MOUNTAIN VIEW, Calif., Jan. 18 /PRNewswire/ -- El Camino Hospital today announced that James Joye, D.O., director of the cardiac catheterization laboratories, will present research updates on minimally invasive treatments at the 2005 International Symposium on Endovascular Therapy (ISET) being held this week in Miami.
Dr. Joye will present new findings from clinical trials and ongoing research in cryoplasty and percutaneous bypass, pioneering endovascular techniques that target peripheral arterial disease (PAD) -- clogged arteries in the legs. Both procedures were 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.
“Patients with severe peripheral arterial disease, many of whom are diabetic, have few treatment options. Cryoplasty has been highly successful in reducing the number of below-the-knee amputations in this population,” said Dr. Joye. “About 10 million people in the United States suffer from PAD, yet only about 25 percent of PAD patients are receiving treatment. With new therapies like cryoplasty, and earlier intervention, we hope to greatly reduce the incidence of amputation for these patients.”
At ISET, Dr. Joye will present the final results of a prospective, multicenter, multi-national trial studying cryoplasty in patients with claudication -- pain in the leg muscle due to inadequate blood flow. In this study, the restenosis (renarrowing) rate was 24 percent, half the rate of conventional angioplasty, which has a restenosis rate of ~50 percent. Dr. Joye also will update the status of a multicenter prospective trial for cryoplasty in patients with limb-threatening claudication (those pending amputation) where the rate of limb salvage in the first 25 of 100 patients has been 100 percent in the early stages of evaluation.
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.
In a clinical study reported at the Cardiovascular Research Foundation’s Sixteenth Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium (TCT 2004), 95 percent of 20 patients who had leg pain at rest or ischemic ulceration and gangrene underwent cryoplasty and were able to avoid almost-certain amputation below the knee.
Dr. Joye also will present an update on the minimally invasive percutaneous bypass procedure for patients with PAD who require bypass but are high-risk for open surgery, which is expected to enter a multi-center clinical trial later in the year. Percutaneous bypass is an advanced technique that achieves the surgical result of bypassing long occlusions in the leg through only a small skin puncture, as opposed to several long leg incisions. The procedure also avoids the need for general anesthesia and greatly reduces recovery time. Dr. Joye will report on the first 12 patients to be treated with this technique (all treated at El Camino Hospital). The patients in this study range from six months to more than two years post-surgery and 92 percent of the bypasses remain open.
About Peripheral Arterial Disease (PAD)
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.
About El Camino Hospital:
El Camino Hospital features state-of-the-art cardiovascular services and a team of dedicated doctors and nurses who provide high quality care in areas ranging from prevention and diagnosis to advanced endovascular procedures and cardiac surgeries. El Camino Hospital’s heart specialists are leaders in the development of minimally invasive techniques, and provide international cardio and vascular expertise in California’s high-tech Silicon Valley.
Consistently ranked as a leading hospital in the area, El Camino Hospital recently received the highest ranking in the California Hospital Experience Survey. The hospital has received national recognition for several pioneering programs in the areas of cardiac treatment, radiation oncology and maternity. For more than 43 years, El Camino Hospital has been distinguished by its high caliber staff and affiliated physicians, comprehensive and innovative services and a long history of responding to the needs of the community it serves.
EDITOR’S NOTE: To interview patients who have undergone cryoplastyprocedures at El Camino Hospital, please contact Jennifer Barfoot, WeissCommPartners, at 415-692-4223
El Camino Hospital Heart and Vascular Center
CONTACT: Jennifer Barfoot of WeissComm Partners, +1-415-692-4223, for ElCamino Hospital