Lead Prep - LEADconnection

Lead Prep

Posted on December 7th, 2022
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Lead prep is a critical component of lead extraction. Dr. Bruce Wilkoff and Dr. Thomas Callahan talk about their approach to lead prep and how these steps can help improve success of a sometimes difficult procedure.

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Podcast: Episode 4 – Lead Prep Transcript
Callahan, M.D., Thomas
Welcome to the Lead Connection Podcast where we talk about all things related to lead management. I’m Tom Callahan.

Wilkoff, M.D., Bruce
And I’m Bruce Wilkoff. We’re both from the Cleveland Clinic and the lead extraction service and leadconnection.org to talk about important topics in lead management.

Callahan, M.D., Thomas
And today, I’d like to talk about lead prep. I mean, it seems like such a simple thing. You know, sometimes you might do it without giving it a whole lot of thought. But it really is a critical part of lead extraction. I think if you can prep the lead well, you really set yourself up for a better chance of success.

Wilkoff, M.D., Bruce
Yeah, Tom, I couldn’t agree more. If I were to take a case that we’re going to do and case planning is about a third of what we do.

Callahan, M.D., Thomas
Right.

Wilkoff, M.D., Bruce
And 50 to 60% of what we do is the lead prep and setting everything up and only 10 to 20% of this is actually the advancing the sheaths and removing the leads.

Callahan, M.D., Thomas
That’s right.

Wilkoff, M.D., Bruce
It is the most important part. If you’ve got it set up and you do it carefully and you get one chance – one chance – beforehand. If you say ohh, this is going to be easy. I don’t need to do all of that stuff. It’s going to save me some time. I’ve got another case to do. Well, that’s not a smart thing to do, in my opinion. You want to be consistent, you want to make sure you get the most out of your prep every single time and being consistent is the key.

Callahan, M.D., Thomas
Right. And the challenges that we face in lead extraction can be quite unpredictable. You might think – this patient has all the characteristics that should be a slam dunk – and then suddenly you’re struggling. But if you’ve gone through the steps of a careful prep, then you really maximize the amount of traction and counter traction you place on the lead. You just set yourself up for success. So when I think about lead prep, I think one of the first things I think about is just getting that clearing stylet down and making sure that the lumen is clear so that I can get my other tools in place – any thoughts about that?

Wilkoff, M.D., Bruce
Well, in the early days we needed to size the lumen in order to get our locking stylets, there was a different size for every 0.01 inch. We no longer need to do that. We have tools that one-size-fits-all or there are two or three sizes at most. So that’s not as important although I think you know, getting that locking style lot down as far as you can is important. And to do that using the clearing stylet. Now there are there are two sizes that I mean Cook makes us standard stylets that is .015”-.016” sizes and if you can get one of those down I think that’s the better way to do it especially if you have an active fixation lead.

I like to actually cut the lead first because if I can’t unscrew the lead, then the next step is I have to cut it anyway and to prep it. And I don’t believe that you have the same power in unscrewing the lead when you go to the pin because you’ve got a connection between the pin and the conductor. So my personal preference, I know there are a lot of people that like to keep the IS1 pin on, but there’s also some narrowness in the pin and sometimes some gunk that gets inside that that pin. So I like to cut it off. To do that allows me to hold on to the inner insulation. Excuse me, the inner coil and be able to put the stylet down. But if you can’t get that .015”- .016” size standard stylet down, then using the .012” size – the one that that comes with the LLDs is better than not doing it at all and because it helps to transmit that torque when you’re trying to unscrew the lead.

Callahan, M.D., Thomas
I agree. Its harder sometimes than I think is maybe worthwhile. But in the end I think it is worthwhile if that makes sense. You know, I think really trying to get that clearing stylet down is important. I’ll place some traction on the lead. Straighten out those bends to get it around the bends; wet the stylet when I think I’m running into some blood in the lumen to try and get through; but yeah I think trying to get that clearing stylet down to the tip so that then I can hopefully get the locking stylet all the way to the tip. I think it’s worth the time.

Wilkoff, M.D., Bruce
You know you bring out a good point here and you know, here we see, maybe even some differences between the two of us?

There’s a lot of variation from operator to operator in how this gets done and everybody seems to be fully convinced of their own technique and the importance of the details of this and I think a little bit of humility here is important because there is not strong data saying you got to do this, you got to do that.

