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posted: 11/4/2013 6:00 AM

Life with a new heart: Transplant patients survive thanks to new devices, drugs

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  • The HeartMate II was approved to keep patients healthy until transplantation. But the device theoretically could work for at least 17 years, according to the head of the company that makes it.

      The HeartMate II was approved to keep patients healthy until transplantation. But the device theoretically could work for at least 17 years, according to the head of the company that makes it.
    Image courtesy of Thoratec

  • An implanted device helped keep Chris Einhorn active for 17 months until she had heart transplant surgery in August. She was able to leave the hospital nine days after the operation.

      An implanted device helped keep Chris Einhorn active for 17 months until she had heart transplant surgery in August. She was able to leave the hospital nine days after the operation.
    Marvin Joseph/The Washington Post photo

 
By Arthur Allen, The Washington Post

In 1983, when Orlando Felice was 28 years old, a summer virus caused his heart to fail. For three months, the Baltimore accountant lay teetering on the edge of death until surgeons found him a new heart, from a 16-year-old girl who had died in a motorcycle accident.

Felice's operation was the third heart transplant performed at Johns Hopkins Hospital.

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Since then, side effects from his anti-rejection drugs have caused Felice to undergo a kidney transplant and numerous skin cancer operations. On the most important score, however, Felice has beaten the odds: He's had 30 years with a stranger's heart beating in his chest, making him one of the longest-lived heart transplant patients.

Contrast Felice's story with that of 63-year-old Chris Einhorn. Three decades after Felice's transplant, Einhorn was out drinking coffee at a Starbucks in Rockville, Md., when Johns Hopkins called to say her new heart was ready for her. That night she underwent surgery, and she left the hospital nine days later. Soon she was on her feet and playing with her grandson.

Felice and Einhorn are both success stories. But Einhorn was in relatively good health when she received her transplant, because for the previous 17 months her native heart had been getting a boost from a left ventricular assist device, or LVAD -- a machine that has transformed prospects for patients with serious congestive heart failure.

Increasingly, such devices sustain people, including most notably former Vice President Dick Cheney, who probably would have died before they could receive a transplant. And the support the devices provide often allows patients to recover faster after they do get a new heart. Felice, without use of an LVAD, had to spend a month in the hospital after his transplant.

As many as 500,000 people suffer heart failure in the United States each year. Yet the number of hearts available for transplant plateaued at around 2,500 in 1995. Medicine is getting better at transplanting hearts and the need for them is growing larger, but the number of organs available is static. So devices are filling some of that gap.

"The whole field is being dominated today and tomorrow by LVAD and artificial hearts, and is becoming a problem of engineering, miniaturization and, believe it or not, batteries," says cardiologist Michael Hess, who directs the Pauley Heart Center's heart transplantation program, one of the world's oldest, at the Medical College of Virginia in Richmond. "The next big breakthrough is going to come out of (engineering schools such as) MIT and not medicine."

He adds: "We can now take someone near death's door, put in a mechanical device, rehabilitate them over several months and improve their state of health, so that when they do have the transplant, they are in much better shape."

That was what happened to Cheney, who was indeed at death's door, his heart and kidneys failing, in July 2010, when he was rushed into surgery to receive an LVAD. It restored his health to the point that he was able to receive a heart transplant 20 months later, at age 71.

"I believed I was approaching the end of my days, but that didn't frighten me," Cheney writes in his memoir "Heart: An American Medical Odyssey," which he published this month with his cardiologist Jonathan Reiner. "If this is dying, I remember thinking, it's not all that bad."

Caring for the heart

Caring for the heart has many dimensions, including diet, drugs, stents and bypass surgery. But it used to be that transplantation was the only solution when a heart was beyond repair.

The first transplant was done in 1967 by South African surgeon Christiaan Barnard, who had learned much of his technique at the Medical College of Virginia. Transplantation was rare -- and post-transplant life expectancy was measured in months, not years -- until the early 1980s, when the FDA approved cyclosporin, an immunosuppressant less damaging to the body than anti-rejection drugs used up to that point. In 1994, the FDA approved the first ventricular assist device, and in 2008 the agency approved the HeartMate II, the current leader in the LVAD market, as a bridge to keep patients healthy until transplantation. Another popular LVAD is made by Heartware International.

The 10-ounce LVAD contains a finger-size pump that pushes blood through the heart. LVADs drive a flow of blood through the heart continuously rather than in pulses. As a result, the patient usually does not have a measurable heartbeat, because the device is doing most of the pumping that the heart once did.

"At the hospital they liked to call us the zombies," Einhorn said.

Use of these devices has expanded quickly. According to heart surgeons at three Washington-area hospitals, more than half of the patients who received transplants at heart centers in this area last year had previously gotten an LVAD.

In 2012, about 2,000 LVADS implantations were done -- a tenfold increase over 2006 -- and doctors say they expect the numbers to continue to sharply increase. A 2011 study suggested that 40,000 to 200,000 patients each year would benefit from either an LVAD or a heart transplant.

