Artificial Heart--a Case of Pushing Science ‘Too Fast’
When famed Houston surgeon Michael E. DeBakey went to Congress in 1963 to peddle the notion of an artificial heart, he was warmly received by two key committee chairmen, Sen. Lister Hill and Rep. John E. Fogarty.
Hill’s father was a surgeon and had named him after the famous physician, Joseph Lister. Fogarty also had a deeply personal interest in cardiac research: He was slowly dying from heart disease.
Beginning with that long-forgotten meeting, the government became an essential partner in launching the artificial heart. And nursed along by Hill, Fogarty, DeBakey and the former director of the National Institutes of Health, the device embarked on what became a tortuous, quarter-century odyssey.
The controversial journey ended, at least for now, when the Food and Drug Administration ordered an Arizona firm this week to stop using the Jarvik artificial heart, which captured worldwide attention when it was implanted in a dying Seattle dentist named Barney Clark seven years ago.
But with an increasing emphasis on constraining health-care costs while improving a patient’s quality of life, experts are now citing the artificial heart as a prime example of a medical technology that never should have been allowed on the market.
“It’s a classic case of a technology being pushed too fast without any facts. More time should have been taken and more questions should have been asked--by everybody,” acknowledged Wayne I. Roe, a health-care consultant involved in the artificial heart’s development.
The origin of the artificial heart can be found in the post-World War II boom in federal funding for biomedical research, said Dr. Michael J. Strauss, a medical historian and consultant.
Then, as now, heart disease was the nation’s No. 1 killer. The development of an artificial heart seemed a logical extension of the many breakthroughs in heart research and treatment that began in the 1960s, such as the heart-lung machine, improved blood products, artificial blood vessels and, above all, the survival for 36 hours of a dog whose heart had been replaced by a plastic, mechanical substitute.
Once Hill and Fogarty were sold by DeBakey on the need for an artificial heart, the two lawmakers teamed up with James S. Shannon, the now-retired NIH director, as the key advocates of financing its development.
“They were quite willing to appropriate funds for that,” Shannon said Thursday in a telephone interview from Oregon.
By 1965, the Artificial Heart Program had a four-year, $40-million budget to develop a fully implantable device, with a target implantation date of 1970.
But researchers quickly realized that they faced two huge engineering obstacles, the same ones that contributed to this week’s FDA decision to withdraw approval of the Jarvik heart: an inability to prevent blood from clotting on the device and the lack of an implantable power source.
To this day, investigators still are not sure what causes the clotting, but the clots have often led to serious strokes. And because there was no internal power source, the artificial hearts had to be connected by tubes to an external machine, and that increased the chances of infections.
It was around 1970 that Shannon developed reservations about the crash program. But his warning fell on deaf ears.
In 1967, Fogarty, a Rhode Island Democrat, died of a heart attack. A year later, both Shannon and Hill, an Alabama Democrat, retired.
Through the 1970s, the program went through numerous reevaluations, as reflected in the five different names it acquired along the way.
Its research focus wandered as well, at one point shifting from a replacement device to a left-ventricular assistance device that helps a weakened heart pump blood, according to Strauss, vice president of Health Technology Associates, a Washington-based consulting group.
But in the private sector, meanwhile, research on the artificial heart continued, clearly demonstrating “the emerging independence of research groups and the limitations of government authority in the application of federally supported research,” Strauss said.
In 1969 and again in 1981, Dr. Denton A. Cooley at Houston’s Texas Heart Institute implanted a temporary artificial heart in patients after all other treatments had failed.
Then, in December, 1982, Dr. William C. DeVries in Salt Lake City burst on the scene by implanting what he called a permanent artificial heart in Clark.
The NIH, having spent $200 million on artificial heart research, had learned of the planned implantation through the news media and opposed it.
But the health institutes had no say in the matter, according to Strauss. The FDA granted DeVries an “investigational device exemption” that allowed the operation to take place.
Clark lived for 112 days with a Jarvik heart.
While some critics raised questions about the quality of life Clark would enjoy after the operation, most scientists were elated by the prospect of a long-term artificial heart that could prolong the life of a patient until a donor heart could be found.
But subsequent attempts to implant artificial hearts resulted in serious complications and failure.
Since 1982, more than 100 patients in the United States have received the device, either as a permanent heart replacement or, far more commonly, as a temporary “bridge” until a human donor heart could be located.
The device was named for Robert Jarvik, a physician who later founded Symbion Inc. Richard Alder, Symbion’s president, said Thursday that the firm will “eagerly cooperate” with FDA officials “in solving the issues identified.”
The FDA said it withdrew its approval because of problems associated with the device and because its inspections of the firm have turned up “serious deficiencies” in the way Symbion was conducting its clinical experiments involving a small group of patients.
In the meantime, research continues into a permanent artificial heart that, unlike the Jarvik, could be contained entirely within the body.
HOW THE SYMBION J-7 HEART WORKS
Formerly known as the Jarvik-7, the plastic and titanium device is about the size and weight of a human heart.
Its two bell-shaped pumps replace the two ventricles, or main pumping chambers, of the human heart. Compressed air is blown into two flexible diaphragms expelling and drawing blood.
1. Pulses of air from an exterior pneumatic pump push against a diaphragm in the right ventricle forcing oxygen depleted blood from the body out of the heart cavity and into the lungs. 2. Oxygen enriched blood from the lungs fills the cavity of the left ventricle between air pulses, then is pumped to the body.
Recipients of Artificial Hearts
Recipient (age) Date Days Cause of Deaths Barney Clark, (61) Dec. 2, ’82 112 Cirulatory failure William J. Schroeder, (52) Nov. 25, ’84 620 Stroke Murray P. Haydon, (58) Feb. 17, ’85 112 Kidney failure Leif Stenberg, (53) April 7, ’85 229 Respiratory and vascular failure Jack Burcham, (62) April 14, ’85 10 Cardiac blood clot
