Studies have shown that hematoma increases risk of infection and other complications of device implantation. Drs. Callahan and Wilkoff discuss the importance of hematoma identification, documentation, prevention and treatment.
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- How do you manage antiplatelet and anticoagulant medications before procedures?
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Podcast Transcript: Episode 8 – Hematoma
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 and we’re both from the Cleveland Clinic and really glad to talk to you through LEADconnection today.
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Callahan, M.D., Thomas
I’m excited for a conversation today. We’ve talked about hematomas sort of loosely before and during some of our other conversations we’ve touched on that topic, but that will be our focus today.
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Wilkoff, M.D., Bruce
Yeah, Tom, it’s interesting how these topics are all interrelated, that you can’t talk about one without another, but a certain focus is ,important.
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Wilkoff, M.D., Bruce
At times I have come out and said that I think a lot of the results that we’ve seen about infection are all about hematomas, hematomas and the things that produce hematomas, and the consequences of hematomas. So the management of hematomas is perhaps one of the more important topics that we could talk about.
Callahan, M.D., Thomas
Right. I think that’s right. And there’s certainly emerging data including some of the WRAP-IT data that that really points to the importance of hematomas in terms of the development of complications, infection and so forth. So maybe we start with just the scope of the problem.
How big of a deal is a hematoma? If a patient develops a hematoma, why should we get so worried?
Wilkoff, M.D., Bruce
Well, even more than that, is how do we define a hematoma? Is it only the big hematomas that we’re talking about, the ones that look like a basketball coming out of somebody’s chest or maybe it never gets that big, but in any case, maybe an orange or even a plum. But is it that kind of hematoma or are we talking about just the small ones and, there were some data from WRAP-IT that sort of put the fear into me in that we defined hematomas in WRAP-IT as any sized hematoma. Small, large didn’t matter, and all the hematomas carried with them a consequences of infection – 11 fold increased risk of having an infection developing if not associated also with an envelope, but that’s not the point. The hematoma itself was associated with the very high risk of infection, so at least one of the consequences of the hematoma was infection, which of course is a terrifying result.
Callahan, M.D., Thomas
Sure. Yeah, absolutely. I mean the consequences can be so devastating, right? We know that the price that patients can pay if they do develop infection. And, it’s interesting that in the WRAP-IT trial it was really any hematoma because you think about well maybe a small hematoma isn’t that big of a deal or if it’s large enough that it requires intervention, maybe that’s when it becomes important. But that study suggested that really any hematoma, so it really points to the importance of trying to avoid these.
Wilkoff, M.D., Bruce
It also points to a problem we have, although in some studies it’s been defined as something that is palpable or something that extends more than two or three centimeters, a lot of different ways. There is not a systematic way that I think we have clinically defined hematomas or even look for hematomas. And/or perhaps even ignored hematoma, small hematomas, and so do we really know when there was one, when there wasn’t one, and should we be doing something differently?
Callahan, M.D., Thomas
Right. I mean some of the trials have used ultrasound to try and identify these. I don’t know that there’s any real role for that in in sort of our day-to-day clinical practice. But if we really want to be diligent about identifying these in trials, that may be one of our best ways to do so.
Wilkoff, M.D., Bruce
I’m more interested right now in in how we manage it clinically. So one of the tools that we’ve talked about and I would propose is useful for several purposes, is documenting with a picture and we don’t do that systematically at the Cleveland Clinic. We do it on occasion when we’re worried, but we don’t document what is normal, what is abnormal.
With that, we don’t ask the patients to do it. We don’t do it. And sometimes people don’t even look at the pocket site. I think it is a problem, but I think that’s something that we should be discussing how best to implement that in a more systematic way and especially if we can identify when they’re occurring. Is there a treatment that’s also useful and unfortunately, the only treatment I know that’s effective against preventing an infection, for instance, would be the envelope, so you’d have to sort of know beforehand that you’re going to develop the hematoma. Of course, the envelope did reduce the rate of infection when there was a hematoma almost back to normal.
Callahan, M.D., Thomas
Dramatically.
Wilkoff, M.D., Bruce
Yes. Dramatically. So I think that’s an important aspect of this as well.
