Raising chances for new heart

The Baltimore Sun

If your heart is failing, your chances of getting a new one might hang on whether your local transplant center concludes that you're too old, too fat or too sick to qualify for a precious donor heart.

If you're turned down, you can shop around and might get a more sympathetic hearing at a hospital in another city, or even across town.

Critics say the criteria that hospitals in Baltimore, across the country and around the world use to select patients for life-saving transplants are inconsistent and sometimes arbitrary - with too little foundation in current science.

"A center in the South can say, 'We're going to transplant all diabetics,' while a center 400 miles up the coast says, 'Absolutely not, we won't transplant any diabetics,'" said Dr. Mandeep Mehra, head of cardiology at the University of Maryland Medical Center. "If each center has this power ... is it truly ethical?"

That's why he agreed to lead a task force, assembled by the International Society for Heart and Lung Transplantation, to write the first set of uniform, science-based guidelines for selecting transplant patients.

Wherever they are adopted by hospitals and insurers, the proposed standards would make new hearts available to more patients over 65, and to more diabetics and cancer patients, among others.

The guidelines were published last month in the society's Journal of Heart and Lung Transplantation.

At the current level of heart donations, the new guidelines could allow doctors to save at least 300 more lives a year, Mehra said.

Dr. Stuart D. Russell, clinical chief of heart failure and transplantation at the Johns Hopkins Hospital who co-authored the guidelines, expects as many as 15 additional transplants per year in this region - which stretches from Northern Virginia to southeastern Pennsylvania.

Under the old standards, some centers might have rejected Tim Heffner as too sick for a heart transplant. The 56-year-old customer services manager from Westminster had heart failure linked to blocked coronary arteries and a heart attack he'd suffered at 41.

He also had blocked arteries and was disabled by a stroke in 2000, induced by a chronic heart arrhythmia.

When he sought help at the University of Maryland Medical Center for arrhythmia, doctors there told him he needed a new heart, and by early this year, they were giving him just six to eight months to live.

But the UM Medical Center already has a transplant policy close to the new guidelines. After extensive tests, the UM transplant team decided that if they could restore proper blood flow to his gut, fix the arrhythmia and get a better handle on his future stroke risk, he could become a good transplant candidate.

So they did.

"When they're at that end stage ... we want to do everything we possibly can to make them into better candidates, and that may mean pushing the envelope a little bit," said Dr. Erika D. Feller, UM medical director for heart transplantation.

In March, Heffner received a heart he believes is from a donor in his 20s. "I can do pretty much anything now," he said. "I don't get winded going up steps like I used to. I would say I'm fairly fit for a man my age."

Best of all, he said, he lived to see his first granddaughter, born last month.

The new, expanded guidelines aren't mandates. But Mehra expects the International Society for Heart and Lung Transplantation's influence in the medical community to lead to their adoption over the next three years by hospitals and - perhaps more importantly - by health insurers.

Not everyone agrees.

"Those are just guidelines," said Dr. David Vega, director of the heart transplant program at Emory University School of Medicine in Atlanta. "Each program is still going to go and do what they think is best for their patient population and their program."

Besides, he added, "I think most of those things are already common practice, to be honest." Emory, for example, increased its heart transplant age limit several years ago, from 65 to 68.

But Russell, who came to Hopkins recently from Duke University's transplant program, found Hopkins "a much more conservative place" than Duke in selecting transplant candidates. "There are other centers much more along the Hopkins mode that will expand their criteria based on this," he said.

And as word of the new guidelines gets out, he said, community hospitals and primary care physicians will begin to refer more patients for transplants.

How a hospital chooses patients can have legal as well as medical complications. For example, a center's decision on whether to follow such guidelines is sometimes cited in lawsuits when a transplant turns out badly, Mehra said.

But he noted that the guidelines are not legal mandates, merely suggestions to be weighed against other considerations. "They ... don't often turn out to be the sole clincher of a decision," he said.

Heart failure is a progressive disease. Hearts weakened by high blood pressure, coronary artery disease, valve damage and other conditions increasingly lose their capacity to pump enough blood to the lungs and other tissues.

Patients weak and breathless enough for a transplant generally have only a 50 percent chance of living another year without it, Mehra noted. But after a transplant, the odds are 50-50 that they will live 10 more years.

"There's not another therapy in cardiovascular medicine that increases survival tenfold," he said.

As of Oct. 6, there were 2,869 people on the waiting list for a new heart in the United States, according to the United Network for Organ Sharing. Last year, 2,125 patients received new hearts - and 416 died waiting.

