Good morning everyone, I am Dr. Karina Hardy, Cardiologist and Electrophysiologist at the Instituto del Corazón in São Paulo, Brazil. It is an honor to participate in this event and chair this table together with Dr. Ana Berni. Dr. Ana Berni is also a Cardiologist and Electrophysiologist at Ángeles Pedregal Hospital here in Mexico City. I would like to thank Lars and Ávod for this opportunity and for the invitation. It will be a very good interactive session where we will have international and national experts in the area of auricular fibrillation. We will talk about advances in the treatment and diagnosis of auricular fibrillation. Good session for everyone. Welcome everyone to the session and we will start with our first speaker, Dr. Alex Pacheco. Dr. Alex is a successful electrophysiologist from the city of Guadalajara, who has a lot of experience in auricular fibrillation. He will talk about auricular fibrillation guides, indications and relevant studies. Go ahead, Alex. Good morning everyone. Thank you very much for the invitation. Today we will talk about auricular fibrillation guides, their indications and relevant studies. Do not forget that from the beginning the guides show us the four important Ss, the evaluation of the risk of embolism, the severity of the symptoms, the evaluation of the rhythmic load of auricular fibrillation, as well as of the substrate. And based on that, we have an adequate indication to look for all this. This is where we will start to base our treatment. The famous ABC of the guides, which is anticoagulation, the treatment of symptoms, as well as of comorbidities, I will not touch them all in this extension because we are going to go a little further towards what is the improvement of the symptoms. For a long time we started to believe that the management of rhythm control versus frequency was important to be able to define what its benefit was. At the time, the AFIM did not manage to show that difference with respect to one versus the other, but taking into account that there are different types of antiarrhythmias currently, and even with this sub-study that was done by AFIM years later, we realize that this effect is not clearly demonstrated, but clearly we also have many different treatments today. Hence the need to make another type of treatment, which is invasive treatment, described since 1998 by Heisager and his group, and which has evolved over time with different types of technology, such as radiofrequency, creolation, and more recently by compulsive field. The number of studies that have supported auricular fibrillation is quite large. Here we have some of them only, where we see that radiofrequency fibrillation effectively managed to significantly reduce the recurrence of arrhythmia, as well as the control of symptoms, without achieving, as was the case at some point of other studies that we are going to see, the mortality per se as such, but that in itself the recurrence of arrhythmia was clearly better with the use of antiarrhythmias. The CAVANA, which was the one that precisely failed to demonstrate a decrease in mortality, but we also knew that at some point during the study there was a great crossover of these patients, and that at some point they could mitigate this beneficial effect. However, with good control of symptoms, with good control of recurrence of arrhythmias in the long term. Starting with cardiac insufficiency, we see that in cardiac insufficiency, in fact, radiofrequency fibrillation of this arrhythmia managed to reduce the point of mortality and hospitalization, but also in an individual way, even mortality for any type of cause, and obviously in a separate way, hospitalization for cardiac failure. There are other studies coming, such as CAMERA MRI, demonstrating the improvement of the fraction of ejection of the left ventricle, as well as an improvement of the control of arrhythmia with respect to antiarrhythmias as such. And the last and much newer, the CASTLE-EF in terminal cardiac insufficiency, where the combined primary point, both death and hospitalization for cardiac failure, and the need for transplant or implantation of ventricular support devices, the patient who is subjected to ventricular arrhythmia is clearly benefited. Among other technologies, we have other studies that compare radiofrequency, creablation, and we see that, in fact, the effectiveness of these methods that we use to do pulmonary vein ablation, we have a similar effectiveness, without sacrificing the safety of our patients. And from there it is concluded, then, that patients who have auricular fibrillation can be subjected to an ablation, practically the first failure of some type of antiarrhythmia, or if it is the patient's choice, at a given moment, even in the first line. One of the most important points is to think about the symptoms, which is precisely what defines or insists the guides of auricular fibrillation. The symptoms are the pivot to indicate the ablation. But sometimes the symptoms can appear at any time of the evolution of the disease, from the beginning to the end or completely in the middle, and perhaps we would have to pay for a slightly different paradigm of how we should do our ablation at what time. In itself, there are several studies, meta-analysis, where it is clearly seen that the treatment of heart rate early is much better than waiting for this to happen later. And these studies, which are finally post-guides, where we have ELISTE and EFNET, where early rhythm control managed to show a decrease in mortality, even individually, compared to patients who were treated only with initial heart rate control. Therefore, early heart rate control becomes much more important, and all the studies that have been coming out show that even for patients with and without EBC prior to ablation, this improves the prognosis. And it is a call, at some point, to treat our patients earlier. Early AF, this is another study where it showed, precisely as a first intention, ablation versus antiarrhythmic treatment, clearly again with the benefit of ablation, and even in this study, in this sub-study, demonstrating a decrease in the progression of the disease. Therefore, we have to think, perhaps, that from left to right we have, as we thought in the past, as the guides tell us, and how we currently have to be much more incisive in heart rate control. Thinking then, this is the current recommendation of ABC, coagulation, evaluating the risk of bleeding, as well as the risk of EBC, of stroke, but also heart rate control, favoring the control, as such, of the rhythm, rather than the heart rate and the control of cardiovascular risk factors. Thank you very much. Thank you very much, Dr. Alex Pacheco. And now, I present Dr. Vidal Esselback, who, well, we have already heard in several talks in this Congress, an extraordinary electrophysiologist in Montreal, Canada. And he will tell us about the role, the role of implantable monitors for the detection of auricular fibrillation in post-ablation patients. Go ahead, Vidal. Thank you very much, again, for the invitation. On this occasion, I will talk about the role of implantable monitors, my conflicts of interest. I start with this slide just to point out the change in the