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.

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.