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Podcast - Season 1 - Episode 8 - Transcript
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Season 1, Episode 8 Transcript

 

This episode of ISAVE That Podcast is made possible by Ethicon BIOPATCH. BIOPATCH, The No. 1-selling CHG dressing on the market is the only antimicrobial dressing with multiple randomized controlled trials and a clear indication to reduce catheter related bloodstream infections in patients with central venous and arterial catheters. For more information, visit www.ethicon.com. BIOPATCH: reach more patients, restore more lives.

From the Association for Vascular Access, this is the ISAVE That Podcast.


Ramzy: And you have discovered Episode 8 of Season 1 of the ISAVE That Podcast. This is Ramzy Nasrallah with AVA. I am in Salt Lake City, Utah Director of Clinical Education, Judy Thompson and Eric Seger, who's joining us from Columbus, Ohio. How are we all doing today?

Judy: It's great. Ramzy, good to be here in Salt Lake City with you. It's even a pretty, gorgeous, warm day. How about you, Eric?

Eric: It's pretty here, too. It's not really the warmest, but it's pushing 50 and the sun's out, so I'm happy. I have no complaints.

Judy: Winner, winner.

Ramzy: We have, mountains here, but it's mitigated by Judy and I are doing budget planning for 2019 and preparing AVA for its next a year and trying to eclipse everything that we were able to accomplish this year. Like the scientific meeting, which we discussed on the last episode, which is a nice bridge to this episode. We talked about the multidisciplinary membership of the Association for Vascular Access and we spoke specifically with Christie Chapman about infection prevention and produced the idea for this episode to talk a little bit more about how infection prevention and Vascular Access are combined, are really joined at the hip because the foundation of everything that Vascular Access is about is preventing that infection first. You do no harm.

Ramzy: Sidebar: When I came to AVA last year, one of the special interest groups I wanted to build was one specifically for infection prevention. I thought that infection preventionists should have their own home within AVA. And that eventually went away because I came to realize and from people like Judy, that infection prevention needs to be the foundation of every special interest group we have. It shouldn't be its own house, it should be everyone's house. So, I came to AVA from Johnson and Johnson. I had infection prevention and Vascular Access obligations. They are combined. Then that's actually the sponsor of this episode is from that business, from, from Ethicon who we'll be talking about. And as I spend time with AVA and as I spent all those years with J and J, I started to realize and now embrace that they're really one department. Infection prevention has tentacles into so many other areas of the building of the hospital of patient care. But we've wrapped Vascular Access decidedly in the, in the same foxhole with them.

Judy: There's few departments within the hospital systems or medicine that have 100% of the patients. And now the data shows that Vascular Access affects 90% of patients. Though I have not done the study, I've yet to see more than one or two patients that are not newborns or psych patients that don't have an IV. So, between Vascular Access and infection prevention, we have everybody.

Ramzy: It's the whole house.

Judy: So, we can't be separate entities. I think some of the best improvement that I've made in my clinical career was in collaboration with infection prevention. I've had some amazing infection preventionists to work with and Vascular Access specialists, but the collaboration is paramount and I'm excited about this podcast and what we're going to do and talk about the infection prevention opportunities for us to even collaborate more.

Ramzy: Yes, we've had some great meetings with APIC and as Judy and I are busily planning 2019 and preparing for a much longer term strategic plan exercise, infection prevention is like our special interest groups, the foundation of everything that we're trying to advance with AVA. Especially since our tagline begins with Protect the Patient. That's where infection prevention lives.

Judy: That is absolutely true. In fact, APIC was kind enough to invite myself and a couple other folks from AVA, to do one of their webinars, which is going to air two days from now.
Ramzy: Yes, Thursday. That's Thursday, October the 25th, right?

Judy: Yes. Thursday.

Eric: The 25th.

Ramzy: For everyone snapping this podcast up right off the fresh podcast heap, that's two days from when we're recording. So, you've probably got about 36 hours. Go to avainfo.org, and you should see it on the website.

Judy: On the APIC website is really where you need to be.

Ramzy: www.APIC.org, yes. And you'll have AVA in APIC working together in tandem to promote infection prevention.

Judy: We're going to be talking about PIVs and bloodstream infections.

Eric: Sounds like it is going to be a really great webinar.

Judy: We're really excited about it. Pretty excited. So, I'm excited to talk about the speaker that we have on this podcast as well.

