New hope for sickest heart valve patients

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In an experimental procedure at Penn, doctors make an incision into the chest of Ralph Miller, 70, to access his heart.

An experimental heart valve that is inserted through veins or a small incision in the chest wall significantly reduced the death rate in patients with serious aortic disease who could not undergo open heart surgery, according to a study in the New England Journal of Medicine on Thursday.

The study, reporting on the results of a clinical trial of a so-called transcatheter aortic valve conducted at the Hospital of the University of Pennsylvania and 20 other U.S. academic medical centers opens the way for a major shift in the care of thousands of patients with severe aortic valve disease, medical experts said.

“This is a huge home run for these patients,” said Howard C. Herrmann, an interventional cardiologist at Penn, who along with heart surgeon Joseph E. Bavaria, led the Penn arm of the study. “I think it is a paradigm shift for how we are going to treat these high risk patients.”

The study tracked 358 patients who were deemed unsuitable for surgery for a year. Half got the experimental aortic valve, and half received standard treatment for inoperable cases – medications and often having their aortic valves opened with balloon angioplasty.

After a year, 30.7 percent of those who got their new valves had died compared to 50.7 percent of those patients who didn’t.

“There are few if any things in medicine that can reduce absolute mortality by 20 percent,” Herrmann said.

But the treatment is not without its risks, especially in the short term. 

The study found that in the first 30 days after their procedure, nine of the patients getting the valve died, compared with five patients in the standard treatment group. Moreover, during that first month, 12 valve patients suffered strokes — nine of them major — compared with three for the group that got the regular care.

And those patients who got the valve were also more likely to have vascular complications, such as blockages.

None of those findings were surprising, said Bavaria and Herrmann since the patients who got the valve had undergone significant medical procedures. Still, the early dangers would be important for patients to keep in mind if, as expected, the valve made by Edwards Lifesciences Corp. of Irvine, Calif. is approved for use in this country by the Food and Drug administration.

“It is an impressive trial and it is an impressive result,” said Harlan M. Krumholz, a Yale University cardiologist and director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation, who was not involved in the study.

Still, Krumholz said, before declaring total victory, it is important to note that the trial involved a very select group of patients who got the valves implanted by teams of the top surgeons and cardiologists at the some of the country’s most elite medical centers.

“This data is certainly strong enough to say here is a good alternative” for patients who cannot undergo surgery, he said. The short-term complications and deaths among this group of patients at these hospitals suggested that there might be problems when this becomes more widely available, Krumholz said.

“The translation of this finding into the general practice is going to have to be done with care, both in the selection of patients and the moving of competence to the physicians,” he said.

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