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FDA Backs Temporary Artificial Heart ; Device Designed to Keep Sickest Patients Alive Until a Donor Organ is Available

Posted on: Wednesday, 20 October 2004, 06:00 CDT

The Food and Drug Administration said yesterday it has approved the first temporary artificial heart for use in patients at risk of dying within 30 days as they await a heart transplant.

The CardioWest Total Artificial Heart, manufactured by SynCardia Systems of Tucson, Ariz., takes over for the patient's failing heart, restoring normal blood pressure and shoring up such vital organs as the kidney and liver. The "bridge" device is intended to help keep patients alive long enough for a heart transplant.

An FDA advisory committee in March recommended that the agency approve the device with caution, because complex surgery to install it raises the potential for such complications as infection, bleeding and stroke.

Despite those risks, the panel found the device to have benefits for a small number of patients with no other choice.

The FDA approved the temporary artificial heart for patients awaiting heart transplants who don't respond to other treatment and who are likely to die within 30 days to because of non-reversible, biventricular failure. In such cases, patients typically are short of breath, even while resting, because their weakened hearts cannot efficiently pump blood.

Donna-Bea Tillman, director of the FDA's Office of Device Evaluation, said the artificial heart would be an option for a very small group of patients, perhaps 100 a year in the United States.

Of 2,200 patients who get heart transplants each year, roughly 500 need some temporary assistance to ensure they're still alive when the donor heart arrives. Within the group of 4,000 waiting for heart transplants, 100 have irreversible failure affecting both the left and right sides of their heart.

SynCardia's clinical trials looked at using the artificial heart in 81 patients eligible for transplants at five medical centers. All the patients had severe biventricular heart failure.

After receiving the artificial heart, 79 percent of those patients remained alive long enough to receive a donor heart. The average patient lived an additional 79 days, and the longest lived for 400 days before heart transplantation, the company said.

The most common adverse events were infection, affecting 72 percent of patients, and bleeding, suffered by 42 percent of patients. One-quarter of the patients suffered a neurological event such as stroke. The device malfunctioned in 18 percent of patients.

Because the clinical trial enrolled so few people, the FDA is requiring the company to monitor an additional 50 patients for one year after they receive the implant.

The heart is implanted in the patient's chest to replace the bottom half of the heart.

It's sewn to the remaining top half of the heart. Tubes connect the device to a console that supplies power and monitors the device's function.

The cost of the device and its components is about $100,000.

Dr. Marvin Slepian, SynCardia president and chief executive, called the FDA approval a "medical milestone" some 40 years in the making.

Bill Wohl of Scottsdale, Ariz., credits the device for saving his life.

A massive heart attack at age 52 destroyed much of Wohl's heart. After suffering later infections and pneumonia, he was transferred to the University of Arizona where his heart and major organs failed. He had a CardioWest device, then experimental, implanted in September 1999. On Feb. 22, 2000, the device was replaced with the heart of a 36-year-old accident victim.

This fall, he competed in Olympic-style events for transplant recipients in Australia, snaring nine medals in cycling, swimming and track events.

"Thank God for the CardioWest," said Wohl, 58. "It kept me alive for that six-month period."

Apples lower cancer risk

Add colon cancer prevention to the possible list of reasons that an apple a day keeps the doctor away.

Studies in lab rats show that certain antioxidants found in apples sharply reduce precancerous lesions in their colons, according to researchers at a cancer prevention meeting yesterday.

The team of French scientists also found that the apple compounds influence cancer by altering specific cell-signaling pathways that lead to cell death.

"These studies not only offer insights into the chemo-preventive properties of these compounds (called polyphenols), they also offer proof of their potential to prevent colon cancer," said Francis Raul, the study's lead investigator and research director of the French National Institute for Health and Medical Research.

He presented the findings before the American Association for Cancer Research international conference held this week in Seattle.

Have a question about health care? Drop us an e-mail at health@seattlepi.com. For a wide variety of health news, go to seattlepi.com/health

Source: Seattle Post - Intelligencer

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