Dr. Douglas Gibson discusses how the incidence of atrial fibrillation differs in women versus men, female outcomes related to ablation treatment, and outcomes from left atrial appendage occlusion studies across patient subsets.
without any delay. I'd like to go ahead and introduce Dr Gibson. A lot of people know him already. He is one of our electro physiologist here. Doctor Gibson specializes in advanced care of patients suffering from arrhythmia atrial fibrillation, S. V. T. Ventricular tachycardia. He's an expert in catheter ablation. Um Additionally he performs the left atrial appendage occlusion, the watchman which I believe he's going to talk about a little bit today. Um And this procedure allows patients to be safely removed from blood thinning medications that reduces the risk of stroke. He's also experienced of course an implantation of pacemakers defibrillators by ventricular uh devices. Dr Gibson's clinical research involves ablation of cardiac arrhythmias and alternatives to blood thinners for patients with atrial fibrillation. This is an excellent way for patients to gain access through groundbreaking technology that may not be widely available. He's one of the investigators that participated in clinical trials involving the watchman device for left atrial appendage inclusion. He's also been involved with trials for advanced catheter ablation technology and the treatment of arrhythmias. Uh In addition to training in internal medicine and general cardiology, Dr Gibson spent two years receiving training um in electrophysiology and he is a fellow of the Heart Rhythm Society, currently serves as the director of cardiac electrophysiology at Scripps Clinic. And um he's also actively involved in our fellowship training um a bunch of us as well as our current fellows as well. So thank you Dr Gibson for us and your morning with us. Thank you probably. Uh so thank you to the conference organizers and also thank you to dr Jordan Adams and kim for having me. It's been a pleasure watching their careers take off. We knew that they would do very well. And these are these are excellent cardiologist, that's been very fun to watch their practices grow. So, uh thank you for the segue. This has been a good transition into talking a little bit more about therapy in female patients in nature fibrillation. And I'm going to talk to you specifically about ablation and left atrial appendage, inclusion. These are my disclosures. So I'm consulting for cutest boston scientific, boston's Webster and Abbott and boston Scientific makes the Watchman device, which we'll talk about. Um and these other companies make ablation technology which will also be talked about and discussed. So it's taking a step back for a minute. It's important to put all this into perspective. There's certain treatment goals that we have with a defibrillation and as has been mentioned already addressing the risk factors is perhaps one of the more important things. And even after patients get to me, we're still uncovering and taking careful looks at risk factors. We do a lot of screaming for sleep apnea. And we've also been more aggressive about referring for weight loss therapies as well. Those are the two big ones that we see that are still either harder to deal with. And and patients just need some another touch in the health care system recommending it or you know, need some extra help with that. So we basically have two major goals when it comes to taking care of aging fibrillation. We want to improve symptoms and prevent stroke. And in terms of improving symptoms, we have medications for rate or rhythm control and catheter ablation. Um, so, so ablation is really indicated his way to make people feel better. The only the only other reason to do an ablation is to help improve cardiomyopathy. There are certain patients that will develop congestive heart failure weakening of the left ventricular ejection fraction associated with nature fibrillation. There are multiple studies now showing that they tend to do better with ablation, primarily because ablation works better than drugs for keeping patients in normal rhythm. In terms of preventing stroke we have or atlantic violence and left atrial appendage closure. Um those are that's basically what we have is an option for reducing the risk of stroke. So that's basically my whole day, is symptoms, stroke symptoms, strokes. This basically what's going through my head when I take care of patients with atrial fibrillation. So we had a good setup, we heard a lot about women in nature of fibrillation. The incidents at a given age is decreased, but women live longer and are more female females in the United States. And so the numbers of female and male patients with atrial fibrillation turned out to be very close to each other. Um Actually, actually what Dr Adams said today makes a lot of sense. Females develop a defibrillation at older ages and as a result they show up with more capabilities at the time of diagnosis. And so some of the some of the lack of referral may be appropriate in female patients. So as you get already developed more comorbidities, uh there are some concerns about being able to safely do procedures on those patients. And so some of what is happening in terms of females not getting referred may be appropriate. And again I'm not here to encourage procedures and so some of the conservative management of women may be appropriate given that by the time they show up they have a lot of other issues. As DR Adams mentioned, um she had four patients on monday going for every node ablation and micro pacemaker. So for