Eric: Yeah, well when we return, we'll be chatting with Dr Liza Ovington from Ethicon as Ramzy mentioned, the sponsor of this episode about reducing –
Ramzy: Dr. O!
Eric: Dr. O, yes. It's a fantastic conversation about reducing catheter-related infections and then a little bit later after that we'll also have a Beyond the Manuscripts segment as I have an interview with an author of an article set to publish in the next issue of JAVA. So please everyone, stay tuned, and Ramzy and Judy keep it cool out in Salt Lake City.

Judy: We'll try. Thanks Eric. Thanks everybody.


BIOPATCH disc with CHG is the No. 1 Selling CHG dressing on the market with a 1A CDC recommendation. Its design makes it easy to apply and remove and provides 360 degree coverage around a catheter insertion site. BIOPATCH is designed to continuously release CHG over 7 days to maintain skin antisepsis while absorbing up to 8 times its own weight in fluid. The BIOPATCH team also offers a point prevalence line surveillance program conducted by a team of registered nurses. Your clinical staff will receive key takeaways and recommendations around the BIOPATCH bundle without compromising HIPAA guidelines. The clinical team will provide an execute an educational plan tailored to address potential risk factors of BSI. Learn more about BIOPATCH at www.ethicon.com. BIOPATCH: Reach more patients, restore more lives.

Eric: And welcome back! Now we have the distinct honor of being joined by Dr. Liza Ovington, Medical Director at Ethicon, who plays a part in all the products that help infection prevention and reducing infection or have an impact on wound healing. She's responsible for the entire BIOPATCH family. Dr. Ovington, thank you so much for joining us. I have Judy Thompson, AVA's Director of Clinical Education on the line with us as well as AVA CEO Ramzy Nasrallah.

Ramzy: Hi, Dr. O!

Judy: Good morning!

Liza: Good morning everybody.

Judy: Good morning. Well, it's a pleasure to talk to you today. I'm excited. At our conference, or our scientific meeting, this year a big push, many of the topics were about PIVs and routine replacement and infection related. So, very excited to talk to you about this topic and get your opinions on it and some of the data on what's going on up there. So, if it's OK with you, let's pop right into it.

Liza: Sure thing.

Judy: So, there's lots of opinions out there related to moving to clinically indicated for dwell times for PIVs. What are your views on the practice implications to that?

Liza: Well, I think that the whole debate around routine replacement of PIVs and moving to clinically indicated replacement has been, kind of being carried out in the real world and in the research world for, for quite some time now. And I think the benefits are, are multiple and I think they're, appropriate and that that we want to move to like reducing unnecessary needle sticks for the patients and improving the patient satisfaction, which then effects as well on staff time, um, and even supply costs potentially. So, I think there's definitely a lot of benefits to moving to clinically indicated replacement and many of the studies that have been done, randomized controlled trials as well as longitudinal studies that have tried to look at the impact of that change have said we really don't see any impact on some of those complications of PIV. Notably phlebitis and infiltration and also infection. But I have to say that the majority of those studies, the primary outcome they were looking at was the phlebitis outcome. And they didn't always differentiate between the types of phlebitis, whether it was chemical and mechanical or bacterial. And oftentimes that would have been hard to do without additional analysis. But, but that was the primary outcome. And everyone seems to be fairly comfortable with the fact that if we move from routine replacement, which has typically been 72 to 96 hours, to clinically indicated, we're not going to see a big difference. And when the studies analyzed how much longer clinically indicated the dwell time was, it wasn't that much longer. I think there've been a number of studies that says the overall average dwell time for PIVs is maybe just over 5 days. So, we're going from to 3 to 4 days to 5 days. And while I say that those, those improvements are things that we should aim for, one potential concern is that the, the outcome of the PIV-related bloodstream infection, or bacteremia, the data there is not as strong.

I think what that tells us, that doesn't say, well we shouldn't go for it, we shouldn't, you know, continue our efforts to go to clinically indicated. But it perhaps implies that we ought to be taking the same care to protect those PIV lines as we do with other lines like central lines. And to that end, we can use technology to become more comfortable and provide more safety around going to that increased dwell time, especially around the outcome of bacteremia.

Judy: Now, you mentioned the bloodstream infection. With PIV-related bloodstream infection, there's a lot of talk about it right now but I don't see a ton of data on it.

