November 30, 2024 • 41 mins
Unlock the future of heart care and understand how a revolutionary cooperative platform is reshaping the landscape of congenital heart disease treatment. Join us as we explore the groundbreaking innovations at HeartWorks, a transformative program at the Mayo Clinic led by Dr. Tim Nelson. With heartfelt insights from Erin Borkowski, a dedicated heart mom, and Rachael Gott, an inspiring adult living with congenital heart disease, we delve into the challenges and advancements that are redefining patient care and clinical trial processes.
Meet the pioneers behind the scenes as Dr. Nelson explains how HeartWorks is bridging the gap between research and real-world applications. By harnessing patient-contributed data, this initiative is overcoming the frustrations of traditional clinical trials, making them more effective and timely. Rachael Gott shares her personal journey with HeartWorks, emphasizing the significant impact of ongoing research and patient empowerment in the fight against congenital heart disease.
Discover how HeartWorks is turning obstacles into opportunities through a data-driven cooperative platform. This patient-owned model is not only increasing enrollment in clinical trials, but also creating a collaborative network of institutions across the nation. From engineering heart muscle cells from skin biopsies to making clinical trials more accessible, HeartWorks is revolutionizing the way we think about congenital heart disease care. Tune in to learn how you can support these efforts and contribute to a brighter future for individuals of all ages affected by congenital heart conditions.
Rachael’s episode: Navigating Life with HLHS and Marfan Syndrome: Rachael’s Powerful Story: https://tinyurl.com/393hbmrm
Dr. Tim Nelson’s other “Heart to Heart with Anna” appearances:
Advancements in Stem Cell Therapies and Research for HLHS Heart Warriors: https://hearttoheartwithanna.buzzsprout.com/62761/episodes/494353-advancements-in-stem-cell-therapies-and-research-for-hlhs-heart-warriors
The Use of Stem Cells in Treatment for Hypoplastic Left Heart Syndrome (HLHS): https://hearttoheartwithanna.buzzsprout.com/62761/episodes/9949984-the-use-of-stem-cells-in-treatment-for-hypoplastic-left-heart-syndrome-hlhs
HeartWorks Update 2023:
https://hearttoheartwithanna.buzzsprout.com/62761/episodes/12191542-heartworks-update-2023
HeartWorks: https://heartworksinc.org/
The Co-Op: https://heartworksinc.org/coop
Become a supporter of this podcast: https://www.spreaker.com/podcast/heart-to-heart-with-anna--1256958/support.
Meet the pioneers behind the scenes as Dr. Nelson explains how HeartWorks is bridging the gap between research and real-world applications. By harnessing patient-contributed data, this initiative is overcoming the frustrations of traditional clinical trials, making them more effective and timely. Rachael Gott shares her personal journey with HeartWorks, emphasizing the significant impact of ongoing research and patient empowerment in the fight against congenital heart disease.
Discover how HeartWorks is turning obstacles into opportunities through a data-driven cooperative platform. This patient-owned model is not only increasing enrollment in clinical trials, but also creating a collaborative network of institutions across the nation. From engineering heart muscle cells from skin biopsies to making clinical trials more accessible, HeartWorks is revolutionizing the way we think about congenital heart disease care. Tune in to learn how you can support these efforts and contribute to a brighter future for individuals of all ages affected by congenital heart conditions.
Rachael’s episode: Navigating Life with HLHS and Marfan Syndrome: Rachael’s Powerful Story: https://tinyurl.com/393hbmrm
Dr. Tim Nelson’s other “Heart to Heart with Anna” appearances:
Advancements in Stem Cell Therapies and Research for HLHS Heart Warriors: https://hearttoheartwithanna.buzzsprout.com/62761/episodes/494353-advancements-in-stem-cell-therapies-and-research-for-hlhs-heart-warriors
The Use of Stem Cells in Treatment for Hypoplastic Left Heart Syndrome (HLHS): https://hearttoheartwithanna.buzzsprout.com/62761/episodes/9949984-the-use-of-stem-cells-in-treatment-for-hypoplastic-left-heart-syndrome-hlhs
HeartWorks Update 2023:
https://hearttoheartwithanna.buzzsprout.com/62761/episodes/12191542-heartworks-update-2023
HeartWorks: https://heartworksinc.org/
The Co-Op: https://heartworksinc.org/coop
Become a supporter of this podcast: https://www.spreaker.com/podcast/heart-to-heart-with-anna--1256958/support.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
So it heartworks. We say we build hearts and our
purposes to cure congenable heart disease. We like to refer
to ourselves as a team of teams, and there's five
things that drive us every day.
Speaker 2 (00:22):
Welcome to Heart to Heart with Anna I am Anna
Juwarski and the mother of an adult with the Single
Ritual Heart. Today's guests are doctor Tim Nelson, Hart Moom,
Eric Workowski and Adult Like.
Speaker 3 (00:33):
The HD Rachel Gott.
Speaker 2 (00:35):
Doctor Ti Minny Nelson directs the Todding Carawonic Family Program
for Hypoplastic Leftart Syndrome at Mayo Clinic.
Speaker 3 (00:42):
His research focuses on cardiovascular regeneration using bioengineered stem cells
to treat degenerative diseases, particularly HLAHS or hypoplastic Rtart syndrome.
Speaker 2 (00:54):
As director of the program, doctor Nelson and his team
are specifically interested in the cause of a HLHS and
finding ways to delay and prevent heart failure for individuals
with HLHS.
Speaker 3 (01:06):
To better understand and treat this congenital heart disease, the
program has taken a multifaceted approach that includes research into
stem cells, genetics, imaging tools, and the creation of a
bio repository.
Speaker 2 (01:20):
Doctor Nelson has been on Hard to Hear with in
numerous times to talk about Heartworks over the years. Will
have links to the other episodes in the show notes.
Eric Wurkowski is Fellow's mom who was diagnosed with HLHS
at twenty weeks. Bella, now eleven, has undergone all three
scheduled surgeries. Erin's family created the nonprofit Beats for Bella
(01:43):
and now she works with Dr Nelson at Heartworks. Welcome
back to Heart to Heart with Anna, Doctor Nelson.
Speaker 1 (01:50):
Anna, It's great to be here and it's a privileged
to be with Aaron and Rachel as well today. So
thanks for having us.
Speaker 3 (01:56):
I'm so excited to have you on a program. And
this is really a dynamic team.
Speaker 2 (02:00):
Isn't it.
Speaker 1 (02:02):
It's a team of teams as we like to say
it Heartworks.
Speaker 3 (02:04):
Oh, I love that.
Speaker 2 (02:06):
Let's start by having you tell us about Heartworks and
the new services for the heart community that Heartworks is
coming up with.
Speaker 1 (02:14):
And the field of congenital heart disease has been stalled
over the last thirty years with products and new innovation
in many ways, and part Works born out of our
program at Mayo Clinic and collaborating with a network of
hospitals across the country. Is really focused on product development,
(02:34):
is really focused on how do we bring the best
science out of labs and get that through an FD
approved process and develop new products to transform the way
we take care of children and adults with congenital heart disease.
So a heartworks, we say we build hearts, and our
purpose is to cure congenital heart disease. We like to
(02:54):
refer to ourselves as a team of teams, and there's
five things that drive us every day. We're driven by
the urgency of PhD families, like the ones we have
with us today. We're motivated by transformative outcomes, meaning products
that can really change the way we do the surgeries.
We're undeterred by obstacles because we know there's obstacles in
(03:15):
this journey. We're ultimately committed to a self reliant ecosystem.
What we mean by that is how do we do
the A to Z product development, get it out of
the lab, get it to the marketplace, and get it
into the hands of families and clinicians, and do that
in a way that we're not dependent on anybody else
helping us. But we do it in a self reliant way.
(03:35):
And finally, as we're all here today, we're aligned by
the shared responsibility that developing products for congenital heart disease
is truly our mission and that's where we aim to
partner with all companies, all academics, and all motivated entities
trying to make it better for congenital heart disease. And
one of those products we'll talk about more today is
(03:57):
the co Op that we're super excited about it of
how that's going to revolutionize the way we do product
development for congenital heart disease.
Speaker 2 (04:08):
Absolutely, I am really impressed with how Artworks doesn't just
want to find the cause and therefore create the cure,
but they're working to help people right now. That sense
of urgency, I think we all feel that we'll hear
more about that from Rachel that as the mother of
an adult who was initially diagnosed with a joy jess
(04:30):
and then it was changed as they go ventricle. For
the last to thirty years, I have seen so many
people growing up with this condition and facing so many
different types of problems. We really do need to find
a cure, and I'm not sure that everybody really understands
how long the process can take to get something from
(04:52):
an idea all the way to something that can actually
be used in the operating room. And this seems to
be something that har Works has decided it's not fast enough,
and you're bounded determined to make things happen faster.
