June 1, 2023 • 21 mins
In this episode, Dr Jamie Coleman is joined by Bradley Kushner, MD, from the Washington University School of Medicine, St Louis. They discuss Dr Kushner’s study, which found that patients who are unvaccinated against COVID-19 have worse compliance and healthcare follow-up after a kidney transplant compared with those who were preoperatively vaccinated.
Disclosure Information: Drs Kushner and Coleman have nothing to disclose.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:01):
Welcome to The Operative Word,
a podcast brought to you by the
Journal of the American College of
Surgeons.
I'm Dr. Jamie Coleman, and
throughout this series, Dr. Dante
and I will speak with recently
published authors about the
motivation behind their latest
research and the clinical
implications it has for the
practicing surgeon.
(00:22):
The opinions expressed in this
podcast are those of the
participants and not necessarily
that of the American College of
Surgeons.
Welcome to The Operative Word, a
podcast from the Journal of the
American College of Surgeons.
I'm Dr. Jamie Coleman, one of your
hosts for the series.
In this episode, I am joined by Dr.
Bradley Kushner, and we
(00:43):
will be taking an in-depth look into
his current article, COVID
Vaccination Status and Operative
Outcomes After Kidney
Transplantation.
Dr. Kushner is a general surgery
resident at the Washington
University School of Medicine in
Saint Louis, Missouri.
Dr. Kushner, welcome to The
Operative Word.
Dr. Coleman, thank you so much for
(01:03):
having me.
Truly a pleasure to be here and
really excited to share
our work with
JACS and the rest of the community
on COVID vaccination and patient
adherence.
Great. All right.
So before we get into it, because
we're definitely headed there, do
you have any conflicts of interest
that you would like to disclose?
No, I do not personally have any
(01:24):
conflicts of interest, and no
authors on the paper who
were affiliated with the work also
have no conflicts of interest.
Perfect.
All right. Well, first,
congratulations on the paper and
its publication.
It's always a big moment for all of
us, and I think especially too when
you're still in training.
But what really stuck out to
(01:45):
me for this is that
I feel like it's really adding
a unique aspect
to our COVID
literature.
We've got great papers that have
come out and have really talked
about outcomes, but kind
of as it relates to having a
coinciding COVID
infection.
But this paper, it's it's different.
(02:05):
I can't wait for our listeners to
hear about it.
So to back up a little bit, as we
know, someone who's receiving
or undergoing an organ donation,
it's really a lifelong commitment.
I mean, it requires a lot of
follow ups and compliance
with medications, lab draws
and office appointments.
And in your paper, what we're really
(02:26):
talking about is patient compliance.
In other words, how potentially
our patients decisions regarding
the COVID vaccine may
give us some insight or tell us a
little bit about their compliance
with other non-COVID related
decisions with their
healthcare.
Can you just start by telling us a
(02:46):
little bit about this concept and
the idea behind your paper?
Yeah, absolutely.
So you hit the nail right on the
head. Kidney transplantation
is the best available treatment that
we really have for patients with
end-stage renal disease; it provides
them extra quality of life years
and improved quality of life
in general.
However, promoting graft longevity
(03:08):
and preventing this
allosensitization is truly a huge
problem and requires patients
to be really compliant with these
medication regimens, these
lab draws, so that these
organs can last them quite a while,
even upwards of 15 to 20 years.
Unfortunately, patient adherence
in this population in general is
notoriously low.
(03:28):
Around 20 to 35%
of patients actually struggle with
adherence.
Oh, wow.
So let's let's pause there for half
a second. And so over
one quarter or about one
quarter, it's even almost one third
of patients struggle with
compliance.
And can you tell us a little bit how
that relates to
the survival of their
(03:49):
kidney transplant?
Yeah, absolutely.
So we know that in general,
patients who have medication
non-adherence and non-compliance,
are directly at increased
risk for late rejection.
Graft loss secondary to nonadherence
is the predominant cause of antibody
mediated late rejection and
confers a 5 to 7 fold
(04:11):
increased risk of graft loss.
So in general, even throwing
COVID vaccinations and
COVID infections general out of the
window, really identifying patients
who are at risk for noncompliance
is is critical for
having these grafts survive to
their fullest extent.
And so that was how you started with
(04:32):
this. I mean, because really, like,
how did it come to you and come
to your group of investigators that,
hey, we should look at
COVID vaccines?
