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Lung Transplants Don't Help Most CF Patients

Only the sickest gain longer life, study says

TUESDAY, Dec. 4, 2001 (HealthDayNews) -- Most cystic fibrosis patients are better off keeping their diseased lungs than getting a transplant, say doctors at the University of Utah.

The doctors concluded that only the very sickest cystic fibrosis patients live longer after lung transplants. Healthier patients are no better off -- and even may be worse off -- after lung transplants, compared with patients who don't have the operation, the researchers say.

The scientists also found that the way people are chosen for lung transplants is inadequate when it comes to figuring out who will benefit most from the operation.

The findings, reported in this week's Journal of the American Medical Association, identify more than a half dozen clinical assessments that should be made before deciding whether a cystic fibrosis patient should have a lung transplant. Currently, only a patient's ability to exhale is used to determine who gets on the lung-transplant list.

Not performing useless transplants would save time, effort and money, the researchers say. A transplant costs about $120,000 and yearly medications and care cost $30,000, they say.

"This study is a giant step forward in the field. It is a very important paper that looks more rigorously at a complex issue that heretofore was often based on a single value, and people are more complicated than that. It helps quantify the impressions that I and other doctors have had, clinically, for a long time," says Dr. James Yankaskas, director of the adult cystic fibrosis program at the University of North Carolina (UNC) at Chapel Hill.

Cystic fibrosis, which affects about 30,000 children and adults in the United States, is a progressive genetic disease that causes the body to produce an abnormally thick, sticky mucus in the lungs, causing severe and life-threatening infections. The mucus also obstructs the pancreas, often prohibiting digestion. The disease has no cure, although improved medical treatments have increased the average life span of sufferers into the 30s.

Lead study author Dr. Theodore Liou says the findings provide much-needed information for cystic fibrosis patients facing a difficult decision.

"It helps answer the clinical question, 'What is the effect of lung transplantation?' A transplant gives hope to those with no option, but does it actually do what you want it to do?" he asks.

The answer seems to be no, except for the sickest patients.

Liou and his colleagues analyzed patient data from the Cystic Fibrosis Foundation from the years 1992 to 1997, during which time 468 cystic fibrosis patients received lung transplants. They divided the patients into five groups, from the sickest to the healthiest, and compared survival rates of patients who had transplants with patients who didn't.

The sickest patients, who faced less than a 30 percent chance to live more than five years, had the most encouraging survival rates after lung transplantation. Two-thirds of the 95 who had lung transplants were alive five years later compared with only 21 percent of the control group.

However, in the next sickest group, who faced a 30 percent to 50 percent chance to live more than five years, the outcomes for the 138 patients who had the surgery was the same as for those who didn't. After five years, only 50 percent of both the transplant patients and the control group had survived.

"This is the group where people might say 'I don't really want a transplant'," Liou says.

In the three healthier groups, whose five-year survival rates were 50 percent to 100 percent, transplant patients had much lower survival rates than those who did not have the surgery. For example, in the fourth group, in which five-year survival rates were 79 percent to 90 percent, 66 percent of the 89 transplant patients were still alive after five years compared with 85 percent of the control group.

"This was a stunning conclusion," Liou says, and it seems to indicate that "if you doing pretty well, you shouldn't have a transplant. If it's not broke, don't fix it."

In further analyzing the data, Liou found that the way cystic fibrosis patients are assessed for transplants should be buttressed by other information. The current method is called the Forced Expiratory Volume 1 (FEV 1). It measures the amount of air, after a full inhalation, a patient can blow out in one second.

Patients with a FEV 1 rating less than 30 percent of normal are considered likely candidates for transplants.

While Liou says the FEV 1 is the single best predictor of cystic fibrosis survival, it alone doesn't identify the sickest patients who would benefit most from lung transplants. Other criteria that should be considered include: gender, because women with cystic fibrosis usually are sicker than men with the disease; weight, because underweight patients usually are sicker; pancreatic function, because cystic fibrosis usually destroys the glandular organ, making digestion difficult; and diabetes, which makes sufferers sicker.

"This actually supports the way that we've been practicing at UNC," Yankaskas says. "[The researchers] have provided a logical set of observations and have done so much more rigorously than prior studies. This will help to quantify the data better."

He says because of the seriousness of lung transplant surgery -- "there is a 20 percent death rate in the first year after surgery" -- multiple assessments are crucial before recommending a patient for the operation.

Liou say while the study followed survival rates, it did not address the quality of life of patients with cystic fibrosis.

"I think people will take this [study] and talk about survival, but the other question is about quality of life. It's a very difficult thing to try to sort out," he says.

Currently, Liou says about 1,500 cystic fibrosis patients are on the list for lung transplants, a number he says that could be reduced to about 150 if his criteria were applied.

He says because the lung transplant list includes patients suffering from every kind of lung disease, the questions his study raises about the value of lung transplants for cystic fibrosis patients could cause some problems.

"There is no logical way to separate out the cystic fibrosis patients, and we have no [similar] models for other diseases, so I'm curious as to what the reaction will be by doctors dealing with other patients," Liou says.

What To Do

For more information about the disease, visit the Cystic Fibrosis Foundation. The National Institutes of Health provides a fact sheet on lung transplantation.

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SOURCES: Interviews with Theodore G. Liou, M.D., University of Utah School of Medicine, Salt Lake City; James Yankaskas, M.D., professor of medicine, director of the adult cystic fibrosis program, UNC at Chapel Hill; Dec. 5, 2001, Journal of the American Medical Association
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