The following
interview was conducted recently with Christopher J. White, MD,
FACC, FAHA. Dr. White is
Chairman of the Department of Cardiology and
Director of the Ochsner Heart & Vascular Institute in New
Orleans, Louisiana.
He is Editor-in-Chief of the prestigious
medical journal, Catheterization and Cardiovascular
Interventions, and he is Co-Director of “Peripheral
Angioplasty and All That Jazz”, now in its 14th year,
one of the largest live-demonstration courses for cardiologists
wishing to learn more
about the endovascular management of peripheral arterial disease.
His group started doing carotid stenting interventions in
1994 and has now done over 1,000 procedures.
The success of coronary angioplasty and stenting has revolutionized
the treatment of heart disease. Angioplasty.Org asked Dr. White
how these catheter-based treatments are impacting
other areas of vascular disease. |
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Q: What are the differences in outcomes and durability between
surgery and angioplasty / stenting in the carotid arteries?
Dr. White: Durability is vessel specific, so if we talk about carotids,
the stent appears to be a little bit better than surgery. There’s
a randomized trial that’s been published, called SAPPHIRE, and the
recurrence rate [for stenting] in SAPPHIRE was slightly less than surgery,
not statistically significantly
different, but numerically was slightly less, and typically is less than
5%. The failure rate long-term for carotid stenting has been reported as
less than 5% in multiple trials.
In fact in the randomized SAPPHIRE trial, which compared
surgery to stenting in high risk patients, the surgical end point which
was a combined end point of heart attack, death and stroke was about twice
more likely to happen at one year than it was for stenting.
Q: Many patients have been done in clinical trials, but since
the FDA approved the first carotid stenting system in August 2004 and
MediCare
announced
reimbursement
in October, what has been
the
response so
far?
Dr. White: We only
have had it the last couple of months, so it’s
been a restricted volume simply because it wasn’t clinical procedure.
Medicare wouldn’t even reimburse you and private insurance
companies would not pay the hospital for the equipment, so we were limited
to only doing the experimental trial patients. But I can tell you that
nobody comes to my office asking for surgery. I mean every patient wants
to avoid surgery. And for good reason. Surgery, in
the medical sense of the term, is a morbid procedure,
meaning
that
it
causes
injury
and
harm
to the patient. So if they can do this through a keyhole or a catheter,
you know, who wouldn’t choose that, and that’s what drives
the technology.
Q: Who is eligible to have carotid stenting done right now?
Dr. White: The current state of the art is that CMS or MediCare will now
reimburse clinically for this procedure if the patient meets the following
criteria:
more than a 70% diameter stenosis of the carotid artery,
in a symptomatic patient, meaning either a transient ischemic attack,
a TIA or stroke, AND the patient has to be at high risk
for conventional therapies or high risk for surgery, which fall into
two categories, things
that are called co-morbidities which are bad heart disease, bad lung
disease, bad kidney disease, or anatomic difficulties which are lesions
that are too high in the skull to be reached by surgery, or prior scarring
of the neck from surgery or radiation therapy, or what we call a contralateral
occlusion, meaning the other carotid is completely occluded and you are
going to work on one that has a narrowing in it – it seems to be
better done with stenting than with surgery.
Now that being said, those clinical cases make up about now probably 15-20%
of our volume. The other 80% of our volume are still investigational procedures,
meaning that there are devices that are trying to gain FDA approval for
carotid stenting, and so we still are enrolling patients in experimental
protocols to use more advanced devices or new devices. And those include
patients who are asymptomatic, meaning they have never had a TIA, or never
had a stroke, they include patients who are at high risk for surgery that
we’ve discussed before and they also include patients who are same
risk of surgery, or at normal risk for surgery and those include both randomized
trials and non-randomized trials.
Q: How many devices have been approved for use in the U.S.?
Dr. White: Good question, but it’s complicated. To the best of my
knowledge, and I’m actually on the FDA panel, so my knowledge ought
to be pretty good, to the best of my knowledge, only the Guidant device…the
AccuLink. The Cordis device, which is the AngioGuard, is called “approvable”.
