So I'm going to go over, basically, how to avoid perforation during implantation of devices. So the outline will be divided into five parts. First of all, I'm going to talk about some epidemiology about perforation, cardiac perforation. Then I'm going to go over some of the contributing factors that lead to perforation, how do we diagnose it, management, and then the bulk, and then the strategies that we can do to avoid myocardial perforation. First of all, about some epidemiology, myocardial perforation during CID implantation is uncommon. However, it's potentially serious. And we can divide it into, it's immediate when the perforation happens quickly. Basically, at the time of the procedure, there is hemodynamic deterioration and instability. It can be acute. It might happen later on, maybe after 24 hours to 48 hours. Usually, there's a slow pericardial leak that may arise, and symptoms may not appear until 24 hours, sometimes 48 hours. It can be subacute. Sometimes nothing happens, but then after three weeks, basically, symptoms and signs of perforation can happen. And in several cases, there are reported cases where there is delayed perforation. It can happen after a month or more from the implantation. What's the frequency, and what's the incidence? Usually, I mean, the reports, they mentioned that with pacemakers, around less than 1% risk of perforation. And in the PACE trial, they reported basically 0.98% perforation on pacemakers. In ICDs, there is variable reporting about perforation on ICDs. It varies between 0.6 to 5.2%. And with LV implantation, perforation can happen also in the coronary sinus. And recently, as we're doing more and more leadless pacemakers, also there is some risk of perforation, has been variable across several publications, between 0.1% to 1.6%. Initially, it was more, but then, as we're trying to avoid putting the leadless in the apex more to the septum, basically, the risk of perforation went down. So, this is from the Danish registry, basically. As we see here, the immediate complication, perforation from a pacemaker, varies between 0.1 to 0.3%. However, this is in the acute setting. It's an immediate complication. With time, and after six months, the perforation, basically, it's around 0.6%. And we see that a good number of patients did not need any intervention. However, some will need intervention. And this is from the leadless pacemaker data. From leadless two-clinical trial, we see that the cardiac perforation was 1.2%. The majority required intervention here, as you see. Some had cardiac perforation, others had cardiac tympanoid. The bulk needed intervention. And few patients, there was just an effusion with no intervention needed. And in the micro-TPS trial, also, the perforation, cardiac perforation was around 1.6%. However, as the technique improved and the device has been placed more in the septum rather than the apex, the number went down. And now, we can quote the number for perforation with leadless pacemaker around 0.13%. What are the contributing factors for perforation? Perforation are more common in the abdomen. The RV wall may be thinner. And then, women tend to have more perforation than men. And in this study by Mahapatra published in Heart Rhythm, they showed that in patients with post-pacemaker implant pericardial effusion believed to be a consequence of perforation, there are some risk factors in the multivariate analysis that increase the risk of perforation. These are, if there's a presence of a transvenous pacemaker, the use of a helical screw, okay, active fixation. And then, if the patient is on steroid, if the patient is on systemic steroid, so these are increased risk of perforation. And they found out a protective from perforation if the RV systolic pressure was more than 35 millimeter of mercury. We can divide the contributing factors to three main categories. Basically, the substrate of the patient that we are implanting a device on, then the lead itself, the size, the fixation mechanism, and three, the implantation technique. So let's go over them, the patient. And we can look at the patient, two things. First, the substrate, the patient, as well as the medications that the patient is taking. So one, the patient, we mentioned before about the frailty. So there is some frailty index here. The elderly, thin body habitus, the body mass index less than 20 kilogram meter square, they have increased risk of perforation. Women tend to have more perforation than men. And also, if there is some structural abnormality in the heart, that's cardiomyopathies, like ARVC, arrhythmogenic cardiomyopathy, we have thin, stretched heart chambers that can basically easily perforate. Also, if the patient has some medications that can increase the risk of perforation, namely if patients are taking steroids, systemic steroids, they're taking immunosuppressants because they inhibit the inflammatory response to the lead tip. If they're taking antiplatelets, anticoagulation, these all increase the risk of perforation. If we look at the lead itself, so two characteristics are important and relevant here. One, the size of the lead. So