Clinical & Industry News

Some Cases of Sudden Cardiac Death May Start in Brain Disrupted signals from the brain to the heart may be responsible for sudden cardiac death caused by emotional stress, says a University College London study. Disrupted signals from the brain to the heart may be responsible for sudden cardiac death caused by emotional stress, says a University College London study. It found that some people have problems with a system that coordinates signals sent from the brain stem to different parts of the heart to control heart rhythm. These people may have a greater risk of potentially fatal heart rhythms when they’re doing stressful mental tasks or during emotional events. The researchers monitored the brain activity of people with heart disease while they performed stressful mental tasks. Stress-induced changes in heart electrical currents were accompanied by uneven activity within the brain stem, the study found. Some people are at risk of sudden cardiac death from stress, mainly people who already have heart disease. In these cases, the combination of heart and brain irregularities means heart failure could occur during a stressful or emotional event like a family gathering or even a boisterous New Year party, said researcher Dr. Peter Taggart, of the university’s Centre for Cardiology. Efforts to prevent the development of potentially dangerous heart rhythms in response to stress have focused on drugs which act directly on the heart, but results have so far been rather disappointing. Our research focuses on what is happening upstream, in the brain, when stress causes these heart rhythm problems. The results so far are very encouraging, Taggart said. It may soon be possible to identify which people are particularly at risk and even to treat a heart problem with a drug that works on the brain, he added. Camtronics’ New Web-Based Registry Reporting Application receives ACC-NCDR Certification Camtronics Medical Systems, Ltd., a subsidiary of Analogic Corporation, announced that its Vericis® Registry Reporting Application has been certified by the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) per the Version 3.04 coding requirements. The new coding requirements, finalized by the ACC in August, are mandatory for all participants in the registry as of Jan 1, 2005. Offered as an option to the Vericis Cardiovascular Information System, the Registry Reporting Application has been redesigned to significantly shorten the time required to enter data required by the ACC-NCDR. The application features a new, easy-to-navigate user interface, on-screen help, new interactive deficiency reports, and intuitive data grouping to streamline the process of data gathering. Because the application is web-based, it can be deployed on any PC on the Vericis network and allows information to be entered at any time over the course of the procedure. The Vericis Registry Reporting Application integrates information from the hospital ADT system, hemodynamic monitoring, and the Vericis Clinical Reporting Application to streamline the process of participating in the ACC-NCDR. Information entered into the Reporting Application also populates Vericis Clinical Reporting, helping to shorten the time required to generate physician reports. The Vericis Cardiovascular Information System captures patient data across the continuum of cardiovascular care. Built on a single information technology platform, Vericis integrates data from different sites (office, clinic, hospital) and different sources (interventional and diagnostic X-ray angiography, echo, nuclear, MR, hemodynamics, reports, and HIS) to create a comprehensive digital record for the cardiac patient. The ACC-NCDR Cath Lab module is a tool for measuring and improving the quality of patient care in cardiac catheterization labs. The ACC-NCDR provides quarterly institutional reports containing national and peer group statistics relating to diagnostic cath and PCI procedures performed in the cath lab. The registry consists of data from more than 500 institutions and over 1.6 million patient discharges. Legality Of Reprocessing of FemoStop® Femoral Compression System Radi Medical Systems, Inc (Radi) announced that on November 2, 2004, the U.S. Food and Drug Administration issued a ruling regarding the regulatory status of various reprocessed single use medical devices for which validation data were required under the Medical Device User Fee and Modernization Act of 2002. FemoStop® Femoral Compression System was included among these. The ruling stated that Adven Medical and Clear Medical may no longer legally market FemoStop Femoral Compression System. The ruling also stated that SterilMed and Vanguard may only legally market FemoStop Femoral Compression System, item number 017500. Since the introduction of FemoStop, Radi Medical Systems has utilized the latest technology to improve this device. These improvements have resulted in the introduction of new versions of FemoStop, including FemoStop®plus Femoral