way we are thinking about auricular fibrillation in terms of thinking more about the load of FAA, what is called the AF burden, which is something that is becoming much more important in the management of FAA patients. And with implantable devices, step markers that can measure it, and implantable monitors, we already have how to better measure the burden of auricular fibrillation. And to carry out studies to have data, to better understand how to use that information for the management of our patients. The duration of FAA and its relationship with cardio-embolic risk. In patients with clinical FAA, we have data that the cardio-embolic risk is higher in patients with persistent FAA compared to patients with paroxysmal FAA. That is, the more FAA a patient has, the higher the risk of cardio-embolism. But that distinction that we have, that we have been using for many years, between paroxysmal FAA and persistent FAA, is a definition of more or less than 7 days, which is very subjective and perhaps does not give a good idea of the burden of FAA. Here is a study that represents it quite well, where you can see on the left side that using the clinical definition of paroxysmal FAA and persistent FAA, and seeing exactly what the burden is, you can see that there is no good correlation between the clinical definition and what can be measured by the implantable device that is measuring the exact face of FAA day by day. And the time that one is in FAA does not correlate well with the clinical definition, but if a precise definition is used by the device, there is a much better correlation with the burden of FAA. And what is the relationship of the duration of FAA with cardio-embolism in patients with FAA detected by implantable devices? Patients who have macrophages or defibrillators, now with hearing electrodes, we can detect episodes of what appears to be FAA. We call that atrial high rate episodes. And in patients who do not have any symptoms of FAA and it is detected only in a macrophage, that is called a subclinical FAA. Then, if it can be documented, then it becomes a clinical FAA. We have to think that patients who do not have these devices may have episodes without knowing it. Why is that important? It is because those atrial high rate episodes have been related with an increased risk of cardio-embolism. It can be seen in different studies with different thresholds of 5 minutes, 24 hours, 5 and a half hours, 6 minutes, 1 hour, and the hazard ratio there is between 2 and 6 times more risk of cardio-embolism. In one of the studies, to give an example, the study TRENDS, we can see that in the group with episodes of more than 5 hours and a half, there was a rate of cardio-embolism or stroke of 2.4% per year and it also depends on the SCORE-CHAT. The higher the SCORE-CHAT, the higher the risk of cardio-embolism. The other point that we can see with implantable monitors is the temporal relationship between cardiovascular accidents and the FAA itself. And we have seen very interesting data that patients with cardiovascular accidents do have a detection of more or less 50% of FAA in the devices. This is the red part. But if you see the blue part, the detection of FAA in the 30 days before the episode of the cardiovascular accident is very low. This means that patients with stroke have an important FAA rate, but they don't necessarily have it in the 30 days before the cardio-embolism. So, one always thinks that FAA is what causes cardio-embolism, and if it has FAA, it means that we have a cardiovascular disease, and if it doesn't have it, not so much. But here we see that having FAA is a marker of atrial myopathy, which is related to a higher risk of cardio-embolism, but a patient doesn't necessarily have to have FAA at the time of the event. So, FAA is also a high-risk marker, like CHADS, which is also a high-risk factor. So, how should we treat these episodes of FAA detected by devices? That Canadian study, ASSERT, which was published, shows that in the yellow line, where the episodes lasted more than 24 hours, those patients had a much higher risk of cardio-embolism, and it was similar to patients with clinical FAA. So, in Canadian guides, for example, if the patient has a FAA duration of more than 24 hours, even if it was asymptomatic and detected by devices, we generally use SCORE-CHADS to guide the decision as if it were a clinical FAA. But there are still studies to decide that. We participated in this international study called Artesia, in which we included patients with at least 6 minutes of atrial high-rate episodes and up to a maximum of 24 hours with risk factors of cardio-embolism and we randomized them to a treatment with apixaban against aspirin. The study ended, we enrolled 4,000 patients, and it will be presented in a couple of weeks in the EHA, both Artesia and another European study, which will give us a lot of important data to guide how to handle those patients. For now, we have some data. The European summary summarizes that the duration of FAA detected by device has a correlation with the progression of FAA to higher burdens, also that the risk of brain injury increases by duration and also by SCORE-CHADS. So, a type of framework or guides is already being proposed to be able to take into account in these patients how much FAA was detected, what is the risk of SCORE-CHADS. Perhaps we will have to include other risk factors and modify the future guides based on the evidence that will come out soon. The other area is the detection of FAA in patients with embolic stroke of unknown source or brain-vascular accident, for which we suspect that it is cardio-embolism, but there is no FAA. In general, we try to detect FAA to indicate anticoagulant. This study, using non-invasive monitoring, shows that the longer one uses monitoring, the higher the detection of FAA. 24 hours a week, 2, 3, up to 4 weeks, much more can be detected. In another study, using implantable monitoring, even more FAA episodes are detected in patients with brain-vascular accident. Both studies have shown effective cost in FAA detection in patients with brain-vascular accident. In my center, we try to put a protocol for neurologists about what to do in patients with brain-vascular accident and there is still no evidence of FAA. Monitoring is done when the patient is in the hospital. A holter is made. If FAA is detected, it is anticoagulated. If there is no FAA, but there is a high load of hexacystols, another holter is made. And if there is still a higher load, a non-invasive monitoring of 4 weeks can be done. And in cases where FAA has not yet been detected, implantable monitoring can be indicated in patients that will change the patient's handling and in patients that we suspect are at high risk of FAA. But why do we do all this? Why not give an anticoagulant to a patient who already had a brain-vascular accident? Now we don't have to use Warfarin, we have easy-to-use drugs. Why not use it in everyone? There are two studies that were done evaluating this question. This is one, Navigate Isis, which randomized patients to anticoagulation or not. No benefit in cardiomobility, but a higher risk of bleeding. Another study, the same, this one with Davigatran, Respect Isis, randomized the