Heart Transplant

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* Heart Transplant Procedure (Montefiore Medical Center, Bronx, NY, 09/19/2007)

REPLAY OF HEART TRANSPLANT PROCEDURE

MONTEFIORE-EINSTEIN HEART CENTER

NEW YORK, NEW YORK

September 19, 2007

00:00:14

ANNOUNCER: Welcome to the Montefiore-Einstein Heart Center in New York City. In just moments you'll see the first heart transplant procedure ever webcast on OR-Live. The procedure was performed by Dr. David D'Alessandro on April 17th at the Heart Center. Dr. Daniel Goldstein will moderate a range of discussion topics, including a clinical description of

the procedure and aftercare. The operation you're about to see is called the orthotopic heart

transplantation. The recipient's heart is taken out and a new heart is placed in the same

exact position that the native heart rested in. OR-Live makes it easy for you to learn more.

Just click on the "request information" button on your webcast screen and open the door to

informed medical care. Now let's go OR-Live.

00:01:04

DANIEL GOLDSTEIN, MD, FACS, FACC: Good evening. Welcome to Montefiore Medical

Center in New York City. We're happy you're able to join us either here in the audience or

anywhere in the greater New York area, United States, or all over the world. You're in for a

special treat tonight. Through the magic of the Internet, we're for the first time ever

featuring a heart transplant operation with the possibility of the audience to be joining us in

an active interactive fashion to find out more about this very exciting operation. By way of

introduction, heart transplantation is really a very radical operation. It's probably one of the

most invasive things that a person can have done to them. This is not taking a gall bladder

out or taking an appendix out, this is really replacing an old, damaged heart for a new,

normally functioning heart.

00:01:48

By way of history, the first heart transplant operation ever performed was performed

in 1967 by Dr. Barnard. Probably most of the audience has heard about that. That patient

lived only for 18 days. And in fact, the next nine operations performed around the world

were pretty much unsuccessful. And in fact, there was a moratorium placed on heart

transplantation in such a way that nobody was allowed to perform another heart transplant

operation. Many people in the field thought, "Huh, this is it. We will never see this done

again." And in fact, it wasn't until 1983 with the advent of very powerful

immunosuppressant medications that clinical heart transplantation became a reality.

Nowadays, approximately 2,200 to 2,300 operations are performed in this country and

probably around 3,000 worldwide. And the life expectancy of patients receiving this

operation is terrific. People who don't receive this operation who are as sick as people who

do live in the order of about a year. If you receive it -- if you're lucky enough to be one of

the few who receives a heart, you have a 50% chance of being alive close to 12 years. So

this is a very powerful therapy for a very bad disease, and the disease we are speaking

about here is end-stage heart failure.

00:03:03

Now, heart transplantation is a unique and rare and unpredictable operation. What

do I mean by that? Well, if Mrs. Smith came to my office and she needed a heart transplant,

I could not say, "Mrs. Smith, we'll do this operation Thursday morning." It just doesn't work

that way. We never know when a heart is going to become available. A team is always

ready, and at the turn of a dime we need to get a big team involved in order to procure the

heart, get the patient into the hospital if they're not already in the hospital, and perform the

operation. So while the operation itself, which you will view in a few minutes, lasts probably

on the order of 45 minutes to an hour, the entire process takes more like 12 to 18 hours.

And Dr. Ricardo Bello, one of our physicians, will describe more regarding this process.

00:03:52

So here we are. Once again we welcome you. We encourage you to email any

questions you might have. There's a text box on your screens which will allow you to

directly text us, and as soon as we can and as often as we can we'll attempt to answer any

questions you might have.

I am the surgical director of the transplant program, but I am not the only person who can

do this. I need a whole team of people and talented people to help me. To my right is Dr.

David D'Alessandro. David came to Montefiore Center shortly after I arrived. We both

trained at Columbia-Presbyterian Medical Center down in -- a few miles down the road. And

to his right is Dr. Ricardo Bello, who's one of our very talented residents who actually

completed his training at Montefiore Medical Center and is now one of our junior attending

physicians. So with not much more to do, I will pass on to Dave so he can describe a little

bit about the patient whose transplantation procedure you're about to witness. David?

00:04:56

DAVID D'ALESSANDRO, MD: Thank you, Danny. This is a real exciting opportunity for us to

introduce to you the heart transplantation procedure and some of the tenets involved in the

operation. The patient whose operation you're about to see is a 53-year-old gentleman who

came to us several months ago with longstanding history of worsening heart failure. This

began for him about nine months prior when he suffered a viral illness which left his heart

permanently damaged and unable to perform the normal functions of a normal heart. His

complaints were mainly shortness of breath and fatigue, and this had again been worsening

over the last several months. When he was evaluated here at the Einstein Heart Center

facility, he had already been maximized on medical therapy and basically had come to the

end of the road. Despite that, several weeks later he was admitted here to this hospital with

worsening congestive heart failure and required administration of intravenous medications

to help his heart to pump. That still was not enough to relieve his symptoms, and his

shortness of breath was so bad that he could not even get himself out of bed. What we had

to do was place a special balloon pump in his groin called an intraaortic balloon pump, which

basically inflates and deflates and helps assist and unload the heart. We were preparing to

put an artificial heart in this gentleman because the balloon pump was a temporizing

measure, but fortunately for him he had a less common blood type which enabled him to

get a heart much more quickly. Whereas most people on the heart transplant list wait

several months, even periods in excess of a year, he was able to get a heart within a couple

months of being listed. So when the call came in, we prepared him for the operating room

and sent a donor team led by Ricardo Bello on my right to go evaluate the organ. In a

minute we're going to cut to the videotape of the operation, which begins after I've already

divided the breastbone to gain access to the heart, but why don't we begin with Dr. Bello's

description of the organ harvest procedure. Rick?

