Heart Replacement—Progress & Problems

Mr. Seymour

Distinguished guests, members, and friends of The Empire Club of Canada: It is my pleasure to welcome as our guest speaker today Dr. Allan M. Lansing, Chairman and Director, Humana Heart Institute International.

Our guest speaker attracted worldwide attention last November 25, when his team of cardiovascular surgeons at the Humana Heart Institute International implanted the Jarvik-7 artificial heart in the chest of William J. Schroeder, who was suffering from terminal heart disease.

The critics immediately challenged the need for the operation and the motivation behind Humana Inc., a public company whose shares trade on the New York Stock Exchange, and its agreement with the institute to finance up to 100 of these artificial-heart implants.

Dr. Rollo May in his book entitled The Courage to Create addressed the critics of change as follows: ". . To live into the future means to leap into the unknown, and this requires a degree of courage for which there is no immediate precedent and which few people realize."

Humana Inc. responded to the critics and the problems they raised, be they ethical, technical, social or financial, in its November 30, 1984, quarterly report. Subsequent devel-

opments helped to further negate the critics' position.

On March 15, 1985, The Toronto Star reported that: ". . An artificial-heart program is planned at St. Michael's Hospital for patients with severe heart disease. . .The University of Toronto has approved the hospital as the site of the program. . .The plan hinges on approval from Ottawa for the use of the artificial-heart device."

On March 23, 1985, The New York Times reported that ". . Doctors are ready to implant a Penn State artificial heart at Hershey Medical Centre."

Then, on April 10, The Globe and Mail reported that ". . Doctors at Karolinska hospital in Stockholm have performed the first artificial-heart implant outside the United States."

Who is this pioneer of artificial-heart transplants? Born September 12, 1929, in St. Catharines, Ont., Allan Lansing graduated from the University of Western Ontario summa cum laude with a Doctor of Medicine degree in 1953 and earned a doctorate in physiology four years later.

After he completed his internship at Victoria Hospital (in London, Ont.) specializing in surgery, he went to the United States to pursue his interests in cardiovascular and openheart surgery. After positions of increasing responsibility at the University of Illinois, the Houston Medical Centre and the Children's Hospital in Boston, Dr. Lansing returned to London "to stay" in 1961.

His restless, pioneering spirit, however, could not be contained. In 1963, he was invited to move to Louisville, Ky., where he has since made a name for himself with several firsts in the world of innovative surgical techniques. Seven years ago, he left the University of Louisville medical faculty and built his own cardiac-surgical practice in Louisville.

Dr. and Mrs. Lansing-his wife is also a University of Western Ontario graduate-have three children: Anne, a doctor; Peter, a landscape gardener; and Michele, a registered nurse who operated the heart-lung machine and assisted her father in the implant operations.

Ladies and gentlemen, I am pleased to introduce Dr. Allan Lansing, a man of outstanding academic achievements, a man of uncompromising ideals, and a man of vision who has had "the courage to create"; who will address us on the subject, "Heart Replacement-Progress & Problems."

Allan Lansing

I thank you very much for that introduction. I hardly recognized myself and you should not believe all the things Mr. Seymour said about me. I wasn't restless, I just couldn't find anything to do in Canada at that time and an opportunity came to go south, which my wife and I took with great regret. I was blessed because I had a fine education in Canada, first in the secondary school system, and then at the University of Western Ontario, and that's what has made it possible for me to achieve what I have.

When I was invited to Louisville, I didn't even know where it was. Donna at least knew that the Kentucky Derby was run there, but I didn't know that either. However, the people were very friendly and it looked as if there was an opportunity. So we moved to Louisville and I worked with the university for 15 years, and built up a private practice at the same time, so that, after 20 years, I had reached the place where our team was the best in the neighbourhood. About three years ago, two of the founders of Humana, Wendell Cherry and David Jones, came to me and said:

"Wouldn't you consider moving from the Medical Centre out to Audubon Hospital and work in our hospital? We have a Centres of Excellence Program in our hospitals around the country and, if you came there to work, we would support your research and education and help you to establish a Centre of Excellence" I replied, "No, I think we're already a centre of excellence and I'm really not interested."

