October 24, 2018 • 45 mins
Episode 8 of the ISAVE That Podcast sponsored by ETHICON - BIOPATCH features a pair of interesting interviews, first with Dr. Liza Ovington on peripheral IVs and controlling infection and Chuck Ramirez, a JAVA author. Hosts Judy Thompson, Ramzy Nasrallah and Eric Seger chat with these two highly intelligent individuals and provide an update on AVA as a whole as we move toward the end of the year.
0:56 – How is it almost Halloween already? Judy and Ramzy join Eric from Salt Lake City, where they are working with other members of the AVA core staff to hash out budget items for 2019.
6:18 – A word from our Episode 8 sponsor, ETHICON - BIOPATCH
7:16 – We are joined by Dr. Liza Ovington, Medical Director at ETHICON - BIOPATCH to hear her thoughts on infection prevention and infection control with regards to peripheral IVs.
32:20 – Beyond the Manuscript: Eric chats with Chuck Ramirez, Director of Cardiopulmonary Services at Estrella Medical Center in Phoenix, Arizona, about his article on hemodialysis catheter insertion without a chest X-ray. His study is set to publish in the upcoming issue of JAVA.
42:25 – AVA Network Events
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
This episode of ISAVE That Podcast is made possible by
Ethicon BIOPATCH.
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1-selling CHG dressing on themarket is the only antimicrobial
dressing with multiplerandomized controlled trials and
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(00:20):
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For more information, visitethicon.com BIOPATCH: reach more
patients, restore more lives.
Speaker 2 (00:34):
From the Association for Vascular Access.
This is the ISAVE That Podcast.
Ramzy (00:56):
And you have discovered Episode 8 of Season 1 of the
ISAVE That Podcast.
This is Ramzy Nasrallah withAVA.
I am in Salt Lake City, UtahDirector of Clinical Education,
Judy Thompson and Eric Seger,who's joining us from Columbus,
Ohio.
How are we all doing today?
Judy (01:12):
It's great.
Ramzy, good to be here in SaltLake City with you.
It's even a pretty, gorgeous,warm day.
How about you Eric?
Eric (01:20):
It's pretty here, too.
It's not really the warmest, butit's pushing 50 and the sun's
out, so I'm happy.
I have no complaints.
Judy (01:28):
Winner winner.
Ramzy (01:29):
We have, mountains here, but it's mitigated by Judy and I
are doing budget planning for2019 and preparing AVA for its
next a year and trying toeclipse everything that we were
able to accomplish this year.
Like the scientific meeting,which we discussed on the last
episode, which is a nice bridgeto this episode.
We talked about themultidisciplinary membership of
(01:50):
the Association for VascularAccess and we spoke specifically
with with Christie Chapman aboutinfection prevention and
produced the idea for thisepisode to talk a little bit
more about how infectionprevention and Vascular Access
are combined, are really joinedat the hip because the
foundation of everything thatVascular Access is about is
preventing that infection first.
(02:12):
You do no harm.
Sidebar (02:14):
When I came to AVA last year, one of the special
interest groups I wanted tobuild was one specifically for
infection prevention.
I thought that infectionpreventionists should have their
own home within AVA.
And that eventually went awaybecause I came to realize and
from people like Judy, thatinfection prevention needs to be
the foundation of every specialinterest group we have.
It shouldn't be its own house,it should be everyone's house.
(02:35):
So I came to, AVA from Johnsonand Johnson.
I had infection prevention andVascular Access obligations.
They are combined.
Then that's actually the sponsorof this episode is from that
business, from, from Ethicon whowe'll be talking about.
And as I spend time with AVA andas I spent all those years with
J and J, I started to realizeand now embrace that they're
(02:58):
really one department.
Infection prevention hastentacles into so many other
areas of the building of thehospital of patient care.
But we've wrapped VascularAccess decidedly in the, in the
same foxhole with them.
Judy (03:12):
There's few departments within the hospital systems or
medicine that have 100% of thepatients.
And now the data shows thatVascular Access affects 90% of
patients.
Though I have not done thestudy, I've yet to see more than
one or two patients that are notnewborns or psych patients that
(03:32):
don't have an IV.
So between Vascular Access andinfection prevention, we have
everybody.
Ramzy (03:41):
It's the whole house.
Judy (03:41):
So we can't be separate entities.
I think some of the bestimprovement that I've made in my
clinical career was incollaboration with infection
prevention.
I've had some amazing infectionpreventionists to work with and
Vascular Access specialists, butthe collaboration is paramount
and I'm excited about thispodcast and what we're going to
(04:05):
do and talk about the infectionprevention opportunities for us
to even collaborate more.
Ramzy (04:10):
Yes, we've had some great meetings with APIC and as Judy
and I are busily planning 2019and preparing for a much longer
term strategic plan exercise,infection prevention is like our
special interest groups, thefoundation of everything that
we're trying to advance withAVA.
Especially since our taglinebegins with Protect the Patient.
That's where infectionprevention lives.
Judy (04:33):
That is absolutely true.
In fact, APIC was kind enough toinvite myself and a couple other
folks from AVA, to do one oftheir webinars, which is going
to air two days from now.
Ramzy (04:47):
Yes, Thursday.
That's Thursday, October the25th, right?
Judy (04:52):
Yes.
Thursday.
Eric (04:54):
The 25th.
Ramzy (04:56):
For everyone snapping this podcast up right off the
fresh podcast heap, that's twodays from when we're recording.
So you've probably got about 36hours.
Go to avainfo.org, and youshould see it on the website.
Judy (05:11):
On the APIC website is really where you need to be.
Ramzy (05:12):
APIC.org, yes.
And you'll have AVA in APICworking together in tandem to
promote infection prevention.
Judy (05:18):
We're going to be talking about PIVs and bloodstream
infections.
Eric (05:22):
Sounds like it is going to be a really great webinar.
Judy (05:23):
We're really excited about it.
Pretty excited.
So, I'm excited to talk aboutthe speaker that we have on this
podcast as well.
Eric (05:32):
Yeah, well when we return we'll be chatting with Dr Liza
Ovington from Ethicon as Ramzymentioned, the sponsor of this
episode about reducing–
Ramzy (05:41):
Dr.
O!
Eric (05:42):
Dr.
O, yes.
It's a fantastic conversationabout reducing catheter-related
infections and then a little bitlater after that we'll also have
a Beyond the Manuscripts segmentas I have an interview with an
author of an article set topublish in the next issue of
JAVA.
So please everyone stay tuned,and Ramzy and Judy keep it cool
out in Salt Lake City.
Judy (05:58):
We'll try.
Thanks Eric.
Thanks everybody.
Speaker 1 (06:18):
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Eric (07:16):
And welcome back! Now we have the distinct honor of being
joined by Dr.
Liza Ovington, Medical Directorat Ethicon, who plays a part in
all the products that helpinfection prevention and
reducing infection or have animpact on wound healing.
She's responsible for the entireBIOPATCH family.
Dr.
Ovington, thank you so much forjoining us.
I have Judy Thompson, AVA'sDirector of Clinical Education
(07:38):
on the line with us as well asAVA.
Ramzy Nasrallah.
Ramzy (07:41):
Hi, Dr.
O!
Judy (07:41):
Good morning!
Liza (07:42):
Good morning everybody.
Judy (07:43):
Good morning.
Well, it's a pleasure to talk toyou today.
I'm excited.
At our conference, or ourscientific meeting, this year a
big push, many of the topicswere about PIVs and routine
replacement and infectionrelated.
So, very excited to talk to youabout this topic and get your
(08:06):
opinions on it and some of thedata on what's going on up
there.
So, if it's OK with you, let'spop right into it.
Liza (08:14):
Sure thing.
Judy (08:14):
So, there's lots of opinions out there related to
moving to clinically indicatedfor dwell times for PIVs.
What are your views on thepractice implications to that?
Liza (08:26):
Well, I think that the whole debate around routine
replacement of PIVs and movingto clinically indicated
replacement has been, kind ofbeing carried out in the real
world and in the research worldfor, for quite some time now.
And I think the benefits are,are multiple and I think
they're, appropriate and thatthat we want to move to like
(08:50):
reducing unnecessary needlesticks for the patients and
improving the patientsatisfaction, which then effects
as well on staff time, um, andeven supply costs potentially.
So, I think there's definitely alot of benefits to moving to
clinically indicated replacementand many of the studies that
have been done, randomizedcontrolled trials as well as
(09:11):
longitudinal studies that havetried to look at the impact of
that change have said we reallydon't see any impact on some of
those complications of PIV.
Notably phlebitis andinfiltration and also infection.
But I have to say that themajority of those studies, the
primary outcome they werelooking at was the phlebitis
(09:35):
outcome.
And they didn't alwaysdifferentiate between the types
of phlebitis, whether it waschemical and mechanical or
bacterial.
And oftentimes that would havebeen hard to do without
additional analysis.
But, but that was the primaryoutcome.
