Sergio Thal, MD, discusses the indications update for lead extraction.
Good morning everyone. Thank you for having me here. I'm going to give an update on the indications for little extractions with some examples that will show what are we doing today. So we start saying that the extractions is one of the most challenging procedures that we do in ep. It requires a specific track of training. It requires some specific skills that needs to be developed during during our training as cps. It requires us to training tools that are completely different from the tools that are used usually for abrasions or device implants. We need to train in specific style. It's to be able to move leads out. We need to be able to train and use of power tools that allowed us to break through all the fiber optic tissue that get attached to the leads with the path of ears. We use tools like this one that shows that use electro culturally energy. We also have laser tools that allowed us to cut through this this growth tissue on the leads in order to be able to free them and pull them out. We have mechanical tools. These are cutting tools that we use to for the same reason. But basically the energy is our arm pushing through this cutting tool. And we have very fancy style its that allowed us to grab the leads from the groin and try to pull them down. So basically it requires a lot of different skills that we use usually in our general E. P. Practice and of course this is not free of risk when we do extractions we are risking damaging the tissue where the lead is embedded. We are going through the veins, the subclavian veins, the sbc the heart. And we can always be risking to cause tears in these structures. So having said all that, the idea is with all this in mind to try to navigate a little bit. What are the indications to send a patient to undergo the extraction So we can divide the indications in basically three groups. The first group will be the lead or device infections. The second one will be the patients that have Trumbo sis associated with these leads or venous stenosis. And finally we have a group of problems with function and non functional leads that we are going to quickly overview. So let's start with the elites or device infections. So not every patient that undergo device implant carries the same risk food to have an infection. So this is data from Probably one of the biggest meta analysis that were published and actually the data impacted the late guidelines in 2017. They review information from 180,000 patients and they came out with different factors that will increase the risk of patients to be to get an infection. So they divided in different kinds of risks. We have risks that are related to the host. So not every patient is equal. So clearly patients with diabetic and stage kidney disease COPD patients that are in use of corticosteroids. Clearly patients had history of previous infections. So having had a previous infection, increase your risk of having another woman malignancies. Heart failure patients were febrile at the time of implant patients on anti coagulation. We'll see later. The anti coagulation increase the risk of having a hematoma in the pocket and associated with the hematoma is an increased risk of later getting infected. We have reached that are associated with the procedure. It's just not only with the patient, but what are we doing to the patient? So as I just mentioned having a hematoma after the procedure increased the risk of infection having to re intervene, meaning that the patient had lied dislodged and we need to bring him back and reopen the pocket. Every time that we re intervene on the patient increase the risk of getting an infection. The type of procedure we do. If we just do a device change, we do an upgrader, we spend time adding more leads. That also adds to the risk of getting an infection. There are some risks related with the type of device that we're implanting. So if we put a device in the abdomen, the risk is higher. If we have a pericardial leads, the risk is higher. If we just put one lead that the procedure is shorter, the risk is lower. But if we put three leads and the procedure takes longer with longer time off the pocket. Open that increase the risk. So this is later. I want to show you because it's very important for many years. We talked that device changes were pretty benign and easy thing to be done. But I it's not the case anymore. I mean, I think that the replaced registry actually show was pretty well that Just bringing a patient up in the pocket increase the risk of of infection. I mean in general we can say that about 1.1.1 to 1.4% of the patients that undergo a lead. A device change has an increased risk of getting infection and just have in mind that if these patients just comfort device change gets an infection, the next step is everything needs to come out. Some of these patients are dependent. It's very complicated because then you need to keep a patient in the hospital with a temporary peacemaker. Some of these leads are really old and then an extraction is not as easy as a brand new lead. So clearly the study also showed that it depends what are you doing If you're just changing the device risk is lower. But the more you are adding like CRT upgrades, the more is your risk at the time of device change to develop an infection. So what are the guidelines they telling us about when to proceed with? In fact with the device extraction in the case of infection. So these are his data from the 2017 guidelines basically it's pretty straightforward in many cases. So basically if we have a suspicious of a device infection and the blood cultures are positive, then that's pretty much an operator. So we think this infected, we have blood cultures are positive. The system is infected. The next step will be just to do A. T. E. Because we want to