TactiFlex™ Duo Ablation Catheter: Key insights on mapping, PFA, and clinical evidence

Q. Could you describe the main challenges associated with treating atrial fibrillation?

For the last few years, we have been pretty good at carrying out pulmonary vein isolation, which is considered by most people to be the cornerstone of an atrial fibrillation (AF) ablation procedure. That, if it can be done effectively and safely, will treat a population of patients who have AF who are relatively early in the disease. By that I mean paroxysmal atrial fibrillation patients, where it comes and goes, or early persistent atrial fibrillation, perhaps when they’ve only had AF for a few months.

On the other side, you have patients who have had AF for a longer period, so longer standing persistent AF, either for more than 6 months or truly long-standing for over 1 year, and these patients don’t respond to only pulmonary vein isolation, or only a small proportion of them do, perhaps 30%. This group is really the challenge for us as a community at present and how to treat this population better.

Q. Can you provide an overview of the TactiFlex™ Duo Ablation Catheter and what differentiates it from existing ablation technologies?

The Tactiflex™ Duo Ablation Catheter is a catheter produced by Abbott. It’s just recently been given its CE mark. It has been developed from the Tactiflex™, which is a catheter that is tried and tested and already integrates into their ecosystem of technologies.

What’s new about Tactiflex™ Duo is that it allows not just delivery of radio frequency energy, which is what the previous catheter could do, but also pulsed field ablation. The catheter itself has got a traditional sized tip, which is 4mm, which is now relatively small. I would consider it a small footprint dual energy catheter. That allows us to be accurate, because you’re doing a small lesion, but it also allows you to choose which energy source you want to use, either radiofrequency or pulse field ablation. There are different reasons why you might want to treat the patient with either of those energies, given a particular location or a particular disease process.

One other thing which sets it apart is that it is very fast, so you can give lesions just a few seconds, allowing good workflow. As I mentioned before, the previous Tactiflex™ catheter integrates with the EnSite X platform, and the Duo does too, so you get all the well-developed software that’s been developed over several years.

Q. How do the catheter’s PFA capabilities and integration with advanced mapping systems enhance the ablation procedure?

The catheter works with their new generator and the EnSite X 3D mapping platform; a well-developed mapping platform. You have access to other technologies, such as contact force sensing with the catheter, which we know is very important for pulse field ablation, not just radiofrequency ablation. You can also visualize the lesion assessment in three dimensions, so when you think you’ve made an ablation in a particular location, it’s marked in space, and you can see whether it’s a good enough lesion or whether you need to deliver another in the same spot before you move on—and how far to move on. Then you have the ability to use advanced mapping as well.

The main catheter that’s used with this system is the HD Grid X, which allows high resolution and accurate mapping. This is an advantage before you perform the ablation because it helps guide where to place it. Then, after you do the ablation, it’s useful in showing whether you’ve made a good lesion or need to do something more.

Q. What clinical evidence supported the CE Mark approval, and what does the data show about safety and effectiveness?

In Brighton, we were one of the centres involved in the FOCALFLEX study (NCT06271967). This was a CE marking international study run by Abbott. In that study, there was approximately 150 patients with paroxysmal atrial fibrillation. The idea of the study was to do pulmonary vein isolation, so encirclement of the pulmonary veins in pairs with the new catheter. Most of the participants did the study by doing pulse field ablation – there was some radiofrequency done, but the vast majority was pulse field ablation. What this study showed was that there was very high acute effectiveness in terms of achieving pulmonary vein isolation on the first pass, a very good safety rate. Then I believe they have just released their 6 month efficacy data as well, which has been favourable, which has allowed them to achieve the CE mark.

Q. Which patients are best suited for this technology, and what impact do you anticipate it will have on patient outcomes?

I think that pulmonary vein isolation is best done with a single-shot technology catheter, so not a point-by-point catheter like the Tactiflex™ Duo that we’ve just been discussing. There are various reasons behind that, but if that’s the case, then patients who have paroxysmal fibrillation or early persistent fibrillation can be adequately treated with pulmonary vein isolation and I think they should have a one-shot technology.

We’re left with all the rest then. Firstly, if any of those patients were to need a redo procedure, they would benefit from this catheter. Then anyone requiring more complex atrial ablation, such as people with atrial fibrillation for over 6 months, would probably benefit from an upfront procedure that includes pulmonary vein isolation plus additional ablation.

In terms of other arrhythmias, because it’s dual energy, I can’t really think of any reason why you wouldn’t use this catheter. Remember, we had radiofrequency alone before, so now you have more choice. That basically means it should be used for everyone as far as I can work out. For instance, SVT ablation, VT ablation, ventricular ectopic ablation, I think would all benefit from the possibility of having the dual energy. The reason for that is that you can choose to use a specific energy in a certain location and that has to lead to better results in terms of preventing arrhythmias, but also safer procedures because you can limit complications by using the safest energy in the right location.