October 31, 2025 • 32 mins
This week we review the results of the new pivotal trial of the 'Minima' stent by Renata Medical. What is special about this new device that makes it particularly desirable for use in small children? How strong is cobalt chromium and what evidence exists that it can be expanded repeatedly over 1-2 decades? Can this technology supplant surgery for certain diseases such as native coarctation? What are the limitations of this device? We speak with the first author of the pivotal trial, Dr. Patrick Sullivan of CHLA who is Associate Professor of Pediatrics at Keck Medicine at USC.
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Episode Transcript
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Speaker 1 (00:16):
Welcome to Pedheart Pediatric Cardiology today. My name is doctor
Robert Pass and I'm the host of this podcast. I
am Professor of Pediatrics at the Icon School of Medicine
at Montsana here in New York City. Thank you for
joining me for this three hundred and sixtieth episode of Ptiheart.
I hope everybody enjoyed last week's episode on the topic
of fetal counseling, in which we spoke with doctor Caitlin
(00:37):
Haxel and doctor Joeann Cheu. For those of you interested
in fetal cardiology as well as fetal counseling, I'd recommend
you tech a listen to last week's episode three hundred
and fifty nine. If you'd like to get in touch
with me, my email is easy to remember. It's Pdheart
at gmail dot com. This week we move into the
world of interventional cardiology for an important new paper. The
(00:58):
title of the work will be reviewing is Multi Sensor
Pivotal Trial of the MINIMU Stent for a vascular Stenosis
in Infants and young Children. The first author of this
work is Patrick M. Sullivan and the senior author Darren P. Berman,
and the first and senior authors come to us from
Children's Hospital of Los Angeles. When we're done reviewing this paper,
(01:19):
doctor Sullivan has graciously agreed to speak with us about it. Therefore,
let's move straight on to this article and then a
conversation with its first author. The work begins by reminding
us that the first descriptions of stent implantation and congenital
heart patients occurred thirty five years ago, and how they
can be particularly useful for the treatment of pulmonary artery
or aortic obstruction. However, most of the time the stents
(01:41):
used are off label, designed for other indications, and for
some patients, particularly small ones, these devices are suboptimal. They
then explained that the Minimus stent was designed to address
some of these issues, and review how the two features
that make it potentially desirable are the low profile nature
mounted on a balloon catheter, meaning it can be delivered
(02:02):
via a very small vascular sheath, and the capacity of
these stents to be dilated serially to adult size, something
previously unheard of. For those of you less familiar, the
minimum stent is a seventeen millimeter long, closed cell balloon
expansible cobalt chromium stent that's designed to maintain structural integrity
(02:22):
and strength over a fairly large or wide range of
sizes everywhere from five point one millimeters at the minimum
diameter to twenty four millimeters at the largest and the
goal of using this would be that it could be
implanted at very small patient size and then serially enlarged
over time. The stent is manufactured on a six or
(02:42):
eight milimeter diameter balloon and comes with a kink resistant
delivery system on a sixty three centimeter long catheter. The
diameter of the catheter is four French, meaning that it
can be used through the skin at four French or
alternatively it could be used through a six French short
introduced and the system is designed to be advanced on
either an one four or an one to eight wire.
(03:05):
The authors explained that the multi center early feasibility study
was performed assessing performance, safety, and efficacy of this device
and these results were promising, so the decision was therefore
made to proceed with a larger so called pivotal trial,
and this is the study that we're reviewing today. This
was a multi center, single arm study in seven United
(03:26):
States centers with forty two neonates, infants and children with
either native or recurrent corrotation or branch pulmonary ary stenosis
treated with the minimum stent. The patients were followed closely
with varying imaging modalities including CAF and CT and ECHO,
and the authors explained that the original ten patients from
the early feasibility study were also included in the forty
(03:48):
two subjects of this work. For this work, the primary
endpoints were technical success or implantation, acute relief of stenosis,
freedom from major device procedure related to sc various adverse
events or surgical intervention through six months, as well as
maintenance of minimal lumin diameter at six months and daught
to the results again, there were forty two patients, with
(04:11):
twenty one having pulmonary artery stents and fifteen a recurrent
corroctation and six native corroctation who underwent minimum stent implantation
at a median age and weight of nine months and
seven point eight kilos, respectively. Implantation success was seen in
forty one of forty two patients, or ninety seven point
six percent. Synosis relief was excellent in this work for
(04:35):
corroctation patients, the median pressure gradient dropped from twenty five
millimeters mercury to zero, with the minimal vessel diameter increasing
by a median of one hundred and thirty one percent,
with a range of forty five percent to four hundred
and eighty three percent increase post endplant. And how did
these stents do and follow up? While at six month imaging,
(04:56):
which was mostly by CT or thirty seven of the
forty two patients, the aluminal diameter was maintained at a
median of eighty nine percent of the implant diameter, with
a range of fifty eight to one hundred and thirty
seven percent. And what about long term overall well, with
the median of five hundred and ninety six days of
follow up, thirteen of forty two patients, or about a third,
(05:16):
underwent a plan's stent re expansion, with seven in the
aorta and six in the pulmonary arteries without any complications.
Re Expansions generally were performed with the goal of making
the stent within two millimeters of the surrounding normal blood vessel.
And what about safety Well, First of all, there were
no x plants or device related serious adverse events through
(05:37):
six months. However, there were some procedural adverse events with
two acute stent embolizations in the pulmonary arteries, but in
both cases they were stabilized in the contralateral lung and
one of these was stabilized with a second minimum stent.
Seven patients with aortic corrotation, who were all less than
six kilograms at the time of cath had transient femeral
(05:58):
arterial thrombosis with US, all resolving with conservative therapy. In
their discussion the author's state and I. In a heterogeneous
cohort of forty two patients, half with native or post
operative recurrent corrotation and half with pulmonary artistenosis, the Minimu
stent was successfully implanted in all but one patient, achieving
safe and durable relief of vascular obstruction. Follow Up multiplanar
(06:22):
imaging demonstrated well maintained lumin calibers and stent integrity without
vessel wall injuries. Based on these findings, in August twenty
twenty four, the Minimus stent became the first stent to
prove by the Food and Drug Administration for use in
small pediatric patients during follow up ranging from thirteen to
thirty two months. Thirty one percent of the cohort underwent
(06:43):
elective redilation of the stent without any procedural adverse events.
