Back In Stride

Laughing gas? Pac-Man through a straw? New tools of vascular intervention at St. Elizabeth's are brightening the outlook for older patients crippled by leg pain

By Bruce Morgan

Raymond S., An 80-Year-Old widower living in Brockton, Mass., set out for his usual morning walk one fine day last fall. He got only about 300 yards before a cramping pain in his right leg forced him to turn around and hobble back to his house. The dash of paralyzing pain was not entirely a surprise. For the past two years, Raymond had been feeling intermittent pain when he walked, and his cardiologist had already referred him to Dr. Peter Soukas, '87, director of the vascular lab at Caritas St. Elizabeth's Medical Center. "Of course I'm a procrastinator, because I could still function," Raymond explains with a wide, gap-toothed grin, tapping the table with his finger.

He could be forgiven for electing to tough things out. Born in Lithuania, Raymond came to the United States in 1949, when he was 22, and made his own way, earning a master's degree in electrical engineering and landing a job as a researcher in geophysics at Northeastern University. He married and fathered three children. Lately, Raymond, who today is neatly dressed in slacks and a checked shirt open at the neck, lives alone but stays busy keeping his house and yard trim ("I like to keep everything in order, and so forth"), reading novels, surfing the Internet and writing computer programs for fun. "But the first thing I do every day," he says, "is go for my three-mile walk."

After the cramping pain, Raymond went to see Soukas, a vascular interventionist (i.e. not a surgeon-there's no cutting involved) who did an ultrasound and found a 25- to 30-centimeter blockage in Raymond's leg below the knee that represented a solid buildup of accumulated fatty deposits typical of atherosclerosis. The disease affects some 10 million Americans, about a third of whom suffer some degree of leg discomfort.

Raymond had an especially nasty case of chronic total occlusion-Soukas calls such cases "the big, ugly ones"-because he was a heavy smoker with elevated cholesterol, high blood pressure and a family history of heart disease. In fact, he had already had a heart bypass operation.

Twenty years ago, for a patient like Raymond, the choice would have been surgery or amputation. But now a gentler, less-risky option is available. Using a new device called Frontrunner that he likens to a Pac-Man, with rounded jaws for safe passage between arterial walls, Soukas was able to enter Raymond's leg through a straw-like catheter in the patient's groin and, bit by bit, burrow through the hardened plaque under local anesthesia, restoring circulation in the calf. Two days later, Raymond was able to resume his regular daily walk, almost completely pain-free.

"The Frontrunner blazed the trail through the blockage," says the doctor, with obvious satisfaction. [Ed. note: Soukas has no financial interest in the Frontrunner device.] It wasn't that long ago, Soukas points out, that he would have been forced to rely on a stiff wire inserted in the artery, then massaged through the hardened plugs. According to Soukas, poking around with a wire like this was "a crude method," both limited in its ability to penetrate the tougher cases and hazardous in its risk of damage to arterial walls.

Vascular medicine has undergone a quiet revolution in recent years, and St. Elizabeth's has consistently been among the first to employ the latest tactics and tools. "I'm 46," says Soukas, a soft-spoken man with warm brown eyes. "I remember what life was like when the only option we had was balloons." He's referring to the child-like simplicity of inserting a miniature balloon in the artery, blowing it up to widen the passage and then removing the balloon.

Metal stents arrived about 10 years ago, enabling physicians to leave something behind to keep the artery propped open. Then lasers appeared in the late 1990s, offering a precision cutting tool to help penetrate blockages. Over the past few years, drug-coated stents, cryoplasty and Frontrunner have joined the fray.

Restenosis, the tendency of any cleared artery to narrow again, is the stubborn foe of arterial intervention. Sooner or later, scar tissue grows back, and the more damaging the intervention, the greater the risk of scarring and narrowing. Variables that affect restenosis rates include whether or not a patient is diabetic, a smoker, is suffering from kidney damage, presents with a short or long blockage and a narrowing or closure of the artery, and exhibits a large or small number of runoff vessels below the knee.

The rate of arterial restenosis in the legs after an intervention runs between 20 and 40 percent, on average. Anything lower than that is moving in the right direction, bettering the odds that a patient won't have to return in a matter of months to go under the bright lights and have the procedure redone.

Some Fancy Plumbing

It's not likely that any device or new technique can ever eliminate the devil entirely- "There will be restenosis after any event," Soukas cautions-but one recent innovation illustrates the gains that are possible. Four years ago, cryoplasty made a local splash when St. Elizabeth's became the first hospital in New England to offer the procedure. Soukas recalls how, in a single day, all the Boston TV stations sent crews over to the hospital to interview him in rapid succession about the latest medical breakthrough.

Part of what the various assignment editors obviously liked about the story was, both figuratively and literally, its "coolness" factor. The concept was easy to grasp. Cryoplasty uses extreme cold to knock down the restenosis response in vascular patients. A fingernail-sized balloon containing nitrous oxide, or laughing gas, is maneuvered to the precise spot in the patient's artery where a blockage is obscuring blood flow; then the balloon is inflated to clear the blockage. As the balloon deflates, it chills the arterial wall to minus 10 degrees Celsius, thereby killing smooth muscle cells that are the prime agents of the scarring response.

