Executives at Jewish Hospital in Louisville, Ky., insist their visions of the hospital becoming a "Mayo Clinic of the South" did not die last month with Robert Tools, the world's first recipient of a self-contained artificial heart, nor with two others who have died at other hospitals during clinical trials of the device.
Jewish Hospital officials, who spent millions to ensure that the 442-bed facility would be the first to host the transplant, said the death of 59-year-old Tools on Nov. 30 did little to detract from the historic procedure that provided Jewish with worldwide attention and acclaim.
So far, the AbioCor artificial heart has been implanted in six patients in five hospitals involved in a clinical trial approved by the U.S. Food and Drug Administration. Three of those patients have died. One patient bled to death during an implant operation at the Texas Heart Institute in Houston, three days before Tools died. Then earlier this month, a 74-year-old patient died of multiple organ failure at UCLA Medical Center, after living 56 days with the plastic and titanium device.
David Lederman, M.D., chief executive officer of Abiomed-the technology firm that developed the device-said he remains confident that "the AbioCor will prove to be a replacement heart that can provide both significant life extension and good quality of life for heart-failure patients who would otherwise have no hope."
Jewish Hospital officials said the landmark procedure was an unqualified success, bolstering the hospital's reputation and providing Tools with several months of life he otherwise would not have enjoyed.
"Being first always gets the most attention," said Linda McGinity Jackson, spokeswoman for Jewish Hospital. "What's important is the success. We believe the first was successful. Some might say, `How can you say that? The patient died.' Well, he lived five times as long as he would have without that device."
Tools' death last month from abdominal bleeding and organ failure attracted scant attention compared with the nonstop media coverage that followed the groundbreaking implant operation on July 2.
What changed in between? Sept. 11. The terrorist attacks changed the priorities of a national media far more focused on America's new war than on developments in medical technology. A second artificial heart was implanted at Jewish just two days after the attacks in New York and Washington. It was barely noticed.
"Jewish Hospital was dealing with the first (operation of its kind)," said Edward Berger, vice president of strategic policy and planning at Abiomed, Danvers, Mass., which spent nearly $60 million developing the device.
"Remember the date of the second operation? It was Sept. 13. Jewish did the first one and the second one-and the only one that was done before this enormous, overarching national political and media crisis, which has done an enormous amount to deflect attention away from subsequent implants."
Jewish Hospital had committed about $8.2 million in a concerted effort to host the procedure, burnishing a growing image as a regional leader in high-tech medical care. Hospital officials made no secret of their long-range effort to transform the hospital into a world-renowned facility (Sept. 10, p. 29).
Describing Tools as a "pioneer," Jackson said the positive impression about both the patient and the hospital will be reflected in the fact that the clinical trial of the mechanical heart will eventually reap rewards "in the years to come."
Jackson attributed the drop-off in media attention to the events of Sept. 11 and also to the "respect level that comes with dealing with death."
Tools, suffering from end-stage heart failure and barely able to summon the strength to lift his head in the days before the operation, stood an 80% chance of dying within 30 days without the mechanical heart, surgeons said at the time.
And the mechanical heart itself, which costs about $75,000, was not to blame for Tools' death. He succumbed to complications after bleeding in his abdomen. Officials said the artificial heart performed flawlessly, beating more than 20 million times in the five months it rested in Tools' chest.
"The fact that Mr. Tools died of abdominal bleeding, after 151 days of support (from the AbioCor device) is, from the perspective of the clinical trial, in fact a very positive result," Berger said. "It's not a result we're happy with, but from the perspective of the trial, Mr. Tools' experience will not have an adverse effect on the process of bringing AbioCor to commercial distribution."
Like Tools, other patients in the AbioCor trial are so desperately ill they don't qualify for regular heart transplants and are given little chance of surviving more than a month or so without the device.
"Mr. Tools and his family are heroes," said Rob Dowling, M.D., one of two University of Louisville transplant surgeons who performed the first procedure at Jewish. "Their willingness to be the first to participate in the AbioCor clinical trial could potentially pave the way for a revolutionary treatment option for advanced heart disease."