Artificial Hearts

For many years scientists and the medical community worked for the day when a mechanical heart would be available. The first successful artificial heart procedure occurred in 1957 when Dr. Willem Kolff and Tetsuzu Akutsu of the Cleveland Clinic developed a heart that kept a dog alive for one and a half hours. Researchers spent the next several decades developing four-chambered hearts for temporary use in humans. Dr. Denton A. Cooley performed the first successful operation to implant the temporary device in 1969. These artificial hearts were originally intended as permanent replacements for a diseased heart. The first artificial heart, the Jarvik-7, was developed by Robert K. Jarvik, working with Kolff in the artificial-organs division of the University of Utah Medical Center. It consisted of compressed-air tubes leading outside the chest to a power source and was first widely tested on animals. Among the more than one hundred calves, sheep, and goats receiving the artificial heart, three had strokes related to infections.

The "Bionic Man": Barney Clark

After the FDA granted approval for human use, the Jarvik-7 was first implanted on 2 December 1982 into the chest of Dr. Barney Clark, a sixty-one-year-old retired dentist suffering from cardiomyopathy, a fatal disease of unknown cause that destroys the heart muscles. After many medical setbacks including subcutaneous emphysema, seizures, pneumonia, and nosebleeds, Clark died on 23 March 1983 of complications from preexisting kidney and lung disease. The Jarvik-7 heart worked until the end, when it was turned off after Clark was "essentially dead." The artificial heart and its implantation were considered a success.

Blood Clots and Strokes

Three of the first five human recipients of permanent artificial hearts suffered strokes. Three of the five also died after relatively short periods. Barney Clark lived 112 days after receiving his artificial heart. Murray Haydon lived for sixteen months. William Schroeder survived the longest, living for 620 days, close to two years, when a fourth stroke and lung infection led to his death. It was not a good life for either Schroeder or his family during the months he lived with his artificial heart. His wife, Margaret, said while he was still alive, "At first I thought it was just for Bill so he would be able to get better and come home. And now I see it as more of a research experiment. The longer he lives the more information they get. Only for us it's just hard sometimes." Unlike the three experimental animals whose strokes were related to infections, the human strokes were caused by blood clots that originally formed in the heart and then traveled to the brain. Anticoagulants were given to artificial-heart recipients to prevent the blood from clotting to try to prevent strokes but produced other serious complications.

A New, Temporary Role

After the disturbing strokes, physicians questioned the use of the devices as permanent replacements and began to use them as a temporary "bridge" for people awaiting a human heart transplant. Some patients did not have a suitable donor heart immediately available, or needed time to recover from health conditions that made a transplant inadvisable. The FDA authorized heart surgeon Dr. William C. DeVries to perform seven permanent Jarvik-7 heart transplants, but after the many complications in his early patients, it recommended that DeVries be required to obtain case-by-case clearance for the remainder of the implants. The first FDA-authorized temporary use of an artificial heart as a bridge to a human heart transplant occurred in August 1985 at the University of Arizona Medical Center in Tucson, where a twenty-five-year-old Arizona man suffering from a severe viral heart infection awaited a new donor heart. Seven days after the surgery, he suffered a series of mild strokes, necessitating an urgent human heart transplant. The Jarvik-7 was later found to have blood clots on its left side, where the main pumping chamber joined the aorta.

Cancellation of the Program

This dramatic new medical technology brought problems along with its many potential benefits. Media reports affected public opinion. Patients and their families lost a great deal of their privacy as the curious public demanded its right to know. The procedure was enormously expensive, and many people raised the question whether such money might be better spent on prevention than on a risky and expensive procedure for one patient. Barney Clark had once been a two-pack-a-day smoker. Quality of life became an issue. With all the medical problems he had had after he received his artificial heart, had Clark lived for 112 days or was he dying for 112 days? The artificial heart did prove potentially useful in a way its original designers had not seen. Originally intended as a permanent replacement for a diseased heart, it became used more as a temporary bridge to keep patients alive until a human heart could be found for transplant. It also contributed in a major way to the wider issue of medical ethics and human experimentation, one of the most important issues in medicine of the time. Federal funding for the Jarvik-7 project stopped in 1988, and implantations were restricted to temporary use. On 11 January 1990, after reviewing the ongoing problems with the device, the FDA recalled the Jarvik-7 and forbade its further use in human patients.

