Ethics of Normothermic Regional Perfusion for Heart Transplantation

October 31, 2023

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00:00OK. Good evening.
00:02Let's go ahead and get started.
00:06My name is Mark Mercurio and you're
00:09at the Yale School of Medicine
00:11program for Biomedical Ethics.
00:12And we have our leadership here,
00:13Jen Miller and Sarah Hall and Jack Hughes,
00:15our manager, Karen Colb.
00:16On behalf of all of us, I welcome you.
00:19This is a pretty exciting evening
00:21for the program and I and I hope
00:23that that you'll find it the same.
00:25It was some time ago that
00:27Doctor Eric Thompson,
00:28an old friend of mine,
00:30reached out to me to talk about
00:32this particular topic,
00:33normal thermic regional perfusion
00:36as it relates to heart transplant.
00:38And in our conversations I thought,
00:41wouldn't this be a fantastic topic?
00:43I did not think I would be so lucky.
00:46We would be so lucky as to get
00:47not only Eric to come here,
00:49but also to get to the people who
00:51want a national level are leading the
00:53conversation 'cause this is a pretty
00:55important conversation and to have Bob
00:56Trug and Brendan Parent here as well is
00:59a is a tremendous treat for the program.
01:01So I think it's going to be a great night.
01:02Let me just tell you how the
01:04night is going to unfold.
01:06I'm going to introduce the
01:07speakers one at a time.
01:08So first I'm going to
01:09introduce Doctor Thompson.
01:10He's going to speak for a little
01:12bit about the technology and about
01:15the Physiology and about the issue.
01:18Then I'm going to come up and
01:21introduce Doctor Bob Trug.
01:22And then after Bob's done speaking,
01:24I'm going to introduce Brendan Parent.
01:27And each one of them, as you'll see,
01:29is a very special guest.
01:30So it's quite an exciting night.
01:31So that that will last for
01:34on the order of 45 minutes.
01:36It's not an exact science, lads.
01:37It'll be what it'll be.
01:39And then and then they're going to come
01:41up here and answer your questions.
01:43They're going to have a conversation.
01:44We will stop.
01:45And that clock's looking pretty
01:46good for a change. It's right.
01:48So we will stop at 6:30.
01:50So I apologize.
01:51I suspect there may be many people
01:53who have something they want to say.
01:54We have leaders of the Yale transplant
01:57program and leaders of UNOS,
01:59and we have all sorts of folks
02:00in the audience.
02:01So I think going to contribute
02:02to the conversation.
02:03And we do hope we get to everybody.
02:05There's going to be a microphone
02:06when the time comes.
02:07I'm going to ask you to wait until
02:09you have a microphone to speak
02:11like the talking stick so that
02:13we can make sure the folks on
02:14Zoom can hear what we're saying.
02:16So we will have the talks,
02:17then we'll have the panel discussion
02:19with the audience question and answer.
02:21And then at 6:30,
02:22we will say goodnight.
02:23So that said,
02:24let me go ahead and introduce
02:27our first speaker for tonight.
02:29This thing keeps stinging.
02:30I'm going to go ahead and guess that
02:32this is Karen trying to remind me to
02:33say something. What are the
02:34chances of that? No, it's not. OK,
02:39so the first speaker is Doctor Eric Thompson.
02:44Eric practiced adult cardiac and
02:45thoracic surgery for 31 years,
02:47most recently at the Mid America
02:49Heart Institute of Saint Luke's
02:51Hospital in Kansas City.
02:52So what exactly does he know
02:54about heart transplant?
02:55Well, he was present for Saint
02:57Luke's second heart transplant
02:59in 1985 and was a participant in
03:02transplant #950 In the fall of 2021,
03:04just before he retired after
03:06moving back home to Connecticut,
03:08Doctor Thompson took a part
03:09time job with the ex vivo.
03:11Is that how we pronounce that ex vivo
03:13with ex vivo procurement services
03:15retrieving hearts and lungs for transplant.
03:17Since early 2022,
03:18he has travelled from his base at the Oxford,
03:21CT airport on more than 120 organ retrievals.
03:24He has a Bachelor of Science in Computer
03:27Science and a Doctor of Medicine degree,
03:29both from Washington University.
03:30He trained in surgery at
03:32Mayo Clinic in Rochester,
03:33MN and in thoracic surgery
03:41at Saint Luke's Hospital in Kansas City.
03:43We are old friends and I've been looking for
03:45a way to get him here and I have found it.
03:47And Eric's extensive experience with heart
03:50transplant makes him just the right
03:51person to begin this conversation.
03:53Welcome, Doctor Thompson.
03:56So what, Mark
03:57didn't tell you about the pinnacle of
04:00my academic career, which
04:01was that I was his high school classmate.
04:05In fact, I've known him since 5th grade,
04:09so isn't that right? That's right. So
04:14the topic is normal thermic
04:15regional perfusion that doesn't
04:17exactly roll off the tongue.
04:19So let's just start calling it NRP.
04:21The rest of the for the rest of the
04:23night and I have I have reservation
04:28and not just me there's a lot of other
04:30you know there's a lot of people have
04:32reservations about this both from
04:33an ethical standpoint and a legal
04:36standpoint and I'm I'm genuinely
04:38interested to hear what my Co panelists
04:40have to say about this and and I'm
04:43hoping that all of you will be asking
04:46questions because it it it's it's
04:49an important topic to consider.
04:51So I'm going to start with
04:53what Well couple things one is
04:56I'm going to show some
04:58slides some pictures of in the operating room
05:01and some videos from the operating room.
05:04So if any of you are thrown to
05:06faint at the sight of blood,
05:08you might consider Watson the
05:09talk like this or something.
05:11And also, I don't, I don't want
05:15anybody to leave here thinking that
05:18heart transplantation is unethical.
05:20That's not the issue.
05:22It's it's this one specific
05:24technique for organ retrieval that
05:26is an issue I want to start with,
05:32with my conclusions
05:38and if you understand this,
05:40you can skip my talk.
05:41You can go take a break for 15
05:42minutes and then come back and
05:43hear what the others have to say,
05:45'cause this is what I'm going to end up at
05:49the ethical issue.
05:51There's two basically you're we're
05:53reanimating a heart that was that was
05:56said to have irreversibly stopped.
05:59And the second issue is during the
06:02operation you clamp the the head
06:05vessels so that you substitute
06:06brain death for circulatory death.
06:08If you understand what this means
06:10you don't have to you you don't need
06:12to hear the rest of what I'm gonna
06:14say I before I get going I think
06:18you'll appreciate this picture.
06:20This is from our senior prom 1974.
06:23And I know we haven't changed at
06:25all but this is this is me and
06:29this is Doctor Mercurio.
06:35You can't you can't pay cancel
06:40and Mark mentioned I was at the Mid America
06:42Heart Institute and I'm going back there.
06:44I'm flying back there Saturday they're
06:46having a gala to celebrate their now
06:48one thousandth heart transplant.
06:52So the job I have now is is kind
06:55of a unique job and I I made this,
06:57I put this map together and I'm
07:01working for a company called Ex Vivo.
07:03It's a Swedish company.
07:05Their business focuses around different
07:07aspects of organ transplantation and
07:10the division of the company that I'm
07:12working for does retrieval services.
07:14We retrieve hearts and lungs.
07:16So currently there are the I put
07:19red dots where the surgeons are
07:21located and I put blue dots where
07:24the transplant centers that we're
07:26working for are located.
07:27And so
07:31so I'm here in Connecticut and
07:34you can see the other the other
07:36four are scattered around.
07:37So what'll happen is like say that say
07:41Christ hospital in Cincinnati accepts
07:44a heart and the and the donor operation
07:47is scheduled for tomorrow morning
07:50and the and the donors in Chicago.
07:52So what what would happen is a plane
07:55picks us up here in Connecticut,
07:57we fly to Chicago,
07:59we do the the procurement operation.
08:02Then we take the heart to Cincinnati
08:06and a Courier would take it on to the
08:09hospital and then we'd fly back home.
08:11And in the last,
08:12since the beginning of last year,
08:14I've done this 120 Times Now
08:18then this, this shows
08:25it's not working.
08:25This heat map shows where
08:29the donors are have been,
08:32so they're scattered all over
08:34the eastern half of the US.
08:35I've gone as far as from Connecticut,
08:38I've gone as far as Dallas,
08:39and I've gone to Minot,
08:41ND to get Oregon's.
08:46This is the Waterbury Oxford Airport.
08:47It's just 15 miles from here.
08:49The pilots love it because has that
08:52long runway with ILS landing capability.
08:55And we we love it because this
08:58hanger right here, we have a space
09:01in there where all our supplies are.
09:03So here's this is my assistant Kareem.
09:08He's got all the supplies that we
09:09take on a retrieval and this Jed,
09:11is typical of the ones that we fly.
09:14This was from the retrieval
09:15we did Friday night.
09:17It's typical that there that there's a,
09:19you know, cast of thousands
09:21in the operating room.
09:22If you if you stripped it down to the
09:24people that are really just the just the
09:26essential people you could do this with,
09:28you could retrieve a heart,
09:30lungs, liver,
09:30kidneys and pancreas with just two
09:33surgeons and maybe a total of 10 people.
09:39This this shows the heart being exposed
09:41and up at the top of the screen you
09:45can see simultaneously while we're
09:47working in the chest other surgeons
09:49are working down in the abdomen.
09:56And then on every case we take
09:58a video of the heart to send
10:01to the an implanting surgeon.
10:02So they get a sense of they
10:04get a sense of the size of
10:05the heart they're going to be
10:06implanting and that that and
10:08that the quality is good.
10:12So normal heart
10:13you can see up here the
10:15livers being mobilized.
10:18So this schematic
10:21I've tried to simplify what's done
10:24during the operation and I've and I've
10:26done it partly just by showing the
10:28heart and the liver and you can add
10:31other organs in to but but the heart
10:33and the liver tell most of the story.
10:35So the the blood each of the organs
10:39is mobilized and the blood vessels
10:42are isolated And then a like
10:44in the abdomen A cannula,
10:451 cannula is put into the portal vein
10:48and another cannula is put into the
10:50abdominal aorta and in the in the chest
10:54canulus put in the ascending aorta.
10:56And then when when everybody's ready
10:58to go you make a cut into the inferior
11:01vena cava that that vents vents the
11:04venous return and you put clamps on the
11:07ascending aorta and the abdominal aorta.
11:10And then the preservation solution
11:12to the liver and abdominal organs
11:14goes in through these two blood
11:17vessels and the cardioplegia,
11:19the solution that stops
11:20and protects the heart,
11:21it goes in into the ascending aorta.
11:25And then once that once that
11:27infusion has been completed,
11:28then you can cut the heart
11:30the the organs out.
11:31So here's here's a heart that's
11:33been removed and it's ready to
11:35go in the sterile packaging.
11:37You've probably seen these trucks
11:39around that this one had just taken us
11:42from the hospital back to the airport.
11:46Here's this is a this cardboard box has
11:50Styrofoam lining it so it's insulated
11:52and the heart's sitting in there in
11:55sterile bags containing saline,
11:57and then surrounding the bags
11:59is ice to keep it cold.
12:04Now here here's a part right after
12:07implantation so you can see right
12:10here is the suture line of the aorta.
12:13And here's the suture line of the
12:15pulmonary artery and you might
12:17be able to appreciate this heart
12:18as sitting inside a big space.
