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4/27/22 – Angela Lorts, MD, MBA – Current Review: Advanced Cardiac Therapies for Children in Heart Failure

April 27, 2022
  • 00:00Still we are have.
  • 00:02We are having this symposium
  • 00:05for cardiology on June 3rd.
  • 00:07The evolution of congenital
  • 00:08cardiac care will be inviting.
  • 00:10Some of our former fellows back
  • 00:12and some friends and colleagues
  • 00:14should be a great event.
  • 00:15So if anyone's interested we're going to put
  • 00:18the information in the chat box for you.
  • 00:20If you're interested in signing
  • 00:21up for that next slide, please.
  • 00:25So today we have our 6th annual
  • 00:28Dinsmore Lecture in Cardiology,
  • 00:31and I just wanted to take.
  • 00:32One minute to briefly recognize this,
  • 00:35so we were approached back in around
  • 00:392016 by Louise and Jeff Dinsmore,
  • 00:42who were the parents to a young
  • 00:45girl named Gabrielle who was born
  • 00:47with complex form of hypertrophic
  • 00:49cardiomyopathy and over her short
  • 00:51life had a couple of cardiac surgeries
  • 00:53and unfortunately succumbed to her
  • 00:56disease around the age of three.
  • 00:58Although she was not cared for here,
  • 01:01the family wanted to recognize her and her.
  • 01:05All all the beautiful things
  • 01:06that she loved in life,
  • 01:07including the ladybug,
  • 01:08which is a symbol here and they
  • 01:10had a lot of ties to this area and
  • 01:11so they approached us and said,
  • 01:13well, how can we help?
  • 01:14We want to support her and her memory
  • 01:16and support the cardiology group.
  • 01:18And so we decided that one of
  • 01:19the ways we could do that is to
  • 01:21establish a lectureship in her honor.
  • 01:23So this is the 6th annual
  • 01:25Lectureship in her honor,
  • 01:26and if you would just hit the next drew,
  • 01:28we've had the opportunity to really
  • 01:31have some outstanding speakers over
  • 01:33the years who have brought excellent.
  • 01:34Teaching about cardiology and cardiac
  • 01:36care to us and I know we're going to be
  • 01:40thrilled to welcome our current speaker.
  • 01:42I just also want to mention one last thing,
  • 01:44which is that we are going to be reviewing
  • 01:46some cases tomorrow with our speaker.
  • 01:47So if anyone's interested in
  • 01:49diving deeper into cases of
  • 01:50heart failure and transplant,
  • 01:52please reach out to me or doctor Hall
  • 01:54and we can certainly plug you into
  • 01:56that tomorrow morning at 9:00 AM.
  • 01:57So without further ado,
  • 01:58I'm going to turn over to my colleague.
  • 02:00Doctor Kevin Hall is going to
  • 02:02formally introduce our speaker.
  • 02:03Kevin
  • 02:05thank you Rob. I also want to extend
  • 02:07our welcome to everyone joining
  • 02:08today and I'm delighted to have the
  • 02:11privilege to introduce our speaker,
  • 02:12doctor Angela Lorts.
  • 02:15Doctor Lawrence is the associate
  • 02:16chief Quality officer and professor
  • 02:18of Pediatrics at the Cincinnati
  • 02:20Children's Hospital Medical Center,
  • 02:21where she practices as a pediatric
  • 02:23cardiologist and where she directs
  • 02:25the ventricular assist device and
  • 02:27total total artificial heart programs.
  • 02:29She's an internationally recognized
  • 02:31leader in the field of cardiology
  • 02:33with broad expertise and outcomes,
  • 02:34measures and quality improvements,
  • 02:35and currently serves on the board of
  • 02:38directors and Executive Governance
  • 02:39Committee with the International
  • 02:41Society for Heart and Lung Transplant.
  • 02:43And while her list of accomplishments
  • 02:45in this field is long.
  • 02:47I want to introduce what I believe will
  • 02:48be one of her more broad and lasting
  • 02:51achievements with a brief historical note.
  • 02:53Only a few years ago,
  • 02:54it seemed that the that pediatric cardiology
  • 02:57programs kept mostly to themselves.
  • 02:59As much as I would imagine
  • 03:01most pediatric fields.
  • 03:02Information was of course
  • 03:03shared behind highly refined,
  • 03:05but far too rarely published reports,
  • 03:07but there was too little, if any,
  • 03:09formalized and open discourse
  • 03:11between programs.
  • 03:12It wasn't that programs trying
  • 03:13to hide knowledge,
  • 03:14but they they didn't actively
  • 03:15seek to share it either.
  • 03:17And so data and experience were
  • 03:18inactively protected secrets,
  • 03:20so to speak.
  • 03:21In a sentiment,
  • 03:22I'm certain you'll recognize the
  • 03:24French poet and novelist Victor
  • 03:26Hugo has been credited with the
  • 03:28phrase that nothing is more powerful
  • 03:29than an idea whose time has come.
  • 03:31And coupled with all the newly emerging
  • 03:34communication technologies we all recognize,
  • 03:36and perhaps the sense that this is
  • 03:38not enough for the children we treat.
  • 03:40Doctor Lawrence co-founded the
  • 03:42International Action Learning Network.
  • 03:44This is an organization dedicated
  • 03:45to improving heart failure and care
  • 03:47for children by broad collaboration
  • 03:49and through her leadership,
  • 03:50the network has grown to not
  • 03:52more than 1000 members and 57
  • 03:54institutions across eight countries.
  • 03:56It's hosted more than 40 quality
  • 03:58improvement projects and has
  • 03:59achieved significant improvements
  • 04:01in clinical outcomes,
  • 04:02including the decreasing of stroke rates
  • 04:04in these patients by more than 50%.
  • 04:06The standardization of clinical practice
  • 04:09across more than 50 institutions.
  • 04:11It's developed collaborations
  • 04:12with six pharmacologic and device
  • 04:14companies and developed a content
  • 04:16learning management system for
  • 04:17members and other stakeholders.
  • 04:19So broad collaboration among
  • 04:21institutions is clearly an idea whose
  • 04:24time has come and doctor Lawrence
  • 04:25deserves much credit for both.
  • 04:27Recognizing this and acting upon it to
  • 04:29build one of the foremost collaborative
  • 04:31networks in pediatric medicine.
  • 04:33So it's my true pleasure to
  • 04:35introduce Doctor Angela Lawrence.
  • 04:36Doctor Lawrence.
  • 04:37Thank you everybody.
  • 04:38I'm going to share my screen.
  • 04:57So thank you for having me.
  • 04:58That was a great introduction Kevin,
  • 05:00to something that I'm very passionate about.
  • 05:02Which is the Action Learning network.
  • 05:03Interestingly, I am not.
  • 05:05I'm going to interject some of
  • 05:07the work we've done with action,
  • 05:08but I'm going to talk more about
  • 05:11advanced cardiac therapies in 2022.
  • 05:12For heart failure,
  • 05:13and I know that it's a big program
  • 05:16for Yale to continue to mature your
  • 05:18heart failure transplant program.
  • 05:21So I thought it would be good to talk
  • 05:22a little bit about device therapy.
  • 05:27So heart disease remains one of the
  • 05:30top ten causes of childhood mortality.
  • 05:32Some of the things that Kevin said are
  • 05:35so important that we, despite this,
  • 05:37we really don't work well together.
  • 05:39We don't collaborate well.
  • 05:40We don't share ideas all the time.
  • 05:43Sometimes we do,
  • 05:44but we are also using manuscript process,
  • 05:47anecdotal reporting,
  • 05:47and how do we make the outcomes of
  • 05:50kids with heart disease even better,
  • 05:52since it is one of the top
  • 05:56reasons for mortality.
  • 05:57There's diverse ideologies of
  • 05:58heart failure in children,
  • 06:00and this is a really important point
  • 06:02because in adult heart failure a
  • 06:05lot of the care and the devices
  • 06:07and the drugs are made or studied.
  • 06:10For one ideology of heart failure.
  • 06:13But for Pediatrics we have to
  • 06:14deal with congenital heart disease
  • 06:16that could be Fontaine failure.
  • 06:18It could be failed palliation
  • 06:20and those patients develop.
