by Mimi Swartz
The best way to explain their relationship is that they are “frenemies.” For decades, they worked together on various pumps, Jarvik refining and sending his designs to Bud at THI for testing in the lab.
Now they joke—probably incomprehensibly to anyone outside ASAIO—about, for instance, the fifty bench tests they did on a device before putting it in a calf who promptly died. In another bovine joke, Jarvik suggests that Bud showcase a long-lived research calf in Houston’s upcoming rodeo.
All of this is more interesting to Bud than the Barney Clark saga, the subject of which can cause him to respond with one of his extended XXXL yawns. It’s hard to tell whether the story bores him or exhausts him; either or both could be true. After all, Bud was there when Cooley implanted a second artificial heart in 1981, something virtually no one remembers but which, in Bud’s mind, paved the way for the events in Utah. And, of course, there’s this: Barney Clark’s surgery has long been perceived as a screwup that set back artificial heart development for decades.
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“The Artificial Heart Is Here,” Life proclaimed on its cover in September 1981. The photograph showed a creepy-looking two-sided plastic device with two holes on each unit and a lot of clear plastic tubing, like something evocative of Jules Verne’s 20,000 Leagues Under the Sea. The two sides were partly held together with Velcro, which, if you thought about it, would not have been very reassuring. The cover promised “exclusive pictures of Dr. Cooley’s historic heart surgery,” which the magazine had been invited to see. (The second story featured on the cover asked whether women could “cut it in the military.”)
As far as the general public knew at the time, the artificial heart had been in exile since Cooley had implanted the stolen heart in Haskell Karp in 1969. In the aftermath, DeBakey had put a serious hex on his future. Cooley received mild censures—but still censures—from the American College of Surgeons and the National Institutes of Health. The Harris County Medical Society issued a censure of its own, as, of course, did Baylor, which eventually led to Cooley’s resignation from the faculty. Cooley rationalized the outcome of all the investigations—he insisted that his colleagues found that physicians had the right to do whatever they thought was necessary to save their patients, but many believe that Cooley’s legacy as a surgeon was irrevocably damaged by his not wholly undeserved reputation as a cowboy.
It certainly hadn’t helped that Mrs. Karp, once bewitched by the Cooley charm, turned around and sued him for malpractice in 1972. She lost for a lot of reasons, but the main one was probably that the star witness for Cooley was Michael DeBakey himself, who refused to testify against his former colleague on the witness stand. As abusive as he might have been in his operating rooms and on rounds, DeBakey had no intention of questioning another doctor’s decision-making in public. (The story that sounds apocryphal but actually isn’t is that the plaintiff’s lawyer asked Cooley to name the best heart surgeon in the world, and Cooley named himself—because, he said, he had sworn to tell the whole truth.)
But Cooley had had enough of the artificial heart business. He was quickly becoming a master of a new kind of heart surgery called the coronary bypass. The bypass was for a time almost a rite of passage for middle-aged, overstressed executives who turned up in their cardiologists’ offices with blocked blood flow to their hearts and, as a result, the stabbing pain known as angina. To get the blood moving again, a surgeon builds a graft around the blocked artery, in the same way a contractor might build a new road alongside one washed out in a flood or blocked by a boulder. More than one artery can suffer a blockage, requiring a double, triple, or even quintuple bypass. By 1989, it would account for more than 60 percent of open-heart surgeries done at St. Luke’s, and at a cost of around $60,000, it was certainly one of the most remunerative. As usual, Cooley could perform the procedure faster than any other doc in the United States, and he set up another assembly line that allowed him to do even more. At one time, surgeons at THI were doing thirty cases of open-heart surgery a day, mostly bypasses. In Houston, having a “Cooley tattoo” became a badge of honor, at least until statin drugs like Lipitor proved a simpler and more effective way to control the problem in the 1990s.