12:19And the the reason for that is the the
12:22sick old heart was enormous and this,
12:25this is heart as normal size.
12:28And what's amazing is I had just taken the
12:32clamp off and it's already in sinus rhythm.
12:35It's just it's just incredible how that,
12:37how how that works.
12:38And this was like less than a
12:40minute after taking the clamp off.
12:44OK. So everything
12:45I've talked about so far pertains to
12:48heart procurement after brain death.
12:50But that's not what we're
12:51going to talk about.
12:52We're going to talk about donation
12:54after circulatory death, DCD.
12:57And to understand that you have to,
12:59you have to understand there's
13:01two defined ways modes of death.
13:04There's brain death and
13:07there's circulatory death.
13:09And if you
13:13brain death is irreversible cessation of
13:15all function of the entire brain including
13:18the brain stem and circulatory death
13:22is defined as irreversible cessation of
13:24circulatory and respiratory function.
13:26And you know just remember
13:29the word irreversible.
13:31So we're going to talk about two ways,
13:34two ways to procure hearts, FDCD hearts.
13:39One is using Transmatic Organ Care
13:42system and the other is using NRP.
13:47So this is the,
13:48this is the Transmedix machine.
13:50It it contains some of the same
13:53features that I'm going to show for NRP.
13:56There's a pump, there's a
13:58reservoir and a gas exchanger.
14:02But the difference is the heart,
14:04the heart is is resuscitated
14:08inside this machine,
14:11so outside the body.
14:13Whereas with NRP the resuscitation
14:15occurs inside the donor's body.
14:19So there's a sequence of events that
14:21there's a sequence of steps that
14:23you follow in doing an ADCD case,
14:26the pay the donors, the donor.
14:29Let me just talk about
14:30the donor a little bit.
14:31It's a the donor has some non
14:34survivable problem, usually usually
14:39a brain problem but not always.
14:41And they they're they're expected
14:44to die shortly after supports with
14:46a decision has been made to withdraw
14:48support and they're expected to die
14:51shortly after support is withdrawn.
14:53So they're they're consented
14:55for as an organ donor.
14:58They're brought to the operating room,
14:59they're given heparin so that the blood
15:02doesn't clot when the circulation
15:03stops and then supports withdrawn.
15:05So they they take them off the ventilator,
15:08they remove the endotracheal tube,
15:11they stop all IV drugs and usually when
15:15that happens an agonal phase begins
15:17where their respirations are inadequate
15:20and they have falling blood pressure.
15:22Their oxygen levels fall.
15:24Then when the heart stops and a
15:27systole occurs at that point the
15:30the clock starts ticking and they
15:33you wait for it varies from place to
15:36place and this is this is an issue.
15:38The variation is to me is an issue,
15:40but you wait typically for 5 minutes of
15:44no cardiac, no cardiac activity at all.
15:47And then so that's called the
15:49standoff period.
15:50At that point death is declared And
15:52then the surgical teams, they say,
15:54OK, you guys come on in and they have
15:56us come in from from another room.
15:58We haven't been involved at all
16:00and we come in from another room
16:02and then we start the operation.
16:04So for the transmatic system,
16:07what you would do is you would rapidly
16:10open the chest and the abdomen,
16:14infuse the preservation solutions,
16:16excise the organs,
16:18and then you would take the heart
16:20and put it onto this,
16:21this, this machine.
16:26So it's the same as what I showed you before,
16:29except that on a brain dead donor you
16:32would do all this dissection preliminarily.
16:35And on this, you don't do that at all.
16:37You just go right in and you put
16:39the cannulas in immediately and
16:41start the infusion of the solutions.
16:44And then you do the dissection
16:46after you've excised the organs.
16:50So here's a here's a heart on the
16:52transmetic system. So oxygenated
16:54blood comes into the aorta up here.
17:01So
17:04one thing I want to emphasize
17:05about this this sequence is from step
17:12#2 to step #7 you have there's warm
17:17ischemia going on and that's that's
17:20damaging the organs and and the heart
17:23and of the organs the heart's the
17:25one that's the most sensitive to
17:27that so that so this this this but
17:30it but it that said it works and the
17:32hearts do well as a matter of fact.
17:35So we'll come to this So here's
17:37here's a picture of the of a heart
17:40on the transmetic system and you can
17:42see it's it it it was taken out of
17:45the chest just you know 10 minutes
17:47before this and here it is it's
17:49beating again looking pretty good.
17:54So this paper was published in the
17:56New England Journal in June and
17:59they randomized heart transplant
18:01recipients to either receive a brain
18:04dead donor heart or a heart that
18:07ADCD heart from a transmetic system
18:09and the outcomes are equivalent.
18:12So this works.
18:14So so I told you there's two ways to
18:17to to currently to there's there's
18:20some stuff on the horizon but there's
18:22two ways to procure DCD hearts
18:25this transmetic system and NRP.
18:26And the key difference between
18:28the two things is transmetics is
18:31is outside the body and while
18:33NRP is inside the donor's body.
18:36And that distinction has,
18:38you know, some ethical
18:42issues with it.
18:44So NRPNRP is actually not a new thing.
18:48The first heart transplant done by
18:50Christian Barnard in 1967 in South
18:53Africa was done with a technique that is
18:57almost identical to what we now call NRP.
19:01They the donor was a young woman
19:03who was crossing the street,
19:05was hit by a drunk driver.
19:07She had a a non survivable brain injury.
19:09So they she was going to be an organ donor.
19:13At the time, the concept of brain
19:15death had not been established.
19:18So what they did was they took
19:20her to the operating room.
19:21They cannulated her for
19:24the heart lung machine.
19:26They withdrew support when her heart stopped.
19:29They immediately turned on the heart
19:31lung machine resuscitated her heart,
19:32And then they and then
19:34they implanted the heart.
19:36And this, this book is fascinating.
19:40It describes the intrigue surrounding
19:43the first heart transplants.
19:46And it it's not, it's not technical at all.
19:49It reads it even though it's not fiction.
19:51It reads like a novel and and it
19:54describes the ethical dilemmas
19:56that they were facing back then.
19:58And the story also is interesting
20:01because it features big doses of
20:04scandalous behavior mostly by Christian
20:06Barnard about things like piracy and
20:12greed. And also he had a steamy affair
20:15with Gina Lola Bridgeta, which is.
20:19So another thing that's in there is that.
20:23And he Barnard himself never
20:25acknowledged this while he was alive.
20:27But in there, they, the patient, the donor,
20:31was surreptitiously given a bolus of
20:34potassium to speed the cardiac arrest.
20:39So this, this schematic shows NRP,
20:42the NRP, with, with, and it's different
20:45than what I've shown you before.
20:47So what you do is you you open the chest,
20:51you put a cannula into the right
20:53atrium and you put a cannula.
20:55OK, I'll stop right there.
20:58I I skipped a step.
20:59You open the chest and you put this
21:01clamp across the arch vessels so
21:03that there's no there's going to
21:05be no blood going to the brain.
21:08And then you put the cannula in
21:10the right atrium and you and you
21:11drain the blood out of the patient.
21:13And then you put a cannula in
21:15the aorta and then that it goes,
21:17it's connected to an ECMO machine.
21:19And this is all done just through the chest,
21:22and it can be done rapidly.
21:23The the center with the most
21:25experience is Vanderbilt,
21:26and they can can pretty consistently
21:29have the patient on the pump 3 minutes
21:31after making the chest incision.
21:35So the sequence of events is exactly
21:39the same as what I showed you for the
21:43transmetic system up until #5 through #5,
21:46and then things diverge.
21:48So on NRP it's only a chest incision.
21:52You clamp the arch vessels,
21:53you establish cardio pulmonary
21:55bypass and this reperfuses all
21:57the organs except for the brain.
22:00And then after the heart's
22:02resuscitated and and and the other
22:05organ dissection is completed,
22:07then you infuse the preservation
22:09solutions and you excise the
22:11heart and the other organs.
22:12So here's a photograph from Vanderbilt
22:15showing the heart cannulated.
22:17So right here is the cannula
22:20in the right atrium,
22:22here's the cannula in the aorta and then
22:24these two clamps are on the arch vessels.
22:29Here's the pump that's used.
22:31It's familiar to any any of you
22:33that work in the ICU as a a typical
22:35ECMO machine with one important
22:37addition is that there's a reservoir
22:39so that when you when you put
22:42the cannula in the right atrium,
22:43you you drain the blood out of the heart.
22:45So the heart's completely emptied and this,
22:49this,
22:49this step is,
22:51is one of the key reasons why this
22:54this system works as well as it does.
22:56Here's a simplified version of the circuit.
22:58So the venous blood comes out and it
23:01goes into this reservoir and then a
23:04centrifugal pump passes it through
23:06the oxygenator and then the oxygenated
23:07blood comes back into the aorta.
23:11So in conclusion, the NRP definitely works.
23:15It's the I haven't shown you the data,
23:17but the outcomes with this are excellent.
23:19In fact, Vanderbilt is of the opinion
23:22that the outcomes from this are better
23:24than the superior to the outcomes for
23:27a brain dead donor.
23:29Also, because of rapid reperfusion and also
23:32decompression of the circulatory system,
23:35it's beneficial for the organs other
23:37than the heart, specifically the patient.
23:39The livers and the kidneys taken
23:42this way do do better than than than
23:46they do with the other approaches.
23:49It saves A NRP saves a substantial
23:52amount of money.
23:53The the disposable cost for the Transmedics
23:56pump are in excess of $65,000 per case.
24:00The disposable cost for NRP are around $1500.
24:05So we're back to the ethical and
24:08legal issues that so that you you
24:10said the patient was dead because
24:12their heart irreversibly stopped and
24:14yet you restart the heart and you're
24:16going to use it in somebody else.
24:19NRP is done in site to inside
24:21the donor's body.
24:21So you not only have the heart,
24:23it's like it's maybe there's a distinction.
24:26The heart in this machine has been
24:28restarted versus the heart is in
24:29the donor and has been restarted.
24:32So you're back to square one.
24:33You're back to right where you were
24:35before you started the process.
24:37And the third thing is you clamp
24:39the arch vessels to substitute
24:40brain death for cardiac death.
24:42And as a surgeon I would my,
24:44you know my reaction to that
24:45is it's just a little bit,
24:46it's kind of a creepy thing to be doing.
24:50So I I don't want to obviously I'm
24:53not going to answer any questions
24:55about the ethics right,
24:56because these guys are going to cover that.
24:58But if are there,
24:59if there are any questions about the
25:01procedure, I can answer those right now. So
25:06OK, sounds good. I
25:09think that's that's great. Thank you.
25:14Yeah, thanks. I'm sure that there may well
25:16have been some questions and I I apologize.
25:18It will do the questions if any
25:20questions you have for all the
25:21all the panelists will answer.
25:22And how about that my prom
25:24picture in Gina Lolo,
25:25Bridget in the same talk and most are
25:28saying who the hell is Gina Lolo.
25:29Bridget. But she wasn't at that prom.
25:31I don't know. Who is she?
25:32The the Kim Kardashian of 1965?
25:35I don't know, something like that.
25:37Well, when Eric first reached out to
25:39me to talk about this, I thought, well,
25:42why don't I talk to to my personal
25:46favorite pediatric ethicist about this?
25:49And so I contacted Bob True and it turns out
25:52Bob was very familiar with the situation,
25:54was actually doing some work on it
25:55with others on a national level.