Because my understanding is that
most centers now actually require
their patients to get a COVID
vaccine. Is that what you found
in the study?
Yeah, Yeah, exactly.
(04:53):
So we're one of the only centers in
the country that at the early part
of the pandemic, were actually not
requiring our patients to get a
mandatory COVID vaccine before
their transplant.
And many, many centers have actually
executed that.
As for this very reason,
that if there's any risk of
COVID related injury to the organ,
(05:13):
you want to be sure that they
reduce that risk of injury
as much as possible.
So we had a really unique
opportunity at WashU to look at
these differences in
organ survival and patient adherence
based on the fact that we
allowed patients to decide whether
they received a COVID vaccination or
not preoperatively.
(05:34):
Okay. And to highlight that a little
bit more of your method.
So you guys looked at patients
at your single academic center
right?
From February 2021
to May 22.
So this was completely retrospective
review, is that right?
Yeah, absolutely.
So. Was completely retrospective.
And certainly the the
(05:56):
cut off date was a little bit
challenging and required
a little bit of forethought.
We chose around three months after
the FDA had approved
for emergency use, the first COVID
vaccination.
So three months after that date was
around February 2021.
And that's when we started including
patients who received a kidney
transplant.
(06:16):
Okay, great.
Well, let's let's dig into the
findings a little bit.
So tell us.
Yeah, just kind of summarize for us,
for our listeners who maybe haven't
had a chance to read your paper yet,
what did you guys find?
Yeah. So as you mentioned, this was
a retrospective cohort study
for around a 15 month period.
We looked at all patients who during
(06:36):
that time period had a deceased
donor kidney transplant.
So it is important to highlight
some of the exclusion criteria
and the patients that we did
ultimately exclude, those
including patients who underwent
living donation,
and certainly happy to talk about
the reasons why we excluded those,
but we also excluded patients who
(06:58):
had simultaneous organs,
so underwent a liver or kidney
at the same time or heart/kidney,
or patients who actually had
multiple transplants during that
study period, as well as
pediatric patients.
So those younger than 18 years old.
Ultimately, we included 301
patients in our study.
Around 40% of those were female.
(07:20):
And in total, patients spent around
two and a half years on dialysis
during that time frame.
Looking at the vaccinated versus
unvaccinated group, 78%
were vaccinated.
And, you know, I'll just pause here
for a second and say how we
define vaccinated, because I think
that's also important to include in
some of our methods.
Certainly we we included
(07:41):
patients at a time where vaccination
was quite early, so we decided
to denote patients as vaccinated
if they had received one or
more doses of any mRNA
or FDA approved vaccine.
So they didn't have to have their
completed full set of mRNA
vaccines. They just had to have at
least one dose, and we included
that as vaccinated.
(08:02):
Thank you for clarifying that,
because you're right. At what point
do you start looking at this?
Do you really expect people to
have kind of gotten the information
they think they need to make that
decision? So it was interesting.
You gave people, you know, really
even really kind of over three
months, if you think about the lead
up information about that vaccine
coming.
(08:23):
I do want to ask a little bit about
why you excluded your living
related, because I would think that
there might have actually been some
patterns there with
people who are donating
who maybe didn't want to
undergo the vaccine as well as the
recipient. I was just curious there.
Yeah. We found looking at our
data retrospectively, not including
(08:43):
this study, but in other studies
that our living donors
are a very different patient
population than many
of our deceased donors.
They're often younger.
Their socioeconomic statuses are
different.
The race, the racial breakdown
of these patients are often
different and
just for the sense of reducing
(09:05):
as much bias in our study as
possible, we decided to exclude
them.
Around 80% of our patients at
our transplant center are deceased
recipients.
So even with excluding these living
donors and living recipients,
we we felt that we had a pretty
good, robust dataset
to choose from.
Okay.
Well, so overall, you
(09:27):
had, like you said, just slightly
over 300 at 301 patients
who were in the study, 234
were vaccinated.
Again with that definition of having
received one dose, 67
were unvaccinated.
So let's talk about nonadherence.
What did you all find after
the end of the study period?
(09:48):
So, you know, I'll start off
and say nonadherence is certainly
difficult to define.
And there's many ways that,
you know, studies have looked at
kind of patient, nonadherence and
adherence in previous studies.
