The Bridge Balloon was designed to aid in the rescue after SVC tears, one of the most serious potential complications of lead extractions. Dr. Bruce Wilkoff and Dr. Thomas Callahan discuss how they use this life-saving tool, as well as other best practices that lead to successful outcomes during lead extraction procedures
Podcast: Episode 1 – Bridge Balloon Transcript
Callahan, M.D., Thomas
Hello, welcome to the Lead Connection podcast where we discuss all topics related to lead management. I’m Tom Callahan.
Wilkoff, M.D., Bruce
And I’m Bruce Wilkoff. We are both from the Cleveland Clinic and leadconnection.org and we are really excited about these podcasts.
Callahan, M.D., Thomas
Yes, I am excited too. I’m excited to jump right in to our topic today where we we’ll be talking about the bridge balloon. The bridge balloon was developed to handle one of the most feared complications of transvenous lead extraction, which are vascular tears – especially SVC tears. And, just to get our head around the scope of the problem, let’s look at some of the larger registries.
ELECTRa identified vascular tears in about .6% of patients. In LExICON, It was about 0.4% and if you throw in cardiac avulsions, it was around 1.5 to maybe up to 2% found in GALLERY. So it’s a rare complication, but it’s really feared. One study found mortality rate about 50% for SVC tears. So something that’s really an important problem to address.
Wilkoff, M.D., Bruce
The other problem is the unpredictability of it. You don’t know when it’s going to happen. It is really difficult to predict major complications. We did some studies looking at how people did a month out. We could predict who was going to die within a month, and those were mostly related to comorbidity situations. But actually, the vascular accidents were hard to predict. And it’s not just about how long the leads have been in or how hard it is to take out the lead or anything else like that. But, they seem to be at some point once you get past the skilled use of the tools, sort of whimsical. And it’s sort of a set up. The patient is set up by their implant or the way they heal, or something else that happens and you just don’t know when it’s going to happen – even what appears to be an easy, straightforward case. You still have some risk of having a tear, and it can be devastating.
There was some work done on the how rapidly the blood flows from the SVC and how little time you really have to respond. And I think that’s the key, because if you take out a half a liter a minute, then within 30 seconds or half a minute, 2 minutes, the game can be over. And so you, you really need to move quickly and know what you’re going to do.
I think the bridge balloon helps to do two things. One is it actually does something for stemming that flow, but second of all, it gives something for the team to rally around as a structure. How to manage that situation.
Callahan, M.D., Thomas
Yes, I think that’s right. You were the lead author in the best practice paper in 2017 and you talked about 7 different critical steps. But some of those critical steps are the balloon competence and the balloon familiarity. And so just having that familiarity and competence with the entire team gives you sort of a structure of how to deal with these problems when they do occur.
Wilkoff, M.D., Bruce
And in addition, it augments what we do when we do what we call a huddle. I’m sure everybody does something like this where we go through the procedure with everybody in the room, patient included, and we talk about all the things we’re doing to help protect the patient. Because it’s not just about the bridge balloon, it’s also about what else is going on in the room: the people, the anesthesiologists, the cardiothoracic surgeon, the nurses, having all the equipment in, how you’re going to be monitoring the patient, the TEE or is it going to be ICE or is it intravascular ultrasound? How are you managing your imaging? How are you going to respond? Whether you’re going to rescue with sternotomy or thoracotomy? So, I think all of these things gives us a construct to work around and I think that that’s extremely important and that’s what the best practice paper was all about.
Callahan, M.D., Thomas
Right. And to your point, you know it’s not just the structure, it’s not just the planning, both of those pieces are critical. I don’t want to minimize those at all, but the bridge balloon also actually does something. And so there’s really good data showing how the bridge balloon is able to dramatically reduce blood flow from SVC tears in animals, but also important outcomes data in patients that have actually had SVC tears.
There’s a study that looked at those patients where the bridge balloon was used and in those patients with SVC tears that the bridge balloon wasn’t used. Survival to discharge was 100% in patients where the bridge balloon was used, and 50% in those where it was not.