make sure this is only a pocket infection or this is an endocarditis. But basically if you're on the left side of this slide it's very clear you're gonna end up getting an extraction. The problem is when you are on the right side of these slides and basically you you suspect the device the system is infected but the blood cultures are negative. In those cases you do a. T. And clearly there is a suspicious and the T. V. Shows there is vegetation. Then the discussion is finished and we move to the left side of the screen and we go with an extraction. But if the tea is also negative, so we have negative cultures, we have negative T. And then we look at the pocket. If the pocket is clearly infected then he will need to have an extraction. But if the pocket is not clearly infected then it's the area where we do not jump into an extraction because we're not going to put a patient through a risky procedure. If we don't have a clear indication to do this is an example of a vegetation. So you can see here this is a growth tissue that gets attached to the leads. Let me tell you that most of the time this is not just attached to the leader attached to the wall of the heart. They're attached to the the risk of embolization is big but always have in mind. This is not just on the lead. So even when we put the leads most of the time this vegetation, this growth tissue that is infected remains attached to the heart. What happened when we have pocket infections? Well the pocket infection I think is more straightforward than the discussion about the endocarditis. Basically if we think that it's a very superficial infection and incision we have some freedom just to do antibiotic treatment and wait and see although if the antibiotic treatment fails or microscopically the pocket looks really infected then there is no question. Everything needs to come out. And when we talk about extractions, if the pocket is infected, even if we don't have evidence of endocarditis, everything needs to come out. These are a few examples. This is a patient clearly you see it's a pocket with an opening so we have the hardware is exposed. Once any piece of the hardware is exposed, then this is contaminated. And considering infected and everything needs to come up. This is a picture that I really love. I mean you have a device completely out with a tiny hole and the question is how did this device came through that hole? And the answer is also nice. I mean this patient unfortunately was a psychiatric patient he has this device hanging out for a long time long enough that allow the skin to heal again and leave only a tiny hole. But clearly this device is clearly infected and needs to come out and that's what we did here is the most common presentation. So here you see there is an inflamed pocket. You have changes in the skin. You see the redness in the inside of the pocket. This is a cellulitis with probably a fluid collection inside probably pass. So this is an indication for pocket infection and it's in need of extraction finally regarding infections this is the most controversial part because he's the patient that has bacteria mia. But there has no other signs of infection. And this is what actually get us in discussions with our ID colleagues most of the time because of course every time they find a patient with Factory Mia and they cannot find any other source of infection. They always the one to blame is the device and they will come to us and say we want the device out. But not always the device needs to come. Basically the decision is based a lot in what is the bag. If the bacteria is one of the typical bacteria that infect devices then the answer is okay since you don't have any other source. We will consider taking it out. But when you have other bacterias at the gram negative bacteria pneumococcus. So basically those are bacterias are not usually associated with device infection. And if this is what it's growing in the in the blood cultures we have the chance to say we were not taking the device, the source should be somewhere else. So I think that with this it looks like we have very clear guidelines and we are expected to be doing great because if we know all this we're supposed to be sending on these patients for extractions and the question comes and say okay how are we really doing? And actually the data is really alarming. So this is data that was its public public data presented in the late breaking clinical trials in the scientific meeting this year. The leading out dr Pokorny he's from new york. But if you read on the outers you have many names that are very well known for the extraction people. And they basically did a retrospective review of Medicare data and see what happens with patients that have lead infections. So they basically review over a million patients. So this is huge information And they find out that 11,000 sorry about 1.1% of the patients actually under undergo a device or system infection. What is alarming if you look at the bottom of the slide is that only 18% of the patient undergo elite extraction. So we think that we're doing a great job. The data is showing us we're doing a very poor job. So and if you look at the chart here, so there is an impact in mortality. So the mortality is showing that if you don't have an extraction within validation, mortality is higher. If you have an extraction with interpretation, mortality is lower. But even it's even lower if you have an extraction within seven days of the diagnosis of the of the infection. But again, only 18% of this group was sent for lead extraction. So I think that we have a big big space to growth here and to improve. So what else are we doing now that is new for the extractions. So that's from our interventional colleagues. So the guidance usually tell us that vegetation over three cm or 2.5 cm needs to go for open heart surgery. Now