Cath Lab Digest - May 2008 - (Page 51)

51 per milliliter (ng/mL) — only 3.7 percent had PAD. Among those with the lowest levels — less than 17.8 ng/mL — 8.1 percent had PAD. “After adjusting for age, sex, race and co-existing health problems, we found adults in the lowest vitamin D group had a 64 percent higher prevalence of PAD compared to those with the highest vitamin D levels,” Melamed said. “For each 10 ng/mL lower vitamin D level, there was a 29 percent higher risk of peripheral arterial disease.” This does not mean that vitamin D is having a protective effect itself, although this is one hypothesis. It is also possible that higher vitamin D levels may be a marker of other health practices, e.g., eating a healthier diet or engaging in more physical activity, which could be related to sun exposure, though not necessarily, researchers said. The findings need to be addressed in a large randomized clinical trial of vitamin D supplementation, Melamed said. This could be done with natural sources from food. “Other vitamins have been thought to help prevent cardiovascular disease, such as vitamin E, which did not pan out after being tested in a randomized clinical trial,” Melamed said. “Therefore, we would not recommend people start taking vitamin D supplements without talking to their doctors. However, we recommend eating a balanced diet. People obtain vitamin D either through exposure to the sun or from foods, especially fish and fortified milk and other fortified foods.” ■ Low Vitamin D Levels cont. cause diseases such as rickets in children. Scientists are only beginning to explore the relationship between 25hydroxyl vitamin D and cardiovascular disease. “In animals, vitamin D has antiinflammatory activity,” said Michal Melamed, MD, MHS, lead author of the study and assistant professor of Medicine and Epidemiology and Population Health at Albert Einstein College of Medicine in New York City. “In addition, in mice, vitamin D is a regulator of one of the hormone systems that affects blood pressure. The cells in the blood vessels in the body have receptors for vitamin D, so vitamin D may have direct effects on the vessels, although this has not been fully worked out.” To study whether there is a relationship of vitamin D with PAD, Melamed and colleagues analyzed data from a national survey measuring vitamin D levels in 4,839 U.S. adults. Researchers in that survey had also documented ankle-brachial index. “We also measured other risk factors for peripheral arterial disease such as cholesterol levels, diabetes, blood pressure and inflammatory markers such as C-reactive protein,” Melamed said. The researchers found that higher levels of vitamin D correlated with a lower prevalence of PAD. In the participants with the highest vitamin D levels — more than 29.2 nanogram FDA Grants Market Clearance for the LipiScan™ Coronary Imaging System A Novel Spectroscopy System for the Identification of Lipid Core-Containing Plaques of Interest in the Coronary Arteries I nfraReDx, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan™ Coronary Imaging System. The LipiScan device uses near-infrared spectroscopy to identify lipid core-containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by commonly used tests such as a treadmill examination and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks. The availability of this tool culminates a decade-long biomedical engineering effort to create an instrument that could perform spectroscopy in the arteries of patients with coronary artery disease. The identification of the chemical composition of coronary plaques is expected to be of value to cardiologists in the selection of medical, stenting or surgical therapy for coronary lesions. The device is also expected to be of value to the pharmaceutical industry as a means to assess the effect of novel anti-atherosclerotic agents on lipid core plaque burden. “The LipiScan System has been validated in tissue samples and a clinical study and has been cleared by the FDA for use in patients,” says James E. Muller, MD, cardiologist, co-founder, President and CEO of InfraReDx, Inc. Dr. Muller noted that the creation of this device was greatly aided by the support and expertise of Sanderling Ventures of San Mateo, California. “Robert McNeil, PhD, Chairman of the Board of InfraReDx, and Timothy Mills, PhD, InfraReDx Board member are managing directors of Sanderling and both have extensive experience in medical device development,” said Dr. Muller. “Sanderling was a seed investor in Advanced Cardiovascular Systems, a company that pioneered development of balloon angioplasty and was acquired by Guidant.” “While angioplasty and stenting were major advances, stenting has not been capable of preventing heart attacks due to the difficulty in identifying lesions likely to rupture and cause thrombosis. With the development of the LipiScan Coronary Imaging System, Sanderling is again contributing to a major step forward in providing a useful tool with which interventional cardiologists may improve the care of cardiac patients.” “There is a real unmet medical need to identify lipid core-containing plaques of interest in the coronary arteries, which before now we could not do,” says James Goldstein, MD, Director of Research and Education at William Beaumont Hospital in Royal Oak, Michigan, who is also an investigator in the SPECTACL clinical trial for the device and a consultant for InfraReDx. “The ability to detect lipid core-containing plaques of interest may go a long way in providing information to help prevent heart attacks in the near future.” Near-infrared (NIR) spectroscopy is commonly used to measure the chemical composition of unknown substances. The LipiScan Coronary Imaging System utilizes advanced optical technology, much of it developed for telecom uses, to The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. deliver and retrieve NIR light from coronary plaques. The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. At the completion of the catheter pullback, the LipiScan console instantly displays the scan results on a “chemogram,” a digital color-coded map of the location and intensity of lipid core-containing plaques of interest in the artery. A Lipid Core Burden Index is also reported, which is a measure of the total amount of lipid core-containing plaques of interest in the coronary artery. The LipiScan catheter interrogates each artery in less than 2 minutes and does not require the interruption of the flow of blood. The SPECTACL clinical trial documented the similarity of near-infrared spectra obtained from 106 patients undergoing coronary angiography compared to spectra obtained in autopsy specimens in which the gold-standard of histology was available. For more information, visit the InfraReDx website at http://www.infraredx.com. ■ http://www.infraredx.com

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Cath Lab Digest - May 2008 The King Faisal Specialist Hospital and Research Centre Cell Therapy in the Cath Lab for Heart Failure: A Look at MyoCell® Therapy and the SEISMIC Trial Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Contents Clinical Editor’s Corner Commentary: Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Ask the STEMI Expert Comparing Drug-Eluting Stents and Bare-Metal Stents SICP: The Ten-Minute Interview with… Christopher Kambak, RT(R) Cardiac Cath Lab Economics in a Public Hospital of a Developing Country Keeping Your Heart & Vascular Employees: Proven Ideas for an Effective Retention Plan Unspoken Words Ask the Clinical Instructor Society of Invasive Cardiovascular Professionals Meetings Calendar Education Center What Do You Think? Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - May 2008

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