So I think #1 is we need to start a wider discussion with the lead management and device community about how do we document pockets and where does the picture go into the electronic medical records. All of those things I think are important.
Callahan, M.D., Thomas
Right. I think as we’ll probably touch on in our conversation, the evolution of the hematoma is important to the management. You know, if you see stability, then you might manage in one way. If you see that the hematoma is expanding, you might take other steps. And so documenting, having photographs marking the site, all of those things can be important tools to help you in managing the hematoma.
Maybe though, can we step back just a second? We’ve touched on this in other conversations, but I think it’s so important. You know probably the most important thing we do in management of hematoma is prevention, right? And so when you’re talking to other physicians about how to prevent hematoma, what sort of advice are you giving them?
Wilkoff, M.D., Bruce
Well, it’s long been said, but usually it’s glossed over. Surgical technique is everything.
Callahan, M.D., Thomas
Right.
Wilkoff, M.D., Bruce
You start off and you end up with surgical technique. So sometimes we’re a little sloppy and we’re not paying enough attention to this as we want to. So I think that’s something that we have to reemphasize – this is important. The second part has to do with what risk factors are for hematomas and certainly the people who are at risk and we have good data on this from WRAPIT, but other situations as well. People who are underweight or people who are malnourished, people who have trouble with platelet dysfunction. That includes our pharmacologically induced platelet dysfunction with aspirin which is an important player here – plavix or even the more potent anti-platelet agents that we use for stent and preventing platelet aggregation and embolus.
Those are really important. I think we talked a lot about anticoagulation, but anti-platelets are often worse and certainly anti-platelets are worse than Coumadin, which actually isn’t such a big problem as long as the INR is not very high.
But I think they add together, so it’s anti-platelets, anticoagulation, how we manage those things. And I would say probably the one thing that we could do other than surgical technique, would be to pay attention to the anti-platelets which we tend to ignore. And I would like to see us holding those agents whenever possible. And I think usually we can, I mean the anti-platelets held for a period of time.
How many times do you get these forms that we have to fill out for every other kind of surgery except for pacemakers and defibrillators, and they are holding them all the time? We should be holding them as well because it’s responsible for a lot of our problems.
Callahan, M.D., Thomas
I think that’s right. I think in the EP community, maybe we feel like we should be continuing these agents; that maybe there’s some cardiovascular benefit, but you know in reality these agents are stopped from almost every other type of surgery when able and you know we should take a page out of that playbook. I would echo your comments about surgical technique. I mean we all have a lot of demands on our time and sometimes we feel like we need to move quickly through a case, but slowing down, being really diligent about hemostasis I think pays dividends both in terms of the potential complications for the patient, but also your time because you have to go back and evacuate the hematoma, et cetera, that costs you time down the road. So I think really careful surgical technique, the importance of that can’t be overstated.
So let’s say you have a hematoma. You’re seeing a patient with the hematoma. Or maybe we’ll take a step back and go even earlier than that. You have a patient that say was oozing from everywhere. You’ve done your best for hemostasis, but you’re still in the operating room with the pocket closed. Are there steps that you take to try and minimize the chance of hematoma development post op?
Wilkoff, M.D., Bruce
Well, the very simplest thing to do is to spend about 5 to 10 minutes after the procedure with your hand on the pocket. That sounds, if it sounds ridiculous, but that’s probably the most important five to 10 minutes that you can spend and you know an ounce of prevention, so to speak. I think it’s a huge difference. It’s a different talk than that about dressings because it has to do with both pressure, but also preventing an ingress of bacteria, and such. Certainly we have to think about, you don’t want to reduce the blood supply to that area and too much pressure and necrosis, especially in these malnourished people, but, I think just putting your hand on there and just leaning on the pocket there for a while. Patient doesn’t love it, but it makes a difference and I think that that’s a big deal. And then a dressing. You got to put the dressing on. And like I said, I think we’ll talk another time about the dressing themselves.
We use pressure dressings, modest pressure dressings, but they can be only modestly effective. I think you determine whether there’s going to be a hematoma by stopping your anti-platelets or anticoagulants if you can, by good surgical technique, by putting pressure on it, you know just manual pressure and the pressure dressing is probably how whatever analogy you want to say, the cats out of the bag, whatever it’s like that it’s already there and you have you have to work with that.