Liza: I think that part of the reason is, you know, it's not mandated necessarily that we track or surveil the PIV. And maybe that will change but there have been a few. There's been a lot of opinion and there have been a number of studies that have tried to look at or get their hands around, or arms around what is this rate of PIV infection. And I think some of the earliest data and the reliable data we can look at was a 2006 systematic review by Maki where he did a paper, he looked at I think over 2000 studies and tried to look at different line types and what the, bloodstream infection risks associated with different line types was. And I think with PIV it was, it was relatively low compared obviously to central lines. But what we need to take an account and looking at kind of a low infection rate is the prevalence of that type of line. And when we think about the fact that probably three quarters of all hospitalized patients end up having a PIV – much, many more patients, you know, are exposed to this type of line than are supposed to central lines.

And so even a low risk of infection could ultimately end up affecting as many patients as a line with a higher risk, but lower prevalence in the patient population. But when people have looked at PIV infections, they do find that, you know, they're out there. It's kind of the scenario, I'm often reminded of the saying that 'you can't only look where the light is good.' You got to look at the other places too. And so, when people have focused on PIV, they found that we do see infections and maybe they're kind of a silent or cause of some of these infections, some of the better studies have looked at cases where, you know, there wasn't a central line. And did that patient have an infection? I think Mill published last year about increasing the awareness of the role that PIVs can play in infections. He estimated that about a third of staph aureus infections may be coming from PIVs. He found an incidence of about, you know, 0.2% for short term PIVs, but that accounted for about 23% of the nosocomial catheter-related bloodstream infection. So, not central line but related to a catheter. And he did find that as you increase the dwell time, you increase the risk of the bloodstream infection. And this is no different. When we think about the pathogenesis of bloodstream infection, we know that the origin of most of the bacteria are from the skin of the patient. And I think that's well accepted and we know probably the most about the pathogenesis of central line infections where you get colonization of the catheter track and then biofilm formation on the catheter and the extra luminal surface. When you think about the pathogenesis that's really device agnostic. From the standpoint of the bacteria that are arising from the layers of the skin or down in the hair follicles and that insertion track. Those bacteria don't know where the tip of the line is. They don't know what it's made of. They just know that there's a surface that they can call colonize. So, when we think about the likelihood of infectious risk with different types of catheters, I think we have to remember that bacteria are device agnostic. They're just thinking of it in terms of a surface. So, other studies that have looked at, you know the rates of PIV infection – our company funded some research a year or so ago looking into premier perspective database, where we looked at patients with peripheral IV lines and we tried to exclude patients who may have had a central line. Then looked at PIV-related complications and we found that they were out there, but you don't necessarily see it unless you're looking for it.

And I think other investigators have found the same thing that these PIV rates are real things out there and they're affecting, you know, a lot of patients. In my own home state of Pennsylvania, Davis in 2014 looked at Pennsylvania data from 2012 from NHSN looking specifically for events associated with PIV use. And he found that primary bloodstream infection was, was pretty high and it accounted for you know, a lot of these bloodstream infections and these were in patients that didn't have a central line, but they had a peripheral line. And we were seeing specifically staph aureus-related BSI. So, I think this idea of PIVRBSI, and that's a long acronym, PIV-related bloodstream infection, it's a real thing.

Judy: Oh, I agree. I agree. In fact, I had a prior patient that had a staph aureus infection that started at the PIV. I had placed a PICC in this patient and the patient actually got infectious thrombophlebitis and it was a staph aureus bug. So, to your point, we aren't going to find what we don't look for. It used to, people used to just report the infections in the ICU, and we didn't think we had a big problem on the floors. And lo and behold we have a bigger problem on the floors. So, we have got to start looking better. Now, you've talked about strategies, technologies to help reduce this risk of infection. Is there any BIOPATCH clinical data on PIVs themselves?

Liza: So, in terms of data that really focused on looking at BIOPATCH, I'm not aware of any studies that specifically did a randomized controlled trial BIOPATCH versus no BIOPATCH and PIV. Although you know, we can't exclude that that might be something that folks do in the future.

