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July News

July 2004
Sodium Bicarbonate Effective For Contrast-induced Nephropathy Researchers report an unexpectedly effective and cheap way of preventing the kidney damage that can be caused by contrast media. The solution? A solution of baking soda. About 5 million times each year, patients have injections of contrast media. In perhaps 50,000 of those patients, the contrast media triggers contrast nephropathy. People have tried a number of different things to treat contrast-induced nephropathy, most of which don’t work, said Dr. W. Patrick Burgess, an attending physician at the Carolinas Medical Center. Burgess is the lead researcher in a report about a treatment that did work and is stunningly simple: A dollar and a half of intravenous sodium bicarbonate. Only one of 59 patients with early warning signs of kidney failure who were given sodium bicarbonate developed nephropathy, compared to eight of 60 patients with the same warning signs who got an infusion or ordinary salt water. Patients received either saline or bicarbonate one hour before and six hours after iopamidol administration. Only one patient in the bicarbonate group (1.3%) had contrast-induced nephropathy versus eight in the sodium chloride group (13.6%). Dr. Glenn M. Chertow of the University of California at San Francisco says that sodium bicarbonate should now be considered the treatment of choice for prevention of contrast-induced kidney failure. The surprising thing about that recommendation is that no one has ever tried sodium bicarbonate before. It has been known that the kidney damage was due to formation of free radicals, so treatment has centered on use of drugs such as N-acetylcysteine, which destroys free radicals as they are made. The sodium bicarbonate treatment was proposed by Burgess on the basis of what he learned in his first career, chemical engineering, which he practiced for 4 years before entering medical school. Essentially, it is the same treatment used by someone who downs a dose of bicarb to ease an attack of indigestion. All the free radical literature in the world says that the more acid in the blood, the higher the rate of free radical formation, he said. The presence of acid accentuates the cascade of formation of free radicals. A normally functioning kidney maintains acid-base balance by generating bicarbonate, Burgess said, so the most plausible explanation is that the infusion of sodium bicarbonate helps maintain the necessary balance that prevents the destructive attack of free radicals on delicate kidney structures. That explanation remains partly speculative, since there is not much in the medical literature on the subject, Burgess said, adding there was only a little bit that showed it might work. More studies will help establish the preventive treatment, Dr. Chertow said, and such studies would be simple, inexpensive and low risk. Impella CardioSystems AG Announces First Patient Treated in U.S. Feasibility Trial with Impella® Recover System Impella CardioSystems AG, a German-based developer, manufacturer and marketer of medical devices, announced that the first patient has been enrolled in the U.S. feasibility trial with the Impella® Recover System at Methodist DeBakey Heart Center and Baylor College of Medicine in Houston Texas. The Impella Recover System is used to provide hemodynamic support for patients suffering from cardiogenic shock as a consequence of an acute myocardial infarction, coronary bypass surgery or other cardiac disorders. The Impella Recover System has been developed to address the clinical need for ventricular support in patients suffering from cardiogenic shock. The system has been designed to provide immediate support and restore hemodynamic stability for a period of up to seven days in order to provide support to recovery or alternative therapy to address the underlying cause of the cardiogenic shock. The implantation technique was simple and quickly performed in the cardiac catheterization lab. The device supported the patient’s circulation, allowing us to reestablish adequate perfusion and blood pressure, so from a technical standpoint the procedure was very successful, says Guillermo Torre-Amione, MD, PhD FACC, Medical Director of Heart Transplant Program at the DeBakey Heart Center about his experience with the Recover System. The Impella Recover System can be inserted in the cardiac catheterization lab via the femoral artery or surgically implanted. Once placed in the left ventricle, the system pumps blood from the left ventricle into the aorta/body. The programmable pump is capable of pumping up to 5 liters of blood per minute, thus unloading the left ventricle and allowing the myocardium to rest and recover by reducing oxygen consumption, while increasing cardiac output and end-organ perfusion. The company plans to use the additional safety and efficacy data collected in this 20-patient, 5-center prospective feasibility trial to gain approval for the U.S. pivotal trial and ultimately support an application for product market clearance by the U.S. FDA. Impella currently markets four configurations of the Impella Recover System in Europe. Metformin Makes Angioplasty Better for Diabetics Treatment with Glucophage (metformin) appears to improve the outcomes of diabetics who undergo angioplasty, new research suggests. The drug improves blood sugar levels by making cells more sensitive to insulin. Senior investigator Dr. Jesse W. Currier said, the use of the insulin sensitizing agent (Glucophage) to treat diabetes was associated with a better clinical outcome than traditional non-insulin sensitizing therapy. Currier of UCLA and colleagues note diabetic patients who undergo angioplasty have poorer outcomes than those without the condition. To determine whether treatment with Glucophage might be helpful in these circumstances, the researchers analyzed data from a study involving 2772 diabetics who underwent angioplasty. Of these, 1110 received non-insulin sensitizing drugs and 887 were treated with Glucophage with or without other agents. After 9 months, Glucophage-treated patients were 28% less likely to experience an adverse outcome compared with their peers who received the non-insulin sensitizing drugs. They were 61% less likely to die and 69% less likely to experience a heart attack. Currier noted that the issue of (angioplasty) in diabetics is complex. However, the use of insulin sensitizers...may ameliorate the poorer outcomes seen in the diabetic population.
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