It means that the panel said that it was pretty good and we recommended
approval, but because of manufacturing
glitches and I’m not sure what else, the agency has not yet certified
Cordis with a letter. So they’re sort of in-between. So really
at this point in time Guidant is the only device that’s been approved,
Cordis is approvable but not through the system and the rumor is that
Abbott
is right on the heels. Abbott should be ready any moment.
Q: There are a number of trials right now associated
with different devices from different manufacturers. For example,
this week
you're presenting the one-year results from the BEACH trial with Boston
Scientific's
device,
and Abbott's has just announced the ACT I trial. Are you
involved
in that as well?
Dr. White: We are. We haven’t begun enrollment yet, but yes, we will
be an investigational site for ACT I. We’ve been an
investigational site for virtually all of the trials. There must now be
8 or 9 of these
trials that have been done. BEACH was one of the bigger ones and one of
the more popular ones because the device that we used was very friendly.
People liked to use the BEACH devices. BEACH was both asymptomatic
and symptomatic patients meaning neurological symptoms:
stroke and TIA. All of the patients were at high risk for surgery, whether
they were symptomatic
or asymptomatic. About 3/4 of the patients were in fact asymptomatic
-- all high risk for surgery.
Q: Vascular surgeons, interventional radiologists and interventional
cardiologists are all working in the carotids. A big question for patients
is who should they see if they suspect a problem?
Dr. White: Well clearly the cardiologists, just in terms of numbers, are
dominant. There are 40,000 interventional cardiologists in this country.
You know,
there are less than 1,000 neuroradiologists, for example. The
vascular surgeons have only this year put in place training programs for
endovascular therapy. So while there are champions of this therapy, guys
like Ken Ouriel and others, Ted Diethrich, who have been doing this for
years, the average vascular
surgeon has not been doing endovascular work and wasn’t trained to
do it in his training program.
So cardiologists by default have become
the biggest group out there who are embracing this technology because
frankly, atherosclerosis, which is the disease we’re talking about
here, doesn’t
know the difference between your carotid artery and your coronary artery.
It simply is a systemic disease that affects vascular structures in your
body. And you may present with angina or you may present with a stroke,
but you have this problem all through your body. So somehow compartmentalizing
patient problems by doctor specialty seems goofy. I mean if a guy comes
to see me with atherosclerosis that affects his legs, his kidneys, his
heart and his brain, why would I, as a cardiologist, say, “Well
I only take care of your heart.” I mean that would not be
the best way to take care of that patient.
So what’s happened in
cardiology for the last 7, 8, 9 years is we’ve actually embraced
the sort of the whole body philosophy that says, “this is a systemic
illness; it does require systemic therapy." Risk factor modification,
for example,
and medical therapy. And then, when revascularization is required, let’s
determine whether we can do this non-invasively, or less invasively,
with a catheter and a balloon, or does the patient require open surgery.
And
the technologies have advanced very rapidly in the last few years for
percutaneous therapies, so most patients now, the vast majority of patients
who have
blood vessel problems, can be treated with a catheter and a stent, and
don’t require surgery. 20 years ago it was just the opposite. That
goes for the heart, the brain, the legs, the kidneys; it doesn’t really matter where you look.
Q: The equipment may be similar but, for the cardiologist,
is doing a carotid similar to doing a coronary case?
Dr.
White: To me it’s a completely different ballgame. The procedures
don’t translate to one another. The complication rate in the brain,
it’s extremely unforgiving territory. You know, one mistake, one
embolism and you deal with a permanent stroke and you just can’t
get that back. So there isn’t any room for error in the carotids
and it demands the absolute most experienced physician you can find to
do that.
Q: What should a patient look for in choosing where to get this
therapy?