The discussion reviews many of the points already made about
how present day's stents are not designed ideally for stenting
vascular structures in small children, and how there have been
some reports of interventionalists doing creative things like putting in
smaller stents and fracturing them intentionally or other approaches, but
(07:05):
clearly the difficult small anatomy of small patients has made
stinting in this group fraught with challenges. They speak of
how this new system, with its delivery catheter should help
with many of these challenges, and they reviewed the cases
of pulse loss and offer some suggestions, such as use
of ultrasound to enhance safe vascular access in the arteries
of small children. The authors explain that the closed cell
(07:28):
design makes the stent more rigid and less amenable to
tightly angled vessels, and they posit that this was part
of the reason that there were two embolizations for pulmonary
artery stents. The authors then reference older works on stinting
in small children, showing that the smaller the child is stented,
the more frequent one encounters narrowing after stenting and the
(07:48):
need for re intervention, and although this was not shown
in this small series, they do have concerns that this
may be similar for the minimum stent. Limitations reviewed included
the short follow up period of six months as a
primary endpoint, longer outcomes are still pending, and the relatively
small cohort, and so they conclude the Minimu's stent system
has demonstrated safety and efficacy in treating native and post
(08:11):
operative pulmonary arteries, stenosis and corrotation in this cohort. On
early follow up, the stent maintained structural integrity and luminal
patency and planned further expansion for somatic growth was well tolerated.
Caution should be exercised in treating challenging and compliant lesions
such as left pulmonary artery osteostenoses. While there remains a
(08:32):
substantial unmet need for technology designed for and tested in
pediatric patients with congenital heart disease, the device is a
promising addition from minimally invasive therapy in this unique population. Well,
the Minimu's stent is certainly potentially a game changer in
the world of interventional cardiology. We in the world of
interventions are all familiar with the famous dictum from the
(08:53):
great Chuck Mullins in his so called Rules of Stenting,
which was never create a surgical lesion with the stent.
This would probably be at least one of the major
reasons that we have not till now stented things like
pulmonary arteries or aortas with any regularity in this size
of a patient, because the technology available would not allow
ultimate expansion to an adult size, and so by definition,
(09:15):
placement of many of the available pre mounted stents like
the Genesis stents, for example, can only be expandable to
eight to ten millimeters, which is inadequate in the aorta
or pulmonary artery of an adult. Another issue not mentioned
is the length of the stent. Oftentimes the stents available
that are expandable to adult size or a bit on
the long side, and this too can prove a contraindication
(09:37):
to stenting in the small patient. This stent seems to
solve both problems. Clearly, we're going to need much longer
term data to know if these stents come through on
the promise that they're making, which is that they can
be re expanded to adult size, sometimes twenty years after implantation.
I also share concerns that the authors have regarding the
in growth that we see with small stents in small patient.
(10:00):
We all know that these need aggressive surveillance and dilation,
and I do wonder if the in growth scene in
small children will prove problematic long term. I will also
mention something not mentioned in this work or podcast thus
far in regards to this stent, but those of us
in the field have been quite shocked by the very
high price of this device and delivery catheter. I can
(10:21):
say that this has been one of the reasons that
we have dragged our feet at my own center, as
we all have some concerns that this extremely expensive device
will not be paid for by insurance carriers in the
United States. Clearly this is going to change over time,
but it would be inappropriate to not at least mention
this factor at this time, which is October twenty sixth,
twenty twenty five. I'm also going to just mention that
(10:44):
a very large number of the authors of this work
are presently working as consultants and or proctors for the company.
We're not a medical that manufactures this stent. In light
of time constraints, I think we should move forward now
with our conversation with the work's first author. Doctor Sullivan
now is the work's first author, doctor Patrick Sullivan. Doctor
Patrick Sullivan is a pediatric cardiologist with advanced training and
(11:06):
epidemiology and clinical research as well as interventional cardiology. He
earned his medical degree from the New York University School
of Medicine and completed both internship and residency and pediatrics
at the Children's Hospital Philadelphia. He went on to pursue
fellowship training in pediatric cardiology at Seattle Children's Hospital. He
also completed advanced training and international cardiology at the Children's
(11:27):
Hospital of Los Angeles. Doctor Sullivan also holds a Master
of Science and Epidemiology and Clinical Research from the University
of Washington School of Public Health. It is a delight
and an honor to have him join us. Welcome doctor
Sullivan to Pdheart. I'm here now with doctor Patrick Sullivan
all the way from Los Angeles. Patrick, thank you very
much for joining me this week on Pdheart.
Speaker 2 (11:46):
Thank you, doctor pass It's great to be here. I'm
a longtime fan of the show. I appreciate you having
me on.
Speaker 1 (11:52):
Thank you great pleasure to have you. Patrick. I thought,
just to start, maybe you can speak to this audience,
which mostly are not interventionalists, about what makes the minimum
stents such a major upgrade over prior stats for the
treatment of stenosis in the Ajorda or Plumoni ority.
Speaker 3 (12:08):
Of small kids.
Speaker 4 (12:10):
Yeah.
Speaker 2 (12:10):
I think that the thing that everybody should know first
off is that this is the first stent available that
was designed, tested in an FDA approved for use in
infants and small children. We've been using stents in babies
and small kids since the nineteen eighties nineteen nineties, but
(12:36):
all of those stents have been used off label, and
all those stents were designed for different adult applications primarily
and repurposed for use in pediatrics. And many of those
stints don't many of those stents don't have you know,
(12:57):
the ideal properties of a pediatric stent, which are our
specific things that we look for in stents. So the
minimum stent, and this is made by Renata company that
was started by some people in biotech who or medical
(13:18):
tech who were inspired by the congenital heart disease space
and inspired by our patients to really focus on creating
minimally invasive devices for our patients.
Speaker 3 (13:31):
So this is a stent that is designed to.
Speaker 2 (13:35):
Be delivered into small blood vessels, to have a low profile,
to be trackable in small babies, but importantly to ultimately
get to adult vessel size, and we haven't had a
stent that is designed to do that in the past.
Speaker 1 (13:55):
Wow.
Speaker 3 (13:55):
Great, real nice summary. Thank you very much.
Speaker 4 (13:58):
Patrick.
Speaker 1 (13:59):
You know in the PA are you and your colleagues
mentioned the stiffness of the stent is making it a
somewhat more difficult stent to maneuver, at least in the
initial experience. Can you discuss this issue with the audience
and any possible thoughts of making adjustments either to the
technique or maybe the device itself, or maybe just the
indications for where it should be used.
Speaker 5 (14:20):
Yeah.
Speaker 3 (14:20):
I think it's an interesting thing that you bring up, and.
Speaker 2 (14:24):
I think that the way we discuss that in this
paper specifically is that.
Speaker 3 (14:32):
The stent.