Early reports of restenosis rates for cryoplasty stood in the tantalizing 10 to 15 percent range. With subsequent wider use of the approach in patients with more complicated conditions, the numbers have edged upward to 25 or 30 percent-still pretty good, but not great. Soukas describes his department's current response to cryoplasty in romantic terms, saying, "We're still very fond of it, but we're past the honeymoon phase." Cryoplasty remains a favored tool in the St. E's arsenal, frequently used in tandem with lasers, balloons, stents and Frontrunner technology. It is especially useful in cases where rigid stents may not be suitable, at a bend in the knee, for example.

Frontrunner, the latest tool in the kit, is designed to deal with the toughest cases. The vascular lab at St. Elizabeth's sees 500 patients annually. Since Frontrunner was introduced nine months ago, the lab has used the device to treat 100 patients with especially tough blockages. Of these, Soukas estimates that perhaps 10 or 15 percent would have lost their legs without the intervention. Before Frontrunner, the lab used a glide wire to poke at arterial blockages, but the chance of breaking through and restoring good blood flow was 50/50. Frontrunner has raised the success rate to 89 percent.

Losing a leg, or any part of a leg, is serious business. "Nothing is more depressing," Soukas says grimly. Half of all patients die within two years of a foot amputation.

What about surgery? Although vascular surgery is always an option, the bypass approach is best held in reserve, in Soukas' view. For elderly patients, especially, surgery can be problematic, considering the latent risk of infection that comes with cutting the body open and all the hazards that attend the administration of general anesthesia. And then the human body has a limited stock of greater saphenous veins to tap for bypass purposes- just two, in fact, and only if they have not been damaged by varicosities. Many older patients who would require a heart bypass in a matter of a few years will want to keep those available. "Veins are a precious resource," Soukas contends. "If we do a bypass, that lasts four or five years. Then what do we do-use another vein?"

As a general rule, Soukas tries to step back and take a long view of a patient's health. To his mind, the driving question shouldn't be: How can we fix this person's damaged artery? It should be more along the lines of:Assuming we fix this person's artery, what are the larger implications for his or her future health?

Patients who show up at his door are generally in failing health. That's a given. Accordingly, arterial blockage is not one of those medical problems that can be treated in isolation, like a broken arm. As Soukas notes, "If you have plaque in one vascular bed, it's likely elsewhere. "Blood flow throughout your body is being impaired, meaning that your body's tissues aren't being properly fed, and you are running an elevated risk for heart attack or stroke. The root causes of impaired blood flow, in turn, raise questions concerning whether people smoke, exercise, eat properly, sleep well and have good emotional health- questions that trail patients home to their kitchens, yards and bedrooms and follow them out onto the patio.

"I can get them some help with my fancy plumbing, but there's always more to talk about, like lifestyle," says the doctor.

From all indications, Soukas seems to be a person who's happy to be alive at the particular time and place he occupies in medical history. He is a tireless, passionate slugger inside the occluded artery and he loves the nifty tools that have come along lately to help.

Buying More Time

Charles F. is someone who would walk through fire to accept just about any deal that Dr. Peter Soukas is handing out. At 74, the Newton resident was a patient of Soukas' earlier this year who faced amputation because of a total blockage in his lower left leg. A retired salesman for Coca-Cola, Charles had been in good health until three years ago, when he required open heart surgery. More recently, he was strolling a golf course in Florida when a surge of pain came up as suddenly as wind off the water, and he could not walk another step. He paid a visit to Soukas as soon as he got home to Massachusetts.

The news of potential amputation was dire ("That was the first time I got scared in my life," Charles says, his voice quavering), but Soukas was there to help. "He worked on me all night-straight through, for eight hours-and then he came back the next morning to be sure everything was all right. He's unreal, I tell you." With the blockage cleared and stents holding the artery open, the pain has subsided. Charles is back to playing his 18 holes of golf a day.

Another patient, Michael W., a 59-year-old financial consultant from West Boylston, Mass., noticed a sore the size of a half-dollar on his lower leg that would not heal. His cardiologist knew Peter Soukas and promptly referred Michael over to St. E's for a consult. Soukas found blockages in the leg and, over three or four hours, managed to clear them, leaving two stents behind in the artery. Donna B., Michael's significant other, who happens to be employed as a nurse at U-Mass Medical Center, notes that "other places would have gone straight to surgery. It's true that Michael may need surgery down the line. But this way, Dr. Soukas has bought us more time. We're very pleased."

The procedure went well. Michael's leg ulcer healed. In the several years prior to Soukas' intervention, Michael had experienced tightening in his calves, and although that has not been eliminated entirely, it has improved. "There's still some cramping, but it's gotten better," Donna confirms. "He's able to walk a longer distance with less discomfort. "Her care in describing her partner's measure of pain is a reminder that few issues surrounding the treatment of arterial blockages are either complete or everlasting. Every success is qualified.

Marjorie R. will take it anyhow. Although the 66-year-old Watertown resident did not have a condition so severe that she faced amputation, the discomfort in her legs when she walked was eroding the simple pleasure she took in being alive. Marjorie went to Soukas and had a stent inserted in each leg. Now she can do all the usual things she loves, like chasing her four-year-old grandson around the house when she babysits for her daughter. "He's a little hellion," she laughs good-naturedly. "Sometimes he does wear me out." (TM)

Bruce Morgan is editor of this magazine. He can be reached at bruce.morgan@tufts.edu.