Well, over the course of the next few months, I started to

think some more about the idea. I started to look at Humana and see that it had enormous resources-administrative, financial and otherwise-and we, as a group of surgeons and cardiologists, had great medical skills. Maybe we could put these two together and build something even better; something even bigger than a Centre of Excellence, something that would be internationally known. So I talked to them some more and finally, with regret and concern, moved our team to Audubon Hospital.

The great concern was about being involved with a forprofit hospital organization, but it meant the opportunity to establish an international centre that would be on the leading edge of cardiology, cardiovascular surgery, research and education.

Not only did we want it to be on the leading edge, but we wanted to maintain what had been characteristic of our particular type of medical practice-that is, the care, the concern for the patient and the family, what I call the "personal touch"; touching the patient, physically, emotionally, looking at him, listening to him, caring about what's happening to the family. In other words, helping him through a trying time. If we did this, it would not only put us on the leading edge and make it internationally known, but at the same time maintain touch and caring, we would have something special. So I said:

"We'll try, but it's going to take ten years."

It has been two years today since we started on the Humana Heart Institute International.

You all know what's gone on in that time. We're best known for the heart-replacement program, which involves two aspects: both transplantation of human hearts and the mechanical-heart program.

As you know, heart transplants started back in 1967 and many centres got on the bandwagon. But the patients all died and the programs were abandoned.

However, thanks to research that continued at Stanford, new progress was made and now it's a very successful proce-

dure. Everybody's adopting it again. Eighty per cent of the patients are alive a year later. The results are improving all the time, because of endomyocardial biopsy and cyclosporine, as well as further understanding of the rejection process.

It can be an ideal answer. We've found that people who are dying, who get a new heart-a new human heart-can live, can enjoy life, can become productive. So certainly, heart transplantation is a wonderful form of therapy.

But it has problems. First of all, there aren't enough donor hearts to go around and, with more and more centres doing heart transplantation, there are going to be even fewer hearts for any one centre.

Secondly, there's a preservation-time problem. That means that you have to get that heart out and reimplanted within four to five hours. Now, we may get it up to 24 hours, but still you can't go very far afield to get a heart. And, finally, it's expensive. The cost is not only the $75,000-$100,000 to do the transplant, but $12,000-$15,000 per year to follow the patient afterwards.

So, transplants are great, but there are problems: donor availability, time, and cost. We know they work. We know there's a need for heart replacement-where do we go? Well, we have to go one of two places. We either have to go to xenografts-that is, we have to learn how to use animal tissues, and we're a long way from that-or we have to go to a mechanical replacement. The heart is a pump, like many other kinds of pump. Why can't we replace it?

Now this program is not new. The first mechanical heart was implanted in an animal by Dr. Kolff at the Cleveland Clinic in 1957, almost 30 years ago. He's been working on it ever since; he's the "father" of the mechanical heart. And he, with the group at Utah, developed it to the present stage. They're the leaders.

But there are still many problems. When we implanted this heart, we ran into a few of them. I ran into one this morning when a national television host immediately got after me about the things that everybody is concerned about,

and that's what I'd like to spend the next few minutes discussing: the cost, the ethical problems, and the involvement of a for-profit hospital corporation in this research.

First of all, cost. It's very easy to say that Humana is going to guarantee the cost of the first hundred implants; it is going to pay for it. The patient pays nothing, the family pays nothing, the doctors give their services. Humana picks up the total cost, not only of the operation and of the hospital care, but it is paying for the cost of the patient and the family living in the special apartment across the street, renovated with air compressors, monitoring lines and computer access. It pays for the specially equipped van when the patient goes off to a ball game, fishing, or to visit his family in Jasper. So the cost is borne by Humana, and it's an enormous cost, let me tell you.

That's all very well, but what about the future? What happens if it's done somewhere else? Or what happens after the hundred are done? Who's going to pay then? The estimate from the University of Utah was $250,000 for Barney Clarke. It's much more than that, I'm sure, for William Schroeder, particularly with the continual ongoing costs.