Speaker 2 (14:33):
We didn't really have any trouble tracking this stent or
with stiffness of the stent, like getting it to where
it needs to be, but it's more like on deployment
of this stent. So the stent is made out of
relatively strong, stiff material, and this has really been a
balancing act trying to create a stent that can get
(14:55):
to adult size.
Speaker 3 (14:56):
But goes in very small.
Speaker 2 (15:00):
Engineers designing this had to had to sort of constantly
be doing a balancing act wall designing this stent. It's
made of some stiff material and that gives it radial
strength over a broad range of diameters from baby sides
to adult size. So when you deploy the stent, uh,
(15:20):
it doesn't really conform to vessels in the same way
that like a coronary stent might or some other stints
that we've used previously in babies and kids. And so
I think our concern with I don't I don't want
to say that we're concerned about this, but I think
(15:42):
that our u the context in which we mentioned the
stiffness of the stent is in just the small number
of patients where we had a stent move out of
position after it was deployed, and the couple of patients
in whom this happened. It was a very compliant left
(16:04):
pulmonary artery lesion. And I think like a repair tetrology
patient where these these stent deployments are are known to
be a high risk for stent embolization and stan migration,
and so we were thinking, does the stiffness of the
stent and the the stent not like taking curves and
(16:28):
conforming to curved vessels, uh contribute to stent migration or
stent embilization.
Speaker 3 (16:34):
Maybe?
Speaker 2 (16:35):
I don't know, But since we've been thinking, you know,
the company and the physicians who participated in the trial,
we've all been thinking really hard about how to roll
this stent out in the most safe way so that
it can be successful. You know, we want pediatric products,
(16:57):
we want pediatric devices to be successful well because this
is an area of industry, it's a market that has
been underdeveloped and underutilized, and we want this to go well.
So we've been thinking a lot about how to best
like avoid any.
Speaker 3 (17:17):
Of these problems going forward.
Speaker 2 (17:19):
So with concerns about the stent, like any concerns about
the stint migrating or.
Speaker 3 (17:29):
Embolizing, we have.
Speaker 2 (17:33):
Instituted techniques to compliance test lesions and better characterized lesions
before we're implanting the stent to know.
Speaker 3 (17:43):
Whether or not that risk is going to be there.
Speaker 6 (17:46):
Sure, Yeah, So I think it's important for people to
understand that in your particular study, it was proximal l
PA where there was a problem. And as you said,
oftentimes it's not a true denosis, more of a fold
and that has always been a difficult area to stent
successfully without embolization.
Speaker 1 (18:08):
Have to be very careful. Oftentimes I have to oversize
it to get it to stay put. So it's not
surprising that that might happen. And as you said, it
may have nothing to do with the stent, more with
the lesion, etc. You know you that you hinted a
little bit Patrick at the at what the stent is
made out of, which is cobalt chromium. And I'm wondering
(18:29):
what do we know about this metal and its strength
and durability and ability for re expansion over long periods
of time. How does it compare, for example, with stainless steel,
which we know has been pretty good at being able
to be re expanded in larger patients. And the other
thing I wondered was how radio opaque these are in
comparison to either a steel or a platinum stent like
(18:51):
the Cheetham stent.
Speaker 2 (18:52):
Yeah, I'm I can talk about radio opacity first. I
think we can see these stints. I don't have any
concerns about that. It's kind of like less visible than
those those highly visible you know, cheat them stents that
are made a platinum iridium, But certainly you can see
this quite well. So I don't have concerns about that
(19:13):
at all. In terms of the material, like I said,
we or like I like I alluded to initially, Uh,
it's an engineering problem coming up with a stint that
has a small enough amount of material that you can
pack it into a system like this that can be
(19:34):
delivered a very low profile into small blood vessels, but
then can maintain radio strength over a broad range of
vessel diameters up to adult size, and have the amount
of material that can be a big sten ultimately a
big adult sized stint.
Speaker 3 (19:54):
So cobalt chromium is one of those materials.
Speaker 2 (19:57):
And I'm not a material science I'm not an engineer,
but based on my understanding of stent mechanics and stent engineering,
this is a nice material that can be used to
accomplish all of those things in the interventional worlds. In
(20:18):
the past, we have somewhat cringed when we are dealing
with cobalt chromium because often that means it's a small
stint that's going to be really hard to fracture, fracture
when the baby gets bigger, and we're going to have
to deal with that potentially surgically. But with this stent,
if used in the way that it is intended, you
(20:39):
should never have to fracture this stent.
Speaker 3 (20:41):
So it's a strong stent. I would imagine that it will.
Speaker 2 (20:46):
Maintain its durability, but I think that only time will tell.
Speaker 3 (20:50):
Sure.
Speaker 4 (20:50):
Sure.
Speaker 1 (20:51):
Well, now I'm going to ask you a provocative question,
which is do you think that this technology could one
day supplant surgery for treatment discrete cohortation in babies? I mean,
what do you think would be the potential benefits versus
the downsides of that type of an approach rather than surgery.
Speaker 4 (21:10):
Yeah.
Speaker 2 (21:10):
I think that's really one of the million dollar questions here.
I think it's really important to talk about. I think
that the fact that you're asking that question tells us
that this is potentially transformative technology. We are now talking
about potentially treating allsion in babies and small kids differently
(21:31):
than we did before.
Speaker 3 (21:34):
The study.
Speaker 2 (21:35):
You know that we're here talking about, of course, was
not designed to answer that question.
Speaker 3 (21:40):
It does not answer that question. Potentially future studies can.
Speaker 2 (21:43):
Answer that question, you know, all I can say My
best answer I think on this is that it is
an option now, right, so it has previously not been
a great option. We've had some stents that we can
put in babies who are not surgical candidates, who we
(22:04):
can then maybe fracture in the future, or maybe go
for surgery to take them out in the future, or
we can struggle to get larger profile stents into small
babies and place them at some risk of vascular injury.
But now we have a product that's designed for this,
so it's an option. Whether or not people will supplant
(22:29):
surgery with that option, I don't know. But in this
trial we found a number of patients who, after hearing
from the interventional cardiologist and the surgeon, shows to have
a stent procedure, and at least at this institution, and
I'm assuming that the other institutions that participated in the
trial and also have implanted these stents. Since the trial
(22:53):
is over it and f the approval was achieved, we
discussed the upsides in the downside, which are surgery presumably
is a one and done procedure and then your corrotation
area that's been removed and the award it will grow
with time, there will be like maybe a ten to
(23:14):
twenty percent risk of recurrent corrotation that you will maybe
have to contend with and hopefully will not but hopefully
a one and done procedure. Now a stent procedure, and
a baby obviously will go in at the baby's aortic
size and need to be upsized with balloon antioplasty over
(23:36):
time as the baby grows. We were quoting up to
maybe four additional procedures, maybe fewer over the course of
childhood and adolescence until the child is fully grown. So
that's what we were quoting, and some people opted for
that instead of undergoing a thor economy surgery. Now there's
(24:00):
other scenarios where maybe a baby is not a surgical candidate.
