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Laser using cool ultraviolet light to clear artery blockage.

Diabetes is a cruel disease that takes a systemic toll on those who are diagnosed with the chronic illness. One common complication is peripheral arterial disease (PAD), in which plaque blocks arteries in the small vessels of the foot and leg and can ultimately lead to lower limb amputation.

"The amount of cost to society is profound with amputation … not to mention pain and suffering of the patient … yet many consider amputation to be the conservative thing to do. It's not. It's very aggressive," Dr. Craig Walker, founder of the Cardiovascular Institute of the South in Houma, La., said passionately.

He adds that while amputation is often a first-line treatment for critical limb ischemia, there are newer options available to salvage the limb. According to recent data from the International Diabetes Foundation, as many as 85 percent of the non-traumatic amputations may be preventable.

Triple board certified in internal medicine, cardiology and interventional cardiology, Walker has come to be a believer in the CLiRpath procedure (Cool Laser Revascularization for peripheral artery therapy) as a way to avoid many amputations. Manufactured by Colorado Springs-based Spectranetics, the excimer laser uses "cool" ultraviolet light delivered in short, controlled energy pulses to clear the blockage. Utilizing a wavelength of 308 nanometers, Walker says the laser breaks up the chemical bonds of tissues, the atherosclerotic plaque and clots to literally vaporize these barriers.

"Where you had a blockage before, you wind up with simply a channel," he said.

For diabetics, this option is "hugely important," said Walker, because they are the group most likely to have major amputations … a growing concern, he added, as "we have an epidemic of diabetes in America.

"Some epidemiologists are predicting by the year 2020, if the trends continue, as much as 50 percent of the U.S. population could be diabetic."

In America, 82,000 non-traumatic lower extremity amputations (LEAs) each year are performed on diabetics, according to the American Diabetes Association. Furthermore, the CDC estimates that diabetics account for more than 60 percent of all LEAs. It's a figure that continues to rise. The CDC reports the number of diabetes-related LEAs jumped 240 percent between 1980 and 2002.

"Amputation is bad … on multiple levels," emphasized Walker. For the patient, it decreases mobility and often results in lifelong phantom pain. From a cost perspective, it's more expensive than revascularization and limb salvage. Finally, amputation leads to significantly increased mortality rates.

"At the best centers in the world, if you have your leg amputated below the knee, within 30 days 5-8 percent of those patients are dead. For amputations above the knee, 8-12 percent of those people are dead in 30 days. And that's at the best centers," he stressed.

Conversely, in three, multicenter clinical trials employing excimer laser angioplasty, with LACI (Laser Angioplasty for Critical Limb Ischemia) being the largest, all achieved better than 90 percent limb salvage one year out.

"In all of these trials, the mortality rate was nowhere near as high as with amputation," he added.

When asked why many physicians still opt for amputation, Walker said that as with anything relatively new, it takes a while to get the information circulated. He, himself, admitted to being skeptical for several years after representatives of Spectranetics began calling on him. However, he has truly turned into one of the company's converts. Walker now even sits on the board of directors and assists with clinical trials in an advisory capacity.

"We didn't always have these tools available to save limbs," Walker concludes. "But they are available now, and they should be utilized."



November 2006

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