You have to find out what’s useful and works for you, but there are principles of what’s going on and what you’re saying is you’re assessing the integrity of the inner coil. You’re trying to straighten it out. You’re trying to get it down so that potentially we can rotate the inner coil and unscrew the lead. Some people don’t think that unscrewing the lead is an important thing. It could be the difference between having a problem at the end and certainly I think lowers my blood pressure when the tip is free. Even though I have to say that intracardiac bleeding is pretty uncommon. It’s the veins leading up to the heart that are the problem. It doesn’t mean that you won’t ever have a problem there, but unscrewing that lead makes me feel a lot better about it. And remember, that’s my feeling. I don’t know that there is outcome data, it’s never been studied one way or the other.

Callahan, M.D., Thomas
Right. And to that point, you know we’ve all run into the situation where the helix just won’t come back, you know, either as you’re backing as you’re countering the helix, you just feel the torque buildup. But it doesn’t want to come free or you just feel absolutely no torque buildup, meaning that there’s some fracture down the road. How hard do you try, you know, especially where you’re feeling that torque buildup? How hard do you try before you say, OK, enough’s enough.

Wilkoff, M.D., Bruce
Well, I look at the integrity of the conductor where I’m holding it,as I’m rotating it, and making sure I’m not destroying it and seeing whether the torque builds up. So, you cannot give up on the potential of putting a locking stylet in just to try harder to unscrew a lead.

On, on the other hand, it does change the approach to how you advance the sheaths, how hard you pull whatever else you do. So, I think it’s worth unscrewing the lead, but I also think it’s not something that I do at all costs.

Callahan, M.D., Thomas
I find it a challenge, you know that it’s sort of a feel, if you will. I’ve had a couple of cases where I ended up creating a fracture or a break somewhere in that inner coil and then I have trouble getting the locking stylets. So I agree with you. I want to try and get that helix back. But I’m just always sort of feeling, trying to get a sense of how much I can go, and I usually have a point where I feel like that it’s too much torque build up. Maybe I’m having difficulty moving even the clearing stylet suggesting that it’s sort of really crimping down on the stylet and then say, OK, it’s not worth it. I’d rather have a locking stylet than the helix back.

Wilkoff, M.D., Bruce
Right. And there’s some leads that are just so fragile that you don’t even try. I mean, there’s not even a point. So I I’m thinking of leads like from the early 90s, late 80s, mid 90s, maybe silicone leads Oscor, Vascor, some of the old St. Jude leads – Uh, actually, they probably were Pacesetter leads at the time – but in any case, those leads.

Two parts to it. One is there’s no way you are going to unscrew those sleeves. The conductors are not strong enough to transmit the torque. But second of all, the screws for those leads are so flimsy that it doesn’t even matter. There are other leads that have much more robust screws on them that you really would like to get it to retract. The modern version of the lead that’s not going to unscrew if it’s been in any length of time would be the Ingevity leads.

Callahan, M.D., Thomas
Right.

Wilkoff, M.D., Bruce
And you know every lead has its advantages and disadvantages.

Callahan, M.D., Thomas
That’s right.

Wilkoff, M.D., Bruce
And, we’re going to talk about from time to time, various specific leads or groups of leads, because that’s the only way you can do this. It has nothing to do with our support or lack of support for various manufacturers. Everybody has some things to offer, but certainly leads have these characteristics and you have to know those characteristics. You wouldn’t even try. You wouldn’t even try to unscrew it.

Callahan, M.D., Thomas
That’s right. And then when it comes to the locking stylet, what sort of factors do you consider when you’re choosing the locking stylet?

Wilkoff, M.D., Bruce
So, I don’t think it usually matters much because all of the locking stylets provide enough ability to produce retraction forces to hold on to the lead, and it’s actually the conductor and the lead that fall apart. Not problems with the locking stylet. On the other hand, leads that have more fragile components that have larger lumens, I like going up to the LD#2 instead of the LLDEZ or the Liberators.

You have to be careful with the Liberators, making sure that it doesn’t fracture. Where the braided part at the end comes off, it can break there. On the other hand, if you’re having trouble putting the locking stylet down a sort of narrow one, it can be very hard to get past a crimped area or a narrow area with the constantly rough LLDs, then I prefer the Liberator. But in most cases – 90% plus cases – it doesn’t matter.

I think they all work well. Find out what you’re most comfortable with and maybe what’s most economical in your environment as to what works in that situation.

Callahan, M.D., Thomas
Right. And then let’s talk about, you know, once you have your locking stylet down, you know there’s a couple of different techniques of securing to the outer insulation. And again, I think it’s probably dependent on the individual scenario. But for just taking your generic pacing lead, what’s your go-to these days?

