Clinical and Industry News for August 2006

Boston Scientific Launches iLab Ultrasound Imaging System Boston Scientific Corporation announced the U.S. launch of its iLab Ultrasound Imaging System. The company will make the system available immediately. The iLab Ultrasound Imaging System can be directly installed into the cardiac catheterization lab or radiology suite, enabling physicians to incorporate IVUS technology into their procedures every day. The system’s tableside controller gives physicians control of the device within the sterile field, and the Dynamic Review feature enhances image interpretation. The system’s touch panel provides a user interface with prompts that correspond to the particular stage of the procedure. In addition, the platform is easy to upgrade, allowing for future innovation. With the introduction of more sophisticated medical devices such as drug-eluting stents, physicians are treating more complex cases than ever before, said Paul Teirstein, MD, of Scripps Green Hospital in LaJolla, CA. That makes the iLab Ultrasound Imaging System an even more important part of my practice. Now I can obtain the images I need quickly and easily. This lets me routinely quantitate the patient’s disease, and make an informed diagnosis. In addition to the introduction of the new IVUS system, Boston Scientific also offers extensive training and education with its iLearn Education Series. Designed for physicians, fellows, nurses and technologists, the iLearn series consists of classroom and hands-on courses that build knowledge and confidence to incorporate IVUS into daily practice. New Training Tool Launched for Interventional Cardiologists TeachFFR.com uses interactive case studies to illustrate FFR techniques TeachFFR.com, a web-based teaching tool sponsored by Radi Medical Systems, has launched as a new resource for interventional cardiologists, interventional technologists, nurses, and catheterization lab staff. At TeachFFR.com, narrated, interactive case studies from leading cardiologists demonstrate the proper use of fractional flow reserve (FFR) measurement techniques, which physicians use during interventions to assess lesion severity. The interactive cases at TeachFFR.com (https://www.teachFFR.com) also demonstrate the versatility of FFR measurement, which aids clinical decision making not only in cases that involve intermediate lesions but also in cases that have traditionally resulted in bypass surgery or unnecessary multiple stent placement. It is critical for interventional physicians to understand the proper use of stents, especially in light of recent concerns about DES thrombosis, noted John McB. Hodgson, MD, Senior Editor for TeachFFR.com and head of Academic Cardiology at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona. Use of FFR should not be considered optional but rather the norm. TechFFR.com illustrates FFR use in specific areas, including multivessel disease and tandem lesions, side branch narrowing, pre-op evaluation for non-cardiac surgery, post bypass, post stenting and a variety of other scenarios. A guess the FFR exercise allows users to compare the use of FFR techniques against traditional angiography. A discussion forum, which allows registered members to interact with peers and top interventional cardiologists, is also under development. Radi is happy to support a new FFR training tool that’s based on interactive, evidence-based case studies, said Anders Qvarnstram, Chief Operating Officer for Radi Medical Systems. Radi manufactures the PressureWire® system, which measures FFR for physiological lesion assessment. MultiWeb, a company that specializes in interactive online learning programs for cardiovascular health professionals, used an unrestricted grant from Radi Medical Systems, Inc. to develop TeachFFR.com. The site currently features cases from Dr. Hodgson and other leading cardiologists, including William Fearon, MD; Morton J. Kern, MD; Peter Ver Lee, MD; Michael Lim, MD; and Habib Samady, MD. New clinical cases will be added to TeachFFR.com over time. Kensey Nash Receives FDA 510(k) Clearance for TriActiv FX® Embolic Protection System Kensey Nash Corporation received 510(k) clearance for its next generation TriActiv FX® Embolic Protection System from the U.S. Food and Drug Administration (FDA). The product is expected to be launched shortly. The clearance was based on data collected from the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study, which demonstrated that major adverse cardiac events (MACE) were reduced to 3.2% by using the TriActiv FX System as an adjunct to stenting in treating saphenous vein grafts. Historically, MACE rates routinely were 15-20% in the same saphenous vein graft population without the use of embolic protection systems and approximately 5“10% in most previous studies using embolic protection systems. Reductions in MACE have been strongly correlated to improved mortality rates for the patient. New Practice Guidelines published by the American College of Cardiology in January 2006 now specifically recommend the use of distal embolic protection devices in patients undergoing treatment of saphenous vein grafts, when technically feasible. The ASPIRE Study demonstrated excellent results in three key areas: 30-day MACE (3.2%), in-hospital MACE (2.2%), and procedure time, commented Chris Metzger, MD, Co-Principal Investigator in the ASPIRE Study from Wellmont Holston Valley Hospital. The TriActiv FX Embolic Protection System will be sold through Kensey Nash’s direct U.S. endovascular sales force, along with its recently cleared QuickCat Extraction Catheter and ThromCat Thrombectomy Catheter System. The TriActiv FX System is a