by Mimi Swartz
Bud ached to try it. People were sick and in need, and coincidentally or not, success with the Bivacor would also ensure the importance of continuous flow, Bud’s legacy. If he wished he had come up with the idea himself, he didn’t show it. Bud bragged about the Bivacor to colleagues and friends like a father whose child had been accepted to every Ivy League school. He knew it would work, he just knew it.
Billy too was ready to move on to the next step—or jump ahead several. He was interested in the Johnson & Johnson gig but he wasn’t sure about giving up surgery, and he had no intention of giving up on the Bivacor. Still, experience told him that $2 million wouldn’t go very far, and he had begun chatting up investors in Houston, Austin, and beyond, using the term “one moving part”—one of the Bivacor’s defining features—like a mantra.
There was certainly reason to be optimistic. Thanks to the money, they had been able to switch from fragile plastic to durable titanium devices as often as they needed to. Calf study after calf study went well—within a couple of years they had done almost a dozen—with calves easily living the FDA requisite of ninety days. (At that point, they “sacrificed the animal,” in the delicate parlance of the lab.) During that time, the calves demonstrated that they could not only wake up and stand and rummage in a brightly colored bucket for snacks, but move easily on a veterinary treadmill with “Good Horsekeeping” emblazoned on its side. The initial goal was five minutes on the treadmill, which then lengthened to eight minutes, ten minutes, and more. The starts could be rocky—in the beginning the calf might lean to one side and then the other, tuckered out. But soon enough he or she began to stroll easily, if not for too long, while the accompanying group of humans jubilantly called out respiratory rates and cardiac output—the number of liters of blood pumped from the heart. Almost from the beginning, those numbers were within normal range, from five to seven liters a minute.
The software-driven miracle that separated the Bivacor from many other devices was also proven time and again: if the animal sped up, the machine pumped more blood throughout its body. If the calf slowed down, the Bivacor took a breather, just like the heart did in normal humans.
But there was always another unknown. “What happens if the animal is frightened?” someone asked Bud one day. “Will the heart speed up then too?” After all, that happened to a human heart if someone was, say, held up in an alley or caught sight of a person he had a desperate crush on.
Bud looked flummoxed, and for just a moment took his eyes off the animal strolling steadily on the treadmill, extending its soft black muzzle in search of a treat Billy was holding just out of reach. “I don’t know,” he said. “Let’s ask Daniel.”
He stepped over a few wires and tubes to saunter over to the spot where Daniel had his eyes fixed on the computer console. Well, what about it? he asked Daniel. Would the Bivacor pump more blood if the calf was scared?
For just a second Daniel looked up from his screen with what was for him the rarest of expressions: surprise. “I never thought about that,” he said.
Precisely for that kind of reason—all the myriad things he might not have thought of, or, more likely, all the things he knew he could make better—Daniel resisted the Cohn/Frazier push for a human implantation. He continued to work painstakingly and methodically to make sure his machine was as close to flawless as he could make it. Maybe if the prongs on the impeller were just a little farther apart or a little closer together, the blood flow could be even better. Maybe they needed more or fewer data points than twenty thousand to keep the center of the device magnetically spinning without touching the sides and causing wear that could lead to bigger problems.
Not that he couldn’t see the future himself. Daniel began traveling to San Diego, where he had found a manufacturer—one who mass-produced pumps for Thoratec and other companies that were now cleaning up on LVADs. Daniel’s Facebook page filled up with pretty Pacific sunsets.
* * *
There was another reason Daniel was spending more time out of town. He was beginning to experience a different curriculum in his education in innovation, or, to put it another way, his initial sense of awe at all he had been given was gradually being eroded by inventors’ paranoia. He was starting to worry about losing control of his creation. Several alarming superhighways could lead to this dangerous destination. Someone could copy it, or borrow enough of the technology to get to market faster, or, as had happened with Wampler and the Hemopump, he could find himself at the mercy of his investors. They could lose interest, something that was not uncommon with venture capitalists, or they could clutch the purse strings even tighter while demanding a larger ownership share. They could object if the pool of investors got too big and diluted both their power and their possible return. Helping humankind was certainly part of the process, but very few people invest large sums without also expecting a big payday down the road.
Keeping the particulars of the device secret wasn’t such a big problem. Daniel started banning cellphones from the implantations—no more selfies with the bionic calves—and he also started limiting the number of people allowed to witness the surgeries, period. If someone asked to listen to the Bivacor’s whooshing inside a calf’s chest and that someone wasn’t a medical professional or an investor, Daniel just said no.
But keeping up a charm offensive with investors was not as easy, particularly because Daniel didn’t have much patience with or interest in people who did not come from his world. Indeed, by January 2016 a couple of fissures were appearing in his relationship with the McIngvales. The problem dated back to what had been said at that first meeting at THI in 2012, specifically whether the fabled $2 million from the couple was an investment in the Bivacor, a charitable donation to be channeled through the Heart Institute, or maybe a little of both. Fundraising, like operating, had always been done somewhat on the fly at Texas Heart; Cooley or Bud or someone else put in a phone call to someone with a lot of money or power and somehow it all worked out.