Callahan, M.D., Thomas
And what do you think? Is there a role for negative pressure dressings?
Wilkoff, M.D., Bruce
I do think there’s a role for negative pressure dressings. But I think the data is not as strong as we’d like it to be. I think there’s room for more collection of information. There are all sorts of different kinds of dressings that we have now. Some preserve the ability to see what’s underneath and some not. If you’re going to use a dressing that’s going to be covering up your wound, you have to be disciplined enough to make sure that nobody starts peeking, taking these things off, but I think the negative pressure dressings particularly are helpful in the times where we’ve done not just a normal procedure, but where we’ve done a debridement after an infection and the surface is a little raw, the negative pressure dressing helps to compress the layers of the pocket together and just that apposition, instead of allowing things to accumulate, I think helps. And but I will freely admit we need more data in that area.
Callahan, M.D., Thomas
Sure. And how about anticoagulation management immediately postop you think that makes a difference?
Wilkoff, M.D., Bruce
Well, I do. I mean in things to avoid in particular. So it’s clear you can continue anticoagulation through the procedure, but it’s also clear that you get better results if you don’t and so this is sort of risk versus risk you have to work with that. So we do our device changes and implants, I prefer to put the keep people on Coumadin for instance, through the procedure. What I try to avoid is anything that has heparin-like properties, so heparin itself, low molecular weight, bridging I think is a particular problem that by trying to prevent, let’s say somebody with a mechanical mitral valve, by trying to prevent a clot, we cause all sorts of hematomas, all sorts of secondary surgeries and infections, and actually more time without anticoagulation all told, because you end up holding it for longer periods of time. So I think yes, there’s some risk, but if you’re going to use Coumadin then what you’re going to do is you just restart the Coumadin. You don’t use the heparin products.
Consider using the novel agents that we have, the apixaban, the rivaroxaban, the pradaxa [dabigatran]. Using those types of agents, but in general, I will hold even the novel agents the night before and the morning of the procedure and then start depending on how urgent I think it is a day or so later. But on a on a troublesome patient I would start it that night.
Callahan, M.D., Thomas
Right. OK. So now let’s talk about a patient who has developed a hematoma. So you’re seeing them maybe the next day and there’s a hematoma. And let’s say it’s the size of your fist or so. So it’s a fairly good size hematoma. Let’s talk about how we how we manage that.
Maybe we’ll start with you know what’s a threshold, what are the features that that make you start to think about going back to the OR for evacuation?
Wilkoff, M.D., Bruce
Well, if it’s expanding, continues to expand, if they appear that there’s leaking from the site and the it’s clearly not controlled. Definitely if it’s starting to, if you see, there’s pressure on the incision.
If it’s going to open up anyway, you might as well go ahead and do it under a controlled circumstance. The previous saw that the ways that we went with it is then less it threatens the incision, we don’t go back in. I’m not sure that’s is true now. Understanding how serious risk of infection there is going back
Probably we should do this in a more randomized fashion. I don’t think that there is good data to say. I mean we’ve said it’s because of the risk of infection that we don’t want to open up the pocket. But on the other hand, the risk of infection is already there, we might as well open it up more. So this has not been tested. But, I think it’s time to actually do a trial and systematically look at this.
Callahan, M.D., Thomas
Sure. Yeah, I think you’re absolutely right. You know, certainly if the incision looks threatened, if it looks like there’s a risk of dehiscence, then it makes the decision a little bit easier. And I think patient pain can factor into this as well. If they’re really comfortable, then that might lead you to manage conservatively. If they’re really having a lot of pain, then that might push you to open it up and evacuate the hematoma. It’s challenging, though, right? When you open these up, so rarely do you see just a single bleeding vessel. Instead, you’re often faced with just diffuse oozing, and it can be quite difficult to control.
Wilkoff, M.D., Bruce
It is but starting over again and closing it up is still useful because if you can’t get reasonable pressure or anything if there is fluid in the pocket. It’s hard to do that. Let me ask you a question, Tom. There are a lot of hemostatic agents and some of these pockets are tough. What do you think about that? And how useful has really been to use the hemostatic agents in your opinion?
