(Circulation. 2001;103:e9015.)
© 2001 American Heart Association, Inc.
Cardiovascular News
A 2-chambered artificial heart has received federal approval to undergo clinical tests as a permanent implant in patients who are not candidates for a heart transplant. The heart’s use was approved for only 5 people in this first test.
Made by Massachusetts-based Abiomed, Inc, the 2-chambered AbioCor Implantable Replacement Heart is said to be quieter than earlier artificial organs, and it is expected to be extremely durable. Unlike earlier forms of artificial hearts, this one requires that no wires pass through the skin, thus reducing the risk of infection. The power for the heart will be transmitted across the skin to a rechargeable internal battery. An external power unit that transmits the power to the heart is worn at the waist.
The 2-pound device (twice the size of a normal heart) has 2 pumping chambers and responds to the body’s needs, pumping faster when exertion requires more blood. Unlike ventricular assist devices, this heart is designed to replace the patient’s heart. According to O.H. Frazier, MD, chief of cardiovascular transplantation at the Texas Heart Institute in Houston (one of the sites at which the artificial heart will be used), the AbioCor improves on the engineering in the Jarvik-7 artificial heart used in the early 1980s. When that device was used in several patients, starting with Barney Clark in Utah, it maintained life for a while, but the patients suffered a series of debilitating strokes and eventually died.
Dr Frazier told the Houston Chronicle that he has implanted the AbioCor device in >100 calves and seen no drawbacks to its use. However, he said, the true test of the device will be in humans, where it will remain for years. Although the success of ventricular assist devices in recent years has slowed the demand for a 2-chambered heart, the device is still needed to maintain some patients.
The sites for testing the new heart will be the Texas Heart Institute in Houston, the Jewish Hospital Heart and Lung Institute in Louisville, Ky, the Brigham and Women’s and Massachusetts General Hospitals in Boston, Mass, and the University of California at Los Angeles Medical Center.
Contaminated Feed Heightens "Mad Cow" Fears in the United States
US fears of "mad cow" disease were heightened on January 26, 2001, when federal regulators revealed that they were investigating the quarantine of 1000 cattle in Texas who may have eaten feed made with animal parts or bone meal. Although no bovine spongiform encephalopathy has been identified in the United States, feeding cows food made from animal parts has been banned since 1997.
The feed maker Purina Mills notified the US Food and Drug Administration (FDA) that it may have mixed up the ingredients. However, within a week, FDA officials found that the amount of contaminated feed eaten by the cattle was probably no more than three-quarters of an ounce. Because each animal weighs, on average, 600 pounds, the agency determined that the risk was negligible, a finding bolstered by the fact that the animals contaminating the feed were all from the United States, where no disease has been identified. Despite the risk, the FDA said that Purina Mills had pledged to buy all the cattle to keep them out of the food chain and eliminate all risk of disease spread.
According to Dr Bernard Schwetz, the FDA’s Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, such as the US Department of Agriculture’s (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections to keep American cattle free of bovine spongiform encephalopathy."
AHA and Federal Agencies Agree to Cooperate to Attack Heart Disease and Stroke
Five federal agencies and the American Heart Association signed a memorandum of understanding on February 1, 2001, that was designed to speed the fight against the occurrence of heart disease and stroke in the United States.
This historic memorandum of understanding will create a working partnership that promises to improve the nation’s cardiovascular health greatly by the year 2010," said Surgeon General David Satcher in a released statement. Rose Marie Robertson, MD, president of the AHA, said that the agreement represents "a milestone in public and private sector cooperation." She said the agencies that had signed the agreement agreed to focus and coordinate efforts to reduce heart disease, stroke, and other cardiovascular ailments dramatically by the year 2020.
The groups said that the need for the cooperative agreement was underscored by recent findings that the progress in reducing death rates from cardiovascular disease had slowed. In addition, the differences in cardiovascular death rates among racial and ethnic groups increased the need for such an effort.
The goals of the agreement include the following.
- Preventing the development of risk factors for
cardiovascular disease and
stroke
- Detecting and treating risk factors for cardiovascular disease
- Achieving early identification and treatment of these diseases, particularly in the acute phases when treatment is most effective
- Preventing the recurrence of such diseases
- Detecting and treating risk factors for cardiovascular disease
The groups plan to attack the problem through public education, improvements in the system to deliver care for heart disease and stroke, and medical research. They plan aggressive awareness campaigns to educate the public about the symptoms of heart attack and stroke and to educate physicians about the best methods for treating such diseases.
The American Heart Association and its division the American Stroke Association signed the memorandum along with the National Center for Chronic Disease Prevention and Health Promotion (Centers for Disease Control and Prevention), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke, the Office of Disease Prevention and Health Promotion, the Office of Public Health and Science, and the Office of the Surgeon General, Office of Public Health and Science (Department of Health and Human Services).
President Bush Sends Medicare Drug Plan to Congress
A preliminary plan to provide prescription drug coverage for low-income Medicare beneficiaries went to Congress January 29, 2001, but President Bush called it a program to offer "interim access to drug coverage" to poor senior citizens until a true Medicare overhaul can be achieved, according to the New York Times. According to the January 30, 2001, issue of the Washington Times, President Bush said, "If they are going to drag their feet, if the members of Congress on both sides of the aisle don’t feel the same urgency I feel...on Medicare reform, then I feel it’s very important for us to have an immediate helping hand."
President Bush was quoted in USA Today as saying that he would consider a plan that would include all seniors in the prescription drug plan. However, Senate Minority Leader Tom Daschle (D-SD) told the Washington Times that approving the temporary drug plan would take the onus of revamping Medicare off of Congress.
Ron Pollack, executive director of the patient advocacy group Families USA, said, "We think the structure of Bush’s proposal will make Medicare reform more difficult to achieve." He and his group issued statements that were skeptical of the Bush plan.
The proposal would create temporary block grants that would
go to states that have their own drug subsidy programs. It would pay
$12 billion annually for the next 4 years for drugs for low-income
Medicare patients and for those who have high prescription drug
bills.
The plan received almost immediate approval from the Health Insurance Association of America, whose president, Chip Kahn, said in a released statement, "Today, the President has followed through with a proposal that would help the most vulnerable seniors better afford the high cost of these drugs." Kahn said the plan builds on drug subsidy programs already in place in more than half of the states and called on Congress to pass the program rapidly.
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