00:07:09

RICARDO BELLO, MD, PhD: Thank you, David, and thank you all for joining us tonight. Well,

as Dr. Goldstein said, this whole process is very unpredictable, but nevertheless there's

always a team ready 24/7 ready to go. From the time that we received our first phone call

to the time that the recipient operation is completely finished, it takes approximately 12 to

18 hours, as Dr. Goldstein had mentioned. However, the actual operating time for procuring

an organ and for implanting the organ is not nearly as long. So what causes all of these --

why so much time, then? Well, the main reason for this is that there's a lot of delays

involved in the process which again are unpredictable to us. For example, normally we

would go to harvest the organs at distant sites, and this does not simply involve hopping in

an automobile or a van to get there but usually involves flying there, and so charter flights

have to be set up. And this not only occurs for our team harvesting a heart but for other

teams harvesting other organs. Once the teams are assembled at the donor hospital and

the donor is brought into the operating room, we proceed with the operation. Throughout

the operation we're in constant communication, and of course, prior to this the donor's

medical records and studies have already been reviewed not only by our transplant

coordinators but by the procurement team. Once we proceed with the operation, the actual

procurement is very straightforward and takes less than approximately a half-hour. This

involves doing some basic dissection to expose the great vessels of the heart and placing a

tube in the ascending aorta to allow for delivery of preservation solution. But again, this is

something that requires us to be in constant communication with the recipient team back at

Montefiore as well as the other teams that are there procuring organs. Once we're ready to

proceed, the aortic cross-clamp is placed on the ascending aorta and preservation solution

is then delivered to the heart. Ice is placed on the heart that stops the heart and helps in

the -- this helps in the preservation of the heart. Shortly after that and over the next 10 to

15 minutes the heart is explanted from the donor and placed in preservation solution and

brought back in a cooler full of ice. We of course try to minimize the time that this takes

because we try to minimize the total amount of time that the heart is without circulation.

And so once the aorta is cross-clamped, we try to speed back to the recipient hospital. Once

we get back, Dr. D'Alessandro will be ready to receive the heart and start the implantation.

As I said before, the timing is critical. We try to minimize the time that the heart is out of

the circulation, and so optimally, as the recipient heart is being remove, we are arriving

with the donor heart. Danny?

00:10:31

DANIEL GOLDSTEIN, MD, FACS, FACC: Thank you, Rick. Just something that the audience

might have not picked up on. Unlike kidney transplants, where you can use a cadaveric --

meaning someone who has died -- you can remove their kidney, when you're dealing with

heart transplants you've got to remove the heart from a patient whose heart is still beating.

So usually in all instances these patients are braindead and the family has been approached

after the brain death, which can occur either as a result of drowning or a gunshot wound or

a stroke or a bleeding to the head, and they're asked for permission to donate the heart as

well as other organs. So just to make that -- that's an important point. This is always a

beating heart harvest unlike the kidney and other organs that can be removed after the

patient's heart has stopped.

00:11:17

We have a question here from the United Kingdom. Someone's viewing and asking if

the procedure we're about to witness is the same procedure that is done in the United

Kingdom, and the answer is yes, with perhaps some minor technical differences, I would say

90% of the heart transplant operations that are performed in the world are performed in the

same way that you will say here, namely by a bi-cable technique. So without more to do,

why don't we start rolling the tape? David?

00:11:45

DAVID D'ALESSANDRO, MD: Yeah, let's get to the exciting part. So the patient is now in the

operating room, and as I mentioned before, the breastbone has already been divided. You

see a retractor in the patient's chest that helps us to expose the heart. And just to orient

the viewer, the patient's head is at the top of the screen and the feet are at the bottom of

the screen. What we're doing now is putting stitches into the aorta. In order to take the

patient's heart out, we need to put him on a heart-lung machine. As you might imagine, by

removing the heart, we're removing the patient's ability to send bloods to the lungs to

oxygenate the blood and deliver that to the rest of the body, so we need a machine that

takes over that function while the heart is removed. And that's called a heart-lung machine,

and that's operated by a specialized team of people known as profusionists. And their job is

to keep that blood circulating, to keep it oxygenated, and to keep the body's metabolic

mechanisms going while the -- during the period of time when the heart's removed. Now

we're putting tubes into the aorta. That's what's called an aortic cannula, which is basically

a large hose that goes into the ascending aorta. And that's going to deliver the blood that

we're soon going to remove from the patient's body. That's going to deliver it back to the

patient's body after it's circulated through the heart-lung machine and been oxygenated.

What you don't see is that the superior vena cava, which is the large vein that drains blood

from the upper half of the body to the heart that has already had a tube placed in it, and

now we're putting stitches on the inferior vena cava, which is the large vein that sends

blood to the heart from the lower half of the body. And we call these purse string sutures

because of the mechanism by which they tighten, similar to a ladies purse, I'm told. The

next thing you're going to see is a -- the cannula that's going to go into the venous side.

That's a -- that's a very sharp knife that we use to make a hole, and through that hole we'll

place the venous tube.

00:13:44

DANIEL GOLDSTEIN, MD, FACS, FACC: As we see in these cannulation of the vena cava, we

have a few questions we'd like to answer. One of the questions is, "What is the current

protocol for screening the donor heart?" There's a number of things we look at in terms of

assessing whether a donor is a good donor to supply the organ for a recipient. From a

cardiac's standpoint we look at cardiac enzymes. We like to know what the mechanism of

death was. We get an echocardiogram of the patient, usually a transthoracic

echocardiogram, and we obtain a cardiac catheterization to make sure the arteries to the

heart are normal. Clearly we only do this in people who are at high risk at having blockages

of the arteries to the heart. So people who are smokers, people who are at advanced age,

people who are diabetic, high blood pressure, these are the kind of people which we would

consider doing that.