25:56And I'm going to let him talk about that.
25:58So to introduce our next speaker,
25:59we have heard here before.
26:01I get him down here as often as I can.
26:03This is Doctor Robert True,
26:04who's the Francis Glessner Lee
26:06Distinguished Professor of Medical Ethics,
26:08Anaesthesia and Pediatrics at Harvard Medical
26:10School and Boston Children's Hospital.
26:13He received the medical degree from
26:14University of California in Los Angeles
26:16and his board certified in Pediatrics,
26:18anaesthesiology and pediatric critical care.
26:20He also holds a master's degree in
26:23philosophy from Brown University.
26:24We actually had the same mentor
26:26just a couple years apart and he's
26:28a senior associate in critical care
26:30medicine at Boston Children's where
26:31he's worked for more than 35 years
26:33including a decade as chief of the
26:35Division of Critical Care.
26:36In 90 two 1992 he Co founded the
26:39fellowship program in medical
26:41ethics at Harvard Medical School.
26:43In 99 he Co founded the Harvard
26:45Ethics Consortium.
26:46And I could go on he has been a
26:48leader on certainly in Boston and
26:49then on a national level as well.
26:51I'm in 2004,
26:51he was recruited at Harvard
26:53to join Dan Brock,
26:54who was the his mentor and mind
26:57actually in building the Division
26:59of Medical Ethics at Harvard.
27:00And in 2014,
27:01when Doctor Brock retired,
27:02Doctor Shrug became director and
27:13reorganize into what is known now as
27:15the Center for Bioethics at Harvard,
27:17which is a most impressive operation.
27:20And he just this year stepped down
27:21as his role as director of that.
27:23So he's a tremendous thinker as
27:26well as an accomplished clinician.
27:28So it's my pleasure to
27:29introduce Doctor Bob True.
27:32Well, Mark, thank you
27:34very much for inviting me.
27:35It's always great to be here.
27:36Doctor Thompson, thank you for
27:38the really nice overview there.
27:39I learned a lot from from your explanation
27:41about what's going on with NRP.
27:43I'm going to talk a little bit about some
27:47of the ethical issues that are involved,
27:50and I want to start with this point
27:53that the fundamental challenge of organ
27:56procurement and transplantation is the
27:59necessity of obtaining living organs
28:02from patients who are deemed to be dead.
28:04And I'd I'd like you to keep this in
28:06the back of your mind as you listen
28:08to the conversation we have today.
28:10Because if the way you think about
28:12being dead is the way that most people
28:14think about being being dead, you know,
28:16a body that is cold and Gray and stiff,
28:20I mean, that understanding of death can
28:23never lead to transplantable organs.
28:25Those organs are just as dead as the body.
28:27So we're always struggling with this
28:30balance between wanting that body
28:32to be as alive as possible so that
28:35the organs are as good as possible.
28:37So let me I'm going to come back.
28:39I think this is kind of nice. Actually.
28:40I'll I'll reiterate some of what you covered.
28:43And I think it's,
28:45it's helpful because often times,
28:47you know,
28:47the whole thing about NRP is really
28:49convoluted and a lot of times the
28:51conversations seem to go down a rabbit hole.
28:53And so I'm hoping that we can lay
28:56it out in a way that is more clear
28:58and comprehensible.
28:59And so NRP is considered a version of
29:02donation after circulatory determination
29:04of death or what we call DCD,
29:06which has been used since the early 1990s
29:09and is generally pretty well accepted.
29:13And let me go through repeating to a
29:15certain extent what Doctor Thompson did,
29:17what that sequence looks like.
29:19So we have a patient who's terminally
29:22ill A decision has been made to
29:24withdraw life support with death
29:26being both inevitable and imminent.
29:28Typically,
29:28these are patients who are on a
29:31ventilator and we expect that when
29:34mechanical ventilation is discontinued,
29:36they will die within 30 minutes or so,
29:39certainly within an hour or two.
29:42The patient or the surrogate has
29:45given authorization for this patient
29:47to be an organ donor.
29:49Life support is withdrawn,
29:51typically a ventilator,
29:52but could also be medications that are
29:55supporting blood pressure, etcetera.
29:57Sedatives and analgesics are given,
30:00but only as much as is necessary to
30:02ensure the comfort of the patient,
30:05not to speed up the patient's
30:07death deliberately.
30:07In other words, this is not euthanasia.
30:10DCD is a passive process of
30:13allowing the patient to die,
30:15not causing the patient to die.
30:19Now, how do we determine death in DCD?
30:22Well,
30:22if and when the patient becomes pulseless,
30:25the five minute hands off period begins
30:28to observe for auto resuscitation.
30:30Where does this 5 minute interval come from?
30:33What we're looking for here is whether the
30:36heart is going to start again on its own,
30:39On its own. And what we know is that
30:42past five minutes of pulselessness,
30:45it's exceedingly rare for a
30:47heart to stop on its own.
30:50But that does not mean that cardiac
30:53arrest or pulselessness is irreversible.
30:56After that 5 minute period,
30:58many, indeed most patients
31:00could still be resuscitated.
31:02And this happens countless times
31:03every day in hospitals where the
31:05code team shows up and, you know,
31:07the patient's already been
31:08pulseless for five, 6-7 minutes.
31:10They're very successful
31:11at resuscitating people,
31:12as are paramedics.
31:13And so by no means is the
31:16loss of circulatory function
31:18irreversible at this point.
31:20And that's why something that I
31:22think is often overlooked is that
31:25it's essential that the patient has
31:26a DNR order in place that would
31:30ethically and legally prohibit any
31:32attempt to establish recirculation.
31:35Because again,
31:36if you do attempt it,
31:38it's a pretty good chance you're
31:39going to be successful.
31:40And so you know you can't declare
31:41the patient dead and then turn
31:43around and have them have them
31:44breathing and doing well after that.
31:45That just doesn't make any sense.
31:48In other words,
31:49after 5 minutes the lingo that
31:50we use is that pulselessness
31:52is deemed to be permanent,
31:54meaning that at that point we
31:57expect if no efforts are made to
31:59a step to re establish circulation
32:01that the loss of cardiac function
32:03will become irreversible within
32:05the next period of time.
32:10At that point death is declared
32:12and then organ procurement begins
32:14as described by Doctor Thompson.
32:16So this is sort of the sequence and I think
32:18contains the main ethical issues here.
32:21So how does standard DCD differ
32:24from thorical abdominal NRP what
32:26Doctor Thompson described for us?
32:29So in standard DCD,
32:31the organs must be recovered as
32:33quickly as possible after the
32:36determination of death, right?
32:37Once the heart stops,
32:39those organs are no longer getting oxygen,
32:41they're no longer getting any blood.
32:43You got to get them out as
32:46quickly as possible.
32:47They in some circumstances might
32:49be immediately transplanted.
32:50But as Doctor Thompson said in
32:52the the sort of standard these
32:54days is that the organs are placed
32:56on ex vivo circulation devices.
32:58This allows the transplant team to
33:01assess their function and to improve
33:03their function before they are transplanted.
33:06Whereas in NRP the patient is placed on ECMO,
33:10restoring organs, sorry,
33:11restoring circulation to all
33:13of the vital organs in the body
33:16except for the brain.
33:18And ideally that organ
33:20function returns to normal.
33:21And in in perfect circumstances,
33:24ECMO support can actually
33:26be completely withdrawn.
33:27And So what you've got is a perfectly
33:30functioning body below the neck, OK?
33:32The heart's pumping blood,
33:35the liver's making bile,
33:37the kidneys are making urine,
33:39the intestines are pink,
33:40and they're functioning.
33:41I mean,
33:42everything's working
33:43perfectly below the neck,
33:44which is the ideal situation
33:46for taking those organs out and
33:49transplanting them into somebody else.
33:52So what are the ethical and
33:54legal challenges to NRP?
33:55There's two first having to do
33:57with restoration of circulation and
33:59the second having to do with the
34:01occlusion of the cerebral arteries.
34:03So let's talk about the first one again.
34:06A prerequisite of death determination
34:08in DCD is that no attempt will be
34:12made to restore the circulation.
34:14I mean, that is the assumption.
34:16If.
34:16If that's not true,
34:18then you cannot pronounce the person
34:20dead after that 5 minute hands off interval.
34:23NRP violates this prerequisite,
34:25since NRP absolutely requires the
34:28restoration of the circulation.
34:30That's how NRP works.
34:32So I think it's pretty straightforward
34:35that in NRP the declaration
34:38of death is not valid.
34:40You violated that prohibition against
34:43an attempt to restart the circulation.
34:47Now,
34:47the way that this has been rebutted
34:50in the literature is to say that the
34:53intention and the intention in NRP
34:55is not to resuscitate the patient.
34:57That's not what they're trying to do.
34:59The intention is only to perfuse the organs.
35:03But regardless of the intention,
35:04the result is the same.
35:06Circulation is restored.
35:07And this was addressed in some
35:10detail a while back by two
35:12prominent healthcare lawyers,
35:15Alex Glazier and Alex Capron,
35:18in an article they wrote in the
35:19American Journal of Transplantation.
35:21And they addressed this point
35:23about the role of intention.
35:25Do intentions matter?
35:27And they wrote that although
35:29intentions may be important
35:30when evaluating the ethical
35:32acceptability of physicians actions,
35:34the legal standard for determining
35:37death is bare of intent.
35:39A patient is dead when circulation
35:41neither can nor will resume,
35:44regardless of what the intention was.
35:47It's important that circulation neither
35:49can nor will resume in order for that
35:51determination of death to be valid.
35:53They go on to say that even assumptions that,
35:57for example, the patient is in a state
35:59where meaningful existence is not possible,
36:01that trying to induce spontaneous
36:03resumption of circulation would be futile,
36:05or even that the NRP protocol is
36:07consistent with the donor's wishes.
36:09These are all irrelevant to whether
36:11the patient is deceased under U.S.
36:13law, which turns on the person's physical
36:17condition and not on anyone's intention.
36:20And so in my mind,
36:22I think it's pretty clear that
36:25the restoration of circulation
36:27in NRP means that the original
36:29determination of death was not valid.
36:31This patient was not dead at
36:33the time that cannulation was
36:36performed and was placed on ECMO.
36:38Problem #2 is occlusion
36:40of the cerebral arteries.
36:41Say a few things about that.
36:43The first little preamble here on
36:45what's called the dead donor rule,
36:46I'm sure many of you are familiar with it.
36:48It's it's not an actual law,
36:51but it's this sort of ethical presumption
36:53that underlies all of our practices about
36:56organ procurement and transplantation.
36:57You can put it in a couple of different ways.
37:00Either vital organs may not be
37:02procured from patients who are dead,
37:03or you can say that physicians may
37:06not cause death when procuring
37:08vital organs for transplantation.
37:11Now,
37:11standard DCD is compliant with
37:13the dead donor rule.
37:15Why?
37:15Because the organs are removed
37:17only after death is declared and
37:19the patients are allowed to die.
37:22They're not caused to die.
37:26The problem with occlusion of the cerebral
37:29arteries in DC in NRP is that occlusion
37:32is absolutely a necessary step for NRP.
37:36Why? They've done experiments in
37:39pigs where they did NRP but without
37:43clamping the cerebral arteries.
37:45And some of those pigs started
37:47to move and to breathe again.
