HeRO Graft & Surfacer Inside-Out Access Catheter System Procedure Guide

[Dr. Christopher Beck]
Talking about the HeRO. What patient population is this for? When do you get to where you start considering having a patient for a HeRO graft?

[Dr. Jason Wagner]
If I have a way to-- and I see, if someone has-- they burn up both arms as far as axillary veins, brachial veins. If you're looking to have to basically be doing an axillary artery and vein cut down in the infraclavicular space to get your inflow and outflow, that's somebody where if I'm having to go that high up the arm to get a venous outflow, that's a pretty morbid thing. I always think, what's the worst thing that could happen to someone with dialysis access, aside from just unmanaged or mitigated steel where they get an ischemic extremity, it's going to be, God forbid, it gets infected.

In vascular surgery, and I'm sure in IR, you're always thinking, what's the next? You're not just preparing for this surgery, but what's the next one after that? I always think, okay, how much is this going to suck to take out if it's infected? I've done cases back in training where we've done axillary cut-downs to get our venous outflow because everything in the arm was just inaccessible or it was all scarred down. When those got infected, or if a stent was in that area, you had to take out an infected stent graft, that's a really morbid operation and you're worried about brachial plexus issues, et cetera.

The nice thing about the HeRO is you're just going straight to the jug. If it's open, you can get a wire through it, you can balloon it up and get the central venous outflow to basically the catheter component in. You've got your outflow, you can connect that any way you want, tell it how you need to get the graft connected to it. For my patients that have had-- actually, going back to the people I do the most Heroes on, I'm actually using it to revise persistent or recalcitrant outflow issues in that proximal brachial to axillary to subclavian region.

I balloon, I put a couple of stents in, it keeps coming back or going down, but their fistula, be it a brachiocephalic or a brachiobasilic, is still open and if you just have massive arm swelling from the central venous occlusion or stenosis, that's someone where I can do a traditional HeRO and I'll just take the outflow portion of their patent fistula or graft and sew it onto the HeRO. Then I've established them a durable means of outflow. I'm probably using it just as much, if not more, for access revisions of a patent access or recently occluded graft as I am for a de novo or a new HeRO placement.

[Dr. Christopher Beck]
One of the questions, and I don't know if it goes without saying, but basically, it's all upper extremity work. The HeRO in your algorithm would always come before any access, like in the leg or the thigh, right?

[Dr. Jason Wagner]
Yes. For me, I will go to the ends of-- I have so many patients, and I'm a nephrologist too. I will go to the ends of the earth to keep a dialysis access above a waistline. I'd probably say it's probably once a month I have to take out an infected femoral loop graft on somebody. It's usually it's come in from out of state or out of our encatchment area here in Sarasota. Those are the people that are then, do the history, do an upper extremity venogram.

Sure enough, yes, that's the person that their next access is going to be maybe take their femoral TDC that they have, convert it, and service them back to an IJ line, put an IJ tunneled line in for a couple of weeks, and then convert that to a HeRO, or just take them straight to HeRO on one side or the other. Going back to your question earlier, as far as other patients I consider it for, aside from the upper extremity revisions, it's also for central venous seclusion disease, it's also going to be the folks that have known strictures with pacemakers and a focal occlusion right there.

It's like, I'm not going to-- say they've had an infection in their left arm, they've got a right-sided pacemaker, they have a focally occluded on venogram or on ultrasound subclavian where the pacers are. I'm not going to try and recanalize that. I'm not going to create an access distal to that knowing it's going to either shut down because of outflow problems or cause severe immediate arm swelling.

That's somebody that I'm going to say, "Okay, look, here are our options. Your jugular is open. I can bypass around your pacer wires by going to your jugular and down to your SVC that way, and I can get them a good durable access that will work the first time, as opposed to see if it takes fistula or the-- and more often than not, they'll work, but they're just going to get massive arm swelling and then the morbidity of that is just terrible.