Wilkoff, M.D., Bruce
Yes, it really improves outcomes. And it’s really going to depend on where the tear is. Not all the tears are in the SVC. Not all are addressable by the bridge balloon. But even if it stops part of the flow, it improves your odds. I mean, there are other things to do. Are you are going to have longer downtime of cerebral blood flow, cooling the patient is key because this is all about preserving the brain. I mean all the surgeons are able to sew a hole and they are really skillful at that. But you have to be there with brain cells after you’re done. So you really have to look at the end game here. And this is just part of this construct. But it actually is the one thing that we know that consistently, and we have data that affirms this, that we improve survival. And, while complications may not be predictable, survival can be predictable if you are approaching this appropriately.
Callahan, M.D., Thomas
Right. And you know, to the point about time being so critical, you really need to not just get the balloon up quickly but very importantly the surgeons have to be there and open that chest very quickly as well. So it is really about preparation and having the right team there and available.
To that point, in order to make sure that things are happening rapidly when a when a complication does occur, maybe we can talk a little bit about which patients you are going to be more aggressive with preparation and where to prepare. One of the things that I was going to ask you about is where do you position your wire, are you pretty specific about where you want that bridge balloon wire to go?
Wilkoff, M.D., Bruce
First of all you need a stiff guidewire. It can be floppy at the very end, so it’s less traumatic, but you want a stiff guidewire and it has to go up pretty high. I prefer to put it in either the right IJ. I put it up through usually the right femoral vein but up through the right IJ or the brachiocephalic. And actually I’m liking the brachiocephalic even better because it gets that turn from the brachiocephalic down to the SVC where there is another problematic point.
The other point here is that without a stiff guidewire and or the ability to anchor the bridge balloon itself up higher, It tends to prolapse back into the atrium. So, a test inflation, I mean just putting up the guide wire is not enough really. I can’t tell you the number of times that we thought we had things, we knew we could do it and then with the advancement of the balloon and the test inflation, we said, ”Oh no, we need to really read redirect this.”
Sometimes that means you’re actually putting up a woolly wire, redirecting it with a JR4 or a multipurpose catheter to get it to go where it needs to go and then exchanging it for the stiffer guide wire. But taking that time to do that is fine at the beginning of the case. It is not fine when the patient is crashing. So that is the real point of at least putting the wire up into a stable position.
Sometimes you’re going to find that the SVC is included or one of the other vessels. I mean, there were other things that happened. You learned some things when you do the test inflation. You learned about how the leads move in the SVC at that point in time, whether they’re lateral or medial and such like that. You learned about how much fibrosis there are and how to pull on the leads later on while you’re trying to advance whatever extraction sheath that you’re using.
But what we have been doing I think is appropriate in virtually all patients since we cannot predict who is going to get into trouble very well. Even low risk people can get into trouble. We put a 12 French sheath in virtually every patient. We use ultrasound to get it in. We don’t want to cause a problem in trying to to do this, and then we put up a stiff dive wire and like I said, I prefer the right IJ or the brachiocephalic. The right subclavian doesn’t work as well. It’s hard to get the balloon up high enough so it doesn’t prolapse back down. Have you had that experience?
Callahan, M.D., Thomas
Yeah, absolutely. I mean the balloon can sort of act like a little bit of a watermelon seed and so to your point, really positioning it, inflating, seeing what the balloon does. I think that’s a really critical step and also repositioning that wire. If you find that the balloon keeps sliding back into the right atrium. I completely agree with that.
You know the other thing I was wondering is, what’s your usual practice with patients with known SVC occlusion. I mean is, in those cases, you’re not going to get the bridge blown up into that SVC.
Wilkoff, M.D., Bruce
No, and that is a problem, but once you have, lets say one of the leads out and you can choose which one you want, the more medial one of the other things that work. Once you choose one, you can also put the guide wire in from above. Now you have to put in a large introducer there too (a shorter one), but you can put the guide in and/or the bridge balloon in from above at times as well, or at least have access to put it in. You don’t have to necessarily inflate it. You don’t have the same problem with watermelon seeding from that scenario.
And the last part here, depending on where in the SVC it is occluded, I’ve put the wire up through the azygos vein. So what happens is the azygos vein starts at the top of the SVC, travels posteriorly a little bit and to the left, towards the left arm and then behind the heart. If you get the guide wire to go down the vein a good distance, then you can put the bridge balloon up the SVC and actually have it sort of like an upside down “U” coming from the the azygos vein and actually that also covers the SVC extremely well.
