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MARGARET WARNER: In Louisville this morning, the doctors who implanted the world’s first self-contained artificial heart Monday offered their first public assessment of the surgery and its aftermath. Speaking to reporters at Jewish hospital this morning, Doctors Laman Gray and Robert Dowling had good news to report about the man they operated on two days earlier.
DR. LAMAN GRAY: Since the surgery, the patient has done, I would say well. As a matter of fact, I will say, and he has done much better than Rob or I would have ever anticipated or expected, considering how sick he was preoperatively.
MARGARET WARNER: The doctors didn’t release the patients name, but said he was in his mid to late 50s and was on the brink of death before surgery, suffering from advanced heart disease, kidney failure and diabetes. The so-called abiocor heart is a yoyo shaped plastic and titanium pumping device that with some operational differences mimics the function of a natural human heart. It’s powered by a battery pack worn outside the body that transmits current through the skin. The device has an internal motor and a backup battery and pumps blood through the lungs and the rest of the body. A surgically-implanted controller regulates the rate and flow. The device was created by the Massachusetts company Abiomed. Doctors hope it will keep the current patient alive for 60 days. Over time, Abiomed officials hope to develop an artificial heart that could extend the lives of terminal patients up to five years. Though the doctors today were pleased with the patient’s progress so far, Dr. Gray also expressed caution.
DR. LAMAN GRAY: This is an experimental procedure. Everybody realizes it is. And there are lots of problems and complications that can occur. And this is the beginning; this is the first step in a long group of steps that we have to do to develop this device. I can’t even predict what the complications could be in the future that we have to deal with, and I’m sure we will have them.
MARGARET WARNER: The two surgeons join us now from the University of Louisville School of Medicine, where they both practice. Dr. Gray is director of thoracic and cardiovascular surgery. Dr. Dowling is an associate professor of surgery. Welcome, doctors both. Congratulations on your successful surgery.
Dr. Gray, first of all, are there any changes to report in the patient’s condition since you had your press conference this morning, any complications developing?
DR. LAMAN GRAY: No. There are no complications at this point. In fact, he continues to do better than what we would even anticipate. And this afternoon he was extubated, which means the tube was taken out of his wind pipe, and he is currently able to talk to his wife and family, talk to us, and really looks very, very good.
MARGARET WARNER: Does that mean that, is he breathing now totally on his own? Or is he still –
DR. LAMAN GRAY: Yes, he’s totally breathing on his own. And all of his neurological function is normal, and he’s able to talk to his wife and the rest of his family.
MARGARET WARNER: Dr. Dowling, all the commentary and analysis of what was, what you all did on Monday, the description was what the big breakthrough was that this artificial heart is totally self contained, that it doesn’t, you don’t have any tubes going into the body. Medically what’s the big advantage of that; explain what the big advantage of that is for the patient.
DR. ROBERT DOWLING: Well, that’s one of the major advances. And the advantage of that is that there’s nothing coming through the skin. The chance of infection is going to drop dramatically. And not only that, the quality of life thing, if you have a cable and you’re constantly tethered to either a wall outlet or battery pack, you’re not as mobile, you’re not able to get up, take a shower, you’re not able to get up at half time and grab a quick bite to eat without being tethered. So the major medical improvements as far as that goes is – we think — we strongly feel that this will lead to much less incidence of infection and just allow the patient more freedom of movement. One thing to say is that I think Abiomed has said it will be considered a success if the patient lives 60 days, but that’s not our hope. Our hope is that he lives months and perhaps even years on this artificial heart.
MARGARET WARNER: Dr. Gray, what is going to be the quality of life for this patient, given how ill he was, is he going to be able to, for instance, leave the hospital?
DR. LAMAN GRAY: Well, it’s going to take time. As mentioned, when he came in the hospital he was so ill he could probably only walk 100 feet at the most. Most of the time he was in a wheelchair because he was just too weak. And actually he was on, over the last three or four days, multiple drugs to keep his blood pressure up. So it’s going to take a long time to rehabilitate him and get him back into, physically back into good shape. But certainly we would hope and anticipate that he would be able to, hopefully get out of the hospital and to function normally, maybe, you know, certainly be able to walk. I don’t think he’d be able to jog, he wouldn’t be able to do strenuous exercise, but any normal activity. And hopefully he could return to work and lead a normal life — or relatively normal life, is what our goal is.
MARGARET WARNER: Dr. Gray, going back to why he was chosen, now he was terribly ill as we reported earlier, not only the heart disease, but he also had kidney failure, diabetes. He was rejected for a human heart transplant. Is that partly what made him appropriate for this artificial heart transplant? What’s the relationship there?
DR. LAMAN GRAY: Exactly. He was worked up in an outside transplant center and then reevaluated here. And both places we thought he was not a candidate for transplant primarily because of his chronic renal failure.
MARGARET WARNER: For a human heart transplant?