But now, as the disparate interest groups—some of them new to the story—tried to formalize their agreement, it became unclear whether, for instance, Billy in his eagerness had promised the McIngvales something he didn’t have the authority to deliver. It was unclear what, exactly, THI’s role was in all of this—were they going to be the recipient of a philanthropic windfall, or was it all supposed to go to the Bivacor? The fact that the Heart Institute had been without a CEO since the CHI takeover contributed to the problems; no one could make a decision.
As time went on, the McIngvales also became concerned about sharing the Bivacor with new investors. Billy had found a Texas venture capital firm that was eager to throw $5 million in the pot, but the couple was not enthused about diluting their interest, and neither was Bud, whose suspicion of venture capitalists dated back to the homicide of the Hemopump. He would have preferred more government grants, assuming any existed. As for Daniel, he had terrified everyone involved by suggesting he might take an open-ended trip back to Brisbane.
The only certainty was this: suddenly everyone, including Daniel, was lawyered up, and everyone was pointing fingers at everyone else. It was Jim McIngvale who proposed a peace dinner at Del Frisco’s Double Eagle Steakhouse, a Houston favorite. Located in the high-end Galleria shopping mall, it had the feel of a dealmaker’s paradise, with dry-aged steaks, dim if flattering lighting, leather banquettes, and, all-important in ultra-casual Houston, no requirement of a coat and tie.
Bud was out of town at a conference; Billy brought the affable Mishaun; Daniel brought his second in command, an electrical engineer by the name of Nick Greatrex, a pensive, bearded Australian who managed to be both warmer and quieter than Daniel. Jim brought Linda, though whether her role that night was as human shield or bad cop was not immediately clear. She wore a pair of unpretentious reading glasses atop her long blond hair, and, like her husband, jeans and a polo shirt embroidered with the Gallery Furniture name. Th
e McIngvales also had a son-in-law in tow whose dress and manner suggested more than a passing acquaintance with a solid MBA program.
At first there was a lot of friendly chitchat of the sort designed to flatter the most important person at the table, even if he was the host. There was, for instance, a discussion of an Arab sheik who was on his way to Houston to look at one of Mack’s racehorses for possible purchase. This was followed by much hilarity over some vibrating test beds Mack had given Billy and Daniel that hadn’t worked so well. Billy did an imitation of a man folded up in a shaking rollaway. “I told him not to do it,” Linda said, shaking her head at her husband in triumph.
Finally Billy reached down under his seat and pulled up a small black box with silver trim, a combination lock, and the word “Vaultz” stamped on it. He placed it atop the white tablecloth with the flair of the magician he was and opened it to reveal…the latest iteration of the Bivacor. This one was made of titanium with a brushed chrome-like finish, and sported four stubby legs protruding from a squat cylinder stamped with the Bivacor logo, a valentine-like heart inside a circle. It was at least 30 percent smaller than the earlier models, closer now to the size of a golf ball than, say, a baseball. If you didn’t know what it was, you might think it was some sort of car part that went somewhere around the air filter. When Billy challenged the tuxedoed waiter to guess its purpose, the young man looked panicky, like a kid who got called on when he hadn’t done his homework. “It’s gonna change the world,” Billy told him. Then he showed the Bivacor to the people sitting at the next table and told them the same thing.
Billy passed the Bivacor around the table and everyone held it gently, as if it were made of the finest crystal instead of hefty metal. He was, he said, beyond optimistic. Thanks to Mack and Linda, he added, they had been able to get twice as much done in two-thirds the time. Another calf implant was scheduled in two months, and soon they were going to take the first steps toward FDA approval by doing the required eight animal implants, each exactly the same. “How long will that take?” Linda asked, a crease forming between her brows.
“With the next $5 million we will start the GLP studies,” Billy said, moving on to discuss the standardized quality control system—good laboratory practice—the government required.
“Why does that take $5 million?” Mr. MBA asked, which was certainly a reasonable question.
Well, Billy explained with none of the testiness he sometimes showed his underlings, they would soon have to go out to other companies to get help refining the design for mass production. They needed input from software engineers, hardware engineers, experts in electronics to make it the best it could be. There would no doubt be many more refinements.
Billy was rolling now. You almost expected him to say, “Pick a card, any card.” It was a good time to bring up the bad news: they were running out of money when there was still so much more to do. “All I gotta do is get this across the goal line and then I’ll sit on the beach and play Words with Friends,” he declared—an unlikely scenario, particularly because he was in the process of talks with Johnson & Johnson, a topic that did not come up.
The large, sizzling steaks arrived, along with generous bowls of glistening creamed spinach, golden potatoes au gratin, colossal onion rings, and just about anything else that could be considered a required side dish in a steakhouse. The talk of calf experiments didn’t seem to diminish anyone’s appetite.
Across the table, Daniel looked thoughtful and sphinx-like. “What do y’all think of the name Bivacor-Timms Heart?” Billy asked, eyeing Daniel as he cut into his dinner.
“You get this thing to work, you can call it poop if you want,” Linda responded.