THE PACEMAKER SCAMS

Colorado ski trips, gold-plated shotguns, and plain old American cash. According to federal investigators, physicians accepted these lures from manufacturers working to convince doctors to implant a particular brand of pacemaker in their patient—including patients who did not need the electronic device that helped to regulate the heart-beat. More than 130,000 Americans underwent surgery in 1982 to get a pacemaker. The device cost from $600 to $900 to make, but hospitals were billed from $2,000 to $5,000 apiece, and then they added a markup of 50 to 150 percent before sending the whole cost on to Medicare or other insurance plans. In a country with too many specialists, unnecessary surgery was a major concern. Senate and Department of Health and Human Services (HHS) investigators estimated that up to 50 percent of the implantations done at some hospitals were unnecessary. They estimated that as much as half of the $2 billion Medicare spent on pacemaker operations each year may have been wasted. Salesmen offered some cardiologists as much as $500 for each of the company's pace-makers that were used. "Criminal prosecutions would be charged," said HHS as it gave its findings to the Justice Department.

Source:

Matt Clark and Mary Hager, "Pacemakers: A Scandal at Heart," Newswek (20 September 1982): 86.

Sources:

Melvin Bergcr, The Artificial Heart (New York: Franklin Watts, 1987);

Carnegie Library of Pittsburgh, Science and Technology Department, The Science and Technology Desk Reference (Detroit: Gale Research, 1993), pp. 425;

Health & Medical Horizons 1986 (New York: Macmillan, 1986), pp. 287-288.

ZAPPING CORONARY ARTERY DISEASE WITH "STAR WARS" LASERS

Instead of using bypass surgery to repair clogged arteries, surgeons began during the 1980s to vaporize plaque and blood clots in peripheral arteries with lasers. A University of California, Davis, assistant professor of internal medicine, Garrett Lee, designed a special fiber-optic catheter that could be threaded through the body's major arteries to deliver bursts of laser light directly at the fatty plaque deposits obstructing the artery. Another laser developed for the Defense Department at Jet Propulsion Laboratories, the eximer laser, used short pulses of ultraviolet light. First successfully used in November 1988, the eximer laser vaporized plaque without the heat-damage problems of the earlier devices.

The major problems still to be solved were how to manipulate the laser beam inside the artery and how to distinguish normal and diseased segments of an artery before using the laser to vaporize tissue. Physicians in future decades would have access to "smart" systems relying on endoscopic fluorescence to perform the task and prevent blood-vessel perforations. The new laser procedures promised to save thousands of patients from open-heart surgery, but doctors still recommended that people should practice preventive measures to stay out of doctors' offices. "Stop smoking, reduce weight, and get on an exercise plan," advised Dr. Thomas Robertson, chief of the cardiac disease branch of the National Heart, Lung and Blood Institute.

Sources:

Teresa Carson, "Now Lasers Are Taking Aim at Heart Disease," Business Week (19 December 1989): 98;

Abraham Katzir, "Optical Fibers in Medicine," Scientific American (May 1989): 120-125;

Lise Spiegel, "Medical Breakthroughs," Harper's Bazaar (April 1983): 199..

Mechanical Hearts

The "Bionic Man": Barney Clark

Blood Clots and Strokes

A New, Temporary Role

Cancellation of the Program

THE PACEMAKER SCAMS

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Sources:

ZAPPING CORONARY ARTERY DISEASE WITH "STAR WARS" LASERS

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ARTIFICIAL HEARTS

At the Heart of the Matter