Most of the transplant literature
when looking at this data, looks
at the number of subtherapeutic
tacrolimus troughs.
(10:08):
So the main immunosuppression
that we use in transplant
as well as the number of times that
patients will show up to their
clinic visit.
So we felt that these were kind of
the best surrogate markers
that we had, certainly
not a perfect, perfect
match for compliance, but kind of
the best that we had available.
So what we found was pretty
(10:29):
incredible.
Looking specifically at the
vaccinated and non-vaccinated
cohort, the non-vaccinated
patients had an increased number
of average number of clinic visits
missed, as well as an
increased average number
of subtherapeutic tacrolimus
troughs.
Looking at the data a little bit
differently, around 50%
(10:50):
of non-vaccinated patients missed
three or more non-clinic visits
as
compared to only around a fourth or
25% of the vaccinated
patients.
So quite a stark, stark
difference between the two groups.
Yeah, that's really what I think got
me too when I was looking through
this, because they're statistically
(11:10):
significant.
But then you're like, well, if they
missed one more appointment and or,
you know, they had one,
you know, increased number of
troughs, but really you're talking
about 28%,
which still, though I was struck by,
was a pretty high number of patients
that missed three
or more.
I mean, again, this wasn't one or
(11:31):
two visits that they missed.
You really. You know, you looked at
three or more post-op visits,
who missed and you had 28%
who missed three or more in your
vaccinated group compared
to almost 50%
missed at least three
clinic visits in your unvaccinated
group. And then
we start looking at those levels,
(11:51):
too. And it was let's
see here I've got it, 1.7
on average
subtherapeutic
FK levels on
your vaccinated group versus
4; 3.9.
Again, that was that wasn't subtle.
Were you surprised by this finding
at all?
(12:12):
Yeah, absolutely.
You know, going into the study, we
knew that noncompliance was a major
factor in all of our deceased kidney
transplant patients.
So as I think I've previously
mentioned it, but other studies
have showed that as many as 25 to
30% of patients are nonadherent
to their post-operative medication
regimens.
(12:32):
And also other studies have shown
that 35 to 40% of
graft losses are actually attributed
to this, nonadherence.
So we certainly thought that we
would see quite a bit of
nonadherence and subtherapeutic
tacrolimus troughs.
We just weren't expecting that the
non-vaccinated cohort to even have
more significant
burden of nonadherence
(12:54):
than kind of the baseline average
deceased donor kidney transplant
patient.
Well, let's kind of do this layer by
layer. So first I'm going to say
let's talk about nonadherence
just in general.
So unrelated to this paper
with, you know, COVID
and the vaccine, we're going to come
back to that.
But what has been found, what
(13:14):
is your center trying to do to
understand why it's happening
so we can improve this?
I mean, we're talking about people
are, there there are barriers
there that are causing people
to not be able to
or not maybe even understand the
importance of this
follow up and the medication
compliance.
So what strategies do you all have
(13:35):
in place?
You know, where where is your center
with all this and trying to just get
it better overall?
Yeah, that's that's kind of the
million dollar question.
Compliance is certainly very
challenging and is also
what has been kind of
pitched as dynamic.
So noncompliance can certainly be
(13:56):
isolated.
It can be recurrence or repeated.
Many times if it's isolated,
it usually doesn't lead to a
problem. But where we really find
issues is that the recurrence
or the repeated levels of compliance
is what leads to recurrent
hospitalizations, ultimately
decreased renal function and
then eventual graft loss.
(14:17):
To date, there's really been no
smoking gun that's been found.
It's really a combination of
socioeconomic and disease related
factors, healthcare organizational
barriers, and therapy related
factors kind of all interlinked
to create this web of noncompliance
and eventual graft loss.
Some of the ways in kind of the
Midwest population, some of the
(14:39):
challenges that we have is many
of our patients are from a very
rural area.
We have a very, very large catchment
area all the way from kind of the
southern aspect of our state down
to Arkansas and all the way up to
Chicago and 3 to 400
miles around.
So we are very fortunate that we
have robust clinic coordinators
and nurse coordinators that are able
(15:00):
to reach out to patients, get in
touch with them and can actually
visit them locally to discuss
some of the factors to help to
improve their compliance. During
COVID period and early
vaccination, all patients
had the opportunity to meet with
their coordinators, and all
coordinators stress multiple
times throughout that waiting list
process to go to their local
(15:22):
healthcare agency to get a COVID
vaccination.