Callahan, M.D., Thomas
I use them rarely. I would say, you know, quite rarely. Maybe I need to use them more. Although I really feel that surgical technique is the key. I’m always concerned that that I’m just introducing something else that could be problematic for the patient, whether it’s sort of a local reaction or even a nidus for infection. So I feel like good surgical technique is really key. And if I’m using a hemostatic agent, it’s sort of a bailout. So, I might consider it in a in a situation where there really is just that diffuse oozing and I’m struggling to really get it under control, but I think I can count the times that I’ve used it probably on one hand.
Wilkoff, M.D., Bruce
No, I completely agree. I think it’s all about surgical technique and getting back to the surgical technique, there’s one other bit of data from WRAPIT that I think is important to point out. We looked at risk factors for hematomas and risk factors for infection and we were hoping that maybe debridement would be something that would help in these device replacements. And it turns out that debridement was not useful, matter of fact increase the rate of hematoma and of infection. So complete capsulectomy – Now there are times where we take the capsules out, certainly from infection. Certainly we have to debris to the point where we loosen up the leads and if there’s thick fibrosis, but there is a risk for bleeding there and it’s at the very edge of where you are, so you do partial capsulectomy – but total capsulectomies are probably not the thing to be doing except if you’re already have an infection.
Callahan, M.D., Thomas
I think one of the ironies of the antibiotic envelope is the fact that you typically need to do more capsule debridement in order to get the thing in there.
Wilkoff, M.D., Bruce
Well, maybe. I mean you have to at least open up the pocket. And I think if you just get the area right around where the leads are tied down, then it opens it up enough. But you’re right, you’re right. There is an irony there.
Callahan, M.D., Thomas
That’s right. Alright. So let’s say we we’ve got a hematoma. We’ve decided we don’t need to go back to the OR.
What other strategies are you looking at for management managing this? You know moving forward? Are you thinking about antibiotics prophylactically and what sort of things are you doing to follow this hematoma?
Wilkoff, M.D., Bruce
So that’s another area where we’re in sort of a desert of information. And in the past I’ve said you know it’s either infected or not when there’s a hematoma, I think it’s impossible to tell the difference between the hematoma and the developing an infection. And of course, there’s that transition that happens between the two.
I don’t think that in general that that antibiotics are useful, but I don’t see in this situation where you’re already watching the pocket where it really hurts to do so. If you’re going to do so that you want to cover with a staphylococcal covering medication, obviously you’re going to use something oral. You’re not going to go to intravenous at this point in time, but you know, this is a pocket. You’re going to have the patient come back, have pictures taken and watch how things go, and it takes a long time for it to resolve. Most of the time that will resolve. And so I think patience and telling the patient that it’s going to turn it every color under the sun and it’s, but usually a soft hematoma just takes time. There’s some bruising. Antibiotics are usually not warranted, but I think it’s an area where we should be studying further as well.
Callahan, M.D., Thomas
Right. I agree. I mean I couldn’t tell you sort of what the antibiotic penetration into these pockets you know might be, my suspicion is it would be relatively low so.
Like you, I don’t routinely use antibiotics in managing hematoma, though I don’t think that there’s a big problem in doing so. I just don’t know that it’s all that helpful and I typically feel that I don’t want to mask an infection. I don’t want to suppress an infection. I’d rather know sooner rather than later.
Wilkoff, M.D., Bruce
Right, right. Sounds good.
Callahan, M.D., Thomas
Well, I think I think this has been really helpful. And I’ll look forward to our next conversation.
Wilkoff, M.D., Bruce
Yeah. I really enjoy these times with you and I hope other people are listening carefully because we hope this will invigorate the discussions amongst the lead community, the lead management community so that we can get some answers to these things because we do not have the answers for all these questions.
Callahan, M.D., Thomas
That’s right. Yeah. And hopefully this sparks more conversation and more research.
Wilkoff, M.D., Bruce
See you. Bye bye.
Callahan, M.D., Thomas
Alright, take care.