example, if females have a higher incidence of diastolic congestive heart fair, they may not be the best candidates verbalization ablation with the current version of technologies will increase stiffening of the left atrium if you do have to do a lot of ablation in particular patients. Um And that may exacerbate the whole diastolic heart failure picture. And so um we may be choosing to divert women to more appropriate therapy or take a more conservative approach which can be uh sounds like it can be appropriate at times. But I think we have a bigger problem with getting women to therapies that are more effective and perhaps that improve their quality of life. And I'll talk to you more about that here. So um again I agree with Dr Adams. I think women should be referred more often and and again, I'm not trying to drum up more procedures here. It's just when you look at the alternatives for taking care of female patients, um They don't do as well with medical therapy as dr both dr and Dr Dr Adams pointed out. Um and tournament drug use is associated with increased death and females in the 95 confidence interval for the habit, hazard ratios anywhere from 1.5 to 6.3. So significant increase in death associated with female patients and enter arrhythmic drugs. And that probably has to do with the fact that they have longer action potential duration, longer QT intervals at baselines. And so they may be more at risk for facades. This doctor didn't mentioned with anti arrhythmic drugs and I still am very careful with low body weight females when it comes to an terrific medical therapy. If I'm starting it out patient I started very low dose or that is the one patient group that people tend to forget about in there, choosing whether not in patient load around patient load, but just be careful with low body weight female patients in general, It comes to particularly Class three entering the drugs. The other thing that happens, you know, just in practical clinical care, I would say, when you're trying to rate control or rhythm control, female patient oftentimes you're starting with a lower baseline blood pressure. Um and I think females in general, the Jackson has chosen uh as a rate controlling drug, there's a couple problems with the Jackson. It has been a couple of studies been associated with increased mortality. Um and it's also been demonstrated in two studies to correlate with breast cancer. So there's been a big push in the field of electrophysiology in general to utilize the Jackson sparingly at least amount of possible and only when needed. So in my practice, the Jackson is one of those drugs kind of like an deodorant that I'm really a large part of my practice is focused on getting people off that kind of medicine. Yeah. So in terms of ablation again, it's indicated for patients that have failed anti arrhythmic drugs are or in whom drug choices are limited. It can be considered in first for first line therapy in some patient populations. For example, in young patients that have lots of years of exposure to anti arrhythmic drugs, the guidelines will now suggest that perhaps a more appropriate choice with the ablation right up front. And so you'll see more and more about ablation as first line therapy. And I agree with that in some patient populations, it's appropriate. It's interesting to go read about success of anti arrhythmic drugs when you go to the literature and try to find what is the success rate of soda lol or what is the success rate of tryptophan on. Um They do not give you like a one year success rate. So for example, with Pepe Fanon blasting, the most recent version of your pathogen to be approved was S. R. And they looked at time to recurrence of atrial fibrillation. So they took half patients and cardioverter than other patients cardioverter and put them on purpose for a non profit, non extended on average the time to first recurrence by 90 days. So basically you just kind of controlling the arrhythmia with the answer of drugs and I think it's appropriate to try it when you can safely. Um But I don't have great faith that those drugs work over a long period of time. That's the reason that Catherine relation has come on so strong over the years. Um So the ablation has become a very reasonable procedure of the years. When I first started, it was a four or six hour procedure. Now, generally it's under two hours. That's all done through venus punctures, Patients are now going home. Probably 90 of our patients are going home the same day. So it's primarily an outpatient procedure. Um there's some different energy sources and this is a field that's very rapidly involving in and we'll talk about some of the updated technology. Mhm. So just to kind of demystify the whole ablation process. Um These are electron atomic models of the left atrium. So atrial fibrillation is the left upper chamber illness. Um Left upper chamber has four little difference in anatomy but generally four pulmonary veins left, upper left, lower right, upper right, lower and the sleeves of myocardial, right here. Around the perimeter gains are where the abnormal heart muscle is. That drives atrial fibrillation and there's a few different reasons for that, but that's the primary target for a fib ablation. So pulmonary vein isolation or PV. I you'll see that term thrown around. Um that's the cornerstone of of all a defibrillation ablation procedures and we'll go over some of the individual studies when it relates to women. One of the issues specific to women with agent fibrillation is they tend to have a higher prevalence, at least in some studies of non