00:14:33

DAVID D'ALESSANDRO, MD: So what you just saw was placing what are known as

tourniquets around the inferior vena cava, and in a few more minutes you'll see another one

placed around the superior vena cava. And those are used to create a seal around those

hoses so that when we cut the heart out the blood doesn't leak around the cannula. At this

point we're creating a tissue plane between the left and the right atria which will assist in

identifying the correct areas to cut when we're removing that part. And basically you see

the operation's proceeding a bit slower at this point, and that's because we're waiting to

hear from Dr. Bello that the organ has arrived within the hospital. We've done nothing

irreversible at this point in time. And if there were an accident of some sort that prevented

the donor heart from arriving, we could always wean the patient from bypass and return

him albeit still with persistent heart failure. So we're waiting to know that that heart has

arrived, and at that point you'll see us place a cross-clamp on the ascending aorta and cut

out the heart. There is constant communication at this point between our donor team and

us in the operating room telling us where they are, how far out they are and basically gives

us an idea of how much more time we have to get this heart out. We're now creating a

similar tissue plane between the pulmonary artery, which is that structure on the right-hand

side of the screen, and the aorta, which is the structure on the left-hand side of the screen

that has the large tube in it. And again, that's just to assist us in knowing where to cut. And

that's the tourniquet going on and being tightened now around the superior vena cava. So

we've now sealed off the inflow of blood to the heart, and you can see how the heart is now

emptying. It's become a much more baggy or flaccid-looking structure, whereas before it

was quite large and distended and beating weakly. I want you to remember how this heart

looks at this point in time because when you see the new heart later on you'll notice that it

beats much more vigorously.

00:16:35

So presumably, Dr. Bello has arrived in the hospital and we're now cutting out the

heart, so this begins the first irreversible step in taking the heart out. We're now cutting

into the right atrium at the border with a secured vena cava. And what you'll see in a

minute are some wires that are coming through the secure vena cava, and that yellow

catheter which is a pulmonary artery catheter -- it's a special catheter designed to measure

pressures in various spots in the heart, and that's going to assist us in caring for this patient

over the next several days. There are special pacemaker wires and defibrillator wires which

enter the heart through the superior vena cava that we're now cutting, and those are going

to retract back into the superior vena cava. And at the end of the case you'll see us

removing those wires and taking that all out of the patient, but at this point we just want to

get it out of the heart and out of the way of the secure vena cava that we're later going to

need to connect.

00:17:28

DANIEL GOLDSTEIN, MD, FACS, FACC: David, how commonly do you see these kind of

pacemakers and different relays in people having these operations?

00:17:33

DAVID D'ALESSANDRO, MD: Defibrillators are indicated in patients with severe forms of

heart failure as a precaution from cardiac arrest, and that's basically everybody that we

transplant, so it's very, very common. It's less common for patients not to have these

devices in this day and age than it is to have them. So it's almost a routine first step of the

operation is to make an incision over those pacemaker pockets, which tend to be up by the

shoulders, and to get them prepared for removal. And it's not much of a nuisance in taking

them out. It's really quite simple.

00:18:06

DANIEL GOLDSTEIN, MD, FACS, FACC: Clearly they have a new perfectly functioning heart,

so they will not need a pacemaker or a defibrillator. For those of you in the audience who

have a pacemaker, don't fear that you're going to need a heart transplant. Most people who

have a pacemaker have it for other reasons and not necessarily end-stage heart disease.

00:18:21

DAVID D'ALESSANDRO, MD: So we're now separating the heart from its juncture with the

inferior vena cava. And that, which you just saw, that rather messy maneuver, was us

cutting into the aorta. And as you might imagine, the aorta is still under pressure, and so

when we first incise that, there's quite a release of blood. But you'll see in a moment that

that quickly clears. And the field that we're operating in remains relatively free of blood for

the remainder of the operation. We're now dividing the aorta and the pulmonary artery, and

we're going to be lastly taking out the left atrium of the heart. Now, when heart transplants

were first performed, the connection to the pulmonary veins used to be connected

individually, and there are four of them. And they're rather difficult to see, and they can be

rather cumbersome to connect. So Dr. Shumway many years ago showed us a very simple

way of connecting that to the left side of the heart, leaving a cuff of the left atrium, the

patient's own left atrium, in the body. And maybe we can pause the tape for just a minute.

00:19:28

DANIEL GOLDSTEIN, MD, FACS, FACC: Can we pause the tape, please?

00:19:30

DAVID D'ALESSANDRO, MD: If we can get a closer view of that. It may be a little hard to

see.

00:19:34

DANIEL GOLDSTEIN, MD, FACS, FACC: Would it be possible to pause the tape as the heart

is coming out? Is it possible to rewind? Thank you. In the meantime, I have two very

interesting questions. Francesco, he's asking me whether animal hearts have ever been

used in human heart transplants and why we're not doing these. Those are not allowed for

various reasons. The most immunologically reasonable organs to be used would be from a

baboon because baboons are the closest animals related to humans. Unfortunately, because

of the animal rights and ethical issues, baboon hearts are not being used in that setting.

Most of the experimentation going on in animal hearts relates to the use of pig hearts. Pig

hearts are abundant. A lot of people eat ribs and eat pork these days, and so there's no

problem in killing pigs and taking their hearts out. The problem is there's such a huge

immunological barrier between the antigens of the pig and the human antigens that we

most of us in the field don't believe that a xenotransplant will ever occur. Can we advance

the film a couple of steps here?

00:20:50

DAVID D'ALESSANDRO, MD: Okay. So you'll see as the heart comes out what's left is the

cuff of left atrium, which connects to the four pulmonary arteries.

00:21:01

DANIEL GOLDSTEIN, MD, FACS, FACC: And there you see it. You see the heart coming out.

So what you're staring at is really an empty chest there. There's nothing there except some

tubes. So the patients are in suspended animation.

00:21:12

DAVID D'ALESSANDRO, MD: This is -- we've obviously passed the point of no return, so we

are confident at this point that our new organ has arrived and that it's going to work. You

can see the pulmonary artery catheter that I showed you before, which is that -- that yellow

structure, and later on in the operation you'll watch us as we reimplant that, reposition it

rather, into the -- into the new heart. So the -- Dr. Bello has just brought the -- the

harvested heart out of the cooler and it's now up on the operative field. That's sitting in

some ice-cold saline. And the next several minutes we are preparing this heart for

implantation. And the first thing that's often necessary is to sew up any holes in the donor

organ, and this particular hole was made purposefully by Dr. Bello in order to vent it. And

it's a small incision in the left atrial appendage, and we quickly sew that up with some

prolene suture. This suture that you'll see us using here is this blue-colored suture. It's

called polypropylene, and it basically feels and acts a lot like fishing line. It glides rather

easily through tissue, which makes it very easy to work with, but it does require several

knots to secure. So at this point we are separating the aorta, which is the structure on the

bottom that we're -- looks like a long tube. And this is now the pulmonary artery, which

branches into right and left. And we're going to open that up and create one large tube. And

again, we're just getting all these structures ready to sew, so we have to make them

symmetric in appearance so that there are no major gaps which might lead to bleeding.