37:49So clearly if you don't clamp these
37:51in a human, you'd have the completely
37:54unacceptable situation of, you know,
37:56taking out the heart for transplantation
37:57at a time that the person may be
37:59actually starting to move or breathe.
38:01So it's absolutely necessary
38:03for performing NRP.
38:05It's also sufficient to actually cause
38:07the death of the patient, right?
38:09We haven't declared the patient dead,
38:10but occlusion of the cerebral arteries
38:13causes a non survivable brain injury.
38:15It causes the patient's death.
38:18And so I would say in my mind pretty
38:21clear that it violates the dead donor rule
38:25that physicians must not 'cause the
38:27death that will actually in NRP,
38:28physicians must cause the death of
38:30the patient in order to procure the
38:33organs through this process of NRP.
38:35So that's kind of the summary of
38:37the ethics of it up to a point.
38:39And you'll see what I mean in a moment
38:41is that the two challenges is that
38:43the original determination of death is
38:44not valid and that occlusion of the
38:47cerebral arteries causes the death of
38:49the patient violating the dead donor rule.
38:52So does this mean that NRP
38:54is not ethical or legal?
38:56I mean, for many people, what I just
38:59said answers this question very clearly.
39:00No, it's not ethical or legal,
39:03but I'd like to explore this
39:04just a little bit more and say,
39:06well, not necessarily the case.
39:08And let me give you what I think is
39:11maybe the best argument in favor of NRP.
39:14And it has to do with the ethical
39:16theory known as consequentialism,
39:17which evaluates the rightness
39:19or wrongness of acts solely in
39:22terms of their consequences.
39:24OK, and consequences matter
39:25a lot in moral theory.
39:27And in fact, most of us are
39:29consequentialist most of the time.
39:31When we think about what
39:32is the right thing to do,
39:33the way our brains typically work is,
39:35well, what will lead to the best outcomes.
39:38And under a consequentialist analysis,
39:39I think NRP fares pretty well.
39:43Here's the key points.
39:44The death of the patient is
39:45virtually certain.
39:46This is somebody who has said,
39:48you know, I'm going to die,
39:49you're going to take away the ventilator,
39:51and I'm going to be dead.
39:53So there's not a doubt about that.
39:55The patient has expressed a
39:56desire to be an organ donor and,
39:58like most organ donors,
39:59want to help as many other people
40:01as they can.
40:02If the occlusion of the cerebral
40:04arteries is effective and there's more
40:05work that needs to be done on this,
40:07but if it is effective after
40:09preventing blood flow to the brain,
40:11then we can be pretty confident that
40:13the patient is insensate and won't
40:15experience any pain or suffering
40:17during the organ procurement process.
40:19And finally,
40:20NRP optimizes both the number and the
40:23quality of the organs that can be obtained.
40:27I mean,
40:27it's amazingly successful in that regard.
40:29And most donors, if you asked them,
40:31they'd probably say,
40:31yeah,
40:32I want to save as many lives as
40:34possible and I would like my organs
40:35to be used in the way that gives the,
40:37you know, the most benefit.
40:40So, you know,
40:41from a from a consequentialist perspective,
40:42we should say there's got NRP must be OK.
40:45I mean,
40:46how could something do so much
40:48good and have a problem?
40:50And the problem, of course,
40:51is, you know,
40:52most of us have thought that isn't it wrong,
40:54always wrong,
40:55for a physician to kill a patient?
40:59And I would say yes,
41:01but I'd I'd like to say a qualified
41:03yes because I think the strength of
41:05this rule and the number of exceptions
41:07to it have been changing over time.
41:09And let me quickly give you a few examples.
41:12So in the 1970s, withdrawal of a ventilator
41:15or any other form of life support
41:18was considered killing the patient.
41:20Back in the 1970s,
41:21physicians never took patients off
41:23ventilators because they believed
41:24it would kill the patient,
41:26and it took the Quinlan case and other
41:29cases to reframe that as not killing
41:32but allowing the patient to die.
41:34In the Up until the 1990s,
41:37physicians were very reluctant
41:39to provide medications to dying
41:40patients to make them comfortable,
41:42for fear that this would be
41:44seen as euthanasia.
41:45And there were some Supreme Court
41:47cases through the 1990s that said no,
41:49no, it's OK to use these medications
41:51in dosages that may
41:53actually speed up the death of the patient,
41:55so long as your intention is to
41:57make the patient comfortable,
41:58not to cause their death.
42:01In the 1990s, we saw the emergence
42:03of physician aid and dying,
42:04beginning in Oregon.
42:07Physician aid and dying could be looked
42:09at very much as physician euthanasia,
42:11physician killing,
42:12with the caveat that it's important
42:15that the patient themselves
42:17swallow the lethal medication,
42:18not that it be administered by the physician.
42:21And today,
42:22more than 20% of the US population has
42:24access to physician aid and dying.
42:26And then finally,
42:27even that last little prohibition has
42:30gone away with our neighbors in Canada
42:32who have fully legalized euthanasia,
42:35and not just for the terminally ill.
42:37My point here is to say that
42:39in the past several decades,
42:41all of these things have been seen
42:44as completely prohibited because they
42:46involve physicians killing patients.
42:48And I'm saying that you can
42:49see how there's been
42:50a shift towards weakening
42:53that prohibition and in some
42:55cases totally eliminating it.
42:56And so the question I would ask is,
42:58can NRP also gain acceptance as a
43:01legitimate exception to the prohibition
43:03against killing by physicians?
43:06I think it's hard to get away
43:07from the fact that it is killing.
43:09But, you know, like many other things,
43:11maybe we could reframe it or
43:13consider it a legitimate exception.
43:15So just to come back here, you know,
43:17the fundamental challenge of organ
43:19procurement and transplantation,
43:20the necessity of obtaining living organs
43:22from patients who are deemed to be dead.
43:24And we continue to pair away
43:28that distinction so that we can
43:30get the best possible organs.
43:32And, you know,
43:34this does remind me of the the quote
43:36from Miracle Max and The Princess Bride
43:38where he says there's a big difference
43:41between mostly dead and all dead.
43:43Mostly dead is slightly alive.
43:45And you know, I say it not really
43:47tongue in cheek because in fact,
43:49it is important that organ
43:51donors be somewhat,
43:52at least slightly alive,
43:53because if they're not,
43:54those organs are not going to
43:57be usable for transplantation.
43:58So let me finish up here.
44:00NRP donors are not dead by
44:03standard DCD criteria.
44:04NRP causes the death of the donor by
44:07occlusion of the cerebral arteries
44:09in violation of the dead donor rule.
44:11But NRP is a very compelling
44:14way to maximize respect for the
44:16altruism of the donors who want
44:17to save the most lives as possible
44:19and the needs of recipients.
44:21We are our waiting lists are far beyond
44:23what what we can provide in terms of organs.
44:26And NRP is,
44:27you know,
44:28sort of,
44:29from an all things considered
44:31consequentialist perspective,
44:31pretty attractive.
44:32But I think where are my biggest concern
44:36is I think that we need to represent
44:38NRP honestly and transparently to the public.
44:41I need, I think we need to be open
44:44about what it actually involves.
44:46And I worry a little bit that among
44:49some transplant professionals,
44:50there's a little bit of gaslighting
44:51going on here with the public.
44:53It's like, oh, you know, no,
44:55no, this is just like DCD.
44:56There's nothing different going on here.
44:58We don't really need to explain to
44:59you what's different about this.
45:01I think it is different.
45:02I think it is different.
45:03And I think individuals should be
45:05fully informed about what NRP involves,
45:12should be free to refuse organ
45:14donation by NRP even if they
45:17are authorized organ donors,
45:18even if they've checked that
45:19box on their driver's license.
45:22So I think we're going to hear a little
45:23different perspective from Brandon,
45:25maybe, maybe not, I don't know.
45:26But so that's sort of my,
45:28my perspective on it.
45:30And Mark, Brandon,
45:33thank you, Bob. That was excellent.
45:36So we hear from a from ACT surgeon greatly
45:39experienced who knows whereof he speaks.
45:41We hear from a bioethicist who is very
45:44expert in the field of bioethics and
45:46in particular with regard to organ
45:49transplantation also very experienced
45:51and I think we haven't we've set the
45:53table very well. But, but again,
45:54my good fortune I share with you.
45:56My good fortune was is knowing Eric and
45:58Bob and getting them here and then.
45:59But folks said to me, well,
46:00if you want to have a conversation
46:02about this, usually they get
46:03Bob Trug or Brendan Parent.
46:04And so I think, well, jeez,
46:06why can't I get them both And and
46:08why indeed And so here we are.
46:10So I I just met Brendan today.
46:11We've communicated about this.
46:12He was kind enough to agree to come
46:14and join us for the conversation.
46:16I'm so grateful.
46:17He is the director of transplant Ethics.
46:19Brendan Parent JDI should point out
46:21he's an attorney and director of
46:24transplant ethics and Policy Research
46:26and assistant professor of bioethics
46:28in the Division of medical ethics
46:30with joint appointment and surgery
46:32at NYU Grossman School of Medicine.
46:34He's PA on nonprofit and government
46:36funded grants studying ethics and
46:38regulation of transplant research.
46:40Parents serves as an independent
46:41living donor,
46:42advocate and Advisory Board member
46:44for the National Kidney Foundation
46:46and a member of the National Donation
46:48Research Council for the Alliance.
46:50He provides ethics consultation
46:52for transplant and medical research
46:54programs across the United States.
46:56He received his JD from Georgetown
46:58University Law Center and Undergraduate
47:00degree in Bioethics from the University
47:03of California in Santa Cruz.
47:04We are very grateful and very
47:06fortunate to have you join us today.
47:07Come on up, Brennan.
47:13There you go. It's all yours.
47:14I had to silence my phone.
47:15I'm so sorry it's been dinging.
47:18I want to start by saying thanks to
47:20setting the stage so incredibly well.
47:22I feel like my job is done.
47:23I mean that's this is to the point
47:27when we were first tapped to do this,
47:30it was Frank, hey you know why don't
47:32we do a pro and con discussion
47:34and you know battle it out.
47:36And I politely requested that we reframe
47:39because the nuance is significant and
47:41and we will obviously you can see this,
47:43Bob did such a great job of
47:45of describing the nuance here.
47:47So instead of saying pro let's
47:50do NRP go gangbusters.
47:52I do want to think about issues
47:55of death trust through the lenses
47:57of both ethics and the law.
48:00And here are my disclosures.
48:02And I think maybe the most
48:03important one for this is that NYU,
48:05my home base,
48:06was the first program to perform
48:09NRP in the United States.
48:12And the surgeons came to me in the
48:14Division of Medical Ethics and my
48:16senior colleague Art Kaplan and said,
48:18hey, we're thinking about doing this,
48:19but we want to make sure we
48:21do it the right way.
48:22So we spent a lot of time thinking
48:26about whether and then how to do
48:29this in the most ethically sound
48:31way with appropriate safeguards,
48:33and what kinds of empirical ethics
48:35research needs to be done to justify it.
48:39And I will now make very explicit that I
48:42sit separate from the Transplant Institute,
48:45which,
48:45after we wrote the sort of ethics
48:47and logistical concerns about NRP,
48:49went ahead and did it
48:53all right. So there's going to be a lot
48:55of stuff in here which is duplicative
48:56of what's already been covered.
48:57I'm going to race through it and get
48:59to hopefully the additive stuff.
49:01But the obvious thing,
49:02which was implied is that we
49:04don't have enough organs.
