A doctor at Scripps Green Hospital this week became the first in California to use a new drug-coated balloon to treat peripheral artery disease in a patient since regulatory approval of the IN.PACT Admiral device in January by the Food and Drug Administration.
Curtiss Stinis, MD, used the device made by Medtronic, Inc., on Feb. 3 to open narrowed arteries in the leg of a patient with peripheral artery disease, a condition which is associated with an increased risk for heart attack and stroke.
“What people don’t realize is that peripheral artery disease is a very common and potentially serious condition,” said Dr. Stinis, who is director of peripheral interventions in the Division of Cardiology at Scripps Clinic. “Importantly, most people who have the disease are entirely asymptomatic and don’t even know they have it.
“Those who do suffer from exercise-related symptoms typically develop a progressive decline in their ability to remain active, yet they often chalk up their symptoms to just getting older,” he said. “This procedure is the latest example of how Scripps Health is making the best cardiovascular program in the region even better.”
The drug-coated balloon angioplasty was a much-needed option for Ralla Rubin, 82, of San Diego, who was the first Scripps patient to receive the treatment from Dr. Stinis after FDA approval. Since the onset of burning pain in her lower leg about two years ago, Ralla has been unable to attend exercise class or walk to the grocery store from her Clairemont neighborhood home. She previously underwent two interventional procedures – a traditional balloon angioplasty and a stent implant – but the blockage returned.
After each procedure, Ralla’s arteries developed excessive scar tissue, which created new blockage, Dr. Stinis said.
“I just want to be able to walk again,” Ralla said prior to the procedure with the drug-coated balloon. “I’m hopeful and thankful that Scripps offered me the option to try this new treatment.”
Affecting an estimated 8 million to 12 million people in the United States, peripheral artery disease is a debilitating condition that occurs when arteries become narrowed or blocked by plaque build-up, restricting blood flow. The condition commonly affects arteries in the upper legs and can cause recurrent and painful muscle cramping in the thigh and/or upper calf during exercise. The discomfort can impair a patient’s ability to adequately exercise, and consequently interferes with a patient’s ability to maintain a healthy weight and lifestyle.
In its more advanced form, peripheral artery disease can lead to a critical restriction in blood flow to the legs and feet, which is often associated with continuous pain, non-healing wounds or gangrene. If not properly treated, the condition can lead to life-threatening complications, and is associated with a four to five time higher risk for heart attack or stroke, according to research published by the Journal of the American Medical Association in 2010.
Once peripheral artery disease is diagnosed, patients can benefit from aggressive lifestyle modification, such as smoking cessation, dietary changes and cholesterol medication.
“When conservative measures fail, we typically recommend intervention to mechanically improve blood flow,” Dr. Stinis said. “In these cases, the drug-coated balloon gives us a new and important minimally invasive treatment option.”
Drug-coated balloons are designed to help restore blood flow by reopening blocked arteries while simultaneously delivering a medication to the artery wall. During the new procedure, an inflated balloon pushes the plaque away to create a channel for blood flow, and the medication on the balloon surface is deposited into the artery wall. The balloon is then removed with only the medication left behind.
Clinical studies, including work done at Scripps, have shown that delivering the medication via the balloon helps keep arteries open longer than standard procedures, including a traditional balloon angioplasty, Dr. Stinis said.
In particular, research has shown treatment with the Medtronic device reduced the need to have a similar repeat procedure within the next year, which is more common with other types of interventional procedures for the treatment of the condition.
Innovative technology such as the IN.PACT Admiral device demonstrates the leadership of Scripps in heart care and research. The $456 million Prebys Cardiovascular Institute, which is scheduled to open in March, will be a center for innovation that brings together top researchers, physicians and staff. The institute will incorporate leading-edge wireless technologies and individualized medicine for the best in patient care.
Each year more than 76,000 patients receive their cardiovascular care from Scripps, making it San Diego County’s largest heart care provider and the only one in the region consistently recognized by U.S. News & World Report as one of the best in the country.
Learn more about Scripps Health, a nonprofit integrated health system in San Diego, Calif.