We're going to remove excess fat or excess blood vessel that's going to make things too

long and lead to kinking. And this still is the pulmonary artery, which we want to shorten

quite a bit. And again, we want to try to make that as symmetric in appearance as possible

to minimize any chance that that might bleed later on in the operation.

00:23:02

DANIEL GOLDSTEIN, MD, FACS, FACC: As you're completing here the maneuvers, Dave,

there's a person who says, "My brother at age 43 received a heart transplant at an

institution and he just celebrated his 64th birthday," so this person has been alive for 21

years with a heart transplant. Is he unusual or just lucky? I would say both. As I stated

earlier, the results of heart transplantation are such that 50% of patients are alive 12 years.

Your brother is certainly lucky and obviously very well-treated, and he's been alive for 21

years. I would say around 15 to 20% of patients will live that long with a heart transplant,

so continued good luck.

00:23:42

DAVID D'ALESSANDRO, MD: That's always nice for us to hear. Now we are preparing the

left atrium and again doing similar things. We join all those pulmonary veins and we make

one large cuff here, and this cuff will later be attached to the left atrial cuff that we left in

the patient's chest that I was describing earlier. And the last thing that you're going to see

us do in just a minute is check for any congenital holes that might exist in the heart, the

most common of which is known as a patent foramen ovale, which is that area that we're

probing right there. And this person did not have one of those, but they're fairly common

even in normal patients. And when we see them, we like to close them. Generally that just

takes a very quick suture in that area of the heart.

00:24:21

So now we've taken the heart out of the ice bucket, and you might notice that this heart is

considerably smaller than the one we took out. Most normal hearts are about the size of

your fist. The one we took out of our patient was considerably larger than that, but this is a

normal-sized heart and much more size-appropriate for this normal-sized patient. The first

stitches that we're going to put in are in the left atrium, and it's really critical as the heart

starts to go in that we have it properly oriented, and when there's no blood in the heart and

it's not beating, you can easily get disoriented as to what goes where. But we want to make

sure that nothing's twisted and that it sits anatomically in the chest. So these first sutures

are really critical. And there are special alignment sutures that we use and tricks that we've

developed over the years that help us do this with relatively minimal errors. So these first

few sutures are going to go in, and we're going to in a moment parachute this down, and

that's exactly how it sounds. We're going to put the first three stitches in. That's going into

the recipient left atrial cuff. And now it's going to -- the next stitch will be down into the --

I'm sorry, that was the donor left atrium, and this stitch is going into the recipient left

atrium. After we get the first three sutures in, we drop the heart down by pulling tension

onto both sides of that stitch and it gradually tightens as it goes down. It's now much easier

because things are aligned, so we know where each successive stitch is going to go by how

the tissues line up as they go in. So in essence, each stitch sets up the next stitch and it

makes things lie rather nicely so that we can put it in.

00:26:02

DANIEL GOLDSTEIN, MD, FACS, FACC: Can we pause the film for a second? Thank you. Are

there any questions from the audience? We have a very robust audience here at Montefiore.

And if there are any questions, feel free to raise your hand and I'll attend to them. There's a

question here of how long will the surgery last. I'm not sure they're asking how long the

webcast is going to last. The surgery itself takes about an hour, and hour and 15 minutes in

the standard routine operation. If someone's had prior surgery, if they have an artificial

heart in place that needs to be removed, then the operation can get more complex and can

last many hours. In the back of Dr. D'Alessandro's mind and Dr. Bello's mind at this point as

you're watching the operation is a little tick-tick-tick, a little thing that reminds you you

know this heart cannot be outside the body more than four hours. And we like to -- at that

point we start having increasing incidence of heart failure. The recipient heart begins to fail.

So we like to keep that time, what we call cold ischemic time, to no more than four hours.

By that reason if we got a phone call from San Francisco that a heart was available, we

probably would not take that heart because that would require a five-hour trip and an extra

half-hour travel in the airport and then another hour to the operation room. We're talking

about six, seven, eight hours, so we don't travel transcontinentally to obtain hearts unless

we're dealing with a very young neonate or something like that where hearts are not as

readily available. Let's go back to the tape.

00:27:30

DAVID D'ALESSANDRO, MD: As Dr. Goldstein just mentioned, as this heart is being in, it's

really not being kept cold except for intermittently when we deliver a preservation solution,

which you'll also see in a moment. So we're also thinking as this goes in that we have to

protect this heart from becoming too warm before we reconnect the blood supply because

that's when damage to the organ can occur. So we're trying to get this heart in as quickly

as possible and -- but carefully and safely so that we do not have bleeding problems once

we reestablish blood flow. So we're now finishing up the left atrial cuff anastomosis, and

those first several sutures were put in from the left side of the table. You see that we

sometimes will change hands depending on who has an easier position at the table to get

the stitches in. So we're finishing up those last several sutures on the left atrium and we're

going to secure that stitch in just a moment. So then here come the knots, and you'll see

that we've also learned to tie knots rather quickly because we do it fairly frequently.

00:28:33

And the next anastomosis that we are going to perform, or the next connection, is the

inferior vena cava. So we just delivered cardioplegia to the aortic root there. We sort of

edited that out a little bit. But that gives some cold preservation solution to the heart to cool

it down again because of those several minutes when we had it in the chest cavity where it

really gets rewarmed quite a bit from circulating blood from the patient. The inferior vena

cava connection, which is this one we're doing now, can also be somewhat difficult to do

because it's low down in the chest cavity and there's often a fairly marked size mismatch

because we're connecting a vein to basically the left atrium of the patient. And we have

special tailoring techniques that we do to make sure that that connection is sound, it's not

too tight, and again, that you want to make sure that it's not twisted. So this requires a lot

of manual manipulation so that we can show the surgeon exactly where the next stitch goes

in. And unfortunately for our viewers, that doesn't leave a lot of room for us to see what's

going on down there.