49:05And how do we do it?
49:06And there was a National
49:07Academies of Science,
49:08Engineering and Medicine report that
49:09came out and said one way to do a
49:12better job of getting more organs in
49:14this country is to do more recovery
49:16after circulatory determination of death.
49:18And as Bob pointed out,
49:20that's a challenge because when
49:21the heart stops,
49:22the organs start dying as well.
49:24So how do we do a better
49:26job of keeping those organs
49:29optimized for transplant?
49:30We can do it XC2 on machines
49:33or in C2 in the body.
49:35So the traditional method of rapid
49:38recovery is difficult because
49:39it leads to more ischemic time
49:41and the outcomes aren't as good.
49:43Then we have XC to perfusion the
49:45transmedics or X vivo systems
49:47which do a fantastic
49:49job but have their own
49:50limitations in terms of cost.
49:52We heard the estimates.
49:53I I you said that 65,000 for the
49:56one time uses for XC2 machines
49:58and what was it, 1500 for NC 2.
50:01And I've heard estimates for
50:03total costs for one instance of
50:06** vivo around 90 or 100,000 for
50:09heart and around 5000 for NRP.
50:11Obviously cost alone is not a
50:13sufficient consideration because
50:14if something isn't ethical,
50:16it doesn't matter how little it costs
50:18or how good the outcomes are, right?
50:20So we can't just be consequentialist.
50:22We have to think about the rights of
50:25individuals and also issues of justice,
50:27etcetera. OK.
50:28So enter the NRP picture.
50:30We've talked about the process.
50:32I'm not going to go through it again.
50:35It can have these benefits of
50:37more time for organ evaluation,
50:39especially under physiologic conditions.
50:41The outcomes look great,
50:43but does undermine,
50:45does NRP undermine the definition of death?
50:48So we'll come back to this definition
50:50which you have already seen today.
50:52Irreversible cessation of all circulatory
50:54respiratory functions or irreversible
50:56cessation of all functions of the brain,
50:59including the brain stem.
51:02So does NRP undermine this definition,
51:05right?
51:06You declare them dead,
51:07you include brain blood flow and
51:10then you restart circulation,
51:12which is the one thing the definition
51:15says you cannot do in order to be dead.
51:17So
51:20I want to put this back in terms
51:22of the irreversibility standard
51:25versus the permanence standard
51:27which Bob put on the table.
51:30OK, so does it meet the letter of the law,
51:33right, that the heart has stopped?
51:36Right, and it cannot be restarted?
51:40It is physically impossible.
51:41And the answer and it's not just
51:43the heart circulation, right?
51:45Because the circulatory death
51:46is not just about the heart,
51:47It's about circulation writ large.
51:50That's not the case, right?
51:52Because when you restart circulation,
51:55you have proven that it's not irreversible.
51:59But does it meet the permanent standard,
52:00right?
52:01And permanence is what is employed
52:04in practice all across medicine,
52:07regardless of organ donation
52:09intentions or goals, right?
52:11If we had to use the irreversibility
52:14standard to declare someone dead,
52:16we would never declare anybody dead, right?
52:19So in practice, we use a permanent standard,
52:22which is that circulation has stopped,
52:25it cannot restart on its own,
52:27and we will not attempt to restart it.
52:30Now here's where I'm going to
52:32hopefully be a little additive.
52:33We just did the crash course.
52:34You would all ace the quiz on what NRP
52:36is and the legal definition of death.
52:38Congratulations, you're all ethicists.
52:39But now I'm going to try to add
52:41something a little bit more,
52:42which is,
52:44is NRP any less permanent in terms
52:49of the cessation of function than
52:52restarting some circulation of that
52:55part of that circulatory system,
52:58the heart, in either the recipient
53:02of that heart or on a machine?
53:06And so let's get back to these questions.
53:09OK.
53:09Does recirculation undermine
53:11the determination of death?
53:12You've heard the yes argument.
53:14You restarted the circulation.
53:15You saw Alex Capron's paper and Bob's very,
53:19very eloquent description.
53:22And it's clear you restart
53:24circulation inside the donor's body.
53:27So yes, you,
53:28you've undermined the definition.
53:31And then when you remove the organs,
53:33the dead donor rule is violated
53:35because that person wasn't dead.
53:37You take the organs out.
53:38You have caused death and so now you're
53:41liable for having killed that patient.
53:44But what about this?
53:47The circulation that is
53:49restored is not resuscitation,
53:52it's perfusion for donation.
53:55OK, Am I just doing some, you know,
53:58gerrymandering of language?
53:59The language says circulation,
54:01right, irreversible circulation.
54:03You recirculated.
54:04So that's enough, right?
54:06You've undermined the the, the definition.
54:08But if we are using the permanence standard,
54:13which we say is that the heart,
54:15the circulation has stopped,
54:16cannot restart on its own,
54:18and we will not attempt to restart it,
54:21then you have to ask why you are
54:24not attempting to restart it.
54:25Because otherwise it's meaningless.
54:26It doesn't matter why don't
54:28you attempt to restart it.
54:29And the answer is because doing
54:32so would be medically ineffective
54:34to save that patient's life.
54:36So the intention is inherent
54:40in the permanence standard. OK.
54:43Otherwise it's meaningless.
54:44And you talk to other lawyers, right?
54:46This.
54:46And there's an interesting little
54:47legal process theory for you, right.
54:49How many lawyers in the room?
54:50Not many. Yeah. Right.
54:52There you go.
54:54There are some who you know,
54:56certain judicial, you know,
54:58context will say, look,
54:59all we can do to make a decision in this
55:02case is look at the black letter of the law.
55:05We're not going to think about anything
55:07outside of the letters on the page.
55:09And if you use this strict
55:11determination of what is legal,
55:13of course this doesn't meet the
55:15irreversibility standard, right?
55:16But wait a minute,
55:17we're already using a different
55:19standard in practice,
55:20which is permanent.
55:20So maybe the law is broken.
55:22But also there are some cases and
55:24some judges who say you can never
55:25just look at the letter of the law,
55:27because letters of the law have
55:30no substance by themselves.
55:31So you have to think about the intention.
55:33What was the goal of the statute?
55:35What is the historical legal
55:36context in which the law grew here?
55:39And in this case,
55:40the definition of death exists to
55:42delineate a line between the rights
55:44that adhere for a living person,
55:47quality of life,
55:48the desire to continue living right
55:50and the capacity to live a life,
55:53and then the rights that no longer subsist.
55:56And then what occurs after death?
55:59OK, so regardless, OK,
56:00so now here's the other piece.
56:02Just because we can read intention
56:05into the definition and we can say,
56:07well,
56:07you didn't intend to kill the patient
56:09or to bring the patient back to life
56:11and then take their organs and kill them.
56:13You didn't mean to.
56:14Well, that's not enough,
56:15right?
56:15Because you can.
56:16And maybe you do,
56:18right.
56:18So take another like adjacent scenario
56:22where there is a patient who maybe
56:25doesn't quite meet the criteria for,
56:28you know,
56:29medical futility and you can
56:31withdraw support and you can have
56:33the intention not to bring that
56:35patient back to life and then kill
56:38them by taking the organs out.
56:40But you could very well do that right?
56:42Especially if you don't occlude
56:43blood flow to the brain.
56:45So intention is enough.
56:47Isn't enough,
56:48right? There has to be, in fact,
56:50whether whether the patient is dead,
56:55So is the donor in fact resuscitated?
56:58OK, so here's the difference between
57:02recirculation and resuscitation.
57:03And I would argue that under
57:06the right NRP protocol,
57:08there isn't resuscitation because of the
57:11occlusion of blood flow to the brain.
57:14Now, does preventing blood flow
57:16to the brain 'cause death?
57:18The one argument is yes, right?
57:21The clinicians who are occluding blood
57:24flow cause death by neurologic criteria.
57:26And the answer is no, no, no,
57:28wait a minute, the patient was already dead.
57:31You declare them dead according
57:32to circulatory criteria,
57:33and everything afterward is just
57:35perfusion and preservation and donation.
57:38All right,
57:39we won't have to go through this all again.
57:41The problem is, look,
57:43the dead donor rule is based on
57:48an outdated definition of death.
57:50It's not an actual law.
57:53And maybe it's time to reconsider
57:56the dead donor rule in at least
57:59some circumstances.
58:00Just because the heart is beating
58:04right doesn't necessarily mean that
58:08this patient has any meaningful
58:10quality of life anymore.
58:12So maybe some say, look, NRP is ethically OK,
58:15it does violate the dead donor rule,
58:19but maybe we should just abandoned
58:21the dead donor rule, right,
58:23and move on from it.
58:24All right.
58:25So I want to ask,
58:26I want to ask here sort of at the end.
58:29Let's forget the law for a moment.
58:30It's very easy to go down the rabbit hole.
58:32As Bob mentioned,
58:33who's harmed, who has helped?
58:35What are the consequences?
58:36Here we have to think about the organ donors,
58:38family members and consider their
58:41experience of having just lost a
58:43loved one and having to make a
58:46decision about what that individual
58:48would have wanted and how to
58:50empower them to make this decision.
58:52How much information do you give
58:54them to make this decision?
58:56And also the ability to realize
59:00the family members desires to
59:02see some good come out of this.
59:05And NRP has good outcomes.
59:07The recipients obviously can
59:08do very well with these organs,
59:10but it doesn't matter how well
59:12they do if you're doing something
59:13wrong in the first instance.
59:15So let's get to the organ
59:16donor for just a moment.
59:18Their decision to be a donor.
59:20For those of you who are are
59:22authorized donors in this room,
59:24hopefully you feel that if and when you die,
59:29your organs can save other people's
59:32lives in optimal ways, right?
59:34But at the same time,
59:37you don't want the experience of
59:40donation to be any way harmful to you.
59:43So the occlusion of blood flow to
59:45the brain is a critical question.
59:47And we haven't talked about some of
59:49the pushback on the current protocol,
59:51which is the ligation of the aortic
59:54arch vessels and the possibility
59:56that there is some collateral flow
59:59to the brain through other channels,
01:00:01including through the spine.
01:00:03And there's now this question about
01:00:05whether the occlusion is sufficient
01:00:07to prevent enough blood flow
01:00:10that could potentially lead to some
01:00:13sort of meaningful cerebral activity.
01:00:15And if we haven't answered that
01:00:17question, that's a problem.
01:00:18There was a paper that came out pretty
01:00:21recently from NYU that suggests based
01:00:24on 2 donors, there was no meaningful
01:00:27collateral flow to the brain.
01:00:282 is not a big enough number to
01:00:30extrapolate and then just assume that
01:00:32this protocol works properly, right?
01:00:33So we need to find ways
01:00:34to replicate this study.
01:00:37There have been updates to
01:00:38the protocol which says, OK,
01:00:39let's not just ligate the vessels,
01:00:42let's sever the vessels so that if you
01:00:45open them to atmospheric pressure,
01:00:47the blood will drain out and there
01:00:49will be no chance of collateral flow.
01:00:51But then say, Oh well, wait a minute,
01:00:53there might be some blood clots because
01:00:55of the amount of time without circulation.
01:00:57So even that might not be sufficient to
01:01:00prevent collateral flow to the brain.
01:01:03So now I'm going to ask you,
01:01:04follow me down the philosophical ether
01:01:06rabbit hole for a moment and say, OK, well,
01:01:08if we're not sure that severing is enough,
01:01:11why not just decapitate the donor, right.
