Pulse Of An Artificial Heart
The first clinical trial of the artificial heart, the AbioCor, has made a slow but steady progress, reports The Early Show medical correspondent Dr. Emily Senay.
For Dr. David Lederman of Abiomed, the company that makes the AbioCor, the development of an artificial heart is the realization of a dream.
"There is no reason a person should die when their heart stops," says Dr. Lederman. "If the person's brain and the rest of the body's in good shape, why should people die?"
The AbioCor is completely contained within the body, powered externally through the skin. And for some, the artificial heart has worked well. Tom Christerson survived for a record 17 months before his death last week. Robert Tools and Bobby Harrison survived five months. James Quinn survived for ten months.
"Looking back at the clinical experience of the AbioCor, the results so far, far exceed any of our expectations," says Dr. Lederman. "We had not planned for some the early patients to be able to go home."
But the artificial heart is still a work in progress. Tom Christerson's AbioCor failed when a membrane within the device wore out. And the design has required modification to avoid blood clots that caused strokes in other patients.
"There is a structure, which we call the cage ... this could be sites of blood clots," says Dr. Robert Kung. "We have removed the cage, which we believe was a potential source of blood clot formation."
The hope is that someday the Abiocor will be an option for the 100,000 Americans who need heart transplants each year.
What would be the end of life if the device allows the heart to work forever?
"We really do not know until we do it," says Dr. Lederman. "There are people who live to be 100 and 110. And what we do know is that the endpoint of life is always defined when the heart stops. But, if the heart continues and is durable enough, we are going to have to redefine it."
Two unidentified recipients received the mechanical heart last month. Dr. Senay says the goal of the trial is to provide quality of life for patients as well as extending life.
However, one family filed a lawsuit against the company because they say the risks of the procedure were not fully explained. But, Dr. Senay reports that most of the men who received the heart have said they were grateful for the chance at longer lives.
The FDA has approved fifteen patients in the initial trials and, Dr. Senay says, there probably will be more patients this year if suitable candidates can be found. But, it will probably be at least five years or more before there are widespread trials.