  • 06:21Heart failure may need to go to transplant,
  • 06:24may need a device,
  • 06:25may need medications,
  • 06:26there's cardiomyopathies.
  • 06:27Which is more similar to the schematic,
  • 06:30heart disease that the majority
  • 06:32of the heart failure patients in
  • 06:34the adult world world look like?
  • 06:36Then there's myocarditis which we all know.
  • 06:39There's kind of a new new interest in
  • 06:42myocarditis not just from the vaccine,
  • 06:44but the viruses that are around us.
  • 06:46But there's many ideologies of these
  • 06:49heart failure patients which make
  • 06:51treating them and using devices
  • 06:53a little bit more complicated.
  • 06:55Not only are the ideologies pretty diverse,
  • 06:57but also the size of the patients.
  • 07:00So we go from infants where you
  • 07:02see this little baby over here
  • 07:04with this temporary device.
  • 07:06So stuck in bed not able to do
  • 07:08much while waiting for transplant
  • 07:09to a younger child to school age
  • 07:12children who were trying to get
  • 07:14home on their device to children
  • 07:16who are more adolescents or young
  • 07:18adults and in some institutions
  • 07:20such as Cincinnati Children's,
  • 07:21we're taking care of all of the
  • 07:23adult congenital heart disease.
  • 07:24Patients that need devices and
  • 07:26transplant so you can imagine the
  • 07:29diverse number of patients that
  • 07:30you're seeing that one day you're
  • 07:32seeing an infant or the same day,
  • 07:34and then you're seeing a 45
  • 07:36year old Fontan failure patient,
  • 07:38and so this makes it really hard to learn.
  • 07:41There's small numbers of each of
  • 07:42these patients at each institution.
  • 07:44Just to reiterate what Kevin said is,
  • 07:47you know,
  • 07:47everyone has a small number to learn from,
  • 07:49and so how do we all learn together?
  • 07:52The other thing that's important
  • 07:53about advanced heart failure?
  • 07:54And Pediatrics is,
  • 07:55we really don't use many things
  • 07:58that are studied in kids.
  • 07:59Most of it is studied in adults and
  • 08:02then we extrapolate the data from the
  • 08:04adult studies to use the medications.
  • 08:06The rehabilitation or monitoring.
  • 08:08In this case,
  • 08:09I would say it would be Cardiomems
  • 08:12is approved for.
  • 08:13Approved for adults,
  • 08:14not for children and we use that most
  • 08:16of the ventricular assist devices
  • 08:18historically have been approved for adults.
  • 08:20Although we're seeing a change with the
  • 08:22network really driving a change in how we
  • 08:26label those devices and then transplant,
  • 08:29so transplant has been around
  • 08:31a long time historically has
  • 08:33been studied more in the adults,
  • 08:36but there are new studies in Pediatrics
  • 08:38that are looking at immunosuppression drugs,
  • 08:40which will be really exciting
  • 08:42for a field to see if.
  • 08:44New immuno everolimus will be the
  • 08:46drug or the teammate trial will give
  • 08:49some results that will help kids.
  • 08:52The scope of the problem is not only
  • 08:55the diverse ideology and diverse
  • 08:56size of the patients and all the
  • 08:59different types and small numbers,
  • 09:01but also 25% of children with
  • 09:03heart failure die during their
  • 09:05first hospitalization.
  • 09:07This is remarkable if you think
  • 09:09about the adult world that a lot
  • 09:12of patients with heart failure
  • 09:13come in and out of the hospital.
  • 09:15In children,
  • 09:16that's not always the case or
  • 09:18fourth of the time it's not the
  • 09:20case that they come in and they
  • 09:22become very sick very quickly.
  • 09:23With that only less than 2% of
  • 09:27the heart failure funding from the
  • 09:29NIH actually goes to Pediatrics,
  • 09:31so obviously this all sounds very negative,
  • 09:33but we let's put it into a positive
  • 09:35spin that what Kevin talked about
  • 09:36is that if we work together,
  • 09:38we can fix the problem so we can
  • 09:40bring devices to children, we,
  • 09:41and that's what I'm going to
  • 09:43really talk about.
  • 09:43But can we also bring medications
  • 09:46and other technologies to children?
  • 09:49So I kind of mentioned
  • 09:50that there's medicines,
  • 09:51devices and transplant to
  • 09:52treat heart failure.
  • 09:53Always think of this in my head.
  • 09:54Like Oh my,
  • 09:55there's so many things,
  • 09:57but let's just talk about devices
  • 09:59because we have only 45 minutes left and
  • 10:02medicines for heart failure and transplant.
  • 10:04Although interesting,
  • 10:05we could be for another day.
  • 10:08So first, just to make sure
  • 10:09everyone's on the same page about it,
  • 10:11what a ventricular assist device is.
  • 10:13I'm going to show you a little video.
  • 10:16My sister.
  • 10:18Help.
  • 10:23Please make the party.
  • 10:27Right, yeah? Why you asking?
  • 10:32It's getting a little bit too big
  • 10:34and the blood just wasn't pumping
  • 10:37out the way it should
  • 10:39have, so it was hard for her to bleed
  • 10:42and they had to put in the pipe where
  • 10:45to help her height to pump a little
  • 10:48better than what it did. She has been
  • 10:51feeling so much better
  • 10:52and really glad that she
  • 10:54got to get this.
  • 10:56So I think she explains it much better
  • 10:58than I could do and quicker probably,
  • 11:00but I've ventricular assist device
  • 11:02can bypass the heart or augment
  • 11:05the blood flow to the organs.
  • 11:07The one that you just saw that that little
  • 11:09girl had what was called a Heartware.
  • 11:11We're going to talk a little bit
  • 11:13more about that device in a second,
  • 11:15but avad is used to support patients
  • 11:17that don't respond to medical management.
  • 11:19I think this is a really important point
  • 11:21is we always try medical management first.
  • 11:24It's a big operation.
  • 11:25It's not something that we.
  • 11:27Take off the shelf if we think we
  • 11:30can use strips or other medications
  • 11:33to help the heart failure.
  • 11:35It's really used to prevent death,
  • 11:36and this could be prevent death to go
  • 11:39home and live their life on a bad or
  • 11:42prevent deaths to get to a heart transplant.
  • 11:45It's implemented to bypass or augment
  • 11:48the function to all vital organs.
  • 11:51And it's becoming increasingly
  • 11:52more common to use a ventricular
  • 11:54assist device to keep these children
  • 11:56with heart failure alive.
  • 11:58The percentage of patients that need a
  • 11:59VAD to as a bridge to transplant while
  • 12:01they wait for an organ really varies,
  • 12:04but a third of those patients are
  • 12:05on a bad prior to transplant.
  • 12:08I think this is an important point,
  • 12:09because this is actually a little bit.
  • 12:11The state is a little bit old.
  • 12:12There's actually not a new graph yet,
  • 12:16but it will come out soon and I
  • 12:17think it's even going to be greater
  • 12:19than 30% of patients.
  • 12:20Need support to wait for an organ and
  • 12:22why that's becoming more and more
  • 12:24important is the organs are becoming
  • 12:26more and more scarce and so are we're
  • 12:28our wait times are extending more
  • 12:31every day so our babies are waiting 5-6
  • 12:35months so they're not going to make
  • 12:37it without ventricular assist devices,
  • 12:39so it's becoming more and more
  • 12:41important to figure this out.
  • 12:43And many of the patients that need
  • 12:44a heart transplant have congenital
  • 12:46heart disease,
  • 12:47so that makes it even a little bit
  • 12:49more complicated for them to wait if
  • 12:50they can't get a surgery so it can
  • 12:52evad improve the outcome of these
  • 12:54patients waiting for transplant.
  • 12:55So these complex congenital heart
  • 12:57disease patients.
  • 13:00The challenges with pediatric bad therapy.
  • 13:03I touched on a little bit,
  • 13:04but really this varied age and size.
  • 13:07I can't say enough because you have to
  • 13:09have a bad that will take care of the
  • 13:11smallest 2K baby and a VAD that will take
  • 13:13care of your adolescence or young adults.
