MOUNTAIN VIEW, Calif., Sept. 21 /PRNewswire/ -- El Camino Hospital today announced that James Joye, D.O, director of its cardiac catheterization laboratories, is available for comment on a recently published study in the Journal of Vascular Interventional Radiology, entitled "Cryoplasty for the Treatment of Femoropopliteal Arterial Disease: Results of a Prospective, Multicenter Registry."
El Camino Hospital was one of 16 centers in the United States and Europe that participated in the prospective, nonrandomized registry evaluating the efficacy of cryoplasty as a stand-alone procedure for the treatment of femoropopliteal arterial disease, or blockage of the main leg artery. Blocked arteries in the extremities are referred to, in general, as peripheral arterial disease (PAD). Cryoplasty is a cutting-edge alternative to conventional balloon angioplasty for unclogging blocked arteries.
Primary endpoints of the study were acute technical success of cryoplasty as a stand-alone procedure, overall procedural success and clinical patency, or openness of artery, at 9 months. Secondary endpoints were adverse events and 9-month primary patency as determined by duplex ultrasound (US)
Results of the trial included an 85.3 percent technical success rate, with a low dissection rate (or tear in the artery) of 6.9 percent. There was a 94.1 percent overall procedural success rate. The 9-month clinical patency rate was 82.2 percent and the primary patency rate assessed by duplex US at 9 months was 70.1 percent. No unanticipated device-related adverse events occurred during the trial.
The cryoplasty procedure was developed and first performed at El Camino Hospital by Dr. Joye and his colleagues. Cryoplasty for PAD received U.S. Food and Drug Administration (FDA) approval in September 2002.
"The results of this study, in combination with other emerging data, demonstrate that cryoplasty is a promising novel treatment for peripheral arterial disease, which affects millions of Americans," said Dr. Joye. "Cryoplasty shows promise in overcoming some of the obstacles associated with conventional angioplasty, which we believe will translate into more effective treatment and better long-term outcomes for patients."
About Cryoplasty
Commonly referred to as "angioplasty on ice," cryoplasty unclogs blocked arteries using a technique similar to balloon angioplasty. A catheter is threaded through the artery and inflated, but instead of filling the balloon with a liquid as in traditional angioplasty, cryoplasty uses nitrous oxide, or laughing gas, for inflation. The nitrous oxide cools the balloon to minus-10 degrees Celsius, which allows built up plaque to freeze. The gentle cooling of the plaque and artery wall results in three potential beneficial effects: weakening the plaque promoting universal dilation and less vessel trauma; reducing vessel wall recoil; and inducing apoptosis (natural cell death in the smooth muscle cells that are implicated in restenosis). The combination of these effects appears to minimize some of the complications that ultimately contribute to the reclogging of the vessels and to result in better long-term patency.
About Peripheral Arterial Disease
Peripheral arterial disease (PAD), also known as peripheral vascular disease (PVD), occurs when arteries in the legs become clogged. The most common cause of narrow or blocked arteries is fatty deposits (also called atherosclerosis). The most common complaint of people with PAD is claudication, or leg pain.
Patients with PAD are at risk for ulceration, infection, gangrene or amputation. Approximately 160,000 amputations are performed every year in the United States as a result of this condition, according to The Sage Group, an independent research firm. This number is expected to grow as the population ages and diabetes incidence increases.
Researchers estimate about 10 million people in the United States suffer from PAD, including 12 to 20 percent of Americans age 65 and older. Despite its prevalence and cardiovascular risk implications, only 25 percent of PAD patients are undergoing treatment. PAD disproportionately affects African Americans, and is at least twice as common in African Americans as in other ethnic groups.
Symptoms of PAD include painful cramping in the legs or hips when walking or exercising, numbness, tingling or weakness in the leg, and cold legs or feet. In severe cases, patients experience pain in the feet or toes even at rest and may develop ulcerations, infection or gangrene, particularly below the knee.
El Camino HospitalCONTACT: Jennifer Pendergrass of WeissComm Partners, +1-415-946-1072
