We believe this award demonstrates our commitment to continuous innovation. The ACIST CVi system is a fourthgeneration product developed as part of a continuing effort to address customer needs. We look forward to ACIST having even more significant innovations in variable-rate contrast delivery coming to market in the near future.” ■ CircuLite Announces Initiation of European Registration Study For Synergy™ Circulatory Assist Device C ircuLite™, Inc. has advanced its Synergy™ Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE Mark approval in the European Union for long-term implantation of Synergy in heart failure patients. This announcement follows successful completion of a first-in-man pilot study of Synergy in four patients. Synergy is a micro implantable blood pump, the size of a AA battery, that can be implanted superficially in a “pacemaker-like” pocket. The device is designed to provide long-term, partial circulatory support in patients with chronic heart failure. The European registration trial is planned to enroll 20 patients with chronic heart failure and will evaluate the safety and patient quality of life improvements associated with device support of greater than six months. To date, seven patients have been successfully implanted with the Synergy device. Six implants were performed by Bart Meyns, MD, PhD, at Gasthuisberg University Hospital (Katholieke Universiteit) in Leuven, Belgium, the site of the first-in-man trial. One patient in the trial was implanted at Hannover Medical School in Hannover, Germany, by André Simon, MD, Managing Doctor of the Thoracic Transplant Program, and Martin Strüber, MD, Director of the Thoracic Transplant Program. Three patients are currently on device support and are doing well. The Company also announced today that a third trial site, University Hospital in Münster, Germany, has completed training and is now screening patients for the CE Mark trial. CircuLite recently reported positive results from the European first-in-man pilot study, for which enrollment is now complete. Four patients were implanted with Synergy in this trial. These patients benefited from significant improvements in hemodynamics and were allowed to return to activities of daily living. All patients reached the primary endpoint of successful heart transplantation, with one patient supported for 7 months. ■ Hospitals That Participate in Clinical Trials May Provide Better Patient Care H ospitals that participate in clinical trials appear to provide better care for patients with heart attacks or other acute heart events and have lower death rates than hospitals that do not participate in clinical trials, according to a report in the March 24th issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Quality of care for common conditions such as acute coronary syndromes has slowly improved after the implementation of clinical guidelines, performance measurement and quality improvement efforts. Recent studies suggest that physician leadership, presence of shared goals, administrative support and credible feedback are associated with better hospital performance. Three of these characteristics are also believed to be important in successfully conducting hospital-based clinical trials. “We hypothesized that these same elements required for hospitals to participate in trials could induce beneficial changes in the hospital environment, thereby leading to better processes and outcomes of care for patients treated outside the trial setting,” the authors write. Sumit R. Majumdar, MD, MPH, of the University of Alberta, Canada, and colleagues analyzed data from 174,062 patients with two specific types of heart conditions, high-risk non–ST-segment elevation acute coronary syndrome with unstable angina and non–ST-segment elevation myocardial infarction. The patients were admitted to 494 hospitals participating in Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) — an ongoing, voluntary, observational data collection and quality improvement initiative — from Jan. 1, 2001 to June 30, 2006. Process-ofcare and in-hospital outcome data were collected. Patients were split into three groups: those treated at hospitals with no trial participation (29,984 patients), low trial participation (93,705 patients) and high trial participation (50,373 patients). In total, 4,590 patients (2.6 percent) were enrolled in clinical trials, with 145 hospitals having no enrollment, 226 hospitals having a midpoint of 1 percent enrollment and Continued on next page

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Cath Lab Digest - April 2008 Kaiser San Rafael Medical Center Orbital Atherectomy: A New Treatment for Complex Peripheral Arterial Disease Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Contents Clinical Editor’s Corner CEU Education Center The Missing Link in STEMI Interventions — Thrombus Aspiration during Primary Percutaneous Coronary Intervention Predicting Stent Thrombosis Using A Clinical Risk Score Use of a New Guidewire: The Tigerwire Should I Stay or Should I Go? Weighing Options for New Opportunities Navigating Tortuous Coronary Sinus Anatomy Using a Bipolar Lead The National Society of Radiology Practitioner Assistants (NSRPA) Holds 9th Annual Educational Conference For Medical Imaging Physician Extenders and Mid-Level Healthcare Providers Cath Lab & Beyond: A Meeting Update The Ten-Minute Interview with… Dale Hansen RT, CVT Sometimes, You Just Know Twin Circumflex Arteries: A Rare Coronary Artery Anomaly What Do You Think? Meetings Calendar News from the American College of Cardiology (ACC) Scientific Session and the Society of Cardiovascular Angiography & Interventions (SCAI) Annual Scientific Sessions in Partnership with the ACC i2 Summit Clinical & Industry News Cath Laughs Classifieds Advertisers Index

Cath Lab Digest - April 2008

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