May 8, 2024

Innovative New Treatment Helps Patients Avoid Leg Amputation

” Patients with enduring diabetes and extreme vascular illness in the foot itself typically have no other way to bring back sufficient blood flow to the foot to recover injuries. In the past, a bulk of these clients ended up losing their limbs,” he stated.
The strategy of arterialization of the veins was initially proposed over 100 years earlier, however it was not up until understanding that blood circulation needed to be directed into the foot veins that limbs were able to be conserved, Clair said.
An estimated 2 million Americans are coping with CLTI. About one-third of amputees become depressed or anxious, and numerous experience “phantom pain” in the limb that is no longer there.
Nearly half of amputees from vascular disease will pass away within 5 years.
The PROMISE II U.S. trial studied 105 CLTI patients (43% Black, Hispanic, or Latino) treated with the minimally intrusive system, created to bypass obstructed arteries in the leg and bring back blood circulation into the foot through the veins.
All clients were dealing with amputation prior to the procedure and had nonhealing wounds on their feet, typically called diabetic ulcers. Clair said amputation-free survival in the trial was 66% due to the fact that some of the patients expired without an amputation.
Researchers found that 76% of clients in the research study were able to keep their legs and had entirely recovered or recovery injuries 6 months post-procedure. Patient pain was likewise substantially decreased. Freedom from all-cause mortality was 87% at six months.
” As these clients tend to be elderly and progressively frail, the capability to do this through the skin uses the possibility to supply this treatment with a minimally invasive technique, providing quicker healing and lower danger for wound problems and less disability,” Clair said.
” Now most of these patients can have their limbs and their self-reliance conserved with this technique to even more lower the danger of amputation for clients with vascular disease,” he said.
Recommendation: “Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia” by Mehdi H. Shishehbor, D.O., M.P.H., Ph.D., Richard J. Powell, M.D., Miguel F. Montero-Baker, M.D., Anahita Dua, M.D., Jorge L. Martínez-Trabal, M.D., Matthew C. Bunte, M.D., Arthur C. Lee, M.D., Andrew S. Mugglin, Ph.D., Joseph L. Mills, M.D., Alik Farber, M.D. and Daniel G. Clair, M.D. for the PROMISE II Investigators, 30 March 2023, New England Journal of Medicine.DOI: 10.1056/ NEJMoa2212754.

The system is designed to bypass blocked arteries in the leg and restore blood flow into the foot through the veins. Credit: LimFlow
According to a multicenter study published in the New England Journal of Medicine, an innovative treatment has actually made it possible for more than 75% of patients with the most extreme type of peripheral artery illness to avoid amputation and retain their limbs.
An option to amputation called “limb salvage” for individuals with persistent limb-threatening anemia (CLTI) was stemmed from the PROMISE II U.S. medical trial, which assessed using LimFlow innovation in carrying out transcatheter arterialization of the deep vein system. The trial concluded recently, and its findings were formally showcased at the VIVA (Vascular InterVentional Advances) conference in Las Vegas.
” This treatment is the only choice for a subset of patients with severe vascular disease who are at risk for amputation of their limbs,” stated the studys co-principal detective Daniel Clair, MD, professor and chair, Department of Vascular Surgery.