Repairing heart arteries that become clogged with plaque--a condition known as atherosclerosis--has become a familiar medical procedure in recent years. Somewhat less well-known to the public is the field of peripheral artery disease in the legs and feet, or PAD. But a new breakthrough in PAD surgery, involving drug delivery via a tiny balloon, is making a dramatic difference in success rates.
Most patients with heart disease also have some buildup of plaque in their legs, says cardiologist Robert Foster, MD of St. Vincent's East. And traditionally, arteries affected by PAD have been roughly twice as likely to re-narrow, or re-occlude, after a procedure as those in the heart, according to Foster.
The new treatment uses a balloon, similar to those used for opening heart arteries, to deliver the drug paclitaxel after the artery has been cleared, which improves blood flow and reduces the rate of artery re-occlusion from about 60 percent to 20 percent.
"Many people underestimate the seriousness of PAD," Foster says, "but if you follow the progress of untreated cases, they actually have worse outcomes than breast cancer, as patients are likely to die from a complication of cardiovascular disease such as a stroke or heart attack. It can also result in amputation, and the need to wear a prosthesis. Maintaining one's mobility is critical for survivors.
"And when you look at the data on amputees, people in their 60s, 70s, and 80s in whom the disease is particularly advanced, fewer than 20 percent ever walk again--generally because their other leg or their arms aren't strong enough. That has a great impact not only on the patient, but on family members."
Formerly, treatment for PAD often involved the insertion of stents, as in heart surgery but with less success. What physicians discovered, says Foster, is that "putting a foreign body into a leg artery doesn't respond like the heart. The nice thing about balloons is that, unlike the stent, they don't leave anything behind after the plaque has been cleared out."
"St. Vincent's is excited to be the first in our market to offer our PAD patients a life-changing technology," says Michael Korpiel, president and COO of St. Vincent's East. "We have a longstanding reputation for providing innovative vascular care to our patients. This new technology builds on that commitment to offer our patients the latest and most effective treatment options to improve their outcomes."
The primary reason the hospital is the first to offer the new balloon technique is its familiarity with PAD procedures, says Foster. "Our volume of cases is probably the highest in the state. We're the training center for a lot of these devices, because we've established a reputation for peripheral work. More than half the procedures in our cath lab are peripheral. In addition, we've established relationships with the provider companies we see at meetings when we do presentations around the country. When there are new developments in the technology, the companies typically seek out the sites with the highest volumes of surgeries.
"Most companies do their initial research in Europe because there's less regulation and the approval processes are faster. So by the time a technology comes to the U.S., it's a second or third generation product and is a better device because of it."
The new PAD device is known as the Lutonix Drug Coated Balloon PTA Catheter, though Foster says several other companies are entering the field.
Another reason the breakthrough is used first in a high-volume center, says Foster, is that "peripherals are different from the heart, more complex, and so the procedures are a bit more operator-dependent to have good results. I started doing peripherals in 1999 and the equipment was pretty simple, but the progression and improvement now makes many of the procedures non-surgical.
"We can open the leg non-surgically, put in a little stitch, and the patient is ready to go. Keeping patients walking is important, and generally they're up walking the same day."