Wilkoff, M.D., Bruce
So I’ve made some changes and we’re going to talk about this more in a subsequent podcast. I think we have data. People have gone from silk to Ethibonds Braided sutures. But all of those sutures can still break, particularly silk sutures break. And so you want something stronger I’ve come more recently to use suture that I like that is very thin, but very strong. It’s a 2-0 suture from Arthrex. These sutures are very thin and do not break and whatever suture you are tying, you don’t want the suture to break. You want to prepare it once and then you have to find a knot that works, that doesn’t increase the bulk of what you’re doing.

We’ve come up with some new suture techniques and mostly it doesn’t matter, you can tie it on. There’s enough clearance. It won’t matter much, but what you’re trying to do is to bind on to the insulation, and if you can, if you can get it tight enough, you would like to bind together the insulation to the outer coil or the inner insulations, the inner coil, the locking stylet – you’d like to crimp them all together.

There’s another tool that does this in addition to the suture, the “One-Tie”, which is also very, very useful. But you’ve got to really crank it on that because vigor of your crimping job depends on how hard you really crimp it down. And if you can get it crimped that is a very useful thing to do.
So that’s kind of what I do. I have a new constrictor knot that we will put up some videos on LEADconnection.org eventually that talk about how to tie this down. I think that this is an area where we can make some improvements.

Having said that, whatever you hold on to is the determinant of how good this knot or whatever it’s going to be. You’ll find that if you crimp, if you tie down hard with a suture, you will cut down through a lot of silicone insulation, and then you’ll see how you distort the lead – Yeah, it’s a balance in in that part.

Callahan, M.D., Thomas
Right. And I think your point is well taken that whatever tool you use, whether its suture or whatever type of suture or if you use a crimping device like the One-Tie, you really want to make sure that you’re securing that insulation, you’re doing what you’re set up to do, which is secure the insulation, but also try and bind those components together. So that hopefully you’re creating a control of all the different components from the locking stylet in the inner coil all the way out to the outer insulation. And then finally when I think about lead prep, I think about protecting the surrounding leads as well. And so typically I’ll place clearing stylets or some sort of a stylet down at least part way down the other leads to try and protect them. Any other thoughts there?

Wilkoff, M.D., Bruce
Yeah. This is when I really prefer to use the .015”-.016” size – rather than the smaller ones, because you’ll be surprised how much force gets put on these other leads, I think protecting them is very important, which means that you also have to dissect those leads out carefully and straighten them out in order to accomplish this, and often retie them down. It’s amazing. I don’t know if they were not tied down well in the 1st place or whether just time and strain has changed things; body habitus has changed. But in any case I want to set up that pocket, separate those other leads, get them down and protect them that way even if you’re not expecting to remove those, those leads.

You know the one other part about the lead prep is whether you just tie down onto the leads or whether you take the suture, the long end of the suture and what you do with the rest of it. And some people insist that they must have them all separated and be able to pull on them separately, whether it’s to the conductors of the defibrillator lead, which we also do, or to the insulation. I personally prefer to make sure that I’ve got it crimped really well and then pull them all straight and tie them to the locking stylet.

If I’ve done my job right with prepping the lead, there should be no differential pulling on the on the leads. It’s when you haven’t prepped it adequately – In my opinion – that you may have to pull on one more than the other. Once you start playing that game, the leads starts to cant a little bit as you’re advancing the sheath and so, in my opinion is that that you prep well on the lead itself and pull them all together. Now having a multi-cord connection to the lead strengthens that connection, strengthens your rail, and gives you better control of the lead body.

Callahan, M.D., Thomas
I agree. I agree. Yeah. For me, at least I have only so many hands. So it’s a challenge to try and deal with more. So I like to tie back to the locking stylet as well, just because I feel I have, you know, limited hands to work with already. So, another other thoughts before we move on.

Wilkoff, M.D., Bruce
No, I think this is the first step and I think we’re going to get back to this trying to differentiate between defibrillator, you know silicone versus polyurethane, conduction system pacing leads, every lead has its own characteristics. And I think once you have the basics down, then we’re going to talk about more detail in the later podcast about specifics.

Callahan, M.D., Thomas
I agree there. There’s plenty to talk about when it comes to f more specific leads. And I think as we see more conduction system pacing, other types of pacing, I think we’ll have to come up with new techniques for those as well, but I think this was a really useful conversation.

Wilkoff, M.D., Bruce
OK, great. Thanks, Tom. And I hope everybody is benefiting from this. We really hope that you’ll also take a look. We’re collecting all the literature about this and come in and see. This should be the gathering place. This should be the place where you come to get more information about lead management and lead extraction. Hope to see you next month.

Callahan, M.D., Thomas
Alright, take care.

Wilkoff, M.D., Bruce
Bye