pulmonary vein triggers. So we'll start with pulmonary in isolation. But it's particularly important in females to think about where else could be triggering the age of fibrillation. In that cabana trial that dr Adams mentioned, females were less likely to have non pulmonary vein ablation. Which is interesting because they have more non pulmonary vein triggers. So that was an interesting dichotomy there. So where to oblate outside of atrial fibrillation, we have a couple of options for figuring that out. You can do a medication challenge and and look to see what other sites in the heart may be triggering or you can map and find abnormal substrates. This is a newer technology. This is a electron atomic map during atrial fibrillation. So, you see these wandering, kind of chaotic, disorganized wave fronts. There's a newer technology now that will be able to make some sense out of this. And so, just kind of focus your eyes here and what you'll see is that these wave fronts come into this area slow down and then break out. Sometimes rotate pivot. We were able to now find these areas that are fairly consistently abnormal. See the way front comes in here slows down, breaks out This way, you see this repeatedly in this area. There's a couple new trials going on right now in a couple of publications showing that if you target these areas and incorporate them into your pulmonary vein isolation, you'll get better success rates. So these are different energy sources. This is what we've primarily done over the years, which is radio frequency energy. Use heat to destroy the abnormal heart muscle around the mouth of the home remains. Uh, the next generation was cryo ablation. You can also freeze abnormal heart muscle. And then this is perhaps the most exciting thing happening in my field right now, there's a new version of a way to destroy remember heart muscle called pulsed field ablation and what this is. It's very high energy but delivered in pulses, very short short duration pulses. And you'll deliver, for example, the different cocktails are different, but you may deliver eight pulses at a time and four rounds of that. And and literally this all happens in under a second. So you're talking about microseconds or nanoseconds of very high voltage. So it's almost like multiple lightning strikes is kind of the way I think about it and it kills by a different mechanism. It actually rearranges the electrical field at the surface of a cell and creates pores in the cell membrane. And because cells can't maintain their internal environment, they die um it creates less inflammation. Um And to make a long story short it's more effective and appears to be safer. So this is the history of radio frequency energy and and the biggest problem that we have with the ablation by the way is that tissue that we think we have destroyed, particularly with heat and as well with cryo ablation, you do the ablation, you test, you retest you wait. But the body will try to heal everything that you do just like cutting your skin and the body will try to heal it. Um so some of these areas that we think we have destroyed can recover. And we've we've known about this for years, about 10 years ago. We did a series of studies where we got more and more aggressive with with what we're doing here to try to prevent these recurrences and we ran into a complication rate that was unacceptable. So we all work within our safety zone. But it's the biggest achilles heel of the radio frequency ablation in cryo as well is that some of these areas that you think you have a bladed will recover. And so you can do your atrial fibrillation ablation procedure. And then some of these studies that are very well done. We'll go back in regardless of record arrhythmia three months later and take a look at at what's been destroyed and see if it continues to be a plated. And you can see here that the best we've been able to do with radio frequency energy is about 80 and oftentimes much lower than 80%. So you do the ablation, you go back and you look three months later and some of what you have to have a bladed has recovered. So these are the cryo balloons same issue. Look at pulse field ablation though, this is the first time in my career that you've been able to get close to 100 success in terms of what you oblate staying a bladed. So it's a very exciting stuff and and not always more effective, but it's safety is dramatically improved as well. So, I've been doing a fair bit of basic science research in this field recently with pulse field ablation and trying to iterate and develop newer versions of it. And literally I've had this technology a bleeding right on top of the esophagus and you cannot injure the esophagus. It's very my cardio selective. So at energy levels that kill my accordion nerves are not damaged, the esophagus is not damaged. And again, I've had this right on top of the frantic nerve that controls the diaphragm uh and intentionally a bladed there and you you cannot injure that nerve with the amount of energy. Now, if you turn up the energy high enough you can, but with what we used to oblate cardiac muscle, even with repeated revelations over the softness of the frantic nerve, you just you cannot injured it. So very exciting in terms of success and safety. So important also to think about the type of a fib again, uh paroxysmal and persistent. They're different animals there. Dr Adams mentioned different types of a fib and I do think defibrillation is kind of a global term and there's different types of a fib within that. And I think we'll be hearing more about that. Not not only