And everyone seems to be fairlycomfortable with the fact that
if we move from routinereplacement, which has typically
been 72 to 96 hours, toclinically indicated, we're not
(09:59):
going to see a big difference.
And when the studies analyzedhow much longer clinically
indicated the dwell time was, itwasn't that much longer.
I think there've been a numberof studies that says the overall
average dwell time for PIVs ismaybe just over 5 days.
So, We're going from to 3 to 4days to 5 days.
(10:21):
And while I say that those,those improvements are things
that we should aim for, onepotential concern is that the,
the outcome of the PIV-relatedbloodstream infection, or
bacteremia, the data there isnot as strong.
I think what that tells us, thatdoesn't say, well we shouldn't
go for it, we shouldn't, youknow, continue our efforts to go
(10:42):
to clinically indicated.
But it perhaps implies that weought to be taking the same care
to protect those PIV lines as wedo with other lines like central
lines.
And to that end, we can usetechnology to become more
comfortable and provide moresafety around going to that
increased dwell time, especiallyaround the outcome of
(11:03):
bacteremia.
Judy (11:04):
Now, you mentioned the bloodstream infection.
With PIV-related bloodstreaminfection, there's a lot of talk
about it right now but I don'tsee a ton of data on it.
Liza (11:17):
I think that part of the reason is, you know, it's not
mandated necessarily that wetrack or surveil the PIV.
And maybe that will change butthere have been a few.
There's been a lot of opinionand there have been a number of
studies that have tried to lookat or get their hands around, or
(11:37):
arms around what is this rate ofPIV infection.
And I think some of the earliestdata and the reliable data we
can look at was a 2006systematic review by Maki where
he did a paper, he looked at Ithink over 2000 studies and
tried to look at different linetypes and what the, bloodstream
infection risks associated withdifferent line types was.
(11:58):
And I think with PIV it was, itwas relatively low compared
obviously to central lines.
But what we need to take anaccount and looking at kind of a
low infection rate is theprevalence of that type of line.
And when we think about the factthat probably three quarters of
all hospitalized patients end uphaving a PIV– much, many more
(12:22):
patients, you know, are exposedto this type of line than are
supposed to central lines.
And so even a low risk ofinfection could ultimately end
up affecting as many patients asa line with a higher risk, but
lower prevalence in the patientpopulation.
But when people have looked atPIV infections, they do find
(12:46):
that, you know, they're outthere.
It's kind of the scenario, I'moften reminded of the saying
that'you can't only look wherethe light is good.' You got to
look at the other places too.
And so when people have focusedon PIV, they found that we do
see infections and maybe they'rekind of a silent or cause of
(13:06):
some of these infections, someof the better studies have
looked at cases where, you know,there wasn't a central line.
And did that patient have aninfection?
I think Mill published last yearabout increasing the awareness
of the role that PIVs can playin infections.
He estimated that about a thirdof staph aureus infections may
(13:27):
be coming from PIVs.
He found an incidence of about,you know, 0.2% for short term
PIVs, but that accounted forabout 23% of the nosocomial
catheter-related bloodstreaminfection.
So, not central line but relatedto a catheter.
And he did find that as youincrease the dwell time, you
increase the risk of thebloodstream infection.
(13:48):
And this is no different.
When we think about thepathogenesis of bloodstream
infection, we know that theorigin of the most of the
bacteria are from the skin ofthe patient.
And I think that's well acceptedand we know probably the most
about the pathogenesis ofcentral line infections where
you get colonization of thecatheter track and then biofilm
(14:10):
formation on the catheter andthe extra luminal surface.
When you think about thepathogenesis that's really
device agnostic.
From the standpoint of thebacteria that are arising from
the layers of the skin or downin the hair follicles and that
insertion track.
Those bacteria don't know wherethe tip of the line is.
(14:33):
They don't know what it's madeof.
They just know that there's asurface that they can call
colonize.
So, when we think about thelikelihood of infectious risk
with different types ofcatheters, I think we have to
remember that bacteria aredevice agnostic.
They're just thinking of it interms of a surface.
So, other studies that havelooked at, you know the rates of
(14:54):
PIV infection– our companyfunded some research a year or
so ago looking into premierperspective database, where we
looked at patients withperipheral IV lines and we tried
to exclude patients who may havehad a central line.
Then looked at PIV-relatedcomplications and we found that
they were out there, but youdon't necessarily see it unless
(15:16):
you're looking for it.
And I think other investigatorshave found the same thing that
these PIV rates are real thingsout there and they're affecting,
you know, a lot of patients.
In my own home state ofPennsylvania, Davis in 2014
looked at Pennsylvania data from2012 from NHSN looking
(15:37):
specifically for eventsassociated with PIV use.
And he found that primarybloodstream infection was, was
pretty high and it accounted foryou know, a lot of these
bloodstream infections and thesewere in patients that didn't
have a central line but they hada peripheral line.
And we were seeing specificallystaph aureus-related BSI.
(15:57):
So I think this idea of PIVRBSI,and that's a long acronym,
PIV-related bloodstreaminfection, it's a real thing.
Judy (16:08):
Oh, I agree.
I agree.
In fact, I had a prior patientthat had a staph aureus
infection that started at thePIV.
I had placed a PICC in thispatient and the patient actually
got infectious thrombophlebitisand it was a staph aureus bug.
So, to your point, we aren'tgoing to find what we don't look
(16:31):
for.
It used to, people used to justreport the infections in the ICU
and we didn't think we had a bigproblem on the floors.
And lo and behold we have abigger problem on the floors.
So, we have got to start lookingbetter.
Now, you've talked aboutstrategies, technologies to help
reduce this risk of infection.
Is there any BIOPATCH clinicaldata on PIVs themselves?
Liza (16:54):
So, in terms of data that really focused on looking at
BIOPATCH, I'm not aware of anystudies that specifically did a
randomized controlled trialBIOPATCH versus no BIOPATCH and
PIV.
Although you know, we can'texclude that that might be
something that folks do in thefuture.
There is one study that I amaware of where BIOPATCH was used
(17:15):
as part of a bundle and this wasby Michelle DeVries.
She was at Methodist Hospital inGary, Indiana.
And when they were adopting thechange going from routine
replacement of their PIVs toclinically indicated
replacement.
And Michelle was kind of athought leader here and is
published on the topic evenbefore this particular study.
(17:38):
They decided that to enable thischange in practice that they
wanted to go at it with a bundleof interventions to help protect
those lines going to the longerdwell time.
Now, BIOPATCH was part of theirbundle.
And in reality, wheneverBIOPATCH is used in clinical
practice, it's always part of abundle.
Any type of infectionprevention, whether it's looking
(18:00):
at trying to reduce the risk ofCRBSI or surgical site
infections or urinary tractinfections, we're always using a
bundled intervention.
So, we're not just doing onething.
So in, in Michelle DeVries's,they went out with No.
1 and, I think being an educatorat heart, the No.
1 parts of their bundle wasstaff education.
(18:21):
Then they did use BIOPATCHspecifically to, you know,
achieve that continuousantisepsis of the skin around
the insertion site andprotecting against extraluminal
route of colonization of thecatheter.
They went with and I'm not sureif the brand, a securement
dressing because we know keepingthe catheter in place and
(18:42):
preventing pistoning isimportant.
So, they opted for a particularsecurement dressing.
They used alcohol impregnatedcaps to address the intraluminal
route of infection.
And they used an integrated,closed IV catheter system and
sterile gloves.
Because one of the things thatsome of the previous studies
have found, not Michelle's work,but some previous studies
looking at PIV infection ratesand the types of pathogen, they
(19:08):
found, not surprisingly, thatstaph aureus was most common
pathogen, but in one study theyalso found a lot of E.
Coli as a pathogen.
And so that tended to imply thatmaybe hand washing and skin prep
and things, wasn't as stringentmaybe in PIVs other types of
lines.
So, they went the sterilegloves.
And with this bundle, they foundthat their hospital after a year
(19:31):
of tracking their data, thatthey achieved a 19% reduction in
their PIVBSI rates and even a34% reduction, 34-37% reduction
in their laboratory confirmedBSI overall.
So, including central lines.
So, I think that just kind ofspeaks to focus on a problem.
And I think importantly thatpart of the bundle of staff
(19:52):
education and raising awareness,I think people just kind of step
up their game overall.
But they did see, like I said, a19% reduction in the PIVBSR
rates, but even a reductionoverall in all their line rates.
Judy (20:05):
That's impressive and I've seen the practice out in the
country and it varies.
There's some people that arejust absolutely spot on, perfect
placing PIVs but I think thoseare the exception, not the rule,
unfortunately.
And I hope in the days coming wewill see sterile bundles for PIV
and I know that's something thatmany people are looking at, but
(20:27):
I hope it continues.
If there were putting in my IV,I'm gonna ask for a sterile
insertion.
Liza (20:33):
Absolutely.
I mean I think the key isawareness and, and the
publications and podcasts likethis one and the debate I think
is all a good thing because itdoes raise the awareness.
