This week we review a recent surgical paper on the 'off-label' use of the Melody valve for replacement of the AV valve in small infants and children. How effective and safe was this procedure? What factors were associated with the need for reintervention and what sorts of reinterventions were most common? Why was catheter based reintervention rarely employed? What sort of anti-coagulation protocol seems best to protect these valves? Assistant Professor of Pediatrics at the University of Nebraska, Dr. Samantha Gilg shares the insights from her work this week.
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Episode Transcript
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Speaker 1 (00:16):
Welcome to Pdheart 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 Mount Signi here in New York City. Thank you
for joining me for the three hundred and forty eighth
episode of Pdheart. I hope everybody enjoyed last week's episode,
in which doctor Nadine Schwader interviewed the pre eminent cardiologist
(00:37):
Brian mccrendall of the University of Toronto. For those of
you interested in learning about the history of pediatric cardiology
in our field, I'd certainly recommend you listen to doctor
Schwad and doctor mccrendall in last week's three hundred and
forty seventh episode. As I say most weeks, 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,
(00:59):
we move on to the world cardiovascular surgery as well
as interventional cardiology. The title of the work we'll be
reviewing is Predictors of valve failure following surgical atriov and
tricular valve replacement with a melody valve in infants and children.
The first author of this work is Samantha Gilg and
the senior author James Hamill. And the authors of this
(01:19):
work come to us from multiple centers, most of them
come to us from Children's Nebraska at the University of
Nebraska Medical Center. When we're done reviewing this paper, I'm
hopeful that the work's first author, doctor Gilg, will be
able to speak with us about it. Therefore, let's move
straight on to this interesting article and then a conversation
with one of its authors.
Speaker 2 (01:37):
This week's work begins with general comments about how limited
we are when dealing with the AV valve and small children,
and how there are almost no approved devices for the
smallest of kids who need AV valve replacement. The authors
then explain that the melody valve has been used in
an off label manner to replace the AV valves in
a few reports and was actually first reported thirteen year
(02:00):
years ago in twenty twelve. They explain that they have
used this approach when AVY valves need replacement for the
past eight years in Nebraska with some frequency, and so
sought to review their single institution experience with this approach
to replacing AV valves in the small child with the
goal of looking for predictors of value or failure when
(02:20):
the melody valve is used, and they comment that their
hypothesis was that smaller or younger children receiving the melody
valve for this indication would require earlier reintervention. Once again,
this was a single center retrospective study from Nebraska assessing
all pediatric patients who underwent melody valve insertion in the
operating room for atroventricular valve replacement between February of twenty
(02:43):
fourteen and November twenty twenty one, and the indication for
this procedure was inability to repair a valve or being
a poor candidate for a mechanical valve to either to
size or other factors. The authors collected as much demographic
data as possible, as well as details of the patient's
cath and echocardiograms, as well as procedural details like valve
(03:03):
annulis size at the time of surgery, duration of the operation,
and size of the implant. The authors also reviewed all
post procedural data for this work. The primary outcome was
duration of reintervention free survival and for this work also,
valvular failure was defined as requiring repeat intervention either via
catheter or surgery, and the authors explained that the intervention
(03:26):
was generally performed when there was worsening valvular function by
echo or clinical symptoms. The authors review the operative approach
and there are some interesting photographs from the surgery in Fig.
Speaker 3 (03:36):
One.
Speaker 2 (03:37):
Basically, the valve and subvalvular apparatus are removed and the
native annulis was measured with vascular dilators, and then a
fifteen millimeter long cuff of Gortec's tube graph equal to
one millimeter or greater to the measured diameter was suture
to the mitrolannulus, and then the melody valve was prepared
and shortened to nineteen millimeters by folding back one row
(03:57):
of metal struts at both the inlet and outlet of
the valve, and the valve would be crimped onto an
antiplastic balloon of equal diameter to the gortex tube graft
that was just sewed in and the valve then inserted
into the gortex tube under direct visualization. The surgeon would
then place two or three interrupted sutures in the valve
trigones to secure the valve in the cuff, and this
(04:19):
was tested for stability and onto the results. In total,
twenty six patients had thirty seven melody valve implants in
the ature of ventricular valve our position, with the majority
or eighty three percent, having it placed in the systemic
AV valve, which was either the mitral or systemic tricospit
and the authors explained that three of the twenty six
(04:40):
patients or eleven point six percent, had single ventrical physiology,
with the remainder bib in tricular. Reviewing the demographics, fifty
percent were male and fifty eight percent hadrogenetic syndrome, with
trisomi twenty one being the most common. The most common
cardiac diagnoses requiring a melody valve replacement in the AV
valve position was a complete av canalty effect in forty
(05:01):
two percent. And what were the indications for replacement? While
valve regurgitation was the most common indication in thirty five percent,
followed by stenosis in thirty two percent and mixed valvear
disease in thirty four percent, the subvalvular ventricular function was
normal in sixty two percent, mildly depressed in nineteen percent,
and moderate or severely depressed in nineteen percent. Of note,
(05:24):
nearly all of these patients who had had a melody valve,
ninety six percent had undergone a prior surgery or catheter
based AV valve intervention. The median agent procedure was seventeen
months with weight of eight point five kilos and the
median balloon size for implantation was twenty millimeters with the
goal annular zescore dimension of zero. And what about procedural complications?