01:01:14And I said, Oh my God, watch.
01:01:15What are you talking about?
01:01:17That's crazy.
01:01:17But I'll say from an ethics perspective,
01:01:21we have to define what is morally different,
01:01:24right?
01:01:24Distinct from severing versus decapitating.
01:01:28Right. If.
01:01:28Well, it's going to,
01:01:29if that's going to maximize the goal and
01:01:32ensure that this donor experiences no harm,
01:01:34right.
01:01:34And and provide the best outcomes
01:01:37through NRP, well, then why not?
01:01:38We have to be able to answer that question,
01:01:40I think.
01:01:42All right.
01:01:42Last thing,
01:01:42back to the issue of what
01:01:44is informed authorization.
01:01:46What would you want to know?
01:01:49You already now you're all sorry
01:01:51you're all you took the red pill or
01:01:52whatever it is and now you're now
01:01:54you're you're in this this crazy world.
01:01:56What information would you want?
01:01:58What do we have to tell people?
01:02:01And what do you want to make sure
01:02:03happens during the actual protocol,
01:02:05right?
01:02:05We're about to start up a a a
01:02:07project to study donor perspectives,
01:02:10donor family member perspectives on NRP.
01:02:13Because even if all of this works great,
01:02:16and even if us ethicists in the
01:02:18ivory tower decide that this
01:02:20is ethical under some rubric,
01:02:21it doesn't matter if this abuses
01:02:24the trust of an already wary
01:02:27public about medicine,
01:02:29about organ transplant and so both,
01:02:31both from a deontological perspective
01:02:33and a consequences perspective,
01:02:35this could have massive blowback.
01:02:36So the issue is trust.
01:02:37And I want to end with just one point,
01:02:39which is we have to go back
01:02:41to this issue of permanence.
01:02:43And I think the most important ethics
01:02:47challenge is ensuring that upstream
01:02:51two donors who are otherwise similarly
01:02:54situated are not treated differently.
01:02:58I'm sorry,
01:02:58not donors at this point.
01:02:59But patients are not treated
01:03:01differently such that one is
01:03:03routed for continued medical care
01:03:05because there's a possibility we
01:03:07might be able to restore some
01:03:09meaningful quality of life.
01:03:11And then the other is routed for
01:03:13any kind of withdrawal of life
01:03:16support and an organ donation.
01:03:18Simply by virtue of the first
01:03:20patient being of a particular socio
01:03:23economic demographic being white,
01:03:24having family members to advocate for them,
01:03:26and another patient being poor and
01:03:29black and not having people to represent
01:03:31their wishes and wanting to, you know,
01:03:34empty out a hospital bed, right.
01:03:36And if we can create better
01:03:39objectivity around these decisions,
01:03:41then hopefully we can do a better
01:03:44job of trusting that the rest of
01:03:46this process is going to lead to
01:03:53decision that respects the donor
01:03:55wishes, respects the community
01:03:57and leads to good outcomes.
01:03:59All right, I'll stop there.
01:04:02Thank you, Brendan.
01:04:03That was fantastic. Let's find a
01:04:05pretty picture to put this on here.
01:04:06Back to Bob's pretty picture.
01:04:08Yeah. Bob has some artwork there
01:04:09for speak on Sound up there.
01:04:12There you go. That looks nice.
01:04:13We'll leave that up.
01:04:14Thank you. Thank you.
01:04:16I'm going to invite Eric and Bob
01:04:18and Brendan to have a seat here
01:04:20and we'll turn those mics on and
01:04:22we're going to open up to you guys.
01:04:23Now ordinarily I'll I I often
01:04:26take as moderator,
01:04:27I take my prerogative to
01:04:29ask the first question.
01:04:30I'm going to actually ask the
01:04:32second question because I want
01:04:33to open up to the first question.
01:04:34Was there a kindly offer
01:04:36to explain the technology.
01:04:37So before we get in to a conversation
01:04:39about the ethical and legal
01:04:41issues that have been so nicely
01:04:42laid out by all three speakers.
01:04:44In fact,
01:04:44I just want to be sure,
01:04:46is there someone in the audience And please,
01:04:48please feel free cause a lot of this
01:04:50stuff is technical and everybody's
01:04:51got varying degrees of expertise.
01:04:53If anybody in the audience has a
01:04:55question specifically about how the
01:04:57technique is done that they want to ask
01:04:59which Eric had offered to answer before,
01:05:00which we can do now.
01:05:01So anyone have a question they want
01:05:03to specifically ask about that?
01:05:04Yes Sir.
01:05:04So wait,
01:05:05wait for the mic if you would.
01:05:06So the folks on Zoom can also
01:05:08hear what you have to say.
01:05:14Yeah, I was just wondering.
01:05:15So you mentioned before with the with
01:05:18the ex vivo method that it's it's
01:05:21transferred like with the the cardboard
01:05:23box like you showed the pictures of
01:05:24how is it transferred in the case of
01:05:27NRP or is it like a patient in the
01:05:29same hospital which is a
01:05:31very specific scenario.
01:05:32So I'm just wondering how is
01:05:34it transferred in vivo in,
01:05:36in the case of in the case of NRP?
01:05:40Not sure I understand except that they're
01:05:42both done in the operating room like the if,
01:05:44if the if the donor was right here
01:05:47you're you're resuscitating the organs
01:05:50inside that donor. And if
01:05:52if, if you were going to use that transmedics
01:05:55machine, the machine's sitting right there.
01:05:56So I I think the I got it, I got it so.
01:05:59So when you get it has to go, it stays,
01:06:02it stays on that machine
01:06:04till it gets to its destination.
01:06:06But in NRP, yeah. So NRP
01:06:08it goes in that it goes in
01:06:10a cardboard box that's insulated
01:06:12potentially and the outcomes are still good,
01:06:14right, because you have improved
01:06:15after the ischemic time even though
01:06:17it has to go back in a cardboard box,
01:06:19but often the donor and recipient
01:06:22could be Co located, right.
01:06:24So your your point you said what
01:06:25if they're in the same place,
01:06:25so that can be done like the the
01:06:27original one and then you are still
01:06:29losing that that ischemic time, right.
01:06:31And the other possibility,
01:06:33something we didn't talk about
01:06:34is that often NRP will be used in
01:06:37conjunction with X vivo, right.
01:06:39So you do it inside the body and
01:06:41then you can put it on a machine
01:06:43for a little bit at least. Yeah.
01:06:46Thank you.
01:06:46Thank
01:06:47you very much. So let me,
01:06:51let me ask the first question.
01:06:53And and this would be to to
01:06:55anyone who wants to address it.
01:06:57I actually got a text in the middle of
01:07:00all this from a colleague halfway across
01:07:02the country who was watching this.
01:07:03This is the fun of doing a list of fun.
01:07:05Zoom was watching this and says,
01:07:06why don't you ask this?
01:07:07And I said I was going to,
01:07:08I'm going to ask all three of them.
01:07:09And of course the question is,
01:07:10and I think Bob,
01:07:10you and I have talked about this in the past,
01:07:12is that so?
01:07:13It seems to me that we're doing
01:07:15all sometimes we're doing a lot of
01:07:18calisthenics to convince ourselves
01:07:20that somebody's dead in order
01:07:21to make it OK to take the organs
01:07:23because we have the dead donor rule.
01:07:25And so another solution to this,
01:07:27rather than the the linguistic
01:07:29calisthenics to decide if somebody's dead,
01:07:31is what about just getting rid
01:07:33of the dead donor duel?
01:07:34The dead donor rule.
01:07:35Excuse me.
01:07:36What do you guys think about that again?
01:07:40Well, I well, Brennan, I think
01:07:42you you suggested this and
01:07:45I could be persuaded that that's not
01:07:49an unreasonable way of resolving this.
01:07:54And I mean, what
01:07:55one of the big advantages of doing
01:07:58that is that we would cut through all
01:08:00of what many people would view as the
01:08:03charade we go through to to be able to,
01:08:06if not convince ourselves,
01:08:09convince lawyers and other people
01:08:11that that the person is dead.
01:08:13Why not right at the beginning
01:08:14of this whole thing,
01:08:15just give the patient an anesthetic
01:08:18dose of fentanyl and we wouldn't have to
01:08:21worry about whatever happened after that.
01:08:23I mean, the patient,
01:08:26you wouldn't have to clamp the arteries.
01:08:28And you know, the argument that look at this,
01:08:30this was somebody who we know
01:08:31is going to die anyway,
01:08:32they want to donate their organs.
01:08:34That seems to me the least we could do is
01:08:36just absolutely guarantee that they're
01:08:38not going to to suffer or feel any pain.
01:08:41But all of this is kind of predicated
01:08:44upon either getting rid of the dead
01:08:46donor rule or or or viewing NRP
01:08:49as kind of an exception that makes
01:08:51sense where the dead donor rule can
01:08:53be honored in the breach, if at all.
01:08:56So this is a very important question that
01:08:58I think we need to be asking right now.
01:09:01And I think one of the most
01:09:02significant potential consequences
01:09:04of doing away with the dead donor
01:09:07rule is the impact on trust, right.
01:09:12And this push, particularly in this
01:09:17country to try to get more organs,
01:09:20which is a good cause and the potential
01:09:26economic motivations to pursue
01:09:30organ transplant in some regards.
01:09:32And the lack of trust that already
01:09:36exists among many communities both in
01:09:38medicine and transplant and how a lot of
01:09:41people choose not to register as donors
01:09:43because they're afraid that if they do,
01:09:45you won't try as hard to save their life,
01:09:48right.
01:09:48And that's a really important consideration.
01:09:50So that now if we,
01:09:51if we try to create a culture where we say,
01:09:54oh, you don't even have to be dead
01:09:56to take your organs, but don't worry,
01:09:58we're going to make sure that
01:10:00you're close enough to death,
01:10:01right.
01:10:01That might sort of breach a line
01:10:04that actually allows some of the
01:10:07other motivations to sort of
01:10:11overwhelm the prioritization of
01:10:12clinical care and well-being of
01:10:14those patients at the end of life,
01:10:17which is you know that I think
01:10:19the beginning of of Bob's talk
01:10:21is it necessarily the case?
01:10:22Not necessarily.
01:10:23I think there would have to be a
01:10:26lot of work done to educate people,
01:10:28to make sure that individuals
01:10:30are empowered to have the right
01:10:32course at the end of life,
01:10:34which I also think includes
01:10:35realizing their transplant wishes.
01:10:37There are some countries now that are
01:10:40either exploring or adopting organ
01:10:43donation after euthanasia, right?
01:10:45Because here,
01:10:45if I want dignity at the end
01:10:47of life and I want to die,
01:10:48but I also want it to be done
01:10:49in such a way that it could
01:10:51save other people's lives,
01:10:52well then let's do that.
01:10:53Could you imagine that in this country?
01:10:55Not, not yet.
01:10:56And I also want to point out,
01:10:58I think somebody else's work in this room.
01:11:03So there have been some studies to
01:11:06suggest that if you are honest with
01:11:09people about what happens that they
01:11:13don't necessarily feel like they
01:11:15have to be dead in order for their
01:11:17organs to save other people's lives.
01:11:20As long as you know that death
01:11:25is imminent and that this could
01:11:28lead to good outcomes and that
01:11:30people are being again honest,
01:11:32transparent and giving them the best
01:11:34clinical care at the end of life.