I always kind of put it to whatI call the'Mom Test.' Like if my
mom was receiving thisintervention, what would I want
my mom to get if she was in thehospital?
If she got a central line orshe's had a surgery or if she
(20:54):
had a PIV.
I think about it in those terms.
I think we all would want ourmom to have a PIV bundle, you
know, to try to address allthose potential routes of
infection.
So, you know when there'sdebate, I think it raises
awareness and where there'sawareness that increases
attention.
Eric (21:11):
Speaking for myself, I think that my mom, I would like
her to have the best carepossible.
So, I think you're correct, Dr.
O, on that.
Ramzy (21:23):
I want your mom to have the best care too for sure.
That study from Chellie isprofound to me, and we've talked
about this on prior episodes ofthe podcast.
Chellie is a friend of thepodcast, she actually was on a
couple of episodes ago, but byhaving this focused intervention
specific to peripheral IVcannulas, they've reduced their
central line infection rate.
Which tells you when you'regetting your house in broken
(21:44):
into, it's not always to thefront door.
Sometimes it's coming in throughthe window.
Judy (21:48):
Yeah, it makes me laugh at times when people say'it's just
a PIV.' Well, it's in thecirculatory system.
What does that mean?
It goes just like you said, itdoesn't matter what device it
comes in on, the bugs like totravel.
Liza (22:00):
Right and at the end of the day, it's a portal of entry.
I also take care of, we haveantimicrobial sutures, which are
aimed at trying to addresssurgical site infection risks.
But you know, when I think aboutthat, it's like, our skin and
that was trained bydermatologists, long ago.
(22:22):
And the skin is an amazing organand it's our barrier between us
and the outside world, ourbarrier between us and bacteria.
And while bacteria can live veryhappily on our skin when it's
intact and we have, you know,normal flora commensal flora,
whatever you want to call it.
When we have a break in thatskin integrity, that's a portal
of entry, that's a place forthem to get in.
(22:46):
And you know, whether that, thatbreak was caused by a central
line or a peripheral line, abreak is a break.
And like you said, it's allgoing into the circulation.
That's where I thinktraditionally we have focused,
started our focus on where therisk was highest, in the ICU and
in the central lines.
But again, when we go back andthink scientifically about the
(23:08):
pathogenesis of infections ingeneral, and vascular-related
infections specifically, again,I keep bringing up the fact that
bacteria are device agnostic.
They've just found a portal ofentry and they're not really
thinking in any way about whattype of device caused that
portal they've just got a way innow.
Judy (23:26):
True.
Now, you spoke a little bit agoabout how you didn't know of any
specific studies that addressBIOPATCH and PIVs.
What size of trial would it taketo prove the efficacy of
BIOPATCH and PIVs?
Liza (23:41):
So, I think, when we think in general about any type of
study to look at infections,thankfully healthcare-associated
infections are relatively lowfrequency.
They typically have highmorbidity.
But when we're talking aboutfrequencies in the 1-2% range or
(24:02):
even lower, what that means isin order to power your study to
have enough patients enrolledthat you're going to see the
outcome, it's hundreds, maybeeven thousands of patients.
And then to see a differencebetween your control and your
intervention, you need even morepatients.
(24:24):
So, we're probably talking, youknow, 1500, 2000, maybe even
more patients to be able tovariance the complication that
we're trying to reduce at a highenough rate that then we could
even detect a difference.
So it would be a large study.
Judy (24:40):
It sounds like it, it sounds like it.
Now, one more question for youbefore we let you go and we
thank you so much for all yourvaluable time you're spending
with us.
What about PIVs, the data forPIVs and other antimicrobial
dressings designed to reduce theBSI risk?
Liza (25:00):
Sure.
And I think, I'm sure ourlisteners are aware of other
antimicrobial dressings on themarket for catheter sites.
I think one of the things weneed to think about is, you
know, an antimicrobial is not anantimicrobial it's not an
antimicrobial.
I'm a chemist by training, I'man organic chemist by training.
So, when I think aboutantimicrobials as chemicals, we
(25:23):
have to consider not just whatit is, but where it's being
designed to have an effect.
And so when we talk aboutcatheter site dressing, we're
thinking about antimicrobialsthat work well on the skin
versus in deeper tissue or on anon-living surface.
We can think of lots ofantimicrobials.
So, in the world ofantimicrobial dressings, we know
(25:45):
we've got chlorhexidine asantimicrobial.
We've got polyhexamethylenebiguanide as an antimicrobial.
We've got silver antimicrobials.
You could kind of drop otherchemicals in the mix.
And so when I try to monitor thedata, no other data specifically
in the realm of PIV-relatedinfections.
(26:06):
Now, that could be due to thefact that, as we've just
discussed, as a community, we'remaybe just early in evolution of
looking at and monitoring andsurveilling PIV-related
infections.
But we haven't seen data fromother antimicrobial dressings.
And I think we also have to becareful in terms of taking data
(26:27):
with a simplifications forpractice.
When I think about particularlymedical devices like, like
antimicrobial dressings, youknow, I don't necessarily think
we can use the data from oneproduct to justify the use of
another product.
Because medical devices, unlikedrugs, when we think about in
pharmaceutical, there'ssomething that I think we're
aware of called the classeffect, right?
(26:48):
We think of classes ofantibiotics.
Classes of oncology drugs, drugsthat may be different
chemically, but they actsimilarly in the body.
That's more accepted in the drugworld.
Although I don't know that it'seven a 100% true there, but it's
(27:08):
this class effect, I don't thinkapplies to medical devices
because they're much morecomplicated.
When we think about say taking adrug, taking a tablet, the
interaction between thehealthcare provider and the drug
and the patient and the drug isminimal.
You know, you write yourprescription, the doctor writes
the prescription, the patientgets it filled and then they
(27:29):
swallow the drug and that's it.
When we think about medicaldevices, you know there's an
interaction that takes placebetween the healthcare provider,
who's usually applying.
When we think about theseantimicrobial dressings, a
healthcare provider is applyingthe dressing to the patient and
then the patient is wearing thisdressing over time.
(27:50):
And then then there's thecomplexity of the dressing
itself.
It has the dressing components,it has the antimicrobial and
what does that specificantimicrobial on?
How is it being released fromthe dressing and contacting the
skin in order to do its job ofantisepsis of the skin?
So, I think that the classeffect doesn't exist for medical
(28:11):
devices.
And so I think even though a lotof our clinical practice
guidelines try to be brandagnostic when they make
recommendations on when we lookat evidence-based
recommendations for infectionprevention, even if all the
studies have been on oneparticular device, in the
interest of not playingfavorites, the evidence-based
(28:32):
committees try to genericize thedescription of that device.
But I think as, as practitionersor as scientists, we need to
remember that, well, you know,one antimicrobial dressing isn't
necessarily the same as anotherantimicrobial dressing.
Even when they have the sameingredient, or different
ingredients because of thoseinteractions that I mentioned
(28:53):
between the healthcare providerapplying the product and the
patient also interacting withthe product during, it's wear
time that there can bedifferences that have have
effect on safety and performanceof the device.
Judy (29:06):
Well, I fibbed a little bit when I said it was my last
question because listening toyou, I have another question for
you! So, if I were a clinicianevaluating products and I have
products X, Y and Z.
Based on what you know, what amI going to go look at to go
evaluate whether I want to gouse a BIOPATCH or a widget or a
(29:26):
wadget, so to speak?
Liza (29:28):
Well, so I think you have to look at the information that
the manufacturer can provide.
And I think one thing that allmanufacturers can provide and
should and I think can provideabout the product is I call
proof of concept.
In other words, if it's anantimicrobial dressing, show me
the proof of concept that you'vegot an antimicrobial in it.
(29:49):
Tell me about antimicrobial.
Does it work in a controlledsetting, like a laboratory in a
petri dish data?
Does it work and if it'sapplicable, animal studies, give
me some interaction studies?
Tell me how the people who areusing it like it, handling
studies.
So healthy volunteer studies,that sort of thing.
(30:11):
Everybody can give you that dataand kind of educate yourself
about how this product might ormight not work in your hands and
in your patient population.
But ideally, and I think themost important to any clinician
or scientists as well is what'sthe end use data?
In other words, where's yourclinical data?
Where are your clinical studies?
Were their clinical studies andthe types of patients that I
(30:32):
treat?
If you're working with elderlypatients, with very thin skin or
if you're working in the NICU orif you're working even in
different climates sometimes,you want to see what is the
clinical data?
And does it, does it pertain to,to my practice?
And I think at the end of theday that that's the feather in
(30:53):
the cap.
All the proof of concept data isgood, but you've got to have
that clinical data.
Judy (30:59):
Perfect.
Thank you.
Well, you're a wealth ofknowledge and it's great
listening to you and hearing youtalk about this product, your
product, but also just the PIVpractice as a whole.
Do you have any other words youwant to pass on to us?
Liza (31:16):
No, just in the overall scope of thinking about
intravascular devices, I thinkwe have a tagline at Ethicon: We
say,'Protect all lines.' I thinkthat there's a lot of technology
that's been developed over timeand utilized very successfully
in protecting central lines.