(05:47):
Eleven percent occurred and these were two patients who had
cardiac arrest with the need for EKMO immediately following surgery,
one case of media stenidis, and one patient who developed
heart block. The median length of state following surgery for
this procedure was thirteen days. And so what were the
reintervention rates like in this fairly large cohort. Well median
(06:08):
freedom from reintervention time was thirty one months, with nineteen
percent having freedom from reintervention at sixty months. And in total,
fifty seven percent of patients needed a reintervention, with the
majority being surgical. The reasons for reintervention was mixed stenosis
and regurgitation in fifty two percent, stenosis in a third,
antocarditis in one patient, thrombis in one and LV alflood
(06:32):
tract obstruction in one pure regurgitation was not the indication
for reintervention in any patient. The following is an important
point highlighting the difficult nature of this problem that these
valves were used for. Specifically, twenty seven percent or seven
patients who had a melody valve placed died and one
died after explantation. The most common reasons for death were
(06:55):
septic shock, necrotic vowel, acute respiratory failure, coagulopathya anechmo, cardiopulmonary arrest,
heemorrhagic shock on an LVAD with a schemic stroke. All
of the deaths occurred within six months a placement of
the melody valve. And what were the factors that were
associated with valvular failure requiring reintervention. Well, these were age
(07:16):
less than twelve months, weight less than ten kilos, and
body surface area less than zero point four meter square,
all significant factors for early valve failure. Single ventrical physiology
was also a risk factor for valve failure early, but
this was only seen in patients less than twelve months
of age, which are a risk factor in and of
(07:37):
themself for having valve failure. The time to failure was
five point six months in that patient group versus twenty
nine months in those who had two ventricles in similar
vein Using a smaller balloon size initially correlated with a
higher risk of early valve failure, and when an intermediate
balloon size of one point two to one point three
five times the valvular annualis Z score was used, there
(08:00):
were better outcomes. In their discussion, the author's state and
I quote the outcomes indicate that this is a reasonable
option to provide medium term valve longevity and allow for
patient growth, which then would provide additional valve replacement options.
Rein intervention rates following melody valve placement in the atree
of inentricular position remain overall high. The author's reference two
(08:21):
other studies on this, one being a larger multi centre
one and the other a smaller single center study, with
both having similar outcomes. They then review how the smallest
prosthesis for atrue of ventricular valve replacement is fifteen millimeters,
which has an overall diameter of eighteen millimeters, and how
this is too large for smaller patients, and they also
(08:42):
review the varied problems with a fixed size mechanical prosthesis
in smaller growing children with the need frantic regulation. The
authors speak about enzocarditis and the known risks for this
in the melody valve and remind that three valves in
this case series or eight point one percent developed anzocarditis,
with one needing surgical explantation, with two being responsive to
(09:04):
intravenous antibiotics. They also mentioned the finding of four patients
having valvular thrombosis and review how all patients received aspirin.
The authors speak about the high rate of death in
this patient group and reminds that many of the patients
were critically ill at the time of surgery. They also
speak a bit about sizing the balloon and review how
too small was clearly bad, but oversizing also is associated
(09:28):
with poor outcomes, and suggests that coaptation of the valve
leaflets at larger sizes may be the reason for this,
and so they conclude this single center experience demonstrated that younger,
smaller patients had earlier valve failure and repeat melody valve
placement was common. Intermediate balloon to z scornnulus ratio was
associated with valve longevity superior to over or undersizing balloons,
(09:53):
single ventrical physiology, and patients less than twelve months of
age was also a significant risk factor for valve failure. Overall,
the melody valve and the ature of inentricular valve position
provides adequate medium term outcomes which will allow the patient
to grow enough to have additional options for valve replacement,
particularly when recognizing that many of these valves are placed
(10:14):
in a salvage attempt. Well, this is an interesting work
and that it gives us real world understanding of the
outcomes of this bailout approach to AV valve replacement in
the small child with a very dysfunctional AV valve. I
think that the high mortality rates reported herein probably better
reflect the level of illness of these patients than the
device's good or bad properties. It seems clear that if
(10:37):
you are going to do this, you likely are in
a very bad situation with poor options. I wonder if
there has been a shift to using sapian valves given
what we know about them in terms of entocarditis. Does
the team think that they have the optimal diameter down
at this point? I also am interested to understand why
almost none of these cases were re dilated in the
cath Lab. In the interest of time, I think we
(10:59):
should go forward to our conversation with the works first author,
doctor Gilg. Samantha Gilg is Assistant Professor of Pediatrics at
the University of Nebraska. She is a critical care cardiologist
at Children's Nebraska. Doctor Gilg received her medical degree from
the University of Iowa and completed her pediatric residency at UNMC.