five is the same animal, we're going to be learning more and more about sub sites of atrial fibrillation coming forward. But for now what we have is para sistema which is shorter episodes of atrial fibrillation and persistent. They have different success rates. So PF is a very it's an optimal target for relations. Success rates are Are very reasonable. Now for first procedure success rate. We have multiple studies 75-85%. Um Dr Olsen, I just participated in one of these studies using a new ablation catheter and our strict success rates where 88 and are clinically relevant success rates were 91%. So we've been held to this definition of success that's a little bit clinically irrelevant in that. We do an ablation six months and one year later we go looking for recurrence of a fib and if we see any a fib more than 30 seconds on a monitor, we call it a failed procedure. So a lot of these success rates that you read are these strict success rates which are not really practical. So in other words, if you have a minute of atrial fibrillation at nighttime, when you're asleep, you're not going to feel it, you're not going to take a drug for it. So for all intents and purposes that you're you're basically improved. If not, you know, for what you can perceive cured of atrial fibrillation. We've just been very careful about that when we evaluate this technologies and going to held to that standard largely by the FDA. But if you look at clinically relevant success rates, you're really getting up into the high 80s in multiple studies now. So good success rates. Initial experience with pulse field ablation is over here and you're looking at 87% strict success, which is which is really impressive. So we've been estimating for years that if you could do a pulmonary vein isolation and guarantee 100% success that you would get a 90% success overall, the 10% basically results from non pulmonary vein triggering sites. That's exactly what we're seeing here. Now, with pulse field ablation we get 100 durable or close to, I should say 100 durable pulmonary vein isolation that translates into clinical success of about 90%. So to push that up to 100%, we're gonna have to do a better job of figuring out where else to oblate. And and females have a at least in some studies have been shown to have higher prevalence of non pulmonary vein triggers. So, you know, continuing to improve our ability to figure out where else to oblate will be very important to carry for female patients going forward. So the risks of part Venable, I'm sorry of atrial fibrillation relation in general. This should be under one at an experienced center, but there are some disastrous complications that we are very paranoid about if we spend a lot of time thinking about these and avoiding them. So for example, a joseph joe fistula particularly you can you can injure it with cryo but more commonly it's injured with radio frequency energy. It's a disaster of a complication. You create a hole or a fistula between the left atrium, the esophagus and so God have done somersaults to try to avoid this. What I do personally is that there's a device that's made to move the esophagus so I'll move that to the left, the blade on the right side of the home ravines and then move the self respect to the right um tends to create some calisthenics in the lab for me, but You know, it's worth it, you know, even though that complication might be one in 10 or one and 40,000, it only takes one of them, but really, you know, be a memorable experience for you. Um So again, perforation of the hard stroke, frantic nerve policy. These things, yeah, you have to hear about them before you undergo the procedure, but they're extremely rare. Now, frantic nerve policy is one that's important to women, particularly with cryo balloon ablation. Cry, we'll talk a little bit more about that but create a balloon ablation is an important therapy. It's a safe and effective way to oblate atrial fibrillation. However, when you freeze the pulmonary veins sleeve, there's an ice ball that will extend beyond the borders of the heart and and can damage the frantic nerve. Females at least in one study, have a higher incidence of that and that probably relates to the tighter proximity of the nerve to the pulmonary veins. In female patients, saying average the chest size and the heart size and the region around the left atrium and pulmonary veins is smaller and things are packed in more tightly in female patients and still, with that ice ball extending beyond the pulmonary veins, you have to worry about that frantic nerve. Um in some studies there's been a higher incidence of bleeding with female patients. I'm not sure that I totally understand that. Although more modern studies have been more reassuring in that regard. And like I mentioned, frank nerve policy, look at, look at the pulse field ablation, complication rates in the in the initial study. So impulses, one pulse field ablation and something called Pet cat is another study of pulse field ablation. I've never seen complication. What creates like this in ages fibrillation studies? So, um lots of zeros and one perforation. This can happen as a result of transept with puncture and multiple other portions during the defibrillation. So, in terms of female versus male outcomes and tribulation, we've we've done a reasonable job of paying attention to this in the field of catholic population, we have some more work to do in the left atrial appendage closure space. But the tally was one of the first, starting in 2010, uh identified the fact that females have a higher incidence of non pulmonary