DR. LAMAN GRAY: For a human heart transplant, yes. And for instance, if you get a human heart transplant on him, he would have problems with the drugs that make the renal failure worse and there are several complications we thought could occur. Therefore, his only option was either continued medical treatment or have this artificial heart. And using a data analysis, we predicted that his mortality for 30 days would be in excess of 80 percent on the current treatment, with maximized efforts, there was nothing else medically we could do to help him.
MARGARET WARNER: So, Dr. Dowling, why would a patient who the doctors say you all, at least the company was only talking about perhaps extending his life by 60 days — why did he undergo this? What did he tell you about that?
DR. ROBERT DOWLING: I think there’s probably a misconception on what the company meant by that. I think the point about the 60 days was, these patients are very unlikely to survive 30 days. So one way –.
MARGARET WARNER: You mean without the heart.
DR. ROBERT DOWLING: Without the artificial heart implant, very unlikely to survive 30 days; just with conventional, maximal medical therapy they’re unlikely to survive 30 days. So the FDA came up with an endpoint that if you can double the projected survival of a patient, that would be defined as an early success. So the 60 day thing came about as if we can, we know the patient aren’t going to live 30, if they live 60, that would be a success by doubling their life span. Our hope is that even as the company — we go well beyond that goal of 60 days, in other words we meet the FDA’s criteria of doubling their life span, but our goal is to provide this patient hopefully with a much longer life span than 60 days.
MARGARET WARNER: So is it fair to say that this patient hopes that his life will be extended substantially?
DR. ROBERT DOWLING: Yes. Yes.
MARGARET WARNER: Dr. Gray, at the press conference this morning on a couple of occasions you said that both you and Dr. Dowling were, let me just get, concerned about the ethics and morality of this. What are the ethical and moral issues involved from where you sit?
DR. LAMAN GRAY: Well, I think there are several ethical issues. Talk about the ethical issues of any experiment, and it’s human experimentation, and you want to make sure that the patient is fully informed and there are no secrets from the patient. And some of the things we have done on this is we’ve discussed the procedure with him on several different occasions. But in addition to that, the patient has an advocate. The advocate is a independent person who has no relationship to either the company, Jewish Hospital, University of Louisville or Dr. Dowling or myself. And this person is totally independent and offers a separate opinion upon what we can say. And the reason we want that is if we happen to give a biased opinion, you know, we are enthusiastic about the potential of the device, but we want to be realistic too. And so we want to have somebody help us and help the patient make sure that everybody is fully informed and the expectations are realistic. So we have this independent person who helps guide the family and give them advice. It’s the family’s decision whatever is done, but we want to make sure that we don’t bias them and tell them the absolute truth and all possible problems and benefits also. The other ethical thing is that I want to stress that none of us have any connection with the company; none of us have any financial reward from this — and no one in either our families so, we cannot benefit financially from anything that is done here. We’re doing this because I think both Dr. Dowling and I honestly feel that this is a very important advancement for medicine.
MARGARET WARNER: Dr. Dowling, ideally, when this artificial heart technology is really perfected, ideally, how long should one operate in a patient? How many Americans do you think could use it, and how long will it take you to get there?
DR. ROBERT DOWLING: Yeah. Well, how long will it take us to get there is an unknown. We’re probably looking, you know, perhaps five or ten years down the road before it’s, if we’re able to accomplish all our goals before it becomes routine. There’s been a lot of estimates by the Institute of Medicine, just like statistics with heart disease, with the increase in congestive failure in our society, but conservative estimate is that tens of thousands of patients probably sixty to a hundred thousand or more patients each year in this country could benefit from some type of cardiac replacement therapy. So if the need is 100,000, the only type of cardiac replacement therapy we have now, until the total artificial heart, was heart transplants. And the number of heart transplants has not increased at all in the last five years, there’s only 2500 performed in the United States each year. So you have a huge discrepancy.
MARGARET WARNER: Let me ask you something about that. Because Dr. Jarvik who helped develop the artificial heart that was I guess state of the art in the mid 80s said he considered this obsolete technology because there are all these other devices, all these advances that assist a diseased human heart in doing its job. What do you say to that?
DR. ROBERT DOWLING: Well, I think there e may be a role for both technologies. I think there may be some patients where — that don’t have such end stage heart disease or some patients we feel that may be able to recover their native heart function where we don’t have to remove the native heart and put an artificial heart in. So I think I disagree with Dr. Jarvik a little bit. I don’t think there’s so much competing technologies, as they may be complementary. I think there may be some patients who will clearly benefit from having their heart removed and some patients that may benefit from not having the heart removed and an assist device put in. As further technologies develop, it may be that we develop ways to get these hearts back to normal function, and maybe there will be a larger role for assist devices. But as it stands now, I’m looking at the fact that they’re probably not going to be competing but complementing for a large number of patients.
MARGARET WARNER: All right. Dr. Dowling and Dr. Gray, thank you both very much and thanks for joining us.