  • 13:15You'll have to have a you know Vads that
  • 13:17will help the right side and bags that
  • 13:20will help the left side and good plans
  • 13:22for right sided and left sided support
  • 13:24the complex anatomic structures of the
  • 13:26congenital heart disease portion is
  • 13:28also very interesting to think about.
  • 13:30And those are the Fontan patients
  • 13:32which I'll touch on in a minute,
  • 13:34are really on the form,
  • 13:36are really important to us right now in
  • 13:38the pediatric bad community because they're
  • 13:40coming to our clinics needing support,
  • 13:42and we don't have great options.
  • 13:43But we think that we're making we're
  • 13:46making some differences that will help
  • 13:48those Fontan patients while they wait.
  • 13:50Implantation indications so.
  • 13:52Decompensated heart failure as I said,
  • 13:56should be unresponsive to medical management,
  • 13:59and I think it's a really important
  • 14:01point for the.
  • 14:02For the cardiologist,
  • 14:02especially in the room who can think
  • 14:04about this a lot is that the decision to
  • 14:06put a VAT in should not be intertwined
  • 14:08with trying to get higher on the list.
  • 14:11It should be to support the patient
  • 14:13because you think that they're not
  • 14:15going to make it to transplantation,
  • 14:16not necessarily to to change the system.
  • 14:20If they're escalating in their
  • 14:22inotropic support,
  • 14:23or they have any indoor organ
  • 14:25dysfunction that you're seeing,
  • 14:26and I think one really important
  • 14:28thing about indoor organ dysfunction
  • 14:29in kids is it's not just creatinine
  • 14:31or bilirubin or something obvious,
  • 14:33sometimes it's just that they're
  • 14:35really fussy or they're vomiting,
  • 14:36and that vomiting can sometimes be as
  • 14:39far as side is a sign of heart failure
  • 14:42and impending a really a decompensation.
  • 14:47There really aren't a lot
  • 14:48of contraindications to
  • 14:49bad therapy and trying it.
  • 14:50You know, these are the historic
  • 14:52complication or contraindications.
  • 14:54Bleeding or having a problem with
  • 14:56clotting because these patients are
  • 14:58have to be anticoagulated if they
  • 15:00already have a neurologic deficit or
  • 15:02irreversible indoor organ dysfunction.
  • 15:04I actually it's very rare that we
  • 15:07find a contraindication because
  • 15:09irreversible end organ dysfunction
  • 15:10is really hard to define.
  • 15:12A lot of times we think that
  • 15:13we can make the indoor organs
  • 15:15better with better blood flow.
  • 15:17I think hypertrophic cardiomyopathy
  • 15:19and restrictive cardiomyopathy,
  • 15:20which I think will probably
  • 15:22talk more about tomorrow,
  • 15:23are difficult to support,
  • 15:24but there are some different
  • 15:26cannulation strategies you can
  • 15:28use to support those patients,
  • 15:30so not necessarily as a contraindication,
  • 15:32but does put it on your list of worries.
  • 15:36Findings that motivate me
  • 15:37to support with the VAD.
  • 15:39I do find that and I'm sure the
  • 15:41cardiologists in the room know this too.
  • 15:44But doesn't it seem like a heart failure,
  • 15:46patient, always decompensated?
  • 15:47The two in the morning?
  • 15:48So for some reason they always wait and
  • 15:50then all of a sudden they're really sick
  • 15:52really fast and they're looking fine all day.
  • 15:55Maybe they're a little like vomiting,
  • 15:56a little bit more and
  • 15:58then they get really sick.
  • 15:59So trying to find some clues to that so
  • 16:01low mixed venous but feeding intolerance.
  • 16:04I can't say enough.
  • 16:05That I really think feeding
  • 16:07intolerances are clue.
  • 16:08So more vomiting,
  • 16:10not tolerating feeds,
  • 16:11no heart rate variability,
  • 16:13how they look on exams.
  • 16:15Sometimes it's not their indoor and sometimes
  • 16:17you can predict just by the touching the toe.
  • 16:20You know how they look and how they
  • 16:23their color and what their mom or
  • 16:26father says about what how they look.
  • 16:28Increasing BNP's despite diuretics.
  • 16:30So using some of the
  • 16:33neurohormonal biomarkers.
  • 16:34Escalating your diuretics but no change
  • 16:38in your urine output is also a bad
  • 16:41sign that they will soon decompensate.
  • 16:44For patient selection.
  • 16:47You know for the non cardiologists in the
  • 16:49room this is is maybe not as interesting,
  • 16:51but it kind of sets up the next
  • 16:53slide is that we have taken our bad
  • 16:55patients and put them into different
  • 16:57profiles of how sick they are.
  • 16:59The reason why we did this and
  • 17:00this was done in the adults and
  • 17:02we have just adopted it,
  • 17:03and Pediatrics is because the sticker,
  • 17:05they are the worst.
  • 17:06The outcome on the back end,
  • 17:08so the worse the outcome after the VAD you
  • 17:11can see here that the sticker patients,
  • 17:13the profiles one and two are the
  • 17:15patients that were really putting bads.
  • 17:17And if we really want to try to be
  • 17:19proactive and prevent bad outcomes
  • 17:21on a bad or prevent decompensation,
  • 17:24we need to,
  • 17:25you know,
  • 17:25push this to two and three and
  • 17:27not let them be in cardiogenic
  • 17:28shock when we take these patients
  • 17:30to the operating room.
  • 17:31So you'll see these outcomes here.
  • 17:35This is the PD Max data from the 3rd annual
  • 17:38report. Just looking at the
  • 17:41overall patient population,
  • 17:42but we know that the sicker the
  • 17:45patient is going into implant,
  • 17:47the less likely they are to do well.
  • 17:49So just to give you some perspective
  • 17:52for those who haven't looked
  • 17:53at these this PD Max report,
  • 17:55this is the Kaplan Meier of the
  • 17:58All pediatric bad patients.
  • 17:59So at this time there was
  • 18:02400 and 2386 deaths.
  • 18:04Or the yeah the at six months you
  • 18:07see you have like a 70 to 80%.
  • 18:09Survival, which in most of these cases
  • 18:12was much better than the survival
  • 18:14they would have without a VAD.
  • 18:17The important part here is that
  • 18:18if you get to a point where you're
  • 18:21in critical cardiogenic shock,
  • 18:22this blue line you can see how
  • 18:25poorly the outcomes become,
  • 18:27so these are the other stages
  • 18:28that I showed you.
  • 18:29We're trying to,
  • 18:30you know,
  • 18:30get more implantation in this range,
  • 18:33knowing that those patients are
  • 18:35sick enough to need a VAD and
  • 18:37not let them get to be in shock.
  • 18:41Historically, there's four main reasons
  • 18:44for Evad Bridge to transplant transplant,
  • 18:47so those are the patients
  • 18:48waiting waiting for an organ,
  • 18:49and that's about 49 percent.
  • 18:5150% of our patients in Pediatrics.
  • 18:54There's a bridge to recovery,
  • 18:55which is not as common,
  • 18:58although we spent three hours of our
  • 19:00action meeting yesterday talking
  • 19:02about how to recover patients,
  • 19:04and so that's something that you'll see
  • 19:06on the horizon is can we put Vads in,
  • 19:08turn them down, put them on medications?
  • 19:11And get the data out so they
  • 19:12don't have to be transplanted.
  • 19:14So there are some patients populations
  • 19:15that we do think that will work in,
  • 19:17but you see here in this older data,
  • 19:19it wasn't very common.
  • 19:20We hope that next time I talk to you,
  • 19:23well, we'll have this number up to 20%
  • 19:25because we think there's probably one
  • 19:27in five patient could be recovered.
  • 19:30Bridge to eligibility or decision.
  • 19:31These are the patients that have
  • 19:33some reason why you can't go straight
  • 19:36to transplant and those patients
  • 19:37need time to get good support.
  • 19:39They may need to recover their
  • 19:41indoor gun function.
  • 19:42You may need to figure out if the
  • 19:43patient the family is going to
  • 19:44be able to care for the patient.
  • 19:46Lots of reasons for that and then
  • 19:48destination therapy is this is.
  • 19:50These are the patients that aren't
  • 19:52going to be transplanted candidates.
  • 19:54In Pediatrics.