vein triggers lower success rates they referred later after onset for ablation. So in other words, a female will be dealing with a fib for five or six years compared to a man 3 to 4 years before they were referred on for therapy. So we had a female patients properly identified. They're coming through the treatment algorithms. But for whatever reason, uh you know, maybe that was as DR Adams mentioned because they have more comorbidities. We were worried about Sending them. I'm sure there's other reasons as well, but that was the first um that goes all the back to 2010 now, where we identified this this treatment disparity and female patients and somehow come disparity as well. The next trial is something called Fire and Ice, and this is radio frequency versus private ablation. Um and this show that females have lower success rates overall in higher rates of cardiovascular hospitalization compared to their male counterparts in this ablation study. So that actually cause some concern. And I think some of the lack of referral has been associated with these early studies. And you know, obviously we don't want to be referring uh female patients for procedures if if it's true that they have a higher complication rate or at least we're gonna be more conservative about that and more selective of who we send. Now there are two more modern trials which really put us at ease and demonstrate that females benefit as much as males are. At least I'll go through some of the details with you. But the safety issues have been addressed. There are some minor differences which I'll go through. But in general ablation is a safe and effective option for female patients that shouldn't really be in question anymore. So the cabana trial was a very large worldwide, well done trial powered appropriately. So this is this is a quality study. You know, this one was planned out years in advance and done by a very good group of investigators and again, what they demonstrated as dr Adams mentioned, there's no difference in the complication rates of females versus males um and irrespective of male or female gender, your recurrence rate of if it was lower in the catheter ablation group. Now the treatment effect was greater in men but women definitely did better with ablation versus drug therapy. So that's an important finding. Something called the circuit does study, which is cryo ablation again, versus radio frequency. Um Again, there's no difference in male and female success rates um and they had similar improvements in quality of life. So, this is a second study now, which has been getting a lot of attention lately and it's a big deal. I mean, this is this, you know, reiterates the fact that when appropriate females do benefit from catheter ablation and should not be held back from that. There were there was a trend towards increased complications, but it was non significant. So this is the study that showed the frantic nerve injury and females. So in the cryo group group, the frantic nerve injury rate was 2.6% versus 0%. So, you know, perhaps it would choose not to use a cry of balloon, particularly in a small body weight female. So there may be some things or some strategies that you can employ that, that would avoid this. And again, no difference in the big complication stroke, during ablation, thrombosis, embolism, vascular complications in some studies were increased in females. Not in the circuit does study so very encouraging results when it comes to ablation of females becomes a stroke prevention. In females they are under treated with oral anti coagulation. Some of that may have been from some data related to warfarin, showing that females on Warfarin had higher rates of stroke. The males perhaps some increased bleeding rates, but the no acts have largely fixed that so on no ax. Females are as protected as males against drug from the data I've seen on warfare now wasn't the case. So the way the guidelines to breakdown is um oral and a coagulation should be considered in female patients with one additional risk factor for stroke. And that's a discussion at that point, it's a class to be recommendation for our national guidelines. Um Not that you're going to end up putting that female patients on oral and regulation, but it's worth a discussion, some of that depends on what your additional risk factor is. Obviously not all of those risk factors are created. Equal age is one of the strongest risk factors as well as previous strokes. So that's kind of the way I use that information. If it's uh female gender and the additional risk factor is an older age. I'm a little bit more aggressive about recommending or limit co regulation. I should say I do a lot more treatment with Orlando coagulation than they do procedures to protect strokes. So, again, my main focus is getting our female patients protected. Um and I feel like it's scripts, dr Newton Adams and kim have done a very good job reaching out to female population is taking good care of them, so I'm not so worried about it, it's scripts, but you know, in general we have some more work to do in that regard. Um Now if you have to if you're female into with two additional risk factors, it's class one, a recommendation for oral and a coagulation. The problem that we have as as our dr Adams mentioned is that women tend to be older with more comorbidities when they're diagnosed with a defibrillation. And so naturally they're going to be some women in that population that are at unacceptable bleeding risk with Orlando coagulation and therefore the left atrial appendage inclusion is a reasonable option to