Research shows minimally invasive procedure saves most patients with severe vascular disease from amputation
A study published in the March 30 issue of the New England Journal of Medicine has shown that there may finally be an alternative to amputation for patients suffering from chronic limb-threatening ischemia (CLTI), the most severe form of peripheral artery disease. This study, co-led by University Hospitals (UH) Harrington Heart & Vascular Institute, could lead to the first FDA approval of a therapy giving thousands of patients hope for an alternative to limb loss.
The PROMISE II U.S. pivotal clinical trial found that minimally invasive LimFlow therapy enabled most patients to avoid amputation and experience wound healing. The procedure is designed to bypass blocked arteries in the leg and rush blood back into the foot through the veins.
In the paper entitled “Transcatheter Arterialization of the Deep Veins in Chronic Limb-Threatening Ischemia: The PROMISE II Multicenter Prospective Study,” investigators evaluated 105 CLTI patients who were treated with transcatheter arterialization of the deep veins (TADV) using the LimFlow therapy. All patients were facing inevitable amputation before the procedure. At six months post-procedure, 76 percent of patients were able to keep their leg (also called limb salvage). Within the same time period, 76 percent of patients had completely healed or healing wounds. Freedom from all-cause mortality was 87 percent at six months.
