Findings of Major Clinical Trial Support Inova’s Approach to Treating Critical Limb Ischemia

A recent clinical trial funded by the National Institutes of Health concluded that vascular bypass surgery offers better outcomes than endovascular techniques for certain patients at risk for limb amputation caused by critical limb ischemia (CLI). Vascular surgeons at Inova Schar Heart and Vascular (ISVH) helped to develop many of the CLI bypass techniques that are now being used around the world.

The study was called BEST-CLI. BEST is an acronym for Best Endovascular vs. Best Surgical Therapy. The results of the clinical trial were recently presented at the American Heart Association’s 2022 Scientific Sessions event and the 49^th annual meeting of the VEITHsymposium®, a week-long international gathering of vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists. The symposium is named after renowned vascular surgeon Frank Veith, MD.

“The results of the clinical trial showed that, for patients at risk for amputation who have a healthy vein in their leg that can be used for bypass, it may be better to begin with the surgical technique rather than a catheter-based procedure,” said Richard Neville, MD, Associate Director of ISHV, System Division Chief of Vascular Surgery and Chairman of the Department of Surgery, who was a speaker at the VEITHsymposium. “This finding is particularly important as endovascular techniques can change the type of bypass needed if the endovascular procedure does not work and make it more difficult to do the bypass later on.”

Ischemia is a serious condition in which there is inadequate blood flow and oxygen to various parts of the body. In the limbs, it can cause severe tissue damage, including skin ulcers and gangrene. CLI, an advanced form of peripheral arterial disease (PAD), is an urgent medical condition that brings significant risk of complications and death. Rapid diagnosis and treatment is required to restore blood flow to the extremity and prevent complications that could lead to amputation. PAD is also referred to as peripheral vascular disease.

The BEST-CLI clinical trial was a prospective, randomized trial of close to 2,000 patients that compared endovascular (catheter-based) techniques such as angioplasty and stenting with surgical bypass of the blocked veins in the leg. The most common clinical approach has been to use endovascular techniques first and then, if they failed, to follow up with bypass surgery, according to Dr. Neville. 

An increasing number of patients with CLI are not suited for the standard surgical technique to restore blood flow, called distal arterial reconstruction. However, limb amputation is no longer the only option for these patients. Inova’s vascular surgeons were among the first in the world to demonstrate that an alternate procedure called distal venous arterialization (DVA) can be a successful intervention for patients with CLI in what otherwise have been viewed as unsalvageable “no-option” limbs. Performing DVA with catheters is also being investigated in cooperation with interventional radiologists at Inova. ISHV is one of just a few institutions performing these intricate procedures.

DVA reestablishes blood flow into the deep veins of the lower leg and foot to get blood to the tissues. Valves in the veins are disrupted, so the blood flowing in a “reverse” direction is not stopped and can reach tissue through the capillary bed. This is accomplished in combination with a bypass technique – distal vein patch bypass – that Dr. Neville developed.

“As limb loss has profound implications for quality of life and long-term survival, DVA should be considered as an alternative prior to amputation when standard techniques are not possible,” said Dr. Neville. “Patients with ischemic rest pain, nonhealing wounds or gangrene, who have been told they have limited options for revascularization, are potential candidates for the procedure.”

According to Dr. Neville, while the data from the BEST-CLI clinical trial will be analyzed further, the initial results suggest that many vascular surgeons will be seeking further training in bypass techniques, including those developed at Inova.