But Cooley never gave up on the idea of an artificial heart entirely—in fact, he never quite got over the fact that what he viewed as a medical breakthrough was seen by many of his colleagues as an unmitigated disaster and, possibly, a violation of the Hippocratic oath. The Karp implant, he wrote in an essay in 1979, “should have stimulated further clinical trials under identical conditions. Unfortunately, it seemed to deter other surgeons from being bolder in their efforts to prolong life in dying patients….In some cardiac centers today, countless opportunities to gain much needed human experience are being wasted while philosophers and critics ponder the social implications.” The increase in medical malpractice lawsuits “against those of us who are trying to make scientific progress” also galled him: “Regrettably, in the future many innovators in the surgical profession, as well as corporations that provide support by introducing new technologies, will be discouraged….The medical profession is under extremely close scrutiny, and the demand for governmental control will, in my opinion, cause a serious handicap for future investigators.”
Once again, Cooley was not going to take orders from anybody, especially the US government.
In fact, Cooley had wasted no time replacing his first replacement heart once Domingo Liotta headed back to Argentina in 1971. Cooley brought on board Tetsuzo Akutsu, a well-regarded Japanese surgeon and inventor whose work on the artificial heart dated back to 1957; it was Akutsu who worked with Kolff to implant one in a dog.
Akutsu arrived in 1974 and quickly became yet another oddball rolling through the halls of the Texas Heart Institute. He was reserved and secretive—“paranoid” was a word some used—maybe because he believed his ideas had already been pilfered under Kolff at the Cleveland Clinic. Akutsu had come to Houston via the University of Mississippi, seduced by Cooley’s reputation as a surgeon as well as his willingness to try anything to keep a patient alive. Akutsu knew that if he built a working artificial heart, Denton Cooley would not let it go to waste.
At first Cooley seemed happy to wait for a flawless finished device. When he ran into Akutsu on his Saturday visits to the Texas Heart Institute, he always had the same question. “Ted,” he would ask, “are you ready to put this heart in a human?” Akutsu always had the same answer: No, he was not. Unlike Cooley, Akutsu was deliberate and methodical, passionate about research, and, most of all, a perfectionist.
To Bud’s way of thinking, all of these early devices were pretty much the same, partly because of the limitations of technology at the time, and partly because a certain degree of adaptation, or borrowing, of ideas was common. Akutsu’s, in fact, was not substantially different from the one implanted in Karp in 1969. It was about the size of two fists, with two air-powered double-chambered pumps made of a plastic approved for medical use. A synthetic membrane filled the chambers with compressed air; one chamber pumped blood to the lungs, the other through the arteries into the rest of the body. There were special valves for inflow and outflow of the blood, and the prosthetic ventricles were attached to the actual atria and veins by flexible tubing with detachable connectors.
The device affixed to an external power console via Dacron velour tubes. The console itself had three basic parts: a pneumatic driver (an air compressor), an electrical monitoring system to measure the heart rate and heartbeat, and an electrical power system that ran on a standard electrical current with a backup battery. The console was about the size of a refrigerator, albeit one with lots of dials and gauges.
Left on his own, Akutsu continued to refine his machine, reducing the size of the control unit and the size of the heart itself, the better to fit it in a human as opposed to a calf. Within a year or so, by 1975, he had put the heart in one hundred calves and implanted it for size in t
he chests of twenty human cadavers, but he still wasn’t satisfied. His device could never be a total replacement heart, he believed. It could, however, keep a patient alive while he or she waited for a transplant. Most of all, Akutsu worried that his heart would be tested on a human too soon. If it was, and it failed, he knew he might never be allowed to try again.
But Cooley was itchy. There is a vast divide between those who design devices and those who use them. Engineers in the medical field—actually, all engineers—want to create foolproof things, especially as the world has grown more litigious and investment capital more scarce. Doctors, on the other hand, are in a hurry—they want to save lives and work the bugs out later. Cooley, certainly, could never resist any new mechanical advance, but there were other reasons to rush. At the Cleveland Clinic, Dr. Yukihiko Nose had perfected an artificial heart that had kept a calf alive for a record-breaking seventeen days. Out at the University of Utah, a team headed by Willem Kolff was working on its own artificial heart, one designed not as a bridge to a transplant but as a permanent replacement. As the 1970s began drawing to a close, Cooley started showing up at Akutsu’s office several times a week. “Is it ready?” he wanted to know.