consider for them. So that's basically the indication for appendage inclusion is patients who are being poor candidates for long term oral and coagulation. There's some typical things that we see that it can be fall risk. It can be other blood thinning medicines, it can be a prior history of bleeding, but in general, these are pretty obvious. There's something called a has blood score which tries to quantify it, I'll sperry that. But in general, anybody who you're worried about, and I think a lot of clinicians are rightly worried about harming our patients with or atlantic coagulation. Just keep this in option. Keep the left atrial appendage inclusion in mind for those patients that you really are just nervous about treating with long turmoil and coagulation. So technically this is an inpatient procedure appendage inclusion. But again, about 90 of our patients are going home the same day. This is performed through one venus puncture is a 14 French sheath and Jim like particularly the Newer Watchman, it's almost routinely taking less than 30 minutes. Um dr Eden and Adams were instrumental in helping me start this whole program. We used to come down and then perform imaging for us. Um and it, you know, as we were working through the beginning of this, it took a little longer. Now it's a very quick procedure. And what this provides is non inferior total stroke protection with significantly less bleeding risk. So it gives you approximate equivalents drug protection, uh and much less bleeding risk. The risk include perforation, Tampa, not bleeding stroke, but these are extremely low. Once again at an experience center, it should be less than 1%. This is the newer watchman called the Washington Flex. You can see the complication rates were 0.5%. And in the later studies of watchmen, the complication rates were very acceptable. But it looks like even in a national study now we're down less than 0.5%. Yeah. So this is how did this is a sort of video illustration of how to do the appendage closure and see the appendage over here. It's in a regular structure. Lots of ridges and pits and crips down inside their places for blood to become very stagnant. There are also some biological effects out here in the appendage which make it more likely to form clots, engages with a pigtail. We take a picture and then we deploy the watchman. And this device we're looking at here will be the older version of the watchman. Mhm. So you can see there's a couple differences. The back into the device has opened feet. These have all been enclosed now and that's a safety improvement. There's something called threaded insert right here, which is where a wire attach is. We were able to use that to tug on the device, make sure you like the position. So this is called the threaded insert. Just keep that in mind because that's important and important design improvement. So these are the demographics for all Washington trials and and we didn't do great, but we didn't be horrible in terms of having female representation. So it's about 30 in general. And these are the results that it gives you. It gives you basically about equivalent all stroke protection with much less bleeding risk. And when it when compared to Warfarin, there was a mortality benefit associated with the Washington device. So the efficacy and females you can see here in terms of primary efficacy. Female patients did well, this is the hazard ratio favours Washington favors Warfarin and the confidence far straddles that This is the newer Washington Washington flex. You can see the back end has been closed in. They added an extra of anchors. They added more fabric. And to me this is one of the more important advancements they got rid of the thread insert or have less metal there so there should be less grade of D. R. T. And there was in that flex I. D. Trial. Historically it was perhaps up to four of the older trials now it's probably going to end up under 1%. I'm sorry. No I'm running a little bit short on time and just a couple more slides to get through. This is how the new ones deployed with this back end. You can really reposition it better. Let's get through this one question. Okay very good. So the pinnacle flexes the watchman flex that that has completed its U. S. I. D. Trial. We don't quite have 24 month follow up for the stroke numbers but we're concerned with two endpoints safety and efficacy and so we looked at the safety and point. The safety is definitely improved under under a percent. And this is, this one is more interesting. We had about a 20-30 lead. Great with the old watchman. What the new watchmen to show that the watchman flex had a 100 occlusion at one year, not not at 45 days. And we do some of our follow up imaging, but at one year It's going to in that study is 100%. I don't think it will end up being 100 as we start to look at thousands of patients, but closer to 100 occlusion. So in the in the Washington Flex ID. E. Um perhaps a little better on the female side, we keep inching up in terms of the female representation of these trials. And so we got up to 35%. We actually tried to do a study, a formal study with watchman, where we had 50% enrollment, 50% female, 50% males. That was called the S up to trial. And it was for patients that are truly contra indicated to blood thinner. In other words, you put in a watchman and you only use aspirin Plavix afterwards. And if this trial failed because of lack of enrollment, we wanted 800 patients. You only got 2 400. I haven't seen the male female breakdown yet, but hopefully we'll get some information from that. So it's a reasonable