THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
LEON HARRIS, CNN ANCHOR: We're going to go to that press conference that's getting under way now in Kentucky, Jewish Hospital, where the artificial heart that is self-contained is now being tested in a patient.
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UNIDENTIFIED FEMALE: We have a short video that we would like to show at this time to give you a little historical perspective about the device and about the research. Following that, Doctor Gray and Doctor Dowling will take over the program and we will have questions and answers following their presentation and more about that a little later.
DR. ROBERT DOWLING, UNIVERSITY OF LOUISVILLE: Could we please roll the video?
UNIDENTIFIED FEMALE: Yes, I can.
DOWLING: Start it over. This is -- Dr. Gray has referred to this as the most sophisticated medical device ever created, and there's absolutely no question that that's the case. So, we'll explain it in a couple of minutes. We'll do the best we can.
The device pumps on one side -- one side and then the other. So all of us here are pumping with our right and left ventricle at the same time. So, one unique thing about this device is that there's never been a patient or a person who pumped blood to his lungs followed by pumping blood to his body before. So, that's one of the unique design.
On the inside, there's a little pump that spins around and around about 10,000 times a minute, and that pump shuttles hydraulic fluid. Actually, it just moves hydraulic fluid, and then there's a, what we call a porting valve that goes back and forth. And when the valve opens one way, it lets the hydraulic fluid move to the right and therefore blood gets pumped to the lungs and when that porting valve moves the other way, the hydraulic fluid moves to the left and pumps blood through to the body.
So, that's that valve I was talking about. When you see it open, it's pumping this way and when you see it's closed, hydraulic fluid is pumping blood the other way. And that's just, again, to show that the hydraulic fluid getting shuttled back and forth, alternately pumping blood to the lungs and the body. All right, enough pumping. OK, that's the hydraulic fluid -- there you go.
And these are the artificial ventricles you saw in red and blue. And this is just a video, I think some of you may have seen this before. This animal was implanted in our lab. We implanted this device in 40 cows, and a smaller number of pigs, and this animal has been implanted for about a month. You can see everything's internal. There's just some IV tubing up here.
But this animal walking down the hall on internal battery power. He's got his little booties on so he doesn't slip on the floor. We actually have a treadmills for the cow. We spent $10,000 and one of our cow sitters made these booties for us for $20. And I think a little bit later we're going to give a summary of our animal experience, but for now. I don't know.
DR. LAMAN GRAY, UNIVERSITY OF LOUISVILLE: I think I'll speak for both Rob and me. We're really thrilled to be a part of this -- the team doing this and as Dr. Lederman mentioned, it's a very large team effort, and it's a team effort not only in Louisville, it's also in Avumed and the other four centers that are associated with this. All of us have worked very closely together trying to make the end result right.
And I will start with a little background, since we sort of mentioned it. Our experience started about 3 1/2 years ago with Abiomed, and actually had been working with them for I guess 10 years, 15 years earlier on other devices. But we began working in the animal lab with the device, and helping them as they've modified the device and changed it and perfected the device. That's taken the last two years.
And then, actually the last year of this has been really the perfected device where we've been working through and helping them test all of the components and the completed system. So, the animal studies were done in detail, and the information obtained from the animal studies was then submitted to the FDA along with what we call reliability studies from Abiomed that everybody is quite familiar by now that looked at the durability of the device.
And having both of these out together plus extensive protocols and everything, the FDA has then given permission to go ahead and now with five initial implants, and then after that, it will be reviewed. Actually, it's reviewed on a case-by-case basis, but the -- we would then plan to expand the study into more centers and also patients in the future.
Now, we did do the implant on Monday, as everybody is aware. I'll tell you a little about the conditions and who we're looking for. The patients that are eligible to go into the study have to have in- stage heart disease.
They have to be -- have basically no other options. They cannot be transplant candidates, and they have to basically have a life expectancy of less than 30 days with any conventional therapy. So, the group who are using are obviously the sickest of the sick patients, and they -- their chances of survival with conventional therapy is very limited.
We have some very sophisticated algorithms to help determine this, and we can statistically through parameters help determine what their probability is of survival or non survival before we put it in. So, the patient have to meet this criteria that they have an 80 percent chance of dying within 30 days with conventional therapy.
The second thing that we look at is the fit of the device, and we take and get a CAT scan of the chest, a chest X-ray, and basically put into a type of CAD program and by computer, we extract the native part and then put in the AbioCor and are able to turn around and look at all angles to make sure it's going to fit properly.
So, once those two things are -- meet the criteria, then, obviously, we discuss this with the patient and the family. We try to do this very honestly. We give them all options and go over everything in detail with them.