small-bodied ICD lead tend to increase the risk of perforation. Also, the fixation mechanism. So active fixation leads, particularly using a retractable screw mechanism, also level to perforation, especially in two sites, like in the RV and the apex, and also in the RA, especially in the RA free wall. Regarding the technique that can increase the risk of perforation, excessive force on the lead against the RV or the RA free wall can increase the risk of perforation. Not recognizing a trapped lead passing through a tricuspid valvular structure when there is like a hinge and the operator pushes can lead to perforation. Also, over-torquing a fixation screw, whether it's fixed or extendable, can lead to perforation. Using stiff stylets can also increase the risk of perforation. Also, there are placement in some vulnerable positions, like the RV apex, RA free wall, especially in high-risk patients like the elderly, the thin woman, patient on steroids. So these increase the risk of perforation. Also, during the procedure, there's repeated attempts of repositioning the lead, several attempts. This can also increase the risk of perforation. Let's move to diagnosis. Clinical findings, usually patient present with pain, intercostal muscle, diaphragmatic contraction, fractional rub. Many patients can be asymptomatic. They have perforation that's asymptomatic. On EKG, so let's say a patient has an RV lead, so you should expect to see a left bundle branch block morphology. If you see a right bundle branch block morphology, it should warn you that there might be a perforation. However, up to 17% of patients who have an RV lead can still have right bundle branch block morphology on EKG. X-ray, you can see the lead going outside the heart contour. You can see also hemothorax. On echo, if you see pericardial effusion, it's suggestive of perforation. However, if you see tamponade, or sometimes you can see the lead basically completely through the pericardium, you have basically conclusive that there is perforation. This is, you see basically a lead perforated with basically loss of sensing and capturing. Here you see on the X-ray, you see also leads outside the silhouette here in the pericardium. Here, like a lead, it has a hinge point with pressure perforated. CT scan is very helpful to diagnose perforation. In a study, they showed that on CT scan, 15% was the incidence of perforation. However, there is some critique about this, that sometimes CT scan can over-diagnose perforation due to the artifact. Rate of perforation by CT scan was shown to be up to 15% of the RA leads, 12% of active fixation, 25% of passive fixation, and 6% in the ventricular leads. 14% if we are having ICDs, 3% if we have RV pacing leads, and 7% majority are, basically, it's more predictive to have active fixation compared to passive fixation. Usually in this study that was published in PACE 2007, they showed that the patient who had perforation, there was no difference in the impedance between perforated and non-perforated leads. However, like in one of the cases, they showed high assimilation threshold. In autopsy, they found a big number of patients have perforation of the RA leads. This is basically a CT scan here, and next day, here you see basically perforation, you see basically prolifusion, you see a shifting of the mediastinum to the right, and here on CT scan, you see here, basically, the lead basically exiting the heart. So here you see the liver, you see here a big prolifusion, you see here, you can still see the equal density of the lead outside in the abdomen. And this is another CT scan diagnosing perforation. Also, you see basically here the liver, and you see here also the lead exiting the cardiac silhouette. On interrogation, you can also diagnose perforation. Basically, you can, by increasing the output, you can see the phragmatic or chest wall pacing. Sometimes it can be painful or not. And also, you can see noise, myopotentials, on the electrogram. Sometimes you don't see them, but you can do maneuvers to elicit them. For example, with breathing, like in this patient, with breathing, basically, you can see here the myopotentials seen on the EGMs. Sometimes you can do also other maneuvers, like breath holds, asthmatic exercises of chest wall muscles, and you can see those myopotentials. Moving to management, if we have basically mild signs and symptoms, some pericardial pain, friction rub, but you could not really found, basically, a persistent perforation, you can observe the patient. If the symptoms improve, signs improve within 24, 48 hours, you can keep the lead in its position. You don't need to reposition the lead. If there is on echo a small pericardial effusion, but no definite perforation, serial echoes are needed to ascertain that the effusion does not increase and cause hemodynamic instability. Now, it's worrisome sometimes, if there is perforation, exit the heart, and the end basically goes to another chamber or another vessel. Here, the perforation can be catastrophic. And in case of hemodynamic compromise in emergency, basically, you need to, if there is no point, you have to do an echo-guided