  • 19:54This is more likely that Duchene
  • 19:56muscular dystrophy patients,
  • 19:58which we do put Vads.
  • 19:59And and they do do well.
  • 20:02We have one that has been out three
  • 20:04years and one that has been out five
  • 20:07years on their ventricular assist
  • 20:09device as a destination device.
  • 20:11And so they go home with their
  • 20:12device and they've lived with it,
  • 20:14knowing they're not going to transplant.
  • 20:19But the bridge concept you know?
  • 20:22We kind of need to get away from
  • 20:24because really a VAT is just
  • 20:25a tool to treat heart failure.
  • 20:27So my new thing I would say is let's just
  • 20:29burn that bridge because we don't need to
  • 20:32think about what we're going to do next.
  • 20:34What we need to think about at this
  • 20:36time is treating the patients heart
  • 20:38failure and making sure that they are
  • 20:40alive and well to make that next decision.
  • 20:43You don't necessarily have
  • 20:44to know where you're going,
  • 20:45and you can change paths.
  • 20:47So you could think the patient
  • 20:48wasn't going to recover.
  • 20:49But you should always be thinking
  • 20:51about can I take that bad out?
  • 20:53Can I recover that patient or the patient
  • 20:56that wasn't a transplant candidate?
  • 20:57Can I make them a transplant candidate?
  • 21:02And patient selection.
  • 21:05This is a little detailed more for the
  • 21:07cardiologist in the room, but you know,
  • 21:09thinking about all the device possibilities
  • 21:11that you could possibly need.
  • 21:13When you think about a patient,
  • 21:15what if it doesn't fit?
  • 21:16What if you take them to the operating
  • 21:18room and that VAD does not fit well, what?
  • 21:20What is your backup plan thinking about?
  • 21:23What if the right ventricle
  • 21:24doesn't do well most of the time,
  • 21:26we're supporters supporting
  • 21:27the left ventricle.
  • 21:28But do you need some kind of
  • 21:29plan in case the right?
  • 21:30Intrical isn't doing well.
  • 21:33We can calculate how much
  • 21:35cardiac output they need,
  • 21:36which goes into which device they get.
  • 21:38And then also,
  • 21:39I think this is a really important point,
  • 21:41not just for Vads,
  • 21:42but anything we do is that you really
  • 21:45need to determine is it a high risk
  • 21:47case and that will help you determine
  • 21:50what your goals are afterwards.
  • 21:52So if we have a low risk case and
  • 21:54we send them to the operating room,
  • 21:55we will say OK,
  • 21:56we want to excavate within 24 hours.
  • 21:58We want the patient to be on
  • 22:00the floor within seven days.
  • 22:01If I've talked to the team and
  • 22:03we've had a good conversation about
  • 22:04this is a really high risk case.
  • 22:06This is going to be really hard
  • 22:08and modify our expectations.
  • 22:09Really helps the entire process go better.
  • 22:14So thinking more about patient selection,
  • 22:16the kids that are high risk when
  • 22:18I'm talking about, you know,
  • 22:19changing your postoperative timeline
  • 22:21or expectations so that everyone feels
  • 22:24good about how the progression is going.
  • 22:27You're not making false
  • 22:29expectations that are too lofty.
  • 22:31These are the kids that are in
  • 22:34cardiogenic shock when they go to
  • 22:36VAD or their little teeny kids.
  • 22:38Single ventricle kids that need
  • 22:41a VAD complex congenital.
  • 22:43Kids, kids with hypertrophic
  • 22:45or restrictive cardiomyopathy.
  • 22:47These are kind of the higher risk VAD
  • 22:49patients that you still can support,
  • 22:51and we have great data to show that
  • 22:54we can support these populations,
  • 22:56but the populations just need to.
  • 22:58You just need to kind of modify
  • 23:00how you're thinking about the what
  • 23:01they're going to look like coming out.
  • 23:06So we talked a little bit about
  • 23:08patient selection, really.
  • 23:08You know, trying to prevent the
  • 23:10patient from having being in shock,
  • 23:12trying to prevent the indoor
  • 23:14organs from getting sick?
  • 23:16Who are the right patients?
  • 23:18Those that can't be managed
  • 23:20with medical management.
  • 23:21But then once you decide
  • 23:22the patient needs one,
  • 23:23what kind of device are you going
  • 23:26to use and what's available?
  • 23:28This is just and you many of you
  • 23:31at Yale have seen some of these
  • 23:34devices come through your ICU.
  • 23:37That centrimag PD Mag wrote a flow
  • 23:39type device which sits outside
  • 23:41the body and the cannulas come
  • 23:43in to the chest is really meant
  • 23:46for more of a short term option.
  • 23:49For urgent cases the these
  • 23:52devices in the middle here.
  • 23:54The Berlin heart comes in a ton of sizes.
  • 23:56I'm going to show you that the
  • 23:58hardware used to be our go to for
  • 24:00little kids and has been taken off
  • 24:02the market and I will touch on that
  • 24:04and then the Heartmate 3 is really
  • 24:06the device we're focused on right now,
  • 24:08which is a great device in the adult
  • 24:10world and it's been great for kids too.
  • 24:12It's just a little bit big
  • 24:14for some of our smaller kids.
  • 24:16And then, in some institutions,
  • 24:18this syncardia or total artificial
  • 24:19heart is available to kids.
  • 24:21There is a smaller.
  • 24:22There's a 50CC which is the smaller
  • 24:24device and then the adult device,
  • 24:27which is a 70.
  • 24:28So if you have biventricular failure just
  • 24:30thinking about that could be available.
  • 24:35Also, thinking about what kind of support,
  • 24:38what kind of ventricle you are supporting,
  • 24:40and I talked a little bit
  • 24:41about this, but are you?
  • 24:43Are you supporting those left side?
  • 24:46A single ventricle?
  • 24:47Which would be an S bad?
  • 24:49Are you supporting the right side
  • 24:51or you supporting both sides?
  • 24:52And what do you predict going
  • 24:54into the operating room that
  • 24:55you're going to need to support?
  • 24:57Are you going to need to support
  • 24:59both or are you going to need
  • 25:00to just support the left?
  • 25:01And having that kind of plan up front?
  • 25:07The Berlin heart.
  • 25:07This is really our go to this is
  • 25:10the pediatric device that has been
  • 25:12around for a decade. It or more.
  • 25:15It has many different cannula sizes,
  • 25:19many different sized blood pumps.
  • 25:21It's a little archaic,
  • 25:23though it's archaic because the
  • 25:25patients are stuck in the hospital.
  • 25:27Right now they're stuck on Ivy
  • 25:29Anticoagulation which is very
  • 25:31different than the adult devices
  • 25:33and they are outside the body.
  • 25:35So the patient has Dr.
  • 25:37Canulas and they have a device.
  • 25:38I'll show you a picture where
  • 25:40the device is outside the body so
  • 25:42those kids are not able to have
  • 25:44a really great quality of life.
  • 25:46But this has all the sizes
  • 25:48so you can support any size.
  • 25:50I would say most most institutions at
  • 25:53this point will support up to 20 kilos.
  • 25:56With the Berlin heart and
  • 25:57then around 20 to 25.
  • 25:59You're starting to think about
  • 26:00what adult device could you use.
  • 26:04Canula placement we kind of touched on this,
  • 26:06but just thinking like.
  • 26:08Is it the left side that you're
  • 26:11supporting the right side?
  • 26:13The svad this is a single ventricle
  • 26:15here and what a buy bad would look
  • 26:18like if you had two Vads in a patient
  • 26:21that needed both sides supported.
  • 26:25The Berliner heart outcomes.
  • 26:26This slide is a little busy.
  • 26:28I don't want you to focus on all the words,
  • 26:30I just want you to focus on really the
  • 26:33Berlin heart outcomes are are good.
  • 26:3686% of the patients in the most recent
  • 26:39cohort had a positive outcome at 180 days,
  • 26:42meaning they were either transplanted
  • 26:44or still alive on device,
  • 26:46which is much different than historic
  • 26:48information about the Berlin heart.
  • 26:50We are getting to a better place with
  • 26:52the Berlin heart and I think a lot of
  • 26:54it is because we're working together.