Liza: There is one study that I am aware of where BIOPATCH was used as part of a bundle and this was by Michelle DeVries. She was at Methodist Hospital in Gary, Indiana. And when they were adopting the change going from routine replacement of their PIVs to clinically indicated replacement. And Michelle was kind of a thought leader here and is published on the topic even before this particular study. They decided that to enable this change in practice that they wanted to go at it with a bundle of interventions to help protect those lines going to the longer dwell time. Now, BIOPATCH was part of their bundle. And in reality, whenever BIOPATCH is used in clinical practice, it's always part of a bundle. Any type of infection prevention, whether it's looking at trying to reduce the risk of CRBSI or surgical site infections or urinary tract infections, we're always using a bundled intervention. So, we're not just doing one thing. So in, in Michelle DeVries's, they went out with No. 1 and, I think being an educator at heart, the No. 1 parts of their bundle was staff education. Then they did use BIOPATCH specifically to, you know, achieve that continuous antisepsis of the skin around the insertion site and protecting against extraluminal route of colonization of the catheter. They went with and I'm not sure if the brand, a securement dressing because we know keeping the catheter in place and preventing pistoning is important. So, they opted for a particular securement dressing. They used alcohol impregnated caps to address the intraluminal route of infection. And they used an integrated, closed IV catheter system and sterile gloves. Because one of the things that some of the previous studies have found, not Michelle's work, but some previous studies looking at PIV infection rates and the types of pathogen, they found, not surprisingly, that staph aureus was most common pathogen, but in one study they also found a lot of E. Coli as a pathogen.

And so that tended to imply that maybe hand washing and skin prep and things, wasn't as stringent maybe in PIVs other types of lines. So, they went the sterile gloves. And with this bundle, they found that their hospital after a year of tracking their data, that they achieved a 19% reduction in their PIVBSI rates and even a 34% reduction, 34-37% reduction in their laboratory confirmed BSI overall. So, including central lines. So, I think that just kind of speaks to focus on a problem. And I think importantly that part of the bundle of staff education and raising awareness, I think people just kind of step up their game overall. But they did see, like I said, a 19% reduction in the PIVBSR rates, but even a reduction overall in all their line rates.
Judy: That's impressive and I've seen the practice out in the country, and it varies. There's some people that are just absolutely spot on, perfect placing PIVs but I think those are the exception, not the rule, unfortunately. And I hope in the days coming we will see sterile bundles for PIV and I know that's something that many people are looking at, but I hope it continues. If there were putting in my IV, I'm gonna ask for a sterile insertion.

Liza: Absolutely. I mean I think the key is awareness and, and the publications and podcasts like this one and the debate I think is all a good thing because it does raise the awareness. I always kind of put it to what I call the 'Mom Test.' Like if my mom was receiving this intervention, what would I want my mom to get if she was in the hospital? If she got a central line or she's had a surgery or if she had a PIV. I think about it in those terms. I think we all would want our mom to have a PIV bundle, you know, to try to address all those potential routes of infection. So, you know when there's debate, I think it raises awareness and where there's awareness that increases attention.

Eric: Speaking for myself, I think that my mom, I would like her to have the best care possible. So, I think you're correct, Dr. O, on that.

Ramzy: I want your mom to have the best care too for sure. That study from Chellie is profound to me, and we've talked about this on prior episodes of the podcast. Chellie is a friend of the podcast, she actually was on a couple of episodes ago, but by having this focused intervention specific to peripheral IV cannulas, they've reduced their central line infection rate. Which tells you when you're getting your house in broken into, it's not always to the front door. Sometimes it's coming in through the window.

Judy: Yeah, it makes me laugh at times when people say, 'it's just a PIV.' Well, it's in the circulatory system. What does that mean? It goes just like you said, it doesn't matter what device it comes in on, the bugs like to travel.

Liza: Right and at the end of the day, it's a portal of entry. I also take care of, we have antimicrobial sutures, which are aimed at trying to address surgical site infection risks. But you know, when I think about that, it's like, our skin and that was trained by dermatologists, long ago. And the skin is an amazing organ and it's our barrier between us and the outside world, our barrier between us and bacteria. And while bacteria can live very happily 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 that skin integrity, that's a portal of entry, that's a place for them to get in.

And you know, whether that, that break was caused by a central line or a peripheral line, a break is a break. And like you said, it's all going into the circulation. That's where I think traditionally, we have focused, started our focus on where the risk was highest, in the ICU and in the central lines. But again, when we go back and think scientifically about the pathogenesis of infections in general, and vascular-related infections specifically, again, I keep bringing up the fact that bacteria are device agnostic. They've just found a portal of entry and they're not really thinking in any way about what type of device caused that portal they've just got a way in now.


