Patient Dies Nearly 5 Months After Getting Mechanical Heart

Robert Tools, the first person to receive a fully implantable artificial heart, died Friday, hospital officials in Louisville, Ky., said.

Medical experts quickly hailed the retired telephone company worker as a pioneer whose unexpectedly long survival with the titanium and plastic AbioCor heart could open the way for treatment to extend the lives of thousands of desperately ill patients.

Tools’ death in no way means the experiment failed, said Dr. Mehmet Oz, director of the cardiovascular institute at Columbia Presbyterian Medical Center.

Indeed, Tools’ doctors noted that the heart continued to beat flawlessly even as he died. Tools’ death was attributed to complications caused by a long-standing problem of bleeding in his stomach, they said.

“This is an experiment, and it’s imperative that the public recognize that,” Oz said.

“As we push the frontier, we have a few brave explorers--not just the physicians, but the patients themselves, who are willing to take chances,” he said.

Each year, at least 50,000 people in the United States need new hearts, but only 2,000 to 2,400 hearts are available for transplant. A reliable artificial heart--along with other mechanical devices that assist the heart’s ability to pump--could potentially save many patients waiting for transplants who would otherwise die.

“Mr. Tools and his family members are heroes,” said Dr. Robert Dowling, one of his physicians. “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.”

When they implanted the experimental heart, Tools’ doctors at Jewish Hospital in Louisville said they did not expect him to survive more than a few weeks. The Food and Drug Administration, in approving the first tests, had determined that these early experiments would be considered successful if a patient survived two months.

But Tools survived just a few days short of five months--recovering well enough to hold a short nationally televised news conference and make frequent day trips out of the hospital, including one well-publicized lunch in early November with Louisville’s mayor.

Doctors will need more experience with the AbioCor before they will know if it holds up to its early promise and what risks it carries for complications like strokes, said Oz and Dr. Hillel Laks, chief of cardiothoracic surgery at the UCLA School of Medicine and the principal investigator for UCLA’s AbioCor program.

But so far, the heart appears to perform extremely well.

Four other patients who have received the heart, including another in Louisville and one at UCLA, continue to do well with it. A sixth patient died during surgery.

At UCLA, the 74-year-old patient who received an AbioCor heart Oct. 17 is making progress, Laks said.

“He’s mentally sound and interacting very well with his family,” Laks said.

The FDA recently approved the next five of planned 15 implants.

“We fully anticipate that we will proceed,” said Edward Berger, a spokesman for Abiomed of Danvers, Mass., the company that makes the AbioCor.

Under FDA rules that govern experiments with the AbioCor, patients are eligible for an implant only if they are very sick with no options left. That rule has led to some debate about whether the device is being given to patients who are too sick, said Oz.

“You always tread a fine line between using a device on end-stage patients who will therefore have complications and problems, and using them in healthier patients who may then develop unforeseen complications,” Laks said.

Tools, 59, a Franklin, Ky., retiree, had endured several heart attacks and quadruple bypass surgery in the 1990s and was suffering from end-stage heart failure. He had diabetes, and his poor health was more than enough to make him ineligible for a heart transplant.

In June, his cardiologist showed him an article about a new artificial heart called AbioCor. Tools traveled to Louisville to be evaluated, and on July 2, under a veil of secrecy, the heart was implanted.

Tools’ condition slowly improved and on Aug. 21, the public got its first glimpse of him at the news conference--a frail man who spoke of the strangeness of having a whirring heart.

“I can sit at home and die or come here and take a chance,” he said at the time. “I decided to come here and take a chance.”