same patients and no benefit. So we cannot allow anticoagulation in patients without any evidence that requires anticoagulation, which is why it is important to monitor patients. The other area where these monitors can be used is in FAA-speaking patients, to detect recurrences. We know that the definition of success or recurrence depends on how we are monitoring patients. And the rate of detecting FAA episodes depends on the amount and intensity of monitoring. With just an ECG, or 24 hours, 7 days, or implantable monitor, the rate of detection increases. And it also depends on how many times this monitoring is repeated. The more times the Holter is repeated, the more likely it is to detect FAA in a patient with infrequent episodes. This point of frequency is also important. The value of a more intense monitoring depends on the load of FAA that a patient has. If there is little FAA or infrequent short episodes, the additional benefit of an implantable monitor increases rapidly. The benefit of repeating non-invasive monitoring also increases in patients with infrequent episodes. Obviously, if the patient is in persistent FAA, you can detect it with an ECG. But if the patient has two minutes every month, you will not detect it if the monitoring is infrequent. So, in research, at least, it is a very useful tool. We used it in early F. All patients had an implantable monitor to detect FAA. It allowed us to have a 100% detection of the cases, and it also allowed us, on the right side, to talk about the burden of F and to be able to calculate exactly what the difference was in the burden of F. Also, in the long term, it allowed us to detect the progression of FAA and the impact on the burden of FAA in the long term. This was also used in the Canadian study CIRCA-2 to be able to precisely measure the burden of FAA. This session is sponsored by Abbott. Abbott obviously has some implantable monitors. There are other companies. Quickly, the one that I understand is present at the moment in Latin America is the Confirm RX-ICM, which has algorithms to detect radicardia. They have improved the sensitivity to detect FAA. It also has a connectivity platform with an intelligent phone that is practical for patients. What will come, perhaps in a year or two, to Latin America is the next version, which is called ASSERT-IQ. There will be two options of longevity devices in this model, the one above, up to 6 years. So, in patients, perhaps, who want to be used for long-term FAA management, a monitor that can last longer can be useful. Here below is a summary of the indications for the use of these monitors. You can see that they can be used for cardiovascular accidents, for FAA management, for syncope, and more and more in clinical studies and, perhaps, in clinical management, they can be used in patients for post-treatment. To conclude, we know that the relative risk of a cardiovascular accident increases with patients who have auricular fibrillation detected by monitors. That is, subclinical auricular fibrillation is important and is correlated with risk. The absolute risk increases with a higher burden of FAA. The SCAF, the Atrial Hybrid Episodes of more than 24 hours, can be an option to consider them as if they were patients with clinical FAA and to use the existing guides for anticoagulation. The role of anticoagulation in shorter episodes is under investigation and we will have a lot of information in a couple of weeks in the IHA. The risk score to decide when to anticoagulate a patient, I think, will evolve in the future, taking into account the burden of FAA in patients in which it can be measured. The implantable monitor can be useful to detect FAA in patients with cerebrovascular events for which an auricular fibrillation has not yet been detected. It can also be useful in patients with FAA treated by ablation or other ways to detect recurrences and measure the burden of FAA in the long term. And with this I finish. Thank you very much. Thank you very much, Dr. Vidal. Excellent presentation. Now I will introduce Dr. Jose Osorio. He is an electrophysiologist cardiologist at Florida Mercy Hospital, Miami, Florida. He is an excellent electrophysiologist with an important career and he will talk to us about what he knows best and what he does and talks about all over the world, which is optimizing efficiency in auricular fibrillation ablation procedures. Okay, thank you. Unfortunately, I will do the talk in English. I think that next year I will be able to do it in Spanish, because now I live in Miami, but excuse me. So, gentlemen, I'm going to be talking about, as Karina said, the only topic I know how to talk about, which is a fibrillation and a workflow and the importance of the use of a workflow, an organized, standardized process to improve not only efficiency, but really improve the outcomes of your procedures. This is an old slide. We've all seen this graph talking about in the United States the explosion in the epidemics of atrial fibrillation. This is from 2010 and we have seen this in the U.S. and all over the world. The number of patients with atrial fibrillation is increasing significantly because of the aging population, because of obesity, hypertension, sleep apnea, other comorbidities. This is a graph from 2015 from an advisory board that expected a significant growth in the number of atrial fibrillation ablation procedures. And what you see is that at this point they were expecting that by 2023 we were doing more AF ablations than any other ablation procedure. And indeed, this is true today. So for all of us, we started from a few AF ablation procedures a month, a few a week, and it's not uncommon now to see physicians performing several in a day, in a single procedural day. So this is a problem I started facing in my career around 2013 when I started doing five to six AF ablations in a day and saw the need to become ever more organized so that I actually could get home in time for dinner. That was my goal, to standardize the procedure and find ways to become more efficient, but not cutting corners, really learning how to use the system, the mapping system, the ablation catheter, in an effective way to also deliver great outcomes. And with that came this concept you all have heard now of workflow. So what is a workflow? Very important. The definition from Wikipedia is an orchestrated and repeatable pattern of activity enabled by systematic organization of resources into processes that transform materials, provide services, or process information. And that's what we're doing. As we create a workflow for our procedures, we're trying to synthesize all of the information that is given to us during the ablation by the mapping system, by the recording system, by the vital signs, and process in an organized way to make quick decisions and repeat this for every case so that you achieve excellence during your procedures. This is not a process unknown to other industries. The concept of Lean Six Sigma, which is known, common to many industries, is a process improvement methodology that uses lean, which is created by Toyota with a focus on eliminating waste, and Six Sigma by Motorola in the 90s, which is the concept of reducing error and variability. And today we commonly