Are insurance companies going to pick it up? No, because that will raise their premiums, and they won't be able to sell any policies. Is the U.S. Federal Government going to pick it up? It has already had experience with the End-Stage Renal Disease Program and the tremendous costs involved there. The legislators are very unlikely to take another millstone and put it around their necks.

Are we going to have to raise money privately from donors as we do now to pay for liver transplants and bonemarrow transplants? We may. However, our hope is that, with success, with time, we can lower the cost and make it affordable.

But this whole problem of cost has brought up some ques-, tions that I raised this morning in talking at Mount Sinai Hospital-age-old problems.

• How much is a single human life worth in dollars and cents, be they Canadian or American dollars?
• How much should society commit from its general funds for the welfare of a few individual lives?
• And, are we getting to the point where certain procedures for saving lives are thought to be too expensive to use in any individual case?

These are questions for which we do not have an answer. J " My approach is, we have to wait and see. We do not know if the heart is going to work. If it doesn't work, if it doesn't give longer life, if it doesn't give improved quality of life, it's not going to be used anyway.

If it does work and it's too expensive, we'll have to find a way to make it cheaper. There's no doubt in my mind that Toyota or Mercedes or Fiat or General Motors (car manufacturers) will be able to make one cheaper and we'll learn how to put it in more easily. If it works, we'll make it affordable.

The next problems were ethical. The first question was, "Why don't you perfect this in animals before you put it in any humans?" Well, hundreds of animal experiments were done; the mechanical heart was put in calves and sheep over and over and over again. The technique was perfected, the power supply was improved, the valves were tested and we got to the point where we weren't learning anything more. And we had to say that people were dying more, and it was time to try the mechanical heart in humans to see if it would help them.

As a result of this, we learned some things that we did not know from animal experiments. We didn't have bleeding problems in animals because we were dealing with a normal aorta, as opposed to a diseased aorta, and the vigorous motion of the mechanical heart and its drive system pulled on the suture lines and produced the leaks and bleeding.

We learned we had to buttress, we had to support those areas of the suture line, a manoeuvre that wasn't needed in the animals. We didn't have the blood clots and the emboli

in the animals as we do in the humans. So we had to adjust the anti-coagulation. We didn't have the hemolysis, the destruction of the red cells; the calves' blood seemed to stand this battering by the pump much better than humans'.

As a result, we've modified the drive system so it's more gentle, so that, instead of slamming the valves shut, we close them more gently. As a result, the blood count is rising and the people are stronger and feel better because they aren't so anemic. We could not find these things out in animals, so we have to try in humans eventually.

Well, if you're going to try such an experimental procedure, why aren't you doing it at an academic institution? Why isn't it at the University of Toronto, rather than in a for-profit hospital? Well, I think this is a perfect example of how things have to be done.

The mechanical-heart program was funded by the U.S. Federal Government through the National Heart Lung and Blood Institute for about 15 years, and they spent money working on power supplies and valves and pumping chambers and materials. After that, they made a decision, like the ones we were just talking about, that there was no future; it cost too much, it had too little to offer. It was a decision based on the best use of general resources. So they stopped funding artificial hearts.

When did they stop? Right at the time that Barney Clarke received the implant. The University of Utah had no more funds to look after Barney Clarke, the first human to have a permanent artificial heart; they had to go out and raise money in the community. They had no funds for a second one. The whole program was dead in the water.

At that stage, a private corporation said:

"We believe in the people. We will support it. We will fund this as long as you are making scientific progress." And they leave it up to us to decide. If we're not satisfied we're making some progress, we switch to another heart or we stop altogether until a new promising development occurs. That's our responsibility, but Humana says it will back

it. As a result, private industry has supported a program that the Federal Government, quite rightfully, gave up as too expensive.

It's exactly the way things have to be done and it's the way you're going to have to do things in Canada as well. You can't expect the Government to fund everything; to support all research projects; to be able to pick out which wild ideas to fund; they have to support the general good. So I think it's an excellent example that should be carefully studied and considered.

The last question was that of the publicity involved. It was said that this was a circus; it was done entirely for the benefit of Humana to get advertising, we didn't have to give all this information out to the press and public; it was not necessary, it was done badly, it should have been done more discreetly, and it should have been done quietly and published later, in a scientific journal such as the New England Journal of Medicine.

