Cath Lab Digest - October 2007 - (Page 57)

57 AHRQ and FDA cont. The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a 7-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data. “Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment,” said Gerald Dal Pan, MD, director of FDA’s Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question." The study will be coordinated by Vanderbilt University researchers on contract through AHRQ’s Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class. The analysis will take about two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions. ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults. Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugs, Concerta, Strattera, and Adderall, ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated. Adult use is also believed to be increasing. In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. ■ AGA Medical Corporation Receives FDA and CE Mark Approvals for the Amplatzer Vascular Plug II A GA Medical Corporation has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the Amplatzer Vascular Plug II. It is designed to embolize blood vessel and blood vessel malformations in the peripheral vasculature. The Amplatzer Vascular Plug II is a self-expandable nitinol mesh occlusion device and is designed to be introduced in a minimally invasive fashion through a catheter. The delivery cable that comes pre-attached uses the Amplatzer user interface to enable the physician to more precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The vascular plug II is designed with multiple lobes to facilitate rapid clotting. “I have used the new Amplatzer Vascular Plug and I found it to be very easy to use and very effective in causing a quick and complete occlusion,” said Dr. James F. Benenati, Medical Director of the Peripheral Vascular Lab at the Baptist Cardiac & Vascular Institute in Miami, Florida. “Deployment is easy, radio-opacity is excellent and occlusion is complete and rapid.” The Vascular Plug II comes in sizes ranging from 3 mm to 22 mm. A single Vascular Plug II is generally required to occlude the targeted vessel. ■ Appropriate Hospital Discharge System Can Prevent Future Cardiac Events I mproving how healthcare providers follow proven protocols could reduce the risks of subsequent heart problems for heart disease patients, according to a study reported in a cardiovascular surgery supplement of Circulation: Journal of the American Heart Association. A study of the American Heart Association’s Get With The Guidelines SM(GWTG) database found significant differences in how hospitals carry out many of the association’s secondary prevention recommendations. Specifically, patients who received percutaneous catheter intervention (PCI) were more likely to get the proven measures that could significantly reduce their risks for later heart attack, as compared to patients who underwent coronary artery bypass graft surgery (CABG) or no intervention at all. GWTG is an evidence-based, hospital quality improvement program that helps ensure patients receive quality care during treatment and discharge based on specific guidelines that will reduce the risk of secondary cardiac events,” said Loren F. Hiratzka, MD, lead author of the study and co-author of the 2006 GWTG update. “The program empowers providers to consistently treat heart and stroke patients according to the most up-to-date guidelines.” Hiratzka said a key part of GWTG is the education healthcare providers give when a patient is discharged from the hospital after a heart attack or other cardiac event. The guidelines call for patients to receive specific instructions, counseling and medication recommendations — all of which can reduce the progression of atherosclerosis. Most hospitals that implement GWTG realize measurable results, including improved patient outcomes. “The scientific evidence shows us that, when used appropriately and consistently, these performance measures can save lives,” Hiratzka said. “The challenge is to ensure that hospitals are providing this care for every patient, every time.” Researchers conducted a study of the GWTG database to determine to what degree hospitalized patients with coronary artery disease were receiving the appropriate medications and advice at discharge. They divided that data of 119,106 hospitalized patients into three groups: those who received CABG (14,118); those who received PCI (58,702), which included balloon angioplasty and stenting to open blocked arteries; and those who didn’t receive either intervention (46,286). Surprisingly, researchers found that CABG patients were less likely than PCI patients to receive all of GWTG’s recommended measures, even when taking into account the exclusion of certain patients for which the measures wouldn’t be medically appropriate. “CABG patients are in the hospital for several days after the operation, during which time we have Continued on next page

Table of Contents Feed for the Digital Edition of Cath Lab Digest - October 2007

Saints Medical Center Fibromuscular Dysplasia in Children and Adolescents Cerebral Vascular Accident Following a Pulmonary Embolism: Search for the Hidden Patent Foramen Ovale Contents Clinical Editor’s Corner Meetings Calendar CEU Education Center Radiation Tracking in the Cardiac Catheterization Lab Letter to the Editor Carotid Stenting: An update Release from Stent-jail: Beneficial Snow-Plowing? Patient Management Guidelines Searching for a Cardiovascular Position? Tips for Creating a ‘Stand-Out’ Resume Long-Term Implications of Short-Term Closure Decisions – The Evolution to Vascular Access Management and the Boomerang Catalyst System The Ten-Minute Interview with… Angie Bowles, RN, CCRN CMS Issues Final FY 2008 IPPS Rule ACVP• Membership Page Experience with a New Workhorse Guidewire Ask the Clinical Instructor: Q&A for Those New to Cath Lab A Glimpse of the Future of Clinical Education: Boston Scientific’s SimSuite Bus Visits Carnegie Institute 2007 Educational Fair Held at the Washington Hospital Center Research Update: Original Contribution Abstracts from The Journal of Invasive Cardiology What Do You Think? A Virtual Cath Lab Viewer (VCL): The Development of an Online 3D C-arm Simulator and Coronary Anatomy Viewer Clinical & Industry News Cost-Effectiveness of the Radial versus Femoral Artery Approach to Diagnostic Cardiac Catheterization

Cath Lab Digest - October 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.