Even as plastic-and-metal hearts were beating in the chests of three new patients, doctors and officials last week debated whether the artificial heart program should be halted, slowed or accelerated.
Testimony during the first congressional hearing on the artificial heart revealed sharp differences of opinion about the program and reemphasized its experimental nature.
Nine witnesses -- including Dr. Robert Jarvik, inventor of the Jarvik-7 artificial heart, Dr. William C. DeVries, the only surgeon with federal approval to implant permanent artificial hearts, and Mel Schroeder, son of the longest-surviving artificial heart patient -- testified Wendesday before a subcommittee of the House Science and Technology.
Jarvik said Food and Drug Administration restrictions on emergency use of the artificial heart are "unrealistic," adding that he hopes to get approval soon for "more rapid use" at more centers.
"A true emergency here is a situation where the patient's going to die and going to die quickly," Jarvik said. "There's really no difference between an emergency and a non-emergency when the patient needs an artificial heart."
But George J. Annas, chairman of the American Bar Association's Committee on Legal Problems in Medical Practice, said the choice for an artificial heart patient is not between life and death but between "two different ways of dying."
Permanent artifical heart implants "should be suspended because of the devastating results they have had on subjects and their families, because their original justifications are no longer valid, and because the consent process is too primitive to protect the rights and welfare of human subjects," said Annas, who is a professor of health law at the Boston University's schools of medicine and public health.
Artificial hearts have been implanted in 12 Americans and one Swede in the past 3 1/2 years. The first four were permanent implants by DeVries, who has FDA approval to perform three more at Humana-Audubon Hospital in Louisville. The other nine -- including implants last week in Houston, Tucson and Pittsburgh -- were temporary "bridges" intended to sustain a dying patient until a transplantable heart could be found.
Most of the artificial hearts used so far are versions of the Jarvik-7, a polyurethane-and-aluminum pump powered by a machine the size of a small refrigerator. Another type, known as the Penn State heart, is approved only for temporary bridge-to-transplant use.
Two of the five recipients artificial hearts intended for permanent use are alive, but they have had a total of four strokes, among other complications. Both remain hospitalized.
"Do Bill Schroeder and Murray Haydon have the quality of life they want, or we want for them?" asked DeVries. "No.
"Is their quality of life adequate, considering their preoperative state? Yes.
"Bill and Murray would be dead if they did not have artificial hearts. Neither has asked me to turn off the power source and end his life. Nor has Juanita Haydon or Margaret Schroeder asked for this, although I have discussed the possibility at length with each of them and will continue to discuss it."
Caught in the middle is the FDA, which regulates artificial heart implants under the 1976 Medical Device Amendments to the food and drug laws. Deputy Commissioner John A. Norris said the FDA must encourage testing of new life-prolonging devices while also protecting the public against unsafe and ineffective treatments.
Balancing such competing goals, Norris said, forces the FDA "to act both as an accelerator and as a brake pedal."
Last December, because of growing concern about medical complications of DeVries' first four patients and the proliferating emergency use of the heart as a temporary measure, the FDA tightened its restrictions on the program. It now requires case-by-case approval of permanent heart implants.
DeVries remains the only heart surgeon authorized by FDA to implant a permanent artificial heart, but heart surgeons in Tucson, Pittsburgh, Minneapolis and Hershey, Pa., have been authorized to use the heart as a temporary bridge in patients awaiting a transplant.
"The situation with temporary use in this country is almost completely out of control," Annas said, "and a real possibility exists that the tragic 'me too' orgy of heart transplants that followed Christiaan Barnard's human heart transplantation in 1968 could be repeated." In the early days of heart transplantation, many medical centers entered the field prematurely and then were forced to abandon it when mortality rates soared.
Much of the debate over the artificial heart centers on cost. No one denies that the artificial heart has prolonged the lives of several patients, but balancing the quality of life against the total cost to society is difficult.
Since 1964, when Congress established the artificial heart program, the National Heart, Lung and Blood Institute has spent $218 million on artificial heart research. Since 1969, federal spending on the artificial heart has averaged between $10 million and $15 million a year.