I tell you that course was absolutely impossible. There was no way that we were going to keep these national and international correspondents from finding out what was going on and from reporting on it-that's their job. The public wanted to know and it was going to find out. So Humana made the decision that, instead of trying to fight the media people off, it would put them in a convention centre seven miles from the hospital; give them everything-all the telephones, all the videotape, black-and-white and colour pictures, and regular medical updates so that they had information coming out their ears.

And the result was that the press never went to the hospital. Reporters never disturbed the patient, the families, the nurses, or any other patient in the hospital. They stayed right down in the Convention Centre and they did a great job.

During the first implant, they stayed there for two months; the second one, they were there for twelve days; and, for the third one, they were there for three days. They may not even come next time. Who knows?

But the publicity was absolutely unavoidable. It had to be handled. For instance, Dr. DeVries tells about an episode in Utah when Barney Clarke was in the intensive-care unit. A laundry cart was wheeled into the intensive-care unit and out of it leaped a little Japanese reporter with a camera, who started taking pictures of everybody in the ICU. These appeared on the front page in Tokyo a day later-pictures supposedly of Barney Clarke.

A university photographer, who took some pictures in the operating room, was offered $50,000 by a magazine for any two pictures. He only made $10,000 a year, but he couldn't sell the pictures or he'd lose his job. That's the kind of temptation that exists, if you don't deal with it.

You've got to recognize the press has a job to do and you had better help it to do it well. That is exactly what was done. Well, I have talked too long, but I have one other observation that I want to make because of all the questions that I got this morning on national television. I have been very fortunate, as a physician, to work in almost every kind of hospital-a VA hospital, a private hospital, and in a forprofit hospital. So I have experienced all of them. Each system has its advantages and each has its disadvantages.

I can say, I do not work for Humana; I receive not one dime from it. I work in a Humana hospital, Humana provides the facilities, but it doesn't pay me a penny. It doesn't pay Dr. DeVries anything either; he works for me. We are independent practitioners working in that hospital.

I can honestly say that Humana has not cut one corner. It has done everything we've asked to improve the quality of the care, the equipment, materials, the staffing or whatever we thought was best for the patient. We do not turn away a single patient, regardless of ability to pay.

When I was discussing a possible move to a Humana hospital, I told Humana that, for years, if a doctor called and wanted to send me a patient and he said: "Mrs. Jones is sixty, she has a little farm, but she has no money and she has

no insurance," I'd say: "Fine, send her in" The hospital would pick up the tab, we'd work for nothing, and she'd get looked after regardless.

When I went with Humana I said: "That's the way I have worked all my life," and Humana said: "Fine, we accept that. We'll go along with it."

You probably don't know about some other programs that this hospital corporation supports. Humana pays for all the care of indigent patients in the entire Jefferson County. It runs the medical school hospital, which was losing $4 million a year before Humana took it over. It is now making $1 million a year, of which the university gets $250,000 and Humana pays taxes on the $750,000. The university staff has the best equipment around; it is much happier.

It can be done. There is a place for every system. None is perfect, but this system has provided the resources for us to do this kind of highly experimental and very expensive work. It has given us the chance to decide on the programs and to direct them, and given us the opportunity to do something that we could never have done in any other way. It could never have been approved or funded by a Federal Government committee. I hope you will look at this role of private business support as a possible model for future consideration in Canada.

In summary, I've been extremely fortunate. I had a fantastic education here in Canada, which gave me my start. I've had the opportunity to work in every kind of hospital and medical system in the world, and I have an opportunity now to build an international institute using private resources on the basis of no contract, no money, no lawyers-just a handshake with David Jones, the Chief Executive Officer of Humana. That's all we have.

In two years, we've made great progress. There have been many questions raised-ethical, legal costs, and others-but the experience has all been worth it.

Finally, I am also particularly grateful for my Canadian heritage, for my background and for the honour that you

The appreciation of the audience was expressed by Dr. Harold Cranfield, a Past President of the Club.