Oussama Wazni, MD, Section Head of Electrophysiology and Pacing at Cleveland Clinic talks about a new intervention method for atrial fibrillation.
So, if can you explain what AFib is and how common it is?
WAZNI: So, Michelle, atrial fibrillation is basically an irregular rhythm that originates from the left atrium most of the time. And there are three aspects of atrial fibrillation that we really need to manage in patients. The most important one, which is not part of this study. However, for the benefit of our audience, they need to know that whenever they’re diagnosed with atrial fibrillation is the most important aspect of managing atrial fibrillation is the prevention of stroke. So, they would have a discussion with their doctor regarding the risk of stroke and how to manage that and how to minimize that. The second most important aspect of atrial fibrillation is the development of heart failure. The good news is that this is rare. This is, again, another aspect that is not in this study. However, it’s also important to discuss with their doctors what the risk of heart failure is and to check for heart failure when they develop atrial fibrillation. Now, the third most important one, and this is what the study was about for symptom relief. So, this is symptom relief in the patient. So, this is why the patient actually comes to us is because they develop symptoms that are related to atrial fibrillation. And our study is very important in this respect because once this symptom is the trigger to go to have this visit with their physician and then later with the electrophysiologist. And it is true that we want to provide symptom relief, but, at the same time, we want to also treat the atrial fibrillation early on. And this is something that we have recognized in our own practice and also in our previous research is that the sooner we intervene and treat atrial fibrillation, the better. Because if atrial fibrillation is allowed to continue, then those changes in the left atrium progress. And it makes it much more difficult for us to treat atrial fibrillation and restore sinus rhythm. If it is difficult for us to restore sinus rhythm, well, one, the patient will continue to have the symptoms that brought them in the first place. They will also continue to have the risk of having heart failure, and they will also need continued management of decreasing the risk of stroke. So that’s why our study was based on and based upon our previous experience where we saw in our own practice. And again, in many different research that we have conducted, that if we wait too long to address atrial fibrillation, it is more difficult for us to manage it. So, to spot atrial fibrillation first, try to answer this question. Right now, the indication for an ablation … So, what are the ways? Let’s back up. What are the ways that we can manage atrial fibrillation? The first thing that shows a patient is in AFib, then we do a cardioversion. And this is for a sinus rhythm, but the cardioversion, which basically, does not maintain sinus rhythm. So, then the patient has a risk of recurrence of atrial fibrillation and then going back to the symptoms. So right now, what we do, and these are the guidelines, is that the first line therapy is to try to give the patients a medication. We call it an antiarrhythmic drug, AAD for short. So, the AAD is first prescribed. And if the AAD fails, then we move on to ablation, which targets areas in the left atrium to basically shortcut that circuit and prevent a recurrence of atrial fibrillation. So now in our own practice, now the usual way of treating it is first we give an AAD. And if the AAD fails, then we will proceed with an ablation. A long time ago, I conducted a study called the trial. But it was a small subset of patients and relatively young patients. And we showed back then that if we ablate sooner than later, then we have better success rates. And this builds upon that knowledge but this time using cryoballoon ablation. So, the cryoballoon is that it is a balloon and one shot basically isolates the whole area instead of doing by spot-by-spot radiofrequency ablation. So, we took about two hundred patients and we randomized them. And these are patients who have AFib but have not taken an AAD for more than seven days. And we randomized them to do an ablation, so first line therapy with ablation, versus taking any other drugs. And the difference in efficacy or effectiveness was very big. So, for example, seventy-five percent in the ablation group continued to have sinus rhythm at one year with no ablation, so only one ablation. Whereas in the drug regimen group, only forty-five percent of those patients maintained sinus rhythm. And they also have to take a drug on a daily basis. Also, in the AAD group, a lot of them, we won’t go into details, but a big subset of those patients ended up with an ablation anyway. So, if you take into account the success rate of the ablation itself, seventy-five percent versus forty-five percent, that’s very good news for our patients. But also, if you take into account health care utilization, those patients took medication and a big proportion of them still ended up needing an ablation. So, this goes along the lines of what we’ve been building on, our theme that has been going on in that maybe it’s time to circumvent needing to take an antiarrhythmic drug with all the side effects and ineffectiveness and just proceed with an ablation.