00:29:47

DANIEL GOLDSTEIN, MD, FACS, FACC: Can you pause the tape a second? David, if you

could answer a couple of questions from our international audience. How long can a patient

be left in the heart-lung machine without experiencing undesirable effects?

00:29:59

DAVID D'ALESSANDRO, MD: Excellent question, and I'm not sure anyone knows the exact

answer to that. We in general think artificial circulation, or circulation of blood through a

heart-lung machine is not physiologic. It's not great for patients. And we know that the

longer you keep patients on heart-lung machines, the more complications you have with

inflammation, with organ dysfunction, with possibilities of stroke or other neurocognitive

events. So there is no set time limit to how long we think is safe, but in general we like to

limit that to as little as possible. Now, most patients for heart transplantation, even if we're

removing an artificial heart or doing something more invasive or more complex than what

you're seeing here, those bypass times are usually limited to periods under four or five

hours, and that's considerable longer than usual. For our routine heart transplant operation

like you're seeing here, bypass times are in general considerably less than two hours unless

you have to resuscitate the heart for prolonged periods of time. But historically, patients

have been on heart-lung machines for periods in excess of 24 hours, although the chances

of getting complications goes up quite a bit as you exceed periods of about four to six hours.

00:31:16

DANIEL GOLDSTEIN, MD, FACS, FACC: There's another quick question here. What would

happen if the donor heart was not received in a usable manner? Could the removed heart

be reimplanted? Well, clearly, David has already told you that we've got to make very sure

the heart is in very good condition before we even cut it out from the donor. So once the

heart is cut out from the donor we've checked EKGs, cardiac enzymes, echocardiograms

cardiac catheterization, Dr. Bello, the harvest team has already visualized the heart. So

we're very sure that the heart is going to be very usable, and nothing usually happens

during transport as long as the transport doesn’t exceed a couple of hours. So could the

heart be removed, be implanted? It could in theory, but that heart is a very sick heart that

has not received blood supply and is now sitting in a bucket without blood supply for a

couple of hours, so the answer is no. Once the heart is cut out, that's it, we're done. We

have to use the new heart that's coming. Let's go back to the tape, please.

00:32:14

DAVID D'ALESSANDRO, MD: So I might only add to that that it is sometimes necessary to

add other means of support to a new heart that's not functioning as we expected it to.

That's very uncommon but sometimes requires special assist devices. And we never like to

see that, and fortunately that happens very infrequently. These are the last several stitches

going into the inferior vena cava, which remember, is the large vein that delivers blood from

the lower body into the lower part of the left atrium. And you might -- left atrium.

00:32:48

DANIEL GOLDSTEIN, MD, FACS, FACC: Right atrium.

00:32:49

DAVID D'ALESSANDRO, MD: Right atrium, I apologize. And you might appreciate there that

there's some excess tissue that is being implanted into the inferior vena cava. And when

that's all said and done, that's going to look like a connection that God might have designed

to be there.

00:33:08

DANIEL GOLDSTEIN, MD, FACS, FACC: I'm being asked how will I reduce the rejection

chances, and that's a good question. What you're seeing here is the exciting, perhaps the

sexy part of heart transplantation, but in all honesty, the art of heart transplant lies in the

immunosuppression management of these people after heart transplantation. Once the

surgery is done and the heart is doing well, clearly the fine balance that needs to be worked

out is between not giving too much immunosuppression and rendering the patient prone to

infection and not enough immunosuppressino where the patient can reject their own heart.

So that's truly an art that requires usually a cocktail of three medications that act at

different limbs of the immune system. So in terms of what are the chances of rejection, I

would say we've gotten so good at it that the chance of acute rejection between the first

year of heart transplant is less than 10% in most active institutions.

00:34:09

DAVID D'ALESSANDRO, MD: All very good questions. So we still are seeing what I thought

before were the last several stitches. I guess I was wrong. We have several more to go. But

in a moment you're going to see this connection completed. The next anastomosis that

you'll see after those knots are tied down is the superior vena cava, and again, that's the

large vein that delivers blood to the upper part of the right atrium from the upper part of

the body. And here again we're delivering cardioplegia again to the aorta, and we do that

through the catheter that was left in the donor heart, and we leave it there so that we're

able to intermittently resuscitate this heart with cold, protective solution while we're putting

it in. And again, just trying to protect that organ as best we can to minimize the possibility

that that organ might have damage and might not work as well as we would like when we

finally remove that cross-clamp. So this is now the back wall of the superior vena cava, and

as you might imagine, we have to connect the back wall before we can get to the front wall,

otherwise it becomes rather difficult to see. And as we're putting this connection in, you'll

notice that those veins seem to fit rather well together. And that's very important. We have

to cut those veins to the exact size that we think is necessary. If you leave them too long,

those veins can kink, or if you cut it too short there can be tension on the anastomosis,

which might lead to pulling on the sutures and bleeding.

00:35:35

The other things that we're very aware of as we are sewing these two vessels

together, these two in particular, is that that suture that we used doesn't cinch up on the

vessel, causing a stenosis or a blockage, which might impede blood flow to the heart. Here

we are using a special clamp and we're putting that pulmonary artery catheter -- we're

repositioning it back into the heart, and that went into the right atrium and up out of the

pulmonary artery, and that's pulling it out of the pulmonary artery right there. And later on

we will position that in the more -- the more distal or faraway branch of the pulmonary

artery, which is where it's going to sit for the next several days and again help us manage

the patient.

00:36:15

So we're now completing the front wall of that vein, and you can see the pulmonary

artery catheter sitting very comfortably in there. No longer is there any defibrillator or

pacemaker leads within the superior vena cava, so it's a nice, wide open vein, and we want

to make sure that we keep that wide open, so we sort of lock those sutures as we put them

in to prevent them from structuring, or purse-stringing. And that's the completion of the

anastomosis, and then we'll tie that suture down or knot it, and then we'll move on to the

next connection.

