Minimally Invasive Approach Helps to Prevent Amputations

Patients Benefit from More Aggressive Endovascular Therapy

June 28, 2007

Research presented earlier this week at a national scientific conference shows angioplasty and stenting can help prevent amputation and restore blood flow in the lower extremities in patients with severe peripheral arterial disease (PAD). Angioplasty and stenting had an overall 91 percent success rate, with the tiny arteries below the knee still open 18 months after the procedure, preventing amputation. This success rate was consistent in all patients who were observed over a six-year period. The research was presented at the Society of Interventional Radiology’s 32nd Annual Scientific Meeting in Seattle

PAD is a hardening of the arteries, the same molecular process that can lead to heart attacks and stroke.  Patients with severe PAD have a significant decrease in blood flow in their lower legs, leading to severe pain, tissue death and infection in the leg below the knee. About 25 percent of these patients will experience an amputation within one year of diagnosis of their condition

“The major problem for patients with severe PAD is inadequate blood flow,” said Nael Saad, M.D., an interventional radiologist at the University of Rochester Medical Center and lead author of the study. “Even if we graft in a new artery and surgically remove the gangrene, the body can have a difficult time healing the wounds on the leg. The trick is to get the blood flowing again without further wounds so the tissue can heal itself on its own, or set the stage for minor surgery and avoid the need for an artery bypass.”

Until recently, treating blockages below the limb presented a challenge due to the small size (3 mm) and quality of the blood vessels. While artery bypass surgery can be successful, the surgical wounds can have complications and hinder a patient’s ability to return to normal life. As more advanced and miniaturized equipment has become available, physicians have increasingly turned to angioplasty and stenting procedures to open up these tiny arteries below the knee, thereby improving blood circulation. According to the study results, the first to look at mid-term limb survival in this patient population, this approach significantly improves the chances of limb survival.

The study was a six-year retrospective review of patients undergoing angioplasty and stenting below the knee by the multidisciplinary endovascular program at the University of Rochester. In all, 47 patients had 81 blockages treated below the knee. At three months, 75 percent of patients’ arteries were still clear, and at 18 months, 55 percent of patients’ arteries remained clear. By re-treating the artery that became re-clogged, the artery remained open, saving the limb in 91 percent at 18 months follow-up. 

“This study shows that with angioplasty and stenting, we can restore blood flow through the smallest vessels in the legs and keep them open long-term, saving these patients from major surgery and possible life-altering amputation,” Saad said. “Aggressive endovascular therapy should be considered in all patients as a first option because, in general, the long-term clinical results are comparable to bypass surgery in the leg using a longer, more complex graft, but with a much lower risk of morbidity and mortality.”

About Peripheral Arterial Disease

PAD develops most commonly as a result of atherosclerosis, or “hardening of the arteries,” which occurs when cholesterol and scar tissue build up, forming a substance called plaque inside the arteries that narrows and clogs the arteries. It is a systemic disease – clogging in one area of the body (legs) indicates clogging is occurring in other parts of the body (heart). 

  • PAD is a disease of the arteries that affects 10 million Americans.
  • It is estimated that as many as 20 percent of Americans over 65 years old, and about half of all Americans over 75 years old have peripheral arterial disease
  • With the rapidly increasing elderly population, it is likely that the incidence of severe PAD will continue to grow. Currently, the annual costs of severe PAD are estimated at $10 billion in the United States alone.

About Angioplasty and Stenting for Treating PAD

Using imaging for guidance, the endovascular specialist threads a small wire through the femoral artery in the groin, to the blocked artery in the calves. He then inflates a balloon to open the blood vessel where it is narrowed or blocked.  In some cases, this is then held open with a stent, a tiny metal cylinder of mesh. This is a minimally invasive treatment that does not require surgery, just a nick in the skin the size of a pencil tip.

In general, balloon angioplasty and stenting has replaced invasive surgery as the first-line treatment for PAD. Randomized trials have shown endovascular therapy to be as effective as surgery for many arterial occlusions, and in the past five to seven years, a very large clinical experience in centers throughout the world has shown that stenting and angioplasty are preferred as a first-line treatment for more and more processes throughout the body.  Although PAD in general is treated nonsurgically, in many cases the superficial femoral artery is still being treated surgically.

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