Q&A: Oussama Wazni Speaks to OPTION Trial, Potential of Watchman FLX in Atrial Fibrillation

Oussama Wazni, MD, section head of Cardiac Electrophysiology and Pacing, Cleveland Clinic, participated in this year’s centennial American Heart Association (AHA) conference, held in Chicago, Illinois, from November 16-18. His presentation shared novel insights from the OPTION trial, which evaluated the impact of post-catheter ablation atrial appendage closure with oral anticoagulation in patients with atrial fibrillation (AFib).

Wazni sat down with The American Journal of Managed Care® to discuss his team’s findings in detail, including key factors of treatment success, subgroup analyses, guidelines for post-ablation management, and more.

This transcript has been lightly edited for clarity.

Transcript

Oussama Wazni, MD, Cleveland Clinic | image credit: my.clevelandclinic.org

Which factors most influenced the success of left atrial appendage closure vs oral anticoagulation post-ablation?

I think the most important factor for success is the fact that once we close the appendage, patients don't have to take oral anticoagulation. And the fact that in OPTION, we showed equivalence between Watchman FLX and oral anticoagulation, with respect to all-cause death, stroke, and systemic embolism, is a very important message and was a very important finding. More importantly, I think, even when we look at the different components of the primary efficacy endpoint, and especially stroke—which I'm most interested in—there was an equivalent number of stroke events in both groups: 1.2% in the device group versus 1.3% in the anticoagulation group.

Did certain patient subgroups respond better to one treatment, and what does this mean for personalized care?

So, we looked at the subgroup analysis, and we found, actually, that it is consistent. The findings are consistent with all the subgroups that we studied. This is very assuring. I mean, I know we all want personalized care, but sometimes, “one fits all” is a good thing.

In all of the subgroups, we found the same results. So, I think it will apply to all of our patients post-ablation.

How do the long-term risks and benefits of closure compare to anticoagulation, especially for stroke prevention and bleeding?

I think that's a very good question. Closure is a procedure, so we also have to address the risks of the procedure with the patient having a procedure, and we also have to balance those with the long-term risks of oral anticoagulation. The good news in OPTION is that the risk of a complication with the procedure was very, very low compared to the oral anticoagulation group.

And then, with respect to bleeding, we found actually that closing the appendage with the Watchman FLX was superior compared with anticoagulation, which makes sense because, of course, in the anticoagulation group, bleeding is going to be so much worse if they're on anticoagulant versus the Watchman FLX.

Based on the results from the OPTION trial, what changes would you recommend for clinical guidelines regarding post-ablation management in this patient population?

I'm glad you mention the guidelines. What really prompted us to look at this question are the guidelines. So the guidelines now say that whether or not we think the ablation was successful or not, we should make decisions on anticoagulation based on the CHA2DS2-VASc score and not based on the outcome or what we think the outcome of the ablation is.

The problem with that is that a lot of patients, after an ablation, you know, come to us and say, “What do you mean I still have to take a blood thinner?” and we have to explain to them that they could have a recurrence of AFib. They might say, “I don't feel anything.” Then, we have to explain to them again that they can have silent atrial fibrillation. Actually, a large number of recurrences after an ablation can be silent. So, in that patient, if we stop oral anticoagulation, we put them at risk of having a stroke. But on the other hand, if you have a patient who does not have recurrence and had a truly successful ablation—and it's very hard for us to know, other than putting continuous monitoring all the time—it's hard to know that that patient truly had a successful ablation because of the issue of silent AFib.

But if that patient truly has a successful outcome from the ablation, and we put them on a blood thinner or an anticoagulant, then we're exposing them to the risk of bleeding without getting the benefit.

So, that's where it all started; it was with these guidelines. So now I think, hopefully, with the results of OPTION, the guidelines can include: if you don't want to worry about all of this uncertainty, then maybe you can consider left atrial appendage closure with the Watchman FLX device.