00:36:53

DANIEL GOLDSTEIN, MD, FACS, FACC: Just to reiterate for the audience, there's five

connections that need to be done: the superior and inferior vena cava, the left atrium,

which was the first one to be done, then the pulmonary artery and the aorta. So there's five

connections. That's the most common way this operation is done. Alternatively, and in the

past, it used to be done only with four connections so that we instead of having a separate

superior and inferior vena cava, we just have a right atrium to right atrium connection. But

it's been found that those kind of connections are more prone to distorting one of the valves

inside of the heart and it more commonly leads to atrial arrhythmias, so by and large that

kind of technique is abandoned in most centers.

00:37:35

DAVID D'ALESSANDRO, MD: So again, this technique that we're showing you is a bi-cable

technique as opposed to a bi-atrial technique. And this is now the pulmonary artery, and

you can see we are again cutting this even shorter than we had cut it previously. And that's

because now that we see how the heart lies or is positioned in the patient's chest cavity and

we see where the patient's own pulmonary artery lies, we want to again make sure that this

is the exact right length that we think it needs to be. And if it's too short, it may pull, and if

it's too long, it may kink, so this we really feel is critical to get these connections just right.

Now, we are going to -- that's the pulmonary artery catheter. We're now going to position

that in the patient's pulmonary artery, and that's going to go down the right pulmonary

artery in this instance. And you can see that that -- and that's where it's going to sit, again,

for the next several days, and we'll use that to help monitor the patient's cardiac output,

which is a measurement of how much blood the patient's delivering into and out of the

heart and also the various pressures within the chamber, which give us a lot of information

about how well the organ's working.

00:38:38

DANIEL GOLDSTEIN, MD, FACS, FACC: Can we pause the film for a second, please? There's

a very interesting question, Dave, that I'd like to address. This is a question most people

ask when they heart about heart transplant is, "Is there an order of priority as to who will

be the recipient?" Is this a random event or is there a very well-defined set of criteria as to

who is going to receive a heart?

00:38:56

DAVID D'ALESSANDRO, MD: Well, that's an excellent question, and fortunately, there is a

very well-designed set of criteria, and that's based on an organing body -- or organization

that helps -- that has created a waiting list of patients. And it has to do with what region of

the country or the world you might live in, but in this particular country it's divided up into

regions. And those patients that are sickest or who have been on the waiting list the longest

get preference to others. Outside of that, it takes into account things like blood type. As you

might imagine, blood-typing is very important in any kind of organ -- well, most kinds of

organ transplantations. And also, the patient's size. You might imagine that if we put a very

small heart into a very large patient, such as Dr. Bello here, that might not work so well. So

size is critical. So those four things are very important in deciding who's going to get a

particular organ.

00:39:48

DANIEL GOLDSTEIN, MD, FACS, FACC: So very important. If you have two recipients that

look exactly -- they have the same blood type, the same size -- the person who is the

sickest will get the heart first. So it makes sense that you don't want to let someone die so

that someone else who could wait another week or month or year is not going to receive

that heart. It just doesn't make sense. So it's a very fair system. There's always issues

surrounding it, but we -- most of us in the field feel that the UNOS, which is the governing

body of -- it's the United Network for Organ --

00:40:21

RICARDO BELLO, MD, PhD: Sharing.

00:40:22

DANIEL GOLDSTEIN, MD, FACS, FACC: Sharing -- thank you, Rick -- governs distribution

and allocation of organs. Why don't we go back to the tape?

00:40:32

DAVID D'ALESSANDRO, MD: So we are nearing the completion of the operation and we are

connecting the pulmonary artery. Again, this is the -- this is now the fourth connection. The

final connection will be the aorta. Once we reconnect the aorta, we are going to reestablish

blood flow to the patient's heart, and usually we will see the heart begin to beat at this point

in time. Now, this particular patient had a fair amount of pulmonary artery return, which

you're not appreciating right now because we have a suction catheter in the patient's

pulmonary artery. But when we complete this anastomosis, or this connection, you will

actually appreciate that the heart will begin to beat, and that's because although we have

not restored the normal circulation, the patient's heart -- or the new heart has begun to see

a small amount of blood circulating, and it will begin to have an organized rhythm, or heart

rate.

00:41:28

So we're now connecting the pulmonary artery. This particular vessel is rather floppy, and

again, it can be quite easily twisted or placed in such a manner that it doesn't sit well within

the cavity. So we're very aware as we're putting these stitches in and we're reassessing

things as we go to make sure that the size is correct and that the alignment is correct, and

in this particular instance, I'm sure you'll agree that it looks quite nice.

00:41:56

DANIEL GOLDSTEIN, MD, FACS, FACC: I have an interesting question here from the

audience. We're getting a barrage of questions. This is very exciting for us here. But it says,

"Can the artificial heart Jarvik perform the same purpose as a human heart transplant?"

That's a tricky question. The shorter answer is yes. There's a total artificial heart. There's a

lot of devices that can be used to support the heart, but there's really only one total

artificial heart that can be used to replace the heart. So you would remove the heart just

like we did now and use a new completely artificial heart. The heart is made by Abiomed --

it's called the AbioCor -- but its use is very limited to a very selective group of patients who

cannot be supported any other way. Our sense is the artificial heart as a clinical device will

probably not be used to replace heart transplantation, but more likely we will have more

and more and smaller and more sophisticated left ventricular assist devices, which are

smaller pumps that assist the failing heart. So the heart, the sick heart, is not removed, but

a machine is attached to it to help it beat and perform its function. David?