01:11:36And I I, I kind of rolled through that a bit.
01:11:38If you want to say a little
01:11:39bit more about it, you can OK,
01:11:41so we'll get to this in one second.
01:11:43I just, I just want to comment that the
01:11:47issue of trust also plays into when we say,
01:11:50well, you know we're well maybe
01:11:51you're not quite dead but you
01:11:52know but by the way we're going to
01:11:53clamp the vessels to your head.
01:11:54So so I mean the the trust issue
01:11:56could play it the other way as well
01:11:58which is essentially you know as I
01:12:00described this to one person it it
01:12:02is the idea of severing a head is
01:12:04is just so so horrific to people.
01:12:06But physiologically we're thinking
01:12:07well if you're going to you know cut
01:12:10off all the blood supply to the head
01:12:12you know there's issues with trust
01:12:13there as well is what I would say.
01:12:15So. So it could go either way.
01:12:16What I'm going to ask and and I
01:12:18don't I mean Brenda cut you up you
01:12:19wanted to say something.
01:12:20But what I'm going to ask is we have
01:12:22a number of individuals here who are
01:12:24leaders in the transplant community locally,
01:12:26nationally and otherwise.
01:12:27So we don't ordinarily do this but just
01:12:29so folks know who they're hearing from.
01:12:31If you'd like please when you
01:12:33get the microphone,
01:12:34I'll call on you as best I can.
01:12:36Just please tell us your name and and
01:12:38what organization you represent or
01:12:40what university you represent etcetera.
01:12:42And by the way, to my friends,
01:12:44the students who are here that
01:12:46whether you're the,
01:12:47the chief of transplant medicine or
01:12:48a first year medical student or a
01:12:50nursing student or a member of the community,
01:12:53we want to hear from everybody
01:12:54in this conversation.
01:12:55Everybody's opinions and thoughts
01:12:56and questions count.
01:12:57So I'm asking people to identify,
01:12:58so you kind of know who you're hearing from.
01:13:00So with that,
01:13:00I think Doctor Formica has
01:13:01the mic and we'll start there.
01:13:03So Rich
01:13:03from Mike, I'm one of the transplant
01:13:05physicians here at Yale and the
01:13:07incoming president for the OPTN.
01:13:08So I will the great conversation,
01:13:10I thought the way it was
01:13:11presented was really great.
01:13:12But I want to ask the reciprocal of what
01:13:14you just asked about doing gymnastics with
01:13:18language to say that somebody's dead.
01:13:20Well, it sounds like you're doing
01:13:22gymnastics to me to say that somebody's
01:13:24live because those of us who have
01:13:26attended the deaths of patients,
01:13:28like the individuals who we are
01:13:30Speaking of have had a tragic accident.
01:13:33They are neurologically so damaged
01:13:35that when we withdraw life support,
01:13:38they expire within a relatively short
01:13:40period of time and then their heart is
01:13:42stopped for an additional 5 minutes.
01:13:45So keep the conversation going,
01:13:47but do the mental gymnastics
01:13:49from the other perspective,
01:13:50like you're really trying to make this
01:13:53person still alive to come up with language,
01:13:55which I think we have to be
01:13:56a little bit careful of,
01:13:57like using the word killing in this
01:13:58context because trust is important.
01:14:00But give me that, You know,
01:14:02give me the opposite argument.
01:14:04Why are they alive versus why
01:14:06aren't they dead?
01:14:07That too.
01:14:07Nice
01:14:12go. Why aren't Of course they're alive.
01:14:17I mean, you know,
01:14:18you've got somebody who's dying,
01:14:20but of course they're alive
01:14:22now you know, you, you,
01:14:24you might be able to cause them to die,
01:14:26allow them to die in a way that it then
01:14:28becomes acceptable to take the organs.
01:14:30But I mean, if you want to just
01:14:32say they're as good as dead,
01:14:33then let's just give them a big dose
01:14:35of fentanyl and take the organs.
01:14:36And I'm not saying that that
01:14:38would necessarily be wrong,
01:14:39but I I I think that the
01:14:41presumption that they're not
01:14:42alive doesn't make any sense.
01:14:44Well,
01:14:44let's imagine that when we're there,
01:14:46we don't do the NRNRP procedure.
01:14:51Their 5 minutes has elapsed,
01:14:53Their medical team has declared
01:14:55them dead by circulatory death,
01:14:57and we just walk out of the room.
01:15:00Well, now they're dead, right?
01:15:04Yeah. So
01:15:08and this is, this is kind of my point, right.
01:15:10And and I feel that the law is
01:15:13a blunt instrument that has to
01:15:15delineate a moment when people are
01:15:17dead versus when they're alive.
01:15:19But I think everybody in this room,
01:15:20this is probably one of the few
01:15:22rooms where probably everybody knows
01:15:23it's messier than that, right.
01:15:25And absolute clarity on dead versus
01:15:28living is kind of impossible to
01:15:30come by especially and this is
01:15:32like the perfect example of that.
01:15:35And I feel that there are already the the,
01:15:39the verbal gymnastics to to be able to
01:15:42declare people dead in light of the
01:15:45broken or insufficient legal definition
01:15:47of death going to the permanent standard.
01:15:50So for I think that is the work
01:15:52that's sort of being done to say,
01:15:53OK, they're they're still alive.
01:15:56And so that's why I try to get out of,
01:15:57out of the, the rabbit hole and say,
01:15:59OK, what are the actual consequences
01:16:01here and how do we meet the requirements
01:16:05of justice? Yes, please. Thanks.
01:16:08Sanjay Kulkarni,
01:16:08I'm a transplant surgeon here.
01:16:10I would just say this to that last question.
01:16:13I think the consensus at least on the
01:16:16Ethics Committee is after DCD donation,
01:16:18at the time of procurement,
01:16:20an individual is dying.
01:16:22And in the process of dying,
01:16:25they are willing to donate their organs.
01:16:28That's not the question I'm trying
01:16:29to ask because there's a lot of
01:16:32gymnastics going on with language.
01:16:34And I as much as I think the
01:16:36dead donor rule is important,
01:16:38I think a lot of the conversation
01:16:40has been really constrained by the
01:16:42UDA and the and the terminology
01:16:44like what irreversibility means.
01:16:46And I think we maybe most people don't know,
01:16:50but the Uniform Law Commission
01:16:52recently said that they aren't going
01:16:54to make major revisions on the UDA.
01:16:56My question is,
01:16:58if you wanted to make a revision
01:17:01for the UDA to and make NRP
01:17:04acceptable and change the language,
01:17:06what does that look like?
01:17:14It's a great question. I spent a lot
01:17:16of time thinking about it and I I I
01:17:19don't have a great answer, right.
01:17:25This is part of why I think we should
01:17:32maintain the determination of death.
01:17:36I think we I I think there's some
01:17:39work that's done by by changing
01:17:41out irreversibility for permanence.
01:17:45But when you open up this can of worms,
01:17:48it can get really messy,
01:17:50as was seen right when they tried to
01:17:52update the Determination of Death Act.
01:17:53There were parties who came to the
01:17:55table who wanted to do away with death
01:17:58by neurologic criteria altogether,
01:17:59even some under what they claimed
01:18:01were disability rights arguments,
01:18:02saying that someone we consider
01:18:04who's dead by neurologic criteria
01:18:06is just severely impaired.
01:18:07Right.
01:18:08So I think the the capacity to update
01:18:12the law in a useful way is is limited.
01:18:20Can I just respond?
01:18:21I disagree with the way you're
01:18:23using this idea of switching to
01:18:25a permanent standard of death.
01:18:28You know when the code team arrives at
01:18:31the bedside of a patient in the hospital,
01:18:33they don't go. It's been 6 minutes.
01:18:36They fulfill the permanent
01:18:38definition of death.
01:18:39So we're not going to
01:18:41try to resuscitate them.
01:18:42The permanent definition of
01:18:44death is entirely contingent
01:18:46upon a promise not to attempt
01:18:49to reestablish the circulation.
01:18:51If if without that promise,
01:18:53of course you should be trying
01:18:55to resuscitate somebody at six
01:18:567-8 minutes and you will likely
01:18:58in many cases be very successful.
01:19:00So I I don't agree with sort of the
01:19:03idea that by by the the permanence,
01:19:05the permanent standard would say
01:19:06that at 5 minutes we can say
01:19:08this person is dead.
01:19:09It's entirely contingent upon
01:19:10a promise not to attempt to
01:19:12establish recirculation.
01:19:15But that doesn't feel different
01:19:16from what I was trying to argue.
01:19:18So maybe I think my maybe I
01:19:20wasn't clear. I don't because
01:19:21the NRP violates that promise. The the
01:19:25promise not to attempt to recirculate the
01:19:27patient NRP with the full
01:19:29expectation that you are going
01:19:31to violate that promise. The the
01:19:34so I I hear you, but the promise for me,
01:19:37this is the difference.
01:19:38I think the promise for me is
01:19:41a promise not to resuscitate.
01:19:43That's the promise, the recirculation,
01:19:46this is the issue, right. It's well
01:19:51intent, but also so is the intention
01:19:53and there was a slide that that
01:19:55you had which which there was,
01:19:57I forget what it was, but there was sort
01:19:59of a distinction in in the top part,
01:20:00you say there's a a promise, let's see
01:20:05what is it not to resuscitate the patient,
01:20:08but then you recirculate, right.
01:20:11And my claim is that the
01:20:14promise not to resuscitate.
01:20:15Has been met and continues to be
01:20:17met because when you recirculate,
01:20:19you're not resuscitating by virtue
01:20:21of the other actions, right. And so.
01:20:23So that's that's the the distinction, right.
01:20:26I I think we can go anyway continue.
01:20:28So
01:20:28Sarah, one thing before you see,
01:20:29so I just to let folks know there's
01:20:31not going to be time for much.
01:20:32The questions come through on the
01:20:34Q&amp;A and zoom, but one point of
01:20:35clarification might be interesting.
01:20:37Someone asked and by the way lots of
01:20:40praise for this conference for your
01:20:42talks from as far away as Berlin here.
01:20:44I'm hoping that's not the Berlin,
01:20:46Connecticut, but in fact Berlin and Germany.
01:20:47I think what it is.
01:20:49Doctor Thompson, a question for you, please.
01:20:51In your personal experience in your new role,
01:20:54what percentage of cases have involved NRP?
01:20:58And if you if you could, Eric,
01:20:59ballpark what percentage of the
01:21:00ones because it says here you
01:21:01mentioned 120 cases ballpark.
01:21:03What percentage of the
01:21:04cases you've done with NRP,
01:21:05but also if you know ballpark and maybe you
01:21:07guys know what percentage of the transplants,
01:21:10heart transplants in the
01:21:12US are currently NRP.
01:21:13Yeah,
01:21:13there are approximately
01:21:153000 heart transplants
01:21:16done in the US and there's projections that
01:21:18if NRP is, is is fully developed
01:21:23that it could generate another
01:21:245 or 600 cases. So it's not
01:21:27it's not a huge number but it's a
01:21:29significant number And as far as
01:21:31my experience I've done, I've had
01:21:33I've been involved in one and and
01:21:36actually it's you know when I
01:21:37called you and I said I I got,
01:21:39I have I have some bad feelings about this.
01:21:42We we have postponed going ahead
01:21:44with it although one of my associates
01:21:46did one yesterday actually.