Judy: True. Now, you spoke a little bit ago about how you didn't know of any specific studies that address BIOPATCH and PIVs. What size of trial would it take to prove the efficacy of BIOPATCH and PIVs?

Liza: So, I think, when we think in general about any type of study to look at infections, thankfully healthcare-associated infections are relatively low frequency. They typically have high morbidity. But when we're talking about frequencies in the 1-2% range or even lower, what that means is in order to power your study to have enough patients enrolled that you're going to see the outcome, it's hundreds, maybe even thousands of patients. And then to see a difference between your control and your intervention, you need even more patients. So, we're probably talking, you know, 1500, 2000, maybe even more patients to be able to variance the complication that we're trying to reduce at a high enough rate that then we could even detect a difference. So, it would be a large study.

Judy: It sounds like it, it sounds like it. Now, one more question for you before we let you go, and we thank you so much for all your valuable time you're spending with us. What about PIVs, the data for PIVs and other antimicrobial dressings designed to reduce the BSI risk?

Liza: Sure. And I think, I'm sure our listeners are aware of other antimicrobial dressings on the market for catheter sites. I think one of the things we need to think about is, you know, an antimicrobial is not an antimicrobial it's not an antimicrobial. I'm a chemist by training, I'm an organic chemist by training. So, when I think about antimicrobials as chemicals, we have to consider not just what it is, but where it's being designed to have an effect. And so when we talk about catheter site dressing, we're thinking about antimicrobials that work well on the skin versus in deeper tissue or on a non-living surface. We can think of lots of antimicrobials. So, in the world of antimicrobial dressings, we know we've got chlorhexidine as antimicrobial. We've got polyhexamethylene biguanide as an antimicrobial. We've got silver antimicrobials. You could kind of drop other chemicals in the mix. And so when I try to monitor the data, no other data specifically in the realm of PIV-related infections. Now, that could be due to the fact that, as we've just discussed, as a community, we're maybe just early in evolution of looking at and monitoring and surveilling PIV-related infections. But we haven't seen data from other antimicrobial dressings. And I think we also have to be careful in terms of taking data with simplifications for practice. When I think about particularly medical devices like, like antimicrobial dressings, you know, I don't necessarily think we can use the data from one product to justify the use of another product. Because medical devices, unlike drugs, when we think about in pharmaceutical, there's something that I think we're aware of called the class effect, right? We think of classes of antibiotics. Classes of oncology drugs, drugs that may be different chemically, but they act similarly in the body. That's more accepted in the drug world. Although I don't know that it's even a 100% true there, but it's this class effect, I don't think applies to medical devices because they're much more complicated. When we think about say taking a drug, taking a tablet, the interaction between the healthcare provider and the drug and the patient and the drug is minimal. You know, you write your prescription, the doctor writes the prescription, the patient gets it filled and then they swallow the drug and that's it. When we think about medical devices, you know there's an interaction that takes place between the healthcare provider, who's usually applying. When we think about these antimicrobial dressings, a healthcare provider is applying the dressing to the patient and then the patient is wearing this dressing over time.

And then then there's the complexity of the dressing itself. It has the dressing components; it has the antimicrobial and what does that specific antimicrobial on? How is it being released from the dressing and contacting the skin in order to do its job of antisepsis of the skin? So, I think that the class effect doesn't exist for medical devices. And so I think even though a lot of our clinical practice guidelines try to be brand agnostic when they make recommendations on when we look at evidence-based recommendations for infection prevention, even if all the studies have been on one particular device, in the interest of not playing favorites, the evidence-based committees try to genericize the description of that device. But I think as, as practitioners or as scientists, we need to remember that, well, you know, one antimicrobial dressing isn't necessarily the same as another antimicrobial dressing. Even when they have the same ingredient, or different ingredients because of those interactions that I mentioned between the healthcare provider applying the product and the patient also interacting with the product during, it's wear time that there can be differences that have effect on safety and performance of the device.

Judy: Well, I fibbed a little bit when I said it was my last question because listening to you, I have another question for you! So, if I were a clinician evaluating products and I have products X, Y and Z. Based on what you know, what am I going to go look at to go evaluate whether I want to go use a BIOPATCH or a widget or a wadget, so to speak?