She completed her fellowship in Pediatric Cardiology at UNMC Children's
(11:21):
Nebraska and participated in a cardiac Critical care instructor year
at Texas Children's. It is a delight to welcome an
up and coming superstar to the podcast. Welcome doctor Gilg
to PD Heart. I'm here now with doctor Samantha Gilg
of University of Nebraska. Doctor Gilg, thank you very much
for joining us this week on PD Heart.
Speaker 4 (11:39):
Thank you so much, Doctor past It's a pleasure to
be here.
Speaker 2 (11:41):
It's a real pleasure to have you. Thank you. In
the preliminary portion of your paper, your team hypothesized that
smaller children would more commonly need re intervention for a
melody valve placed in the AV position, and I was
wondering why your team thought that was likely to be
the case. Intuitive it seems that way, but I was
wondering how you had come to that hypothesis.
Speaker 4 (12:04):
Yeah, I completely agree.
Speaker 5 (12:05):
It seems intuitively that that would make sense. Our team
definitely felt that the smaller size of patients would require
a smaller valve implant size that would likely lead to
more rapid development of synosis of the valve and therefore
would require a repeat intervention on the sooner side.
Speaker 2 (12:21):
Well, in your work, too small of a melody valve
or even too large, we're both bad in regards to
long term follow up data in your work, and I wonder,
based on your data, if you could share with us
what you and the group believe are sort of the
optimal initial size of the valve that should be used
relative to the annular dimension.
Speaker 5 (12:41):
Yeah, our group found that the ideal melody implant size
was one point two to one point three, five times
a diameter of what would be an annular Z.
Speaker 4 (12:51):
Score of zero for that size of patient.
Speaker 5 (12:54):
So you're exactly right, and that the patients that we
implant it too small as well as the implants that
we patient implanted too large. Both of those had poorer
outcomes or were more likely to need a rerevention on
the sooner side, so the smaller implants were likely to
developed synosis sooner simply because of the smaller valve implant
size relative to patient size. We felt that the larger
(13:17):
valve became more dysfunctional due to changes in co optation
of the valve leaflets when they were implanted at a
larger diameter relative to the patient size, although we have
no way of knowing that for sure improving that, but
that was kind of what our team felt was the
likely ideology.
Speaker 2 (13:32):
See it's interesting because intuitively one would have thought that
if you could make it bigger, it would be better.
Speaker 4 (13:38):
But yes, completely agree.
Speaker 2 (13:39):
But you demonstrated that was actually not the case. And
I'm wondering, doctor Gilg if there were patients in which
this approach of a melody in the AVY valve wasn't appropriate.
And I wondered if any patients who had an AVY
valve problem during the period of your study, which was
about eight years, actually did not get offered to melody
and was considered by your group to be a suboptimal candidate.
(14:03):
In other words, who is not a candidate for this
when they have this problem of a very bad AV
valve and a small sized patient.
Speaker 5 (14:12):
Yeah, I don't have specific patient details on those patients
who weren't offered a melody during this time period. However,
thinking back about this time period, there were certainly some
patients who may have.
Speaker 4 (14:24):
Benefited from having a melody valve in place, but were
simply too small.
Speaker 5 (14:28):
Additionally, we found in our research that patients with single
ventrical physiology certainly were at higher risk of having poorer
outcomes and needing reintervention on the sooner side. So, again
not knowing specific patient details off the top of my head,
there were likely single ventrical patients during that time. As
we got more experience that we've been no longer offered
a melody too.
Speaker 2 (14:49):
You know, one of the more important theoretical benefits I
would think of a melody valve for this indication is
that it has the chance for reintervention in the cathlab.
And a good number of the patients in your work
had stenosis as the major problem in follow up, which
might suggest, at least to someone reading the paper like
(15:10):
myself was an interventionalist, that they might be a candidate
for balloon dilation. But I noticed that catheter reintervention was
very rarely used in your particular group, and I wondered
why why those patients tended to just go back for surgery.
Was it concerned that the dilation would just cause regurgitation?
Was it that the size of the catheter was very
(15:31):
large relative to the small patient? How did the decision
get made to not try an intervention.
Speaker 3 (15:37):
In the lab?
Speaker 5 (15:38):
Yeah, you're exactly right on both of those points. Our
team certainly had concerns specifically about worsening the regurgitation. While
stenosis was a main contributing factor for needing reintervation reintervention
on most of these valves, a vast majority of them
still had mixed disease and so with some underlying regurgitation
at the time of meeting repeat intervention, our team felt
(16:01):
like intervening on that in the cath lab would likely
just worsen that regurgitation and potentially lead to worsen team
in dynamics and make them a poor surgical.
Speaker 4 (16:10):
Candidate at that point.
