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2019 Focused Update of the 2014 Guideline for Mana ...
2019 AF Guideline Update
2019 AF Guideline Update
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Hello, this is Hugh Calkins, I'm Director of Electrophysiology at Johns Hopkins, and it's a pleasure to talk with you tonight about the 2019 updates of the 2014 ACC, AHA, HRS, AFib guidelines. My disclosures are shown on this slide. Our objectives of this 15-minute brief presentation is to present the rationale and methodology for updating the 2015-2014 ACC, AHA, HRS, AFib guidelines. I also want to increase awareness of the most important modifications of the 2019 AFib guidelines, and many of these have a very significant impact on patient management. And then we'll discuss how precisely these recommendations impact our everyday care of the patients we all see in our office on a daily basis. So let me quickly walk through the history of these guidelines. In 2006 was the last sort of major document, AFib guidelines, that was put together by Val Fooster and really was in effect, if you will, for many, many years. In 2010, the ESC broke away from the ACC and the AHA and wrote their own AFib guidelines. This was led by John Kam and was a very important document. In response to that, the ACC updated their guidelines in 2011. In 2012, the second consensus document on catheter ablation of atrial fibrillation was published. In 2014, there was a total rewrite of the AHA, ACC, HRS, AFib guidelines. This was a soup to nuts rewrite of those 2006 guidelines. In 2016, the ESC did an update of their AFib guidelines. And then in 2017, we, HRS, published the 2017 update on the consensus guidelines on AFib ablation. But what we're here to talk about today is this 2019 focused update of the 2014 guidelines, and this was published earlier this year. As we think about the background for this, obviously the ACC, the AHA, and HRS are committed to updating guidelines when new data becomes available or when new approvals by the FDA are granted. One of the unusual things about the guidelines is they only can recommend treatments for which there's FDA labeling. In terms of the Watchman device, for example, in 2014, it was not FDA approved, so it wasn't included in the guidelines, and this is one of the many things updated in this focused update. Now, there were six topics that were updated. The first and most important and most sweeping were the anticoagulation recommendations. There also were revisions to the recommendations for appendage occlusion for stroke prevention. There were slight tweaks in the catheter blyation recommendations. There was a rewrite of the management of AFib-complicating acute coronary syndrome. There were new recommendations about device-detected AFib, and also, importantly, recommendations about the importance of weight loss in AFib management. Now, I'll walk through each of these one by one. So let's start with the anticoagulation recommendations. The first change is that the definition of valvular AFib has been revised and clarified, and valvular AFib is now defined as AFib in the setting of moderate to severe mitral valve stenosis with the presence of an artificial mechanical valve, and this is a much crisper definition that was used in 2014, and I think it gets rid of a lot of confusion about when you can use Warfarin and when you can use NOAC. Valvular AFib is considered an indication for long-term anticoagulation with Warfarin, and that remains unchanged. And then antithrombotic, the term antithrombotic therapy has been replaced by anticoagulant therapy, and aspirin has been removed from the guidelines. So back in 2014, the recommendations for anticoagulation in the CHADS-VASc1 patient were Warfarin or aspirin, and now aspirin has disappeared from the guidelines and is not seen at all in these guidelines, and that really reflects the very poor level of evidence supporting aspirin as an important stroke prevention treatment and also the recognition of the significant risks of bleeding with aspirin. So this is sort of the recommendations, Class 1, Class 2A, Class 2B, and so if you look at the Class 1 recommendations, the document now says for patients with an elevated CHADS-VASc score, and then they define an elevated CHADS-VASc score as 2 in men or 3 in women. So female gender has been eliminated as a risk factor for stroke prevention. So this has had a very sweeping impact on my management of AFib patients. If you have a woman who is 66, according to the 2014 guidelines, that person would be a CHADS-VASc of 2, you'd strongly be pushed to anticoagulation. Now with this revision, female gender is taken out, that woman would have to have a CHADS-VASc score of 3 to be a Class 1 recommendation for anticoagulation. So anyhow, this was changed throughout the document that we now have a gender-neutral CHADS-VASc score, and this is in keeping with the European guidelines that made this change before the ACC, AHA, and HRS made these guidelines. Just walking through the rest of it, the guidelines say that if your CHADS-VASc score is 0 in men or 1 in women, it's reasonable to omit anticoagulation therapy. And it's interesting how this is phrased. It doesn't say there's harm to anticoagulating these patients, it says it's reasonable not to use anticoagulation therapy. And we all know there's some patients that have a CHADS-VASc score of 0 or 1 in women that have an enormous