You know, if your occlusion is distal in the SVC, then that’s not going to work. But, but those are the kind of opportunities. The other problem is that it gets in the way sometimes. Let’s say you’re doing femoral extraction and the guidewire keeps you from snaring, at a certain point you’ve got to decide when to pull the wire down or to repurpose that access for femoral extraction. And so I I think there is a time where you’re going to say the benefit is not there compared to you know your inability to do the job that you’re there to do and the risk is actually of a problem is so small, it’s appropriate to do some trade-offs every once in a while.
Callahan, M.D., Thomas
So we talked about putting a wire up in in basically all patients and having that that large bore access in all patients. How about staging the balloon, I mean do you have a threshold where you say, OK, I’m going to stage the balloon or do you stage it for everybody?
Wilkoff, M.D., Bruce
I have been staging it for almost everybody. The only problem with pre staging the balloon is that it’s been demonstrated that clots can form on a once inflated balloon and then deflated. Sort of like a wrinkled Raisin. And so what we do is, let’s say we’re using a laser or we have some other extraction sheath, we get everything ready. We have the wire up, we put the balloon up. We test inflated. Pull it back down. Then we take the leads out and then as soon as all the leads are out, we’re done. We’re sure everything’s good. We pull the bridge balloon back out in a majority of patients. That’s not a very long time. And we have not found the clots to be a problem.
And you know, I know there’s a cost trade off here, but, I think that by doing it as a routine it does several things. It’s sort of does some team formation that the people are all engaged. They know that it’s there. It’s really good for your relationship with the cardiothoracic surgeons, the anesthesiologist. They all know what’s going to happen. So, you know, you may have some variation in your personnel from time to time. You know, if they’re not doing it as often, it brings them all together. It gives us time to review what we are going to do. So I’m a big advocate for pre staging it in virtually every patient.
Callahan, M.D., Thomas
Yes, I agree. For basically every patient. I’ll stage it and I think it just gives you a lot more comfort as you’re as you’re going through some more challenging extractions.
Wilkoff, M.D., Bruce
The other question is you know, this is all tough. I mean, we don’t know when somebody loses their blood pressure, why they lost their blood pressure at 1st. And obviously you’re going to look at the cardiac silhouette and you’re going look at the fluoroscopy. People appear to lose their blood pressure when the extraction sheath goes by and compresses the right subclavian artery at its take off as the sheath goes around when the arterial line is in the right arm, and if the arterial line is in the left arm and people lose their pressure when you when you compress over the subclavian artery on the left side there is an apparent loss of blood pressure, people also actually lose their blood pressure from vagal reasons not infrequently. So you don’t know what the problem is at first. Sometimes the patients are volume depleted (under-filled), sometimes when you’re pulling on the lead, the lead sort of ratchets back and you’re progressively embarrassing the right sided filling of the heart and you don’t even realize it. You think you’re being really gentle but you sort of pulled back a little at a time on the lead and you are not allowing the heart to fill properly. It’s OK to inflate these balloons when you are not sure of the etiology of the hypotension.
And it’s not an automatic to open the chest. Usually it is an automatic to open the chest, but occasionally there’s enough questions you may want to watch. But even the inflation of the balloon on some occasions will lower the blood pressure a little bit because you’re embarrassing the flow from above. Having said that, that happens pretty rarely and so I don’t think that’s usually the case.
Callahan, M.D., Thomas
Yes, that’s right. Those are all great points. I mean, I’ve certainly seen this. I think you’ve developed a comfort level for if you’re seeing these drops in blood pressure, especially as you’re pulling on a lead that goes to the right ventricle. And so if that recovers pretty quickly, I think most people don’t get too panicked, but the ones where it’s not recovering quickly, I think getting the bridge balloon up and starting to inflate it. You don’t have to wait until you’re seeing a hemothorax fluoroscopically. In fact, if you’re seeing it fluoroscopically, it’s probably getting a bit late.
Wilkoff, M.D., Bruce
Yes, you know this has been a great discussion, Tom. I think we’ve sort of talked about the big picture and it’s sort of a primer. I mean really it’s important that you get that experience. I mean I really do encourage people to get that experience through prophylactic deployment of the bridge balloon, rather than waiting for the emergency because everything is different during the emergency. And I’m really glad we’ve had the time for this discussion.
Callahan, M.D., Thomas
Yes, this was a great talk.
Wilkoff, M.D., Bruce
So I hope you join us in the future for more of our leadconnection.org discussions and look forward to talking to you again soon.