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by Mimi Swartz

  Nonetheless, Wampler gave his design specifications to a retired engineer who designed liquid hydrogen pumps for missiles. “Does this require a redefinition of the laws of physics or can this be done?” Wampler asked him. He had a hunch that if he could design a pump that spun fast enough, the blood would pass through safely, the way you can speed a finger through a candle flame.

  The engineer agreed to give Wampler’s idea a try, and soon came back to him with a working sketch and some calculations. Wampler then went to his workshop and fashioned the first blades out of mahogany, with a file and chisel. Eventually, after about a year, his team had something ready to test in calves. The device was remarkably small: the pump itself was encased in a titanium shell that fit easily in the palm of a hand. It was an axial pump, meaning it was long and extremely narrow, twice as long, in fact, as it was wide.

  Essentially, it was a high-tech Archimedes’ screw kept in place on either end by two magnetic bearings. Instead of carrying water for crops, it would—he hoped—ferry blood around the body. When Wampler began testing his device in the lab, he was surprised and encouraged to find that the bearings did not seem to crush blood as it flowed through the pump. What if the conventional wisdom was wrong?

  As he had promised himself, Wampler greatly simplified the implantation process as well. His pump could be guided from the femoral artery in the leg up into the aortic valve—the valve between the aorta and the left ventricle—with the help of a fluoroscope. Once there, it could give a boost to a damaged left ventricle, which lacked enough blood to pump on its own.

  At the time, there were no batteries or any other power source small enough to implant inside the body, so Wampler devised a motor that attached to the cable on the outside of a patient’s leg as the power source.

  It was around this time that Wampler, then forty, decided he was ready to reach out to a surgeon. And the surgeon who came highly recommended was named Bud Frazier. When Wampler finally contacted him at that fateful conference in 1986, Bud turned the device over in his hands, listening to Wampler’s explanation. Then he told him it would never work. Sure, he believed in a pulseless pump, but he was also pretty sure that a pump spinning as fast as Wampler’s would destroy the blood cells and lead to certain death. Still, he agreed to try the pump in a few calves.

  That’s when weird things started happening. The calves who were implanted didn’t die right away. In fact, they lived long enough to suggest that Wampler’s invention would work just the way he’d envisioned—not forever, but long enough to keep patients alive until they could get a transplant.

  Bud became like a man who had found religion—or, maybe, like a man who now had proof that the God he’d never quite trusted actually existed. He started giving talks on the success of Wampler’s pump. This could be it: a left ventricular assist device that was small and self-contained, with the kind of engineering that might later be applied to total artificial hearts. “We all thought that a pump spinning at 2,500 rpms would destroy the blood cells,” he said in his first talk. “But we were wrong.”

  The ever-polite Wampler, who had been listening from the back of the room, waited until Bud was done before taking him aside to correct one small mistake in his talk. The pump actually spun at 25,000 rpm, not 2,500, he said. Bud looked at Wampler as if he had been kicked by a mule. “If you’d told me that before, I never would have tried it,” he said.

  Still, neither Wampler nor Frazier was sure the animal tests told them much of anything about the success of the pump in humans. (“You just don’t find cows with hardening of the arteries,” was the way Wampler put it.) Eventually Bud recommended two patients who, as Wampler and Bud both recalled, had no chance of survival, so if the pump failed, Bud wouldn’t have to feel guilty. The two doctors then got FDA approval for emergency use and got the hospital’s permission to operate, and Wampler shipped down an operating console while hand-carrying the pump to Houston himself. When he met up with Bud again, Wampler was unnerved to see Bud wearing cowboy boots. Was this guy really okay?

  The patient ultimately chosen was a sixty-two-year-old Colorado man named Herb Kranich. Kranich had the weathered skin of the Colorado outdoorsman he once had been. He had silver hair, twinkling eyes under thick dark brows, and a warm, stoic nature. But he was a goner. He had had a transplant a month before, and his body was rejecting it by the minute; at this point he was pale, bedridden, and barely able to breathe, much less communicate. “If you’ve been in clinical medicine awhile, you can tell when someone is circling the drain,” Wampler said.