[Dr. Christopher Beck]
I guess my next question is, how exactly do you do the procedure? If I had to guess, the hardest part of the procedure is working out how you're going to get the catheter side of the catheter in the atrium. I just want to hear about the process of actually putting in a HeRO graft, and then we can actually dig into the advanced stuff, which I think will segue us into the Surfacer. Just tell me, how do you put in the HeRO graft?

[Dr. Christopher Beck]
Before you get too far into it, will you just tell the audience, what is a Surfacer? What are the components of this? Why do you like it?

[Dr. Jason Wagner]
The Surfacer is, imagine someone took-- there's the movie, Honey, I Shrunk the Kids, right?

[Dr. Christopher Beck]
Now we're really dating ourselves here. Early Rick Moranis.

[Dr. Jason Wagner]
Yes. Early Rick Moranis is everything seems really big. I think there was a sequel or a secondary sequel, Honey, I Blew Up the Kid. It's like a Honey, I Blew Up the Kid. It's basically a dial-able curvilinear needle guide that you will use fluoroscopic landmarks and fluoroscopic targeting to basically direct the needle guide out. Then you have a step-advanceable needle wire that is a super sharp tipped wire that you'll advance through this curved needle guide directed towards a very, very fancy polished stainless steel washer that you're taping at your target exit site on the skin and you basically line it up.

Then once you're lined up and oriented and you've done a two-view to confirm you're appropriately oriented, you're basically accessing from the right femoral coming up. The steps are coming up from the right groin, you're rewiring a femoral TDC or just a fresh access. You're coming up the right groin, up your iliac vein, up to the IVC to SVC. You basically are going to first go through this with a glide wire to catheter to get it as distal as you can.

Then you put a stiffer wire there to guide your support sheath up, then you're going to guide your HeRO device, your Surfacer device up to this position. Then you're going to have your targeting disc, which is basically a washer that's taken a position at the skin, and you're going to look down the barrel of the washer to the orienting function like crosshairs are opening in the tip of the surfacer.

Through this, you're going to advance your curved needle guide out, and it's a sharpish hollow tube on a curve, like a pioneer. Then you're going to just advance a needle wire. Basically, it's a wire that's super sharp, straight up through that, and that will tint the skin or poke through the hole. Ideally, if everything's just right, you'll get the bullseye and you'll poke through, and you're just happy if it just comes out adjacent to it or near it.

Then a couple more advances, then you've got the needle wire sticking out of the skin, so it's inside-out, hence inside-out surfacer. Then you'll advance a little more wire, and then basically what you're going to do is you're going to make a small nick in the skin, and you will actually pull in a tear-away sheath at this level. Instead of pushing and kinking, you're simply just going to draw it back and pull in the nice tear-away sheath. Then through this, you'll drop a TDC, be it whatever brand you want.

It'll be a nice way to develop the track to eventually then convert to a HeRO. You could also use it for if someone needs to get central venous access for a poor or other things, you don't necessarily have to pull in the 16 French or 15 French or however big it is.

[Dr. Christopher Beck]
Right. You pull in whatever you need.

[Dr. Jason Wagner]
Yes. It's a nice way to get central venous access, again, from above.

[Dr. Christopher Beck]
Say you have an SVC occlusion, and so you're able to get just in the very lowest portion of the SVC, you can't just go-- I imagine if it's angled, you want to angle anteriorly. First, you have to go cephalad, and then angle anteriorly. How does that work? First, you just go the SVC portion, and then you turn the angle guide on and you can push anterior and up.

[Dr. Jason Wagner]
Correct. You want to be able to get it up to where the angle guides going to be up above or at the level of the clavicle because the needle guide will come up a little bit. One of the big things for this, and I know it's part of the IFU for sure, is that you need to have preoperative imaging. You can't just say, "Oh, this person's got a jugular occlusion. Sure. I wish to pull out a HeRO and a photosurfacer and just shove it in there and we'll do this thing."

