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From the FDA

FDA OK's Artificial Heart

An expert advisory panel to the US Food and Drug Administration voted to approve an updated version of an artificial heart that was first used over 20 years ago. The group of FDA scientific advisers, in a 10-1 vote after considerable debate, recommended the full agency approve the device, made by SynCardia Systems of Tucson, Ariz. The artificial heart would be used only on a short-term basis, while patients wait for a donor heart. Once implanted, patients are tethered to a power generator the size of a washing machine.

The original Jarvik heart was implanted with great fanfare in Seattle dentist Barney Clark in 1982, and he survived on the experimental device for 112 days. If the FDA follows the panel's advice, the latest version of the heart will be the first-ever total artificial heart approved for sale in the United States. The agency usually follows the advice of its expert advisory committees.

Despite voicing reservations during a daylong hearing about which patients should be eligible for the device, the committee voted to approve it for those with no other options. The panel recommended the company be required to do follow-up research. In addition to making the mechanical heart more widely available, formal FDA approval also would make it much more likely that insurance companies would pay for the device, which will cost about $100,000. Approximately 3,500 Americans are currently awaiting heart transplants.
Ref: home.businesswire.com

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Anticoagulation News

Post-surgical anticoagulation management

In performing non-cardiac surgery on patients on anticoagulation, the major concern is when is it safe to perform surgery without increasing the risk of hemorrhage or increasing the risk of thromboembolism (venous, arterial) after stopping the use of Coumadin. In treating patients on long-term Coumadin after surgery, the risks of hemorrhage versus thromboembolism has to be considered.

Patients with prosthetic heart valves pose a particular problem. Arterial thromboembolism from the heart often results in death (40% of events) or major disability (20% of events). When considering non-cardiac surgery, these factors and the need to weigh the risk of hemorrhage against that of thromboembolism become critical.

Any patient who is on long-term anticoagulation therapy and is to undergo a major surgery needs proactive management. Some physicians believe that patients can be maintained on oral anticoagulation for minor procedures, such as dental extractions, biopsies, and ophthalmic operations, as long as the therapeutic range of the prothrombin time (PT) value is not greater than 2.5.

Usually, unless accompanied by significant cardiomyopathy or recent arterial embolus, patients with atrial fibrillation (A-fib) can have their Coumadin stopped 4 days prior to surgery, then resumed at the usual dose the night of surgery.

If you or a family member, on long-term warfarin therapy is considering any kind of minor surgery, be sure and notify your physician to see how the procedure will affect your warfarin management.
emedicine.com/med/topic3173.htm

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Readers Comments

Benefits of "Good" Cholesterol Questioned

Recent research calls into question the medical community's assumptions that "good" cholesterol, HDL, can cancel or overcome the "bad" cholesterol, LDL. For years, doctors have recommended that patients pay attention to both HDL and LDL levels. Conventional wisdom said that if LDL is high, that is OK if HDL is also high-the good would counteract the bad. Now scientists say that is not necessarily so.

LDL carries cholesterol to the arteries of the heart. Plaque builds up and leads to heart disease. HDL can take some cholesterol away, doctors say. Researchers from the University of Pennsylvania, however, now state that high HDL levels do not ensure immunity from heart disease. Patients with high HDL levels along with other risk factors may still develop heart disease. Consequently, HDL levels should play a more minor role in a doctor's decision to prescribe cholesterol-lowering medications.

New drugs are in the pipeline that would raise HDL and might reverse heart disease. The American Heart Association says your LDL should be below 100 and a healthy HDL level is anything above 60. A study released last week showed that using Statins aggressively could lower heart disease patients' LDL to 60 and could help stop the progression of the disease.
Ref: NY Times.com/2004/03/15/health/15HEAR

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New Treatment

Shrub Could Fight Prostate Cancer

A shrub found in Southeast Asia can create a rash like poison ivy, but it could also stop prostate cancer. The croton plant has an oil in its seeds that shows promise for the treatment of prostate cancer - the second leading cause of cancer death in men in the United States. The active ingredient in the oil is 12-O-tetradecanoylphorbol-13-acetate, a compound generally known as TPA.

Researchers demonstrated that TPA could simultaneously stop the growth of new prostate cancer cells, kill existing cancer cells and ultimately shrink prostate tumors. In addition to studies on the effect of TPA alone, the researchers also tested TPA in combination with all-trans retinoic acid (ATRA), a vitamin A derivative previously shown to be effective in treating leukemia. The studies are the first to show synergy between TPA and ATRA in inhibiting the growth of cultured prostate cancer cells and the first to assess their combined effects, and the effects of TPA alone, on human tumors grown in mice.