And I think that we do have as aclinical community, a lot of
(31:41):
things to choose from anddesigning a bundle like Chellie
DeVries did to protect ourperipheral lines as well.
Judy (31:49):
Very good.
I can't thank you enough foryour time.
I appreciate it.
Liza (31:53):
Oh, it's my pleasure.
Eric (31:54):
Yes.
Thank you Dr.
Ovington.
That was amazing.
Ramzy (31:57):
Thanks, Dr.
O.
Liza (31:59):
You're very welcome.
Eric (32:20):
And welcome to the Beyond the Manuscript segment of this
episode of the ISAVE ThatPodcast.
I'm Eric Seger, JAVAEditor-in-Chief and I have the
pleasure of being joined byChuck Ramirez, who is the
Director of CardiopulmonaryServices at Banner Estrella
Medical Center in Phoenix,Arizona.
And he's going to chat with me alittle bit about his article
titled, Hemodialysis CatheterInsertion Without A Chest X-Ray:
(32:41):
Review of a 24-Month Study.
So Chuck, how are you doing thismorning?
Thanks for joining us.
Chuck (32:47):
Good morning.
I'm doing fine.
Eric (32:48):
Yeah, happy to have you here.
Now as I understand, sort of thepremise of your study was
hemodialysis catheter insertionand you guys used the dual
vector positioning system, butyou did not have a post-chest
X-ray for validation.
As I understand, you and yourteam have been using this
technique for a few years now,correct?
Chuck (33:06):
Yes.
Yeah.
We're, at about three years now.
Eric (33:10):
And what was sort of the idea to do this and to come up
with or to perform this specificstudy and to record this data?
Chuck (33:19):
So, we've been using, we've been inserting, PICC lines
obviously for decades.
And we were, we were doing acentral line insertions since
about 2007.
So early on we got, we startedusing a tip locating device for
our PICC lines.
And we went to the process thateverybody else did, did some
(33:41):
validation.
And over the years that has justbecome the standard in and PICC
placement where we just don'ttake X-Rays anymore.
Success rates are really well,positioning is good and all the
issues that were around PICCplacement and not taking an
X-Ray kind of all went awaybecause it was highly
(34:02):
successful.
Yeah.
So, fast forward, several yearsor so now we've had a lot of
years placing central lines ofvarious types.
We primarily do the IJinsertions, Internal Jugular.
We do have the ability to dosubclavians, but we only have a
(34:24):
couple of people that arechecked off on it.
And there's just such a higherrisk with it, of catheter
complications that almosteverybody, even though we have a
few people that were validated,very, very frequently used.
So from the IJ perspective, wejust did not have very many
complications.
I mean, we just didn't have anycomplications.
Once in a while, we had trouble,placing a catheter.
(34:46):
Wouldn't draw blood.
We take an X-Ray.
It was just a positioning issue.
But we never had anypneumothorax issues or any
hemothorax issues, which is themain complication associated
with central line placement.
So, after many years of the PICCplacement going well and really
no complications associated withcentral lines, we went to our
(35:07):
medical team, ICU medical team,and said, why don't we start
placing these with atip-locating case system and
that do this X-Ray?
We're taking X-Rays routinelyand they don't, they never come
back with any problems.
And there's a lot of issues withcorrect placement with a X-Ray.
(35:32):
Because one radiologist toanother will interpret the tip
location differently.
For the most part, theradiologist is pretty concerned
as long as they're in the SVC,doesn't have to be in the distal
end.
As long as it's in the SVC, theycall it good.
So optimal placement, maybe notbe there 100% of the time.
(35:52):
So, after that discussion we puttogether this process and had a
couple of team meetings aboutit.
That's kind of how we gotstarted.
Just because it didn't seem likeit was necessary and we could
probably get better placement.
And then the other issue was,because we insert double lumens,
(36:12):
triple lumen central lines aswell.
So, the other issue was we do wego to all catheters or do we
just focus on one particularcatheter and limit the
variables.
So, that was the other decision.
Hemodialysis catheters are verypositional– really, you want
them to be tipped into theatrium a little bit.
(36:33):
So, tip location is at a higherpremium.
So, we thought maybe thedialysis catheter would be the
catheter that we would, that wewould focus on.
So, that's kind of how we gotstarted.
And that's why we picked thatcatheter because we want an
optimal tip positioning of thedialysis catheter.
Eric (36:51):
Did you run into any, once you've got your study going, did
you run into any issues?
I think I read in yourmanuscript, you had one instance
of CLABSI to hemodialysiscatheter, correct?
Chuck (37:04):
Yes.
Yeah.
So, out of all the cathetersthat we inserted, I think it was
448 catheters during that periodof time, we only had 4 catheters
that could not get placedcorrectly.
Two of them just were, we endedup getting X-Rays.
Two of them were just in thedominant vein and had to be
advanced forward.
And then two of them, wecouldn't figure out where they
(37:25):
were at.
They appeared to be in some kindof a false track maybe.
They weren't arterial, but theyweren't in the right place,
either.
So we ended up just pullingthose catheters.
There was no subsequent issueswith chest tubes or anything
like that.
We just put in a new catheterand everything was good.
So, those are the onlycomplication.
We had one CLABSI during thatperiod of time on a dialysis
(37:46):
catheter.
We had some other CLABSIs.
But on the dialysis group, onlyone catheter in two years.
So, that was pretty good.
Eric (37:54):
Yeah.
That's excellent
Chuck (37:55):
Yeah.
So, those kinds ofcomplications, the complications
were actually very, very low.
Probably the bigger issue wasgetting, we have about 12 people
that insert 24/7.
And the bigger issue wasprobably getting everybody
moving forward and gettingvalidated.
Because you start off withgetting one person validated, or
two people validated.
And so it took time to get all12 people validated.
(38:15):
So it was a little slow to rampup.
But once we got everybodyvalidated, the taking of X-Rays
just dramatically dropped off.
Eric (38:25):
And is this sort of something that you've heard from
maybe your colleagues at otherhospitals across the country
that they're considering doingas well?
I mean, have you shared thisinformation with them?
Chuck (38:35):
So I was at AVA not last year, but two years ago when
they were in Phoenix here,actually.
And I gave a lunch and learnthing and we talked about
inserting central lines with atip-locating device and the
success that we were having.
So, I have had some discussions,but part of the issue is I
(38:58):
talked to people doing VascularAccess is the a number of
non-physicians inserting actualcentral lines is few.
So I have had some interest, butmost teams are just casually
interested because they'reprimarily focused on PICC lines,
peripheral IVs, things likethat.
(39:20):
I'm hoping this will expand.
Eric (39:23):
Yeah.
Well is that kind of your wishor your hope for those that read
your manuscript that comes outin the December issue of JAVA?
To kind of take away from yourstudy to spread this idea as far
as continuing practiceelsewhere?
Chuck (39:37):
Oh, absolutely.
That's the whole purpose.
I think we have to like questionthe norms that have been out in
place for decades.
That's just the gold standard,right?
Is Take an X-Ray following acentral line insertion.
But we insert very differentlythan a lot of the mechanical
complication data comes from.
(39:58):
Everybody's using ultrasound.
We hardly do any subclaviansanymore because they're just
higher risks.
So, the complications that areextremely low, even when even
when physicians were inserting,you know, 99% of the catheter.
If you look at the number ofpneumothorax and hemothorax, the
numbers are like 1%.
They've always been historicallypretty low compared to the total
(40:19):
number that get inserted.
We have better guidance,tip-locating devices.
It's just a different time andit's time to move on to trust
the technology.
Eric (40:32):
Sort of a new era.
Chuck (40:33):
A new era, new era.
Yeah.
And plus it is a big timeelement involved here.
So you can, with using atip-locating device, you can
insert a central line and whenyou leave the bedside they can
start using it.
Which is really important insome cases.
So, in the dialysis casesprobably not as important to use
(40:54):
it immediately.
But we have since– so thepaper's focusing on the dialysis
catheter, but we havesubsequently moved on to the
central lines as well.
Now we're putting them all underwith a typical pain device.
Time is of essence, you know.
So we don't wait for X-Rays werewe know right there, it's good
(41:15):
to go and, and uh, you can givefluids, whatever.
We're ready to go immediately atthe bedsides.
You can eliminate, so you're notonly eliminating the X-Ray, but
you're eliminating theinterpretation depending on
where you're at.
Some of these interpretationsare done by a central hub and so
you're like in a rotation and ifsomebody, is busier, it could
(41:35):
take a long time to getinterpretation back.
So depending on your patient,that whole process, will stop
therapy from being given forwhat can be quite a while.
So we have eliminated that wholeissue there.
So that that's just where weneed to go and I'm hoping that's
what people take away from this.
Eric (41:54):
For sure and I think you and your team have provided some
excellent data.
So for everyone listening tothis podcast, check out Chuck
and his team's article coming upon hemodialysis catheter
insertion without the chestX-Ray– review of a 24-month
study.