Speaker 5 (16:12):
In addition, as you mentioned, a lot of these patients
are on the smaller side and needing to go transseptal
for an intervention with a large balloon and a large
sheath and a small patient.
Speaker 4 (16:22):
Likely would not have been well tolerated.
Speaker 5 (16:24):
In patients with overall unfavorable human dynamics at the time.
Speaker 4 (16:28):
So it was a combination of.
Speaker 5 (16:29):
Not wanting to worsen regurgitation, but also concerns for them
not tolerating the procedure itself in the cathlab.
Speaker 2 (16:36):
You know, I found it interesting that four of the
patients in your cohort developed valvular thrombosis and all of
your patients were receiving aspen therapy, and I wondered if
your group has considered a different approach to antiquagulation in
this patient group, given that there has been a not
insignificant amount of thrombosis seen.
Speaker 5 (16:57):
Yeah, so our group overall has been much more aggressive
about anti platelet therapy in the last two years.
Speaker 4 (17:02):
We now use platelet inhibition testing to ensure patients are
adequately inhibitive on aspirin, and if not.
Speaker 5 (17:08):
They're given either a higher dose of aspirin and or
plavix is added in. And this applies to these patients
with melody valves in the avy valve position, but also
to the majority of our higher risk patients on anti
playlot therapy.
Speaker 2 (17:21):
Well, for those in the audience that DARCTA gilg has
been nice enough to speak with us after an entire
night on calling the ICU, So I really appreciate Sammy,
You're being kind enough to stay up and speak with us.
So I'm going to finish this up with one final question.
And I was just wondering the paper you wrote the
cohort ended a couple of years ago, and I wondered
(17:41):
if your group had any change in the past few
years regarding how you manage these patients. You just mentioned
the anti coagulation changes, and I wondered if you have
used any other types of valves, such as like a
safeian valve for similar indication.
Speaker 4 (17:56):
Yeah, good question.
Speaker 5 (17:57):
So our group actually overall has done fewervalves in the
AhR of ventricular position in the last couple of years.
Speaker 4 (18:03):
In large part due to change in surgical preference.
Speaker 5 (18:07):
Melody valves are still frequently a discussion that we have
on these patients that are in a difficult situation of
needing a repair of an AHO of ventricular valve in
a smaller patient size, but overall our volume of doing
these has become less over the last couple of years
following the time of this study. But again I do
believe that's in large part in change in surgical team
(18:28):
and preference.
Speaker 2 (18:29):
Well, doctor Gilger, I want to thank you for presenting
this very interesting paper on a very rare topic. It's
not something that you see very often, and so having
the opportunity to have for everybody to share the experience
that your team in Braska has had is very very useful,
and I want to congratulate you and your co investigators,
(18:49):
and once again thank you for joining us this week
on Pdheart.
Speaker 4 (18:52):
Thank you so much, Doctor pass I really appreciate being here.
Speaker 2 (18:54):
Thank you. I hope you enjoyed doctor Gilg's insights into
her data. It seems clear that in most cases this
is probably the optimal approach for these types of problems
will be surgical repair of the avy valves that are dysfunctional.
We all know that this is a very difficult thing
to do in a small infant, and I've heard from
many different surgeons in my career that the tissue of
these valves can be very challenging to work on, particularly
(19:17):
when the baby is very young. Thankfully, in the majority
of cases, surgeons can palliate these patients with repairs. But
this work this week clearly offers some insights into an
approach when all the usual palliative surgical approaches are not
feasible or effective, and though the results might be viewed negatively,
it's of course important to remember that for the majority
(19:39):
of these patients it may have been the only option,
and so for sharing these data for all of us
to learn, I am appreciative to the team in Nebraska,
and once more wish to thank doctor gilg for taking
time from her very busy schedule to speak with us
this week about it on PD Heart. To conclude this
three hundred and forty eighth episode of PD Heart Pediatric Cardiology,
today we hear the wonderful Belgian based baritone Jose van Dam.
(20:04):
Van Dame started his studies at the Brussels Royal Conservatory
and made his opera debut in nineteen sixty and most
of his operatic career was in Europe, though he did
sing in New York at the Metropolitan Opera in addition
to all of the major opera houses throughout the world.
He was also known as a great recitalist, and I
well remember hearing him sing in recital at Carnegie Hall
(20:25):
roughly twenty to twenty five years ago, and it was
a delightful concert. Today we hear him sing the lovely
dupart song Chanson triste or Song of Sadness. Thank you
very much for joining me for this three hundred and
forty eighth episode, and thanks so much to our guest.
I hope we'll have a good week.
Speaker 3 (20:42):
Ahead for quantity Land. One cannotity.
Speaker 6 (21:33):
Fold more possyb quityson want us to coy.
Speaker 3 (21:50):
By possy.
Speaker 7 (21:56):
Call fla time, but oh will.
Speaker 8 (22:29):
Idea all about about law.
Speaker 3 (22:47):
School?
