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
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
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
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
‘‘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
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
‘‘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,
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.’’