You're going to want to have either venography and non-contrast CT or ideally a CT venogram or a CT with venous phase contrast so you can delineate the anatomy. Odds are the patients probably had it recently. If not, just get it because you want to make sure that if, a lot of these folks, one of the major contraindications to using a surfacer is if they have a nominal vein stent coming across from the left to the right, you're going to get tangled up in that and that's going to be a bad time. That's a direct against the IFU approach.

For me, I have been moderately aggressive in my use of it, but I think for me, the best part about it is if someone's got an occluded IJ from having prior catheters and you know where it's going to be occluded, there's going to be a little stump just off the SVC that you're going to be able to get your Surfacer into. Then from there, guide comes out, needle goes up, you're through the skin, and now you're back into the SVC from above.

[Dr. Christopher Beck]
Then, yes, you have access and you have–

[Dr. Jason Wagner]
Yes. I don't want to call it the chip shot Surfacer use, but it's a lot easier and a lot safer to start with those cases before you're doing the super aggressive, half the SVC is out and you're just wedging up into some collateral branch to then get your needle guide out. I have not been that aggressive yet. I also have just been fortunate that the patients that I've had have been relatively, I don't want to say chip shot, but more straightforward and approachable anatomy.

[Dr. Christopher Beck]
This was the reason I thought these two devices would marry well to each other. I guess I just thought there was room for patients who were maybe central venous occlusion, exhausted, access options in the arm, and then you use the Surfacer, recan the IJ or the SVC, and then boom. It's game on, you have access and then you could pull whatever you want. You mentioned a TDC, but you could also pull a HeRO grafted, right?

[Dr. Jason Wagner]
Yes. You can pull the HeRO in. They recommend that you do a TDC as a placeholder just to let the tissues maturing, so the tissues can just-

[Dr. Christopher Beck]
Acclimate.

[Dr. Jason Wagner]
-stabilize a bit around the catheter tract because it's not a true-- as of now, they don't have a way to easily pull in the HeRO stepwise dilator because you're not really going into a normally easily compressible from the outside place. It's better to have that pseudo-scarred into place tract first to then dilate that up, versus, if God forbid, you have a problem getting your dilator or something, you're not dealing with functionally a 20 French hole coming off the proximal SVC.

[Dr. Christopher Beck]
I see. I want to know, so if you have someone vacationing in Florida for the month and they end up seeing you for whatever reason and they're getting dialysis through a tunneled femoral catheter, is this a good patient if they have--? Will you work that patient up for potentially like, why do they have the groin catheter? Have you seen some situations where that led you to then use a Surfacer to then bring something up and get the tunnel catheter out of the leg and then put it in your standard IJ really?

[Dr. Jason Wagner]
Yes. I had one, we've had access to it in our hospital for about the past eight months. It's just right towards the tail end of our seasonal. You get the purchasing agreements and all this stuff approved through the hospital to actually get it on the shelf. As a shout out to Sarasota Memorial Hospital, they did a great job getting it approved quickly.

[Dr. Christopher Beck]
That's nice. We don't always get shoutouts to the hospital. That's a nice move.

[Dr. Jason Wagner]
They were great. It was towards the tail end of the snowboard season that we had access to it. I do have a standing, the wanted poster at a lot of the dialysis units and definitely the one in the hospital that if someone coming with a femoral line, call this number, call my office because we want to know that that's somebody that, at a minimum, we can get it above the waist. If they're going to be here for a month or two, then you can easily get the imaging and hopefully get them converted to a HeRO.

Some of the patients might just have a femoral line. Also, I'll map their upper extremities because some of them just have a femoral line because for some reason they might've had an occluded IJ on one side, nobody tried or whatever. They always throw an ephemeral line to be done. That's somebody that might just, if they've got an open IJ, don't worry, I love the Surfacer, but I'm not going to.

[Dr. Christopher Beck]
Yes, of course. [laughs]

[Dr. Jason Wagner]
That person can get a regular TDC on the right side, or even the left. Then we'll be able to go from there to get them an upper extremity access again, usually.