  • 26:56So all the institutions are really
  • 26:59working hard to make this better and we
  • 27:02have seen improvements only 11% of the
  • 27:04patients in this cohort had had a stroke,
  • 27:07which is down from 30% prior to the
  • 27:11older historic data before the network.
  • 27:14So we are seeing some really
  • 27:16great differences in outcomes for
  • 27:19our Berlin patients.
  • 27:20So definitely if needed if
  • 27:22you need to use a Berlin it,
  • 27:24there's lots of different opinions,
  • 27:28experiences to learn from.
  • 27:32One of those. Experiences that helped
  • 27:36us decrease stroke rates in the Berlin
  • 27:39heart happened with the network,
  • 27:40so when the network started in 2017,
  • 27:43our number one priority was
  • 27:45to decrease the stroke rate.
  • 27:47In Berlin heart patients we changed
  • 27:50the anticoagulation strategy,
  • 27:52we changed the blood pressure how
  • 27:54we monitored blood pressure and how
  • 27:56we treated it and we changed how we
  • 27:58communicated at the bedside amongst
  • 28:00staff and teams to really see if we
  • 28:03could decrease the stroke rate quickly.
  • 28:07One of the biggest things was the
  • 28:09anticoagulation and I used this example
  • 28:11to just show you the power of this
  • 28:14network that we have developed is that
  • 28:17at the time there were 25 centers in 2018.
  • 28:20Now there's 60 but at the time we all
  • 28:23decided we were going to change how
  • 28:25we thin the blood for these patients
  • 28:28how we anticoagulate these patients?
  • 28:31We'll just all change at the same
  • 28:33time so one day everyone changed.
  • 28:35We had the day set.
  • 28:36And at that point on we changed
  • 28:39from heparin to buy Valley Routin.
  • 28:41I'll never forget the CEO of Berlin Heart
  • 28:43calling and saying what just happened.
  • 28:45Like we've been trying to do
  • 28:46this for a decade.
  • 28:47We've been trying to change how
  • 28:49we anticoagulate for a long time.
  • 28:50It was the power of that network and we
  • 28:52really learned from some of the centers
  • 28:54who had used by Valley Ruden and said,
  • 28:56you know their outcomes are better.
  • 28:57They will us decrease the variation
  • 28:59and let's just change what we're
  • 29:01doing right now is not working.
  • 29:03So with that,
  • 29:04we wrote a harmonization document which
  • 29:06is a little bit like a standard practice.
  • 29:08Although people do a little bit
  • 29:10different things of each institution.
  • 29:12Which is fine.
  • 29:13It's really what has built the network
  • 29:15to move forward with standardizing
  • 29:18care and you can see here the stroke
  • 29:20rates coming down in these Berlin
  • 29:22heart patients where we had 25 to 30%
  • 29:24depending on which data source you
  • 29:27looked at and down to 13% in the network.
  • 29:30And now we're at 11.6% stroke
  • 29:33rate for these patients and so you
  • 29:35can see with an intervention.
  • 29:37We've really worked together to improve
  • 29:39the outcomes of these patients.
  • 29:44I'm going to, but despite better
  • 29:47results with Berlin heart,
  • 29:49we still want to use these adult devices,
  • 29:52and one of the reasons that I kind of
  • 29:55alluded to earlier is that these patients
  • 29:57are still hooked to this huge driver.
  • 30:00You can see the device here hanging on this
  • 30:03patient little girl with a big wrap here,
  • 30:05so not very conducive to play.
  • 30:09Quality of life is not great and the
  • 30:11patients are stuck in the hospital.
  • 30:13Wouldn't be much more want this for
  • 30:16our patients where this little girl is
  • 30:18out in the community coming back for
  • 30:20rehab and so we're really trying to get
  • 30:23these adult devices and kids so that
  • 30:25we can get them out of the hospital.
  • 30:27Going to school, getting better,
  • 30:29waiting for their heart transplant.
  • 30:36Sorry. So these three size kids,
  • 30:39we're just going to talk a teeny bit about.
  • 30:41So this is the Berlin heart.
  • 30:42Here. This is the size baby that
  • 30:45we usually gets a Berlin heart.
  • 30:47This happens to be a heart mate,
  • 30:49three which we're going
  • 30:49to touch on in a minute,
  • 30:50which is the device we now are
  • 30:52you using for big bigger kids?
  • 30:54And then this is the hardware which
  • 30:56we were were sad to have seen go go.
  • 30:59It was taken off the market in June,
  • 31:01but it was really a great device
  • 31:03for kids because it was a little bit
  • 31:05smaller than the device we have now.
  • 31:08So Medtronic stopped the
  • 31:10distribution of the HVAD in 2021.
  • 31:14And so we were back to having
  • 31:16only the heart made three,
  • 31:18which is a great device and I'm going to tell
  • 31:20you why it's a great device in a minute,
  • 31:21but you can see it's a little bit bigger.
  • 31:23So where we thought the HVAD were
  • 31:26squeezing into these little kids,
  • 31:29we're now squeezing in something even bigger.
  • 31:31So we went backwards a little bit there.
  • 31:34And you can see the difference
  • 31:35here in the size of these pumps.
  • 31:37And so you know, this is the base of the
  • 31:39pump and this is the base of the H fad.
  • 31:42This is the pump we're using now.
  • 31:44A little bit bigger,
  • 31:45a little bit harder to get
  • 31:46into some of the smaller kids.
  • 31:51So the tweeners.
  • 31:52This is what we have, you know,
  • 31:54talk about these school age kids
  • 31:56that we talked about at Berlin heart
  • 31:58and the babies and then the bigger
  • 32:00pump in the in the adolescence.
  • 32:02Or the young adults we really are
  • 32:05trying to figure out the best
  • 32:08device for those kids in the middle.
  • 32:11So and Kevin knows that there's lots
  • 32:13of talk in the bad community about HVAD
  • 32:17leaving the market and what we do instead.
  • 32:20We think we can place a heart.
  • 32:2123 and a kid.
  • 32:22That's 2025 kilos.
  • 32:23And we're trying and we're
  • 32:25following that data really closely
  • 32:27to see if it's the right thing.
  • 32:29But we're also having to go back to
  • 32:31using more Berlin hearts than we did
  • 32:33in the past without when we had the aged fad.
  • 32:36We're using a lot of fit studies
  • 32:38to figure out what will fit.
  • 32:39This is happens to be a hardware,
  • 32:41but this is a CT reconstruction
  • 32:43of a child's chest.
  • 32:44With CT,
  • 32:45we reconstruct the device
  • 32:46in the CT scanner as well,
  • 32:48and then we can place it and
  • 32:50reposition it in all different ways.
  • 32:51To figure out the right device
  • 32:53for that child.
  • 32:56And when you're thinking about
  • 32:57these small patients and trying
  • 32:59to use this bigger device,
  • 33:00you know the the Heartmate 3
  • 33:02is very is a very good device.
  • 33:05It is a great device for adults.
  • 33:07It's more forgiving.
  • 33:08There's less bleeding,
  • 33:09there's less clotting,
  • 33:10the drive line is a little heavier.
  • 33:13The low flow alarms are a little different,
  • 33:15so just things to be thoughtful about,
  • 33:17especially for the cardiologists
  • 33:18in the room that are thinking
  • 33:21about you know what device do I
  • 33:22use for a child that is school age?
  • 33:25And above.
  • 33:28There are some trials going on for
  • 33:29these tweeners these kids in the middle
  • 33:31that don't have the perfect device.
  • 33:33There's the pumpkin trial which is the
  • 33:35Jarvik device which is going on now.
  • 33:37It's been going on for a long time and
  • 33:39it's very hard to recruit patients
  • 33:41into a pediatric device trial.
  • 33:43There's also the new driver
  • 33:45for the Berlin heart,
  • 33:47so this Berlin heart will be the same,
  • 33:49but the driver will be able
  • 33:51to be put on a stroller.
  • 33:53The child will be able to stand
  • 33:55and walk with it, it might improve.
  • 33:57Quality of life.
  • 33:58So we are really focused in trying
  • 34:00to get this patient population cared
  • 34:03for as the HVAD has left our use.