There certainly wasn't a difference
in the amount that we pushed
patients to get COVID vaccinations,
depending on where they lived.
But certainly, as you can imagine,
there's many socioeconomics and
disease related factors and
geopolitical barriers that patients
faced.
For sure. I think, you know, COVID
really highlighted that for us.
And I think that that it is really
(15:44):
a bit of what struck me with this,
because when I think about our
patients who chose
not to get the COVID vaccine,
you know, you can you can understand
it to a certain extent, right.
There was so much, and is
so much bad information
out there about the COVID
vaccine and side effects.
(16:04):
And it it also it became
politicized, unfortunately, for
a lot of people.
And so the reasons for
people choosing to not
get vaccinated, to me,
I can work through, you
know, that they seem a little bit
obvious, you know, in a sense.
But I guess for me, it was almost
taking that leap of
that's an indicator
(16:26):
for additional
or potential future nonadherence
to something that isn't COVID
related.
In other words, the fact that there
was bad information out there about
COVID, how did that impact
people's decisions to get their
blood drawn or to take their
medication for their kidney
transplant, which as you stated
again with your methods, these
(16:47):
recipients, these patients were
on dialysis for an average of two
and a half years before
their transplants.
In other words, they've been dealing
with just the crushing has
to be reality of
their kidney failure for years.
So, you know, where do you where
did you see that overlap or
(17:08):
why do you think that is?
Why do you think that a decision
that seems like it should be
completely independent of their
behavior after a kidney transplant
didn't seem like it really was?
Do you have any theories on that?
Yeah, it's it's certainly
complicated.
As we mentioned before, I think the
politicalization of COVID
vaccination makes it challenging
(17:29):
for many of our rural patient
populations.
I think if you look at our patients
as compared to maybe some of the
other larger transplant centers
around the country, maybe on the
coasts, we cater towards
a much more rural population,
a much more conservative population
that has typically been associated
with some barriers against the COVID
vaccination.
You know, one of the things that
(17:49):
we're looking into in the future
in some of these prospective works
that we're doing as follow up is
some of the geopolitical barriers
that our patient populations have
faced. So their education status,
their higher degree status,
as well as their average income
and potentially some of their
political swings as well to see
if there was a relationship between
(18:10):
those.
While we we don't want this to
be a blame game or to
say that these patients should not
be getting the organs, what we want
to do is potentially identify
patients who are at greater risk
for having issues postoperatively.
So we know that maybe one
nonadherence episode may not
lead to any difference in short term
(18:30):
outcomes, but as these nonadherences
is repeated over and multiple period
or a long period of time on several
levels, this patient is at risk
for losing their graft.
So our goal is to really look at any
surrogates that can tell us that
patients are at risk, whether
this be preoperative COVID
vaccination, that would be great.
So that the fact that we can really
(18:50):
identify these patients so that our
transplant coordinators follow up
with these patients more and really
look at any psychosocial screening
prior to transplantation to improve
the outcomes for this type of
patient is our true goal.
Absolutely.
I mean, I think that came across
very well in the paper that, you
know, really it's just like
any other high-risk marker for a
(19:12):
poor outcome.
How can we find it so that
we can deliver the solutions
and deliver the support that these
patients need? Because their
goal is our goal and our goal is
their goal. You know, we're on the
same team with this, in that they
want to live a long, healthy life
and we want to give them the means
to do so.
And I agree with you.
(19:34):
I think that this is just
another effort trying to figure
out who needs what
in order to get us to the same goal
and get us across the finish line.
What do they need and how do we get
them there? It may not look the same
for every patient that
has these episodes of nonadherence.
So I, I really applaud
you all on your efforts on
(19:56):
this really important
topic and approaching
it really in a in a novel
way.
Thank you so much for your time
today. This was just great.
We really appreciate you
and all your efforts and taking
the time to discuss your recent
article. And thank you to our
listeners as well.
If you happen to have any feedback
(20:17):
for us here at The Operative Word,
please drop us a line at
Postmaster@facs.org.
Thank you very much, Dr. Coleman,
for your time and the efforts
putting this together.
And if anyone would like to reach
out for further questions, I'm
certainly available by email or
phone at any time.
Thank you. See you on the next
episode.
