ORLANDO, Fla. - For the first time, a miniature heart pump shows the potential to become a widely used, permanent treatment for many older people with severe heart failure. But can we afford it?
In a study of 200 patients, the new device increased by four times the number who survived at least two years compared with an older pump that had drawbacks limiting its use, doctors reported Tuesday.
However, the HeartMate II costs $80,000 plus $45,000 or so for the surgery and the hospital stay necessary to implant it.
"It will allow older people who are not heart transplant patients to stay alive but at a higher cost. It's all about who's going to pay," said Cleveland Clinic heart chief Dr. Steven Nissen, who had no role in the research.
Even now, "the amount of money spent in the care of advanced heart failure patients is extraordinary," said Dr. Robert Harrington, heart research chief at Duke University, which helped test the device. "These are societal questions - how much is too much?"
Study results were presented Tuesday at an American Heart Association conference and published by the New England Journal of Medicine.
About 5 million Americans have heart failure, which occurs when the heart weakens over time and cannot pump enough blood. Heart transplants are one solution. But few patients find a donor, and many are too old or sick for a transplant.
Left ventricular assist devices, or LVADs, can be implanted next to the heart to help it pump. However, current ones wear out too fast to be long-term solutions, and survival remains dismal - only half of patients live a year and only one-quarter live two years.
The HeartMate II, made by Thoratec Corp. of Pleasanton, Calif., is the first of a new generation of smaller pumps that push blood continuously rather than simulating a heartbeat as older pumps do. A wire from the patient's abdomen connects the pump to equipment outside the body - a small computer and batteries that the patient wears in a belt pack or harness.
The device was approved last year for short-term use in people awaiting a transplant. The new study tested it as a permanent therapy in people with severe heart failure who were not candidates for a transplant. The study was sponsored by Thoratec, and many study leaders consult for the company or rival device makers.
While other manufacturers make similar pumps, the study was the first large test of these new-generation devices as a permanent treatment.
It enrolled 200 severely ill patients as young as 26 and as old as 81. Two-thirds got the new device. The rest received an older HeartMate pump. After two years, 46 percent of those on the new pump and 11 percent of those on the old one were alive without having suffered a stroke or a device failure.
A cost-effectiveness study has not been done, but doctors hope the new device will prove cheaper by preventing the many complications and hospitalizations these patients endure now, said Duke's Dr. Joseph Rogers, a study co-leader.
There is a high death rate from the surgery or soon after it: 14 percent with the newer pump and 25 percent with the older one. Even so, most patients will still risk the surgery "because the alternative is worse," and far more perish without a device, said study co-leader Dr. Mark Slaughter, heart surgery chief at the University of Louisville.
It was an easy choice for Chuck Sixour, a retired school administrator in suburban Knoxville, Tenn.
"I'm 78. My heart's probably 90, but I feel 60, and the doctors tell me I look 60, mainly because I've been very active all my life," he said.
He received the new device in August 2007 as part of the study. And now? "You name it - I do it," he said. "I golf two or three times a week. I go shopping with my wife."
Many older people are healthy other than having weak hearts, said Dr. Alfred Bove, a Temple University heart specialist and president of the American College of Cardiology.
"There are so many of these people that would enjoy life if we could get them out of heart failure," he said.
Not all are old, either. Leonor Ortiz Childers, a 46-year-old lawyer in Durham, N.C., developed heart failure when she had to be treated for breast cancer while pregnant with twins. The federal Food and Drug Administration allowed her to receive a HeartMate II for emergency use a year ago.
Now, with four children under 4, the device makes it possible "to live a fairly normal life," she said. "Every day I can hug my children. And as long as I have that, I'm a happy woman."
On the Net:
Medical journal: www.nejm.org
Heart meeting: www.americanheart.org