left atrium, that might have mitral annular calcification, that may be in continuous AFib, where we're really going to lean on the side of anticoagulating these patients. And then for CHADS-VASc 1 in men or 2 in women, anticoagulation is sort of optional. It's reasonable to anticoagulate these patients, and that is given a 2B recommendation. I know from my own perspective, I'm fairly aggressive about anticoagulating patients, recognizing the very significant impact of stroke. So another big change is, for the first time, NOACs are recommended over Warfarin. And we're all aware of all the big studies that have been done showing that NOACs are more effective than Warfarin, and in 2014, the evidence wasn't felt to be there to strongly support this. But now, it's a class 1A recommendation that NOACs are recommended over Warfarin, and certainly in my practice, and I suspect in all of your practice, you've basically largely eliminated using Warfarin, except in patients with valvular atrial fibrillation. So let's move on and touch on some of the other, I think, features of these guidelines, which were not changed, but I think it's important to be aware of. One, it says if you're using Warfarin, you should check the INR level weekly during initiation of therapy, and then monthly. These guidelines remind us that the recommendations for anticoagulation are the same for paroxysmal persistent and permanent or long-standing persistent AFib. So AFib burden, if you will, doesn't play an impact in these recommendations for anticoagulation. It's all about the CHADS-VASc score without the female gender included. And then I think it's also important to realize that, you know, the recommendations say that if a patient is atrial flutter but not AFib, you should use the same CHADS-VASc risk score to determine long-term anticoagulation, even if you ablate the flutter. And that's because, one, you know, AFib tends to occur in 30% to 50% of AFlutter patients over time, and two, there's no good data saying that you can stop anticoagulation in someone where you've successfully ablated their atrial flutter. So let's move on. There's some new recommendations about bridging, and these are based on some of the recent studies that were done, and they're all cited. And I think all of us have learned that for patients, you know, on a NOAC, the risk of bleeding are remarkably small, and that usually, you know, there's no real need for bridging with Lovenox or Heparin, that it's better to either hold a dose or two of the NOAC or perform the procedure on uninterrupted NOAC. There's also a new recommendation on Idaria-Sizumab, the reversal agent for dabigatran. It's recommended for reversal of dabigatran in the event of life-threatening bleeding or an urgent procedure, and that's a Class I Level of Evidence B recommendation. And I think you're aware of these papers that were published in the New England Journal of Medicine that are the basis of that recommendation. Now if you look at a dexanet-alpha, the level of evidence is weaker. It's only a two-way recommendation, and it's only been tested in patients with life-threatening or uncontrolled bleeding. It hasn't been tested in patients who need an urgent procedure, so that recommendation only exists for Idaria-Sizumab. Moving on to appendage occlusion, the Watchman device was approved after the last guidelines were published, so now the Watchman device is included in the guidelines. And like surgical appendage occlusion, it's given a 2B Level of Recommendation, and if you look at this, it says percutaneous left atrial appendage occlusion may be considered in patients with AFib at increased risk of stroke who have contraindications to long-term anticoagulation. Now, I know there's lots of new large studies being done of appendage occlusion as an alternative to a NOAC, if you will, but until these data are out, we're left with this relatively soft recommendation for the appendage occlusion devices. So now let's switch over to catheter ablation. Nothing has really changed except there was a specific indication for catheter ablation of AFib in patients with heart failure, and this was based on the CASEL-AF study as well as some other non-randomized and small randomized studies. And that's given a 2B Recommendation, and you may wonder why it's a 2B Recommendation, but if you look at the editorial by Milt Packer, you know, he sort of spells out the limitations of the CASEL-AF study. Certainly we're all moving to performing more AFib ablation in patients with heart failure, but this was a highly selected population of patients, a small number of patients, very few heart endpoints, so that's why it only ended up with a 2B Recommendation. So then moving on, there's a big section on AFib-complicating acute coronary syndrome, and as electrophysiologists, we don't spend a lot of time dealing with acute coronary syndrome. Mainly I think for our interventional or general cardiology colleagues, so I won't walk through all of these, but it talks about acute management, it talks about anticoagulation, the value of low-dose rivaroxaban, the value of dual antiplatelet therapy instead of triple antiplatelet therapy. So I just want to alert you that these recommendations are there, so if you have a patient with ACS, by all means, pull these out, look at them, and see what applies, but I won't spend a lot of time this evening or today going over these. Another change is there's