"I'm Professor Roland Tilz. I'm the director of the Department of Rheumatology at the University Hospital in Lubeck, Germany. So it's a great pleasure to share the Volt Awake series with you.

Currently there is a big shift from RF and cryo-based AF ablation procedures towards pulsed field ablation procedures. It's the energy source number one in many countries around the world. However, most procedures around the world are performed in general anesthesia. It is also increasingly performed using deep sedation in Europe.

However, in many countries deep sedation, propofol sedation can only be administered by an anesthesiologist, and this counterbalances the benefit of this technology. You need more hospital resources, it's not cost effective, and importantly it gets less efficient.
We evaluated a new workflow aiming for an AF ablation procedure using the Volt technology and keeping the patient awake — so without GA, without propofol administration — which is reproducible all around the world. Our aim was to make the procedure safe, effective, keep the patient happy and streamline the workflow, which is particularly important in an era where same-day discharge procedures are increasingly performed.

We collected consecutive patients undergoing Vault AF ablation procedures. All of them underwent PVI. A subgroup also underwent common-type flutter ablation, posterior wall ablation, anterior line ablation or SVC ablation. All of these additional applications were successful and feasible in keeping the patient awake.

In terms of what we administered: patients received a combination of midazolam, fentanyl and lidocaine. Lidocaine has not only a positive effect in terms of pain relief, but it also reduces coughing — keeping the patient free of pain but also more stable, which is extremely important when using a 3D map. We were able to complete all procedures successfully without complication. We did not have to switch to propofol sedation or GA in any patient.

What is remarkable is that patients reported significant pain immediately after each application — around a 7 out of 10 during the procedure. But when asked simultaneously how they were feeling overall — whether they were comfortable — they were very happy, rating their comfort at around 2 out of 10. So patients did feel the pain, but they said "I'm fine, I don't worry about the pain." And after the procedure, they rated the pain at just 2 or 3 out of 10, quickly forgetting how intense it had felt in the moment. Most patients said they would recommend this approach to others.

In summary, this approach is excellent for patient convenience, was successful in all patients, and follows a standardized protocol. I believe it gives physicians around the world the opportunity to perform this procedure without an anesthesiologist.

Looking ahead, we have further optimized patient convenience by providing goggles so patients can watch Netflix during the procedure. We are also about to start a randomized trial of 200 patients comparing the awake procedure against nurse-administered propofol sedation. I hope to be able to present that data at this meeting next year.”