New treatment offers hope to patients who have aortic stenosis
By Luis Fábregas
Published: Saturday, Dec. 31, 2011,
Paul Weaver's shortness of breath became so severe that he had to give up his job as a machinist.
"I was coughing constantly," said Weaver, 67, of New Alexandria. He began using oxygen at home. "I couldn't do a lot of the strenuous things I was used to doing. It was just getting too tough."
In addition to lung disease, Weaver suffered from aortic stenosis, an illness that caused the main valve of his heart to calcify and thicken. The disease afflicts more than 100,000 people in the United States, with symptoms such as chest pain and fatigue. Doctors can treat it by inserting a heart valve using conventional open-heart surgery.
Doctors at UPMC Presbyterian in Oakland told Weaver that his condition was too serious for the surgery. Instead, they encouraged him to enroll in a trial of an experimental heart valve implant called CoreValve, manufactured by Minneapolis-based Medtronic Inc.
The CoreValve comes with a key advantage: An interventional cardiologist can place it without opening the chest, avoiding potential complications in elderly people.
"We're seeing the sickest of the sick," said Dr. William Anderson, director of interventional cardiology at UPMC. "Many of them are over 80 years old and have had bypass surgery. A lot of them have heart failure. Opening up the chest can be a great insult to their bodies."
The valve is placed in the body by using a catheter in much the same way that doctors place heart stents to open clogged arteries. They insert the catheter through the femoral artery in the groin or the subclavian artery near the neck. It requires an incision smaller than 2 inches.
Weaver received the valve in February during a procedure performed by Anderson and Dr. Thomas Gleason, a cardiothoracic surgeon. The day after his surgery, Weaver was able to get out of bed, and his doctors released him in three days.
"It was like they didn't do anything, and I felt so much better," said Weaver, now working again as a meat wrapper for Giant Eagle. "I had a small scar in my groin area, and that was it."
The CoreValve is the second such device tested in the United States. Though its cost is undetermined because it is investigational, similar devices cost up to $35,000. The Food and Drug Administration last month approved another called Sapien, manufactured by Edwards Lifesciences Corp. Doctors in Europe have used both devices for nearly a decade.
Doctors at UPMC and at Allegheny General Hospital in Pittsburgh's North Side are preparing to use the Sapien valve. Medtronic won't make the CoreValve device commercially available in the United States until the clinical trial ends.
Federal regulators are trying to determine which Medicare patients will be covered to receive the valve, said Dr. Stephen Bailey, director of cardiac surgery at Allegheny General.
"We see a tremendous number of people with aortic stenosis," Bailey said. "This new technique is very appealing."
Despite its benefits, some doctors caution that the device carries substantial risks such as bleeding or the potential for strokes, said Dr. Bruce Rutkin, an interventional cardiologist at North Shore University Hospital in Manhasset, N.Y. In Europe, up to 20 percent of patients had to use pacemakers after getting the device, according to published studies.
"This procedure does carry risks, but we're hoping that by avoiding opening the chest and putting the patient on a heart-lung machine, we'll minimize some of the potential risks," said Rutkin, co-investigator of the trial in New York.
Anderson said it's too early to tell whether the valve has potential to become standard treatment, but he believes its benefits outweigh the risks. Most patients with aortic stenosis are older, and the device could extend their lives.
"If they do well for five years, that's good," Anderson said. "If they do well for 10 years, that's a home run."Additional Information:
UPMC is one of 40 U.S. hospitals testing a valve for patients with severe aortic stenosis.
Researchers enrolled 21 patients in the study and hope to get 30 more.
For more information, call 877-412-8258 or e-mail ValveCenter@upmc.edu .
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