Speaker 3 (24:05):
For example, I proctored.
Speaker 2 (24:06):
A procedure where we had a baby with chrysomy eighteen
who was not a surgical candidate and had a hypoplastic
aortic arch.
Speaker 3 (24:15):
Now we have an option for this baby.
Speaker 2 (24:17):
We put minimum stents in it covered the transverse and
distal arch, and opened up the aor and that baby
was able to come off prostaglandin, which was the goal.
And so I think it's an option, and we'll have
to see how all that plays out.
Speaker 1 (24:35):
Yeah, I think it seems at least at this point
a good option for patients such as the one you
described too are not considered good surgical candidates, and maybe
with time that may change. But I guess, like all
new technologies, we need more data to inform these decisions.
You know, in this case, in this paper, you guys
studied its use in the pulmonary arteries and in the aorta.
(24:57):
I'm wondering are there any other areas that you think
this might be a good match for.
Speaker 2 (25:02):
Yeah, and uh, you know, I have to say I'm
talking about off label uses of this device at this point,
and it's something that as far as I know, has
has not been done in humans. But yes, of course,
we always are thinking about additional applications for these devices.
(25:25):
The device was designed for baby vessel sizes and they
were in the pulmonary arteries, but I've encountered a number
of cases of superior vena, cavasnsis, other systemic vein obstructions
that may lend themselves well to minimal therapy. Fortunately I
(25:46):
had another option in all of those cases and went
with the other option. But I think that off label
uses are are coming down the pipeline. The other thing,
potentially is that this stink could be used to prepare
right matricular outfloat X in young kids for future valve implantation. Sure, yeah, sure,
there's always there's always things that we can think of.
Speaker 1 (26:08):
Right again, well off label recommendations or thoughts at least,
well for those in the audience, it was very nice
of doctor Sullivan to join us right in the middle
of his afternoon. So we'll finish up with this last question.
And I'm wondering is the intention to continue following these
forty two patients. I think that's really going to be
very interesting to know how easy it is to expand
(26:30):
them and in the future. What's what's the plans for
RENATA and this type of study.
Speaker 3 (26:35):
Yeah, you know, we have had.
Speaker 2 (26:39):
Over three and a half years of follow up at
this point in some of the earliest patients, so we
have quite a bit of follow up. We've presented follow
up over the fall at the PICKS meeting in Chicago.
Speaker 3 (26:51):
We've had a lot of.
Speaker 2 (26:52):
Re expansions of this stint in babies for somatic and
bessel growth, and those procedures have and really gone quite
well and have shown that we can expand this stent
serially and it gets bigger and bigger and keeps pace
with somatic growth, so that all seems to be going well.
Speaker 3 (27:12):
The protocol calls for follow.
Speaker 2 (27:15):
Up for five years of these patients so that it
will be periodically reported and.
Speaker 3 (27:21):
Maybe out beyond them. But it'll be really important to
see how this stent holds up as kids grow.
Speaker 5 (27:27):
Now.
Speaker 2 (27:27):
Renatt is also very committed to to monitoring their post
approval implantation. So there's a I think a fifteen site
post approval study that's currently enrolling as of spring of
twenty twenty five. So that's going to be a larger
cohort with similar follow up of real world implantation, So
(27:51):
that'll be really exciting to see as well.
Speaker 1 (27:53):
I see, Well, I really want to congratulate you and
your co investigators, and I want to thank you so
much for a discussing this very exciting new technology with us.
Thank you so much, and congratulations.
Speaker 2 (28:04):
Patrick, Yeah, thank you, thank you for having me, who's
a butter pleasure.
Speaker 1 (28:08):
Well, I'm sure that, like me, you learned a lot
about this new technology. As doctor Sullivan was really terrifically
clear in his comments offline, he had an important point
to make that I think I have not yet made
in this podcast, which is that when we consider this
to be a game changing technology, it might be said
that what's most game changing about this story is the
(28:29):
company itself or not a medical which is one of
the very first companies that are actively working to design
and improve upon technologies for catheterization in small infants and children.
Their efforts are important for the products they're developing, but
maybe might even be more important in their ability to
demonstrate that this is a potentially profitable line of business.
(28:50):
Profits drive most things in this world, and if we're not,
it can demonstrate that this mission of THEIRS not only
helps children, but as profitable as well. It may expand
a new industry of device companies for children, and how
wonderful would that be. We also discussed the high cost
of this device, and he mentioned that new devices are
usually more expensive due to research and development costs, particularly
(29:13):
for a small company, but he suggested that one could
argue that in comparison with surgery, an argument might be
made that it is comparable in cost. I don't know,
but time will certainly tell. I'll simply just end by
saying how appreciative I am to doctor Sullivan for sharing
his expertise with us all this week on Pete Heart.
To conclude this three hundred and sixtieth episode of pet
(29:36):
Heart Pediatric Cardiology, to day, we hear the wonderful American
baso Giorgio Tozzi, who was born in Chicago and studied
at DePaul University in the nineteen fifties and sixties. He
was a base on many of the greatest opera recordings
of that time, and he won Grammy Awards for his work.
He also dubbed the voice of the character Emil de
(29:57):
Beck in the movie South Pacific. Today we hear him
singing the famous this nearly was Mine, one of the
greatest of the many wonderful songs in this Rogers and
Harrison show. Thank you very much for joining me for
this episode, and thanks once again to dark to Sullivan.
Speaker 3 (30:12):
I hope I'll have a good week ahead.
Speaker 5 (30:15):
Oh dream, my ah love be living for a.
Speaker 4 (30:27):
Love for.
Speaker 5 (30:32):
Yes, mel was mod aco for my dream not in
a hordles. Peace, honis all the pardas peace Me was mid.
Speaker 4 (31:00):
Close to my hard check or my past.
Speaker 7 (31:18):
Form.
Speaker 5 (31:29):
No, no model.
Speaker 4 (31:35):
Steebe, other bad stee say like Bana spe
Welcome to Pedheart Pediatric Cardiology today. My name is doctor
Robert Pass and I'm the host of this podcast. I
am Professor of Pediatrics at the Icon School of Medicine
at Montsana here in New York City. Thank you for
joining me for this three hundred and sixtieth episode of Ptiheart.