talk about these two processes together to synergistically reduce waste and improve process efficiency and quality. So let's apply this to an AF ablation procedure. When you're doing an ablation procedure, it's not uncommon to see labs that you are using intracardiac echo, fluoroscopy, CT merge, mapping systems, so you have four different mapping imaging technologies being used. If it's redundant and you can remove one without compromising safety, that's eliminating waste. And the same can be done for many things during our procedure. So I believe to achieve an excellent procedure with great outcomes, but also efficiency and reduce complications, you have to know quite well the technology you're using, so the innovations that are continuously happening in our field. We're going to talk today about the InsightX mapping system, the TacticFlex catheter, so with new catheters, there's new knowledge we have to get accustomed with. There's different ways to use these technologies, and you have to master it to achieve optimal results. And once you master the technologies, then develop workflows to use it in a very organized way. So over the next few slides, what I'm going to do is share with you a little bit about the mapping system and the ablation catheter and discuss the workflow I use during my procedure. So we'll talk about the X system, how I perform mapping with this system, the concepts of catheter stability and how to easily improve catheter stability during your procedures, and then discuss step-by-step how to perform an ablation with these technologies. So talking about the InsightX system, I had a recent publication in Journal of AFib that all these methods that I'm going to be discussing now, this is documented, I think this is from last month, if I'm correct. So as we discuss the InsightX system, you have to understand the differences between the X and the Precision system. So in this slide, what you see on the left panel is the 3D reconstruction before you have the magnetic field scaling. So in the Precision system, although you are collecting magnetic points, they're not being used to create the map in real time. They're just being used to improve the accuracy of the impedance-based map you have created. And these dots you see, they are the electromagnetic points. After you have acquired them, you can see that the map can be adjusted. So this is called field scaling. It is a great system, but purely electromagnetic mapping is more accurate with submillimeter accuracy. And this is what the InsightX system does. So as you start using it, you have to be mindful of the concept of voxels, and what these points are is 3D points, electromagnetic-generated points, that they are now used not only to visualize the ablation catheter, but also catheters that don't have sensors, so the decapolar, for example, or the electrodes off the grid. So anything that is going to be impedance-based mapping uses these electromagnetic points that we call voxels to have accurate displaying of these catheters. And this is important to understand. So it is great in terms of accuracy, but it has some of the same limitations, for example, that the CARDO system will have. Understand that the sensor of the catheters we're going to be using to map or to ablate, they're not in the same place. The sensor for the grid is in the shaft before the electrodes, so approximately, and it is in the distal tip for the tacti-flex. And the implication of that is if you insert the grid into a vein where you don't have voxel, you're not going to have accuracy, and you're not going to be creating a good map, or you may not acquire any points, any geometry at all. The same is true with the CARDO system. If you insert the pantoray and you don't have what they call matrix in that area, you're not going to see the splines of the pantoray. So be mindful as you're doing this, but there are workflows, there are ways to work around this quite quickly. So understanding the X system and its main differences between that and the precision is important for you to make the most out of that system. And the most important thing to have in mind is the concept of it being a complete electromagnetic mapping system and the voxel mode. So how do I perform mapping with this system? What I have found for all mapping systems is that modulating the respiratory rate and tidal volume has really striking implications for your procedure, not only in terms of mapping. It's a lot easier to map if you have a stable respiratory rate and pattern, but also during the ablation. So in this publication what you see is that after we perform respiratory compensation, respiratory training, and we start with the respiratory compensation, the patients are paralyzed. Once we have mapped the phrenic nerve and tagged the phrenic nerve, so at that point we give rocuronium, and at that point we will change the ventilation to 25 breaths a minute and a 250 tidal volume, and we'll maintain that throughout the procedure. It is easy to understand as you look at this graph how it's a lot easier for the system to gait if you have a stable, not gait, to compensate if you have a stable respiratory pattern. So this is when the system is mapping and when it stops mapping. So it maps, it prefers to map during the expiration. So it is a lot better for not only mapping, but also the ablation if you're cognizant of that. Patients tolerate 25 breaths a minute and 250 tidal volume quite easily. Most patients, rarely you have patients that will start having some CO2 retention, and if you see that, you can take breaks in between the veins and allow the CO2 to come down before you continue your procedure. Now, compare that with this. When you do not have a stable respiratory pattern, when you don't have a paralyzed patient, or even a heart rate that is very irregular, it will be a lot harder for the system to map, and you may have a lot of blur and displacement and inaccuracies in your map. So if possible, work with your anesthesiologist and try to standardize changes in ventilation that will improve mapping and ablation conditions. So how do I perform mapping, being cognizant of the voxels? Once I'm transeptal, I always like to start with simply moving the ablation catheter across each vein. You see, all I'm trying to do here is create enough voxel density. You don't have to go throughout the chamber, but preferably go to each one of the pulmonary veins, the appendage, the mitral valve annulus, so that you have enough of a cloud of voxel points, because that will make mapping a lot quicker. You're going to be a lot less likely to see the HD grid disappearing or go into the low confidence mode if you're using the X system. And here, what you see as I'm mapping, I always space at 500 milliseconds, because that will create stability for the cycle length, making it easier for the system to collect more points. I always like to map as I watch the number of points I'm collecting, so that you have high density of points that can be used not only for the voltage information, but also to trim anatomy that may not be accurate. With these techniques, hopefully you can make consistently really great anatomical representations of your maps, which will make the ablation process