our colleagues are working with new tools that they can be used to approach to the vegetation and actually aspirated what we call vasectomy and take a big part of this chunk of growth tissue out of the heart. So basically this is an example we have on the left side, big vegetation, the result after they did the vasectomy, almost no vegetation in place. This doesn't take care of the infection but allowed us to then proceed with an extraction. This is an example of the material that they removed with the project to me and these were patients that were being sent for open heart surgery before. Nowadays if they produced this, if they do this procedure allowed us to do a trans vascular extraction without the requirement of an open heart surgery moving a little forward. I'm going to speed up because running out of time. So the embassies of venus stenosis indications these are patients that have any issues needs to have an upgrade. The vein is included. There is strong evidence related to the lead. These are indications for the distractions. Example of this in the screen you see these are vina grams where you see a heart stopping the contrast going. These patients need an upgrade and they find that they have the vein is included. So the indication is to remove the lead in order to make space to put a new lead. Another option that we're doing today is we can if we are able to put a wire through and we consider that the patient is too high risk to undergo an extraction. We can do balloon plastics of these veins opening these veins to allow space for the upgrade. And these are a few examples. We actually have done one of these about a week ago and these are very good procedures for patients again that we consider a very high risk to undergo to undergo an extraction is an example of an sbc syndrome basically is a patient that has a has the occlusion of the sbc because of the growth of tissue mix of neo intimate hyperplasia and from the level of the sbc you can see here a hard stop in the heart stopping the contrast and then you see the lead going to the atrium. This is you see how the stop the patient develops a huge as it goes vein that is bypassing the obstruction of the N. D. S. B. C. Okay so this is the patient. You can see huge Jessica's vein at this time the leaves were already extracted. We were able to find a path of the abstraction and basically the same story here. The biggest it goes with the obstruction. You need to talk to your interventional friends for this because they are going to have to do this part. So we extract the leads but then we need we need something to be done to open that obstruction and actually this is an interventional part. And here in this particular case they choose to deploy the stent. We did a case actually this week where because of the age of the patient and the quality of destruction, our interventional people decided not to do a stand but they did a balloon. So very similar thing, very similar outcomes. So just moving forward. Finally functional and nonfunctional leads. So these are the competition guidelines from 2009 and the updating the guidelines from 2017 basically the indication remained the same probably moved some of the class one indication to class too much Still indications for lead extraction. So these are indications for when the lead is cussing problem discussing arrhythmias discussing inappropriate shocks. So this needs to come out in order to prevent these issues. Here is an example of a fractured lead. This was a Fidelis leader Can see how the impedance was stable until the day where it fractured and impedance goes up. So this created a lot of noise in the system and the noise is causing the device to think the patient has a VT or VF and providing a shock to the patient. This particular patient got over 60 shocks due to this lead. Even the rep from the company that approached the patient to shut down the device and by accident was touching the patient at the time and got shocked when the patient got a shock. Another another example our leads that are touching each other and causing noise because of the contact between the leads. There's an example a patient with Brugada, you can see the shadow of the old lead just behind the new lead and this was touching each other causing a noise in the system. Again, the device thinking there is a VT or VF and giving inappropriate shocks to the patient is another indication for lead extraction is a patient with multiple leads. You can see has leaked from the right leads from the left, the vascular spaces completely invaded this patient may need an upgrade or something else. Clearly you need to pull out leads in order to make space to do what you need to do. Finally, there are some leads that have some Manufacturer defect. This was a very old lead. Nobody uses anymore of this from the 90s. But just as an example a portion of the lead was sticking out of the lead and caused preparations. Clearly this is another indication to proceed with extraction. So and finally that's my last image you have perforations. This lead that you can see is going beyond the limits of the hearts of these leaders in thoracic space. This will be also an indication for proceeding with the extraction. So as a conclusion I think that I hopefully told you that it's not appropriate not to do extractions in patients that are infected as I showed you before. We're not doing a very good job in the US numbers are still very low. Please have in mind any infection needs to be treated with extraction as soon as possible. Hopefully we'll see new technologies that are developing new devices that lead lists, pacemakers, little devices that will not have leads involved and hopefully will reduce the risk of infections and the need for extractions in the future. With all these. Say I think questions will be at the end. So thank you very much