Liza: Well, so I think you have to look at the information that the manufacturer can provide. And I think one thing that all manufacturers can provide and should and I think can provide about the product is I call proof of concept. In other words, if it's an antimicrobial dressing, show me the proof of concept that you've got an antimicrobial in it. Tell me about antimicrobial. Does it work in a controlled setting, like a laboratory in a petri dish data? Does it work and if it's applicable, animal studies, give me some interaction studies? Tell me how the people who are using it like it, handling studies. So healthy volunteer studies, that sort of thing. Everybody can give you that data and kind of educate yourself about how this product might or might not work in your hands and in your patient population. But ideally, and I think the most important to any clinician or scientists as well is what's the end use data? In other words, where's your clinical data? Where are your clinical studies? Were their clinical studies and the types of patients that I treat? If you're working with elderly patients, with very thin skin or if you're working in the NICU or if 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 the day that that's the feather in the cap. All the proof of concept data is good, but you've got to have that clinical data.

Judy: Perfect. Thank you. Well, you're a wealth of knowledge and it's great listening to you and hearing you talk about this product, your product, but also just the PIV practice as a whole. Do you have any other words you want to pass on to us?

Liza: No, just in the overall scope of thinking about intravascular devices, I think we have a tagline at Ethicon: We say, 'Protect all lines.' I think that there's a lot of technology that's been developed over time and utilized very successfully in protecting central lines. And I think that we do have as a clinical community, a lot of things to choose from and designing a bundle like Chellie DeVries did to protect our peripheral lines as well.

Judy: Very good. I can't thank you enough for your time. I appreciate it.

Liza: Oh, it's my pleasure.

Eric: Yes. Thank you, Dr. Ovington. That was amazing.

Ramzy: Thanks, Dr. O.

Liza: You're very welcome.


Eric: And welcome to the Beyond the Manuscript segment of this episode of the ISAVE That Podcast. I'm Eric Seger, JAVA Editor-in-Chief and I have the pleasure of being joined by Chuck Ramirez, who is the Director of Cardiopulmonary Services at Banner Estrella Medical Center in Phoenix, Arizona. And he's going to chat with me a little bit about his article titled, Hemodialysis Catheter Insertion Without A Chest X-Ray: Review of a 24-Month Study. So, Chuck, how are you doing this morning? Thanks for joining us.

Chuck: Good morning. I'm doing fine.

Eric: Yeah, happy to have you here. Now as I understand, sort of the premise of your study was hemodialysis catheter insertion and you guys used the dual vector positioning system, but you did not have a post-chest X-ray for validation. As I understand, you and your team have been using this technique for a few years now, correct?

Chuck: Yes. Yeah. We're, at about three years now.

Eric: And what was sort of the idea to do this and to come up with or to perform this specific study and to record this data?

Chuck: So, we've been using, we've been inserting, PICC lines obviously for decades. And we were, we were doing a central line insertions since about 2007. So early on we got, we started using a tip locating device for our PICC lines. And we went to the process that everybody else did, did some validation. And over the years that has just become the standard in and PICC placement where we just don't take X-Rays anymore. Success rates are really well, positioning is good and all the issues that were around PICC placement and not taking an X-Ray kind of all went away because it was highly successful. Yeah. So, fast forward, several years or so now we've had a lot of years placing central lines of various types. We primarily do the IJ insertions, Internal Jugular. We do have the ability to do subclavians, but we only have a couple of people that are checked off on it. And there's just such a higher risk with it, of catheter complications that almost everybody, even though we have a few people that were validated, very, very frequently used.

So, from the IJ perspective, we just did not have very many complications. I mean, we just didn't have any complications. Once in a while, we had trouble, placing a catheter. Wouldn't draw blood. We take an X-Ray. It was just a positioning issue. But we never had any pneumothorax issues or any hemothorax issues, which is the main complication associated with central line placement. So, after many years of the PICC placement going well and really no complications associated with central lines, we went to our medical team, ICU medical team, and said, why don't we start placing these with a tip-locating case system and that do this X-Ray? We're taking X-Rays routinely and they don't, they never come back with any problems. And there's a lot of issues with correct placement with a X-Ray. Because one radiologist to another will interpret the tip location differently. For the most part, the radiologist 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, they call it good. So optimal placement, maybe not be there 100% of the time. So, after that discussion we put together this process and had a couple of team meetings about it. That's kind of how we got started. Just because it didn't seem like it was necessary and we could probably get better placement. And then the other issue was, because we insert double lumens, triple lumen central lines as well. So, the other issue was we do we go to all catheters or do we just focus on one particular catheter and limit the variables. So, that was the other decision. Hemodialysis catheters are very positional – really, you want them to be tipped into the atrium a little bit. So, tip location is at a higher premium. So, we thought maybe the dialysis catheter would be the catheter that we would, that we would focus on. So, that's kind of how we got started. And that's why we picked that catheter because we want an optimal tip positioning of the dialysis catheter.