(20:38):
Thank you for listening to the
Journal of the American College of
Surgeons Operative Word Podcast.
If you've enjoyed today's episode,
spread the word on social media by
using the hashtag
#JACSOperativeWord.
Subscribe to The Operative Word
wherever podcasts are available
or listen on the American College of
Surgeons website at
facs.org/podcast.
Welcome to The Operative Word,
a podcast brought to you by the
Journal of the American College of
Surgeons.
I'm Dr. Jamie Coleman, and
throughout this series, Dr. Dante
and I will speak with recently
published authors about the
motivation behind their latest
research and the clinical
implications it has for the
practicing surgeon.
(00:22):
The opinions expressed in this
podcast are those of the
participants and not necessarily
that of the American College of
Surgeons.
Welcome to The Operative Word, a
podcast from the Journal of the
American College of Surgeons.
I'm Dr. Jamie Coleman, one of your
hosts for the series.
In this episode, I am joined by Dr.
Bradley Kushner, and we
(00:43):
will be taking an in-depth look into
his current article, COVID
Vaccination Status and Operative
Outcomes After Kidney
Transplantation.
Dr. Kushner is a general surgery
resident at the Washington
University School of Medicine in
Saint Louis, Missouri.
Dr. Kushner, welcome to The
Operative Word.
Dr. Coleman, thank you so much for
(01:03):
having me.
Truly a pleasure to be here and
really excited to share
our work with
JACS and the rest of the community
on COVID vaccination and patient
adherence.
Great. All right.
So before we get into it, because
we're definitely headed there, do
you have any conflicts of interest
that you would like to disclose?
No, I do not personally have any
(01:24):
conflicts of interest, and no
authors on the paper who
were affiliated with the work also
have no conflicts of interest.
Perfect.
All right. Well, first,
congratulations on the paper and
its publication.
It's always a big moment for all of
us, and I think especially too when
you're still in training.
But what really stuck out to
(01:45):
me for this is that
I feel like it's really adding
a unique aspect
to our COVID
literature.
We've got great papers that have
come out and have really talked
about outcomes, but kind
of as it relates to having a
coinciding COVID
infection.
But this paper, it's it's different.
(02:05):
I can't wait for our listeners to
hear about it.
So to back up a little bit, as we
know, someone who's receiving
or undergoing an organ donation,
it's really a lifelong commitment.
I mean, it requires a lot of
follow ups and compliance
with medications, lab draws
and office appointments.
And in your paper, what we're really
(02:26):
talking about is patient compliance.
In other words, how potentially
our patients decisions regarding
the COVID vaccine may
give us some insight or tell us a
little bit about their compliance
with other non-COVID related
decisions with their
healthcare.
Can you just start by telling us a
(02:46):
little bit about this concept and
the idea behind your paper?
Yeah, absolutely.
So you hit the nail right on the
head. Kidney transplantation
is the best available treatment that
we really have for patients with
end-stage renal disease; it provides
them extra quality of life years
and improved quality of life
in general.
However, promoting graft longevity
(03:08):
and preventing this
allosensitization is truly a huge
problem and requires patients
to be really compliant with these
medication regimens, these
lab draws, so that these
organs can last them quite a while,
even upwards of 15 to 20 years.
Unfortunately, patient adherence
in this population in general is
notoriously low.
(03:28):
Around 20 to 35%
of patients actually struggle with
adherence.
Oh, wow.
So let's let's pause there for half
a second. And so over
one quarter or about one
quarter, it's even almost one third
of patients struggle with
compliance.
And can you tell us a little bit how
that relates to
the survival of their
(03:49):
kidney transplant?
Yeah, absolutely.
So we know that in general,
patients who have medication
non-adherence and non-compliance,
are directly at increased
risk for late rejection.
Graft loss secondary to nonadherence
is the predominant cause of antibody
mediated late rejection and
confers a 5 to 7 fold
(04:11):
increased risk of graft loss.
So in general, even throwing
COVID vaccinations and
COVID infections general out of the
window, really identifying patients
who are at risk for noncompliance
is is critical for
having these grafts survive to
their fullest extent.
And so that was how you started with
(04:32):
this. I mean, because really, like,
how did it come to you and come
to your group of investigators that,
hey, we should look at
COVID vaccines?
Because my understanding is that
most centers now actually require
their patients to get a COVID
vaccine. Is that what you found
in the study?