Speaker 1 (05:07):
Yeah, you're right, Anna. The thing that we've pioneered and
perfected at Heartworks is the cell based therapies for regenerative medicine,
and we're committed to developing cell based products that can
regenerate the heart for everybody with congenital heart disease. But
we've learned in the last twelve years that the biggest
bottomne to our progress and our cycles of learning is
(05:29):
actually the enrollment and recruitment of patients into clinical trials.
In the congenital heart community. We don't have a culture
and infrastructure a process to be able to inform patients
which studies are available, which clinical trials are available, and
how to enroll those patients so that they can be
part of the future and they can be part of
(05:51):
pushing the boundaries and pioneering. And the co op, as
you'll hear about today, is really designed to directly address
that gap and accelerate the way we can enroll patients
across the country, no matter what institution you're at, no
matter if you're doing well and thriving today or if
you're doing poorly and need help today, even for our
(06:14):
families that have lost somebody in the congenital heart community,
it's literally open for anybody with congenital heart disease, and
everybody together in the co OP is what's going to
allow us to accelerate the clinical trials that are so
vital for moving this field forward.
Speaker 3 (06:32):
I love that Welcome to Heart to heartway Anna Aaron,
thanks for having Nanna happy to be here. I'm happy
to have you here too, because I know that you're
working with doctor Nelson it Heartworks, and I'd love to
know more about your role in the co OP. I
have always been inspired by the team at Heartworks, and
(06:54):
Tim mentions the team. It truly is, and it's incredible
the dedication from the physics, clinicians, everybody that support of
Heartworks to.
Speaker 2 (07:05):
Solve this problem and help find a cure for HD.
Speaker 3 (07:09):
And I'm always very moved by people who are not
directly impacted and still dedicate so much of their time
and energy and Heart and soul to finding a cure
for congenital heart disease.
Speaker 4 (07:21):
And as far as the co Op goes, my role
with the co Op is to help families understand the
power of this platform, to educate them, and to inspire
them to become members.
Speaker 3 (07:34):
We live in a world now with Fella that is
a wait and see and this is something that we
can do by simply donating her data and by helping
educate the team different symptoms that she might be having,
but sharing the goals of the co Op with families
and helping them feel inspired to share their voice and
(07:57):
help change the future. I love it You're coming at
this and as a heart mom like me because we
had that sense of urgency, don't we. We want our
children to live happy, productive lives. Yes, one hundred percent.
I get very frustrated by the slow moving world belived
sometimes and totally understanding that research takes time and childs
(08:22):
take time. But as her mom, I want things done yesterday.
I want a plan for the next twenty years. I'm
just happy to be a part of this team and
do my part and share my passion. I love that.
Speaker 5 (08:36):
I know when Help was young, I just kept praying
that medical technology would stay a step ahead of her,
and she is now thirty and it.
Speaker 3 (08:46):
Has stayed a step ahead, but just barely. But I
think Heartworks can be a game changer and I'm looking
forward to seeing how we parents can help this organization.
And there's so much more for us us to learn
there is. Heartworks is the only one that I know
doing what they're doing, the work, the research, the team,
(09:09):
bringing families, physicians, clinicians, patients together to change your future.
That's the power here right exactly.
Speaker 2 (09:18):
So, doctor Nelson, you were talking before about the main
reason for developing a cop is because of that bottleneck.
Can you talk to us a little bit more about
that and how discovering what the problem was led to
this revolutionary solution.
Speaker 1 (09:34):
Yes, we've done five i and ds with the FDA
since the beginning of our program. And an I and
D is the permission that the FDA gives you to
do world's first clinical trials for patients with congenital heart disease.
And as we've done that, we've learned that we've always
enrolled patients far more slowly than what we intended to.
(09:55):
So we get the study approved from the FDA, we
get the study approved in the local and then we
go try to find the patients and recruit them to
be part of these first and human clinical trials, and
it ends up taking us four times longer than we
expected it to take, and that becomes really frustrating for everybody,
everybody on the team, our clinicians, are scientists, our manufacturing team,
(10:19):
our researchers, and especially our families. Our families get very
frustrated by the fact that it takes much longer than
we get hoped for. So after doing this for fourteen
years now, we finally have figured out a way that
we think we can change that, and not only for
Heartworks and our technology, but for literally the entire field
(10:40):
of congenital heart disease. So, rather than designing studies that
we think are perfect fit for families, what if we
could have all families with congenital heart disease donating their
data to a platform, and then using that donated data,
we can build the clinical trial for the patients that
(11:02):
have the highest unmet need, the patients that have raised
their hand and said I need help, I want to
be part of something, and we design clinical trials for
those patients in need. Imagine how much easier it is
for those patients to sign up for the clinical trial
once it's developed. So they raise their hand, they donate
(11:22):
their data, We design the clinical trials for them, and
then we go back to them and say we heard you,
we listen to you, and we now have a clinical
trial that's open for you. This is a game changer,
and we're super excited to be able to make this
available to the whole PhD community and go well beyond
the products that we have at Heartworks.
Speaker 2 (11:42):
What I love about this is you're continually assessing the
data that you get, and you may end up creating
products or studies completely different than you would have otherwise
because the data that you're getting be so rich that
that will tell you where that basic need is.
Speaker 1 (12:05):
Yeah, that's right. And keep in mind that this is
fundamentally different than the registries that have been built over
the last decade. There's great work being done in many
registries that collect data in a de identified way and
look at best practices and standardized cares across institutions. That's wonderful,
really important work. Our mission is to transform the way
(12:29):
we take care of kids and adults going forward, developing
new products and to do that. We need to identify
the right patients at the right time to be part
of these clinical trials. So it's fundamentally different in a
patient centric way, listening to the voice of the patient,
interacting bi directionally with the family and with the patient
(12:52):
to educate us on what we should focus on, and
then educating back to the families what is currently available
for clinical trials across the country. This is the platform
that is fundamentally unique to any of the other registries,
and so we encourage everybody in the congenital heart community,
whether you are a warrior or an angel, you can
(13:14):
donate your data and make this process go much much faster.
Speaker 6 (13:23):
Heart to Heart with Anna is a presentation of Hearts
Unite the Globe and is part of the hug podcast network.
Hearts Unite the Globe is a nonprofit organization devoted to
providing resources to the congenital heart defect community to uplift,
empower and enrich the lives of our community members. If
you would like access to free resources pertaining to the
HD community, please visit our website at Wwwcongenitalheartdefects dot com
(13:49):
for information about HD. The hospitals that treat children with HD,
summer camps for HD survivors, and much much more.
Speaker 3 (13:57):
Rachel god is an adult who was born in nineteen
eighty eight with hypoplastical oft heart syndrome or HLHS. She
to date has not had any major corrective BIRT surgeries.
She has had thirteen cardiac relations along with two device implants.
Rachel is an advocate in the cojab or Heart community
and a former nurse. She's passionate about helping others on
(14:21):
their own HD journeys. My loyal listeners, well remember Rachel
from earlier this summer when she was on the program,
and the link to that episode will be in the
show notes. Welcome back to Heart to Heart with Anna Rachel,
thank you for having me.
Speaker 2 (14:36):
I'm favor bleas of me here. Well, I'm super excited
to see you, and I wish everybody else could.
Speaker 7 (14:42):
See you too.
Speaker 2 (14:44):
You're weared your heartworks Hoddy, You've got your heart works
water bottle.
Speaker 3 (14:50):
Why don'd you tell us a little bit about your
connection with heartworks, Rachel, You're absolutely right.
Speaker 2 (14:56):
I became fully a number in part works.
Speaker 8 (15:00):
After the Virtual Dinner last year, when doctor Nelson and
Greg Olsen talked about the co OP program, that was involved.
Speaker 3 (15:08):
With me, and I was super excited.
Speaker 8 (15:11):
I didn't give it another thought. This is such an
awesome program for people like me who have been mistaken
used as a baby and haven't had cracked in surgeries.
I am super excited to be in part, and it's
clinical trial to get help.
Speaker 3 (15:27):
Absolutely, you are the only person I've ever met who
was born with HHS and has survived to adulthood without
some kind of corrective surgery. So I'm very hopeful that
Hard Works will be able to help you, because I
don't think there were many people out there like you.
Speaker 8 (15:44):
I'm getting across a very small handful, and by mean
so I'm talking two or three people that have had
maybe one surgery but not all three, or just haven't
had any cracktive surgeries altogether. So I am very much
amiked the rare popular hlhl's uncorrected and it's all God.
I'm very blessed to be here. He's paved the way,
(16:07):
he's kept me stay and I'm very thankful for that,
and I'm thankful for what the future holds and working
with doctor Nelson.
Speaker 3 (16:14):
And seeing what we can do.
Speaker 2 (16:16):
Absolutely, So, what do you think the benefits will be
for you working with hard Works.
