Clinical and Industry News January 2008
- Posted on: 6/19/08
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The American Heart Association also reports continued improvements in quality of care, through its Get With The Guidelinessm (GWTG) program, which works with participating hospitals to increase adherence to treatment guidelines for patients with coronary artery disease (CAD), stroke and heart failure:
• Using data from 58,847 patients who were admitted to 315 participating hospitals in 2006, the GWTG–CAD program reports the composite quality of care based on several performance measures was 89 percent, up from 86.3 percent in 2005. Performance measures include whether patients received aspirin, cholesterol-lowering drugs and other medications when they were discharged from the hospital and whether they were counseled to quit smoking.
• From 2006 data of 141,449 patients at 778 hospitals, the GWTG–Stroke program reports a composite quality of care score of 90 percent, up from 88 percent in 2005. Key performance measures for stroke include the administration of clot-busting therapy in eligible patients, proper anti-clotting medications during the hospital stay and, upon discharge, cholesterol-lowering therapy and counsel to quit smoking.
• GWTG–Heart Failure reports a composite quality of care score of 88 percent based on data from 35,576 patients in 231 hospitals in 2006, up from a 2005 composite score of 82.5. Performance measures include giving patients a complete set of discharge instructions, measuring left-ventricular function, counsel to quit smoking, and release from the hospital with proper medications.
While the quality of hospital care for patients with cardiovascular disease appears to be improving, the cost associated with cardiovascular disease will rise to a projected $448.5 billion in 2008, an increase of more than $16 billion over projections for 2007.
Vascular Solutions Launches Pronto® LP Extraction Catheter
Vascular Solutions, Inc. recently launched the Pronto® LP (low profile) extraction catheter. The Pronto LP catheter is designed for soft thrombus aspiration from coronary and peripheral arteries as small as 1.5mm in diameter. The rapid exchange Pronto LP catheter is compatible with any 0.014” guidewire and is designed specifically for aspirating soft thrombus from smaller distal vessels. It combines a low crossing profile with a hydrophilic coating and a braid- and stylet-reinforced proximal shaft. The preloaded stylet provides kink-resistant delivery that can be removed rapidly to allow for full-lumen aspiration. Compatible with all 6F guide catheters (min I.D. 0.066”), the catheter is packaged with all components necessary for soft thrombus removal. The Pronto LP is currently available in the United States, along with additional Pronto catheters: the Pronto V3 catheter, the larger Pronto .035 catheter and the specialty Pronto-Short catheter.
U.S. Physician Wants All Non-heart Drugs Tested for Cardiovascular Risk
A U.S. physician-scientist insists that current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of medicines primarily developed for non-cardiovascular medical problems. Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, recommends earlier testing of all drugs’ cardiovascular effects. He also stresses the importance of authorising regulatory bodies to mandate continuing evaluation of drug effects, even after approval for marketing.
“The importance of evaluating the cardiovascular safety of new drugs has been highlighted by recent examples of drugs — anti-arthritis drugs and others — that were withdrawn from the market when unacceptable cardiovascular risks were discovered after regulatory approval,” says Dr. Borer.
Even though a medicine has been developed to cure some other condition, he says, its possible effects on cardiac physiology/pharmacology should be tested in animal studies. Dr. Borer stresses that similar evaluations should begin in the earliest phases of drug testing in patients.
He says that the definitions of adverse cardiovascular events like heart attacks and strokes should be standardized for all observers before the drug is administered to any patient. Currently, the definition of adverse events is left up to each observer individually, limiting the strength of conclusions about cardiovascular safety.
Dr. Borer also suggests that regulatory bodies be given more teeth so that they can withdraw approval of medicines if mandated post-marketing studies have not been performed. He made these suggestions at the recent annual meeting of the European Society of Cardiology in Vienna. A report on his recommendations has been published in the European Heart Journal.