4/27/22 – Angela Lorts, MD, MBA – Current Review: Advanced Cardiac Therapies for Children in Heart Failure
April 27, 2022Information
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- 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.