University Hospitals (UH) physicians believe a procedure they've developed has the potential to offer thousands of patients hope to retain their limbs.
In a study of 105 people just published in the New England Journal of Medicine, UH doctors said an experimental new therapy called transcatheter materialization has helped about two-thirds of their patients at greatest risk for amputation keep their leg.
An estimated two million Americans have vascular disease so severe they could lose a limb, according to UH.
For some patients with advanced poor circulation in their limbs current medical therapies to restore oxygen flow don’t work, and amputation above the ankle is needed to save their life.
Dr. Mehdi Shishehbor, president of UH’s Harrington Heart and Vascular Institute, said those who can't be helped by bypass surgery or endovascular revascularization procedures make up 20 to 30% of his patients. But he said a recently-discovered procedure can bypass blocked arteries in the leg and move blood through the veins to the foot.
“We are going to deal with the veins which are not diseased and make the veins become an artery and supply blood, oxygenated blood to the foot to heal the wounds,” said Shishehbor.
The procedure improved outcomes for a majority of his patients, who otherwise would have had to resort to amputation, he said.
"This is incredible because hope has arrived," Shishehbor said. "Seventy-six percent of the time utilizing this technology we can save their limbs and allow them to have their quality of life back, be able to enjoy their life, wear a regular shoe, be able to go to work."
Not only does the procedure save his patients from the psycho-social implications of amputation, it saves lives, he said. Nearly half of all patients with vascular disease will die within five years after amputation, said Shishehbor.
He said the study included a diverse group of patients. Almost half were Black, Hispanic or Latino because, according to Shishehbor, non-white people are disproportionally at risk of amputation compared to white patients.
He hopes it leads to FDA approval, but said the UH Heart and Vascular Institute will continue using the therapy as part of a new trial currently underway.
The study was funded by LimFlow, which developed the procedure.