a recommendation on device-detected AFib. I think we're all aware this is a big issue when you get AFib on your pacemaker or defibrillator, what are you supposed to do with it? And what this recommendation says is in patients with cardiac implantable devices, the presence of a recorded atrial high rate episode should prompt further evaluation to document clinically relevant AFib to guide treatment decisions, and I think everyone's been made aware that pacemakers and defibrillators can over-diagnose AFib just because there's a mode switch. Just because it shows up on your AFib burden bar as X amount of AFib, by no means does it mean it really is AFib, so in those patients, you should look at the actual intracardiac tracings or get another type of monitor, and generally, you know, I think what most people are doing these days, if someone's having long episodes of AFib, five hours or more, have a high CHAZ-VASc score, then there's a pretty low risk to low threshold anticoagulate these patients. Now, there's also a new recommendation on cryptogenic stroke. Patients with cryptogenic stroke in whom external ambulatory monitoring is inconclusive, implantation of an implantable monitor is reasonable to optimize detection of saline AFib, and we're all aware of a lot of the studies, Chris DeLayoff and others, that have looked at the value of long-term monitoring in these cryptogenic stroke patients, you know, a negative 16-day or 30-day monitor is really not sufficient to exclude AFib. The implantable monitor seems to add real value in this setting, and then the final recommendation is weight loss, and if you look at the 2014 document, weight loss was not even included, and I think all of us are aware of the remarkable body of evidence telling us of the link between AFib and obesity, telling us that the treatment of AFib is much improved by losing weight, whether it's post-catheter ablation or pharmacologic therapy, and so this now gets a class one level of evidence B recommendation, and I think we thank Parash Sanders and his group in Australia for doing a lot of this pioneering work, which has really been confirmed at sites all over the world. So let me just conclude. The 2019 update of the 2014 AFib guidelines is an important document that the EP community should be aware of. At least in my impression, working here in Baltimore, I think a lot of cardiologists and electrophysiologists are not aware of this update, and particularly they're not aware of female gender being removed from the CHADS-VASc score and anticoagulation recommendations. They also are not aware that aspirin's been eliminated from the anticoagulation guidelines, so I think these are very important messages to get out, because otherwise we're over-anticoagulating patients and we're not really giving our patients the best information when we see them in clinic. Valvular AFib has been redefined. I think that the definition was given in 2014 was imperfect and it's been corrected. Antithrombotic therapy has been replaced by anticoagulant therapy and aspirin's been removed, because it's not about antithrombosis that has to do with MIs and unstable angina. It's about anticoagulant, NOACs, and warfarin. The gender-neutral CHADS-VASc score is now recommended. NOACs are recommended in preference to warfarin. I think we've all shifted in this direction by now. We now have an official indication for the Watchman device, a 2B indication. We also have a 2B indication for select heart failure patients that get catheter ablation. We have new recommendations for anticoagulation and management of AFib in ACS patients. And importantly, we have recommendations for the importance of weight loss in treating our AFib patients. It's not good enough to just put them on a drug and do an ablation and ignore their obesity. We really have to, as a community, embrace this and get on board with trying to make this better. So with that, I will stop, and again, it's been a pleasure to spend some time with you today. And if you have questions or have concerns, please feel free to email me, hcawkins at jhmi.edu. I'd be happy to dig into more detail about the guidelines and why the recommendations were made. And it's a very interesting topic, and I always enjoy chatting about this. Thanks so much.
Video Summary
Dr. Hugh Calkins provides an overview of the 2019 updates to the 2014 ACC, AHA, HRS, AFib guidelines. The updates include important modifications to patient management and focus on six main topics: anticoagulation recommendations, appendage occlusion for stroke prevention, catheter ablation recommendations, management of AFib-complicating acute coronary syndrome, device-detected AFib, and the importance of weight loss in AFib management. Key changes include the redefinition of valvular AFib, the removal of aspirin from the anticoagulation guidelines, the recommendation for NOACs over Warfarin, and the inclusion of the Watchman device as a potential treatment option. Additionally, the guidelines now recommend the use of implantable monitors for detection of silent AFib in patients with cryptogenic stroke. Dr. Calkins emphasizes the importance of understanding and implementing these updated guidelines for optimal patient care.
Asset Caption
Hugh Calkins, MD, Johns Hopkins Medicine
Keywords
2019 updates
anticoagulation recommendations
catheter ablation
Watchman device
implantable monitors
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