Speaker 8 (16:23):
I'm very excited about the whole process with themselves and
trying to regenerate the valves all my Valdor leakings. I'm
very excited to dive into that process and see what
I may or may not.
Speaker 3 (16:38):
I'm out out of it for myself.
Speaker 2 (16:41):
Okay, that's good. You have a very specific focus and
that you're interested in. And as a nurse, what do
you think about this co op? Have you ever experienced
anything like this before in your medical career. I have not,
and I'm very excited that they take together.
Speaker 8 (17:00):
I feel like it's a great opportunity to have a
central have database for different patients than different types of
the few, than just one great day central resource center.
And super excited they did it. And I hope this
podcast well I educate more people about the co OP
because a lot of people I know are very intimidated
(17:23):
by it.
Speaker 3 (17:25):
Exactly.
Speaker 2 (17:25):
I think there are a lot of people who are
intimidated by it.
Speaker 3 (17:28):
I think that currently in the United States anyway, there's
so much fear of regarding identity BAFT and I'm sure
I'm not alone and having had to get new credit
cards periodically because some person or entity has stolen my
credit card information.
Speaker 2 (17:46):
It's so frustrating, and it seems to be happening so
much more today that the thought of sharing are very
private medical information with somebody else. It is scary because
we know that something.
Speaker 3 (17:58):
Could go wrong. Did that concern you at all before
you joined the co op?
Speaker 2 (18:04):
Absolutely not.
Speaker 8 (18:06):
I figured with it being professional with a medical institution
and company, that my data would be saved.
Speaker 2 (18:14):
I know it is through my target atdate, so that
was not a negative factor.
Speaker 3 (18:18):
In my mind.
Speaker 2 (18:19):
It didn't weigh me one way or the other. I
was on board from it from the second I heard
about it. I love that. I as a former nurse
and now a SHD advocate, what advice would you have
for other adults with hlhs or parents of children who
have hlhs regarding participating and research studies? For taking part
is something like the Heart Works co op.
Speaker 8 (18:41):
Ask your questions if you have and I'm sure feeling
about something asked because nine times out of ten, somebody
else out there has the same question that you're wanting
to ask. That's the only way you're going to get
over your fear. Always asked because I'm sure somebody has
that question. And doctor Nelson and who came there fantastic
(19:04):
about getting to the bottom of things making it's all
comfortable and safe.
Speaker 2 (19:09):
You've dealt with EPIC as a nurse. Maybe not everybody
who's listening to this program knows what EPIC is and
can understand why having dealt with something like that would
make you feel more comfortable with the co op. Can
you explain a little bit about that to us.
Speaker 8 (19:24):
We cancel with EPIC obviously hit the laws arm place
depending on the Hufel institution. They've gotten great software security
and your information is one hundred percent safe, secure and protected.
I hadn't came a cost any issues with patients and
information getting leaked down there. That's what fieled my mind
(19:46):
to do their tilout program because I know if my
information and I beg is protected as a patient, that
it would still be the same throughout the.
Speaker 3 (19:55):
Matrix program with their kill out. Not everybody who listens
to my shows for me, and they may not know
what EPIC is. My husband uses EPIC a hospital where
she works as well. That kind of streamlines the data
that all of the nurses and doctors put in across
the hospital. The hospital my husband works at is the
(20:17):
biggest hospital for over one hundred miles in radius in Texas,
and there are lots of little satellite clinics. It's really
nice that through.
Speaker 2 (20:28):
EPIC, all of the information from the patients can be
shared practically instantaneously.
Speaker 3 (20:33):
But it's a way of communicating.
Speaker 2 (20:35):
Information very quickly, very accurately, and much more detailed than
what we probably ever thought would be Possibly before you
can look at X rays, you can look at echoes,
Doctor NASA, do you want to weigh in on this
how EPIC can be helping the co OP and how
through working with the co OP and maybe some of
(20:56):
these other medical repositories, that we can and keep medical
information safe and yet still have access to some really
powerful data.
Speaker 1 (21:06):
Yeah, the electronic medical record, which EPIC is one of
many and is arguably the largest electronic medical record. All
of our data is electric these days, right, It's all
in the database, it's all available, and if you're in
one organization or one platform, you can get that data
downloaded to you and you can even share it quite easily.
(21:27):
The problem is if your data is in multiple systems
and multiple providers over a long period of time, with
different hospitals, it becomes very hard to aggregate that altogether.
And that's one thing the co op does allow us
to do is to pull electronic medical records from multiple
hospitals and put it into one place under the banner
(21:48):
of the Heartworks co op. That has a lot of
advantages to be able to simplify the medical record back
to the patients, but it then also allows us to
do something as a community that no one hospital could
do by themselves. And that is again the reason why
the team of teams at Heartworks becomes such an important concept,
(22:08):
because it allows us to bring tens of thousands of
congenital heart families and patients together into one unifying platform
and just imagine what that will allow us to do.
The safety concerns we take as serious as anybody. We
have the same safety protocols that any of the large
electronic medical record systems have, and it is a concern
(22:31):
for us all. And yet the power of aggregation is
such a transformative approach that we have to continue to
focus on making it safer and making sure that we
educate patients of how powerful this aggregation can be.
Speaker 7 (22:46):
This content is not intended to be a substitute for
professional medical advice, diagnosis, or treatment. The opinions expressed in
the podcasts are not those of Heart to Unite the Globe,
but of the hosts and guests, and are intended to
spark discussion about issues pertaining to congenital heart disease or bereavement.
Speaker 6 (23:07):
You are listening to Heart to Heart with Emma. If
you have a question or comment that you would like
to addressed on our show, please send an email to
Anna Jaworski at Anna at Heart to Heartwanna dot com.
That's Anna at Heart to Heart with Anna dot com.
Now back to Heart to Heart with Anna.
Speaker 2 (23:25):
Now, we're all in this studio together, and I want
to talk a little bit about research because when I
was in college studying research, one of the problems that
we would see is maybe there were twenty people in
a study and that was it, So it was hard
to generalize anything from a study with such a small
(23:48):
number of subjects.
Speaker 3 (23:50):
Tell us how this co op can change that for.
Speaker 1 (23:53):
The heart world. Yeah, it's exactly right that we need
a large number of patients, a large number of diverse experiences,
a wide spectrum of ages, a wide spectrum of good
and bad outcomes that people have experienced to be able
to get the true picture of what is the reality
and what is the opportunities to move forward. So the
(24:15):
co op allows us to aggregate that across multiple institutions,
literally any institution, because the patient themselves owns their own data,
and the patient themselves can donate their data to the
platform at the co OP, So that donation of their
data and participation in this research study is really what
(24:37):
allows us to do it at scale. And if it
were my son or daughter that was being asked to
be part of a research study, I'd be asking is
it safe?
Speaker 2 (24:46):
What do you know?
Speaker 1 (24:47):
Is this really the right thing to do? And the
only way we can get some of those answers that
we all need is by aggregating the data together in
a unique way. And the beautiful thing about today's electronic
medical records is that data is available to be able
to be donated and shared and aggregated. And as long
(25:07):
as we can at Heartworks earn the trust of families
and patients to be that custodian of the data, to
be that agent of change with that data, we believe
we can move faster than anybody else with this type
of an approach.
Speaker 2 (25:23):
Are you also looking for data that's old. For example,
my daughter's thirty and she had her surgeries at a
different hospital than the one that she is seeing now.
Speaker 3 (25:36):
Is there any value to her asking if the other
hospital where she had her surgeries could send data to you.
Speaker 1 (25:43):
Absolutely? Right, I mean, this is the beautiful thing. To
be able to look at the longitudinal outcomes of patients
like your daughter over the past thirty years gives tremendous
power to being able to predict what's coming in the future,
or to be able to identify pasters and trends where
patients that maybe just like your daughter are going to
(26:04):
do great, but maybe if they're not like your daughter,
maybe they have a higher risk situation that we should
be intervening and doing things sooner. The aggregation of the
data in a personalized, prospective way is what makes this
platform fundamentally different.
Speaker 3 (26:21):
Now.
Speaker 1 (26:22):
The one thing that prevents people, and Aaron can speak
to this perhaps better than I is that people get
worried about how much time and energy is it going
to take to get that data. And if anybody's ever
signed up for life insurance or had to get medical
records from law one provider and sent to another, they
know how complicated that is. And people are tapping out
(26:45):
saying I don't have the time to do that. But
before you say that, you must realize that the co
op has done something really revolutionary. With your permission, the
system can go talk to the system, grab the data,
and pull it into the co op, so you don't
even have to transcribe the data and manually enter the data.
(27:07):
There are options to automate this, which changes in level
of involvement and time needed to make that work.
Speaker 3 (27:16):
But my daughter was born before EPIC was created, I think,
or at least it wasn't at the hospital which she
was an infant. I mean, she has I don't even
know how many folders of information at the hospital.