Finally Akutsu decided it was. The finished product was sterilized. Then it sat entombed in a file cabinet, where it waited for its star turn. Cooley wasn’t worried about performing preliminary animal testing. “Why should I spend time sewing it into a cow?” Cooley asked at the time. “You don’t even need a medical degree for that.”
Meanwhile, the headlines kept coming from the West. “Utah Doctors to Try Mechanical Heart,” claimed one. “Surgeons Are Ready for Mechanical Heart Transplant,” read another. Kollf’s team, it was rumored, had submitted a proposal to the University of Utah’s Institutional Review Board, the ethics committee that would decide whether or not the team could go forward.
Tuesday, July 21, 1981, was a typical stifling summer day in Houston. Akutsu was making plans to move back to Japan to begin a prestigious new job when he got a frantic call from Cooley’s secretary. Cooley needed him in the ICU immediately. Akutsu threw on a pair of scrubs and raced to the intensive care unit, where he found Cooley trying frantically to save a heart patient who showed every sign of dying. His pupils looked fixed, and, off and on, his EKG would go flat.
“Are you ready with that thing?” Cooley asked. “That thing” was, of course, Akutsu’s mothballed heart. And Cooley wasn’t really asking. Akutsu sprinted to his office; meanwhile, the surgeons rushed their patient to the operating room, tore out the stitches from his earlier surgery, and reached into his chest, trying to keep his real heart alive by massaging it rhythmically by hand.
The patient, Willebrordus Meuffels, a thirty-six-year-old Dutch tour bus driver with thick eyebrows and dark wavy hair, had been flown into Houston from the Netherlands in a special government-subsidized airlift to receive a bypass operation. Somehow it had become an article of faith among Dutch doctors that it was cheaper to fly desperately ill heart patients on a medically equipped KLM jet to Houston twice a month than to risk inferior results at home. For five years, beginning in 1976, more than fifteen hundred heart patients, mostly men aged forty-five to sixty, arrived at St. Luke’s for what was at best lifesaving coronary care and at worst a marketing opportunity designed to burnish THI’s reputation. Most of the patients, like Meuffels, were close to death before they even boarded their flight to Houston. It was a dark joke at THI that it was best to get them back on a plane ASAP after surgery so they could expire back home, or at least on the plane.
Meuffels’ bypass surgery had seemed successful at first. Cooley sewed three pieces of vein cut from one of Meuffels’ legs to replace three clogged coronary arteries. But five hours later, around two-thirty in the afternoon, he had suffered a massive heart attack. The doctors tried injecting him with drugs to restart his heart, and followed that with heart massage. But when he still did not respond, Cooley had sent Akutsu racing back to his office for his artificial heart.
One thing that Cooley did not do was seek approval from the FDA to proceed. He was well aware of new FDA restrictions on medical devices; he’d been partly to blame with the Karp implant, but problems with the intrauterine device (the IUD) had also added to stricter controls. The FDA now limited when certain devices could and could not be used, and made a clear delineation between emergency use and experimental use and the requirements for each.
Cooley could not have been less interested. He had slipped out of so many controversies by that time that his belief in asking for forgiveness instead of permission was his standard operating procedure. In his mind, waiting for bureaucratic approval could not be allowed to trump saving, or at least attempting to save, a life. As he would note a few months later, “If a man is overboard and someone throws him a life preserver, he’s not going to inspect it and see if it has a guarantee.”
Within an hour and a half, the Akutsu heart was pulsing successfully in Meuffels’ chest, and twelve years after Haskell Karp’s surgery, Denton Cooley had completed the world’s second artificial heart implantation.