Additional studies are necessary to explore the plant's efficacy in treating humans. Further research with these compounds and others could provide hope for the half million new cases of prostate cancer each year.
Ref: food navigator.com

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Life Style

Sherry Benefits Cardiovascular Health

A recent study shows that sherry, like red wine, can benefit the heart because it contains antioxidants called polyphenols, which reduce the occurrence of coronary artery disease. They work by preventing the oxidation of LDL, which is associated with the disease. Drinking sherry can also increase the body's production of HDL cholesterol, which is associated with longevity and a decreased incidence of coronary artery disease.

To test the effects, researchers at the University of Seville in Spain gave rats daily quantities of sherry. Control rats were given the same amount of either water or ethanol in water. Intake of sherry every day over two months did not affect the weight of the rats or have any other significant impact on other metabolic processes, but it did result in the decrease in serum total (bad) cholesterol and an increase in HDL (good) cholesterol.

Four of the most commonly produced sherries in Andalucia, Spain, bearing the generic names Oloroso, Manzanilla, Fino and Amontillado, were tested. All four types had the same effect. Moderate consumption of both red and sherry wines have beneficial effects on cardiovascular health.
Ref: Journal of the Science of Food and Agriculture

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Tech Talk

Sugar Sensor Improves Diabetes Monitoring

A glucose monitor that is implanted under the skin shows promise in improving blood sugar monitoring among adults with type 1 diabetes. The device offers a continuous, real-time reading of glucose levels. Researchers at the University of Colorado Health Sciences Center's Barbara Davis Center for Childhood Diabetes conducted a study of the sensor and its affects on periods of hypo- or hyperglycemia. For their study, 15 patients with type 1 diabetes had DexCom glucose sensors implanted under the skin of the abdomen.

The study showed that when participants observed data from the implanted continuous glucose monitor, they experienced 47 percent less time in hypoglycemia, a state of low or below normal blood sugar levels. The participants also spent 25 percent less time in hyperglycemic states, or states of high blood sugar.

The sensor is about the size and shape of an AA battery. The participants then used an externally-worn, pager-sized receiver that received wireless-transmitted information.

The sensor device was not only capable of providing study participants continuous glucose level data, but it could also provide auditory or vibratory alerts when glucose levels were high. Researchers suggest the new device could reduce the long-term complications of diabetes.
Ref: Heart Center Online

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Fitness Watch

Folate in Food Reduces Heart Disease and Stroke

A new study conducted by the US Centers for Disease Control and Prevention found that adding the vitamin folate to food not only prevents birth defects, but also appears to reduce cardiovascular disease. The fortification of enriched grain products with folic acid, required by the U.S. Food and Drug Administration since 1996, was designed to reduce the number of children born with neural tube defects, such as spina bifida. CDC researchers estimate in their study that 31,000 stroke-associated deaths and 17,000 deaths related to heart disease may have been prevented annually since the fortification was implemented.

They analyzed national death certificate data to evaluate the number of deaths from stroke and heart disease in the United States for people aged 40 and older. Folic acid reduces concentrations of homocysteine, an amino acid in the blood. Too much homocysteine has been associated with a higher risk of stroke and heart disease.

More research is needed to determine the exact mechanism of the action of the folic acid. The current daily recommended dietary allowance (RDA) of folic acid is 400 micrograms, an amount typically found in a multivitamin. Folate can also be found in enriched bread, flour, corn meal, rice, pasta, and other grain products.
Ref: Washingtonpost.com

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Product of the Month

Easy to use home test for nicotine and tobacco exposure

The TobacAlert home test provides a quick and accurate determination of a person's level of exposure to tobacco products. Second hand smoke is a growing health concern for families at home and work. TobacAlert can measure the level of exposure to pipes, cigars, chewing tobacco and cigarettes in the privacy of your home or office.

This home testing product is ideal for parents, coaches and business applications in preventing unwanted exposure to harmful products that directly affect the health of you and your loved ones.

TobacAlert is not intended for medical use and is not a substitute for professional medical treatment. FDA clearance is not necessary for this easy to use, accurate home testing product.

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Copyright ©2003 QAS, Inc. All rights reserved. The information provided in this Newsletter and on the Hometestmed site is intended for your general knowledge only and is not a substitute for professional medical advice or treatment for specific medical conditions.