Speaker 8 (22:57):
Don't want issue.
Speaker 7 (23:00):
If belt least, but the lot isier.
Speaker 8 (23:09):
S one.
Speaker 3 (23:11):
O the beasy than more the
Speaker 2 (23:22):
It
Welcome to Pdheart 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 Mount Signi here in New York City. Thank you
for joining me for the three hundred and forty eighth
episode of Pdheart. I hope everybody enjoyed last week's episode,
in which doctor Nadine Schwader interviewed the pre eminent cardiologist
(00:37):
Brian mccrendall of the University of Toronto. For those of
you interested in learning about the history of pediatric cardiology
in our field, I'd certainly recommend you listen to doctor
Schwad and doctor mccrendall in last week's three hundred and
forty seventh episode. As I say most weeks, 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,
(00:59):
we move on to the world cardiovascular surgery as well
as interventional cardiology. The title of the work we'll be
reviewing is Predictors of valve failure following surgical atriov and
tricular valve replacement with a melody valve in infants and children.
The first author of this work is Samantha Gilg and
the senior author James Hamill. And the authors of this
(01:19):
work come to us from multiple centers, most of them
come to us from Children's Nebraska at the University of
Nebraska Medical Center. When we're done reviewing this paper, I'm
hopeful that the work's first author, doctor Gilg, will be
able to speak with us about it. Therefore, let's move
straight on to this interesting article and then a conversation
with one of its authors.
Speaker 2 (01:37):
This week's work begins with general comments about how limited
we are when dealing with the AV valve and small children,
and how there are almost no approved devices for the
smallest of kids who need AV valve replacement. The authors
then explain that the melody valve has been used in
an off label manner to replace the AV valves in
a few reports and was actually first reported thirteen year
(02:00):
years ago in twenty twelve. They explain that they have
used this approach when AVY valves need replacement for the
past eight years in Nebraska with some frequency, and so
sought to review their single institution experience with this approach
to replacing AV valves in the small child with the
goal of looking for predictors of value or failure when
(02:20):
the melody valve is used, and they comment that their
hypothesis was that smaller or younger children receiving the melody
valve for this indication would require earlier reintervention. Once again,
this was a single center retrospective study from Nebraska assessing
all pediatric patients who underwent melody valve insertion in the
operating room for atroventricular valve replacement between February of twenty
(02:43):
fourteen and November twenty twenty one, and the indication for
this procedure was inability to repair a valve or being
a poor candidate for a mechanical valve to either to
size or other factors. The authors collected as much demographic
data as possible, as well as details of the patient's
cath and echocardiograms, as well as procedural details like valve
(03:03):
annulis size at the time of surgery, duration of the operation,
and size of the implant. The authors also reviewed all
post procedural data for this work. The primary outcome was
duration of reintervention free survival and for this work also,
valvular failure was defined as requiring repeat intervention either via
catheter or surgery, and the authors explained that the intervention
(03:26):
was generally performed when there was worsening valvular function by
echo or clinical symptoms. The authors review the operative approach
and there are some interesting photographs from the surgery in Fig.
Speaker 3 (03:36):
One.
Speaker 2 (03:37):
Basically, the valve and subvalvular apparatus are removed and the
native annulis was measured with vascular dilators, and then a
fifteen millimeter long cuff of Gortec's tube graph equal to
one millimeter or greater to the measured diameter was suture
to the mitrolannulus, and then the melody valve was prepared
and shortened to nineteen millimeters by folding back one row
(03:57):
of metal struts at both the inlet and outlet of
the valve, and the valve would be crimped onto an
antiplastic balloon of equal diameter to the gortex tube graft
that was just sewed in and the valve then inserted
into the gortex tube under direct visualization. The surgeon would
then place two or three interrupted sutures in the valve
trigones to secure the valve in the cuff, and this
(04:19):
was tested for stability and onto the results. In total,
twenty six patients had thirty seven melody valve implants in
the ature of ventricular valve our position, with the majority
or eighty three percent, having it placed in the systemic
AV valve, which was either the mitral or systemic tricospit
and the authors explained that three of the twenty six
(04:40):
patients or eleven point six percent, had single ventrical physiology,
with the remainder bib in tricular. Reviewing the demographics, fifty
percent were male and fifty eight percent hadrogenetic syndrome, with
trisomi twenty one being the most common. The most common
cardiac diagnoses requiring a melody valve replacement in the AV
valve position was a complete av canalty effect in forty
(05:01):
two percent. And what were the indications for replacement? While
valve regurgitation was the most common indication in thirty five percent,
followed by stenosis in thirty two percent and mixed valvear
disease in thirty four percent, the subvalvular ventricular function was
normal in sixty two percent, mildly depressed in nineteen percent,
and moderate or severely depressed in nineteen percent. Of note,
(05:24):
nearly all of these patients who had had a melody valve,
ninety six percent had undergone a prior surgery or catheter
based AV valve intervention. The median agent procedure was seventeen
months with weight of eight point five kilos and the
median balloon size for implantation was twenty millimeters with the
goal annular zescore dimension of zero. And what about procedural complications?