What did this specific study look at and then what did you find?
WAZNI: The STOP AFib First study specifically looked at the efficacy, so how effective ablation with the balloon, with the cryoballoon is compared to antiarrhythmic drugs when we use it as first line therapy, so in patients who have not been on an antiarrhythmic drug for more than seven days. So, we call them drug naive patients. So, we’re comparing ablation with the cryoballoon as a first line therapy in drug-naive patients. And then we randomized patients to ablation versus a drug, the antiarrhythmic drug that we talked about. And also, we looked in the study at the safety profile of the ablation. Results; let’s talk about the efficacy and the results next. So what we found after following the patients that we had in each arm, about one hundred patients. To be exact, one hundred and two patients in the ablation arm and ninety-one patients in the drug arm, those are the ones who finished the study and completed the study. And after one year of follow up, we found that 75 percent of the patients who had the ablation remained in sinus rhythm without the use of antiarrhythmic drugs on top of the ablation and without another ablation. So just one ablation, one ablation managed to keep 75 percent of those patients in sinus rhythm compared to forty-five, only forty-five percent in the antiarrhythmic drug. And it’s also important to point that a lot of the patients in the antiarrhythmic drug trial, more than 30 percent reduction. So again, like we said, forty-five percent of the drug arm in the study had recurrence of AFib, only 45 percent maintained sinus rhythm in the patients who were in the antiarrhythmic drug arm. And then in the antiarrhythmic drug arm, there were so many patients who ended up with an ablation anyway. Now if we’re talking about the safety, the safety of doing an ablation was very much is the same. There’s only two events that happened in the ablation arm. One was what we call an effusion, and it was treated and managed successfully with no untoward sequelum. And also, another patient had a minor heart attack which could have been related to the ablation or not. It happened a few days after the ablation. But these are considered, you know, very rare. And in taking everything into consideration, it’s a very safe procedure.
So, can you talk about just go into what are some of the benefits of the ablation?
WAZNI: So, there are two main benefits. One of them is that the patients maintain sinus rhythm and they won’t have symptoms. But I think the other benefit that, based on this, we don’t know for sure, but we know from our previous research is that if we maintain sinus rhythm, we will also decrease the progression of the disease process so that the patients will not go into what we call persistent atrial fibrillation where they’re going to AFib and it’s very difficult for us to get them out of atrial fibrillation. And also, if they maintain sinus rhythm, the risk of having heart failure becomes much less. Now, with respect to stroke, that relies on some other risk factors. But I think maintaining sinus rhythm would also decrease the risk of having stroke. But the main point is that the patient will also feel a lot better. And they maintain sinus rhythm without having to take an antiarrhythmic drug, and the procedure itself was shown to be very, very safe.
So, will this change the standard of care at Cleveland Clinic?
WAZNI: I think there is a potential for this to change the standard of care around the country, frankly. This was an FDA-regulated study so that the data is going to be submitted to the FDA and the indications may change. So, the indications right now say that, you know, ablation is reasonable and also is recommended when patients have certain disease. This statement may change to that it is reasonable to do an ablation before trying an antiarrhythmic drug.
And can you talk about what can happen if a patient’s atrial fibrillation is not brought under control? What are some of the long-term effects?
WAZNI: So, we have addressed those, but we will address them again. So, if atrial fibrillation is not addressed, you know, in an expeditious manner, it is possible that it will become more intense, so to speak, and more difficult to get the patient out of atrial fibrillation. And we have written about this in several papers along the years. And we’ve shown that the longer patients are kept in AFib, the more difficult it is for us to get them out of atrial fibrillation. So that’s something that then will be addressed with this kind of management. The other one is we talked about is that also I think the risk of having heart failure will decrease over time if we maintain people in sinus rhythm.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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