pericardial synthesis, put a big tail, leave it for at least 48, 72 hours, until there is no additional drainage, and then basically re-image. If it's improved, you can take it out. And if the threshold remains stable, you don't need to reposition, but if there is any increase in threshold, they need to reposition and have the surgeon on standby, as well as in the EP lab, have an echo-guided pericardial synthesis. What are the strategies to avoid a hole in the heart during device implantation? So, first of all, careful review of the patient's history at the time of the implant, especially the high-risk are the elderly, patients on steroids, anticoagulants, women, thin patients. Lead sliffness, as well as lead caliber size, affect perforation rate, with basically, as I said, small ICD leads tend to have higher perforation rate. Avoid over-torquing of the active fixation leads, and try to use basically the active fixation leads against the interventricular septum, rather than the apex. And this also can provide some pacing physiologic from the septum to the apex. Consider passive fixation lead in affected elderly patients, especially the high-risk elderly, octogenarians, and non-generals, very thin on steroids, so probably passive fixation lead is preferred. And then do many projections before screwing. For example, sometimes if you take just one view, the lead might look like it's going to the RV, but might be like a branch, the MCV, for example, in the coronary sinus. And if you screw it, you can cause perforation. So very important, take several views, make sure that you're not in the coronary sinus, you're not in the middle cardiac vein, you're really in the right ventricle. And also always test the intrinsic lead passively before screwing the lead. And if you're doing the leadless pacemaker, always aim for the septum, rather than the apical implantation. So in conclusion, perforation of cardiac device leads is a real complication of device implantation. Maintaining a high index of suspicion is necessary to make diagnosis. Many strategies can help, as I've mentioned, to decrease the risk of cardiac perforation. And management choices are dictated by the clinical presentation, comorbid conditions, and the resources available. Thank you. Thank you, Marwan. We can take one or a couple of questions. Any questions from the audience? Dr. Krohn. It's sort of a comment, but it could be a question. So one of the little tips that I do when I teach is there is a tradition of putting RV leads in where you put a curved stylet in, you put the lead out into the outflow tract, take the curved stylet out, put a straight stylet in, and then drop it down towards the apex. And I think some of that process then leads to actually the sort of harpoon concept at the apex. And what I often do is I under-curve my stylet, so it's a bit of work to get it into the ventricle, but I don't change stylets, because I don't put my stylet all the way out at fixation. And so then you have a floppy noodle at the very tip, which is less likely to perforate, and you probably do increase dislodgement rate, but if you're careful and thoughtful about it and your impedance is good, it's not a big risk. So I'm just curious whether people think of the stylet as an element of perforation risk. I teach that never advance the stylet to the tip, keep it floppy, and position it that way. I think it's very important. Once it goes out to the tip, you have a harpoon, and you have a good chance of perforation. Yeah, and it's a tiny little thing, but I actually think it probably matters. Absolutely, I fully agree. And also try to avoid this, the phone. One comment I made, we see sometimes patients come in with clear lead perforation, but just a word of caution about CAT scan, it might overestimate whether you see the shining of the tip. Not everything that you see shining in the tip is necessarily perforation. And we had a discussion the other day about those that are clearly perforated, that clearly you see like two centimeters of the lead out of the ventricle border. It's a great thing to take those out in the hybrid OR with a surgeon on board, but there was a proposal about preemptively doing, kind of laparoscopically, open like a window and put a stitch. I can make some comments, but any input about this, Dr. Rafat, about needing to preemptively do it surgically? I mean, I didn't have it, I didn't have the case that needed to be laparoscopically done, but it's good to be minimally invasive if needed. Yeah, so again, anybody who has also some experience to share, but most of the time they come out and the RV is a bit forgiven and nothing happens. We watch them closely in the hybrid OR with a surgeon on the side. They end up like, thank you for wasting my time, and they leave, so to me, I think it's certainly we have to take it seriously, but not everything that's perforated is necessarily an open heart and necessary to need to be taken out surgically. I agree with you, and many, many can be treated, managed just observant. Great, thank you so much. Thank you.

cardiac devices

perforation

epidemiology

diagnosis

management