So my name is Roberto Galea from University Hospital of Bern, and today we are going to talk about the three-year outcomes from SWISS-APERO trial.

What is the background and the aims behind the SWISS-APERO trial?

The SWISS-APERO trial is a multicentre randomized clinical trial designed in 2017 in order to assess if Amulet is superior or not to Watchman in terms of a composite of residual LA patency, as evaluated by 45-day CT, and the crossover to the non-randomly allocated devices occurred during the procedure.

We decided to include the residual LA patency in the primary endpoint since in 2017 we thought this had clinical relevance and, actually, this was confirmed in the last three years by two multicentre observational studies conducted in US and one substudy from [illegible].

Then we decided also to include the crossover to the non-randomly allocated device in order to capture the feasibility of the device implantation during the procedure. And we decided to assess this primary endpoint by means of CT—that is the most sensitive imaging exam to detect residual LA patency after procedure.

What were the key factors that motivated comparing the Amplatzer Amulet and Watchman/FLX devices?

So we decided to include these two devices in our trial since these are the two most frequently used LA closure devices in clinical practice worldwide and are actually the only two devices with both FDA and EMA approvals. This study can be also used as a comparison between two different system of percutaneous closure: a single closure system device has Watchman/FLX and a double closure system has Amulet device.

What was the study design and patient population?

So the SWISS-APERO trial is a multicentre randomized clinical trial including eight European centres. We screen basically all percutaneous left atrial appendage closures scheduled at the participating centres, and we include only patients with nonvalvular atrial fibrillation with a CHA2DS2-VASc score greater or equal than two and a high bleeding risk, defined as either a HAS-BLED score greater or equal than three or a high bleeding risk criteria according to the consensus document of Munich published in 2017. Then we excluded the LA morphologies not suitable for both devices.

What were the key findings?

So we observe at the three years, that is the current substudy, a trend toward a lower ischemic risk observed in the Amulet group as compared to Watchman/FLX group in terms of composite of cardiovascular death, stroke, TIA or systemic embolism.

However, in the as-treated and the per-protocol population we observe a significant difference in favour of Amulet as compared to Watchman/FLX in terms of composite of cardiovascular death, stroke, TIA and systemic embolism.

On the other hand, we did not observe any difference in terms of major bleedings between the two groups and in terms of device- related complications despite numerically lower rates of device- related complications were observed in the Amulet as compared Watchman/FLX group.

How should this finding impact clinical practice, and what are the next steps?

So this is a very important question. I think that the results of this substudy can provide two very important messages. One from a clinical perspective is that for the LA closure operators that should be encouraged to implant any of these, one of these two devices based on the confidence that they have with these devices, knowing that these two devices provided a similar protection against ischemic outcomes at three years after procedure.

From a research point of view, these results provided a warning flag, I guess, that should be better investigated in further and larger randomized clinical trial [illegible] for detecting differences in clinical outcomes between the two devices.