Speaker 2 (27:31):
Are hospitals taking all of those old fashioned folders full
of information and putting them into their computers, doctor Mouson.
Speaker 7 (27:40):
Some are.
Speaker 1 (27:40):
Some are going back into the medical record and transcribing
old data into the electronic medical records. So that is
happening automatically in many institutions. But it's also true that
not all of that data is going to be transcribed.
The co OP is really focused on grabbing the data
that is immediately available to us in the electronic medical record.
(28:02):
There's always ways where patients can upload the data manually directly,
and we would welcome that, but we also recognize that
that takes a lot more time and energy to be
able to accomplish.
Speaker 2 (28:14):
Ered What common misconceptions have people expressed about the co.
Speaker 3 (28:18):
Op to you? I think that it's just a general
understanding because this is something that didn't exist before the
co op at Artworks began. So I think that educating
families and patients that this is not your typical registry,
that your voice is important, and that sharing their data
(28:42):
is simple. I heard earlier is that this can seem intimidating,
which I didn't feel that way. I think that making
families and patients aware how secure the system is and
that your data is safe is really important. I have
heard that from some families, But I think that the
(29:04):
more people become educated and how simple registering is and
becoming a member is. The more we talk about the cop,
the more we share, the possibilities that will come. The
evolution of it will be pretty incredible to see over
the years as we build the database to five hundred
(29:24):
and one thousand and ten thousand members, I think that
we'll have more soldiers on the street for lack of
a better phrase, sharing this platform and sharing the story
of how to take a hold of your future and
help impact the future for HD careen treatment. I love that, Rachel.
Speaker 2 (29:46):
Do you have any questions for doctor Nelson or Aaron
about the co op?
Speaker 8 (29:51):
I do, Doctor Nelson? How long exactly does the clinical trial?
Speaker 3 (29:58):
Wow?
Speaker 1 (30:00):
Great questions. So to be a member of the co op,
you actually sign a research consent form that's I or
be approved, and you can withdraw that consent at any time.
So our goal is to be able to bring families
and patients into the co op and keep them there
for as long as they're willing to participate. The longer
the better because it gives us that longitudinal data. But
(30:22):
it's also true that if for any reason, anytime, somebody
wants to withdraw from the co op, it's a simple
undo if people want to. But this is a living,
breathing data collective. But that brings people together for the
long term. Now, one exciting thing that has come out
of this we have over one hundred patients that have
(30:42):
already signed up for the co op, and we had
a new clinical trial that became available in the last month.
A new clinical trial where we can consent patients to
a skin biopsy, get their cells manufactured, and prepare for
future clinical trials with their stem cells. And in the
co op, there were twenty eight out of one hundred
patients that were eligible for this new research protocol. With
(31:06):
the skin biopsy, we were immediately able to reach out
to those twenty eight people and inform them that because
they donated their data, because we had a clinical trial
that was available, we then could screen their medical record
and who they are and inform them that they may
want to learn more about this particular clinical trial that
(31:28):
is now enrolling, and then they can reach out to
the study coordinators learn more and do that. We imagine
that this is the platform that people will stay in
the co op because as they go forward, as their
medical conditions change and evolve, we'll be able to keep
them updated on what clinical trials are available anywhere in
the country. That value add, I think is going to
(31:50):
keep people engaged for the long term in the co op.
Speaker 8 (31:55):
I am happy to fay that I whires lyodverge twenty
eight participants that reach out to you from their skin
bypsy So I'm very excited to be there, and they
were happens.
Speaker 1 (32:07):
Well, we thank you for being a member of the
co op because that's exactly what allows us to move
so much faster, is that few weeks when from a
protocol being available to you being aware of it, to
you being able to engage in that that previously took
us months and months and months to figure out. So
it's a perfect example, Rachel, and we're grateful that you
(32:30):
were able and willing to trust the co op to
allow us to do that so much more quickly.
Speaker 3 (32:35):
Oh absolutely, Rachel.
Speaker 2 (32:38):
Were you surprised that you signed up with the co
op only this year and you already got a call
saying that you qualified for one of the studies.
Speaker 8 (32:47):
I was surprised. Hill Ever, this shock didn't last long
because I am seeing a venture calls. I figured I
would again get you tank sure that it's organistation too.
Speaker 3 (32:58):
I think one of the scary things is this way,
you don't know a whole lot of other people with COCHD.
You feel so isolated, you feel so alone, but this
co op helps you to realize you're not alone. There
were twenty seven other people who got the same call you.
Speaker 2 (33:12):
Did, and that's actually a decent number to get started
with this study, isn't it. I'm completely angry.
Speaker 3 (33:20):
Is a fanta fit Starry, and.
Speaker 1 (33:23):
I think it's allowing us to get started with something
so much even bigger, Annah and Rachel. I'd like to
think of folks like this as the pioneers. We need
to get back to the day where we were in
the sixties and seventies and eighties, where we had a
culture and an expectation to pioneer new therapies, new surgeries
(33:45):
for these children that we had no options for at
that time. And that pioneering spirit is what together I
think we can reignite. And the technology is available, the
science is available in getting more patients enrolled in clinical
trials is a game changer for the future of congenital
heart disease. Imagine the day when we have ten thousand,
(34:08):
not one hundred, but ten thousand individuals with congenital heart
disease in the co op, and imagine how much easier
it will be to engage drug companies, device companies, researchers
across academia. We will have a patient owned data set
that will drive the innovation that we've so desperately been
(34:30):
lacking over the last thirty years. That's why this co
op is a game changer, and these individual stories and
these individual examples of how we can do it today
is what's really propelling us forward into a much, much bigger,
and much faster future. And I think that's really motivating
for our families.
Speaker 2 (34:50):
It seems like in the past, doctor Nelson, so many
of the research studies that we're done were single institution studies,
and what you're tucking about doing is a multi institution stating.
It's only as small as you want it to be.
Speaker 3 (35:05):
You have the ability once you get information from.
Speaker 2 (35:08):
People in Hawaii, are people at Philadelphia, are people in Houston.
You're getting all this information from everywhere, and I think
that makes it even more powerful.
Speaker 1 (35:18):
We're one hundred percent dependent on institutions with their massive
skill sets. As clinicians and providers, we need to partner
with institutions, and yet the co op allows us to
go above the demands of institutions and be one institution,
one community of congenital heart disease. And that's really empowering
(35:41):
for families and individuals to realize that it doesn't matter
what institution they're at, they can be part of a nationwide,
global wide effort. So yes, we'll always be dependent on
institutions to be our partners to do the clinical trials,
but we also as a community can help the institution
do more.
Speaker 2 (36:00):
Because of this, you are based at Mayo, So if
somebody does qualify for your study, do they have to
go to the Mayo Clinic to take part in that
study or will there be opportunities much closer to home
where they can still participate in a study.
Speaker 1 (36:20):
Well, something we haven't talked about today that we're also
very proud of is the consortium of hospitals that we've created.
So yes, we do a lot of things for the
first time at Mayo Clinic because that's where we're home
based and that's where core team works out of. But
we recognize that we need to make these therapies and
these clinical trials available more locally, and we have worked
(36:42):
with eleven pediatric hospitals across the country, and as we
go forward with more adult than general heart protocols, you
will expect to see from Heartworks a network of hospitals
working collaboratively. And really the place that we're going to
go with this network is the institutions that have the
most patients. The institutions that have the highest density of
(37:05):
people in the co op. That allows us to centralize
and focus on the most patients in one location. That's
going to allow us to go faster than what we've
been able to do before. So this isn't about one institution.
It isn't even about a few institutions. It's about how
do we make all institutions allow their patients to be
(37:26):
available in participating in research studies because it's all of
us together that's got to move this field faster than
what we're doing right now.
Speaker 3 (37:35):
Absolutely, So, you had this one study going on. Does
a person have to be a member of the co
op in order to be eligible to take part in
a study?
Speaker 1 (37:45):
It's the best way for us to find out if
you're eligible for the study is using the co op,
as we've talked about. But it's not the only way
you can directly reach out to us, and we're happy
to work with patients one on one with our study
coordinator team, but the co op is definitely the way
that allows us to streamline it, simplify it, and hopefully accelerated.
Speaker 3 (38:06):
I love it, Aaron. Is there anything else we need
to know about the co op?
Speaker 2 (38:11):
I encourage people to reach out and connect with the
team if you have any questions.
Speaker 3 (38:15):
I think that it's going to be an.
Speaker 2 (38:17):
Incredibly powerful tool for the future.
Speaker 3 (38:20):
Nothing like it exists today. So I'm excited for what
it will do for the adult population as soon as possible.
I'm excited for what it will do for babies just
being born and twins like my daughter bella advocate get involved.
Speaker 1 (38:39):
That would be my best advice.
