New device gives doctors better insight into leg artery blockages
Allegheny General Hospital surgeons are using a newly approved medical device to clear blockages in leg arteries as part of a program to speed technological developments to clinical use.
The device, called Pantheris, treats peripheral artery disease, in which plaque builds up in arteries and impedes blood flow. The device uses laser fiber attached to a catheter to help surgeons visualize and remove the plaque with more precision than prior treatments allowed, said Dr. Bart Chess, a vascular surgeon at the North Side hospital.
“Now we can actually look from within and directly see where the problems are,” Chess said.
Allegheny General started using the device in April as part of the plaque removal procedure, known as optical coherence tomography. The Food and Drug Administration approved the device for use in leg arteries in March.
Previous treatments relied on X-rays, Chess said. Doctors dyed blood and used radiation to identify blockages based on how the blood flowed through vessel segments. They then scraped the area with a catheter to remove the plaque. With less visibility than they have now, doctors scraped more of the vessel, risking scarring the vessel wall. Scarring hardens the vessels, which doctors think might be associated with recurrence of the disease.
“The hope is that by being able to directly visualize and directly treat the areas of the artery involved with the disease process, that we increase durability of our procedures and of our long-term outcomes,” Chess said.
Kyle Leibach, 50, of Franklin Township, Beaver County, was the first to undergo the procedure at Allegheny General. A Type 1 diabetic, Leibach had lost his smallest toe due to circulation problems. His big toe became badly infected in March and he feared it would be removed as well after antibiotics failed to improve it. Using the procedure, doctors found a blockage in his leg and removed it April 6. Leibach was up and walking around the next day.
“I thought it was just like getting a tooth pulled or something,” he said.
Allegheny General doctors received approval to start using the procedure through a Highmark Health initiative called VITAL, which aims to use treatments that have received FDA approval but are not yet commonly covered by insurers. Highmark owns the Allegheny Health Network hospital system, which includes Allegheny General.
A trial of 130 patients showed statistically significant improvement on tests for peripheral artery disease 30 days after the procedure. There were low rates of complications, including three dislodged clots and one pseudoaneurysm, an injury to the blood vessel wall. The FDA said in its review that the procedure was no more dangerous than standard treatments.
UPMC vascular surgeon Rabih Chaer said the hospital system has not yet adopted the technology.
“It’s perhaps promising, but I’m not sure we know for a fact that it improves outcomes compared to what we do so far,” Chaer said.
He said patient outcomes with the X-ray method have been good, and he would like to see evidence that the new technology is more effective than existing technology before switching.
The procedure has so far been approved only for peripheral artery disease in the legs, not other parts of the body. Among people who have it in their legs, the procedure is not always appropriate, Chess said. Peripheral artery disease is associated with risk factors including high blood pressure, high cholesterol, smoking, diabetes and family risk factors. Quitting smoking and better management of blood pressure or diabetes often are recommended before surgery, he said.
Peripheral artery disease can cause pain and numbness and increases the risk of coronary heart disease, heart attack and stroke.
Chess estimated peripheral artery disease in the lower extremities affects 40 to 50 percent of patients treated in the hospital’s cardiovascular unit. Nationally, the disease affects 8 million to 12 million people, according to the National Heart, Lung and Blood Institute.
Wes Venteicher is a Tribune-Review staff writer. Reach him at 412-380-5676 or [email protected]