I hope everybody enjoyed last week's episode on the topic
of fetal counseling, in which we spoke with doctor Caitlin
(00:37):
Haxel and doctor Joeann Cheu. For those of you interested
in fetal cardiology as well as fetal counseling, I'd recommend
you tech a listen to last week's episode three hundred
and fifty nine. If you'd like to get in touch
with me, my email is easy to remember. It's Pdheart
at gmail dot com. This week we move into the
world of interventional cardiology for an important new paper. The
(00:58):
title of the work will be reviewing is Multi Sensor
Pivotal Trial of the MINIMU Stent for a vascular Stenosis
in Infants and young Children. The first author of this
work is Patrick M. Sullivan and the senior author Darren P. Berman,
and the first and senior authors come to us from
Children's Hospital of Los Angeles. When we're done reviewing this paper,
(01:19):
doctor Sullivan has graciously agreed to speak with us about it. Therefore,
let's move straight on to this article and then a
conversation with its first author. The work begins by reminding
us that the first descriptions of stent implantation and congenital
heart patients occurred thirty five years ago, and how they
can be particularly useful for the treatment of pulmonary artery
or aortic obstruction. However, most of the time the stents
(01:41):
used are off label, designed for other indications, and for
some patients, particularly small ones, these devices are suboptimal. They
then explained that the Minimus stent was designed to address
some of these issues, and review how the two features
that make it potentially desirable are the low profile nature
mounted on a balloon catheter, meaning it can be delivered
(02:02):
via a very small vascular sheath, and the capacity of
these stents to be dilated serially to adult size, something
previously unheard of. For those of you less familiar, the
minimum stent is a seventeen millimeter long, closed cell balloon
expansible cobalt chromium stent that's designed to maintain structural integrity
(02:22):
and strength over a fairly large or wide range of
sizes everywhere from five point one millimeters at the minimum
diameter to twenty four millimeters at the largest and the
goal of using this would be that it could be
implanted at very small patient size and then serially enlarged
over time. The stent is manufactured on a six or
(02:42):
eight milimeter diameter balloon and comes with a kink resistant
delivery system on a sixty three centimeter long catheter. The
diameter of the catheter is four French, meaning that it
can be used through the skin at four French or
alternatively it could be used through a six French short
introduced and the system is designed to be advanced on
either an one four or an one to eight wire.
(03:05):
The authors explained that the multi center early feasibility study
was performed assessing performance, safety, and efficacy of this device
and these results were promising, so the decision was therefore
made to proceed with a larger so called pivotal trial,
and this is the study that we're reviewing today. This
was a multi center, single arm study in seven United
(03:26):
States centers with forty two neonates, infants and children with
either native or recurrent corrotation or branch pulmonary ary stenosis
treated with the minimum stent. The patients were followed closely
with varying imaging modalities including CAF and CT and ECHO,
and the authors explained that the original ten patients from
the early feasibility study were also included in the forty
(03:48):
two subjects of this work. For this work, the primary
endpoints were technical success or implantation, acute relief of stenosis,
freedom from major device procedure related to sc various adverse
events or surgical intervention through six months, as well as
maintenance of minimal lumin diameter at six months and daught
to the results again, there were forty two patients, with
(04:11):
twenty one having pulmonary artery stents and fifteen a recurrent
corroctation and six native corroctation who underwent minimum stent implantation
at a median age and weight of nine months and
seven point eight kilos, respectively. Implantation success was seen in
forty one of forty two patients, or ninety seven point
six percent. Synosis relief was excellent in this work for
(04:35):
corroctation patients, the median pressure gradient dropped from twenty five
millimeters mercury to zero, with the minimal vessel diameter increasing
by a median of one hundred and thirty one percent,
with a range of forty five percent to four hundred
and eighty three percent increase post endplant. And how did
these stents do and follow up? While at six month imaging,
(04:56):
which was mostly by CT or thirty seven of the
forty two patients, the aluminal diameter was maintained at a
median of eighty nine percent of the implant diameter, with
a range of fifty eight to one hundred and thirty
seven percent. And what about long term overall well, with
the median of five hundred and ninety six days of
follow up, thirteen of forty two patients, or about a third,
(05:16):
underwent a plan's stent re expansion, with seven in the
aorta and six in the pulmonary arteries without any complications.
Re Expansions generally were performed with the goal of making
the stent within two millimeters of the surrounding normal blood vessel.
And what about safety Well, First of all, there were
no x plants or device related serious adverse events through
(05:37):
six months. However, there were some procedural adverse events with
two acute stent embolizations in the pulmonary arteries, but in
both cases they were stabilized in the contralateral lung and
one of these was stabilized with a second minimum stent.
Seven patients with aortic corrotation, who were all less than
six kilograms at the time of cath had transient femeral
(05:58):
arterial thrombosis with US, all resolving with conservative therapy. In
their discussion the author's state and I. In a heterogeneous
cohort of forty two patients, half with native or post
operative recurrent corrotation and half with pulmonary artistenosis, the Minimu
stent was successfully implanted in all but one patient, achieving
safe and durable relief of vascular obstruction. Follow Up multiplanar
(06:22):
imaging demonstrated well maintained lumin calibers and stent integrity without
vessel wall injuries. Based on these findings, in August twenty
twenty four, the Minimus stent became the first stent to
prove by the Food and Drug Administration for use in
small pediatric patients during follow up ranging from thirteen to
thirty two months. Thirty one percent of the cohort underwent
(06:43):
elective redilation of the stent without any procedural adverse events.
The discussion reviews many of the points already made about
how present day's stents are not designed ideally for stenting
vascular structures in small children, and how there have been
some reports of interventionalists doing creative things like putting in
smaller stents and fracturing them intentionally or other approaches, but
(07:05):
clearly the difficult small anatomy of small patients has made
stinting in this group fraught with challenges. They speak of
how this new system, with its delivery catheter should help
with many of these challenges, and they reviewed the cases
of pulse loss and offer some suggestions, such as use
of ultrasound to enhance safe vascular access in the arteries
of small children. The authors explain that the closed cell
(07:28):
design makes the stent more rigid and less amenable to
tightly angled vessels, and they posit that this was part
of the reason that there were two embolizations for pulmonary
artery stents. The authors then reference older works on stinting
in small children, showing that the smaller the child is stented,
the more frequent one encounters narrowing after stenting and the
(07:48):
need for re intervention, and although this was not shown
in this small series, they do have concerns that this
may be similar for the minimum stent. Limitations reviewed included
the short follow up period of six months as a
primary endpoint, longer outcomes are still pending, and the relatively
small cohort, and so they conclude the Minimu's stent system
has demonstrated safety and efficacy in treating native and post
(08:11):
operative pulmonary arteries, stenosis and corrotation in this cohort. On
early follow up, the stent maintained structural integrity and luminal
patency and planned further expansion for somatic growth was well tolerated.