Speaker 3 (38:41):
I love it well, Rachel, good luck in the study.
How long is this study going to take? Doctor Nelson?
Is this something that's going to go on for years?
Speaker 1 (38:52):
The skin biopsy study is you've heard us talk about
before we take a piece of your skin, we engineer yourselves,
and then we make your beating tracting heart muscle cells
have launched that we have patients in the process of
their cells being manufactured. It's a nine month process to
make cells, and we will then go on to the
next step for the right patients at the right time
(39:13):
to do the transplant for them. So this is always
a long process, but we're super excited to scale it
and make it available to as many people as possible.
Speaker 3 (39:22):
I just put it. I'm so excited and Rachel, we're
gonna have to add you and doctor Nelson and hopefully Aaron.
I'm back into future and let us know how things
are going. This time has just flown by. I want
to thank all of you so much for coming on
a program. Thank you doctor Nelson for bringing us up
to speed on what's going on and explaining to Collot
be even more in depth with us this time.
Speaker 7 (39:45):
Well.
Speaker 1 (39:45):
Thanks for being part of the team of teams. Anna.
We can't do this without folks like you communicating, so
thank you for your time today.
Speaker 3 (39:53):
Thank you. I'm hoping that this will help my daughter.
Speaker 2 (39:56):
It's a little bit selfish that I do this too,
because I want to make sure that she has opportunities
that are on the cutting edge, just like what you're
providing Erin. Thank you so much for coming on a
program today. I'm so excited to finally meet you. Thank you, Annah,
it's great to meet you too, And Rachel, I always
love having you on the program. Thank you for coming
on today.
Speaker 3 (40:17):
Thank you for having me well.
Speaker 2 (40:20):
Friends. That does conclude this episode of Art to Heart
with Anna. Thanks for listening today. If you want to
learn more about the co Op, please check the link
in the show notes and hope you have a great
week and remember, my friends, you are not alone.
Speaker 6 (40:34):
Thank you again for joining us this week. We hope
you have become inspired and empowered to become an advocate
for the congenital heart community. Heart to Heart with Anna
with your host Anna Jaworski can be heard at any
time wherever you get your podcasts. A new episode is
released every Tuesday from noon Eastern time.
So it heartworks. We say we build hearts and our
purposes to cure congenable heart disease. We like to refer
to ourselves as a team of teams, and there's five
things that drive us every day.
Speaker 2 (00:22):
Welcome to Heart to Heart with Anna I am Anna
Juwarski and the mother of an adult with the Single
Ritual Heart. Today's guests are doctor Tim Nelson, Hart Moom,
Eric Workowski and Adult Like.
Speaker 3 (00:33):
The HD Rachel Gott.
Speaker 2 (00:35):
Doctor Ti Minny Nelson directs the Todding Carawonic Family Program
for Hypoplastic Leftart Syndrome at Mayo Clinic.
Speaker 3 (00:42):
His research focuses on cardiovascular regeneration using bioengineered stem cells
to treat degenerative diseases, particularly HLAHS or hypoplastic Rtart syndrome.
Speaker 2 (00:54):
As director of the program, doctor Nelson and his team
are specifically interested in the cause of a HLHS and
finding ways to delay and prevent heart failure for individuals
with HLHS.
Speaker 3 (01:06):
To better understand and treat this congenital heart disease, the
program has taken a multifaceted approach that includes research into
stem cells, genetics, imaging tools, and the creation of a
bio repository.
Speaker 2 (01:20):
Doctor Nelson has been on Hard to Hear with in
numerous times to talk about Heartworks over the years. Will
have links to the other episodes in the show notes.
Eric Wurkowski is Fellow's mom who was diagnosed with HLHS
at twenty weeks. Bella, now eleven, has undergone all three
scheduled surgeries. Erin's family created the nonprofit Beats for Bella
(01:43):
and now she works with Dr Nelson at Heartworks. Welcome
back to Heart to Heart with Anna, Doctor Nelson.
Speaker 1 (01:50):
Anna, It's great to be here and it's a privileged
to be with Aaron and Rachel as well today. So
thanks for having us.
Speaker 3 (01:56):
I'm so excited to have you on a program. And
this is really a dynamic team.
Speaker 2 (02:00):
Isn't it.
Speaker 1 (02:02):
It's a team of teams as we like to say
it Heartworks.
Speaker 3 (02:04):
Oh, I love that.
Speaker 2 (02:06):
Let's start by having you tell us about Heartworks and
the new services for the heart community that Heartworks is
coming up with.
Speaker 1 (02:14):
And the field of congenital heart disease has been stalled
over the last thirty years with products and new innovation
in many ways, and part Works born out of our
program at Mayo Clinic and collaborating with a network of
hospitals across the country. Is really focused on product development,
(02:34):
is really focused on how do we bring the best
science out of labs and get that through an FD
approved process and develop new products to transform the way
we take care of children and adults with congenital heart disease.
So a heartworks, we say we build hearts, and our
purpose is to cure congenital heart disease. We like to
(02:54):
refer to ourselves as a team of teams, and there's
five things that drive us every day. We're driven by
the urgency of PhD families, like the ones we have
with us today. We're motivated by transformative outcomes, meaning products
that can really change the way we do the surgeries.
We're undeterred by obstacles because we know there's obstacles in
(03:15):
this journey. We're ultimately committed to a self reliant ecosystem.
What we mean by that is how do we do
the A to Z product development, get it out of
the lab, get it to the marketplace, and get it
into the hands of families and clinicians, and do that
in a way that we're not dependent on anybody else
helping us. But we do it in a self reliant way.
(03:35):
And finally, as we're all here today, we're aligned by
the shared responsibility that developing products for congenital heart disease
is truly our mission and that's where we aim to
partner with all companies, all academics, and all motivated entities
trying to make it better for congenital heart disease. And
one of those products we'll talk about more today is
(03:57):
the co Op that we're super excited about it of
how that's going to revolutionize the way we do product
development for congenital heart disease.
Speaker 2 (04:08):
Absolutely, I am really impressed with how Artworks doesn't just
want to find the cause and therefore create the cure,
but they're working to help people right now. That sense
of urgency, I think we all feel that we'll hear
more about that from Rachel that as the mother of
an adult who was initially diagnosed with a joy jess
(04:30):
and then it was changed as they go ventricle. For
the last to thirty years, I have seen so many
people growing up with this condition and facing so many
different types of problems. We really do need to find
a cure, and I'm not sure that everybody really understands
how long the process can take to get something from
(04:52):
an idea all the way to something that can actually
be used in the operating room. And this seems to
be something that har Works has decided it's not fast enough,
and you're bounded determined to make things happen faster.
Speaker 1 (05:07):
Yeah, you're right, Anna. The thing that we've pioneered and
perfected at Heartworks is the cell based therapies for regenerative medicine,
and we're committed to developing cell based products that can
regenerate the heart for everybody with congenital heart disease. But
we've learned in the last twelve years that the biggest
bottomne to our progress and our cycles of learning is
(05:29):
actually the enrollment and recruitment of patients into clinical trials.
In the congenital heart community. We don't have a culture
and infrastructure a process to be able to inform patients
which studies are available, which clinical trials are available, and
how to enroll those patients so that they can be
part of the future and they can be part of
(05:51):
pushing the boundaries and pioneering. And the co op, as
you'll hear about today, is really designed to directly address
that gap and accelerate the way we can enroll patients
across the country, no matter what institution you're at, no
matter if you're doing well and thriving today or if
you're doing poorly and need help today, even for our
(06:14):
families that have lost somebody in the congenital heart community,
it's literally open for anybody with congenital heart disease, and
everybody together in the co OP is what's going to
allow us to accelerate the clinical trials that are so
vital for moving this field forward.
Speaker 3 (06:32):
I love that Welcome to Heart to heartway Anna Aaron,
thanks for having Nanna happy to be here. I'm happy
to have you here too, because I know that you're
working with doctor Nelson it Heartworks, and I'd love to
know more about your role in the co OP. I
have always been inspired by the team at Heartworks, and
(06:54):
Tim mentions the team. It truly is, and it's incredible
the dedication from the physics, clinicians, everybody that support of
Heartworks to.
Speaker 2 (07:05):
Solve this problem and help find a cure for HD.
Speaker 3 (07:09):
And I'm always very moved by people who are not
directly impacted and still dedicate so much of their time
and energy and Heart and soul to finding a cure
for congenital heart disease.
Speaker 4 (07:21):
And as far as the co Op goes, my role
with the co Op is to help families understand the
power of this platform, to educate them, and to inspire
them to become members.
Speaker 3 (07:34):
We live in a world now with Fella that is
a wait and see and this is something that we
can do by simply donating her data and by helping
educate the team different symptoms that she might be having,
but sharing the goals of the co Op with families
and helping them feel inspired to share their voice and
(07:57):
help change the future. I love it You're coming at
this and as a heart mom like me because we
had that sense of urgency, don't we. We want our
children to live happy, productive lives. Yes, one hundred percent.