(05:47):
Eleven percent occurred and these were two patients who had
cardiac arrest with the need for EKMO immediately following surgery,
one case of media stenidis, and one patient who developed
heart block. The median length of state following surgery for
this procedure was thirteen days. And so what were the
reintervention rates like in this fairly large cohort. Well median
(06:08):
freedom from reintervention time was thirty one months, with nineteen
percent having freedom from reintervention at sixty months. And in total,
fifty seven percent of patients needed a reintervention, with the
majority being surgical. The reasons for reintervention was mixed stenosis
and regurgitation in fifty two percent, stenosis in a third,
antocarditis in one patient, thrombis in one and LV alflood
(06:32):
tract obstruction in one pure regurgitation was not the indication
for reintervention in any patient. The following is an important
point highlighting the difficult nature of this problem that these
valves were used for. Specifically, twenty seven percent or seven
patients who had a melody valve placed died and one
died after explantation. The most common reasons for death were
(06:55):
septic shock, necrotic vowel, acute respiratory failure, coagulopathya anechmo, cardiopulmonary arrest,
heemorrhagic shock on an LVAD with a schemic stroke. All
of the deaths occurred within six months a placement of
the melody valve. And what were the factors that were
associated with valvular failure requiring reintervention. Well, these were age
(07:16):
less than twelve months, weight less than ten kilos, and
body surface area less than zero point four meter square,
all significant factors for early valve failure. Single ventrical physiology
was also a risk factor for valve failure early, but
this was only seen in patients less than twelve months
of age, which are a risk factor in and of
(07:37):
themself for having valve failure. The time to failure was
five point six months in that patient group versus twenty
nine months in those who had two ventricles in similar
vein Using a smaller balloon size initially correlated with a
higher risk of early valve failure, and when an intermediate
balloon size of one point two to one point three
five times the valvular annualis Z score was used, there
(08:00):
were better outcomes. In their discussion, the author's state and
I quote the outcomes indicate that this is a reasonable
option to provide medium term valve longevity and allow for
patient growth, which then would provide additional valve replacement options.
Rein intervention rates following melody valve placement in the atree
of inentricular position remain overall high. The author's reference two
(08:21):
other studies on this, one being a larger multi centre
one and the other a smaller single center study, with
both having similar outcomes. They then review how the smallest
prosthesis for atrue of ventricular valve replacement is fifteen millimeters,
which has an overall diameter of eighteen millimeters, and how
this is too large for smaller patients, and they also
(08:42):
review the varied problems with a fixed size mechanical prosthesis
in smaller growing children with the need frantic regulation. The
authors speak about enzocarditis and the known risks for this
in the melody valve and remind that three valves in
this case series or eight point one percent developed anzocarditis,
with one needing surgical explantation, with two being responsive to
(09:04):
intravenous antibiotics. They also mentioned the finding of four patients
having valvular thrombosis and review how all patients received aspirin.
The authors speak about the high rate of death in
this patient group and reminds that many of the patients
were critically ill at the time of surgery. They also
speak a bit about sizing the balloon and review how
too small was clearly bad, but oversizing also is associated
(09:28):
with poor outcomes, and suggests that coaptation of the valve
leaflets at larger sizes may be the reason for this,
and so they conclude this single center experience demonstrated that younger,
smaller patients had earlier valve failure and repeat melody valve
placement was common. Intermediate balloon to z scornnulus ratio was
associated with valve longevity superior to over or undersizing balloons,
(09:53):
single ventrical physiology, and patients less than twelve months of
age was also a significant risk factor for valve failure. Overall,
the melody valve and the ature of inentricular valve position
provides adequate medium term outcomes which will allow the patient
to grow enough to have additional options for valve replacement,
particularly when recognizing that many of these valves are placed
(10:14):
in a salvage attempt. Well, this is an interesting work
and that it gives us real world understanding of the
outcomes of this bailout approach to AV valve replacement in
the small child with a very dysfunctional AV valve. I
think that the high mortality rates reported herein probably better
reflect the level of illness of these patients than the
device's good or bad properties. It seems clear that if
(10:37):
you are going to do this, you likely are in
a very bad situation with poor options. I wonder if
there has been a shift to using sapian valves given
what we know about them in terms of entocarditis. Does
the team think that they have the optimal diameter down
at this point? I also am interested to understand why
almost none of these cases were re dilated in the
cath Lab. In the interest of time, I think we
(10:59):
should go forward to our conversation with the works first author,
doctor Gilg. Samantha Gilg is Assistant Professor of Pediatrics at
the University of Nebraska. She is a critical care cardiologist
at Children's Nebraska. Doctor Gilg received her medical degree from
the University of Iowa and completed her pediatric residency at UNMC.