That was the good news. But then Cooley’s team couldn’t wean Meuffels off the heart-lung machine. Every time they tried, his heart stopped pumping blood to the lungs, which resulted in hypoxia, as oxygen stopped flowing to the body’s tissues. Bud, assisting in surgery, jerry-rigged a temporary fix, but he and the other twenty-five medical people in the room realized that, overall, the Akutsu heart was just too big on Meuffels’ body. While Meuffels remained heavily sedated, the doctors put out the word for a human heart. If he was to survive, he would need a transplant. Immediately if not sooner.
The implantation took place on Thursday; a donor heart was found on Saturday. A twenty-nine-year-old Nashville man had been left brain-dead after an auto accident. (The concept of brain death was still so novel—or frightening—after nearly two decades that the term showed up in quotes in newspaper stories of the time.) His body was flown into Houston’s Hobby Airport aboard a Learjet and then helicoptered to the Texas Heart Institute. By this time, Meuffels had been alive with an artificial heart for fifty-four hours.
It took Cooley about an hour and fifteen minutes to remove it. When he was done, Akutsu held his bloody device aloft for the Life photographer, his expression triumphant behind his mask and glasses. During the next hour, Cooley sewed the donor heart in place. The team gathered around Meuffels, staring into the massive bloody chasm that ran the length of his chest. No one spoke.
Then, as if on cue, Meuffels’ new heart began to beat, pulsing impatiently, like a child awakening from a dream too soon. Everyone who had been watching the surgery from the gallery above started clapping furiously.
But then, just as quickly, Meuffels began to fail. By the following Sunday he had a raging infection, and his kidneys and lungs were barely functioning. He was able to breathe only with the help of a respirator, and he lay in the ICU amid a thicket of tubes, wires, and IV poles. On the one hand, the surgery was miraculous: Meuffels lived significantly longer than Haskell Karp, who survived for only a day and a half after being transplanted. And Meuffels was the only man in history to have survived for a week with three different hearts, as Life jubilantly reported. But the prognosis wasn’t good. A journalist reported that Meuffels was “barely able” to squeeze his wife’s hand; in truth, he never regained consciousness. By Sunday morning, August 2, he was gone. Still, Meuffels’ wife was grateful. “I have never seen so much effort for one human life,” she told Cooley and his team.
They didn’t know at the time how lucky they were—lucky that their patient died.
* * *
Gratitude was not, in fact, a universal reaction. Out in Utah, the team that included Robert Jarvik and a surgeon by the name of William DeVries had been furiously working on their own artificial heart under the direction of Willem Kolff. This heart was, ostensibly, different from the one used by Cooley: it was devis
ed for permanent use, not as a bridge to transplant. The distinction was important, because it required the Utah team to follow the strict rules set out by the FDA for permanent rather than emergency use. In other words, they weren’t cowboys out in Utah. These guys played by the rules.
For the last few months, the team had been scrupulously attending to the questions posed by the Utah Medical Center’s Institutional Review Board, which, in turn, would be used to make their formal request to the FDA. They all had a lot on the line: Kolff was ready to make the successful implantation of the artificial heart the crowning achievement of his career. His faith in engineering and mechanical devices—“the body as an entity of replaceable parts,” in the words of medical historian Shelley McKellar—had never been shaken, despite limited success. “If a man can grow a heart, he can build one,” Kolff famously stated.
The university had lured Kolff to Utah by offering him the post of chief of its new, custom-designed Institute for Biomedical Engineering and the Division of Artificial Organs. He’d been working in Utah since 1967, after a falling-out with administrators at the Cleveland Clinic over their commitment to his artificial heart research. Kolff soon showed himself to be a difficult leader, a demanding taskmaster in the DeBakey mold. He also believed in management by creative tension—pitting designers and researchers in his lab against one another. Kolff knew that government enthusiasm for the artificial heart was waning, with priorities shifting toward LVADs, and that he had to keep interest high if he wanted to keep his lab and his position. By the early 1980s, he was promising doctors and hospitals that his mechanical heart would be available soon. Very soon.