Eric: Did you run into any, once you've got your study going, did you run into any issues? I think I read in your manuscript, you had one instance of CLABSI to hemodialysis catheter, correct?

Chuck: Yes. Yeah. So, out of all the catheters that we inserted, I think it was 448 catheters during that period of time, we only had 4 catheters that could not get placed correctly. Two of them just were, we ended up getting X-Rays. Two of them were just in the dominant vein and had to be advanced forward. And then two of them, we couldn't figure out where they were at. They appeared to be in some kind of a false track maybe. They weren't arterial, but they weren't in the right place, either. So, we ended up just pulling those catheters. There was no subsequent issues with chest tubes or anything like that. We just put in a new catheter and everything was good. So, those are the only complication. We had one CLABSI during that period of time on a dialysis catheter. We had some other CLABSIs. But on the dialysis group, only one catheter in two years. So, that was pretty good.

Eric: Yeah. That's excellent.

Chuck: Yeah. So, those kinds of complications, the complications were actually very, very low. Probably the bigger issue was getting, we have about 12 people that insert 24/7. And the bigger issue was probably getting everybody moving forward and getting validated. Because you start off with getting one person validated, or two people validated. And so, it took time to get all 12 people validated. So, it was a little slow to ramp up. But once we got everybody validated, the taking of X-Rays just dramatically dropped off.

Eric: And is this sort of something that you've heard from maybe your colleagues at other hospitals across the country that they're considering doing as well? I mean, have you shared this information with them?

Chuck: 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 learn thing and we talked about inserting central lines with a tip-locating device and the success that we were having. So, I have had some discussions, but part of the issue is I talked to people doing Vascular Access is the number of non-physicians inserting actual central lines is few. So, I have had some interest, but most teams are just casually interested because they're primarily focused on PICC lines, peripheral IVs, things like that. I'm hoping this will expand.

Eric: Yeah. Well is that kind of your wish or your hope for those that read your manuscript that comes out in the December issue of JAVA? To kind of take away from your study to spread this idea as far as continuing practice elsewhere?

Chuck: Oh, absolutely. That's the whole purpose. I think we have to like question the norms that have been out in place for decades. That's just the gold standard, right? Take an X-Ray following a central line insertion. But we insert very differently than a lot of the mechanical complication data comes from. Everybody's using ultrasound. We hardly do any subclavians anymore because they're just higher risks. So, the complications that are extremely low, even when even when physicians were inserting, you know, 99% of the catheter. If you look at the number of pneumothorax and hemothorax, the numbers are like 1%. They've always been historically pretty low compared to the total number that get inserted. We have better guidance, tip-locating devices. It's just a different time and it's time to move on to trust the technology.

Eric: Sort of a new era.

Chuck: A new era, new era. Yeah. And plus, it is a big time element involved here. So you can, with using a tip-locating device, you can insert a central line and when you leave the bedside they can start using it. Which is really important in some cases. So, in the dialysis cases probably not as important to use it immediately. But we have since – so the paper's focusing on the dialysis catheter, but we have subsequently moved on to the central lines as well. Now we're putting them all under with a typical pain device. Time is of essence, you know.

So, we don't wait for X-Rays were we know right there, it's good to go and, and uh, you can give fluids, whatever. We're ready to go immediately at the bedsides. You can eliminate, so you're not only eliminating the X-Ray, but you're eliminating the interpretation depending on where you're at. Some of these interpretations are done by a central hub and so you're like in a rotation and if somebody, is busier, it could take a long time to get interpretation back. So depending on your patient, that whole process, will stop therapy from being given for what can be quite a while. So, we have eliminated that whole issue there. So that that's just where we need to go and I'm hoping that's what people take away from this.

Eric: For sure and I think you and your team have provided some excellent data. So, for everyone listening to this podcast, check out Chuck and his team's article coming up on hemodialysis catheter insertion without the chest X-Ray – review of a 24-month study. And Chuck, I wanted to thank you again for joining me today on the podcast.

Chuck: My pleasure.