I get very frustrated by the slow moving world belived
sometimes and totally understanding that research takes time and childs
(08:22):
take time. But as her mom, I want things done yesterday.
I want a plan for the next twenty years. I'm
just happy to be a part of this team and
do my part and share my passion. I love that.
Speaker 5 (08:36):
I know when Help was young, I just kept praying
that medical technology would stay a step ahead of her,
and she is now thirty and it.
Speaker 3 (08:46):
Has stayed a step ahead, but just barely. But I
think Heartworks can be a game changer and I'm looking
forward to seeing how we parents can help this organization.
And there's so much more for us us to learn
there is. Heartworks is the only one that I know
doing what they're doing, the work, the research, the team,
(09:09):
bringing families, physicians, clinicians, patients together to change your future.
That's the power here right exactly.
Speaker 2 (09:18):
So, doctor Nelson, you were talking before about the main
reason for developing a cop is because of that bottleneck.
Can you talk to us a little bit more about
that and how discovering what the problem was led to
this revolutionary solution.
Speaker 1 (09:34):
Yes, we've done five i and ds with the FDA
since the beginning of our program. And an I and
D is the permission that the FDA gives you to
do world's first clinical trials for patients with congenital heart disease.
And as we've done that, we've learned that we've always
enrolled patients far more slowly than what we intended to.
(09:55):
So we get the study approved from the FDA, we
get the study approved in the local and then we
go try to find the patients and recruit them to
be part of these first and human clinical trials, and
it ends up taking us four times longer than we
expected it to take, and that becomes really frustrating for everybody,
everybody on the team, our clinicians, are scientists, our manufacturing team,
(10:19):
our researchers, and especially our families. Our families get very
frustrated by the fact that it takes much longer than
we get hoped for. So after doing this for fourteen
years now, we finally have figured out a way that
we think we can change that, and not only for
Heartworks and our technology, but for literally the entire field
(10:40):
of congenital heart disease. So, rather than designing studies that
we think are perfect fit for families, what if we
could have all families with congenital heart disease donating their
data to a platform, and then using that donated data,
we can build the clinical trial for the patients that
(11:02):
have the highest unmet need, the patients that have raised
their hand and said I need help, I want to
be part of something, and we design clinical trials for
those patients in need. Imagine how much easier it is
for those patients to sign up for the clinical trial
once it's developed. So they raise their hand, they donate
(11:22):
their data, We design the clinical trials for them, and
then we go back to them and say we heard you,
we listen to you, and we now have a clinical
trial that's open for you. This is a game changer,
and we're super excited to be able to make this
available to the whole PhD community and go well beyond
the products that we have at Heartworks.
Speaker 2 (11:42):
What I love about this is you're continually assessing the
data that you get, and you may end up creating
products or studies completely different than you would have otherwise
because the data that you're getting be so rich that
that will tell you where that basic need is.
Speaker 1 (12:05):
Yeah, that's right. And keep in mind that this is
fundamentally different than the registries that have been built over
the last decade. There's great work being done in many
registries that collect data in a de identified way and
look at best practices and standardized cares across institutions. That's wonderful,
really important work. Our mission is to transform the way
(12:29):
we take care of kids and adults going forward, developing
new products and to do that. We need to identify
the right patients at the right time to be part
of these clinical trials. So it's fundamentally different in a
patient centric way, listening to the voice of the patient,
interacting bi directionally with the family and with the patient
(12:52):
to educate us on what we should focus on, and
then educating back to the families what is currently available
for clinical trials across the country. This is the platform
that is fundamentally unique to any of the other registries,
and so we encourage everybody in the congenital heart community,
whether you are a warrior or an angel, you can
(13:14):
donate your data and make this process go much much faster.
Speaker 6 (13:23):
Heart to Heart with Anna is a presentation of Hearts
Unite the Globe and is part of the hug podcast network.
Hearts Unite the Globe is a nonprofit organization devoted to
providing resources to the congenital heart defect community to uplift,
empower and enrich the lives of our community members. If
you would like access to free resources pertaining to the
HD community, please visit our website at Wwwcongenitalheartdefects dot com
(13:49):
for information about HD. The hospitals that treat children with HD,
summer camps for HD survivors, and much much more.
Speaker 3 (13:57):
Rachel god is an adult who was born in nineteen
eighty eight with hypoplastical oft heart syndrome or HLHS. She
to date has not had any major corrective BIRT surgeries.
She has had thirteen cardiac relations along with two device implants.
Rachel is an advocate in the cojab or Heart community
and a former nurse. She's passionate about helping others on
(14:21):
their own HD journeys. My loyal listeners, well remember Rachel
from earlier this summer when she was on the program,
and the link to that episode will be in the
show notes. Welcome back to Heart to Heart with Anna Rachel,
thank you for having me.
Speaker 2 (14:36):
I'm favor bleas of me here. Well, I'm super excited
to see you, and I wish everybody else could.
Speaker 7 (14:42):
See you too.
Speaker 2 (14:44):
You're weared your heartworks Hoddy, You've got your heart works
water bottle.
Speaker 3 (14:50):
Why don'd you tell us a little bit about your
connection with heartworks, Rachel, You're absolutely right.
Speaker 2 (14:56):
I became fully a number in part works.
Speaker 8 (15:00):
After the Virtual Dinner last year, when doctor Nelson and
Greg Olsen talked about the co OP program, that was involved.
Speaker 3 (15:08):
With me, and I was super excited.
Speaker 8 (15:11):
I didn't give it another thought. This is such an
awesome program for people like me who have been mistaken
used as a baby and haven't had cracked in surgeries.
I am super excited to be in part, and it's
clinical trial to get help.
Speaker 3 (15:27):
Absolutely, you are the only person I've ever met who
was born with HHS and has survived to adulthood without
some kind of corrective surgery. So I'm very hopeful that
Hard Works will be able to help you, because I
don't think there were many people out there like you.
Speaker 8 (15:44):
I'm getting across a very small handful, and by mean
so I'm talking two or three people that have had
maybe one surgery but not all three, or just haven't
had any cracktive surgeries altogether. So I am very much
amiked the rare popular hlhl's uncorrected and it's all God.
I'm very blessed to be here. He's paved the way,
(16:07):
he's kept me stay and I'm very thankful for that,
and I'm thankful for what the future holds and working
with doctor Nelson.
Speaker 3 (16:14):
And seeing what we can do.
Speaker 2 (16:16):
Absolutely, So, what do you think the benefits will be
for you working with hard Works.
Speaker 8 (16:23):
I'm very excited about the whole process with themselves and
trying to regenerate the valves all my Valdor leakings. I'm
very excited to dive into that process and see what
I may or may not.
Speaker 3 (16:38):
I'm out out of it for myself.
Speaker 2 (16:41):
Okay, that's good. You have a very specific focus and
that you're interested in. And as a nurse, what do
you think about this co op? Have you ever experienced
anything like this before in your medical career. I have not,
and I'm very excited that they take together.
Speaker 8 (17:00):
I feel like it's a great opportunity to have a
central have database for different patients than different types of
the few, than just one great day central resource center.
And super excited they did it. And I hope this
podcast well I educate more people about the co OP
because a lot of people I know are very intimidated
(17:23):
by it.
Speaker 3 (17:25):
Exactly.
Speaker 2 (17:25):
I think there are a lot of people who are
intimidated by it.
Speaker 3 (17:28):
I think that currently in the United States anyway, there's
so much fear of regarding identity BAFT and I'm sure
I'm not alone and having had to get new credit
cards periodically because some person or entity has stolen my
credit card information.
Speaker 2 (17:46):
It's so frustrating, and it seems to be happening so
much more today that the thought of sharing are very
private medical information with somebody else. It is scary because
we know that something.
Speaker 3 (17:58):
Could go wrong. Did that concern you at all before
you joined the co op?
Speaker 2 (18:04):
Absolutely not.
Speaker 8 (18:06):
I figured with it being professional with a medical institution
and company, that my data would be saved.
Speaker 2 (18:14):
I know it is through my target atdate, so that
was not a negative factor.
Speaker 3 (18:18):
In my mind.
Speaker 2 (18:19):
It didn't weigh me one way or the other. I
was on board from it from the second I heard
about it. I love that. I as a former nurse
and now a SHD advocate, what advice would you have
for other adults with hlhs or parents of children who
have hlhs regarding participating and research studies? For taking part
is something like the Heart Works co op.
Speaker 8 (18:41):
Ask your questions if you have and I'm sure feeling
about something asked because nine times out of ten, somebody
else out there has the same question that you're wanting
to ask. That's the only way you're going to get
over your fear. Always asked because I'm sure somebody has
that question. And doctor Nelson and who came there fantastic
(19:04):
about getting to the bottom of things making it's all
comfortable and safe.