She completed her fellowship in Pediatric Cardiology at UNMC Children's
(11:21):
Nebraska and participated in a cardiac Critical care instructor year
at Texas Children's. It is a delight to welcome an
up and coming superstar to the podcast. Welcome doctor Gilg
to PD Heart. I'm here now with doctor Samantha Gilg
of University of Nebraska. Doctor Gilg, thank you very much
for joining us this week on PD Heart.
Speaker 4 (11:39):
Thank you so much, Doctor past It's a pleasure to
be here.
Speaker 2 (11:41):
It's a real pleasure to have you. Thank you. In
the preliminary portion of your paper, your team hypothesized that
smaller children would more commonly need re intervention for a
melody valve placed in the AV position, and I was
wondering why your team thought that was likely to be
the case. Intuitive it seems that way, but I was
wondering how you had come to that hypothesis.
Speaker 4 (12:04):
Yeah, I completely agree.
Speaker 5 (12:05):
It seems intuitively that that would make sense. Our team
definitely felt that the smaller size of patients would require
a smaller valve implant size that would likely lead to
more rapid development of synosis of the valve and therefore
would require a repeat intervention on the sooner side.
Speaker 2 (12:21):
Well, in your work, too small of a melody valve
or even too large, we're both bad in regards to
long term follow up data in your work, and I wonder,
based on your data, if you could share with us
what you and the group believe are sort of the
optimal initial size of the valve that should be used
relative to the annular dimension.
Speaker 5 (12:41):
Yeah, our group found that the ideal melody implant size
was one point two to one point three, five times
a diameter of what would be an annular Z.
Speaker 4 (12:51):
Score of zero for that size of patient.
Speaker 5 (12:54):
So you're exactly right, and that the patients that we
implant it too small as well as the implants that
we patient implanted too large. Both of those had poorer
outcomes or were more likely to need a rerevention on
the sooner side, so the smaller implants were likely to
developed synosis sooner simply because of the smaller valve implant
size relative to patient size. We felt that the larger
(13:17):
valve became more dysfunctional due to changes in co optation
of the valve leaflets when they were implanted at a
larger diameter relative to the patient size, although we have
no way of knowing that for sure improving that, but
that was kind of what our team felt was the
likely ideology.
Speaker 2 (13:32):
See it's interesting because intuitively one would have thought that
if you could make it bigger, it would be better.
Speaker 4 (13:38):
But yes, completely agree.
Speaker 2 (13:39):
But you demonstrated that was actually not the case. And
I'm wondering, doctor Gilg if there were patients in which
this approach of a melody in the AVY valve wasn't appropriate.
And I wondered if any patients who had an AVY
valve problem during the period of your study, which was
about eight years, actually did not get offered to melody
and was considered by your group to be a suboptimal candidate.
(14:03):
In other words, who is not a candidate for this
when they have this problem of a very bad AV
valve and a small sized patient.
Speaker 5 (14:12):
Yeah, I don't have specific patient details on those patients
who weren't offered a melody during this time period. However,
thinking back about this time period, there were certainly some
patients who may have.
Speaker 4 (14:24):
Benefited from having a melody valve in place, but were
simply too small.
Speaker 5 (14:28):
Additionally, we found in our research that patients with single
ventrical physiology certainly were at higher risk of having poorer
outcomes and needing reintervention on the sooner side. So, again
not knowing specific patient details off the top of my head,
there were likely single ventrical patients during that time. As
we got more experience that we've been no longer offered
a melody too.
Speaker 2 (14:49):
You know, one of the more important theoretical benefits I
would think of a melody valve for this indication is
that it has the chance for reintervention in the cathlab.
And a good number of the patients in your work
had stenosis as the major problem in follow up, which
might suggest, at least to someone reading the paper like
(15:10):
myself was an interventionalist, that they might be a candidate
for balloon dilation. But I noticed that catheter reintervention was
very rarely used in your particular group, and I wondered
why why those patients tended to just go back for surgery.
Was it concerned that the dilation would just cause regurgitation?
Was it that the size of the catheter was very
(15:31):
large relative to the small patient? How did the decision
get made to not try an intervention.
Speaker 3 (15:37):
In the lab?
Speaker 5 (15:38):
Yeah, you're exactly right on both of those points. Our
team certainly had concerns specifically about worsening the regurgitation. While
stenosis was a main contributing factor for needing reintervation reintervention
on most of these valves, a vast majority of them
still had mixed disease and so with some underlying regurgitation
at the time of meeting repeat intervention, our team felt
(16:01):
like intervening on that in the cath lab would likely
just worsen that regurgitation and potentially lead to worsen team
in dynamics and make them a poor surgical.
Speaker 4 (16:10):
Candidate at that point.
Speaker 5 (16:12):
In addition, as you mentioned, a lot of these patients
are on the smaller side and needing to go transseptal
for an intervention with a large balloon and a large
sheath and a small patient.
Speaker 4 (16:22):
Likely would not have been well tolerated.