Yeah, Yeah, exactly.
(04:53):
So we're one of the only centers in
the country that at the early part
of the pandemic, were actually not
requiring our patients to get a
mandatory COVID vaccine before
their transplant.
And many, many centers have actually
executed that.
As for this very reason,
that if there's any risk of
COVID related injury to the organ,
(05:13):
you want to be sure that they
reduce that risk of injury
as much as possible.
So we had a really unique
opportunity at WashU to look at
these differences in
organ survival and patient adherence
based on the fact that we
allowed patients to decide whether
they received a COVID vaccination or
not preoperatively.
(05:34):
Okay. And to highlight that a little
bit more of your method.
So you guys looked at patients
at your single academic center
right?
From February 2021
to May 22.
So this was completely retrospective
review, is that right?
Yeah, absolutely.
So. Was completely retrospective.
And certainly the the
(05:56):
cut off date was a little bit
challenging and required
a little bit of forethought.
We chose around three months after
the FDA had approved
for emergency use, the first COVID
vaccination.
So three months after that date was
around February 2021.
And that's when we started including
patients who received a kidney
transplant.
(06:16):
Okay, great.
Well, let's let's dig into the
findings a little bit.
So tell us.
Yeah, just kind of summarize for us,
for our listeners who maybe haven't
had a chance to read your paper yet,
what did you guys find?
Yeah. So as you mentioned, this was
a retrospective cohort study
for around a 15 month period.
We looked at all patients who during
(06:36):
that time period had a deceased
donor kidney transplant.
So it is important to highlight
some of the exclusion criteria
and the patients that we did
ultimately exclude, those
including patients who underwent
living donation,
and certainly happy to talk about
the reasons why we excluded those,
but we also excluded patients who
(06:58):
had simultaneous organs,
so underwent a liver or kidney
at the same time or heart/kidney,
or patients who actually had
multiple transplants during that
study period, as well as
pediatric patients.
So those younger than 18 years old.
Ultimately, we included 301
patients in our study.
Around 40% of those were female.
(07:20):
And in total, patients spent around
two and a half years on dialysis
during that time frame.
Looking at the vaccinated versus
unvaccinated group, 78%
were vaccinated.
And, you know, I'll just pause here
for a second and say how we
define vaccinated, because I think
that's also important to include in
some of our methods.
Certainly we we included
(07:41):
patients at a time where vaccination
was quite early, so we decided
to denote patients as vaccinated
if they had received one or
more doses of any mRNA
or FDA approved vaccine.
So they didn't have to have their
completed full set of mRNA
vaccines. They just had to have at
least one dose, and we included
that as vaccinated.
(08:02):
Thank you for clarifying that,
because you're right. At what point
do you start looking at this?
Do you really expect people to
have kind of gotten the information
they think they need to make that
decision? So it was interesting.
You gave people, you know, really
even really kind of over three
months, if you think about the lead
up information about that vaccine
coming.
(08:23):
I do want to ask a little bit about
why you excluded your living
related, because I would think that
there might have actually been some
patterns there with
people who are donating
who maybe didn't want to
undergo the vaccine as well as the
recipient. I was just curious there.
Yeah. We found looking at our
data retrospectively, not including
(08:43):
this study, but in other studies
that our living donors
are a very different patient
population than many
of our deceased donors.
They're often younger.
Their socioeconomic statuses are
different.
The race, the racial breakdown
of these patients are often
different and
just for the sense of reducing
(09:05):
as much bias in our study as
possible, we decided to exclude
them.
Around 80% of our patients at
our transplant center are deceased
recipients.
So even with excluding these living
donors and living recipients,
we we felt that we had a pretty
good, robust dataset
to choose from.
Okay.
Well, so overall, you
(09:27):
had, like you said, just slightly
over 300 at 301 patients
who were in the study, 234
were vaccinated.
Again with that definition of having
received one dose, 67
were unvaccinated.
So let's talk about nonadherence.
What did you all find after
the end of the study period?
(09:48):
So, you know, I'll start off
and say nonadherence is certainly
difficult to define.
And there's many ways that,
you know, studies have looked at
kind of patient, nonadherence and
adherence in previous studies.
Most of the transplant literature
when looking at this data, looks
at the number of subtherapeutic
tacrolimus troughs.
