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Hearts Recover With Combination Of Drugs And Device

Aside from heart attacks, heart failure is caused by heart valve disease, untreated high blood pressure, use of substances such as alcohol or chemotherapy drugs used to fight cancer, and from idiopathic cause -- that is, unknown reasons, Renlund said.
by Ed Susman
UPI Correspondent
Boston (UPI) Nov 01, 2006
British doctors reported Wednesday that the combination of a mechanical device and a cocktail of drugs reversed heart failure in a small group of patients supposedly suffering from "end-stage" disease. "These results are truly remarkable and dramatic," said Dale Renlund, professor of medicine at the University of Utah in Salt Lake City.

"Even though this group of patients in the British study did not include the largest group of heart failure patients -- people who have suffered a heart attack -- the study suggests there may be treatments for this group of patients as well," Renlund told United Press International.

"We can now say that end-stage heart failure is not necessarily end-stage," he said.

In the study, to be published in Thursday's edition of the New England Journal of Medicine, Emma Birks and colleagues at Royal Brampton and Harefield National Health Service selected 27 patients with end-stage heart failure to undergo treatment with a mechanical, partially implanted device that assists the left ventricle -- the pumping chamber of the heart -- to improve its function.

The heart pump device is imbedded into the chest and is connected to wires that attach to an external battery pack. Birks said that eventually, 15 patients were eligible to use heart drugs known to help "remodel" the heart toward a more normal size. In heart failure, the heart changes shape, expending and losing its ability to efficiently pump blood through the body.

After nearly a year of pharmaceutical treatment, four of the 15 patients achieved a remodeling of their hearts sufficiently to allow doctors to remove the assist devices. "This procedure is an extensive operation," Renlund said. "It requires opening the chest, so this is not a simple matter."

One of the 11 patients developed uncontrolled heart rhythm disturbances following the operation and died within 24 hours. A second patient succumbed to lung cancer more than two years later. Of the remaining nine patients, eight remained free of heart failure after four years.

"The cumulative rate of freedom from recurrent heart failure among the surviving patients was 100 percent at one year and 88.9 percent at four years after explantation of the device," Birks said. "The quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire score at three years was nearly normal."

Renlund said that the left ventricular assist device is only implanted into the sickest patients -- those who have an expected survival of less than 50 percent over the next two years. "We (currently) use these devices as a bridge to heart transplantation -- to keep people alive long enough for a heart to be found for them," he told UPI, "or as a permanent implantation because they are too sick or not eligible for heart transplant.

"Now," he said, "We have a new use: a bridge to recovery."

He said spontaneous recovery from heart failure occurs less than once in 20 cases, or less than 5 percent of the time. "Even considering they started with 27 patients, that means they have a 33 percent recovery in this study," he said. "That is simply remarkable."

Both Birks and Renlund said the small study reported in the journal has several limitations, including the lack of a control group to truly show that the treatment was the main factor in recovery.

The study also does not tease out which of the drugs in the drug cocktail may have been a main factor in the positive remodeling of the hearts. One of the drugs used in the treatment, clenbuterol, is available in Europe but not in the United States, Renlund said.

Renlund said clinical trials designed to answer some of these questions and to test the utility of clenbuterol are just getting under way.

In Birks' trial, patients who had heart attacks that caused heart failure were excluded. About half of the heart-failure cases in the United States are caused by patients with coronary artery disease.

Renlund explained that heart attacks cause scars on the heart muscle that cannot be repaired spontaneously with medicines used in the trial. However, he said that future use of stem cell or gene therapy or use of growth factors might be used in conjunction with the left ventricular assist device in the future to repair these failing hearts.

Aside from heart attacks, heart failure is caused by heart valve disease, untreated high blood pressure, use of substances such as alcohol or chemotherapy drugs used to fight cancer, and from idiopathic cause -- that is, unknown reasons, Renlund said.

Source: United Press International

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