a lot easier. Now, if we're trying to do RF-based, point-by-point ablation, the holy grail is catheter stability. If you focus on catheter stability, your outcomes will be better, your success rates will be better long-term, but also the procedure time will be significantly shorter. We have done a study looking at predictors of one-year outcomes, and the more important predictor was first pass isolation. If you're able to isolate the pulmonary veins with one pass, which makes sense, the chances that you're going to have long-term outcomes, successful outcomes, are much higher. So, how can you improve first pass isolation? Catheter stability is the most important way to do it. And we have seen, as I've discussed, with first pass isolation, procedure times are much shorter, and the success rate is better as you go from no veins isolated here to all veins isolated at first pass. You see not only the success rates being 50% at one year if you don't have any veins isolated, but a procedure time that is almost 40 minutes longer. So, focusing on first pass isolation by means of working on your catheter stability will improve your outcomes and procedure efficiency. How do I focus on catheter stability? The ventilation mode I discussed is perhaps one of the most important and easy and free techniques. It does not require a special ventilator. This is really poor man's jet ventilation. There's plenty of studies showing improved catheter stability with jet ventilation. If you're doing high frequency, low tidal volume with a regular ventilator, you can improve stability. We have done studies looking not only at one-year outcomes, but also looking specifically at catheter stability, which was significantly better. One-year outcomes, we did a study that was published this year across 25 centers showing a 30-minute decrease in procedure time simply by using this technique of high frequency, low tidal volume as opposed to traditional standard 12 breaths a minute, 500 tidal volume ventilation. And also improved first pass isolation and improved one-year outcomes. Another simple and quite easy technique is pacing during ablation. What you see on the slide is how when you stop pacing, the catheter stability, this is the variation in contact force, this is impedance variation, is much wider if you're not pacing. If you have a patient in sinus rhythm, pace the coronary sinus, pace the atria. If you have a patient in AFib, you could pace the ventricle as well to maintain catheter stability. So I'd never perform an AF ablation without pacing at 500 milliseconds. Finally, the use of steerable sheaths. This is well documented in the literature. So these three simple techniques will improve catheter stability and long-term outcomes. Now let's move on to ablation. Talk about new technologies and then how to incorporate all the things we have discussed. The Tective Flex catheter is now approved in the U.S., soon to be approved in many countries across Latin America. Uses the Flex tip, which has a quite unique irrigation design, but also has contact force. It has really great electrogram signal quality. Very interesting, because of the Flex tip design, this catheter improves your stability. And there's data showing this. There is a publication this year, an abstract at HRS this year. What you see here is auto mark showing the stability for each one of these ablation tags. And you can see this is outstanding stability. The physician maintained, this is from the publication, maintained really millimeter to two millimeter stability for each one of these tags. So the design of the catheter compared to Tacticatheter or other catheters will improve stability. What are the results of the Tective Flex trial? At one year, we had 72% success rate, 76 symptomatic. However, when you break down between those that use high power and low power, you see really great results in the high power group. So perhaps this is a catheter that is well designed to be used in that mode. When used in high power, procedure time was much shorter, fluoroscopy time as well as irrigation. This study had a very similar design to the Tacticath study. So if you compare Tective Flex versus Tacticath under same conditions, same study designs, you see a 30% decrease in procedure time, fluoroscopy time of over 50% as well as irrigation. So the catheter will improve outcomes as well as procedural efficiency. So how do you now put together the mapping system, the X, and the use of this catheter? When you're performing ablation remember that power is meaningless, what matters is current or more importantly current density. So when you're performing an ablation you should look at the impedance and the current density. I look at the impedance continuously, I look at the current density continuously. The Abbott system makes it easier because as you see on the next slide you can have the current displayed continuously. Different catheters have different current and current densities that you can push the catheter to. The Tacticath I would never go above 600, 650 milliamps. With this catheter you can get to 750, 800 milliamps with no char, with no increasing temperatures. So it is clearly a catheter that the irrigation design makes it a lot easier to use high power, short duration. So I will vary my ablation between 40 to 50 watts depending on the system circuit impedance. If you have an impedance of 80 to 90 ohms you can do 40 watts. If you have an impedance that's 110 perhaps use 50 watts trying to maintain a current at the 700 to 750 ma level. If I'm using a Tacticath I would use a 40 degree temperature cutoff. This is rarely an issue with this catheter, I haven't seen that to be an issue. And I use 6 millimeter tags so that you are able to see good overlap to maintain an interlesion distance of 4 millimeters. Whatever we achieve, pulmonary vein isolation as you see here, we will tag that location. So let's look at the user interface and this is what I'm talking about. You can see the current displayed continuously during the ablation. This will make it easier to understand why if you have significant impedance drops in the 10, 20, 25 ohm range, you may go from a current of 650 to 800 getting to dangerous levels. This is why when you're doing an ablation in an 80 year old female perhaps with a lower BMI, you have to be much more careful about the power settings because their impedance is so low that it's not difficult to get to dangerous levels of current. So do not look at just power, really focus on the current for you to truly standardize your procedures. This is a final lesion set. So you see good map, very good display of the lesions around the map. And what I'm trying to hopefully show to you is that I think we should all focus on a very repetitive procedure. One that once you have a workflow, you're chasing your perfect lap and there are improvements we can do every procedure we do to where you have almost no variation. I've been measuring my standard deviation of pulmonary vein RF times since 2013. Today, during an AF ablation, I have a one minute standard deviation for pulmonary vein RF times. So meaning the procedures have become quite reproducible. So for those that like cars and have watched this movie, it is really