00:43:03

DAVID D'ALESSANDRO, MD: So this is -- back to the patient's aorta, we're now trimming

the patient's aorta. And you can see the cross-clamp still just above where those scissors

are being applied. And that cross-clamp is separating our operative field from a very large

amount of circulating blood. And in a moment after that connection is established, we're

going to release that, and that will restore blood to the patient's coronary arteries, and the

heart at that point in time will begin to beat quite vigorously. And you'll notice that the

heart has already started to beat, and that is because there is a small amount of blood

circulating through this heart, albeit at a low pressure, and that's supplying just enough

blood to resuscitate the electrical activity to the heart. And I think you can appreciate that

the aorta is quite a bit of a more robust vessel than the pulmonary artery or those other

veins that you saw us sewing earlier. Sometimes looks like a piece of calamari in thickness

there. And it holds sutures quite nicely. This vessel in particular is under quite a bit of

pressure, so we have to be very aware that our sutures are going in at the proper depth

and at the proper spacing, especially in this part of the vessel that we're sewing now. This

part of the vessel we're going to have a lot of difficulty seeing later on in the operation, and

if there's any bleeding from that suture line, we will have difficulty controlling that. So we're

very careful at that part of the connection. We're now moving our way up the left side.

00:44:34

DANIEL GOLDSTEIN, MD, FACS, FACC: Can we pause the tape for a second? I have some

wonderful emails here that I must share with you. And I've had now three or four heart

transplant recipients that are getting in touch with us. One of them says, "Do most

transplanted hearts restart when blood supply is reintroduced? Do many have to be shocked

to start beating properly? And thank you, donor families, for allowing your loved ones'

organs to allow us to go on. I am out 11.5 years." Dave, can you answer those questions

for us?

00:45:06

DAVID D'ALESSANDRO, MD: Most hearts will begin to beat spontaneously once you

reestablish blood flow. Now, that rhythm is not always organized, but in general, once we

see that heart begin to move in some manner, we're all quite relieved that we know that

heart's going to be okay. Most of the time it's an organized rhythm and we might have to

start some medications to assist that heart in beating more vigorously, but it will start to

beat. And if the rhythm is unorganized or in some sort of a fibrillating rhythm, we do often

need to give it one or two shocks of electrical energy in order to sort of jolt that heart back

into an organized rhythm. But once that's done it usually beats just fine on its own and

there's very little we have to do to assist it.

00:45:47

DANIEL GOLDSTEIN, MD, FACS, FACC: Quick question here. Did I understand correctly

some of the old heart was left in and the new heart was attached to a part of the old heart?

The answer is yes, we leave a cuff of the aorta, a cuff of the pulmonary artery, a little piece

of superior and inferior vena cava, and the large part of the left atrium intact. Let's go back

to the tape, please.

00:46:08

DAVID D'ALESSANDRO, MD: So we're now completing the aortic anastomosis, and again

you might also notice that this is a larger structure than some of the other connections that

we had. So this is the final phase of the operation. As we're again putting this sutures in, we

want to make sure that the spacing is just the way we want it and that the size of the two

vessels match. There are occasions where the donor aorta is either considerably smaller

than or considerably larger than the aorta that we're sewing to. And when that's the case

there are certainly tailoring techniques that we sometimes need to employ in order to get

that fit just right. But the basic tenet is we need to make a good seal and we need to make

sure that connection is nice and wide open and there will be no obstruction or turbulence in

the blood flow. And that was the last suture, and that's the securing knot that's going to

secure that connection. And the final thing that you'll see after we release those cable

snares, those snares that prevent the inflow of blood to the heart, and that's removing the

cross-clamp right there. So we've now reestablished blow flow to the heart. We have a

suction catheter in the ascending aorta that's removing any stray blood that might be

leftover in the chambers of the heart. And those little air bubbles can cause real problems if

they get down into the coronary arteries or travel elsewhere. So we leave that catheter in

there to remove any stray air that might have been left behind.

00:47:33

And you'll notice in a minute that the heart will really start to beat quite vigorously, and the

first several beats are often less vigorous, but you'll see that that quickly changes. And the

other thing I hope you can appreciate is that this heart is considerably smaller than what

you saw when we first opened the chest. The patients with longstanding heart failure, their

hearts tend to get quite large and the cavity that contains the heart correspondingly gets

quite large so that the new hearts often look like small peas in a large pod. And that's

sometimes quite marked in appearance. And what we -- these final maneuvers we put these

temporary pacing wires on the heart. These are pacing wires going on the ventricle. We'll

later add some pacing wires onto the aorta. You'll see as we go that the heart is really

beating quite vigorously now.

00:48:24

DANIEL GOLDSTEIN, MD, FACS, FACC: The magic of heart transplantation.

00:48:27

DAVID D'ALESSANDRO, MD: And that is a very normal-looking decompressed heart. That's

what we like to see when we're all done. So we've now -- are weaning the patient and we've

resuscitated it now for several minutes on the heart-lung machine to allow this heart to

recover slowly. We don't want to shock it. And so once we think that heart is ready to take

on the work of supplying blood to the lungs and the rest of the body, we slowly take them

off the heart-lung machine, we open up those vessels that are taking blood away from the

heart so that the heart is now getting the full supply of blood from the patient's body, and

then we ventilate the lungs again and we turn off the heart-lung machine. This patient is

now completely surviving on the new heart that we just put in, and that's always exciting to

see. And these are now drainage tubes which we're leaving behind. You might imagine that

that space that once contained a very large heart is now a potential space that can collect

fluid or clot or other things that might inhibit this new heart's ability to work the way we

want it to work. So we leave all these drains behind to prevent that fluid from accumulating.

And this is a larger tube that again serves the same purpose, just keeps that heart nice and

dry and free of any unwanted fluid that might collect around it.

00:49:42

DANIEL GOLDSTEIN, MD, FACS, FACC: Will you stop the tape for a second? There's a

question from a -- I guess he's a urologist who's joined us. He says, "Is there a certain

stitching pattern that must be followed, like that of stitching a new-formed bladder or the

urethra?"

00:49:55

DAVID D'ALESSANDRO, MD: No. I think you urologists have developed all sorts of fancy

techniques for connecting ureters, or the tube that connects the kidney to the bladder.

Fortunately, we've not needed to be so clever. So we use a standard running suture on

most of these connections, which is basically just and over and over stitch that pulls

through the tissue as we go. We find that to be -- create a very nice seal and to be

watertight. It very nicely prevents bleeding. Now the only caveats to that are those that I

described earlier, where that sometimes has the tendency to purse-string suture, or to

tighten it as it goes in a manner that we're not anticipating. So there are certain lockingtype

sutures that we'll throw in on occasion just to prevent that from happening to make

sure those connections remain wide open and don't obstruct any blood flow. That's a very

good question.