  Decades later, Wampler could clearly recall the stream of thoughts that flowed swiftly through his mind when he and Bud went in to ask Kranich’s wife, Leslie, for permission to operate. “Your husband is going to die, and we know you are desperate—but we have this idea that has worked pretty well on cows…but we’ve never used it on a patient, here are two or three pages of complications, and in all honesty there’s probably another page of complications, we just don’t even know what they are yet. So what do you think? Do you want us to try?” Wampler was stunned when she agreed. Leslie Kranich felt that her husband had been so sick, and in and out of hospitals so much, that they had to go for broke. “This isn’t living,” she told the doctors.

  Bud rushed Kranich into surgery on April 26, 1988—taking a little time off from the national artificial heart debate still raging in Washington. The actual operation took only twenty minutes or so. Inserting the cable on a course through Kranich’s body turned out to be a lot easier than navigating the vicissitudes of Congress. Bud positioned the device—christened the Hemopump—in the aortic valve, and waited. He did not have to wait long, because it started working right away. Within twenty-four hours, the color returned to Kranich’s face, his breathing became less labored, his blood gases rose, his fingers warmed. He was returned to life, even though he had only the faintest pulse; instead, there was the soft rushing sound of his blood spinning through the pump, which was pushing three or so liters through Kranich’s body; five was normal, but for a man on bed rest, three would do just fine.

  Within a few months, Herb Kranich was able to pack his bags and leave St. Luke’s Hospital to return home to his family. There was no reason for a longer stay. The Hemopump demonstrated what DeBakey had suspected back in 1963: that given help and time to rest, the heart could sometimes recover on its own. Wampler and Frazier, neither of whom was given to hyperbole, were confounded. Heart failure, it turned out, didn’t have to be a death sentence. They had also upended what doctors thought they knew about the blood, which had turned out to be a lot less fragile than previously believed. Both men would say that witnessing Kranich’s miraculous recovery was one of the most astonishing experiences of their lives. As Wampler would later say, “It convinced me that these perceived barriers were not barriers. The paradigms are very powerful, even if they are totally wrong.”

  Indeed, the Hemopump looked like nothing short of a medical miracle, and it was covered as such by the Los Angeles Times and the New York Times. Discover magazine called the device one of the 100 best inventions of the year. Even the National Enquirer featured it on the cover, next to game-show eye candy Vanna White. Wampler and Frazier were celebrities at the next ASAIO meeting; even Kolff made a point of congratulating them. If no side effects were discovered in future operations, Bud believed, the temporary pump could save as many as 150,000 lives a year.

  There were, of course, more hurdles before the Hemopump could be used that way. Most crucial was winning FDA approval, which demanded extensive and stringent clinical trials for life-sustaining devices like the Hemopump, which were ranked in the strictest category. A recent scandal involving a defective and deadly heart valve meant the federal agency was even more vigilant than usual. The prospect of widows testifying in tears before a congressional committee wasn’t good for anyone except plaintiffs’ lawyers. The era of medical malpractice and product liability laws
uits was by then well established. The inventor of the Hemopump also had to show that the medical device could be commercially reproducible—safely—on a mass scale. Many companies came courting—what business wouldn’t be interested in a device that could promise to commute the death sentence of at least 150,000 people overnight?

  At first, things went well. Wampler’s original company, Nimbus, raised enough capital to move forward. Seventy centers were set up to implant the Hemopump, and more than a hundred patients were saved. But over time, operating and production issues crept in, which did not sit well with officials at the FDA. The Hemopump wasn’t a simple medical device, like a syringe or a tongue depressor. It took highly skilled teams to implant and monitor it, and sufficiently qualified people were not used often enough. So the pumps started failing. Suddenly Wampler found himself shuttling to Washington, trying to explain his device and its problems to anxious young bureaucrats who were not in the medical field, much less experts on blood pumps. He would try to dumb down his presentations but knew the officials were in over their heads. He could sense what was coming. FDA regulators were not risk takers by nature or by training; the penalty for approving a medical device that could fail—that is, kill people—was severe.