(10:08):
So the main immunosuppression
that we use in transplant
as well as the number of times that
patients will show up to their
clinic visit.
So we felt that these were kind of
the best surrogate markers
that we had, certainly
not a perfect, perfect
match for compliance, but kind of
the best that we had available.
So what we found was pretty
(10:29):
incredible.
Looking specifically at the
vaccinated and non-vaccinated
cohort, the non-vaccinated
patients had an increased number
of average number of clinic visits
missed, as well as an
increased average number
of subtherapeutic tacrolimus
troughs.
Looking at the data a little bit
differently, around 50%
(10:50):
of non-vaccinated patients missed
three or more non-clinic visits
as
compared to only around a fourth or
25% of the vaccinated
patients.
So quite a stark, stark
difference between the two groups.
Yeah, that's really what I think got
me too when I was looking through
this, because they're statistically
(11:10):
significant.
But then you're like, well, if they
missed one more appointment and or,
you know, they had one,
you know, increased number of
troughs, but really you're talking
about 28%,
which still, though I was struck by,
was a pretty high number of patients
that missed three
or more.
I mean, again, this wasn't one or
(11:31):
two visits that they missed.
You really. You know, you looked at
three or more post-op visits,
who missed and you had 28%
who missed three or more in your
vaccinated group compared
to almost 50%
missed at least three
clinic visits in your unvaccinated
group. And then
we start looking at those levels,
(11:51):
too. And it was let's
see here I've got it, 1.7
on average
subtherapeutic
FK levels on
your vaccinated group versus
4; 3.9.
Again, that was that wasn't subtle.
Were you surprised by this finding
at all?
(12:12):
Yeah, absolutely.
You know, going into the study, we
knew that noncompliance was a major
factor in all of our deceased kidney
transplant patients.
So as I think I've previously
mentioned it, but other studies
have showed that as many as 25 to
30% of patients are nonadherent
to their post-operative medication
regimens.
(12:32):
And also other studies have shown
that 35 to 40% of
graft losses are actually attributed
to this, nonadherence.
So we certainly thought that we
would see quite a bit of
nonadherence and subtherapeutic
tacrolimus troughs.
We just weren't expecting that the
non-vaccinated cohort to even have
more significant
burden of nonadherence
(12:54):
than kind of the baseline average
deceased donor kidney transplant
patient.
Well, let's kind of do this layer by
layer. So first I'm going to say
let's talk about nonadherence
just in general.
So unrelated to this paper
with, you know, COVID
and the vaccine, we're going to come
back to that.
But what has been found, what
(13:14):
is your center trying to do to
understand why it's happening
so we can improve this?
I mean, we're talking about people
are, there there are barriers
there that are causing people
to not be able to
or not maybe even understand the
importance of this
follow up and the medication
compliance.
So what strategies do you all have
(13:35):
in place?
You know, where where is your center
with all this and trying to just get
it better overall?
Yeah, that's that's kind of the
million dollar question.
Compliance is certainly very
challenging and is also
what has been kind of
pitched as dynamic.
So noncompliance can certainly be
(13:56):
isolated.
It can be recurrence or repeated.
Many times if it's isolated,
it usually doesn't lead to a
problem. But where we really find
issues is that the recurrence
or the repeated levels of compliance
is what leads to recurrent
hospitalizations, ultimately
decreased renal function and
then eventual graft loss.
(14:17):
To date, there's really been no
smoking gun that's been found.
It's really a combination of
socioeconomic and disease related
factors, healthcare organizational
barriers, and therapy related
factors kind of all interlinked
to create this web of noncompliance
and eventual graft loss.
Some of the ways in kind of the
Midwest population, some of the
(14:39):
challenges that we have is many
of our patients are from a very
rural area.
We have a very, very large catchment
area all the way from kind of the
southern aspect of our state down
to Arkansas and all the way up to
Chicago and 3 to 400
miles around.
So we are very fortunate that we
have robust clinic coordinators
and nurse coordinators that are able
(15:00):
to reach out to patients, get in
touch with them and can actually
visit them locally to discuss
some of the factors to help to
improve their compliance. During
COVID period and early
vaccination, all patients
had the opportunity to meet with
their coordinators, and all
coordinators stress multiple
times throughout that waiting list
process to go to their local
(15:22):
healthcare agency to get a COVID
vaccination.
