John (Jack) C. Lewin, MD; Helene Eltchaninoff, MD; David R. Holmes, Jr., MD

Disclosures

April 18, 2012

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John (Jack) C. Lewin, MD: Hi. I'm Dr. Jack Lewin, here at the American College of Cardiology big meeting in Chicago, and today I'm fortunate to be joined by 2 very informed guests who are going to talk with us today about transcatheter aortic valve replacement (TAVR), a kind of miraculous new scientific achievement. Dr. Helene Eltchaninoff -- am I pronouncing it right?

Helene Eltchaninoff, MD: Yes, thank you.

Dr. Lewin: [Dr. Eltchaninoff] is from the French Society of Cardiology and is an interventional cardiologist who is very familiar with this procedure. Also, Dr. David Holmes, who was president of the American College of Cardiology until just yesterday and is a leader in this field. Helene and David, what is TAVR going to mean for the future of cardiology?

David R. Holmes, Jr., MD: I'll start it off, although you started it off before we did. I think that it's transformational technology and was brought along by clinical need that came out of taking care of patients who were felt to be either too high risk or, indeed, inoperable for conventional aortic valve replacement. [Dr. Eltchaninoff,] you've now had it for 10 years -- I think the first experience will be 10 years ago as of April of this year.

Dr. Eltchaninoff: Yes.

Dr. Holmes: The experience that we are trying to move along follows the experience that you have had in terms of the registry development and of selection of centers. Maybe you could tell us a little bit about [these aspects] in your experience, and then I can talk about what path we're trying to take.

Dr. Eltchaninoff: In France it was quite a long [attempt] to obtain the reimbursement for this new treatment and technology, and it was obtained at the end of 2009. The condition was to have each patient included in the registry. This was asked by the French Ministry of Health, and I think this was very good, because since the end of 2009 we have had more than 4000 patients included who were treated by either the Edwards or the CoreValve and by transapical or transfemoral approaches. So we have a very exhaustive, well-conducted registry that has been accepted for publication in the New England Journal of Medicine, which for us is a kind of consecration 10 years [after] the first case.

Dr. Lewin: You know, David, we've had some experience here in the United States with the US Food and Drug Administration (FDA) and Center for Medicare & Medicaid Services (CMS). Could you share with us what's going on here?

Dr. Holmes: Sure. We are working closely with our government agencies (as you have worked in France with yours), with both FDA and CMS, to try to identify those criteria for centers that should be implanting the valve. Our goal, I suspect, is the same as your goal: to make sure that these valves are implanted in expert centers by expert physicians and surgeons in appropriate patients. We would then hope, that by working with our registry following your line, that we will have all patients enrolled in that registry so that we'll be able to track the long-term outcome in terms of the risk and the benefit ratio. So, we are following your lead in this regard.

One other question that comes up is in terms of off protocol or off-label indications. How do you do that? We have the indications of high-risk or prohibitive surgical-risk patients. What do you do with valve-in-valve or other indications?

Dr. Eltchaninoff: It's difficult. As in the United States and everywhere, only patients who are inoperable or at high risk should be treated, because we cannot extend the indications today. But the registry will include all of the treated patients, and we have patients who are off label. We have, as you say, valve-in-valve, etc. The government is very strict on that. In 2012, we will not be able to treat valve-in-valve anymore.

[crosstalk]

Dr. Eltchaninoff: They will follow that very carefully. They want also to have a paper from the heart team stipulating that the patient has been discussed by the surgeon and the interventional cardiologist, and that the procedure was decided by the team. In fact, it's becoming even more difficult, probably because they really don't want to have off-label indications.

Dr. Lewin: Do either of you think that 5 or 10 years from now we will be extending this particular new and wonderful technology to people who are, perhaps, operable, but because this is a percutaneous procedure that people will choose this? How long do you think it's going to take, experience-wise, until we can begin to expand the offering of TAVR to younger patients?

Dr. Holmes: I can answer that from the US perspective; I'm not going to talk about the European perspective. What we will need is more data. There are currently the PARTNER II and IIa trials[1] in this country, which will look at extending it to patients who are at less high surgical risk, and that will increase the number of patients that are being evaluated. You have SURTAVI in Europe.[2] Maybe you can tell us about that.

Dr. Eltchaninoff: Yes. SURTAVI will also be international. It's only for the CoreValve, and PARTNER II will be for the Edwards valve. I agree with you: It's crucial to have the data before extending [its use], because surgery is a very, very good option with very low mortality in selected patients. So, we cannot extend it before having the data of these very big, important studies.

Dr. Holmes: The question is going to be whether we will need randomized trials in other groups of patients -- lower-risk patients or patients with other diseases, such as chronic renal disease or something like that -- or whether registry experiences will serve to play and fulfill that role. What are your thoughts on that? Do we need randomized trials?

Dr. Eltchaninoff: For lower-risk [patients], for sure we need randomized trials. I think the easiest extent of indication should be to the old patients, such as 85-year-olds. Maybe it could be done [using] registry [data] because it's a very comfortable procedure when done transfemorally. You can do it without anesthesia. The patient can be discharged on day 2. That's what we do in our center, so with someone who is 85, it's really a good option and is also less costly, in fact.

Dr. Lewin: Well, you know, Dr. Eltchaninoff and Dr. Holmes, I suspect that if we have this interview again in 5 years there will be some exciting new things happening in this area.

Dr. Holmes: Let's plan on it.

Dr. Lewin: It's terrific that this procedure is finally available in the United States. Thank you so much for being here today.

Dr. Eltchaninoff: Thank you.

Dr. Holmes: Thank you.

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