  • 34:10So I'm going to just switch kind of thoughts
  • 34:13a little bit about removing barriers,
  • 34:16and I think this is a really
  • 34:18important concept, and Kevin alluded
  • 34:20to this concept of collaboration,
  • 34:22but it's not just collaboration with
  • 34:25all the centers that we've really
  • 34:28been pushing and successful with,
  • 34:30but also collaboration with
  • 34:33industry and the FDA.
  • 34:35And the story that I'm going to tell you
  • 34:37right now is just about labeling devices.
  • 34:40And why is it important to advocate for
  • 34:42children to get devices and drugs for them?
  • 34:44And why do we want to change
  • 34:46that historical way?
  • 34:47We've done things where we use
  • 34:50adult devices and adult drugs,
  • 34:52and then just extrapolate them to kids.
  • 34:56Well, there's many reasons I'm going to
  • 34:59tell you that for devices in particular.
  • 35:02This is a backpack that this little girl
  • 35:05made so she we used an adult device.
  • 35:08The mom made this.
  • 35:09You can see the Rick Rack here with the
  • 35:12little vent and the reason is because
  • 35:14the accessories aren't the right for
  • 35:16children and so if they're not labeled,
  • 35:18if the device is not labeled for children,
  • 35:20or the FDA hasn't approved it for
  • 35:22children or we're using it off label,
  • 35:24no one will make the right
  • 35:27accessories for the kids.
  • 35:29So that's one reason.
  • 35:31They don't.
  • 35:32Industry doesn't necessarily
  • 35:33do human factors on these kids,
  • 35:35so this happens to be the syncardia.
  • 35:37Human factors wouldn't have had to be done
  • 35:40on a non pediatric device and you see,
  • 35:42you're trying to hold this huge backpack.
  • 35:45The drive of the vacuum tubing
  • 35:47is too long for that child,
  • 35:49so just thinking about you know how
  • 35:51do we test that these children are
  • 35:52going to be safe and then the education
  • 35:56materials really not pediatric friendly
  • 35:58unless we get these devices labeled for kids.
  • 36:02So we action went to the FDA and
  • 36:05worked with the industry and said,
  • 36:09let's try this.
  • 36:10Let's try to expand a label for kids and
  • 36:12see if it changes how we treat these kids.
  • 36:15So we worked with industry and
  • 36:17the FDA and it was collaboration.
  • 36:20It was the greatest partnership that
  • 36:22we have had in action and we said This
  • 36:24is why we told all the reasons why we
  • 36:27needed these devices labeled for kids.
  • 36:29We said we'll collect the data.
  • 36:31The action.
  • 36:32Industry collected all the data
  • 36:34for the Heartmate 3 patients.
  • 36:36We adjudicated all the data and
  • 36:38we worked with Abbott to submit
  • 36:40the application to the FDA.
  • 36:42And on December 17th 2020.
  • 36:44We had the first device in
  • 36:46a decade approved for kids,
  • 36:47which is the hard made 3
  • 36:49and we're continuing to do.
  • 36:50The post surveillance in action.
  • 36:52So it was 18 months from an idea of
  • 36:54getting a device approved for kids
  • 36:56to getting it actually approved.
  • 36:58And I think the really important
  • 37:00point of this is that it was all
  • 37:02just working together advocating for
  • 37:04the kids and why we had to do things
  • 37:07differently and why we couldn't
  • 37:08do a clinical trial when there's
  • 37:10so few children that need a device.
  • 37:12And really, why it was important,
  • 37:13I think that that was the most enlightening.
  • 37:17Part is that everyone thought, oh,
  • 37:19Pediatrics, they can get the device.
  • 37:21So what's the what? What, Matt?
  • 37:23Why does it matter?
  • 37:24Why do they care?
  • 37:25Well, insurance now pays for
  • 37:28it easily all the device.
  • 37:30Education is the appropriate for kids
  • 37:32and now we can all learn together openly
  • 37:35instead of saying oh it's off label.
  • 37:37We can't talk about it.
  • 37:40This was the press released
  • 37:42from the Abbott Heartmate 3
  • 37:45expanded pediatric approval.
  • 37:49We're going to talk a little better
  • 37:51about patient outcomes in these kids.
  • 37:53The one thing to know is that these
  • 37:56adult devices that we're using in kids,
  • 37:58the outcomes are the same as adults.
  • 38:00They're really good.
  • 38:02These kids do really well and
  • 38:04we have multiple papers kind
  • 38:07of outlining these results.
  • 38:09And then we've been looking close
  • 38:10at our own results in action to
  • 38:12make sure that pushing this forward,
  • 38:14expanding the label was the
  • 38:16right thing to do,
  • 38:17and we're seeing that our results are
  • 38:20actually better than some of the adult.
  • 38:22Adult data that has been published.
  • 38:24We have a 94% positive outcome
  • 38:26in these patients even though
  • 38:28there are kids with a big device,
  • 38:30very low stroke rate.
  • 38:3452% of these patients are
  • 38:36discharged before transplant,
  • 38:37so they're getting back into the Community,
  • 38:39so this is a really exciting way
  • 38:41to follow these outcomes and make
  • 38:43sure that this expanded label
  • 38:45was the right thing to do,
  • 38:47that getting them to kids is the
  • 38:48right thing for these children.
  • 38:53And I'm just going to touch on
  • 38:54just in the last 10 minutes or so
  • 38:57of the five current bad trends.
  • 38:59Some of them I've alluded to,
  • 39:00but I think to take away from this lecture,
  • 39:03if you're thinking about what is
  • 39:05avad and what can it do for me,
  • 39:06or what am I gonna see it
  • 39:09doing at your institution?
  • 39:12I think we've talked about this,
  • 39:14but bad use is increasing and it's
  • 39:17decreasing weightless mortality.
  • 39:18More centers are using the Vads to
  • 39:21rehabilitate their patients and make
  • 39:23them better transplant candidates,
  • 39:24and so I think you will start to see
  • 39:27more and more bads if you're developing
  • 39:30or maturing your transplant program.
  • 39:33We know from this data this
  • 39:34is now a little bit old,
  • 39:35but this was 2015 that patients
  • 39:37supported with a VAD were four times
  • 39:40more likely to survive transplant.
  • 39:42So this is just really impressive that
  • 39:46even in 2015 without all the knowledge
  • 39:49that we've now gained with bad support,
  • 39:51we really were getting
  • 39:53more kids to transplant.
  • 39:56And the allocation system has changed
  • 39:58things dramatically because now
  • 40:00in 2016 there was a view vision
  • 40:02of the pediatric allocation and
  • 40:04that's really pushed,
  • 40:06not going to get into all
  • 40:07the details about it,
  • 40:09but it's really pushed people to use
  • 40:11bads more or need to use Vads more
  • 40:13because the there are many kids that
  • 40:16aren't getting transplanted because
  • 40:17of how they're listing status is.
  • 40:19So that's especially true for kids with
  • 40:22cardiomyopathy that they can't be the
  • 40:24highest status unless they have a VAD.
  • 40:26It's a whole nother hour talk
  • 40:28about why that is,
  • 40:29and if that's the right thing to do,
  • 40:30but the reality is,
  • 40:31it's really pushing the bad
  • 40:33use in the community.
  • 40:37This is just touching on that that the
  • 40:39second most you know trend that we're
  • 40:41seeing is that you can't really have the
  • 40:44dilated cardiomyopathy and be A1A, and
  • 40:46milrinone just doesn't change your status,
  • 40:48which for the cardiologist in the room
  • 40:50you know that we used to be able to put
  • 40:51a child on milrinone and they could sit
  • 40:53in the hospital and wait for transplant,
  • 40:55and now they're not in the highest
  • 40:57status and they're waiting a long time.
  • 41:00I have one patient that's on
  • 41:01milrinone that's waited 18 months.
  • 41:05Some of the listing status issues
  • 41:08as I said, You know really.
  • 41:10I'm really passionate about this.
  • 41:11But I think that it is another talk,
  • 41:14but it's just you know how we list.
  • 41:16A 17 year old versus an 18 year old
  • 41:18is different and that's driving
  • 41:19some of the need for more bads
  • 41:22because we are going to need to
  • 41:24support these patients longer.
  • 41:25Some of the listing status
  • 41:27changes have made a dilated.