interesting scene when they talk about the chase for the perfect lap. We're never going to get there, but I think that's what workflow has meant to me. So to summarize, I think if we're trying to develop a workflow, it starts with a deep understanding of the technologies you have at hand, the mapping system and the ablation catheter. That's how you're going to optimize your results. Focus on catheter stability. There's really simple techniques that would allow you to improve catheter stability and they're free, easy to incorporate. Always attempt to obtain first pass isolation. If you're going to create a database, if you're going to track one thing, track first pass isolation. If you're improving first pass isolation, you're going to be decreasing procedural times and you're going to be increasing your success rates at one year. And to finalize, I think the InsightX and TactiFlex combination allow for really flexible workflows, particularly now that you can toggle from the voxel mode to the insight mode, allowing you to have good visualization of the impedance-based only visualization of catheter, such as a decapolar when you're coming from the veins, for example. And you can really optimize your procedure, improving both mapping conditions and ablation short-term and long-term outcomes with this combination. Thank you. Let's review the data on auricular fibrillation and why it's important to talk about auricular closure. 12.1 million Americans will have auricular fibrillation in 2030. It's more common in men than in women. The risk of cardiovascular accidents, or ACVs, is five times higher. And one in four ACVs in patients over the age of 80 is due to auricular fibrillation. And an ACV is the most devastating complication in a patient with auricular fibrillation. And we know that ACVs due to AFAs are much more severe than in other conditions. We need an alternative for anticoagulant therapies. Anticoagulant therapies, like Warfarin or Dovax, have cost limitations, adherence, bleeding, complications in surgical procedures, etc. And also high cost. Therefore, auricular fibrillation makes sense. And we know that more than 90% of thrombi are caused by auricular fibrillation. And long-term results have shown to be favorable and equivalent to Warfarin in Protect-F and Prevail studies. The auricular fibrillation market is growing. Auricular fibrillation devices are growing more rapidly. And the American market continues to grow and provide more reimbursement and coverage for patients. What are the candidates for auricular fibrillation? Patients who have had a previous bleeding event, with a high risk of bleeding in the future, due to their lifestyle or occupation, poor adherence to anticoagulants, and medical interactions. Currently, auricular fibrillation has a 2B indication for patients with anticoagulant indications that have a long-term anticoagulant contraindication. Unfortunately, most auriculars have multiple lobes. And a single-mechanism closing device is not enough to close all auriculars. We also know that the most common anatomy is called chicken wing. And a double-closing technology can virtually seal most auriculars. A double-closing technology consists of a lobe inserted into the auricle, and a disc that sits on the cuma of the auricle and on the osteo of the auricle. The AMULET has shown its priority in closing auriculars compared to other devices such as the WATCHMAN. Also, the discontinuation of anticoagulants is superior in patients who have an AMULET compared to a WATCHMAN. With the double-closing mechanism, we have the versatility of covering most auriculars with a high probability of success. Unlike the WATCHMAN, which in many cases has failures because of the simple closing mechanism of a single lobe, it cannot cover all possible auricular lobes and leaves leaks around the device. And a longer-term survival. Here we review the multiple morphologies of auriculars and why a simple closing mechanism is not capable of covering all possible anatomies. And therefore, a double-closing mechanism with a disc that sits on the osteo gives greater efficiency to the procedure and better results. The transeptal function is key in the procedure. And for most cases, an inferior-posterior or inferior-medium function would be adequate. In certain anatomies, such as very dilated auriculars or reverse chicken wing anatomy, a slightly more advanced function is adequate. The advanced and advanced function is only left for lobes or posterior-location auriculars. All these difficulties will be solved when we have a deflectible shirt and we can use it to direct the device coaxially. There are many ways to make a transeptal position, but at this time I believe that the safest way is using a radiofrequency guide needle that can be passed through the septum and has the tendency to be placed directly on the auricle. Therefore, certain steps are obvious in the procedure, such as the use of a pigtail catheter and the time of fluoroscopy is also reduced. It is also necessary to have a clear understanding of the view of the transeptal echo. The view of 135 degrees is the one that gives us the best clarity to perform the procedure. In this view we can see what is anterior and what is posterior and how we can reach the auricle coaxially to release the device in this way. The view of 135 degrees in the transeptal echo is correlated with the view of the right aureocaudal oblique, which gives us the best visibility of the auricle in fluoroscopy. Everything above is superior or anterior and everything below is inferior or posterior. Once we have measured the size of the auricle, we decide the size of the device to release or use. We have 8 device sizes and we try to use a device of 3 to 6 millimeters larger than the maximum diameter of the auricle. These are the different sizes compared to the Watchman. We already have the Watchman Flex Pro, which has a size of 40 millimeters. But we see here that the AMIRA has 8 different sizes from 16 to 34 millimeters. The 34-millimeter device disc can cover up to 42 millimeters. This is the well-known European table in which the maximum and minimum size of the auricle is used, and it helps us in the proper selection of the device to use. These are some examples. This is an 18-millimeter amulet used to close an auricle in chicken wing with a conventional approach. As we can see here, we have a better quality of the angiogram by eliminating the contrast through the shirt and not through the pigtail. This is a reverse chicken wing auricle in which we use a 20-millimeter amulet with the technique called the sandwich, in which we insert the device as close as possible, and we make a sandwich of the chicken wing septum between the lobe and the device disc. Here we use a 32-millimeter device to close a fairly large auricle. This morphology of the device is known as the marshmallow shape, and the disc takes an elliptical shape of martini glass. And this is a windsock-shaped auricle in which we use a 25-millimeter device. Before releasing the device, we must confirm the closing criteria. C is the circumflex, and the device must be more than two-thirds in front of the circumflex. There must be compression of the lobe, coaxial orientation of the device with