  In the early 1990s, the FDA refused to grant free market approval, which meant Nimbus could not market the Hemopump commercially. The CEO suggested an IPO to raise more money for new trials, but the Nimbus board wouldn’t approve it. They didn’t want to dilute their ownership of what they knew was a miracle device. Instead, as Wampler would say, they got 100 percent of nothing.

  Johnson & Johnson bought the technology and hired Wampler as a consultant, but ultimately the complexity of the product defeated them. They sold the Hemopump to Medtronics, another large medical device company. The pumps were cheap—$3,000 or so—but hospitals just wouldn’t bite when told they had to make an expensive, up-front investment on the operating console.

  The Hemopump was as good as dead, commercially. Medtronics buried their surplus consoles in a landfill, and with them Rich Wampler’s dreams.

  11

  SYNCHRONICITY

  There is an aspect of medical progress, or probably progress in any field, that has to do with something indefinable in the air, a breeze that only a select few can feel against their skin. Bud likes to cite a mass-market movie released in 1981 called Threshold, which starred Jeff Goldblum as a nerdy inventor and Donald Sutherland as a Cooley-type surgeon, both of whom become obsessed with creating an artificial heart. The screenwriter was James Salter, who, along with producing great novels like A Sport and a Pastime, also wrote a pre–Barney Clark profile of Robert Jarvik and covered the Akutsu implantation with Cooley in 1981 for Life.

  To see Threshold today is a little eerie. It isn’t a very good movie, but the characters speak authoritatively about technology that had not yet been invented. Actors use the term “continuous flow,” for instance, long before Bud Frazier and a few colleagues started using the term to describe an alternative to the heart’s pulsations. The movie also came out before Barney Clark got his Jarvik-7 and long before the Challenger explosion—that is, before the American public’s faith in science and technology started to slip.

  Sutherland did some of his research for the role at THI, and does a pretty good if somewhat severe impression of Cooley, who in the film is tortured because he cannot save his patients from dying of heart disease. (Cooley let Sutherland do a few stitches on a patient to get into his role, and makes a cameo appearance in the movie.) The basis for Goldblum’s on-the-spectrum character is harder to pinpoint, but some of his awkwardness and obsessiveness is reminiscent of Robert Jarvik. The only thing that seems far too optimistic is the (not uncommon) premise that the artificial heart is just a few years away: Mare Winningham, playing a teenager who nearly dies of heart failure, walks out of the hospital under her own power, her mechanical heart whirring in her chest, no strings or wires or battery packs attached. You’d never even know she had one.

  Bud still shakes his head in wonder at the movie, which he’s seen more than a few times. How a Hollywood screenwriter could imagine a notion that he was just beginning to conjure still amazes him. “The actors even said things I’ve said,” he likes to say, and it’s true. The funny thing about the real development of continuous flow and its effect on artificial heart development is that it is far more entertaining and fluky than Threshold suggests, at least from that day in Louisville in 1986 when Bud encountered both Rich Wampler and Rob Jarvik.

  Wampler’s approach to Bud was straightforward because he is a straightforward man. Jarvik’s approach reflected his personality too. He took Bud into a corner, where he surreptitiously opened a small package to show Bud the contents. The way Bud tells it, Jarvik acted like a person does “when you were in old Mexico and someone said they had pictures of naked girls—‘Hey, come ’ere, señor.’ Rob didn’t want anybody to see it even then.” The moment was a turning point for Bud: two total strangers picked up on the same idea—building a nonpulsatile heart pump—and then separately came to him because he was the best person to do the lab experiments that would make their idea a reality. Put another way, he was the only person with the clinical expertise and the lab resources who did not think the idea was a ludicrous, hopeless waste of time and money.