  • 41:30Cardiomyopathy have a lower status than
  • 41:32a congenital heart disease patient.
  • 41:35Maybe that's the right thing to do.
  • 41:36I think we'll have to see as we
  • 41:38look at that data.
  • 41:42We're using these devices in
  • 41:43really creative ways and I
  • 41:45think this is really important.
  • 41:46Point is that we used to not
  • 41:48use Vads and single ventricles.
  • 41:51Very rarely did we think it would work,
  • 41:53and the data is supported
  • 41:54that it wasn't a good idea.
  • 41:56I mean, there's a patient from
  • 41:58or a paper from six years ago or
  • 42:01so that showed really awful bad
  • 42:03outcomes with all three stages.
  • 42:06It's not really true anymore.
  • 42:07We're actually having really good
  • 42:09outcomes in our single ventricle stage ones.
  • 42:12Shunted patients,
  • 42:13there are some centers who have done
  • 42:16multiples and we've learned a lot
  • 42:18from them sharing that knowledge,
  • 42:20so some really good success
  • 42:21stories of supporting these single
  • 42:23ventricles in different ways.
  • 42:25So not only the shunted patients are
  • 42:27we seeing supported more frequently,
  • 42:29but also the Glen patients
  • 42:31were always or the stage.
  • 42:33Two patients were really hard to support.
  • 42:36We are supporting more and
  • 42:37then the Fontan patients,
  • 42:39which I'll talk about in a second.
  • 42:43So Fontan patients also a
  • 42:46preview to another hour talk,
  • 42:48but really an exciting thing is that
  • 42:52Fontan patients are coming to your center.
  • 42:55They're coming into your
  • 42:56center with heart failure,
  • 42:58and they're going to need transplants.
  • 43:00We don't have enough transplants,
  • 43:02so we need some kind of life
  • 43:04saving device or something that
  • 43:06can get them to the transplant.
  • 43:07Or they can live on and I think we're
  • 43:10really starting to understand who the
  • 43:12best Fontaine candidates are for a device,
  • 43:14and so that's exciting.
  • 43:15Like that's a new thing for the field
  • 43:17is that we can support Fontan patients,
  • 43:19not all of them,
  • 43:20but a group of them.
  • 43:22And they could do really well.
  • 43:24We also have been showing that Fontan
  • 43:26Vads can be a bridge to a heart
  • 43:28transplant or a bridge to a heart and liver.
  • 43:30Transplant so once again it's
  • 43:33a very big topic,
  • 43:34but I just wanted to give a touch of
  • 43:37that coming up in the next couple years.
  • 43:40And the Fontan data outcomes looking good.
  • 43:43This is a little bit old now.
  • 43:45It was published in 2021,
  • 43:47but you know how long it takes
  • 43:48to get a manuscript published.
  • 43:50But this was 45 pontians,
  • 43:5369% transplanted, 21% mortality.
  • 43:55But thinking about how many patients
  • 43:58would have died waiting for a transplant,
  • 44:01which would probably be all of them.
  • 44:04That is great news for our Fontan
  • 44:07patients that are are failing
  • 44:09and waiting for transplant.
  • 44:14We often get a lot of
  • 44:16questions about fontains.
  • 44:17I think that action is working really
  • 44:19hard to answer these questions.
  • 44:21I touch on these here because I'm
  • 44:23sure that when you if you have
  • 44:25done your first Fontan bad or you
  • 44:27plan to or you have a patient,
  • 44:28all of these questions will be
  • 44:30on your question list and I think
  • 44:32we have some answers from the
  • 44:34experience across the network,
  • 44:35but we are always welcome to work
  • 44:38with anybody who has the Fontan bad.
  • 44:40I think there are some nuances
  • 44:42to trying to support. And while.
  • 44:47The fifth thing last trend is always being
  • 44:49open to recovery and I touched on this
  • 44:51and I think this is really an important
  • 44:53concept is that once you put a VAD in,
  • 44:55that doesn't mean that you can't
  • 44:57keep trying to get the VAT out so we
  • 44:59always can try to recover the patient
  • 45:01and this is a big concept in the
  • 45:03adult field is like is it can we get
  • 45:06them on heart failure medications?
  • 45:08Can we support them and unload that
  • 45:09heart and then get the device out?
  • 45:11Does it always have to be a
  • 45:13bridge to transplant?
  • 45:14So also a very exciting thing to think about.
  • 45:19Collaboration Kevin touched on it.
  • 45:21I've touched on it multiple times.
  • 45:24There's nothing more exciting to talk
  • 45:26about than the collaboration that's
  • 45:28happened in the heart failure community.
  • 45:30Really, what Kevin said is exactly
  • 45:32right is that everyone got together.
  • 45:34There's 60 leaders and 1100
  • 45:37members of action, and now 6.
  • 45:42Sorry I can't see my screen.
  • 45:43I think we're at 6058.
  • 45:45Sixty centers that are all working together
  • 45:49to improve the outcomes of these patients.
  • 45:52Our mission has been the same
  • 45:53since 2017 that we're really
  • 45:56focused on collaborative learning,
  • 45:57uniting all stakeholders.
  • 45:58I showed a few examples of what we've
  • 46:01done in action, being the change in
  • 46:03the anticoagulation all in one day.
  • 46:06I also showed the example of working with
  • 46:08the FDA and industry to say, you know what?
  • 46:11This isn't good enough like we
  • 46:12have to do better for these kids.
  • 46:13And we have to change the outcomes
  • 46:16of these kids and that worked.
  • 46:17And we did.
  • 46:18We did make a difference,
  • 46:20so I really think that this is just an
  • 46:23important concept that I have a lot of
  • 46:25passion about and love to talk about more.
  • 46:27If anyone has a disease process
  • 46:29that they think are learning
  • 46:31network or a collaborative.
  • 46:33Would would be something
  • 46:35they would be interested in.
  • 46:36We we are always welcome to
  • 46:37talk about how we did it.
  • 46:42Action also has really focused on
  • 46:44education and there's a learning
  • 46:46management system that really looks
  • 46:48at heart failure education for the
  • 46:50provider and the patient and family.
  • 46:52And I'm bringing this up if there's
  • 46:54questions that came out of this talk.
  • 46:56Kevin has access to the provider
  • 46:58site and can give access to your
  • 47:00center if you don't have it,
  • 47:02and then patients and caregivers you
  • 47:03can always refer to the site too.
  • 47:05If you're starting to think about
  • 47:07treatment for heart failure or Vads
  • 47:09or understanding the diagnosis.
  • 47:13Standardizing protocols,
  • 47:14these are our harmonization protocols.
  • 47:16I mentioned these with the BYVAL,
  • 47:18but an important concept when you're trying
  • 47:20to work together and share experiences.
  • 47:23There are 35 now harmonization
  • 47:25protocols and so really anything
  • 47:27that you think you might come across
  • 47:30that you've never seen before.
  • 47:32There should be some kind of
  • 47:34protocol from some site that's been
  • 47:36harmonized into one document that you
  • 47:38can use as a as a like jumping off
  • 47:40point for caring for that patient.
  • 47:44Just stay. Summarize collaboration.
  • 47:51Giant drinks, unfortunately our
  • 47:53numbers are smaller, right?
  • 47:54There's just not as many
  • 47:56children as there are adults.
  • 47:58It's also important to realize
  • 48:00that more children die of heart
  • 48:02disease than any other disease.
  • 48:04With that being said,
  • 48:06it's very hard to do traditional research,
  • 48:08so it's hard to do randomized
  • 48:09controlled trials.
  • 48:10A lot of our experiences, anecdotal,
  • 48:13and so there's no great way to
  • 48:16learn except for collaboration.
  • 48:19Like many. I think that just
  • 48:21summarizes kind of the whole talk.
  • 48:23This is a really evolving field of
  • 48:26really complicated field for Pediatrics.
  • 48:28For all the reasons that I I discussed
  • 48:30and this collaborative effort and this
  • 48:32action Learning Network has really
  • 48:34brought everyone together and so
  • 48:35anyone who is interested in working
  • 48:37in action working on a project.
  • 48:41We would be open to.
  • 48:44Any involvement so excited to
  • 48:46talk more about it?
