At four U.S. medical centers, surgeons, nurses and anesthesiologists are quietly scrubbing in for the return of one of the most vilified medical devices ever conceived-the artificial heart. Each of the four teams was tapped a year ago by Abiomed, a little-known Danvers, Mass., company whose engineers have worked for more than a decade to build a 900-gram electromechanical pump they call the PulsaCor. Surgeons at the Texas Heart Institute and Massachusetts General Hospital, among others, are now practicing putting the synthetic heart into calves. David Lederman, Abiomed’s CEO, says they’ll be performing the surgery on a human before 2000 is out.
That first patient will, in all likelihood, already be dead. Lederman confides that Abiomed, moving cautiously, will seek permission to undertake a surgical dry run on a brain-dead individual on total life support. Before the doctors and nurses don their gloves, Abiomed’s recently convened board of ethical advisors will have spent months overseeing the selection of candidates. What’s more, Lederman has devised a complicated credit-sharing scheme to ensure that no single player steals the limelight of what he believes will be a “very visible” event. Even the decision to grant TR access to Abiomed’s engineers and facilities was a carefully considered media “test case.”
The reason for this extraordinary kid-gloves approach is the artificial heart’s troubled history. A one-time medical miracle, the device now resides on the short list of technologies American society has labeled “Just Not Worth It.” How it ended up there, alongside supersonic planes and nuclear power plants, is a story that dates back to 1982, when a University of Utah surgical team replaced the diseased heart of 61-year-old dentist Barney Clark with a device called the Jarvik-7. Powered by air cables running from a washing-machine-sized console into Clark’s chest, the pneumatic pump proved that a mechanical heart could sustain human life. Clark lived for 112 days. The second patient to get the Jarvik-7, William Schroeder, lived for an amazing 620 days.
If you call it living. Boston University bioethicist George Annas, an expert on human experimentation, says: “I talked to Bill…and he hated the artificial heart. There are things that are worse than death and this was one of them.” By the 21st day the device had infected Schroeder’s blood. For 420 days he had a fever. For 366 days, he was fed through a tube. Four times, Schroeder suffered strokes as hardened clots of blood that had built up in the heart broke off into his bloodstream. As the Jarvik-7’s deadly failings became plain, the media’s breakthrough hype turned to condemnation of a cruel and premature experiment.
Now, the concept a New York Times editorial once termed “The Dracula of Medical Technology” is back-and some old, thorny questions are back with it. Some say the government’s artificial heart program (which paid for Abiomed’s R&D until now) is a creature of politics, not science. Others fear another precipitate adventure by gung-ho surgeons. And many question whether a machine will ever amount to anything more than a misery-prolonging understudy for heart transplantation.
In Abiomed’s suburban labs a PulsaCor pumps away in a tank of salt water, hardly stirring the plastic balls that float on the tank’s surface to stop evaporation. The salt, which mimics the body’s corrosive effects on metal, is part of extensive lab testing to determine whether this titanium-and-plastic device can pump 160 million times without failing-enough to move the 2 million liters of blood a patient needs to live for five years.