Ventricular assist devices -- in addition to LVADs, there are units that support the right ventricle, or both sides of the heart -- allow doctors to give transplants to older, sicker patients. When Felice got his new heart, 50 was the absolute upper age limit for transplant recipients, says his cardiologist Edward Kasper.

Now, the absolute limit is 75. Hearts are a scarce resource, and doctors are reluctant to put them into people who aren't likely to live very long. Cheney, who had suffered five heart attacks and undergone many surgeries, was one of the oldest patients at Virginia's Inova Fairfax Hospital ever to receive a new heart.

"Mechanical circulatory support has been a real game-changer," says Nelson Burton, chief of heart and lung surgery at Inova Fairfax. He says he implants twice as many LVADs as hearts these days, and "I'm sure that ratio will increase as the technology improves. We'll be putting in more and more of them."

Patients in search of a new heart face an uncomfortable reality: Most hearts become available when young people die of head trauma, usually through homicide, suicide or car wreck. Medicine is getting better at keeping such patients alive, which decreases the number of hearts available for transplant.

The future

Given this fact, the future points to a device industry making gadgets that guarantee longer lives without transplant.

In 2012, 40 percent of LVAD recipients got their devices as "destination therapy," meaning they are permanent implants. Already, many LVAD recipients don't expect ever to receive a heart transplant. Some recipients of the HeartMate II have lived with it for eight years. The device theoretically could last in a patient for at least 17 years, according to Gary Burbach, chief executive of Thoratec, the Pleasanton, Calif., company that makes it.

A small percentage of LVAD patients have had the devices removed after their native hearts recovered sufficient function following a period attached to the pump.

Using the device has drawbacks, including an increased risk of infection and blood clots.

Edward Baldwin, a 64-year-old retired Navy man living in Portsmouth, Va., received an LVAD at the VA hospital in Richmond in February 2012 after many years of heart trouble. But the device caused intestinal bleeding, he said, and he required blood transfusions every four or five days until he received a transplant five months later. Since then, Baldwin says, he has been doing better.

At best, the device is burdensome. Patients must carry a sling holding a power module and eight pounds of batteries that require recharging after a maximum of 14 hours; the patient is hooked up to a wall power unit at night. To prepare for a shower, patients with LVADs must carefully wrap themselves in plastic to guard against infection from the electrical leads that pass through their abdomens.

But a heart transplant also has medical and psychological costs.

Chris Einhorn was happy to get rid of her LVAD gear when she got her heart transplant in August, but adjusting to someone else's heart has had its ups and downs. Using the LVAD meant having to take a blood thinner but no immunosuppressants. Now she is on an antiviral drug required to prevent rejection of her new heart, as well as three types of immunosuppressants that cause tremor, indigestion and emotional swings.

She had to be taken off a heart medicine that led to muscle spasms, and she is monitored daily to check her blood pressure, weight and signs of incipient diabetes, a frequent side effect of her high-dose steroid use.

Einhorn, a well-informed and careful patient, says she's been doing well on the post-transplant drugs but finds it's a "mixed emotional bag" to be running on an organ that belonged to someone who died tragically.

"For the most part, I am thrilled to be a recipient. I thank my donor every day," she says. "It makes you sad and happy at the same time, and very, very, very thankful."

All Einhorn knows about her donor is that she was a 30-year-old woman living about two hours away by plane. "She had to have been, no matter what her circumstances, a good person. That's all I know," Einhorn said.

Implant to transplant

For some patients, moving from an implant to a transplant would require too large a trade-off.

Laura Huber of Aberdeen, S.D., received an LVAD in 2007 at age 26, after a virus or autoimmune reaction attacked her heart. She doesn't want a transplant, at least for now.

"The device won't necessarily last forever," said Huber, who works as a physical therapist in a cardiology ward. "But the risks of a transplant, based on how well I've been functioning for almost seven years -- I don't see enough benefit to it."

Huber's heart, like those of many VAD patients, continues to function at a minimal level, and she feels there's a glimmer of hope it will recover enough to have the device removed someday. Or perhaps, some years down the road, she can get an improved version of her current device.

"I can't swim or do contact sports. I can't sit in a hot tub. But I play golf instead of basketball, and I don't really feel limited physically," she said. "I'm anxious about a transplant. I feel that my native parts give me a longer chance of survival, or at least of not rejecting a new organ."

The next generation of pumps will use maglev technology and hopefully will lower the risk of blood clots, rejection and infections, according to Thoratec officials.

But the holy grail for Huber and other patients -- as well as the device manufacturers -- is a pump that would have no external wires, no external battery pack.

Thoratec in 2012 licensed wireless electricity technology that would allow pump batteries to be charged through the skin. Burbach, the company's chief executive, says the device could be ready "within a few years." Others expect it could take at least a decade.

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