And Chuck, I wanted to thank youagain for joining me today on
the podcast.
Chuck (42:13):
My pleasure.
This episode of ISAVE That Podcast is made possible by
Ethicon BIOPATCH.
BIOPATCH, The No.
1-selling CHG dressing on themarket is the only antimicrobial
dressing with multiplerandomized controlled trials and
a clear indication to reducecatheter related bloodstream
infections in patients withcentral venous and arterial
(00:20):
catheters.
For more information, visitethicon.com BIOPATCH: reach more
patients, restore more lives.
Speaker 2 (00:34):
From the Association for Vascular Access.
This is the ISAVE That Podcast.
Ramzy (00:56):
And you have discovered Episode 8 of Season 1 of the
ISAVE That Podcast.
This is Ramzy Nasrallah withAVA.
I am in Salt Lake City, UtahDirector of Clinical Education,
Judy Thompson and Eric Seger,who's joining us from Columbus,
Ohio.
How are we all doing today?
Judy (01:12):
It's great.
Ramzy, good to be here in SaltLake City with you.
It's even a pretty, gorgeous,warm day.
How about you Eric?
Eric (01:20):
It's pretty here, too.
It's not really the warmest, butit's pushing 50 and the sun's
out, so I'm happy.
I have no complaints.
Judy (01:28):
Winner winner.
Ramzy (01:29):
We have, mountains here, but it's mitigated by Judy and I
are doing budget planning for2019 and preparing AVA for its
next a year and trying toeclipse everything that we were
able to accomplish this year.
Like the scientific meeting,which we discussed on the last
episode, which is a nice bridgeto this episode.
We talked about themultidisciplinary membership of
(01:50):
the Association for VascularAccess and we spoke specifically
with with Christie Chapman aboutinfection prevention and
produced the idea for thisepisode to talk a little bit
more about how infectionprevention and Vascular Access
are combined, are really joinedat the hip because the
foundation of everything thatVascular Access is about is
preventing that infection first.
(02:12):
You do no harm.
Sidebar (02:14):
When I came to AVA last year, one of the special
interest groups I wanted tobuild was one specifically for
infection prevention.
I thought that infectionpreventionists should have their
own home within AVA.
And that eventually went awaybecause I came to realize and
from people like Judy, thatinfection prevention needs to be
the foundation of every specialinterest group we have.
It shouldn't be its own house,it should be everyone's house.
(02:35):
So I came to, AVA from Johnsonand Johnson.
I had infection prevention andVascular Access obligations.
They are combined.
Then that's actually the sponsorof this episode is from that
business, from, from Ethicon whowe'll be talking about.
And as I spend time with AVA andas I spent all those years with
J and J, I started to realizeand now embrace that they're
(02:58):
really one department.
Infection prevention hastentacles into so many other
areas of the building of thehospital of patient care.
But we've wrapped VascularAccess decidedly in the, in the
same foxhole with them.
Judy (03:12):
There's few departments within the hospital systems or
medicine that have 100% of thepatients.
And now the data shows thatVascular Access affects 90% of
patients.
Though I have not done thestudy, I've yet to see more than
one or two patients that are notnewborns or psych patients that
(03:32):
don't have an IV.
So between Vascular Access andinfection prevention, we have
everybody.
Ramzy (03:41):
It's the whole house.
Judy (03:41):
So we can't be separate entities.
I think some of the bestimprovement that I've made in my
clinical career was incollaboration with infection
prevention.
I've had some amazing infectionpreventionists to work with and
Vascular Access specialists, butthe collaboration is paramount
and I'm excited about thispodcast and what we're going to
(04:05):
do and talk about the infectionprevention opportunities for us
to even collaborate more.
Ramzy (04:10):
Yes, we've had some great meetings with APIC and as Judy
and I are busily planning 2019and preparing for a much longer
term strategic plan exercise,infection prevention is like our
special interest groups, thefoundation of everything that
we're trying to advance withAVA.
Especially since our taglinebegins with Protect the Patient.
That's where infectionprevention lives.
Judy (04:33):
That is absolutely true.
In fact, APIC was kind enough toinvite myself and a couple other
folks from AVA, to do one oftheir webinars, which is going
to air two days from now.
Ramzy (04:47):
Yes, Thursday.
That's Thursday, October the25th, right?
Judy (04:52):
Yes.
Thursday.
Eric (04:54):
The 25th.
Ramzy (04:56):
For everyone snapping this podcast up right off the
fresh podcast heap, that's twodays from when we're recording.
So you've probably got about 36hours.
Go to avainfo.org, and youshould see it on the website.
Judy (05:11):
On the APIC website is really where you need to be.
Ramzy (05:12):
APIC.org, yes.
And you'll have AVA in APICworking together in tandem to
promote infection prevention.
Judy (05:18):
We're going to be talking about PIVs and bloodstream
infections.
Eric (05:22):
Sounds like it is going to be a really great webinar.
Judy (05:23):
We're really excited about it.
Pretty excited.
So, I'm excited to talk aboutthe speaker that we have on this
podcast as well.
Eric (05:32):
Yeah, well when we return we'll be chatting with Dr Liza
Ovington from Ethicon as Ramzymentioned, the sponsor of this
episode about reducing–
Ramzy (05:41):
Dr.
O!
Eric (05:42):
Dr.
O, yes.
It's a fantastic conversationabout reducing catheter-related
infections and then a little bitlater after that we'll also have
a Beyond the Manuscripts segmentas I have an interview with an
author of an article set topublish in the next issue of
JAVA.
So please everyone stay tuned,and Ramzy and Judy keep it cool
out in Salt Lake City.
Judy (05:58):
We'll try.
Thanks Eric.
Thanks everybody.
Speaker 1 (06:18):
BIOPATCH disc with CHG is the No.
1 Selling CHG dressing on themarket with a 1A CDC
recommendation.
Its design makes it easy toapply and remove and provides
360 degree coverage around acatheter insertion site.
BIOPATCH is designed tocontinuously release CHG over 7
days to maintain skin antisepsiswhile absorbing up to 8 times
(06:40):
its own weight in fluid.
The BIOPATCH team also offers apoint prevalence line
surveillance program conductedby a team of registered nurses.
Your clinical staff will receivekey takeaways and
recommendations around theBIOPATCH bundle without
compromising HIPAA guidelines.
The clinical team will providean execute an educational plan
tailored to address potentialrisk factors of BSI.
(07:03):
Learn more about BIOPATCH atethicon.com.
BIOPATCH (07:07):
Reach more patients, restore more lives.
Eric (07:16):
And welcome back! Now we have the distinct honor of being
joined by Dr.
Liza Ovington, Medical Directorat Ethicon, who plays a part in
all the products that helpinfection prevention and
reducing infection or have animpact on wound healing.
She's responsible for the entireBIOPATCH family.
Dr.
Ovington, thank you so much forjoining us.
I have Judy Thompson, AVA'sDirector of Clinical Education
(07:38):
on the line with us as well asAVA.
Ramzy Nasrallah.
Ramzy (07:41):
Hi, Dr.
O!
Judy (07:41):
Good morning!
Liza (07:42):
Good morning everybody.
Judy (07:43):
Good morning.
Well, it's a pleasure to talk toyou today.
I'm excited.
At our conference, or ourscientific meeting, this year a
big push, many of the topicswere about PIVs and routine
replacement and infectionrelated.
So, very excited to talk to youabout this topic and get your
(08:06):
opinions on it and some of thedata on what's going on up
there.
So, if it's OK with you, let'spop right into it.
Liza (08:14):
Sure thing.
Judy (08:14):
So, there's lots of opinions out there related to
moving to clinically indicatedfor dwell times for PIVs.
What are your views on thepractice implications to that?
Liza (08:26):
Well, I think that the whole debate around routine
replacement of PIVs and movingto clinically indicated
replacement has been, kind ofbeing carried out in the real
world and in the research worldfor, for quite some time now.
And I think the benefits are,are multiple and I think
they're, appropriate and thatthat we want to move to like
(08:50):
reducing unnecessary needlesticks for the patients and
improving the patientsatisfaction, which then effects
as well on staff time, um, andeven supply costs potentially.
So, I think there's definitely alot of benefits to moving to
clinically indicated replacementand many of the studies that
have been done, randomizedcontrolled trials as well as
(09:11):
longitudinal studies that havetried to look at the impact of
that change have said we reallydon't see any impact on some of
those complications of PIV.
Notably phlebitis andinfiltration and also infection.
But I have to say that themajority of those studies, the
primary outcome they werelooking at was the phlebitis
(09:35):
outcome.
And they didn't alwaysdifferentiate between the types
of phlebitis, whether it waschemical and mechanical or
bacterial.
And oftentimes that would havebeen hard to do without
additional analysis.
But, but that was the primaryoutcome.
And everyone seems to be fairlycomfortable with the fact that
if we move from routinereplacement, which has typically
been 72 to 96 hours, toclinically indicated, we're not
(09:59):
going to see a big difference.