Between 17,000 and 35,000 patients a year eventually would be eligible for the artificial heart, the institute estimated last year. To keep these patients alive, it would cost an estimated $150,000 per patient per year, or between $2.5 billion and $5 billion a year.
"Are we as a human community going to be better off with this device?" asked Daniel Callahan, director of the Hastings Center, who debated Jarvik last week at the National Press Club. "I don't really think so."
Money spent on the artificial heart, Callahan said, could be better spent on preventive efforts to reduce heart disease through better nutrition and stop-smoking programs.
Congress, which saw kidney dialysis grow to a multi-billion-dollar item in the federal budget after it was included under Medicare in 1973, is unlikely to do the same for artificial heart operations.
"Congress is not going to underwrite the cost," Callahan said, "and therefore it's going to be a market item and go to people who can afford it."
Jarvik said the high cost of the artificial heart "is not relevant since we seem to spend $3 billion on video games."
But the cost issue will "have to be addressed sooner or later by society," DeVries told the subcommittee. "It is possible that we'll make a device that the public can't afford. It's also possible that we'll make a device that will save hundreds of thousands of lives.
"At this point it's too early to say which."
Within 20 years, Jarvik predicted, artificial hearts will be "standard, accepted therapy" for terminal heart disease, and implants will be "commonplace."
Some critics worry that the device will be overused.
"Invention is the mother of necessity," said Callahan. "There will be enormous pressures on people to use it the artificial heart . That's been the history of medical devices."
But Jarvik, asked about possible undue pressures on patients from their families and doctors to try the artificial heart, said he had never considered the issue.
"I absolutely have never thought of that before," he said. "I never thought of that as a possibility."
Using an artificial heart as a bridge in a patient awaiting a heart transplant does not increase the number of lives saved. It merely moves that patient to the head of the line waiting for the next available heart donor.
That raises troubling issues, Annas said, by giving the artificial heart patient "priority over other individuals who may have been on the waiting list longer, may be better suited for the available heart, may be in better physical condition to benefit from the available heart and who may well die because of this reallocation."
"It saves life A -- but at the expense of life B," Callahan said.
Jarvik said even temporary implants would save lives, because publicity generated by the artificial heart program would educate the public about the need for organ donation and boost the supply of donor hearts.
"The best way of making that waiting list shorter is prevention," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group and a critic of the artificial heart program. With broadened criteria for heart transplants, Wolfe said, artificial heart candidates have a better chance of becoming eligible for a human heart transplant.
But Jarvik said the artificial heart would never be used where a transplant is available, and DeVries said that each of the four patients in whom he implanted an artificial heart was ineligible for a transplant because of age and other factors, such as diabetes.
The only members of the subcommittee on investigation and oversight who attended the hearing were chairman Harold Volkmer (D-Mo.) and Rep. Ron Packard (R-Calif.). Both indicated their firm support for the artificial heart program.
Before the hearing began, Packard released a statement that "the need for the artificial heart, either temporary or permanent, is clearly justified by the simple reality that heart disease is the leading cause of death in this country." At the close of the hearing, he said that to abandon the artificial heart program because of its initial problems would be "irresponsible -- perhaps even criminal negligence."
Mel Schroeder, the son of William Schroeder, who received an artificial heart 15 months ago and has had many complications including a series of disabling strokes, praised his father as a pioneer "who chose life and the artificial heart." But he said the family should have been more involved in the consent process and discussion of possible longterm complications.
"A lot of things were happening real quickly," he said. "A lot of times you're more concerned with the situation at hand than what might happen in the future."
As for whether it was worth it, he said, "That seems to be a very difficult question to answer."
DeVries said consent is not just a form to be signed, but an evolving process that would be revised "hundreds of times," he said.
"We basically told them just about everything we know," DeVries said. We didn't foresee that strokes were going to be as big a problem . . . We ourselves learn."
At the end of his testimony on this controversial new technology, Schroeder raised the analogy of the space shuttle.
Like most Americans, Schroeder said, he watched the news of the recent space shuttle disaster on television. Like most Americans, he thought about what the families of the victims must be experiencing.
"I could relate somewhat to what they might be going through," he told the subcommittee.
"You recall and hold on to the success you have experienced, you praise the pioneers of technology and you dream for the future success for mankind."