HearMate II is yet to gain approval from the Food and Drug Administration (FDA), but the Barnes-Jewish Hospital in Missouri has implanted it in Wilson Guthrie, a 61-year-old man from Kansas, suffering from end-stage heart failure.
He has since left for home, with that experimental heart-assist device that keeps his heart pumping.
Hospital officials said it's the longest stay the cardiothoracic ICU has had, and that a lot of technology was used to keep Wilson Guthrie alive.
"We're very excited to see him go home," Guthrie's sister, Teresa Rico, a family practitioner, said. "He's a lot better."
Guthrie was waiting at home for a heart transplant. But when his condition "profoundly deteriorated" last fall, he was airlifted to Barnes-Jewish for a temporary mechanical heart pump, "to see if he would turn around," his physician, Nader Moazami, said.
"I told the family he has a 90 percent chance of dying," said Moazami, surgical director of the hospital's and Washington University School of Medicine's heart transplant and artificial heart programs.
First the regular mechanical pump was tried out. It is an external device that can only be used in an ICU and is intended to support a patient for a month or two. Over the next few months, his liver function and breathing recovered enough that Guthrie was ready for the next step. But what?
He was reconsidered for a transplant, but with his kidneys still in failure and with intermittent internal bleeding, he was disqualified. The temporary pump kept him captive to the ICU.
Guthrie's small stature made him unsuitable for larger heart pumps, which would not have fit into his body.
The only option was the smaller HeartMate II pump, which wasn't approved by the FDA, and Guthrie's insurance company wouldn't pay for it — initially.
Through a series of letters and phone calls to the FDA and Humana Health Care, Moazami was able to persuade them to allow the compassionate use of the experimental device for Guthrie.
"We had no choice with this gentleman," he said. "He was too healthy not to do anything, but he was stuck in the ICU."
Once the new device was implanted, Guthrie recovered remarkably. His kidney function and physical strength returned, and he got out of the ICU. He has not yet regained his appetite, but "given what he's been through, this is minor," Moazami said.
"He's got nine lives. I think we've used eight of them."
Barnes-Jewish doctors are familiar with HeartMate II because the hospital is one of the institutions participating in the clinical trial.
A small pump implanted in the body, it is attached to a half-inch cable connected to a battery pack that recharges it. It's mobile. Moazami said one of his patients in the clinical trial delivers pizzas.
The device will stay inside Guthrie, and he should do well, as long as it's durable — perhaps as long as five years. When it fails, he'll either get a replacement or be considered for a heart transplant.
Guthrie should be hoping to pull through, along with the physicians,not to speak of the HeartMate II manufacturers.