protection system designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events such as a heart attack. This is accomplished with three integrated system features: an embolic protection balloon, and a combined active flush and extraction system to remove the problematic debris from the target vessel. The TriActiv System is the only distal embolic protection system that actively removes the debris from the vessel by gently flushing the treatment area within the vessel. The TriActiv ProGuard System is another version of the System that is currently in clinical studies to evaluate its performance in preventing strokes and other adverse events during carotid stenting procedures. The TriActiv ProGuard device is being commercialized in the European Union for treatment of SVG patients. The TriActiv FX System incorporates several important ease-of-use design enhancements to the TriActiv System platform. These include a new balloon inflator that simplifies catheter exchanges during the procedure, and a new flush catheter design to enhance device usage and reduce procedure time. New Risk Factors Do Not Improve Assessment of Coronary Heart Disease Risk Screening for levels of C-reactive protein and other compounds recently found to be associated with coronary heart disease may not help physicians predict risk for the condition with any more accuracy than traditional major risk factors, according to a report in the Archives of Internal Medicine. Major risk factors for coronary heart disease (CHD), which include age, race, sex, blood pressure, diabetes, total and HDL (good) cholesterol levels, smoking status and the use of medications to control blood pressure, predict an individual's probability of developing the condition with reasonable accuracy. Most are also modifiable, so physicians can advise patients on how to change their lifestyle to reduce their risk, according to background information in the article. In recent years, researchers have identified additional risk factors and chemical markers associated with CHD, such as C-reactive protein, a compound in the blood that signifies inflammation caused by injury or infection. Aaron R. Folsom, MD, MPH, University of Minnesota, Minneapolis, and colleagues with the Atherosclerosis Risk in Communities (ARIC) Study assessed the benefits of screening patients' levels of 19 novel chemical markers, including C-reactive protein, antibodies against infectious diseases, B vitamins and compounds involved in the functioning of blood vessel lining. The ARIC Study enrolled a total of 15,792 adults between the ages of 45 and 74 years in 1987-1989. The participants underwent a physical examination, including assessment of major risk factors, at the beginning of the study and every three years afterward. At four times during the follow-up period, researchers collected blood and DNA samples for analysis. Patients continue to be tracked for the development of CHD. Several of the compounds tested, including C-reactive protein and vitamin B6, were significantly associated with CHD. The researchers looked at each marker and assessed the probability that a participant who developed CHD within a five-year period had a higher risk score than a participant who did not develop CHD. Using this method, they determined that most of the novel markers did not significantly increase the ability of physicians to predict CHD. Although the significant and independent association of a novel risk factor with CHD often does not equate to improved prediction of CHD beyond that of basic risk factors, this does not imply that the novel risk factor is pathophysiologically unimportant or unsuitable as a target for intervention, the authors write. Based on the totality of evidence, however, C-reactive protein level does not emerge as a clinically useful addition to basic risk factor assessment for identifying patients at risk of a first CHD event. Routine screening is not warranted for any of the other 18 novel risk factors tested either, the authors conclude. On the other hand, our findings reinforce the utility of major, modifiable risk factor assessment to identify individuals at risk for CHD for preventive action, they write. The 19 novel markers studied may someday be useful in assessing risk in certain subpopulations, but for now physicians must focus on improving already recognized risk factors, write Donald M. Lloyd-Jones, MD, ScM, Northwestern University Feinberg School of Medicine, Chicago, and Lu Tian, ScD, in an accompanying editorial. We need to ensure that the tools we currently have for risk prediction are applied more broadly and routinely throughout clinical practice, they write. We must also address the enormous gaps between the promise of cardiovascular disease prevention and its reality. We have improved our recognition of those with an elevated blood pressure or cholesterol level, but fewer than one of three Americans with adverse levels of these factors are controlled to goal levels. These issues must be addressed and improved urgently. Source: Arch Intern Med. 2006;166:1368-1373. Results of Hospital Performance Measures Do Not Always Reflect Patient Outcomes Hospital quality measures do not fully account for the variation in hospital death rates for heart attack patients, according to a study in a recent issue of the Journal of the American Medical Association. As part of the national effort to improve hospital quality, the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) monitor and publicly report hospital performance on acute myocardial infarction core process measures approved by the Hospital Quality Alliance, according to background information in the article. Although the CMS/JCAHO