  Jarvik, like Wampler, had come up with a tiny heart assist pump—an LVAD—that used continuous flow instead of pulsations. It was an axial pump, about the shape and size of a C battery, with a mechanism like an Archimedes’ screw. The difference between the two was that Jarvik’s heart, unlike Wampler’s, was designed not as a temporary device but as a permanent one.

  Bud studied the pump as well as he could, given Jarvik’s furtiveness, and agreed to try it on some animals in his lab. How was it that Wampler and Jarvik, two men who had never met, came up with the same idea at the same time? No one knows. There had been some debate already about pulseless devices, and some hypothetical papers written. And guys with engineering and design backgrounds were probably among the most likely to catch the breeze.

  There was one other notable difference between the two men: Robert Jarvik was more difficult to deal with than Richard Wampler.

  When Bud reflects on his decades-long relationship with Jarvik, he sounds like someone talking about a difficult family member who wouldn’t be missed at Thanksgiving dinner. The two spent several years paired on various medical panels at various conferences around the world. Bud had pegged Jarvik as “a chatterbox.” It annoyed him that Jarvik never missed a chance to one-up everybody else, including him. Whenever he came to Houston, Jarvik always wanted to go to chi-chi restaurants that Bud wasn’t interested in. Sometimes Bud would say, explaining his relationship, “I was one of the few people who could get along with Jarvik,” and at other times he would say, “I never really got along with Jarvik very well,” or “Rob is hard to like,” depending on where they were in their relationship. The truth is that they were lashed together by mutual interest. Both were determined to come up with a total artificial heart, which probably made working together simultaneously more collegial and more fraught. Jarvik knew how to make devices, and Bud knew how they would work in the body and had the best lab for testing them. Neither man, however, was particularly skilled at give-and-take.

  Still, there was a lot more tolerance among the community of heart surgeons for Bud, partly because he was a heart surgeon, and an accomplished one, and also because he was just a nicer guy. Bud can suck the air out of the room as well as or better than anybody, but you also feel that if you really had to tell a story of your own, he would at least try to listen. And, of course, if you were sick, you could be absolutely sure that he would sit by your bedside until the sun came up and went down again.

  Jarvik, on the other hand, is not a heart surgeon and never practiced medicine; he belongs to no fraternity and has never seemed to care in the least about joining one. He is an inventor firs
t and foremost, and not at all what you would call a people person. In fact, Jarvik often radiates a kind of weary boredom, unless he is demonstrating something he has invented; then his personality and passion bloom as he offers lots of eye contact while casually caressing his device in a way that is almost erotic. He has the bust of a mannequin in his office that is outfitted with something that looks like a cochlear implant. In fact, it is a heart assist device in which a power cable is snaked from the pump through the neck and connected to a skull-mounted pedestal behind the ear. When Jarvik starts talking about design and function, caressing the dummy’s head with his long, delicate fingers, your thoughts might wander to that part of the book of Genesis where God makes man.

  On that fateful day Jarvik showed Bud his super-secret pump, an LVAD that would come to be known as the Jarvik 2000, things were not going so well. The board of the company he had founded to market the Jarvik-7, Symbion, had invested $40 million and had little to show for it. Symbion was becoming a takeover target because it was badly managed—some would say by Jarvik himself. (He would be fired by the board within the year, with a $3 million payout.) “Jarvik was run out of Utah,” is the way Bud put it. He moved to Manhattan, but kept working with William DeVries, the surgeon who had implanted the heart in Barney Clark. Having shifted his base of operations to Louisville, Kentucky, DeVries’ work on artificial hearts was now underwritten by Humana, the giant for-profit healthcare conglomerate.

  The good and bad news was that this was the tightfisted, authoritarian era of managed care. Humana, often portrayed in the media as the biggest villain on the healthcare block for denying care, was in need of a little positive PR of its own. The corporation became just the angel Jarvik and DeVries needed when it agreed to underwrite one hundred artificial heart implants at an estimated cost of $25 million.