Video

AF Symposium 25: Balloon-Based PFA for De Novo PVI in PAF and PersAF

Published: 21 Jan 2025

  • Views:

    Views Icon 128
  • Likes:

    Heart Icon 0
Average (ratings)
No ratings
Your rating
View Transcript Download Transcript

AF Symposium 25 - Safety and effectiveness results show the Volt (Abbott) pulsed field ablation (PFA) system for pulmonary vein isolation (PVI) is a successful treatment option for paroxysmal and persistent atrial fibrillation patients.

Prof Roland Tilz (University Heart Centre Lübeck, Lübeck, DE) joins us onsite at AF Symposium 25 to discuss the findings of balloon-based PFA for PVI. The pre-market, single-arm study's safety endpoint was major adverse events within 7 days post-ablation, and the efficacy endpoint was arrhythmia recurrence within 6 months post-ablation.

Findings revealed that the Volt PFA system met its safety and efficacy endpoints with a low occurrence of major adverse events.

Interview Questions:
1. What is the reasoning behind the trial?
2. What was the study design, safety endpoints and patient population?
3. What are the key findings?
4. What are the take-home messages for practice?
5. What further study is needed?

Recorded on-site at AF Symposium in Boston, 2025.

Editors: Yazmin Sadik, Jordan Rance
Videographers: Oliver Miles, David Ben-Harosh
Interviewer: David Ramsey
Support: This is an independent interview produced by Arrhythmia Academy.

Transcript

My name is Roland Tilz. I'm Professor of Cardiac Electrophysiology at the University Heart Center in Lübeck, Germany.

What is the reasoning behind the trial?

We all share the enthusiasm about pulsed field ablation. It's a very powerful and safe energy. However, recent trials demonstrated that first generation PFA tools are only as good but not better than thermal ablation.

And they're only as safe but not safer as thermal ablation technologies. So the balloon design is aiming to combine the best of three worlds. So the balloon, which has the advantage that you can push the catheter and get very good wall contact, that you can deliver the energy into the tissue and not into the blood pool.

Second, it has a PFA as a very powerful and safe energy. And third, it is fully integrated into a 3D mapping system.

What was the study design, safety endpoints and patient population?

It is a pre-market, single-arm study.

150 patients were enrolled at 11 sites in the world, 70% of patients had paroxysmal AF and 30% persistent AF. The mean age was 62 years old and more than 70% of patients were pre-treated with CLASS I or III antiarrhythmic drugs.

Two thirds were male. The safety endpoint were major adverse events within seven days after the procedure. The efficacy endpoint were arrhythmic recurrence within six months post ablation.

What are the key findings?

The key findings of the study were that the Volt balloon was safe and effective to isolate the pulmonary veins. More than 99% of all veins could be isolated in a single patient, a single vein could not be isolated. Major adverse events occurred in 2.7%. There was a single cardiac tamponade, two vascular access complications and one patient had pneumonia - so the safety profile of the device was very good.

What are the take-home messages for practice?

So the take-home message of the Volt study is that the balloon is back. It is a safe and effective way to isolate the veins with pulsed field ablation. The safety profile was excellent and the efficacy was very good as well.

What further study is needed?

Now we need further studies to confirm that the balloon design is more effective and safer as compared to thermal ablation.

Comments

You must be to comment. If you are not registered, you can register here.