numbers of females, but not as not as much as we would like. And again, there doesn't seem to be any treatment in the Washington studies that I've seen. And again, we have more work to do on this, that there doesn't appear to be a difference in complication rates between females and males. Or what there was one study that showed perhaps females have a slightly higher rate of device related thrombosis, but that was refuted in a later trial. Yeah. So we talked about safety in point. Good. I want to bring your highlight, bring your attention to one of their trial, which is called the Product 17 trial. This is a No ac vs. Watchman. Obviously most of us are using no ax. Historically, the watchman is compared to Coumadin. So we're starting to get more information about comparing watchman and no ac. Um, these are higher risk patients. So First of all, female breakdown again about 35%. So not terrible, but we certainly could do better. And these are sick patients. They chose these patients to have a history of bleeding requiring intervention. Uh They wanted another including criteria was having an event on anti coagulation. So we've all seen that where patients have been on anticoagulants and had a stroke and then they wanted chad fast for more than three and has been more than two. So this is this is a typical for our previous watchman trials. This is a sicker group of patients. These are the endpoints of it's a composited point, which there's some valid criticism to using composite endpoints. But these are all very relevant to the watchman population. Yeah. And this is how it broke down. So basically not inferior. So when you're comparing watchman to Nowak, there was some ambulance in this trial as well, um not inferior. And you can you can see the left atrial appendage group even trended a bit lower in terms of the cumulative incidence. Very well done trial intention to treat very formal statistical trial. So here's the stroke rates, you can see very comparable between peniche closure and no accent. Here's the death rates again very comparable. So good numbers, all of it turned out to be not inferior. Then they went back and took a look with intention to treat. You can actually pull up on the data and look at some of the patients who actually got appendage closure, who actually took their no ax is what we call on treatment analysis. You can see there is even a wider separation of the curves favoring the left atrial appendage closure. So, um in conclusion, um it's pretty clear now that female patients dr significant benefit from major fibrillation ablation. Independent conclusion. I would say we have more work to do on the appendage occlusion side. Um Again, some of this, I think we do a good job this here at scripts, but I think some of this involves just getting this information out to our colleagues and female patients that look, it's a safe procedure for females. They drive as much benefit as males do, particularly compared to drugs versus ablation. Um, and then some of it I think is maybe helping our female patient population to recognize, you know what these symptoms are, what they mean. And you know, I do a lot of car diverting affect when it's unclear what the symptoms are. A trial of cardioversion. People can, men as well, men are basically not much different than female. There's a lot of atypical symptoms that men as well. So what I tend to do and it's nice to do this early in the care of a patient is get them cardi murders and see if they feel better. So, thank you guys for having me. Thank you Doctor Gibson. I'm really glad you got into kind of the nitty and gritty of it and went through those trials, because that's what we're always emphasizing is that we need more data. So I'm glad you showed that the actual techniques, uh, there was one question for you, um which I think we can take right now and then we'll get into the other is the question for you that came up, Dr Gibson is uh, what was the smoke that came out in the video of the Washington plant? And how long are those patients on aspirin and Plavix post watchman procedure? So the smoke was meant to represent an angiogram. So one of the things that we do when we put the watchman is we do an angio graphic image of it afterwards. And so that white smoke was there. You know, that's an older video now, I think, and that was their attempt to show what contrast imaging looks like. And what was the second part of that question? The second part of that question was how long do they stay on aspirin or Plavix or what's the antiquities? Yeah, We've kind of changed that over the years. It's three months of anti coagulation post watchman and there are a couple different versions of that patients are after that three months of we're using no X now. So three months of no ac plus aspirin. And then the the way the historical trials were done work was aspirin indefinitely. We have two studies coming out showing that aspirin probably doesn't do very much in this patient population. So there's uh some better results coming out with just no ac and perhaps instead of aspirin using half dose, no ac long term as an alternative. So, I think, I think the days of aspirin and the pending conclusion space are probably going away. Aspirin seems to be on a kind of going the way of the Jackson. You have bleeding risk and not much benefit associated with it. So I think ultimately, probably the next couple of years will be more and more trials showing that aspirin provides very little if any benefit in these patients. Great, thank you. Thanks again. Dr Gibson, that was really great. Really helpful.