Compression System (Item #11163) and FemoStop® HD Femoral Compression System (Item # 11161). These devices may not be marketed legally as reprocessed devices. The materials, components, and adhesives used in the manufacturing of these devices have only been validated for single use. The only legally reprocessed FemoStop (Item #017500) has not been marketed in the United States by Radi Medical Systems Inc. or any authorized distributor since 2002. Therefore, it is unlikely that your hospital has any inventory of legally reprocessed FemoStop. Please review your inventory to ensure that your hospital is not using FemoStop products that have not been legally reprocessed. To learn more about the FDA ruling regarding legal marketing of reprocessed single use medical devices, please visit https://www.radi.se/ or https://www.fda.gov/ cdrh/reuse/svs/index.html Terumo Initiates Vulnerable Plaque Program with Exclusive License from Massachusetts General Hospital Terumo Corporation has entered into development and license agreements with Massachusetts General Hospital (MGH) in Boston relating to an intravascular imaging technology used in the diagnosis and management of coronary artery disease. Known as optical frequency domain imaging (OFDI), the technology is a light-based imaging modality that can be used to examine tissues in vivo with near histological resolution and sensitivity. Infrared light is delivered to the imaging site through a single optical fiber integrated within a catheter. The OFDI imaging catheter containing a complete lens assembly can be independently deployed, or integrated into existing therapeutic or other imaging catheters. Advanced algorithms are used to extract the reflected optical signals from the infrared light used in OFDI to provide real-time cross sectional and 3-dimensional images. The technology was invented and developed in the Wellman Center for Photomedicine at Massachusetts General Hospital. This agreement gives Terumo a dynamic new platform from which we plan to derive a number of intravascular imaging systems, said Koji Nakao, director and managing executive officer. And our interventional catheter development and manufacturing capabilities create substantial synergy for this program. A key promise of OFDI is its potential for in vivo visualization of coronary artery microstructures, particularly as a tool to better understand and diagnose vulnerable plaque, and guide appropriate therapy. Rox Anderson, MD, director of the Wellman Center for Photomedicine at the MGH, said he is pleased that this agreement will enable the technology to be further developed so it can help an increasing number of patients. OFDI lets us see so well and so fast during catheterization that it almost feels like being inside a coronary artery, he said. This technology is better than ultrasound, much faster than previous optical techniques, will advance our understanding of cardiovascular disease, and could ultimately save many lives. OFDI was created by three scientists from the Wellman Center for Photomedicine: Brett Bouma, PhD, Gary Tearney, MD, PhD, and Johannes de Boer, PhD, who are all expected to play key roles in the future development of this technology. The development and refinement of OFDI also has benefited from seed funding from the Center for Integration of Medicine and Innovative Technology (CIMIT), a consortium comprised of the MGH and other Harvard Medical School teaching hospitals, along with the Massachusetts Institute of Technology and Draper Laboratory. Boston Scientific Announces Medicare Reimbursement Codes for Intravascular Ultrasound (IVUS) Procedures Boston Scientific Corporation announced that its Intravascular Ultrasound (IVUS) procedures have been recognized for payment under a new Medicare ultrasound subcategory titled Intravascular Vessel Imaging. The newly assigned codes will enable tracking of IVUS procedures separately from other types of ultrasound procedures. Boston Scientific’s IVUS technology differs from other traditional ultrasound technologies in that it provides views from inside a patient’s blood vessels rather than from the outside. With this new seven-code subcategory, specific IVUS use can now be tracked through hospital data to assist with resource alignment as Medicare reviews the costs of IVUS procedures. Previously, hospitals could track IVUS procedures only through general ultrasound codes. Neither hospitals nor CMS could accurately track the use and costs specifically associated with IVUS, making appropriate reimbursement difficult. With the new codes in place, hospitals may benefit from easier revenue tracking, more accurate coding and more accurate utilization reporting, which are critical factors in hospitals administrators’ ability to control health care costs and efficiencies. IVUS technology is the most accurate way to visually confirm that optimal stent deployment has been achieved during a DES procedure. We are pleased that SCAI’s collaboration with Boston Scientific and CMS has reached a