And when the studies analyzedhow much longer clinically
indicated the dwell time was, itwasn't that much longer.
I think there've been a numberof studies that says the overall
average dwell time for PIVs ismaybe just over 5 days.
So, We're going from to 3 to 4days to 5 days.
(10:21):
And while I say that those,those improvements are things
that we should aim for, onepotential concern is that the,
the outcome of the PIV-relatedbloodstream infection, or
bacteremia, the data there isnot as strong.
I think what that tells us, thatdoesn't say, well we shouldn't
go for it, we shouldn't, youknow, continue our efforts to go
(10:42):
to clinically indicated.
But it perhaps implies that weought to be taking the same care
to protect those PIV lines as wedo with other lines like central
lines.
And to that end, we can usetechnology to become more
comfortable and provide moresafety around going to that
increased dwell time, especiallyaround the outcome of
(11:03):
bacteremia.
Judy (11:04):
Now, you mentioned the bloodstream infection.
With PIV-related bloodstreaminfection, there's a lot of talk
about it right now but I don'tsee a ton of data on it.
Liza (11:17):
I think that part of the reason is, you know, it's not
mandated necessarily that wetrack or surveil the PIV.
And maybe that will change butthere have been a few.
There's been a lot of opinionand there have been a number of
studies that have tried to lookat or get their hands around, or
(11:37):
arms around what is this rate ofPIV infection.
And I think some of the earliestdata and the reliable data we
can look at was a 2006systematic review by Maki where
he did a paper, he looked at Ithink over 2000 studies and
tried to look at different linetypes and what the, bloodstream
infection risks associated withdifferent line types was.
(11:58):
And I think with PIV it was, itwas relatively low compared
obviously to central lines.
But what we need to take anaccount and looking at kind of a
low infection rate is theprevalence of that type of line.
And when we think about the factthat probably three quarters of
all hospitalized patients end uphaving a PIV– much, many more
(12:22):
patients, you know, are exposedto this type of line than are
supposed to central lines.
And so even a low risk ofinfection could ultimately end
up affecting as many patients asa line with a higher risk, but
lower prevalence in the patientpopulation.
But when people have looked atPIV infections, they do find
(12:46):
that, you know, they're outthere.
It's kind of the scenario, I'moften reminded of the saying
that'you can't only look wherethe light is good.' You got to
look at the other places too.
And so when people have focusedon PIV, they found that we do
see infections and maybe they'rekind of a silent or cause of
(13:06):
some of these infections, someof the better studies have
looked at cases where, you know,there wasn't a central line.
And did that patient have aninfection?
I think Mill published last yearabout increasing the awareness
of the role that PIVs can playin infections.
He estimated that about a thirdof staph aureus infections may
(13:27):
be coming from PIVs.
He found an incidence of about,you know, 0.2% for short term
PIVs, but that accounted forabout 23% of the nosocomial
catheter-related bloodstreaminfection.
So, not central line but relatedto a catheter.
And he did find that as youincrease the dwell time, you
increase the risk of thebloodstream infection.
(13:48):
And this is no different.
When we think about thepathogenesis of bloodstream
infection, we know that theorigin of the most of the
bacteria are from the skin ofthe patient.
And I think that's well acceptedand we know probably the most
about the pathogenesis ofcentral line infections where
you get colonization of thecatheter track and then biofilm
(14:10):
formation on the catheter andthe extra luminal surface.
When you think about thepathogenesis that's really
device agnostic.
From the standpoint of thebacteria that are arising from
the layers of the skin or downin the hair follicles and that
insertion track.
Those bacteria don't know wherethe tip of the line is.
(14:33):
They don't know what it's madeof.
They just know that there's asurface that they can call
colonize.
So, when we think about thelikelihood of infectious risk
with different types ofcatheters, I think we have to
remember that bacteria aredevice agnostic.
They're just thinking of it interms of a surface.
So, other studies that havelooked at, you know the rates of
(14:54):
PIV infection– our companyfunded some research a year or
so ago looking into premierperspective database, where we
looked at patients withperipheral IV lines and we tried
to exclude patients who may havehad a central line.
Then looked at PIV-relatedcomplications and we found that
they were out there, but youdon't necessarily see it unless
(15:16):
you're looking for it.
And I think other investigatorshave found the same thing that
these PIV rates are real thingsout there and they're affecting,
you know, a lot of patients.
In my own home state ofPennsylvania, Davis in 2014
looked at Pennsylvania data from2012 from NHSN looking
(15:37):
specifically for eventsassociated with PIV use.
And he found that primarybloodstream infection was, was
pretty high and it accounted foryou know, a lot of these
bloodstream infections and thesewere in patients that didn't
have a central line but they hada peripheral line.
And we were seeing specificallystaph aureus-related BSI.
(15:57):
So I think this idea of PIVRBSI,and that's a long acronym,
PIV-related bloodstreaminfection, it's a real thing.
Judy (16:08):
Oh, I agree.
I agree.
In fact, I had a prior patientthat had a staph aureus
infection that started at thePIV.
I had placed a PICC in thispatient and the patient actually
got infectious thrombophlebitisand it was a staph aureus bug.
So, to your point, we aren'tgoing to find what we don't look
(16:31):
for.
It used to, people used to justreport the infections in the ICU
and we didn't think we had a bigproblem on the floors.
And lo and behold we have abigger problem on the floors.
So, we have got to start lookingbetter.
Now, you've talked aboutstrategies, technologies to help
reduce this risk of infection.
Is there any BIOPATCH clinicaldata on PIVs themselves?
Liza (16:54):
So, in terms of data that really focused on looking at
BIOPATCH, I'm not aware of anystudies that specifically did a
randomized controlled trialBIOPATCH versus no BIOPATCH and
PIV.
Although you know, we can'texclude that that might be
something that folks do in thefuture.
There is one study that I amaware of where BIOPATCH was used
(17:15):
as part of a bundle and this wasby Michelle DeVries.
She was at Methodist Hospital inGary, Indiana.
And when they were adopting thechange going from routine
replacement of their PIVs toclinically indicated
replacement.
And Michelle was kind of athought leader here and is
published on the topic evenbefore this particular study.
(17:38):
They decided that to enable thischange in practice that they
wanted to go at it with a bundleof interventions to help protect
those lines going to the longerdwell time.
Now, BIOPATCH was part of theirbundle.
And in reality, wheneverBIOPATCH is used in clinical
practice, it's always part of abundle.
Any type of infectionprevention, whether it's looking
(18:00):
at trying to reduce the risk ofCRBSI or surgical site
infections or urinary tractinfections, we're always using a
bundled intervention.
So, we're not just doing onething.
So in, in Michelle DeVries's,they went out with No.
1 and, I think being an educatorat heart, the No.
1 parts of their bundle wasstaff education.
(18:21):
Then they did use BIOPATCHspecifically to, you know,
achieve that continuousantisepsis of the skin around
the insertion site andprotecting against extraluminal
route of colonization of thecatheter.
They went with and I'm not sureif the brand, a securement
dressing because we know keepingthe catheter in place and
(18:42):
preventing pistoning isimportant.
So, they opted for a particularsecurement dressing.
They used alcohol impregnatedcaps to address the intraluminal
route of infection.
And they used an integrated,closed IV catheter system and
sterile gloves.
Because one of the things thatsome of the previous studies
have found, not Michelle's work,but some previous studies
looking at PIV infection ratesand the types of pathogen, they
(19:08):
found, not surprisingly, thatstaph aureus was most common
pathogen, but in one study theyalso found a lot of E.
Coli as a pathogen.
And so that tended to imply thatmaybe hand washing and skin prep
and things, wasn't as stringentmaybe in PIVs other types of
lines.
So, they went the sterilegloves.
And with this bundle, they foundthat their hospital after a year
(19:31):
of tracking their data, thatthey achieved a 19% reduction in
their PIVBSI rates and even a34% reduction, 34-37% reduction
in their laboratory confirmedBSI overall.
So, including central lines.
So, I think that just kind ofspeaks to focus on a problem.
And I think importantly thatpart of the bundle of staff
(19:52):
education and raising awareness,I think people just kind of step
up their game overall.
But they did see, like I said, a19% reduction in the PIVBSR
rates, but even a reductionoverall in all their line rates.
Judy (20:05):
That's impressive and I've seen the practice out in the
country and it varies.
There's some people that arejust absolutely spot on, perfect
placing PIVs but I think thoseare the exception, not the rule,
unfortunately.
And I hope in the days coming wewill see sterile bundles for PIV
and I know that's something thatmany people are looking at, but
(20:27):
I hope it continues.
If there were putting in my IV,I'm gonna ask for a sterile
insertion.
Liza (20:33):
Absolutely.
I mean I think the key isawareness and, and the
publications and podcasts likethis one and the debate I think
is all a good thing because itdoes raise the awareness.
I always kind of put it to whatI call the'Mom Test.' Like if my
mom was receiving thisintervention, what would I want
my mom to get if she was in thehospital?
If she got a central line orshe's had a surgery or if she
(20:54):
had a PIV.