I'll mention that we're very concerned about the ethics and the morality of doing this. So, every patient that will be entered into this study has a patient advocate. The patient advocate is somebody who is unrelated to Abiomed, unrelated to the University of Louisville Jewish Hospital and is a totally independent person who is available to advise the patient and the family of anything they want. It's their helper. It's their person that will help if they -- if the family wants it to guide them through the process and what needs to be done.
The -- following that and the decision is made to do this, which was done sort of over the weekend, we then were able to proceed. The patient and family have asked not to release information on them, and we will honor that, and I hope that everybody will respect their wishes.
But what we can say about them is, I think, most people understand it's a gentleman at this time, is he's in his late to mid- 50s. He was turned down at transplant center not in this area and was -- had no other option. When he came to see us and we evaluated him, he was extremely sick, what we call Class IV patient. We admitted him to the hospital and actually wound up that he had -- at the time he came in, he was so sick we had to out antriatic (ph) balloon pump to help support his pressure.
And in addition, he was on three drugs to help maintain his pressure. So, he was as dire shape as you could ever have anybody in.
In addition, he had had chronic, preexisting renal failure with an acute exacerbation because he had gotten sicker recently the week or so before he had came in. And his creatinine when he came in was three range, which means he has moderately severe in-stage -- not in- stage, but renal problems.
For the technical people, we, with all the (UNINTELLIGIBLE) and maximum support, we did get his creatinine down some, but we never got it down under about 2.2. In addition, he has diabetes and he had severe, severe biventricular failure. By that, I mean the heart, when you consider it, has two hearts -- it's a right and the left side -- both the right and the left side were severely failing.
And our feeling was that he would not be a very good candidate because of the right ventricular failure and some high blood pressure and the lung circuit for a left ventricular assist device.
The operation was then performed on Monday morning. Oh, I want to mention one other thing. I forgot, he had had previous coronary bypass surgery, and the reason for the cardiomyopathy was he had had multiple heart attacks in the past and he had had bypass surgery in 1992 or something around there. So, he had had -- it was an ascemic (ph) cardiomyopathy.
We began the implant, and Rob, why don't you go through the technical aspects of the implant.
DOWLING: All right. Are we going to show that video or just talk about it?
HARRIS: At this time, let's bring in our Elizabeth Cohen, who has been standing by and monitoring that press conference under way in Louisville. She is there now -- Elizabeth.
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: Well, Leon, what we learned is that this surgery was performed on a man in his mid-50s who was, as the doctor said, in about as bad as shape as you could ever think to see. He was -- not only was his heart failing him and certain to die within a month, we also just learned that he had renal or kidney chronic problems, chronic failure; that he also had had coronary bypass surgery; that he also had diabetes.
Now, they haven't told us quite yet how he is doing, but we sort of get a picture for what kind of choice this family had. This man was going to die, and they are hoping that this artificial heart will keep him alive. They've told me this morning that they really aren't sure exactly how long he'll live on this heart.
What they're hoping for is that he will live for six months, but they said that they were very clear with the family, they followed all the ethical rules about not giving them too much hope.
Now, they also showed us in the press conference just now a little -- a calf with the artificial heart implanted inside it walking around in booties to show that this -- you really can walk around with this artificial heart, unlike the old ones in the 1980s where the patients like Barney Clark were tethered to a machine, a power source the size of a dishwasher, that this animals could actually walk around.
And I'm sure that's what eventually they're hoping for with their patients who they put the artificial hearts in. Right now with this patient, the feeling that I'm getting is that they're not necessarily thinking that he will be up and walking. They just don't know at this point -- Leon.
HARRIS: Well, Elizabeth, one question for you. You say that they expect -- they are hoping that this patient can last some six months. Is that six-month figure the factor of the heart itself, this artificial heart that it only lasts that long is this because of the condition of the patients' body right now?
COHEN: Well, it's really the patient was in a terrible condition and without the heart he wouldn't have lasted anywhere -- for a month at the absolute most is what they've been saying. It's not so much that the artificial heart would fail, it's that a combination of just -- they don't know what the artificial heart will and won't do in a human being and the fact he was in bad condition to begin with.
But again, they've never put this in a human being. When they put it in calves, it only lasted three months and that's because the calves grew out of it. They wanted to test it in animals that wouldn't grow out of it, but they couldn't find a good model. So, the best evidence they have are the calves who lasted for three months. Beyond that, they just don't know.
HARRIS: That's interesting, so there's still a lot to learn yet, here. Stay...
HARRIS: All right, good deal. Thanks, Elizabeth Cohen, standing by for us there Louisville, Kentucky.
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