process measures are considered indicators of quality of AMI care, little is known about how these measures track with each other. And the degree to which process measure performance conveys meaningful information about short-term death rates remains unclear. Elizabeth H. Bradley, PhD, of the Yale University School of Medicine, New Haven, Connecticut, and colleagues used data from the National Registry of Myocardial Infarction (NRMI) and CMS to determine the correlations among AMI process measures and the association between hospital performance on process measures and hospital-specific, risk-standardized, 30-day death rates, derived from Medicare claims data. The researchers used 2002-2003 data from 962 hospitals participating in the NRMI and used information on AMI patients aged 66 years or older. The researchers found moderately strong correlations between beta-blocker use at admission and discharge, aspirin use at admission and discharge, and angiotensin-converting enzyme (ACE) inhibitor use, and weaker, but statistically significant, correlations between these medication measures and smoking cessation counseling and time to reperfusion therapy measures. Some process measures were significantly correlated with risk-standardized, 30-day death rates but together explained only 6.0 percent of hospital-level variation in risk-standardized, 30-day death rates for patients with AMI. This finding suggests that a hospital’s short-term mortality rates after AMI cannot be reliably inferred from performance on the publicly reported process measures. Our results highlight that the current process measures provide information that is complementary to, but not redundant with, a measure of 30-day mortality, the authors write. In conclusion, although the core measures are important in pursuing improved AMI outcomes, they capture in aggregate only a small proportion of the hospital-level variation in short-term 30-day mortality rates. Until additional process measures are developed that explain more of the variation, reporting not only the current core measures but also short-term risk-standardized mortality rates is a reasonable approach to characterize hospitals’ overall quality of care, the researchers write. In an accompanying editorial, Ashish K. Jha, MD, MPH, of the Harvard School of Public Health and Brigham and Women’s Hospital, Boston, comments on the findings by Bradley et al. Although the U.S. health care system is now committed to quality measurement and the public reporting of such data, debates will continue about what to measure, who collects the data, and what to report publicly. More information is needed on processes and outcomes across a large number of conditions for hospitals, physician practices, and other health care settings and practitioners. Much of these data are on their way, led by major payers such as Medicare and coalitions of employers who want greater accountability for the care they purchase and to stimulate improvements in quality of care. In the most expensive health care system in the world, patients and physicians should expect nothing less. Source: JAMA 2006;296:72-78. Mobile Aspects’ Radio Frequency ID System Automates Storage, Tracking and Inventory Management Wilford Hall Medical Center (WHMC) of Lackland Air Force Base, Texas, successfully installed a computerized inventory system to support cardiology services provided by the United States Air Force's 759th Surgical Operations Squadron. The system is deployed in the cardiac catheterization and electrophysiology laboratories of the hospital. Developed by Mobile Aspects, Inc., of Pittsburgh, Pennsylvania, the system, called iRISupply, uses a radio frequency identification (RFID) tracking architecture to automatically track medical devices and supplies. The system provides automated storage, tracking, and inventory management capabilities to support the operational processes of the clinical setting. Installed on May 15, products being stored and tracked within the system include stents, balloons, and implantable devices such as pacemakers that are used for interventional cardiology procedures. WHMC joins a growing list of hospitals that are leveraging RFID technology to achieve positive financial outcomes and better patient care. Common benefits include more accurate charge capture, improved security and retrieval of stored items, and management of product expiration and recall for time-sensitive products such as drug-eluting stents. It is common for implants, stents, and other devices to occupy 40% of supply budgets for a typical hospital, so finding opportunities to optimize resource utilization can yield significant improvements to a care provider's bottom line. The IRISupply system is part of the Mobile Aspects One System of CARE solution, which uses identification and information technologies to automate processes for clinical resource management by healthcare providers. Wilford Hall Medical Center, the Air Force’s largest medical facility, is a national resource, providing complete medical care to military healthcare beneficiaries in the south central United States as well as specialized care to patients referred from all over the world. Wilford Hall’s patient care mission includes more than 16,000 inpatient admissions per year, and more than 700,000 clinic visits. The medical center provides the entire range of care from sick call to surgery, and serves as the national center of excellence for a number of programs. Military readiness is Wilford Hall’s prime mission. From the time of the organization’s founding in 1942, the medical center has put the defense of the nation first. Wilford Hall Medical Center can be found on the web