NICK EICHER, HOST: Coming up next on The World and Everything in It: Some good news: a possibly huge medical breakthrough for people suffering from severe heart disease. It’s a tiny device doctors can use to repair damaged heart valves.
MARY REICHARD, HOST: Apparently, this reduces the death rate for people who face a poor prognosis from heart disease.
Charles Horton is a medical doctor and he is on the line to discuss this with us. Dr. Horton, first of all, what will this device address for people suffering from this?
CHARLES HORTON, REPORTER: For people who have severe heart failure—and there are a lot of them, perhaps 2 million people in America—even getting through routine, everyday tasks is very difficult or impossible, depending on how serious the heart failure is. You can, in severe cases, lose your breathtaking even a few steps. You might have to sleep sitting up instead of lying on your back. And it often advances. It often gets worse with time.
REICHARD: And now we have some news that might brighten up their lives at least a little bit. What do you know about this?
HORTON: So, a large clinical trial called COAPT found a little clip called a MitraClip that could be used to compensate for this process by attaching to parts of the mitral valve together in the heart. It seemed to reduce death rates, reduce hospitalizations, and also improve quality of life. Surgeons are clipping together two parts of the mitral valve to improve the way that the valve closes—so that it can help the heart pump more effectively.
REICHARD: And where is the device in the approval process here in this country?
HORTON: Here in America, it’s awaiting FDA approval. If it’s approved, insurers will probably cover it, which is an important consideration. The device itself is $30,000 and putting it in is an extremely complicated process. The New York Times had this picture at the top of their article which showed basically a hybrid approach using a transesophageal echo, a special little echo probe that is put—under anesthesia, of course—into to the esophagus while also using what looked like a radiology study to further evaluate where it was and all this while a catheter is advanced through the groin. So, in addition to making for a very crowded operating room, you’re using three different high-end, expensive techniques simultaneously. Impressive and not cheap.
REICHARD: So what did the trial study show?
HORTON: The trial study showed that the malfunctioning valve started to work much more like the way it was supposed to work. It helped blood to flow forward through the heart properly. Now, this was the U.S.-Canadian study, not the French study, which we’ll get to in a minute, but there are over 600 patients in this study and it showed that the ones who had the device, along with the previously standard treatment, really had better outcomes. Of course, the other big thing is despite all the technology and all the human effort that’s needed to place this clip, it’s much less invasive for the patient and these patients, being very sick, often won’t tolerate conventional heart surgery, which is very demanding for the body. They’re often too sick to have that.
REICHARD: Okay. No medical study is without some trouble. I know that there was this prior study in France that you just mentioned. It came to a different conclusion, so how should lay people evaluate this?
HORTON: That brings up some great questions about looking at research studies in general. Now, they’re both randomized studies, that’s a very good sign. They both had a reasonable number of patients—one always wants to be leary of “hey, we did a great study. We had four people in it.” The French study had 300, the American study had 600. These are good numbers. But the big question, of course, is why did the American study show a big difference and the French study showed basically no difference? There are several possibilities. The one that we all hope for, and I think there’s a good chance of it, is that the doctors have gotten more skilled at putting these devices in, they know more about it, there’s more experience out there now. Whenever a new device is introduced, whenever a new device hits the market, there’s always a learning curve as we learn how to deploy it, when to deploy it, etc.
But that’s not the only possibility. Other possibilities include: is something different about French patients versus American patients? Some other aspect of how they’re treated? Some aspect of their lifestyle? Are the French doctors different in some other aspect of how they’re treating heart failure? We don’t know yet. Probably what will end up having to happen is, yep, a third study. So I’ll bet in the next year or two we’ll see an even bigger study to answer these conclusively.
REICHARD: Well, we will keep an ear out for that. Dr. Charles Horton is our medical correspondent. Doctor, as always, thanks for talking with us today.
HORTON: Thank you, Mary.