Caution should be exercised in treating challenging and compliant lesions
such as left pulmonary artery osteostenoses. While there remains a
(08:32):
substantial unmet need for technology designed for and tested in
pediatric patients with congenital heart disease, the device is a
promising addition from minimally invasive therapy in this unique population. Well,
the Minimu's stent is certainly potentially a game changer in
the world of interventional cardiology. We in the world of
interventions are all familiar with the famous dictum from the
(08:53):
great Chuck Mullins in his so called Rules of Stenting,
which was never create a surgical lesion with the stent.
This would probably be at least one of the major
reasons that we have not till now stented things like
pulmonary arteries or aortas with any regularity in this size
of a patient, because the technology available would not allow
ultimate expansion to an adult size, and so by definition,
(09:15):
placement of many of the available pre mounted stents like
the Genesis stents, for example, can only be expandable to
eight to ten millimeters, which is inadequate in the aorta
or pulmonary artery of an adult. Another issue not mentioned
is the length of the stent. Oftentimes the stents available
that are expandable to adult size or a bit on
the long side, and this too can prove a contraindication
(09:37):
to stenting in the small patient. This stent seems to
solve both problems. Clearly, we're going to need much longer
term data to know if these stents come through on
the promise that they're making, which is that they can
be re expanded to adult size, sometimes twenty years after implantation.
I also share concerns that the authors have regarding the
in growth that we see with small stents in small patient.
(10:00):
We all know that these need aggressive surveillance and dilation,
and I do wonder if the in growth scene in
small children will prove problematic long term. I will also
mention something not mentioned in this work or podcast thus
far in regards to this stent, but those of us
in the field have been quite shocked by the very
high price of this device and delivery catheter. I can
(10:21):
say that this has been one of the reasons that
we have dragged our feet at my own center, as
we all have some concerns that this extremely expensive device
will not be paid for by insurance carriers in the
United States. Clearly this is going to change over time,
but it would be inappropriate to not at least mention
this factor at this time, which is October twenty sixth,
twenty twenty five. I'm also going to just mention that
(10:44):
a very large number of the authors of this work
are presently working as consultants and or proctors for the company.
We're not a medical that manufactures this stent. In light
of time constraints, I think we should move forward now
with our conversation with the work's first author. Doctor Sullivan
now is the work's first author, doctor Patrick Sullivan. Doctor
Patrick Sullivan is a pediatric cardiologist with advanced training and
(11:06):
epidemiology and clinical research as well as interventional cardiology. He
earned his medical degree from the New York University School
of Medicine and completed both internship and residency and pediatrics
at the Children's Hospital Philadelphia. He went on to pursue
fellowship training in pediatric cardiology at Seattle Children's Hospital. He
also completed advanced training and international cardiology at the Children's
(11:27):
Hospital of Los Angeles. Doctor Sullivan also holds a Master
of Science and Epidemiology and Clinical Research from the University
of Washington School of Public Health. It is a delight
and an honor to have him join us. Welcome doctor
Sullivan to Pdheart. I'm here now with doctor Patrick Sullivan
all the way from Los Angeles. Patrick, thank you very
much for joining me this week on Pdheart.
Speaker 2 (11:46):
Thank you, doctor pass It's great to be here. I'm
a longtime fan of the show. I appreciate you having
me on.
Speaker 1 (11:52):
Thank you great pleasure to have you. Patrick. I thought,
just to start, maybe you can speak to this audience,
which mostly are not interventionalists, about what makes the minimum
stents such a major upgrade over prior stats for the
treatment of stenosis in the Ajorda or Plumoni ority.
Speaker 3 (12:08):
Of small kids.
Speaker 4 (12:10):
Yeah.
Speaker 2 (12:10):
I think that the thing that everybody should know first
off is that this is the first stent available that
was designed, tested in an FDA approved for use in
infants and small children. We've been using stents in babies
and small kids since the nineteen eighties nineteen nineties, but
(12:36):
all of those stents have been used off label, and
all those stents were designed for different adult applications primarily
and repurposed for use in pediatrics. And many of those
stints don't many of those stents don't have you know,
(12:57):
the ideal properties of a pediatric stent, which are our
specific things that we look for in stents. So the
minimum stent, and this is made by Renata company that
was started by some people in biotech who or medical
(13:18):
tech who were inspired by the congenital heart disease space
and inspired by our patients to really focus on creating
minimally invasive devices for our patients.
Speaker 3 (13:31):
So this is a stent that is designed to.
Speaker 2 (13:35):
Be delivered into small blood vessels, to have a low profile,
to be trackable in small babies, but importantly to ultimately
get to adult vessel size, and we haven't had a
stent that is designed to do that in the past.
Speaker 1 (13:55):
Wow.
Speaker 3 (13:55):
Great, real nice summary. Thank you very much.
Speaker 4 (13:58):
Patrick.
Speaker 1 (13:59):
You know in the PA are you and your colleagues
mentioned the stiffness of the stent is making it a
somewhat more difficult stent to maneuver, at least in the
initial experience. Can you discuss this issue with the audience
and any possible thoughts of making adjustments either to the
technique or maybe the device itself, or maybe just the
indications for where it should be used.
Speaker 5 (14:20):
Yeah.
Speaker 3 (14:20):
I think it's an interesting thing that you bring up, and.
Speaker 2 (14:24):
I think that the way we discuss that in this
paper specifically is that.
Speaker 3 (14:32):
The stent.
Speaker 2 (14:33):
We didn't really have any trouble tracking this stent or
with stiffness of the stent, like getting it to where
it needs to be, but it's more like on deployment
of this stent. So the stent is made out of
relatively strong, stiff material, and this has really been a
balancing act trying to create a stent that can get
(14:55):
to adult size.
Speaker 3 (14:56):
But goes in very small.
Speaker 2 (15:00):
Engineers designing this had to had to sort of constantly
be doing a balancing act wall designing this stent. It's
made of some stiff material and that gives it radial
strength over a broad range of diameters from baby sides
to adult size. So when you deploy the stent, uh,
(15:20):
it doesn't really conform to vessels in the same way
that like a coronary stent might or some other stints
that we've used previously in babies and kids. And so
I think our concern with I don't I don't want
to say that we're concerned about this, but I think
(15:42):
that our u the context in which we mentioned the
stiffness of the stent is in just the small number
of patients where we had a stent move out of
position after it was deployed, and the couple of patients
in whom this happened. It was a very compliant left
(16:04):
pulmonary artery lesion. And I think like a repair tetrology
patient where these these stent deployments are are known to
be a high risk for stent embolization and stan migration,
and so we were thinking, does the stiffness of the
stent and the the stent not like taking curves and
(16:28):
conforming to curved vessels, uh contribute to stent migration or
stent embilization.