the neck of the auricle, separation between the disc and the lobe, and an elliptical or concave shape of the disc. It is important to have an exact correlation and to be aware of the location of the pulmonary artery. Unlike the Washman, this device is placed more proximally, and there is no need to tend to overcompression, because if there is a distance of less than three millimeters and the device is overcompressed, there may be a risk of pulmonary artery erosion. Post-implant pharmacological regimes include DOACs, double antiplaque therapy with aspirin and Plavix for six months, double antiplaque therapy for 90 days and then aspirin only. Some patients use only simple therapy with aspirin. In selective cases, a medium dose of DOACs, such as Epixivan. Peridispositive flows are an inheritance and a concern in patients with Washman. This is partly due to the fact that the closure of a single mechanism is often not able to cover most of the morphologies available. And the release of the device not coaxially, or the lack of visualizing lateral lobes that cannot be covered with the lobe, cause peridispositive flows. It is also important to have an adequate imaging, because if we do not have adequate echocardiographic images, we may not be able to observe lobes that may be left uncovered. The clinical importance of peridispositive flows has been documented in several studies. At 45 days, one in four patients has peridispositive flows. Patients with peridispositive flows less than 5 mm have a risk of 2 to 3 times higher cardiovascular accidents. And 51% of patients with peridispositive flows are not able to discontinue oral anticoagulants. Again, the double closure technology gives us the ability to seal the auricles in a superior and more durable way, compared to the simple closure technology. A few words about the intracardial echoes in the closure of auricles. The 2D intracardial echo is the best way to visualize the procedure. It only has 64 elements of the face array. If we compare it with other modalities, the 3D intracardial echo is as good as the 3D echo that we have available now. These are the images and views that are used when the intracardial echo is used. This is an example of an amulet release with 4D intracardial echo. Amulet has been the last technology or the last option for the prevention of cardiovascular accidents in the auricular fibrillation. It was approved quickly without any problem by the FDA. The Amplacer IDE clinical study, one of the largest randomized studies in which the amulet versus the watchman was compared, achieved all objectives in the long term. Sealing of the auricle for 45 days, security of the procedure at 12 months and effectiveness in the prevention of cardiovascular accidents at 18 months. The amulet achieved a higher percentage of closure of the auricle compared to the watchman. Again, the amulet has shown through different sizes of peridispositive flows, which is more effective in the sealing of the auricle at 45 days as well as at 12 months. And the monitoring of these patients has reinforced the findings previously discussed. At 12 months there is superiority, also the decrease in peridispositive flows and the outcomes at 3 years. Speaking of workflows, the optimal workflow, because we will have basically the same situation as with the auricular fibrillation, the number of patients will be very large, we have to work in workflow. There will be no need to return the patient before the procedure. The procedures will be done with moderate sedation, with 3D intracardiac echo, in which we will prepare the device while we manage to do that venous. There is no need to do more measurements to determine the size of the device to use. We will release the device and, through fluoroscopy and intracardiac echo, evaluate the position. Basically, and in summary, with the amulet we can test a benefit for the patient, with greater superiority in the closure of the auricle, greater success in the discontinuation of anticoagulants, and a lower rate of repetition of procedures, since success with a single attempt is higher than with the Weizmann. Well, thank you very much. Thank you very much. We invite all the professors here to the panel for questions and answers, please. Anyone from the auditorium would like to ask a question, a comment to our professors? Good morning, thank you. Vidal, it is very interesting all the register of electrical activity with implantable devices. Recently, a work was published in the European Journal on the meaning of high-frequency hearing tachycardia detected with this type of devices. And if they have or do not benefit from being anticoagulated. There was an important clinical trend where if you detected multiple episodes of hearing tachycardia in a step-by-step mark or in an implantable device, a confirm or whatever, the trend was to start anticoagulating. Because the works that you told us of high incidence of rhythmic load of hearing transistors, seemed to have more risk of having embolism than those who did not have it. But in this work they tell us there is no benefit of anticoagulation. So, what is your opinion based on this new light of these works? Well, I still use episodes more than 24 hours and with more reason waiting for the results of Artesia, which is going to be presented in a couple of weeks. But before, what I did was to enroll those patients in Artesia. So, a patient who had in that intermediate zone, I proposed them to participate in the study. And those who did not want to participate, without having strong evidence, I left them to their clinical doctor. But for me, unless it was more than 24 hours of continuous episodes, a very high-risk patient, I left them without anticoagulation, but with a follow-up. I left a note saying that the next remote transmission, and if the load is increasing, perhaps in those patients it is more aggressive. And also look for clinical episodes, if you have a symptomatic or clinical episode again, then it is another category. But it will be interesting what we see in the studies that are going to be presented. Any other questions from the public? I have a question for José. José, let me ask you a question. I saw when you were building the map for the left atrial ablation, you were doing a voxel map with the ablation catheter first. Can you accomplish that map with the grid itself, or do you need to use a double transeptal? Because I saw both catheters on the left side. So, I typically perform a single transeptal stick. I'll get the ablation catheter through the body next to the wire. So, I'll have both catheters there at the same time. For those that are doing catheter exchange, if you start with the ablation catheter in the veins to build the voxel, this will improve the ability to see the grid all the time. So, you don't have to do it that way. But what you're going to find if you don't have the ablation in each vein, deep in the vein, before you put the grid is as you're entering the grid into the vein. It disappears. It disappears, or it goes to what they call to a low confidence mode and stops collecting data. So, I don't spend that voxel map. I will spend maybe 30 seconds doing it. In the new version, the version 3 of the InsightX, you can move