UNOS allocates scarce hearts among transplant centers based on such considerations as heart size, tissue type, location, urgency and a patient's time on the waiting list. But to get on the list in the first place, patients must be approved by panels of doctors, social workers, psychologists and others at transplant centers - each with its own policies.

The International Society for Heart and Lung Transplantation panel said those decisions should ensure that scarce donor hearts go to people "most likely to benefit, both in terms of quality of life and survival."

"Typically they're based on the experience of the team that is transplanting at that institution, plus checks and balances placed by insurance carriers," Mehra said.

Ideally, medical advances and clinical findings should spur policy revisions at least once a year, Mehra said. But "that process is really weak. In fact, most people just rehash the current written policies and move on."

As a result, critics say, selection criteria become outdated and inconsistent. According to Mehra, ISHLT guidelines released in 1992 were revised in 1997. But the updates were not research-based and never gained traction.

"Much has changed in the field of heart failure and transplantation in the last 15 years, and it was time we sat down and really discussed all our listing criteria," he said. "ISHLT is uniquely privileged to be a society that could promulgate a guideline that is truly international."

The society established three task forces. Mehra's developed the new guidelines for transplant eligibility. The others drew up criteria to improve the care of transplant patients so that more survive to get a new heart or, in a few cases, avoid transplants altogether.

Where hard scientific data was unavailable, the panels arrived at a consensus and clearly labeled their recommendations as such.

For example, the old ISHLT guidelines cut off transplant eligibility after 65 because studies linked advancing age to increased post-transplant mortality. But older patients take better care of themselves, and experience has shown many do well with new hearts. So the new guidelines extend the age limit to 70.

Under the old cutoff, Thomas B. Edwards of Hagerstown would have been passed over. The retired Army personnel manager and father of four was 66 in January, when he found himself increasingly short of breath.

By July, he was on heart drugs and oxygen, and had to be propped up in bed to breathe. And Russell, his Hopkins cardiologist, told him he needed a new heart. "That was the biggest shock I've had," Edwards said. "I never thought it could happen to me."

But in the spirit of the new guidelines, no one on the transplant team brought up his age. Since he was otherwise in good shape, he made the Hopkins' transplant list and got a new heart July 30 - after a wait of only five days.

"It feels great," Edwards said recently. He's no longer short of breath, and, while he takes up to 25 pills a day, "I can now drive, which is the best thing that's happened," he said.

The new ISHLT guidelines even open a door for patients over 70. Transplant centers are urged to make them eligible for "older" hearts. Mostly from donors 50 or older, these organs account for up to 23 percent of the hearts offered, but they're usually rejected as too old.

"We think dropping those hearts is crazy," Mehra said. Clearing out any clogged coronary arteries and making them available to patients over 70 would save at least 300 more lives a year, he said.

Obese patients, too, are often considered bad transplant risks because they're more likely to reject their hearts or die after transplants. Until the new guidelines there were no standards for how fat is too fat.

The new guidelines still draw the line at the "morbidly" obese - patients with a body mass index of 40 or more, or roughly 100 pounds above the ideal weight for one's height and sex.

But the guidelines also expand eligibility for patients with a BMI of 30 to 39, if they can lose enough weight to bring their BMI to 30 before surgery. That's about 200 pounds for a man 5 feet 8 inches tall, or about 170 pounds for a 5-foot-3 woman.

Most cancer patients had to be in remission for five years under the old transplant guidelines because doctors feared the cancer would return, perhaps spurred by the drugs that fight organ rejection.

Mehra's panel found such policies arbitrary because many cancer patients receive immunotherapy without triggering a relapse, and new cancer therapies are more effective. So the new guidelines advise doctors to consider the type of cancer and the longer life expectancies possible with advanced treatment.

Diabetes is another issue. About 97 percent of transplant centers have reported good results with diabetics whose condition is controlled and relatively free of advanced complications such as kidney, nerve and eye damage. The panel recommends transplants for them. Even some patients with kidney failure should be considered for a new kidney along with their new heart.

But cigarette smokers and alcohol or drug abusers should be passed over unless they are successful in quitting well before surgery, and closely monitored afterward.

The expanded guidelines will increase the demand for already scarce donor hearts, Mehra said. But the ISHLT task forces detail the optimal use of new drugs, pacemakers and implantable defibrillators to prolong the survival of heart failure patients, helping more of them delay or avoid transplants entirely.

"We are no longer seeing transition to late-stage heart failure in a majority of patients as we were 10 years ago," Mehra said.

"Many people you previously thought absolutely should be listed for a transplant, should not be," he said.

frank.roylance@baltsun.com

The new heart transplant guidelines are posted at www.ishlt.org.

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