Speaker 3 (16:34):
Maybe?
Speaker 2 (16:35):
I don't know, But since we've been thinking, you know,
the company and the physicians who participated in the trial,
we've all been thinking really hard about how to roll
this stent out in the most safe way so that
it can be successful. You know, we want pediatric products,
(16:57):
we want pediatric devices to be successful well because this
is an area of industry, it's a market that has
been underdeveloped and underutilized, and we want this to go well.
So we've been thinking a lot about how to best
like avoid any.
Speaker 3 (17:17):
Of these problems going forward.
Speaker 2 (17:19):
So with concerns about the stent, like any concerns about
the stint migrating or.
Speaker 3 (17:29):
Embolizing, we have.
Speaker 2 (17:33):
Instituted techniques to compliance test lesions and better characterized lesions
before we're implanting the stent to know.
Speaker 3 (17:43):
Whether or not that risk is going to be there.
Speaker 6 (17:46):
Sure, Yeah, So I think it's important for people to
understand that in your particular study, it was proximal l
PA where there was a problem. And as you said,
oftentimes it's not a true denosis, more of a fold
and that has always been a difficult area to stent
successfully without embolization.
Speaker 1 (18:08):
Have to be very careful. Oftentimes I have to oversize
it to get it to stay put. So it's not
surprising that that might happen. And as you said, it
may have nothing to do with the stent, more with
the lesion, etc. You know you that you hinted a
little bit Patrick at the at what the stent is
made out of, which is cobalt chromium. And I'm wondering
(18:29):
what do we know about this metal and its strength
and durability and ability for re expansion over long periods
of time. How does it compare, for example, with stainless steel,
which we know has been pretty good at being able
to be re expanded in larger patients. And the other
thing I wondered was how radio opaque these are in
comparison to either a steel or a platinum stent like
(18:51):
the Cheetham stent.
Speaker 2 (18:52):
Yeah, I'm I can talk about radio opacity first. I
think we can see these stints. I don't have any
concerns about that. It's kind of like less visible than
those those highly visible you know, cheat them stents that
are made a platinum iridium, But certainly you can see
this quite well. So I don't have concerns about that
(19:13):
at all. In terms of the material, like I said,
we or like I like I alluded to initially, Uh,
it's an engineering problem coming up with a stint that
has a small enough amount of material that you can
pack it into a system like this that can be
(19:34):
delivered a very low profile into small blood vessels, but
then can maintain radio strength over a broad range of
vessel diameters up to adult size, and have the amount
of material that can be a big sten ultimately a
big adult sized stint.
Speaker 3 (19:54):
So cobalt chromium is one of those materials.
Speaker 2 (19:57):
And I'm not a material science I'm not an engineer,
but based on my understanding of stent mechanics and stent engineering,
this is a nice material that can be used to
accomplish all of those things in the interventional worlds. In
(20:18):
the past, we have somewhat cringed when we are dealing
with cobalt chromium because often that means it's a small
stint that's going to be really hard to fracture, fracture
when the baby gets bigger, and we're going to have
to deal with that potentially surgically. But with this stent,
if used in the way that it is intended, you
(20:39):
should never have to fracture this stent.
Speaker 3 (20:41):
So it's a strong stent. I would imagine that it will.
Speaker 2 (20:46):
Maintain its durability, but I think that only time will tell.
Speaker 3 (20:50):
Sure.
Speaker 4 (20:50):
Sure.
Speaker 1 (20:51):
Well, now I'm going to ask you a provocative question,
which is do you think that this technology could one
day supplant surgery for treatment discrete cohortation in babies? I mean,
what do you think would be the potential benefits versus
the downsides of that type of an approach rather than surgery.
Speaker 4 (21:10):
Yeah.
Speaker 2 (21:10):
I think that's really one of the million dollar questions here.
I think it's really important to talk about. I think
that the fact that you're asking that question tells us
that this is potentially transformative technology. We are now talking
about potentially treating allsion in babies and small kids differently
(21:31):
than we did before.
Speaker 3 (21:34):
The study.
Speaker 2 (21:35):
You know that we're here talking about, of course, was
not designed to answer that question.
Speaker 3 (21:40):
It does not answer that question. Potentially future studies can.
Speaker 2 (21:43):
Answer that question, you know, all I can say My
best answer I think on this is that it is
an option now, right, so it has previously not been
a great option. We've had some stents that we can
put in babies who are not surgical candidates, who we
(22:04):
can then maybe fracture in the future, or maybe go
for surgery to take them out in the future, or
we can struggle to get larger profile stents into small
babies and place them at some risk of vascular injury.
But now we have a product that's designed for this,
so it's an option. Whether or not people will supplant
(22:29):
surgery with that option, I don't know. But in this
trial we found a number of patients who, after hearing
from the interventional cardiologist and the surgeon, shows to have
a stent procedure, and at least at this institution, and
I'm assuming that the other institutions that participated in the
trial and also have implanted these stents. Since the trial
(22:53):
is over it and f the approval was achieved, we
discussed the upsides in the downside, which are surgery presumably
is a one and done procedure and then your corrotation
area that's been removed and the award it will grow
with time, there will be like maybe a ten to
(23:14):
twenty percent risk of recurrent corrotation that you will maybe
have to contend with and hopefully will not but hopefully
a one and done procedure. Now a stent procedure, and
a baby obviously will go in at the baby's aortic
size and need to be upsized with balloon antioplasty over
(23:36):
time as the baby grows. We were quoting up to
maybe four additional procedures, maybe fewer over the course of
childhood and adolescence until the child is fully grown. So
that's what we were quoting, and some people opted for
that instead of undergoing a thor economy surgery. Now there's
(24:00):
other scenarios where maybe a baby is not a surgical candidate.
Speaker 3 (24:05):
For example, I proctored.
Speaker 2 (24:06):
A procedure where we had a baby with chrysomy eighteen
who was not a surgical candidate and had a hypoplastic
aortic arch.
Speaker 3 (24:15):
Now we have an option for this baby.
Speaker 2 (24:17):
We put minimum stents in it covered the transverse and
distal arch, and opened up the aor and that baby
was able to come off prostaglandin, which was the goal.
And so I think it's an option, and we'll have
to see how all that plays out.