00:50:48

DANIEL GOLDSTEIN, MD, FACS, FACC: As we finish the tape here, just Rick, can you

comment on what happens -- what are the things you worry about once the patient gets to

the intensive care unit? You've closed the chest. Patient's on a couple medications. What are

the early things you worry about as a heart surgeon that can happen to a patient in the first

few hours after heart transplantation?

00:51:07

RICARDO BELLO, MD, PhD: Well, the primary thing we worry about is bleeding. Bleeding in

and of itself, the initial treatment is transfusion and making sure that the blood is clotting

properly, but those transfusions can then affect the transplanted heart, and so if we suspect

that there's any bleeding, we would want to return back to the operating room and address

that as quickly as possible. Other than that we worry about the patient's hemodynamics, or

blood pressure, and blood flows, and we manage that with medications. There are frequent

adjustments to the medications early on. So those are the major things that I think we tend

to worry about.

00:51:47

DANIEL GOLDSTEIN, MD, FACS, FACC: You see on the film as David and Rick are finishing

the finishing touches on hemostasis, or stopping any potential bleeding there from the bone

marrow. Another thing we worry about is the issue of right heart failure. You must

remember, people who have heart failure have very high pressure on their lungs because

they've been having -- they had left heart failure for a long time. And now you're asking a

new heart that was beating inside a normal person to pump against the high pressure in the

lungs. So we're very cognizant and wary about right heart function right after the operation,

and to do that, to manage that, we maintain the filling pressure to a certain level, we use

what we call inotropic medications, or medications to help the right heart beat better. We're

very careful how much fluids are going into the patients and how many fluids are going out

of the patient. So that's one of the issues besides the bleeding, which is the most common

one that we follow immediately after transplantation. Once the initial few-couple days are

by and the patient is stable, usually within 6 to 12 hours the patient is removed from the

breathing machine if everything else is okay. And then we start introducing the

immunosuppressant medications slowly. And from then on is the -- really the art of

transplantation, as I mentioned earlier, is basically preventing rejection from happening

while not allowing the patient to get infected. And that's a team effort. It's done by our

heart failure colleagues at this institution: Dr. Simon Maybaum, Dr. Julia Shin, and Dr. Ron

Zolty are involved in the management of our patient postoperatively in this regard. Are

there any questions from the audience at all? Yes, Dr. Attai?

00:53:35

DR. ATTAI: [unintelligible]

00:53:52

DANIEL GOLDSTEIN, MD, FACS, FACC: That's an excellent question. We explain to every

question this is really a marriage. They're getting married again. And they're getting

married to us, and they married a big team. This is not Danny Goldstein or Simon Maybaum,

this is a whole team that's required to really have a successful heart transplant program.

There's a surgical team, which is a team you've met today, there's a medical team headed

by Dr. Simon Maybaum, and there's a cadre of very hardworking transplant coordinators

that make it all happen. These -- in our program there's four women who take call every

night, field a lot of phone calls. Many times they're up in the night and then it turns out that

the organ is not usable. And they're really our front line, they're our cannon fodder, to use a

term, but they're the ones that really seek out all of the problems, put out all of the fires

and let us know what's happening. And they really are the engine of the program. So you

need transplant coordinators, you need surgeons, you need an anesthesiology team to do

the transplant, you need a profusionist to run the heart-lung machine, you need the medical

doctors to make sure they're giving the right immunosuppressant medications. And usually

the protocol after transplantation, it varies from center to center. But by and large, patients

remain in the hospital after everything goes well about a week or two after surgery, at

which time if they're capable they go home to begin their recovery. They're seen every

week for the first four to eight weeks. They have a heart biopsy. This is very important .

The medical team performs a biopsy of the heart by a small incision made in the neck. It

passes an instrument right into the heart and takes a piece of the muscle. Then it's sent to

the pathologist to review to make sure that the patient is not experiencing a rejection. And

that's done quite frequently: once a week for the first eight weeks or so and then it's spaced

out every two weeks to every four weeks and then monthly. By the end of the year -- by

the beginning of the second year they're doing this every six months or so. So this is what

we call surveillance biopsies. If there's a change in the clinical condition and we think the

patient might be rejecting, then that biopsy is done in an urgent manner. The patient is

brought into the hospital and biopsied as necessary. But this is a lifelong intervention.

Patients need to be seen frequently, they need to be very in touch with their body. A little

fever in a normal person like you and I, Dr. Attai, would just lead us to take a Tylenol or

two. In a patient, a little fever can unmask a life-threatening infection within 24 hours. So

usually we tell our patients, and we repeat it to them and to their families, that any little

cough, any little shortness of breath, any little symptom that a normal person will disregard

should prompt contact to the medical center, and that is key.

00:56:41

One of the issues about addressing who is a candidate for heart transplantation, it's a very

important question. And in general, each patient -- any potential candidate is examined

from head to toe literally. We've got to make sure that the heart is basically the only thing

that's wrong with a patient. If a patient has a heart that's not functioning or the kidneys are

not good and they have a history of depression and perhaps their liver function is not

normal, those people are not candidates for heart transplantation. We need to be very

restrictive because we have a donor crisis. There's about 2,200 donors available a year. It is

estimated that in this country if criteria were loosened, 60,000 to 100,000 patients could

benefit from a new heart. So we need to -- so you're talking about a ratio of 20:1. So we

need to be extremely selective. And a big part of the selection process is assessing the

compliance of the patient. If the patient's smoking every day and then go out and have a

couple drinks every day, we cannot offer a heart to those patients. If they have an unstable

social environment where they don't have a family or loved ones who are going to help

them through this very difficult process, then it becomes more challenging to offer a heart

to those patients. So yes, Dr. Attai, it's a whole team effort. And the follow-up after the

operation, after the procedural from the hospital, is a very, very serious and thorough one.

00:58:05

DAVID D'ALESSANDRO, MD: Just to clear up any misconception, Danny mentioned that our

team of coordinators were made up of four women. You do not need to be a woman to be a

coordinator. We are an equal opportunity employee --