successful resolution with the adoption of these new IVUS codes, said John McB. Hodgson, MD, FSCAI, of the Society for Cardiovascular Angiography and Interventions. SCAI encourages cath lab administrators, coding staff and billing specialists to familiarize themselves with the new codes as soon as possible and to coordinate their departments for the accurate coding of claims for their hospitals. For more information about the new ICD-9-CM codes, please contact the Society for Cardiovascular Angiography and Interventions (SCAI), www.SCAI.org, or the Centers for Medicare and Medicaid Services (CMS), www.cms.hhs.gov. CytRx Corporation Announces Scientific Data Showing That Its Oral Drug Candidate Iroxanadine May Help Reduce Blood Vessel Damage in Heart Attack & Stroke CytRx Corporation announced the publication of scientific data showing that its oral drug candidate iroxanadine may help to reduce damage to blood vessels that occurs when blood flow is restricted and then restored such as during and immediately after heart attack and stroke. The data was published by researchers collaborating with Biorex Research and Development Company in the December 2004 issue of Cell and Molecular Life Sciences. The researchers demonstrated that iroxanadine protects human endothelial cells that line the walls of blood vessels in an in vitro cellular model system of ischemia followed by reperfusion. Normally when oxygen is restored to oxygen-starved endothelial cells the resulting oxidative cell damage triggers apoptosis. However, research shows that cells treated with iroxanadine showed significantly less cell death under those conditions even when the drug was added 20 hours after onset of oxygen deprivation. Steven Kriegsman, Chairman and Chief Executive Officer, said, Iroxanadine has already been shown to be well tolerated in three clinical safety trials and we recently announced that it showed promise in animal models of atherosclerosis. If iroxanadine behaves in patients as it did in this cell culture model the drug could help prevent oxidative damage to endothelial cells that occurs as a result of ischemia/reperfusion from stroke or heart attack, said Louis Ignarro PhD, Nobel Laureate and world-acclaimed expert in the field of cardiovascular disease. Although this won’t necessarily prevent damage to the target tissue supplied by the blood vessel it could prevent the failure of the blood vessel barrier that results in complications such as thrombosis and edema. The apparent ability of iroxanadine to protect endothelial cells from damage reported in the research is also important because it is believed that stress-induced endothelial cell damage is a crucial step in atherosclerosis. I believe that protection of endothelial cells from damage is the reason that iroxanadine was previously shown to help prevent atherosclerosis in experimental animals, added Dr. Ignarro. Iroxanadine is believed to activate the expression of molecular chaperone proteins that repair or degrade damaged proteins in stressed cells. The company plans to seek a corporate partner to develop iroxanadine for cardiovascular indications and also plans to evaluate the drug candidate in preclinical animal models for other indications thought to be caused by damage to endothelial cells, such as diabetic foot ulcers. . Anti-Inflammatory Protein Cuts Heart Attack Risk High circulating levels of a protein called mannan binding lectin (MBL), which prompts scavenger cells to remove various inflammatory agents, appear to reduce the risk of having a heart attack, especially for people with diabetes, Icelandic researchers report. Although the protein was known to have potentially beneficial anti-inflammatory effects, the ability of MBL to ward off heart attacks had not be studied before. Dr. Helgi Valdimarsson, from Landspitali-University Hospital in Reykjavik, and colleagues analyzed data from the Reykjavik study, which includes 20,000 subjects recruited starting in 1967. Among about a thousand 70-year-old participants from the original enrollment, high MBL levels were linked to a 36 percent reduced risk of heart attack compared with lower levels. To confirm this finding, the researchers followed another 1300 middle-age subjects. In this analysis, the link between high MBL levels and a reduced likelihood of having a heart attack was not as strong as in the original group and was not significant from a statistical standpoint for the whole group, or for subsets of smokers or those with high blood pressure. However, the analysis did show that high levels were tied to greatly reduced risks for a heart attack among subjects with diabetes or high cholesterol. In fact, people with diabetes with high MBL levels had a risk on par with non-diabetic subjects. For people with diabetes, the team concludes, measuring MBL might actually aid in the evaluation of the need for preventive treatment for heart disease. Source: Journal of Experimental Medicine, January 3, 2005.

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