at www.whmc.af.mil. Mobile Aspects, Inc. is a healthcare technology supplier focused on providing an integrated suite of clinical resource management solutions to automate the management of supply, asset, drug and patient tracking through the One System of CARE solution. The cornerstone of these technological capabilities is Intelligent Radio Frequency Inventory System (iRISTM), a patent-protected tracking architecture that leverages radio frequency identification technology. Through this technology, clinicians and other care providers experience a hands-free approach to managing the resources used in the patient care process. Mobile Aspects can be found on the web at www.mobileaspects.com. R.T. Health Study Looks at Breast, Skin Cancers Women working in radiologic technology during the early years, particularly before 1950, demonstrated a higher risk of developing breast cancer according to prior analyses from an ongoing health study. Now they’re taking a look at the genetic influences on the radiation - breast cancer association, using improved exposure assessment, additional cases identified in a survey, and blood samples donated by participants with and without breast cancer. Breast cancer is a current focus of the United States Radiologic Technologists (USRT) study. Other than non-melanoma skin cancer, breast cancer is the most frequently diagnosed cancer in women. To date, the results of the study indicate that radiation exposures experienced by technologists today are not associated with an increased risk of cancer. Beginning in 2004, the USRT study team contacted more than 97,000 past participants to update information on medical history, work history (for dosimetry estimation), and sunlight exposure. The survey process was completed in 2005, with more than 71,000 current and former technologists responding. Skin cancer is the most common type of cancer and can be caused by both ionizing radiation and ultraviolet (UV) radiation from sunlight. The USRT study provides a unique opportunity to study the independent and combined effects of these types of radiation on skin cancer and melanoma, which is also linked to sunlight exposure. More than 4,000 new cases of skin cancer and 700 new cases of melanoma were identified on the third survey. In the past year, the USRT research team has been developing methods to estimate the effects of UV radiation in the study participants, based on their questionnaire responses. A pilot UV dosimetry study, completed in 2005, will help assign UV exposures to questionnaire information. Pilot study participants kept a daily activity diary and wore UV dosimeters. They were queried six and nine months later to determine how much exposure can be assigned to reported activities in the past. This was the first step in developing historical UV exposure estimates. Findings from this survey will allow the study team to complete the goals of: improving estimates of past exposure (dosimetry); a follow-up study of breast cancer, including evaluating potential genetic influences on breast cancer risk; and a study to evaluate how the combined effects of ionizing radiation and ultraviolet radiation affect the risk for skin cancer and melanoma. In 1983, the University of Minnesota, National Cancer Institute, and American Registry of Radiologic Technologists started a study of cancer risk in radiologic technologists. In a mailed survey, more than 1,800 new cases of breast cancer were identified; of these, more than 700 have already donated a blood sample. The purpose of this study is to evaluate the risk of cancer from repeated low-dose occupational ionizing radiation exposure. While it is known that radiation exposure at high doses can cause cancer, the effects of smaller amounts over many years are not as well understood. All persons who were registered with the ARRT for at least two years before 1983 were invited to participate in the study. One of the greatest challenges for the USRT study is to estimate the amount of ionizing radiation exposure that radiologic technologists received through their work. This would be easy if accurate and complete dosimetry records were available for all participants in the study for all the years they worked. But because the study is interested in work experience going back several decades, this type of information is not available. Using the detailed information collected from the questionnaires, experts’ knowledge about radiation exposure and protection, and historical dosimetry data obtained from several hospitals and the armed forces, the study team is developing mathematical models to reconstruct the amount of exposure a technologist was likely to receive. This will allow the research team to evaluate the occurrence of cancer and other diseases with reference to these exposures. Substantial progress has been made in this effort, and the final models will be completed in the coming year. The USRT study continues to provide unique information about potential health effects of working as a radiologic technologist and the biology of cancer. As results of the study are available they are posted on the study web site: https://www.radtechstudy.nci.nih.gov. Analyses of leukemia (Linet et al, Occupational and Environmental Medicine, 2005;62(12):861-867) and non-melanoma skin cancer (Yoshinaga et al, International Journal of Cancer, 2005;115:828-834) showed results similar to those for breast cancer, where people working before 1950 were at higher risk. Papers further exploring breast cancer and thyroid cancer are scheduled to be published in 2006 in the Cancer Journal and the International Journal of Cancer.

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