the catheter very quickly and it keeps obtaining voxel. In the first version, it was a little more difficult because if you move too quickly, it would not obtain voxel. Now, it takes me 30 seconds, and I feel like it saves me five minutes later on because during the map with the grid, things will be a lot faster. I have a question for Dr. Osorio. Great presentation for workflow, and most importantly for us in Latin America, just to improve efficacy and timing of the procedures. So, it is important in Latin America cost effectiveness, and just to be honest, we have all the resources, but sometimes some of the tools we have to take into account. For example, I prefer to have my 3D mapping system, my HD grid, my Tactive LESS, but I have to compromise my agility ability, right, in order to compromise stability. Do you have any other options out there because of the cost? Right now, we're currently using SL1, SL2. However, I would love to have my Agilis, right, but it's just you have to compromise a little bit in order to achieve that. So, any other options for us? So, my sequence of events, how I kept adding technologies and different tools and techniques, was actually the last thing I added to my procedure was the Agilis. So, for a while, I was not using the Agilis, but I was using fast pacing and the ventilation mode. I think the most important technique for stability, it's not the Agilis, and it's not the pacing, it's the ventilation. If you do either 30 breaths a minute with 200 tidal volume, or 25 with 250, depending on the patient, what you find is the stability is so much easier that if you're using an SL2, it may be enough. Now, I think another important thing to discuss about the Agilis, or any steerable sheath, or any sheath for that matter, what's one of the problems with using sheaths is that when you're in the roof, the patient, if you're not controlling the ventilation, you can have extreme peaks of contact force. The best thing about using high frequency, low tidal volume is that the heart's no longer moving when the patient takes a breath, so you do not see those peaks of force anymore. So, I think if you are going to use a steerable sheath, you absolutely should use high frequency, low tidal volume, because you don't want to have a 40 gram, 50 gram force. So, I agree with your comments, and for a long time, that was my choice, was to eliminate steerable sheath. I think the steerable sheath makes it better. The combination with the other techniques is the ideal, but if you're going to try to save money, I think use a high frequency, low tidal volume and pacing. The worst patient for stability, the worst patient is a patient in AFib with a slow ventricular response and irregular cycle lengths. Those are very difficult. You can't maintain stability with different stroke volumes and heart motion. So, if the patient is in AFib, I'll pace the ventricle continuously. So, I think all these techniques are important. One that's more important to me is the ventilation change. Thank you so much. That's where we are right now, no steerable sheath. Any other questions from the audience? I have a question for Dr. Jorge Diaz. Looking at this flow of patients for eagle-eared occlusors, where is the tomography before the implantation of an occlusor? Is it useful? Is it no longer useful? Is it not necessary to plan an eagle-eared occlusor? The flow of work with tomography and with the intracardiac was an inheritance of the initial device, which was the Watchman, because there are anatomies that are basically impossible to seal with a simple closing mechanism. There are already several people, several implanters, who are no longer using any evaluation mechanism. We are already, due to the number of patients we are treating, we are trying to avoid even doing intracardiac echoes, sorry, transesophageal echoes before the procedure or even tomographies. Tomography helps if an adequate image is not going to be used during the procedure. Suddenly, there is no availability of a transesophageal echo, and you are going to use an intracardiac 2D echo. But in general, the ideal workflow is that we do not have to do any evaluation before reaching the procedure, because the number of patients with trauma, with thrombosis, is minimal, it is quite low. The evaluation of the anatomy is more important than having a single device. But now, with the double-closing mechanism, most of the headphones can be successfully sealed. One question for Dr. Osorio. Dr. Osorio, what do you think about a picaridal connection and first-place isolation? Have you seen any relationship with using the high-power short duration? And do you make an activation map for detecting this connection? So, the question is about high-power short duration and epicardial connections, which is a particular problem for the right pulmonary veins, right? If you think about the septal pulmonary bundles as it courses through the roof, going towards the posterior wall, connecting to the carina, you may have, if you don't have a great lesion, a transmural lesion, you may have those epicardial connections causing problems to achieve first-pass isolation. So, I have seen that as I have gone to shorter and shorter ablation times for the posterior wall to protect the esophagus, because I typically would do 5 to 6 second lesions only. In the posterior wall, we're doing lesions that are not as deep. This is a problem also, for example, with the Q-dot catheter. If you're doing 90 watts for 4 seconds, you may do lesions that are wider and more superficial. So, I think the area for me that is the most important to focus on and have more stability to prevent those epicardial connections is actually at the roof of the right pulmonary veins. I think if you have great stability at the roof, it will make it easier to stop those connections, to make sure I can deliver higher power and sometimes longer lesions in that posterior wall for the right veins from 12 to 3 o'clock. I start the ablation in the right veins at 3 o'clock and go all around so that I give time for the esophagus to cool down before I get back there. But I have not gotten to... So, I use a very strict definition for first pass isolation, but I'm at about 80 to 85% first pass isolation. So, I don't think we're going to see 100% with RF. It's not going to happen. So, if I don't get it, yes, I'll map immediately to see where the earliest activation is. And to finalize this, with very high power, short duration, sometimes you have a problem that makes mapping very challenging because you ablated the endocardial surface, and now you have really poor electrograms and you cannot see where the conduction gaps are and more detailed maps have to be done. So, it is a challenge. High power, short duration is not perfect. Thank you. Well, due to time issues, we are going to close the session. Thank you very much to all the speakers. Excellent presentations. And again, thank you to Abbott for facilitating this conference. Thank you all.

cardiologists

electrophysiologist

atrial fibrillation

workflow efficiency

catheter stability

InsightX mapping system

TacticFlex catheter

double-closure technology

ablation procedures

high-power ablation

periprocedural flows

imaging techniques