Speaker 2 (19:09):
You've dealt with EPIC as a nurse. Maybe not everybody
who's listening to this program knows what EPIC is and
can understand why having dealt with something like that would
make you feel more comfortable with the co op. Can
you explain a little bit about that to us.
Speaker 8 (19:24):
We cancel with EPIC obviously hit the laws arm place
depending on the Hufel institution. They've gotten great software security
and your information is one hundred percent safe, secure and protected.
I hadn't came a cost any issues with patients and
information getting leaked down there. That's what fieled my mind
(19:46):
to do their tilout program because I know if my
information and I beg is protected as a patient, that
it would still be the same throughout the.
Speaker 3 (19:55):
Matrix program with their kill out. Not everybody who listens
to my shows for me, and they may not know
what EPIC is. My husband uses EPIC a hospital where
she works as well. That kind of streamlines the data
that all of the nurses and doctors put in across
the hospital. The hospital my husband works at is the
(20:17):
biggest hospital for over one hundred miles in radius in Texas,
and there are lots of little satellite clinics. It's really
nice that through.
Speaker 2 (20:28):
EPIC, all of the information from the patients can be
shared practically instantaneously.
Speaker 3 (20:33):
But it's a way of communicating.
Speaker 2 (20:35):
Information very quickly, very accurately, and much more detailed than
what we probably ever thought would be Possibly before you
can look at X rays, you can look at echoes,
Doctor NASA, do you want to weigh in on this
how EPIC can be helping the co OP and how
through working with the co OP and maybe some of
(20:56):
these other medical repositories, that we can and keep medical
information safe and yet still have access to some really
powerful data.
Speaker 1 (21:06):
Yeah, the electronic medical record, which EPIC is one of
many and is arguably the largest electronic medical record. All
of our data is electric these days, right, It's all
in the database, it's all available, and if you're in
one organization or one platform, you can get that data
downloaded to you and you can even share it quite easily.
(21:27):
The problem is if your data is in multiple systems
and multiple providers over a long period of time, with
different hospitals, it becomes very hard to aggregate that altogether.
And that's one thing the co op does allow us
to do is to pull electronic medical records from multiple
hospitals and put it into one place under the banner
(21:48):
of the Heartworks co op. That has a lot of
advantages to be able to simplify the medical record back
to the patients, but it then also allows us to
do something as a community that no one hospital could
do by themselves. And that is again the reason why
the team of teams at Heartworks becomes such an important concept,
(22:08):
because it allows us to bring tens of thousands of
congenital heart families and patients together into one unifying platform
and just imagine what that will allow us to do.
The safety concerns we take as serious as anybody. We
have the same safety protocols that any of the large
electronic medical record systems have, and it is a concern
(22:31):
for us all. And yet the power of aggregation is
such a transformative approach that we have to continue to
focus on making it safer and making sure that we
educate patients of how powerful this aggregation can be.
Speaker 7 (22:46):
This content is not intended to be a substitute for
professional medical advice, diagnosis, or treatment. The opinions expressed in
the podcasts are not those of Heart to Unite the Globe,
but of the hosts and guests, and are intended to
spark discussion about issues pertaining to congenital heart disease or bereavement.
Speaker 6 (23:07):
You are listening to Heart to Heart with Emma. If
you have a question or comment that you would like
to addressed on our show, please send an email to
Anna Jaworski at Anna at Heart to Heartwanna dot com.
That's Anna at Heart to Heart with Anna dot com.
Now back to Heart to Heart with Anna.
Speaker 2 (23:25):
Now, we're all in this studio together, and I want
to talk a little bit about research because when I
was in college studying research, one of the problems that
we would see is maybe there were twenty people in
a study and that was it, So it was hard
to generalize anything from a study with such a small
(23:48):
number of subjects.
Speaker 3 (23:50):
Tell us how this co op can change that for.
Speaker 1 (23:53):
The heart world. Yeah, it's exactly right that we need
a large number of patients, a large number of diverse experiences,
a wide spectrum of ages, a wide spectrum of good
and bad outcomes that people have experienced to be able
to get the true picture of what is the reality
and what is the opportunities to move forward. So the
(24:15):
co op allows us to aggregate that across multiple institutions,
literally any institution, because the patient themselves owns their own data,
and the patient themselves can donate their data to the
platform at the co OP, So that donation of their
data and participation in this research study is really what
(24:37):
allows us to do it at scale. And if it
were my son or daughter that was being asked to
be part of a research study, I'd be asking is
it safe?
Speaker 2 (24:46):
What do you know?
Speaker 1 (24:47):
Is this really the right thing to do? And the
only way we can get some of those answers that
we all need is by aggregating the data together in
a unique way. And the beautiful thing about today's electronic
medical records is that data is available to be able
to be donated and shared and aggregated. And as long
(25:07):
as we can at Heartworks earn the trust of families
and patients to be that custodian of the data, to
be that agent of change with that data, we believe
we can move faster than anybody else with this type
of an approach.
Speaker 2 (25:23):
Are you also looking for data that's old. For example,
my daughter's thirty and she had her surgeries at a
different hospital than the one that she is seeing now.
Speaker 3 (25:36):
Is there any value to her asking if the other
hospital where she had her surgeries could send data to you.
Speaker 1 (25:43):
Absolutely? Right, I mean, this is the beautiful thing. To
be able to look at the longitudinal outcomes of patients
like your daughter over the past thirty years gives tremendous
power to being able to predict what's coming in the future,
or to be able to identify pasters and trends where
patients that maybe just like your daughter are going to
(26:04):
do great, but maybe if they're not like your daughter,
maybe they have a higher risk situation that we should
be intervening and doing things sooner. The aggregation of the
data in a personalized, prospective way is what makes this
platform fundamentally different.
Speaker 3 (26:21):
Now.
Speaker 1 (26:22):
The one thing that prevents people, and Aaron can speak
to this perhaps better than I is that people get
worried about how much time and energy is it going
to take to get that data. And if anybody's ever
signed up for life insurance or had to get medical
records from law one provider and sent to another, they
know how complicated that is. And people are tapping out
(26:45):
saying I don't have the time to do that. But
before you say that, you must realize that the co
op has done something really revolutionary. With your permission, the
system can go talk to the system, grab the data,
and pull it into the co op, so you don't
even have to transcribe the data and manually enter the data.
(27:07):
There are options to automate this, which changes in level
of involvement and time needed to make that work.
Speaker 3 (27:16):
But my daughter was born before EPIC was created, I think,
or at least it wasn't at the hospital which she
was an infant. I mean, she has I don't even
know how many folders of information at the hospital.
Speaker 2 (27:31):
Are hospitals taking all of those old fashioned folders full
of information and putting them into their computers, doctor Mouson.
Speaker 7 (27:40):
Some are.
Speaker 1 (27:40):
Some are going back into the medical record and transcribing
old data into the electronic medical records. So that is
happening automatically in many institutions. But it's also true that
not all of that data is going to be transcribed.
The co OP is really focused on grabbing the data
that is immediately available to us in the electronic medical record.
(28:02):
There's always ways where patients can upload the data manually directly,
and we would welcome that, but we also recognize that
that takes a lot more time and energy to be
able to accomplish.
Speaker 2 (28:14):
Ered What common misconceptions have people expressed about the co.
Speaker 3 (28:18):
Op to you? I think that it's just a general
understanding because this is something that didn't exist before the
co op at Artworks began. So I think that educating
families and patients that this is not your typical registry,
that your voice is important, and that sharing their data
(28:42):
is simple. I heard earlier is that this can seem intimidating,
which I didn't feel that way. I think that making
families and patients aware how secure the system is and
that your data is safe is really important. I have
heard that from some families, But I think that the
(29:04):
more people become educated and how simple registering is and
becoming a member is. The more we talk about the cop,
the more we share, the possibilities that will come. The
evolution of it will be pretty incredible to see over
the years as we build the database to five hundred
(29:24):
and one thousand and ten thousand members, I think that
we'll have more soldiers on the street for lack of
a better phrase, sharing this platform and sharing the story
of how to take a hold of your future and
help impact the future for HD careen treatment. I love that, Rachel.
Speaker 2 (29:46):
Do you have any questions for doctor Nelson or Aaron
about the co op?
Speaker 8 (29:51):
I do, Doctor Nelson? How long exactly does the clinical trial?
Speaker 3 (29:58):
Wow?
Speaker 1 (30:00):
Great questions. So to be a member of the co op,
you actually sign a research consent form that's I or
be approved, and you can withdraw that consent at any time.