“I like the Biva-Cohn,” Billy cracked, keeping all the happy plates spinning. He chuckled, and everyone, including Daniel, smiled at him indulgently.
“You know,” Mack said, “they oughta do a reality show on you.” Then he turned serious. “Tell me,” Mack said, fixing his eyes on Billy. “How many lives is the heart gonna save?”
There wasn’t really a good answer to that question, but Billy punted, citing the number of possible recipients as “millions.”
Mack turned to fix a level gaze on Daniel. “Daniel, how much more money do you need?” he asked.
No time elapsed before the answer. “Four hundred grand a month for eighteen months,” he said, without a trace of anxiety. The Aussie was becoming more Texan by the minute.
Of course, Billy added hurriedly, they would need at least $15 million more for a human study. “And then,” he said, chewing furiously, “the value goes through the roof.”
In fact, he already had several other angels interested in investing. “I’ve been involved in a lot of projects,” he added. “I’ve never been involved in a project where everybody wants in.”
Linda’s face clouded up again. “What are the terms?”
“Exact terms as you,” Billy said with a shrug, cutting into his steak again.
“What are you valuing the company at today?” she pressed.
“Twenty million flat,” Billy said. A venture capital firm in Austin was desperate to invest. “They are pounding us,” he said.
Linda asked to see a budget sheet and a business plan for the next phase. “Try to find investors we approve of,” she said quietly.
Billy nodded, but something else was pinching at his enthusiasm. “It’s imperative that we have it in a person while Bud is still standing,” he declared, “it” being the Bivacor. Everyone nodded in agreement, and no one laughed.
There was no specific thing to point to, when it came to Bud’s aging. He seemed reasonably healthy. Often, when someone asked how he was, he would joke, “I’m better, thank you,” which made the person asking wonder what he had missed, which was usually nothing. Still, the stress of the regime change was beginning to take its toll, and on particularly bad days, Bud would give in to self-pity, claiming that his only remaining goal was to see the Bivacor through to human trials, a date he set for about two years hence.
And then, he got a call from Los Angeles on a spring day in March 2016. His beautiful daughter, Allison, forty-five, who was happily married with a young son and a daughter, had to have emergency surgery—doctors had discovered a tumor in her bowel. Rachel was already packing for California. Bud kept trying to pretend it was an ordinary day—working on an introduction for a new book about pumps (Circulatory Assistance and the Artificial Heart), telling a story about a medical conference in Moscow (“We’d present something, then the Russians would present something that looked like a high school science project”), but he couldn’t quite pull it off. It was as if his ability to compartmentalize was finally failing him, maybe a function of age, or something else.
There were interruptions from his assistant, Libby, who kept giving him updates as she continued trying to get him on the earliest possible flight. There were calls from a former student Bud had contacted for referrals for Allison. She was now a prominent surgeon who was also an author with her own TV series on the heart, which seemed to make Bud contemplate his own path once more.
He made it to California and refused to stay at the hotel, choosing instead to park himself at the hospital before, during, and after his daughter’s surgery. When Allison talked about her successful operation later, it was her father she talked most about—how present he was for her, checking her chart and her meds, asking the right questions, pushing for answers, making sure nothing went wrong. If he had missed so many years of her life saving others, he was certainly there for her now.
* * *
Despite Billy and Bud’s hopes, the team had one big hurdle to clear, the one that would forever distinguish the Bivacor from its competitors: a sustainable power source that functioned inside the body. The pacemaker, which regulated abnormal heart rhythms, was such a fully implantable device, to use the lingo of the medical professionals. But no LVAD w
as, as yet, and neither was the SynCardia artificial heart, that updated version of the old Jarvik-7. They all still required an external power source, a battery pack that recipients can tuck into specially designed shoulder bags. This situation was not ideal for several reasons. First, any tubes or wires going in and out of the body are prime sites for infection—just ask anyone who is stuck wearing a catheter. Second, the battery packs looked like any purse or man bag, especially to thieves. Jarvik recalled one patient who fell victim to purse snatchers, collapsing as soon as the drive lines in their bags were snapped away by the miscreants. Third, the batteries didn’t last long enough. A patient with a flat tire or any other minor inconvenience could suddenly find herself in a dire situation if she didn’t have a spare battery or enough time to get home to recharge.
The main reason an implantable power source doesn’t exist is that for decades there was no reason to develop one. A heart assist device that only lasted two years or so didn’t need a battery that could last for ten. Where was the incentive in that? But as the LVADs improved in durability, and particularly as continuous flow replaced pulsatile pumps, the need suddenly appeared on the horizon. Once Daniel and his team got closer to freezing the design of the actual pump—FDA-speak for Daniel to stop tinkering—they would have to start thinking about new ways to power his invention. The optimum solution, of course, would be something self-contained inside the body.
This was not a new idea. In 1967, before the implantation of the artificial heart in Haskell Karp, and long before Barney Clark was driven nearly mad by the pounding of the enormous air compressor keeping his heart pumping—that is, when faith in the artificial heart was still unshakable—the US government and several big engineering companies were certain they could find a way to power the artificial heart internally. The energy generator of choice? Plutonium-238.