Technology wasn’t the only problem. “The symbolic meaning of the human heart seems to carry people away, and blind those involved to what the obstacles are,” says Rene Fox, a medical anthropologist at the University of Pennsylvania. In her 1992 book Spare Parts, Fox chronicled how the combination of technological shortcomings and surgical zeal led to the Jarvik-7 fiasco.
Since the ’80s, the artificial heart has struggled to survive-and has gotten caught up in a battle between politicians and NIH leaders. In January 1988, spending legislation required NHLBI to award $22.6 million to four contractors (including Abiomed) to design and build a totally implantable artificial heart. NHLBI officials, citing inadequate technology, canceled the contracts a few months later, only to reinstate them when Sens. Ted Kennedy and Orrin Hatch (both of whom had constituents working on the project) intervened. Since then, the program has been moving ahead with little fanfare-but under suspicion that politics, rather than science, is driving it forward.
By now NHLBI has thinned the field from the original four to just two teams: Abiomed and Pennsylvania State University (whose heart is similar to Abiomed’s in conception, but different in detail). Each team has received approximately $13 million from NHLBI so far, placing them ahead of less-well-funded efforts at universities in Europe and Japan. In 1997, Lederman says, his technical staff and advisors concluded it was time to start putting Abiomed’s own money behind the project, separating it from the academic pack and moving ahead of the NHLBI schedule (at Penn State, researchers don’t expect clinical tests before 2001). In 1998, Abiomed poured $10 million into the PulsaCor project, and this year Lederman expects to spend even more.
For the time being, Abiomed doesn’t have any commercial competitors. The artificial heart’s daunting engineering challenges, combined with its troubled public image, says Victor Poirier, CEO of Waltham, Mass.-based Thermo Cardiosystems, mean that “the only reason people have continued to work on the artificial heart is because the government paid for it.” Thermo dropped its own program years ago and, along with most of the field’s other players, has turned its attention to a simpler type of implantable pump known as a left ventricular assist device (LVAD), which aids a weak heart rather than replacing it.
The Food and Drug Administration (FDA) has already approved the use of the LVAD as a temporary “bridge-to-transplant” that helps patients in need of a human heart hold out until a donor organ becomes available. Bridge-to-transplant would be an obvious initial application of a total artificial heart, but because of ongoing negotiations with the FDA, Lederman won’t say if this will be the first use of the PulsaCor. Ultimately, he says, Abiomed plans to prove the artificial heart’s mettle as a permanent implant for the 315,000 Americans that he estimates die every year from sudden heart attacks and other types of acute heart failure that leave no time for transplants. “That is the bulk of patients that we have to deal with,” says O. H. Frazier, a top scalpel at the Texas Heart Institute and longtime Abiomed collaborator. “We had a 40-year-old who came in last night with a [heart attack] and basically his heart was destroyed. The only thing that could have saved him was a total artificial heart.”