UConn debuts procedure to restore bloodflow to leg
Maureen Marchetti was worried. A year ago, the 78-year-old grandmother from Rhode Island noticed her toes change color, first pink, then purple, then black “like ash.”
“They were burning and painful,” said Marchetti. “I went to the hospital to the foot doctor and they determined it was a vascular issue.”
After a lot of testing and a lot of “pain and suffering,” the doctors told Marchetti she had to have the toes on her right foot amputated. While she was recovering, her big toe on her left foot started to turn. UConn Health's doctors realized they were in a race against time to save her remaining toes and feet.
“The doctors said it was going to be very invasive on both legs,” said Marchetti of the procedure they initially wanted to use, describing being cut from “ankle to groin” to bypass the blockages in her leg arteries. “I was really fearful of it, but I knew I needed to have it done because I didn't want to lose my other toes.”
Marchetti needed the surgery, but there was a problem. She would be in the hospital for a while, and at her age, and as a former smoker and cancer survivor, the recovery period would be rough. Marchetti, who stays active with her grandkids and daily life, feared not being able to take stairs or walk very far.
That's when her doctors suggested a new procedure. The minimally-invasive surgery that routes blood around large blockages in the legs had just won approval by the U.S. Food and Drug Administration in June of 2023.
“She's the perfect candidate,” said Dr. Justin D'Addario an assistant professor of surgery at UConn Health in Farmington, whose team reached out to the company shepherding the treatment through the FDA trials. “They were really receptive and really ecstatic to see our appreciation for the technology.”
Marchetti is getting the new procedure done on Thursday. Doctors expect she'll be home by the weekend with a much shorter recovery period.
What’s bad about PAD
The new therapy treats peripheral artery disease, also known as PAD, a circulatory condition caused by blockages in the femoral artery, between the hip and the knee. The disease cuts off blood to the lower extremities.
D'Addario said that many people don't know they have it until its has progressed in severity. Patients typically feel heaviness, cramping, or pain in the lower leg, feet, and toes. Typically people won't seek help unless they notice poor circulation, extreme pain or weakness, or wounds that won't heal in the lower leg.
“They'll bump themselves and then three months will go by and the wound is still there,” D'Addario said. “Unbeknownst to them, they have either partial or complete blockages in the arteries going to their legs.”
The disease typically strikes people with diabetes, who are advanced in age and who have high blood pressure or high cholesterol. Family history of heart attack and stroke can also contribute to the illness. D'Addario said that it's caused by the same process that causes atherosclerosis near the heart.
“The coronary arteries are kind of small,” D'Addario said. Blockages in the leg arteries can be much larger, over a foot long, he said, adding: “Your body will naturally build up alternative pathways, natural bypasses. But there comes a point where if you continue to progress in the disease … your body just can't keep up.”
The standard treatment for this disease involves grafting a vein from elsewhere in the leg to produce a bypass, which carries a risk of heart attack or stroke. Other treatments expand the arteries from within, typically with a stent, or to try and drill through the blockage and allow the blood to flow. But D'Addario said that these other treatments weren't as “durable” as bypasses.
New treatment
The new treatment, called “DETOUR” created by Californiabased medical technology company Endologix, is different. Rather than massive surgery that opens up an entire leg, this new procedure routes a stent graft through a small incision and the bloodstream to a space in a vein located near the blocked artery.
“The vein and artery are stuck together,” said Dr. Matt Thompson, CEO of Endologix and a vascular surgeon. “The easiest route for the stent graft system is through the vein, it provides you almost a set of railroad tracks where you can feed the stent graft over the entire length of the artery.”
Using a small needle a surgeon enters the femoral artery from the groin above the blockage with a probe. Another probe enters the vein from below the blockage. The doctor makes a small hole in the artery, connecting it to the vein. A wire from the probe above the blockage is grabbed from below and a series of stents are gently guided downward past the blockage, through the vein, and then back into the artery below the blockage. This technique took about a decade to produce, Thompson said.
Thompson said that in order for the surgery to be effective, the patient needed to have wide enough veins, otherwise they would risk further complications. He said his company was working very closely with major medical centers to train surgeons in the new procedure.
“Most companies approach a therapy rollout in a different way to a product rollout,” he said, adding that Endologix had to work with receptive hospitals and doctors to train people in the particulars of the procedure.
Marchetti says that she is looking forward to a quick recovery and some peace of mind. She plans on taking a trip down to Virginia to see her sister later this year.
“I have so much hope. I don't have the fear I had before,” said Marchetti. “It's not like I have rose colored glasses on, I know everything is a risk … but I have faith in my team and hope that this will be the answer for me to save the toes on my other foot.”