I think about it in those terms.
I think we all would want ourmom to have a PIV bundle, you
know, to try to address allthose potential routes of
infection.
So, you know when there'sdebate, I think it raises
awareness and where there'sawareness that increases
attention.
Eric (21:11):
Speaking for myself, I think that my mom, I would like
her to have the best carepossible.
So, I think you're correct, Dr.
O, on that.
Ramzy (21:23):
I want your mom to have the best care too for sure.
That study from Chellie isprofound to me, and we've talked
about this on prior episodes ofthe podcast.
Chellie is a friend of thepodcast, she actually was on a
couple of episodes ago, but byhaving this focused intervention
specific to peripheral IVcannulas, they've reduced their
central line infection rate.
Which tells you when you'regetting your house in broken
(21:44):
into, it's not always to thefront door.
Sometimes it's coming in throughthe window.
Judy (21:48):
Yeah, it makes me laugh at times when people say'it's just
a PIV.' Well, it's in thecirculatory system.
What does that mean?
It goes just like you said, itdoesn't matter what device it
comes in on, the bugs like totravel.
Liza (22:00):
Right and at the end of the day, it's a portal of entry.
I also take care of, we haveantimicrobial sutures, which are
aimed at trying to addresssurgical site infection risks.
But you know, when I think aboutthat, it's like, our skin and
that was trained bydermatologists, long ago.
(22:22):
And the skin is an amazing organand it's our barrier between us
and the outside world, ourbarrier between us and bacteria.
And while bacteria can live veryhappily on our skin when it's
intact and we have, you know,normal flora commensal flora,
whatever you want to call it.
When we have a break in thatskin integrity, that's a portal
of entry, that's a place forthem to get in.
(22:46):
And you know, whether that, thatbreak was caused by a central
line or a peripheral line, abreak is a break.
And like you said, it's allgoing into the circulation.
That's where I thinktraditionally we have focused,
started our focus on where therisk was highest, in the ICU and
in the central lines.
But again, when we go back andthink scientifically about the
(23:08):
pathogenesis of infections ingeneral, and vascular-related
infections specifically, again,I keep bringing up the fact that
bacteria are device agnostic.
They've just found a portal ofentry and they're not really
thinking in any way about whattype of device caused that
portal they've just got a way innow.
Judy (23:26):
True.
Now, you spoke a little bit agoabout how you didn't know of any
specific studies that addressBIOPATCH and PIVs.
What size of trial would it taketo prove the efficacy of
BIOPATCH and PIVs?
Liza (23:41):
So, I think, when we think in general about any type of
study to look at infections,thankfully healthcare-associated
infections are relatively lowfrequency.
They typically have highmorbidity.
But when we're talking aboutfrequencies in the 1-2% range or
(24:02):
even lower, what that means isin order to power your study to
have enough patients enrolledthat you're going to see the
outcome, it's hundreds, maybeeven thousands of patients.
And then to see a differencebetween your control and your
intervention, you need even morepatients.
(24:24):
So, we're probably talking, youknow, 1500, 2000, maybe even
more patients to be able tovariance the complication that
we're trying to reduce at a highenough rate that then we could
even detect a difference.
So it would be a large study.
Judy (24:40):
It sounds like it, it sounds like it.
Now, one more question for youbefore we let you go and we
thank you so much for all yourvaluable time you're spending
with us.
What about PIVs, the data forPIVs and other antimicrobial
dressings designed to reduce theBSI risk?
Liza (25:00):
Sure.
And I think, I'm sure ourlisteners are aware of other
antimicrobial dressings on themarket for catheter sites.
I think one of the things weneed to think about is, you
know, an antimicrobial is not anantimicrobial it's not an
antimicrobial.
I'm a chemist by training, I'man organic chemist by training.
So, when I think aboutantimicrobials as chemicals, we
(25:23):
have to consider not just whatit is, but where it's being
designed to have an effect.
And so when we talk aboutcatheter site dressing, we're
thinking about antimicrobialsthat work well on the skin
versus in deeper tissue or on anon-living surface.
We can think of lots ofantimicrobials.
So, in the world ofantimicrobial dressings, we know
(25:45):
we've got chlorhexidine asantimicrobial.
We've got polyhexamethylenebiguanide as an antimicrobial.
We've got silver antimicrobials.
You could kind of drop otherchemicals in the mix.
And so when I try to monitor thedata, no other data specifically
in the realm of PIV-relatedinfections.
(26:06):
Now, that could be due to thefact that, as we've just
discussed, as a community, we'remaybe just early in evolution of
looking at and monitoring andsurveilling PIV-related
infections.
But we haven't seen data fromother antimicrobial dressings.
And I think we also have to becareful in terms of taking data
(26:27):
with a simplifications forpractice.
When I think about particularlymedical devices like, like
antimicrobial dressings, youknow, I don't necessarily think
we can use the data from oneproduct to justify the use of
another product.
Because medical devices, unlikedrugs, when we think about in
pharmaceutical, there'ssomething that I think we're
aware of called the classeffect, right?
(26:48):
We think of classes ofantibiotics.
Classes of oncology drugs, drugsthat may be different
chemically, but they actsimilarly in the body.
That's more accepted in the drugworld.
Although I don't know that it'seven a 100% true there, but it's
(27:08):
this class effect, I don't thinkapplies to medical devices
because they're much morecomplicated.
When we think about say taking adrug, taking a tablet, the
interaction between thehealthcare provider and the drug
and the patient and the drug isminimal.
You know, you write yourprescription, the doctor writes
the prescription, the patientgets it filled and then they
(27:29):
swallow the drug and that's it.
When we think about medicaldevices, you know there's an
interaction that takes placebetween the healthcare provider,
who's usually applying.
When we think about theseantimicrobial dressings, a
healthcare provider is applyingthe dressing to the patient and
then the patient is wearing thisdressing over time.
(27:50):
And then then there's thecomplexity of the dressing
itself.
It has the dressing components,it has the antimicrobial and
what does that specificantimicrobial on?
How is it being released fromthe dressing and contacting the
skin in order to do its job ofantisepsis of the skin?
So, I think that the classeffect doesn't exist for medical
(28:11):
devices.
And so I think even though a lotof our clinical practice
guidelines try to be brandagnostic when they make
recommendations on when we lookat evidence-based
recommendations for infectionprevention, even if all the
studies have been on oneparticular device, in the
interest of not playingfavorites, the evidence-based
(28:32):
committees try to genericize thedescription of that device.
But I think as, as practitionersor as scientists, we need to
remember that, well, you know,one antimicrobial dressing isn't
necessarily the same as anotherantimicrobial dressing.
Even when they have the sameingredient, or different
ingredients because of thoseinteractions that I mentioned
(28:53):
between the healthcare providerapplying the product and the
patient also interacting withthe product during, it's wear
time that there can bedifferences that have have
effect on safety and performanceof the device.
Judy (29:06):
Well, I fibbed a little bit when I said it was my last
question because listening toyou, I have another question for
you! So, if I were a clinicianevaluating products and I have
products X, Y and Z.
Based on what you know, what amI going to go look at to go
evaluate whether I want to gouse a BIOPATCH or a widget or a
(29:26):
wadget, so to speak?
Liza (29:28):
Well, so I think you have to look at the information that
the manufacturer can provide.
And I think one thing that allmanufacturers can provide and
should and I think can provideabout the product is I call
proof of concept.
In other words, if it's anantimicrobial dressing, show me
the proof of concept that you'vegot an antimicrobial in it.
(29:49):
Tell me about antimicrobial.
Does it work in a controlledsetting, like a laboratory in a
petri dish data?
Does it work and if it'sapplicable, animal studies, give
me some interaction studies?
Tell me how the people who areusing it like it, handling
studies.
So healthy volunteer studies,that sort of thing.
(30:11):
Everybody can give you that dataand kind of educate yourself
about how this product might ormight not work in your hands and
in your patient population.
But ideally, and I think themost important to any clinician
or scientists as well is what'sthe end use data?
In other words, where's yourclinical data?
Where are your clinical studies?
Were their clinical studies andthe types of patients that I
(30:32):
treat?
If you're working with elderlypatients, with very thin skin or
if you're working in the NICU orif you're working even in
different climates sometimes,you want to see what is the
clinical data?
And does it, does it pertain to,to my practice?
And I think at the end of theday that that's the feather in
(30:53):
the cap.
All the proof of concept data isgood, but you've got to have
that clinical data.
Judy (30:59):
Perfect.
Thank you.
Well, you're a wealth ofknowledge and it's great
listening to you and hearing youtalk about this product, your
product, but also just the PIVpractice as a whole.
Do you have any other words youwant to pass on to us?
Liza (31:16):
No, just in the overall scope of thinking about
intravascular devices, I thinkwe have a tagline at Ethicon: We
say,'Protect all lines.' I thinkthat there's a lot of technology
that's been developed over timeand utilized very successfully
in protecting central lines.