Speaker 1 (24:35):
Yeah, I think it seems at least at this point
a good option for patients such as the one you
described too are not considered good surgical candidates, and maybe
with time that may change. But I guess, like all
new technologies, we need more data to inform these decisions.
You know, in this case, in this paper, you guys
studied its use in the pulmonary arteries and in the aorta.
(24:57):
I'm wondering are there any other areas that you think
this might be a good match for.
Speaker 2 (25:02):
Yeah, and uh, you know, I have to say I'm
talking about off label uses of this device at this point,
and it's something that as far as I know, has
has not been done in humans. But yes, of course,
we always are thinking about additional applications for these devices.
(25:25):
The device was designed for baby vessel sizes and they
were in the pulmonary arteries, but I've encountered a number
of cases of superior vena, cavasnsis, other systemic vein obstructions
that may lend themselves well to minimal therapy. Fortunately I
(25:46):
had another option in all of those cases and went
with the other option. But I think that off label
uses are are coming down the pipeline. The other thing,
potentially is that this stink could be used to prepare
right matricular outfloat X in young kids for future valve implantation. Sure, yeah, sure,
there's always there's always things that we can think of.
Speaker 1 (26:08):
Right again, well off label recommendations or thoughts at least,
well for those in the audience, it was very nice
of doctor Sullivan to join us right in the middle
of his afternoon. So we'll finish up with this last question.
And I'm wondering is the intention to continue following these
forty two patients. I think that's really going to be
very interesting to know how easy it is to expand
(26:30):
them and in the future. What's what's the plans for
RENATA and this type of study.
Speaker 3 (26:35):
Yeah, you know, we have had.
Speaker 2 (26:39):
Over three and a half years of follow up at
this point in some of the earliest patients, so we
have quite a bit of follow up. We've presented follow
up over the fall at the PICKS meeting in Chicago.
Speaker 3 (26:51):
We've had a lot of.
Speaker 2 (26:52):
Re expansions of this stint in babies for somatic and
bessel growth, and those procedures have and really gone quite
well and have shown that we can expand this stent
serially and it gets bigger and bigger and keeps pace
with somatic growth, so that all seems to be going well.
Speaker 3 (27:12):
The protocol calls for follow.
Speaker 2 (27:15):
Up for five years of these patients so that it
will be periodically reported and.
Speaker 3 (27:21):
Maybe out beyond them. But it'll be really important to
see how this stent holds up as kids grow.
Speaker 5 (27:27):
Now.
Speaker 2 (27:27):
Renatt is also very committed to to monitoring their post
approval implantation. So there's a I think a fifteen site
post approval study that's currently enrolling as of spring of
twenty twenty five. So that's going to be a larger
cohort with similar follow up of real world implantation, So
(27:51):
that'll be really exciting to see as well.
Speaker 1 (27:53):
I see, Well, I really want to congratulate you and
your co investigators, and I want to thank you so
much for a discussing this very exciting new technology with us.
Thank you so much, and congratulations.
Speaker 2 (28:04):
Patrick, Yeah, thank you, thank you for having me, who's
a butter pleasure.
Speaker 1 (28:08):
Well, I'm sure that, like me, you learned a lot
about this new technology. As doctor Sullivan was really terrifically
clear in his comments offline, he had an important point
to make that I think I have not yet made
in this podcast, which is that when we consider this
to be a game changing technology, it might be said
that what's most game changing about this story is the
(28:29):
company itself or not a medical which is one of
the very first companies that are actively working to design
and improve upon technologies for catheterization in small infants and children.
Their efforts are important for the products they're developing, but
maybe might even be more important in their ability to
demonstrate that this is a potentially profitable line of business.
(28:50):
Profits drive most things in this world, and if we're not,
it can demonstrate that this mission of THEIRS not only
helps children, but as profitable as well. It may expand
a new industry of device companies for children, and how
wonderful would that be. We also discussed the high cost
of this device, and he mentioned that new devices are
usually more expensive due to research and development costs, particularly
(29:13):
for a small company, but he suggested that one could
argue that in comparison with surgery, an argument might be
made that it is comparable in cost. I don't know,
but time will certainly tell. I'll simply just end by
saying how appreciative I am to doctor Sullivan for sharing
his expertise with us all this week on Pete Heart.
To conclude this three hundred and sixtieth episode of pet
(29:36):
Heart Pediatric Cardiology, to day, we hear the wonderful American
baso Giorgio Tozzi, who was born in Chicago and studied
at DePaul University in the nineteen fifties and sixties. He
was a base on many of the greatest opera recordings
of that time, and he won Grammy Awards for his work.
He also dubbed the voice of the character Emil de
(29:57):
Beck in the movie South Pacific. Today we hear him
singing the famous this nearly was Mine, one of the
greatest of the many wonderful songs in this Rogers and
Harrison show. Thank you very much for joining me for
this episode, and thanks once again to dark to Sullivan.
Speaker 3 (30:12):
I hope I'll have a good week ahead.
Speaker 5 (30:15):
Oh dream, my ah love be living for a.
Speaker 4 (30:27):
Love for.
Speaker 5 (30:32):
Yes, mel was mod aco for my dream not in
a hordles. Peace, honis all the pardas peace Me was mid.
Speaker 4 (31:00):
Close to my hard check or my past.
Speaker 7 (31:18):
Form.
Speaker 5 (31:29):
No, no model.
Speaker 4 (31:35):
Steebe, other bad stee say like Bana spe
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Crime Junkie
Does hearing about a true crime case always leave you scouring the internet for the truth behind the story? Dive into your next mystery with Crime Junkie. Every Monday, join your host Ashley Flowers as she unravels all the details of infamous and underreported true crime cases with her best friend Brit Prawat. From cold cases to missing persons and heroes in our community who seek justice, Crime Junkie is your destination for theories and stories you won’t hear anywhere else. Whether you're a seasoned true crime enthusiast or new to the genre, you'll find yourself on the edge of your seat awaiting a new episode every Monday. If you can never get enough true crime... Congratulations, you’ve found your people. Follow to join a community of Crime Junkies! Crime Junkie is presented by audiochuck Media Company.
The Brothers Ortiz
The Brothers Ortiz is the story of two brothers–both successful, but in very different ways. Gabe Ortiz becomes a third-highest ranking officer in all of Texas while his younger brother Larry climbs the ranks in Puro Tango Blast, a notorious Texas Prison gang. Gabe doesn’t know all the details of his brother’s nefarious dealings, and he’s made a point not to ask, to protect their relationship. But when Larry is murdered during a home invasion in a rented beach house, Gabe has no choice but to look into what happened that night. To solve Larry’s murder, Gabe, and the whole Ortiz family, must ask each other tough questions.