Dr. White: Surgeons have demonstrated that volume
matters: that someone who does one operation in a month doesn’t
get the same results as somebody who does one operation a week. Volume
is what
makes people good at these things. And makes hospitals good at these
things. So if you’re choosing a place to get carotid stenting done,
you want to choose a relatively busy operator and you want to choose
a relatively busy hospital. You don’t want to go out into the periphery
to tiny hospitals and tiny volume operators.
Q: Recurrences, or reblockages, are talked about in angioplasty and
stenting, although that's changed significantly with the advent of drug-eluting
stents.
How does that work in the carotids?
Dr. White:
It is vessel-specific, I can tell you that in the legs, for example, we
still are having a lot of trouble with recurrences, even with stents in
the leg, even with drug-coated stents in the femoral arteries. So that’s
true still in the femoral arteries, but it is absolutely not true in the
carotids. Stenting works very well, less than 1 in 20 patients will have
a recurrence.
No one really understands why the vessels respond differently, but clearly
the carotid is the most favorable place to place a stent in the entire
body.
Q: Regarding stroke prevention, how do you diagnose patients
with potential problems in the carotids?
Dr. White: There are two ways. First of all, we screen patients who have
no symptoms by listening to them during a physical exam. So every time
I see a patient in my office for anything, for heart murmur,
for angina, for a checkup for blood pressure, I, as a routine,
examine both their pulses and I always listen to their neck with my stethoscope
for what’s called a a bruit or a "whoosh" sound. And when
you hear that whoosh sound that indicates sometimes turbulent flow, and
some
of those patients will in fact end up having asymptomatic blockages of
the neck, we then go to do ultrasound or MRA or CTA. There are three
ways to find these. Ultrasound is the cheapest and probably the most commonly
used way, but MRA and CTA are also alternative ways to screen these patients.
The other one is the patients who come in complaining
of a neurological event, someone who had a minor stroke or a transient
problem and they come and tell you “I think I had this problem” and
then, of course. you would screen them also for the carotids. But we
found in the BEACH trial, 3/4 of the patients were
asymptomatic, meaning that they were found during routine exams before
they ever had
an event. And let me just say, that’s
the best way I know to practice medicine. If we’re going to spend
money and spend time and effort, we need to spend it on prevention. We
need to
spend it on keeping people from having these bad things happen. We don’t
want people to come to see us after big strokes and then we try to figure
out why the big stroke happened, because the damage is done. We really
do want to spend a lot of time and be working very hard
at
screening patients before they have the events, and then treating to
prevent the event from ever happening. That’s the ideal way to
do this: prevent heart attacks, prevent strokes. I feel strongly about
that.
Q: That kind of wraps up my questions. Is there any big topic that you
would like to get out to patients?
Dr.
White: I mean I don’t want to proselytize too much. Obviously I
have a, my problem is that I have a bias. And I’m proud of my bias.
But when you talk to patients, they come to see me, I always make sure
-- patients who come to us always see a neurologist. And the reason we
do that is to
keep our enthusiasm in check. And I would strongly recommend to your patients,
people who are coming to your site: always get a second opinion.
Because I think that you can’t help but benefit when somebody who
is not actually doing the surgery or doing the procedure
is able to give you another opinion. There was a time there back in the
80’s when second opinions
were really common, and lately I’ve gotten the feeling that people
don’t do that much. But I would encourage people with vascular disease
to talk to more than one physician, preferably one that’s not a “do-er”,
you know, someone who’s a non-invasive person, who would give them
an honest opinion about whether or not they think they really would benefit
from revascularization and then whether it be surgery or angioplasty.
If
you go to a surgeon, you know, there’s an old saying...that if
you have a hammer in your hand, the whole world looks like a nail. And
we
need to avoid over-treatment of these patients, which is one of the
severe criticisms that’s leveled at us. And the way that we do
this here at the Ochsner Clinic is that if you come to see me for your
carotid
stenosis, you will see the neurologist as well, and if we don’t
agree, if there’s no consensus, then the patient won’t be
treated. And I think that keeps us on the straight-and-narrow and makes
sure that
our selection is unbiased. Q: Thank you very much. Those are important words and I think this will
be very helpful to our readers.
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