And I think that we do have as aclinical community, a lot of
(31:41):
things to choose from anddesigning a bundle like Chellie
DeVries did to protect ourperipheral lines as well.
Judy (31:49):
Very good.
I can't thank you enough foryour time.
I appreciate it.
Liza (31:53):
Oh, it's my pleasure.
Eric (31:54):
Yes.
Thank you Dr.
Ovington.
That was amazing.
Ramzy (31:57):
Thanks, Dr.
O.
Liza (31:59):
You're very welcome.
Eric (32:20):
And welcome to the Beyond the Manuscript segment of this
episode of the ISAVE ThatPodcast.
I'm Eric Seger, JAVAEditor-in-Chief and I have the
pleasure of being joined byChuck Ramirez, who is the
Director of CardiopulmonaryServices at Banner Estrella
Medical Center in Phoenix,Arizona.
And he's going to chat with me alittle bit about his article
titled, Hemodialysis CatheterInsertion Without A Chest X-Ray:
(32:41):
Review of a 24-Month Study.
So Chuck, how are you doing thismorning?
Thanks for joining us.
Chuck (32:47):
Good morning.
I'm doing fine.
Eric (32:48):
Yeah, happy to have you here.
Now as I understand, sort of thepremise of your study was
hemodialysis catheter insertionand you guys used the dual
vector positioning system, butyou did not have a post-chest
X-ray for validation.
As I understand, you and yourteam have been using this
technique for a few years now,correct?
Chuck (33:06):
Yes.
Yeah.
We're, at about three years now.
Eric (33:10):
And what was sort of the idea to do this and to come up
with or to perform this specificstudy and to record this data?
Chuck (33:19):
So, we've been using, we've been inserting, PICC lines
obviously for decades.
And we were, we were doing acentral line insertions since
about 2007.
So early on we got, we startedusing a tip locating device for
our PICC lines.
And we went to the process thateverybody else did, did some
(33:41):
validation.
And over the years that has justbecome the standard in and PICC
placement where we just don'ttake X-Rays anymore.
Success rates are really well,positioning is good and all the
issues that were around PICCplacement and not taking an
X-Ray kind of all went awaybecause it was highly
(34:02):
successful.
Yeah.
So, fast forward, several yearsor so now we've had a lot of
years placing central lines ofvarious types.
We primarily do the IJinsertions, Internal Jugular.
We do have the ability to dosubclavians, but we only have a
(34:24):
couple of people that arechecked off on it.
And there's just such a higherrisk with it, of catheter
complications that almosteverybody, even though we have a
few people that were validated,very, very frequently used.
So from the IJ perspective, wejust did not have very many
complications.
I mean, we just didn't have anycomplications.
Once in a while, we had trouble,placing a catheter.
(34:46):
Wouldn't draw blood.
We take an X-Ray.
It was just a positioning issue.
But we never had anypneumothorax issues or any
hemothorax issues, which is themain complication associated
with central line placement.
So, after many years of the PICCplacement going well and really
no complications associated withcentral lines, we went to our
(35:07):
medical team, ICU medical team,and said, why don't we start
placing these with atip-locating case system and
that do this X-Ray?
We're taking X-Rays routinelyand they don't, they never come
back with any problems.
And there's a lot of issues withcorrect placement with a X-Ray.
(35:32):
Because one radiologist toanother will interpret the tip
location differently.
For the most part, theradiologist is pretty concerned
as long as they're in the SVC,doesn't have to be in the distal
end.
As long as it's in the SVC, theycall it good.
So optimal placement, maybe notbe there 100% of the time.
(35:52):
So, after that discussion we puttogether this process and had a
couple of team meetings aboutit.
That's kind of how we gotstarted.
Just because it didn't seem likeit was necessary and we could
probably get better placement.
And then the other issue was,because we insert double lumens,
(36:12):
triple lumen central lines aswell.
So, the other issue was we do wego to all catheters or do we
just focus on one particularcatheter and limit the
variables.
So, that was the other decision.
Hemodialysis catheters are verypositional– really, you want
them to be tipped into theatrium a little bit.
(36:33):
So, tip location is at a higherpremium.
So, we thought maybe thedialysis catheter would be the
catheter that we would, that wewould focus on.
So, that's kind of how we gotstarted.
And that's why we picked thatcatheter because we want an
optimal tip positioning of thedialysis catheter.
Eric (36:51):
Did you run into any, once you've got your study going, did
you run into any issues?
I think I read in yourmanuscript, you had one instance
of CLABSI to hemodialysiscatheter, correct?
Chuck (37:04):
Yes.
Yeah.
So, out of all the cathetersthat we inserted, I think it was
448 catheters during that periodof time, we only had 4 catheters
that could not get placedcorrectly.
Two of them just were, we endedup getting X-Rays.
Two of them were just in thedominant vein and had to be
advanced forward.
And then two of them, wecouldn't figure out where they
(37:25):
were at.
They appeared to be in some kindof a false track maybe.
They weren't arterial, but theyweren't in the right place,
either.
So we ended up just pullingthose catheters.
There was no subsequent issueswith chest tubes or anything
like that.
We just put in a new catheterand everything was good.
So, those are the onlycomplication.
We had one CLABSI during thatperiod of time on a dialysis
(37:46):
catheter.
We had some other CLABSIs.
But on the dialysis group, onlyone catheter in two years.
So, that was pretty good.
Eric (37:54):
Yeah.
That's excellent
Chuck (37:55):
Yeah.
So, those kinds ofcomplications, the complications
were actually very, very low.
Probably the bigger issue wasgetting, we have about 12 people
that insert 24/7.
And the bigger issue wasprobably getting everybody
moving forward and gettingvalidated.
Because you start off withgetting one person validated, or
two people validated.
And so it took time to get all12 people validated.
(38:15):
So it was a little slow to rampup.
But once we got everybodyvalidated, the taking of X-Rays
just dramatically dropped off.
Eric (38:25):
And is this sort of something that you've heard from
maybe your colleagues at otherhospitals across the country
that they're considering doingas well?
I mean, have you shared thisinformation with them?
Chuck (38:35):
So I was at AVA not last year, but two years ago when
they were in Phoenix here,actually.
And I gave a lunch and learnthing and we talked about
inserting central lines with atip-locating device and the
success that we were having.
So, I have had some discussions,but part of the issue is I
(38:58):
talked to people doing VascularAccess is the a number of
non-physicians inserting actualcentral lines is few.
So I have had some interest, butmost teams are just casually
interested because they'reprimarily focused on PICC lines,
peripheral IVs, things likethat.
(39:20):
I'm hoping this will expand.
Eric (39:23):
Yeah.
Well is that kind of your wishor your hope for those that read
your manuscript that comes outin the December issue of JAVA?
To kind of take away from yourstudy to spread this idea as far
as continuing practiceelsewhere?
Chuck (39:37):
Oh, absolutely.
That's the whole purpose.
I think we have to like questionthe norms that have been out in
place for decades.
That's just the gold standard,right?
Is Take an X-Ray following acentral line insertion.
But we insert very differentlythan a lot of the mechanical
complication data comes from.
(39:58):
Everybody's using ultrasound.
We hardly do any subclaviansanymore because they're just
higher risks.
So, the complications that areextremely low, even when even
when physicians were inserting,you know, 99% of the catheter.
If you look at the number ofpneumothorax and hemothorax, the
numbers are like 1%.
They've always been historicallypretty low compared to the total
(40:19):
number that get inserted.
We have better guidance,tip-locating devices.
It's just a different time andit's time to move on to trust
the technology.
Eric (40:32):
Sort of a new era.
Chuck (40:33):
A new era, new era.
Yeah.
And plus it is a big timeelement involved here.
So you can, with using atip-locating device, you can
insert a central line and whenyou leave the bedside they can
start using it.
Which is really important insome cases.
So, in the dialysis casesprobably not as important to use
(40:54):
it immediately.
But we have since– so thepaper's focusing on the dialysis
catheter, but we havesubsequently moved on to the
central lines as well.
Now we're putting them all underwith a typical pain device.
Time is of essence, you know.
So we don't wait for X-Rays werewe know right there, it's good
(41:15):
to go and, and uh, you can givefluids, whatever.
We're ready to go immediately atthe bedsides.
You can eliminate, so you're notonly eliminating the X-Ray, but
you're eliminating theinterpretation depending on
where you're at.
Some of these interpretationsare done by a central hub and so
you're like in a rotation and ifsomebody, is busier, it could
(41:35):
take a long time to getinterpretation back.
So depending on your patient,that whole process, will stop
therapy from being given forwhat can be quite a while.
So we have eliminated that wholeissue there.
So that that's just where weneed to go and I'm hoping that's
what people take away from this.
Eric (41:54):
For sure and I think you and your team have provided some
excellent data.
So for everyone listening tothis podcast, check out Chuck
and his team's article coming upon hemodialysis catheter
insertion without the chestX-Ray– review of a 24-month
study.
And Chuck, I wanted to thank youagain for joining me today on
the podcast.
Chuck (42:13):
My pleasure.
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