Speaker 5 (16:24):
In patients with overall unfavorable human dynamics at the time.
Speaker 4 (16:28):
So it was a combination of.
Speaker 5 (16:29):
Not wanting to worsen regurgitation, but also concerns for them
not tolerating the procedure itself in the cathlab.
Speaker 2 (16:36):
You know, I found it interesting that four of the
patients in your cohort developed valvular thrombosis and all of
your patients were receiving aspen therapy, and I wondered if
your group has considered a different approach to antiquagulation in
this patient group, given that there has been a not
insignificant amount of thrombosis seen.
Speaker 5 (16:57):
Yeah, so our group overall has been much more aggressive
about anti platelet therapy in the last two years.
Speaker 4 (17:02):
We now use platelet inhibition testing to ensure patients are
adequately inhibitive on aspirin, and if not.
Speaker 5 (17:08):
They're given either a higher dose of aspirin and or
plavix is added in. And this applies to these patients
with melody valves in the avy valve position, but also
to the majority of our higher risk patients on anti
playlot therapy.
Speaker 2 (17:21):
Well, for those in the audience that DARCTA gilg has
been nice enough to speak with us after an entire
night on calling the ICU, So I really appreciate Sammy,
You're being kind enough to stay up and speak with us.
So I'm going to finish this up with one final question.
And I was just wondering the paper you wrote the
cohort ended a couple of years ago, and I wondered
(17:41):
if your group had any change in the past few
years regarding how you manage these patients. You just mentioned
the anti coagulation changes, and I wondered if you have
used any other types of valves, such as like a
safeian valve for similar indication.
Speaker 4 (17:56):
Yeah, good question.
Speaker 5 (17:57):
So our group actually overall has done fewervalves in the
AhR of ventricular position in the last couple of years.
Speaker 4 (18:03):
In large part due to change in surgical preference.
Speaker 5 (18:07):
Melody valves are still frequently a discussion that we have
on these patients that are in a difficult situation of
needing a repair of an AHO of ventricular valve in
a smaller patient size, but overall our volume of doing
these has become less over the last couple of years
following the time of this study. But again I do
believe that's in large part in change in surgical team
(18:28):
and preference.
Speaker 2 (18:29):
Well, doctor Gilger, I want to thank you for presenting
this very interesting paper on a very rare topic. It's
not something that you see very often, and so having
the opportunity to have for everybody to share the experience
that your team in Braska has had is very very useful,
and I want to congratulate you and your co investigators,
(18:49):
and once again thank you for joining us this week
on Pdheart.
Speaker 4 (18:52):
Thank you so much, Doctor pass I really appreciate being here.
Speaker 2 (18:54):
Thank you. I hope you enjoyed doctor Gilg's insights into
her data. It seems clear that in most cases this
is probably the optimal approach for these types of problems
will be surgical repair of the avy valves that are dysfunctional.
We all know that this is a very difficult thing
to do in a small infant, and I've heard from
many different surgeons in my career that the tissue of
these valves can be very challenging to work on, particularly
(19:17):
when the baby is very young. Thankfully, in the majority
of cases, surgeons can palliate these patients with repairs. But
this work this week clearly offers some insights into an
approach when all the usual palliative surgical approaches are not
feasible or effective, and though the results might be viewed negatively,
it's of course important to remember that for the majority
(19:39):
of these patients it may have been the only option,
and so for sharing these data for all of us
to learn, I am appreciative to the team in Nebraska,
and once more wish to thank doctor gilg for taking
time from her very busy schedule to speak with us
this week about it on PD Heart. To conclude this
three hundred and forty eighth episode of PD Heart Pediatric Cardiology,
today we hear the wonderful Belgian based baritone Jose van Dam.
(20:04):
Van Dame started his studies at the Brussels Royal Conservatory
and made his opera debut in nineteen sixty and most
of his operatic career was in Europe, though he did
sing in New York at the Metropolitan Opera in addition
to all of the major opera houses throughout the world.
He was also known as a great recitalist, and I
well remember hearing him sing in recital at Carnegie Hall
(20:25):
roughly twenty to twenty five years ago, and it was
a delightful concert. Today we hear him sing the lovely
dupart song Chanson triste or Song of Sadness. Thank you
very much for joining me for this three hundred and
forty eighth episode, and thanks so much to our guest.
I hope we'll have a good week.
Speaker 3 (20:42):
Ahead for quantity Land. One cannotity.
Speaker 6 (21:33):
Fold more possyb quityson want us to coy.
Speaker 3 (21:50):
By possy.
Speaker 7 (21:56):
Call fla time, but oh will.
Speaker 8 (22:29):
Idea all about about law.
Speaker 3 (22:47):
School?
Speaker 8 (22:57):
Don't want issue.
Speaker 7 (23:00):
If belt least, but the lot isier.
Speaker 8 (23:09):
S one.
Speaker 3 (23:11):
O the beasy than more the
Speaker 2 (23:22):
It
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