So our goal is to be able to bring families
and patients into the co op and keep them there
for as long as they're willing to participate. The longer
the better because it gives us that longitudinal data. But
(30:22):
it's also true that if for any reason, anytime, somebody
wants to withdraw from the co op, it's a simple
undo if people want to. But this is a living,
breathing data collective. But that brings people together for the
long term. Now, one exciting thing that has come out
of this we have over one hundred patients that have
(30:42):
already signed up for the co op, and we had
a new clinical trial that became available in the last month.
A new clinical trial where we can consent patients to
a skin biopsy, get their cells manufactured, and prepare for
future clinical trials with their stem cells. And in the
co op, there were twenty eight out of one hundred
patients that were eligible for this new research protocol. With
(31:06):
the skin biopsy, we were immediately able to reach out
to those twenty eight people and inform them that because
they donated their data, because we had a clinical trial
that was available, we then could screen their medical record
and who they are and inform them that they may
want to learn more about this particular clinical trial that
(31:28):
is now enrolling, and then they can reach out to
the study coordinators learn more and do that. We imagine
that this is the platform that people will stay in
the co op because as they go forward, as their
medical conditions change and evolve, we'll be able to keep
them updated on what clinical trials are available anywhere in
the country. That value add, I think is going to
(31:50):
keep people engaged for the long term in the co op.
Speaker 8 (31:55):
I am happy to fay that I whires lyodverge twenty
eight participants that reach out to you from their skin
bypsy So I'm very excited to be there, and they
were happens.
Speaker 1 (32:07):
Well, we thank you for being a member of the
co op because that's exactly what allows us to move
so much faster, is that few weeks when from a
protocol being available to you being aware of it, to
you being able to engage in that that previously took
us months and months and months to figure out. So
it's a perfect example, Rachel, and we're grateful that you
(32:30):
were able and willing to trust the co op to
allow us to do that so much more quickly.
Speaker 3 (32:35):
Oh absolutely, Rachel.
Speaker 2 (32:38):
Were you surprised that you signed up with the co
op only this year and you already got a call
saying that you qualified for one of the studies.
Speaker 8 (32:47):
I was surprised. Hill Ever, this shock didn't last long
because I am seeing a venture calls. I figured I
would again get you tank sure that it's organistation too.
Speaker 3 (32:58):
I think one of the scary things is this way,
you don't know a whole lot of other people with COCHD.
You feel so isolated, you feel so alone, but this
co op helps you to realize you're not alone. There
were twenty seven other people who got the same call you.
Speaker 2 (33:12):
Did, and that's actually a decent number to get started
with this study, isn't it. I'm completely angry.
Speaker 3 (33:20):
Is a fanta fit Starry, and.
Speaker 1 (33:23):
I think it's allowing us to get started with something
so much even bigger, Annah and Rachel. I'd like to
think of folks like this as the pioneers. We need
to get back to the day where we were in
the sixties and seventies and eighties, where we had a
culture and an expectation to pioneer new therapies, new surgeries
(33:45):
for these children that we had no options for at
that time. And that pioneering spirit is what together I
think we can reignite. And the technology is available, the
science is available in getting more patients enrolled in clinical
trials is a game changer for the future of congenital
heart disease. Imagine the day when we have ten thousand,
(34:08):
not one hundred, but ten thousand individuals with congenital heart
disease in the co op, and imagine how much easier
it will be to engage drug companies, device companies, researchers
across academia. We will have a patient owned data set
that will drive the innovation that we've so desperately been
(34:30):
lacking over the last thirty years. That's why this co
op is a game changer, and these individual stories and
these individual examples of how we can do it today
is what's really propelling us forward into a much, much bigger,
and much faster future. And I think that's really motivating
for our families.
Speaker 2 (34:50):
It seems like in the past, doctor Nelson, so many
of the research studies that we're done were single institution studies,
and what you're tucking about doing is a multi institution stating.
It's only as small as you want it to be.
Speaker 3 (35:05):
You have the ability once you get information from.
Speaker 2 (35:08):
People in Hawaii, are people at Philadelphia, are people in Houston.
You're getting all this information from everywhere, and I think
that makes it even more powerful.
Speaker 1 (35:18):
We're one hundred percent dependent on institutions with their massive
skill sets. As clinicians and providers, we need to partner
with institutions, and yet the co op allows us to
go above the demands of institutions and be one institution,
one community of congenital heart disease. And that's really empowering
(35:41):
for families and individuals to realize that it doesn't matter
what institution they're at, they can be part of a nationwide,
global wide effort. So yes, we'll always be dependent on
institutions to be our partners to do the clinical trials,
but we also as a community can help the institution
do more.
Speaker 2 (36:00):
Because of this, you are based at Mayo, So if
somebody does qualify for your study, do they have to
go to the Mayo Clinic to take part in that
study or will there be opportunities much closer to home
where they can still participate in a study.
Speaker 1 (36:20):
Well, something we haven't talked about today that we're also
very proud of is the consortium of hospitals that we've created.
So yes, we do a lot of things for the
first time at Mayo Clinic because that's where we're home
based and that's where core team works out of. But
we recognize that we need to make these therapies and
these clinical trials available more locally, and we have worked
(36:42):
with eleven pediatric hospitals across the country, and as we
go forward with more adult than general heart protocols, you
will expect to see from Heartworks a network of hospitals
working collaboratively. And really the place that we're going to
go with this network is the institutions that have the
most patients. The institutions that have the highest density of
(37:05):
people in the co op. That allows us to centralize
and focus on the most patients in one location. That's
going to allow us to go faster than what we've
been able to do before. So this isn't about one institution.
It isn't even about a few institutions. It's about how
do we make all institutions allow their patients to be
(37:26):
available in participating in research studies because it's all of
us together that's got to move this field faster than
what we're doing right now.
Speaker 3 (37:35):
Absolutely, So, you had this one study going on. Does
a person have to be a member of the co
op in order to be eligible to take part in
a study?
Speaker 1 (37:45):
It's the best way for us to find out if
you're eligible for the study is using the co op,
as we've talked about. But it's not the only way
you can directly reach out to us, and we're happy
to work with patients one on one with our study
coordinator team, but the co op is definitely the way
that allows us to streamline it, simplify it, and hopefully accelerated.
Speaker 3 (38:06):
I love it, Aaron. Is there anything else we need
to know about the co op?
Speaker 2 (38:11):
I encourage people to reach out and connect with the
team if you have any questions.
Speaker 3 (38:15):
I think that it's going to be an.
Speaker 2 (38:17):
Incredibly powerful tool for the future.
Speaker 3 (38:20):
Nothing like it exists today. So I'm excited for what
it will do for the adult population as soon as possible.
I'm excited for what it will do for babies just
being born and twins like my daughter bella advocate get involved.
Speaker 1 (38:39):
That would be my best advice.
Speaker 3 (38:41):
I love it well, Rachel, good luck in the study.
How long is this study going to take? Doctor Nelson?
Is this something that's going to go on for years?
Speaker 1 (38:52):
The skin biopsy study is you've heard us talk about
before we take a piece of your skin, we engineer yourselves,
and then we make your beating tracting heart muscle cells
have launched that we have patients in the process of
their cells being manufactured. It's a nine month process to
make cells, and we will then go on to the
next step for the right patients at the right time
(39:13):
to do the transplant for them. So this is always
a long process, but we're super excited to scale it
and make it available to as many people as possible.
Speaker 3 (39:22):
I just put it. I'm so excited and Rachel, we're
gonna have to add you and doctor Nelson and hopefully Aaron.
I'm back into future and let us know how things
are going. This time has just flown by. I want
to thank all of you so much for coming on
a program. Thank you doctor Nelson for bringing us up
to speed on what's going on and explaining to Collot
be even more in depth with us this time.
Speaker 7 (39:45):
Well.
Speaker 1 (39:45):
Thanks for being part of the team of teams. Anna.
We can't do this without folks like you communicating, so
thank you for your time today.
Speaker 3 (39:53):
Thank you. I'm hoping that this will help my daughter.
Speaker 2 (39:56):
It's a little bit selfish that I do this too,
because I want to make sure that she has opportunities
that are on the cutting edge, just like what you're
providing Erin. Thank you so much for coming on a
program today. I'm so excited to finally meet you. Thank you, Annah,
it's great to meet you too, And Rachel, I always
love having you on the program. Thank you for coming
on today.
Speaker 3 (40:17):
Thank you for having me well.
Speaker 2 (40:20):
Friends. That does conclude this episode of Art to Heart
with Anna. Thanks for listening today. If you want to
learn more about the co Op, please check the link
in the show notes and hope you have a great
week and remember, my friends, you are not alone.
Speaker 6 (40:34):
Thank you again for joining us this week. We hope
you have become inspired and empowered to become an advocate
for the congenital heart community. Heart to Heart with Anna
with your host Anna Jaworski can be heard at any
time wherever you get your podcasts. A new episode is
released every Tuesday from noon Eastern time.
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