There certainly wasn't a difference
in the amount that we pushed
patients to get COVID vaccinations,
depending on where they lived.
But certainly, as you can imagine,
there's many socioeconomics and
disease related factors and
geopolitical barriers that patients
faced.
For sure. I think, you know, COVID
really highlighted that for us.
And I think that that it is really
(15:44):
a bit of what struck me with this,
because when I think about our
patients who chose
not to get the COVID vaccine,
you know, you can you can understand
it to a certain extent, right.
There was so much, and is
so much bad information
out there about the COVID
vaccine and side effects.
(16:04):
And it it also it became
politicized, unfortunately, for
a lot of people.
And so the reasons for
people choosing to not
get vaccinated, to me,
I can work through, you
know, that they seem a little bit
obvious, you know, in a sense.
But I guess for me, it was almost
taking that leap of
that's an indicator
(16:26):
for additional
or potential future nonadherence
to something that isn't COVID
related.
In other words, the fact that there
was bad information out there about
COVID, how did that impact
people's decisions to get their
blood drawn or to take their
medication for their kidney
transplant, which as you stated
again with your methods, these
(16:47):
recipients, these patients were
on dialysis for an average of two
and a half years before
their transplants.
In other words, they've been dealing
with just the crushing has
to be reality of
their kidney failure for years.
So, you know, where do you where
did you see that overlap or
(17:08):
why do you think that is?
Why do you think that a decision
that seems like it should be
completely independent of their
behavior after a kidney transplant
didn't seem like it really was?
Do you have any theories on that?
Yeah, it's it's certainly
complicated.
As we mentioned before, I think the
politicalization of COVID
vaccination makes it challenging
(17:29):
for many of our rural patient
populations.
I think if you look at our patients
as compared to maybe some of the
other larger transplant centers
around the country, maybe on the
coasts, we cater towards
a much more rural population,
a much more conservative population
that has typically been associated
with some barriers against the COVID
vaccination.
You know, one of the things that
(17:49):
we're looking into in the future
in some of these prospective works
that we're doing as follow up is
some of the geopolitical barriers
that our patient populations have
faced. So their education status,
their higher degree status,
as well as their average income
and potentially some of their
political swings as well to see
if there was a relationship between
(18:10):
those.
While we we don't want this to
be a blame game or to
say that these patients should not
be getting the organs, what we want
to do is potentially identify
patients who are at greater risk
for having issues postoperatively.
So we know that maybe one
nonadherence episode may not
lead to any difference in short term
(18:30):
outcomes, but as these nonadherences
is repeated over and multiple period
or a long period of time on several
levels, this patient is at risk
for losing their graft.
So our goal is to really look at any
surrogates that can tell us that
patients are at risk, whether
this be preoperative COVID
vaccination, that would be great.
So that the fact that we can really
(18:50):
identify these patients so that our
transplant coordinators follow up
with these patients more and really
look at any psychosocial screening
prior to transplantation to improve
the outcomes for this type of
patient is our true goal.
Absolutely.
I mean, I think that came across
very well in the paper that, you
know, really it's just like
any other high-risk marker for a
(19:12):
poor outcome.
How can we find it so that
we can deliver the solutions
and deliver the support that these
patients need? Because their
goal is our goal and our goal is
their goal. You know, we're on the
same team with this, in that they
want to live a long, healthy life
and we want to give them the means
to do so.
And I agree with you.
(19:34):
I think that this is just
another effort trying to figure
out who needs what
in order to get us to the same goal
and get us across the finish line.
What do they need and how do we get
them there? It may not look the same
for every patient that
has these episodes of nonadherence.
So I, I really applaud
you all on your efforts on
(19:56):
this really important
topic and approaching
it really in a in a novel
way.
Thank you so much for your time
today. This was just great.
We really appreciate you
and all your efforts and taking
the time to discuss your recent
article. And thank you to our
listeners as well.
If you happen to have any feedback
(20:17):
for us here at The Operative Word,
please drop us a line at
Postmaster@facs.org.
Thank you very much, Dr. Coleman,
for your time and the efforts
putting this together.
And if anyone would like to reach
out for further questions, I'm
certainly available by email or
phone at any time.
Thank you. See you on the next
episode.
(20:38):
Thank you for listening to the
Journal of the American College of
Surgeons Operative Word Podcast.
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