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Revolutionary procedure helps keep arteries clear

Knight Ridder Newspapers June 23, 2000
FORT LAUDERDALE, Fla. - Cardiologists call them ‘‘frequent flyers,’’ people for whom stents - a common treatment to prop open clogged arteries - don’t seem to work. These patients’ own tissue causes the arteries to renarrow in a condition called restenosis. Then they must undergo repeat procedures, frustrating them and their doctors, who can do little to break the cycle.

Now for the first time a handful of South Florida hospitals offer their frequent flyers hope for a one-way trip out of the catheterization lab.

The Food and Drug Administration recently approved two devices that deliver a quick dose of radiation at the offending site to prevent the exaggerated tissue growth associated with restenosis. That’s good news for the estimated 140,000 patients a year who suffer restenosis after having stents placed as part of the treatment to open clogged arteries.

In a darkened room at North Ridge Medical Center’s catheterization lab, Naomi Denson a few weeks ago became one of the first patients in Florida treated with one of the two products, known as intravascular brachytherapy systems.

The 56-year-old Delray Beach, Fla., resident is no stranger to the cath lab. She has been there eight times before. Eight times in the past five years, doctors reopened a blocked artery that caused the tightness in her chest, the shortness of breath that kept her from her beloved choir practice. And each time within five to six months the pain came back.

‘‘Every time you go in you think the next time is going to be all right,’’ Denson says. ‘‘It was just heart-breaking.’’

Doctors agree. They will return to the catheterization laboratory as often as needed with restenosis patients, but they know the time is likely to come when bypass surgery is the only solution left. That’s one reason they’re embracing the new brachytherapies.

‘‘This was the so-called Achilles’ heel of interventional cardiology,’’ says Dr. Ali Ghahramani, director of North Ridge’s cardiac catheterization laboratories.

A few weeks ago, North Ridge in Fort Lauderdale, Fla., became the first hospital in Florida to use the beta-catheterization system designed by the Atlanta-based company Novoste. Only about 40 others nationwide have the technology. Mount Sinai Medical Center on Miami Beach scheduled its first procedure with the gamma-radiation system earlier this week and Miami Cardiac and Vascular Institute at Baptist Hospital expects to perform its first procedure soon.

Both procedures have roots in angioplasty, a procedure perfected years ago to restore blood flow to blocked arteries. Doctors inflate a balloon in the congested coronary artery, which creates a clear passage for blood flow. In many patients, doctors shore up the ballon with a stent, a tiny tube made out of metal mesh that acts as scaffolding for the artery and increases the odds the artery will stay clear.

For most patients this one-two punch seemed to do the trick. But in 10 to 25 percent of those who have stents placed, the tiny metal mesh tube opens the door to more problems. It’s perfectly normal for tissue to grow back over the stent. With restenosis, however, for some reason patients overcompensate. The tissue grows back full force and the artery gets blocked once more.

Both beta- and gamma-catheterization rely on radioactive material to zap the cells near the stent to stunt their growth and keep the artery open. The doctor sends radioactive seeds in an enclosed delivery train up the patient’s body, tracking the same route the balloon and stent traveled. After allowing the radiation to sit there for a brief period - two to three minutes with the beta system, about half an hour with the gamma - the doctors remove the radiation from the patient.

‘‘It’s clear that both of them work, both are very efficacious and either one is going to be great,’’ says Dr. Paul Vignola, director of cardiac catheterization at Mount Sinai Medical Center. ‘‘In my mind there’s a slight advantage with gamma radiation.’’

Some studies suggest that the gamma system may carry a stronger punch, but doctors must leave the room while the radiation is being administered to the patient. That requirement leads some physicians to prefer the beta system, for which the doctors can remain with the patient.

‘‘We don’t feel very comfortable with everyone leaving the room,’’ Ghahramani says.

The Miami Cardiac and Vascular Institute plans eventually to use both systems, beta for those with more minor problems and gamma for those with more serious needs. ‘‘That will be the ultimate goal,’’ says Dr. Ramon Quesada, medical director of interventional cardiology at the Institute. ‘‘It’s easier with beta radiation. It’s more user-friendly, but on the other hand it’s probably less effective with patients who have long, diffused lesions.’’

Still, some doctors express reservations about the potential long-term effects of both therapies, noting that they rely on radiation. While studies have shown that brachytherapy is not likely to have ill effects in the short or medium term, it is still unknown whether there will be any fallout 20 or 30 years down the road, Quesada says.

In the future doctors may have another weapon in the battle against restenosis, one that does not employ radiation. Researchers are experimenting with stents coated with drugs that would prevent the proliferation of cells that leads to restenosis.

For now, however, patients like Don Toler don’t have much choice. Toler journeyed from Bloomington, Ind., to Fort Lauderdale to try the new beta system at North Ridge.

‘‘The only alternative would be to have a couple of heart bypasses. That wasn’t something I wanted,’’ says the 71-year-old former air-traffic controller.

One day after having the procedure, he had left the hospital and already noticed a difference. ‘‘I don’t have this heavy feeling on the left side of my chest that was associated with the vein being clogged up,’’ he says. ‘‘The proof is going to be in the pudding when I get back on the treadmill and see how far I can go.’’