01:21:49So so. So my understanding is that some
01:21:51that some centers at Vanderbilt for
01:21:53example are are full speed and other
01:21:55centers have said we're not doing this
01:21:57and the conversation because and I know
01:21:59that that that Bob and Brendan are
01:22:01both the leaders in this conversation.
01:22:03So we have time for Doctor Hull
01:22:05and then perhaps one more after
01:22:06that if there's a comment.
01:22:08OK, just checking.
01:22:10Thank you all for this
01:22:11really wonderful conference.
01:22:12This has been been so illuminating and
01:22:15really insightful and and really nuanced,
01:22:18which I I really appreciate.
01:22:19You know, I wonder if sort of getting
01:22:21back to this question of you know,
01:22:23the gymnastics that we're doing either to
01:22:25say that this person is dead or you know,
01:22:27alternatively, well,
01:22:28can you really argue that they're alive?
01:22:31You know, I, I, I almost, I'm,
01:22:33I'm struck by the fact that I,
01:22:34I I don't think they're,
01:22:36but really if we sort of step back and
01:22:38interrogate our moral intuition in a
01:22:39in a way they're almost neither, right?
01:22:41Like they're not.
01:22:42You know Especially if someone doesn't
01:22:44have perfusion to the brain it's
01:22:46kind of hard to argue they're alive.
01:22:48But at the same time if if you
01:22:50can restart their heart beating,
01:22:51it's kind of hard to argue that they're dead.
01:22:53And I wonder if you know in in
01:22:54sort of talking about what kind
01:22:56of language that we can use that
01:22:57more accurately captures what's
01:22:59going on both biologically and I
01:23:01think sort of metaphysically.
01:23:02You know, what about some of the,
01:23:04you know,
01:23:04I I think about the language of
01:23:06of liminality like is there a
01:23:08sort of a third state or is this
01:23:10sort of liminal state that that
01:23:12may be helpful for us to use in
01:23:14terms of conceptualizing this?
01:23:15Because I I,
01:23:16I think they're kind of both alive
01:23:18and dead and also neither alive and
01:23:19dead and and maybe do we need to
01:23:21sort of take a step back from this
01:23:22dichotomy because that dichotomy is
01:23:24not serving us in this discussion.
01:23:25Did
01:23:29you want to say something?
01:23:35Let us know who you are and you're
01:23:36kind enough to come and join the
01:23:37conversation I'd like to hear.
01:23:38I have to echo thanks to everyone.
01:23:40This was fantastic.
01:23:41I learned a ton. Andy Fleischer,
01:23:44Stony Brick University Stony Brick Medicine,
01:23:46and also Startup University Professor
01:23:50of Bioethics, Public Health and English.
01:23:54And I'm also chair of the,
01:23:55you know, Ethics Committee.
01:23:56I'm sitting next to my wonderful Vice chair,
01:23:58Sanjay, and Bob is the intellectual
01:24:03haft on the committee OK.
01:24:07I can't do a better job than Brenda
01:24:09did explaining my reservations,
01:24:11not getting rid of the dead donor roll,
01:24:14both with respect to trust and with
01:24:16respect to our current culture.
01:24:18And Bob, you've made that point
01:24:19as well in in person meetings.
01:24:21So let's just assume for the sake of
01:24:25argument with the compelling weight
01:24:26of that de facto state of affairs.
01:24:29We're not getting rid of the
01:24:30dead donor rule anytime soon,
01:24:31and I don't think we should
01:24:33for ethical reasons.
01:24:34I have slippery slope concerns
01:24:35about getting in.
01:24:36Brendan alluded to those.
01:24:39However,
01:24:39I disagree with Brendan that
01:24:42that solves any problem
01:24:46because I'm completely compelled
01:24:47by your number two reason, Bob,
01:24:49I can't get past, as you well know,
01:24:52the occlusion of these critical
01:24:54arteries to the brain.
01:24:56I think that violates even the weaker
01:24:58version of the dead dollar rule,
01:24:59which is that you can't get organs
01:25:02by virtue of causing death sold.
01:25:05And there in lie my reservations with NRP.
01:25:09But I have real questions for
01:25:10you and maybe all of you,
01:25:12with regard to your number one argument.
01:25:14And this is awkward for me because
01:25:16UI and Karen Ladine, the former
01:25:17chair of the UNOS Ethics Committee,
01:25:19published a piece in JAMA,
01:25:21a viewpoint piece,
01:25:23where we argue that intention,
01:25:25even the best intentions,
01:25:26does not override actions.
01:25:28I completely agree.
01:25:30From a legal perspective,
01:25:31it doesn't and can't.
01:25:33And that, frankly,
01:25:34is the argument that Alex and Alex
01:25:36made in the piece to which you alluded.
01:25:38That doesn't solve the ethics issue, though.
01:25:40Here's my question.
01:25:42Why should, from an ethical perspective,
01:25:46that be the overriding thing?
01:25:48We all agreed at the beginning
01:25:50of our deliberations,
01:25:51both with regard to the work group and
01:25:54then subsequently on the Ethics Committee,
01:25:56that utility would not carry the day.
01:25:57So I categorically reject a
01:26:00consequentialist conclusion to this
01:26:02Utility is just a species of the
01:26:05larger genus of consequentialism
01:26:07that won't work.
01:26:09We are here to make sure that
01:26:11utility doesn't overrun.
01:26:12Why doesn't intention count more how
01:26:15we we say we balance these principles,
01:26:18these classic principles whether
01:26:19you know Beechman,
01:26:20Childress or or any other version.
01:26:23Why are we giving such a massive
01:26:27coefficient to the variable of of action?
01:26:30I understand the answer legally,
01:26:32but why in terms of ethics?
01:26:36So this is ultimately,
01:26:37and I'm going to allude to Sanjay
01:26:39now because Sanjay is the first
01:26:41person who said this out loud to me,
01:26:42this is ultimately a values
01:26:44question for society.
01:26:47Are we in a position to answer?
01:26:48And that's where we basically end up
01:26:50on the Ethics Committee. Well said,
01:26:57I take a second. Yeah, yeah, yeah,
01:26:58take a breath.
01:26:59Because what's going to happen now,
01:27:00as promised is, and I and I,
01:27:02I'm sure there are other folks that
01:27:03think that what's going to happen now
01:27:05is that anything that either or all of
01:27:07the three of you would like to say,
01:27:09I'd like you to say.
01:27:09And then that will close the evening.
01:27:12Yeah, I just have to be careful here.
01:27:13And I won't take the last word.
01:27:14I'll give it over there.
01:27:15But I will respond and say again,
01:27:18I said in one of my slides,
01:27:19and I think this is a really
01:27:21important point that you have made
01:27:23that intention isn't enough alone.
01:27:25It also depends on action.
01:27:26So just because you don't intend
01:27:28to kill the patient doesn't mean
01:27:31you're not actually doing that,
01:27:33which I think goes back to why
01:27:35we maintain the dead donor rule.
01:27:37And that dead donor rule
01:27:41corresponds to an ethically founded
01:27:44notion of the line between life and death.
01:27:48And what is that notion?
01:27:49I did the best I could to represent it,
01:27:51which is what actually matters
01:27:54about when we declare someone dead,
01:27:56the heart stopped, can't restart on its own,
01:27:59and we're not going to try
01:28:00to resuscitate the patient.
01:28:01So I see that that that is the intention and
01:28:05that if NRP protocol is followed correctly,
01:28:08that patient is not in fact resuscitated.
01:28:11So my biggest ethics issues and I'll end
01:28:14here my biggest ethics concerns aren't this,
01:28:17you know, I think philosophically
01:28:19interesting conversation that
01:28:20takes us down the rabbit hole.
01:28:22But really is this protocol
01:28:25empirically valid?
01:28:26Are we actually ensuring that there
01:28:28is no meaningful harm to the donor?
01:28:31One And two,
01:28:33can we be honest enough with potential
01:28:36donors and their family members that
01:28:38they can make informed decisions about
01:28:42whether to to authorize this or not?
01:28:49Would you like to say something,
01:28:50Bob? You don't have to.
01:28:51We're happy to hear if there's some.
01:28:54I'm going to address your your
01:28:55point, Where are we going?
01:28:57I'm old enough to remember when DCD
01:28:59was first getting started back in
01:29:01the 1990s and they were the same
01:29:03debates that were happening then.
01:29:04The donor's not really dead because
01:29:06the the loss of of Pulse is not
01:29:10irreversible and several people
01:29:11were actually charged with homicide
01:29:15for participating in DCD donations.
01:29:17But the utility of saving lives
01:29:20through that ultimately just won the
01:29:23day and eventually the arguments
01:29:25died down And now DCD happens
01:29:28with virtually no objections.
01:29:31I predict that the same thing
01:29:32is going to happen here,
01:29:33that the utility and the
01:29:36incredible success of
01:29:37NRP is going to become a standard. And
01:29:40there's enough debate about, you know,
01:29:42the legality and the ethics of it that I
01:29:44think ultimately overtime it's just going
01:29:46to fade away and it will become the de
01:29:48facto standard for organ procurement.
01:29:51Thank you. So Doctor Thompson,
01:29:53the guy who's actually a lot of
01:29:55lives are getting saved by these
01:29:57heart transplants and you're one
01:29:58of the guys who's doing that.
01:29:59And I appreciate that you raised this
01:30:02important question for us to have a
01:30:04conversation as a bioethics community
01:30:06here and as a as a medical community here.
01:30:08Having heard all of this,
01:30:10I wonder any thoughts you might
01:30:11want to share with the crew?
01:30:12We'd be happy to hear.
01:30:14Well first I want to thank you for doing
01:30:17this because I think it was a great
01:30:18idea to have this this was Mark's idea
01:30:21to have this gathering I just called.
01:30:23I just called Mark up on the phone
01:30:25and said Mark this is bothers me what
01:30:27do you think And then he's the one
01:30:29that set this up and I'm and I'm I'm
01:30:31sure I speak for everybody that's
01:30:33that's we appreciate that you did this
01:30:36I'm not sure about DCD
01:30:38whether that's gonna
01:30:40whether it's it's gonna fit the
01:30:42controversy is gonna fade away
01:30:44because I can tell you
01:30:45from going on these retrievals if I
01:30:47go on a brain dead donor there is no
01:30:49controversy at all from anybody. And if we
01:30:53go on ADCD case,
01:30:56there is always an issue of something
01:30:59like somebody either either
01:31:01there's like some variability
01:31:03and exactly how you're going to
01:31:05proceed or there's some question about
01:31:09you know one thing or one
01:31:11aspect of it or another. And I I
01:31:13just, I think it's it's just too
01:31:18and and clearly the patients are not
01:31:20dead. I mean they're not,
01:31:24they're they're they're
01:31:26alive when you start. They are, they're
01:31:28alive when they come in the room. And
01:31:32I don't know, I'm not sure
01:31:33it's going to, I'm not sure the
01:31:35controversy is going to go away. Well,
01:31:38thank you very much all three of
01:31:39you for a fantastic presentation
01:31:46and the
01:31:49really it was a remarkable
01:31:50night and the and the beauty
01:31:52of it is you each get some Yale swag.
01:31:55So we'll pass out.
01:31:56Thank you guys very much.
01:31:58Thank you all for coming.
01:31:58We'll see you again in two weeks.
01:31:59We're back in Cohen
01:32:01Auditorium in two weeks.
01:32:02Good night. Thank you.