  • 48:47I think there's a few questions in the chat.
  • 48:51Thank you very much.
  • 48:53Doctor Lawrence. What I wonderful
  • 48:55overview of both the problem.
  • 48:57I loved hearing your that sort of
  • 48:59discussion in between the lines
  • 49:01and the great highlight of all the
  • 49:03great work that action is doing.
  • 49:05We do have a few questions I'd like to jump
  • 49:09in and start with one and then that is.
  • 49:13While there have been clear
  • 49:15improvements in in post transplant
  • 49:16management and and obviously
  • 49:18survivability in the recent decades,
  • 49:20and we're still suffering
  • 49:21from organ shortages,
  • 49:22and so one when one pays attention,
  • 49:24I think can almost sense an alternate
  • 49:26convergence of two different approaches.
  • 49:28There's the first,
  • 49:28which is the improvements and
  • 49:30mechanical devices as you mentioned,
  • 49:31where the devices are becoming smaller and
  • 49:33more indwelling and less failure prone,
  • 49:35both from a mechanical and biological aspect.
  • 49:38Less redundant, right?
  • 49:40The ICAS drivers getting smaller than
  • 49:42everything, but at the same time.
  • 49:44The recent news.
  • 49:45There's a second wave of sort
  • 49:46of xenotransplant and tissue
  • 49:48engineering coming in,
  • 49:49such as the report of the first pig
  • 49:51heart transplant down in Maryland,
  • 49:52and so these were sort of approaching
  • 49:55this problem of a kind of a complete
  • 49:57solution from two different angles,
  • 49:58and I was wondering,
  • 49:59sort of where you thought,
  • 50:01maybe the next leaps would come,
  • 50:02whether it's indwelling batteries,
  • 50:04and conductive charging so that they
  • 50:05don't have to have external devices?
  • 50:07Or is that close or far or or how
  • 50:09do you see this specific thing out?
  • 50:11These are great questions,
  • 50:12I think that we're going to add it.
  • 50:14In this field, from every angle,
  • 50:16because we know it's a problem
  • 50:17and we know that there's less.
  • 50:19There's less organs and
  • 50:20more patients needing them.
  • 50:21So you're exactly right.
  • 50:23I think that there's going to be an
  • 50:26indwelling no drive line device that will be
  • 50:29for kids before we are using xenotransplant.
  • 50:32That's just my prediction there.
  • 50:35I think there's some really great devices
  • 50:37that are available not to patients yet,
  • 50:41but are actually built.
  • 50:42So I would love to see those coming through.
  • 50:45For kids,
  • 50:46definitely something smaller on the back end.
  • 50:50And with no drive line,
  • 50:51it's going to be perfect for kids.
  • 50:53And if we were able to support children for
  • 50:56three 5-6 years before we have to transplant,
  • 50:59that's another 365 whatever years
  • 51:01before they they're transplant fails,
  • 51:04so any amount of time we can
  • 51:06push that transplant off,
  • 51:08I think,
  • 51:08is where we really need to think and get to.
  • 51:10Whether that's medications,
  • 51:12whether that's whatever it is like not
  • 51:15jumping to transplant if we don't have to.
  • 51:18I think it's going to be a really important.
  • 51:20Concept,
  • 51:20but I do think we're going to
  • 51:21have really good devices before
  • 51:23we have snow transplant,
  • 51:24but I might be wrong.
  • 51:27Thanks so much for the the talk.
  • 51:29There's a couple of quick questions
  • 51:30I want to see if we get a couple
  • 51:32of them in the in the chat.
  • 51:33This is an interesting question
  • 51:34from one of our ER doctors.
  • 51:35What's the protocol for CPR with bad?
  • 51:38Do you recommend holding compressions
  • 51:40so we tell everyone to
  • 51:42do CPR if they need CPR,
  • 51:45there's some nuances. Obviously.
  • 51:47Listen, make sure the device is
  • 51:48going and then you're whoever's
  • 51:49taking care of the device.
  • 51:50If it's Kevin or his team to make
  • 51:53sure that they're on the phone,
  • 51:54but we would do CPR if there's if there's
  • 51:57a need for CPR and they meet those criteria.
  • 52:00If they you get ROSC,
  • 52:02then you you know look at drive line
  • 52:04sites and do chest xrays and echoes to
  • 52:07see what has happened to the device.
  • 52:09The only device we do not do CPR in,
  • 52:12which isn't necessarily an
  • 52:13issue for you guys right?
  • 52:14This moment is the total artificial heart.
  • 52:17Obviously that's not going to help,
  • 52:19so that one is a little different,
  • 52:21but everything else we would do CPR.
  • 52:25OK, from from one of our cardiologists.
  • 52:28Would you ever consider ads as
  • 52:30destination therapy for patients with
  • 52:32congenital heart disease like a Fontan?
  • 52:34Yes, it's like I gave you that question.
  • 52:35I love that question.
  • 52:37I think it is definitely a way of the
  • 52:40future because there's many fountains
  • 52:42that aren't transplant candidates.
  • 52:44They're not transplant candidates
  • 52:45because they have antibodies to oregons
  • 52:47or they have indoor organ failure,
  • 52:48or they have been lost.
  • 52:50I mean not that an adult congenital
  • 52:52has ever been lost to follow up,
  • 52:53but maybe they've been lost
  • 52:54to follow up for a decade.
  • 52:56Those are the patients that are great
  • 52:59options for destination therapy and
  • 53:01as we get better and better at this,
  • 53:03I think it's going to be their option.
  • 53:05I just don't think going to
  • 53:06have enough organs.
  • 53:09Alright, and I'm gonna.
  • 53:10I think we have time for one
  • 53:11last question so I'm gonna
  • 53:12give it to our boss and David.
  • 53:14I'll save your question for when you
  • 53:15meet with Doctor Lawrence tomorrow.
  • 53:17So he says thank you for a fantastic talk.
  • 53:19Can you speak a bit to how you
  • 53:20came to your career path and what
  • 53:22supports and types of mentors you
  • 53:23draw on and supported you as you
  • 53:25developed an expertise in your
  • 53:27learning network development?
  • 53:30Interesting background in that I am a
  • 53:33cardiac intensivist left that I see and
  • 53:36I did basic science bench research.
  • 53:38I had a patient who had a stroke.
  • 53:40It's now been a decade.
  • 53:41It's been he's 12 now so and his mom was
  • 53:45a nurse and it really hit me that we
  • 53:48needed to do better and so I left the ICU.
  • 53:51I left the bench and I went and
  • 53:54learned quality improvement.
  • 53:55Science got my MBA.
  • 53:58Thought about collaboration science.
  • 54:01UM knew that we had to do
  • 54:02something for this stroke issue,
  • 54:04and that's when in 2017 it was five
  • 54:06centers decided to work on this.
  • 54:08I have a lot of mentorship because
  • 54:11Cincinnati children host many learning
  • 54:13networks, so the concept is very, very clear.
  • 54:16In Cincinnati,
  • 54:17Children's of this improved Care
  • 54:18now is probably the biggest oldest,
  • 54:21but NPC QIC,
  • 54:22those cardiologists in the room know.
  • 54:24So I was able to kind of model
  • 54:26what we did after it,
  • 54:28although we've really changed
  • 54:29from just a learning network.
  • 54:31Your research collaborative as well,
  • 54:33because we have all these
  • 54:34research studies going on,
  • 54:35we have innovation projects
  • 54:36that Kevin's involved in.
  • 54:37We have the, you know,
  • 54:38FDA relationships,
  • 54:39so it it it has morphed into
  • 54:42many different things.
  • 54:44But the Learning Network concept
  • 54:47is very very strong in Cincinnati.
  • 54:52Perfect, I think we're going to
  • 54:53end there because it's 1:00 o'clock
  • 54:54and I want to be respectful.
  • 54:56Everyone's time if anyone's interested.
  • 54:57I put in the chat.
  • 54:58We're going to be reviewing
  • 55:00cases with Doctor Lawrence,
  • 55:01Doctor Hall tomorrow morning,
  • 55:02so anyone's welcome to join that and
  • 55:04then we have some time carved out for
  • 55:05you to meet with our fellows tomorrow.
  • 55:07So thank you so much.