Hi, my name is Frédéric Sacher. I'm a cardiologist and electrophysiologist at Bordeaux University Hospital and Liryc Institute. And today I will discuss a late-breaking trial on the European Affera Ventricular Arrhythmia Ablation Registry.

What is the reasoning behind the registry?

The purpose of the study was to get an exhaustive registry of ventricular arrhythmia ablation with the Affera Sphere-9 catheter. As it is a new system, it's very important to collect all cases performed with this kind of catheter to make sure there's no safety issue.

What was the study design and patient population?

Therefore, we decided to contact every single centre in Europe using this catheter and to include all the patients in whom we performed ventricular arrhythmia ablation. So it's really exhaustive for any kind of ventricular arrhythmia ablation. And in our population, we do have VT ablation, but also PVC ablation and VF ablation. And what interesting point is that only 1/3 of the patient was de novo procedure, meaning that 2/3 of the patients were redo procedures.

Concerning the population, we contacted all centres in Europe using this system and we tried to get an institutional registry to get any information about the cases performed for ventricular ablation with these devices and, therefore, making sure there was no safety issue. And of note, 2/3 of the population were redo procedures— so the most complicated cases.

What were the key safety outcomes?

The primary endpoint was safety outcomes, and we had a 6% rate of major complication, which is expected in such a sick population. Once again, we were dealing with patients with cardiomyopathy, low ejection fraction and 2/3 of these patients were redo procedures, so having failed previous intervention, even 15% gained more than three previous procedures. So those were the most severe patients.

Concerning this complication, we did have some which were related to the procedure and expected in such types of ventricular arrhythmia ablation. And we did have also some that could be linked or not to the device that we need to further explore.

What are the next steps in evaluating this technology beyond this initial safety-focused registry?

Concerning the complication rate, we are with 6% in the range of what has been described so far in various studies dealing with such a population.

How do these early safety results compare with historical data from other ablation techniques?

Now the next step would be to get prospective randomized control study to make sure this is as or more effective, especially in these kind of patients, and also making sure there's no other safety issue we have not seen in this initial registry.