Transseptal Tailored for a FARAPULSE™ Pulsed Field Ablation System Workflow

Interview With Suneet Mittal, MD

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EP LAB DIGEST. 2024;24(11):18,20.

In this feature interview, EP Lab Digest talks with Suneet Mittal, MD, Director of Electrophysiology and Chair of the Cardiovascular Service Line at the Valley Health System in New Jersey, about his transseptal workflow and experience with the VersaCross Connect™ Access Solution for FARADRIVE™ in FARAPULSE™ Pulsed Field Ablation (PFA) System procedures (Boston Scientific).

How has your transseptal tool selection and workflow evolved over the years?
That is a great question. For one thing, we do a lot more transseptal punctures than I did in fellowship. It is such a routine part of our workday. The evolution has really been in stages. For the first stage, like many people, we started with a standard mechanical needle to do our transseptal punctures. Over time, for a variety of reasons, we moved over to a dedicated radiofrequency (RF)-based needle (NRG™ Transseptal Needle, Boston Scientific) for transseptal puncture. The big advance for us was moving to a solution where instead of an RF needle, we transitioned to an RF wire to do the transseptal puncture. The newest advent for us now is the incorporation of the VersaCross Connect System (Boston Scientific) with an RF wire, which allows us to do transseptal puncture, often with larger sheaths, without having to do catheter exchanges in the left atrium (LA). The net result for us is that we believe the procedures are faster and safer for our patients. 

Why did you transition from a mechanical needle to the RF NRG Transseptal Needle? Did you have any concerns with electrifying mechanical needles that encouraged you to switch to a purpose-built RF system?
Initially, the mechanical standard needle was something that we all trained on and had been around for the longest period of time. However, we started to realize that for many patients who had thicker septums, either because that is what their septum was, or in individuals who had undergone prior LA procedures of any kind, the septum hypertrophied and sometimes it was difficult to penetrate with a standard needle. Increasingly, we found ourselves having to use an electrocautery probe to essentially convert that needle into an RF-based needle system to cross into the LA. Some initial histologic work led us to be concerned that that may not be as precise as we wanted, and that we may be coring a ragged and larger hole than would be ideal. It seemed that the RF needle would be ideally suited to mitigate these 2 issues: the inability to cross a big septum but also have a much more controlled crossing of the septum. That was really the first switch for us moving from a standard needle to an RF-enabled needle. 

What guidance would you give to a Fellow starting their career when considering transseptal tools available today?
There are so many transseptal tools currently available on the market, I think that you need to have a tool that delivers consistent results. Ideally, it should be one that minimizes some of the challenges that have been present with the historical tools like the RF and standard needles—flushing the system, having to rewire systems should you not hit the initial area that you want to cross with on the first pass, or having to use an electrocautery system to cross. All these things need to be considered when choosing the optimal system. It is still an area where many complications occur during procedures, and it is one that you want to make as free of complications as possible to ensure that you have great outcomes after procedures that require transseptal puncture. 

Does your transseptal tool selection change depending on the procedure type (eg, left atrial appendage closure/pulmonary vein isolation/ventricular tachycardia)?
At this point, our transseptal only changes in terms of the sheath that we are using to cross, but otherwise, it is a very standard procedure where we incorporate the VersaCross Connect dilator with the VersaCross™ RF-enabled guidewire. The only other aspect of the procedure that changes is where on the septum we want to cross, which will be a little different for a catheter ablation versus for a left atrial appendage closure. With the latter types of procedures, our puncture site is typically guided by knowledge of preprocedural computed tomography (CT) imaging. 

What is your experience with the dilator-to-sheath transition while using the VersaCross Connect Access Solution for FARADRIVE? 
We have been able to cross with the VersaCross Connect system and FARADRIVE sheath in every case without having to resort to any other solutions. I think that the VersaCross Connect dilator has been great in being able to torque the sheath as we would want. Of course, we would still like to see some improvements. I think the biggest is to be able to lock the connector and sheath together in a way that we are used to when we deal with transseptal sheaths and the inner dilator. That is still not possible with this system yet. However, the key for us has been that by using this system together with the VersaCross RF wire, an exchangeless catheter entry to the LA has been possible in every single patient. Furthermore, since we use CT preprocedural planning to guide whether we want to puncture more inferior or anterior, more mid or posterior or anterior, that has also been possible with this system without fail. So, that has really saved us procedural time and the need to do repeat transseptal punctures. Again, I think it results in less procedural time, which inevitably improves patient outcomes. (Figure 1)

How do you shape your VersaCross Connect Access Solution for FARADRIVE dilator prior to using it in a case? Does the dilator maintain its curve to accommodate anatomy variation?  
We typically will shape the dilator on the table before inserting it, very much like those that are available with the needle, the BRK™ (Abbott), or BRK-1, which offers a slightly greater angle. We find that this is a little necessary because the sheath is not steerable, and therefore, you want to ensure that you can reach the septum, especially in patients with a larger atrium. So, preshaping the dilator to take on that more exaggerated bend has been very useful. Then, when you introduce that to the sheath, rarely do you also have to add some curvature to the sheath, but normally the dilator will hold that exaggerated curvature all through the transseptal puncture process. The shapability of the sheath and dilator is an important component of any RF transseptal system and what makes the VersaCross™ system unique.

How was your experience using a large bore sheath for transseptal? What was your learning curve, if any, with this technology? What tips/tricks do you have for new users?
I definitely think that the larger bore sheaths are a little different than the smaller sheaths. We had extensive experience using this system when we were doing cryoballoon procedures, and that was already a larger bore sheath, so this is only minimally larger. Like anything else, the biggest safeguard that needs to be done is good sheath management to make sure that no air is trapped in the system. We have all gotten used to aspirating and flushing appropriately to minimize any air entry through the sheath. If you take that caveat, the rest of the procedure should be relatively straightforward. 

In what ways has the VersaCross Connect Access Solution for FARADRIVE helped to reduce or eliminate fluoroscopy in your transseptal workflow?
I think that anytime you have these simplified transseptal procedures and you are using fluoroscopy to cross the septum, you save time simply because you eliminate exchanges. So, if you are coming down and you miss the sweet spot, it is very easy to wire back up and retry again. None of that is going to take a lot of time. It is not going to require movement or removal of equipment from the body and then reintroduction of the process. All those steps that are now all incorporated into one inevitably leads to less fluoroscopy time, because the procedure is not requiring us to do all these other individual components that were previously necessary. 
What value does eliminating exchanges with your transseptal bring to your FARAPULSE PFA System workflow?

In general, I think we all want to eliminate any catheter exchanges for a variety of reasons. First, of course, it saves time. Every one of those exchanges takes time. Second, there are occasions where you cross into the LA and in the process of exchanging from one sheath to another, you can lose transseptal access, and that is obviously frustrating and time consuming, and certainly not what we want with our patients. But lastly, and most importantly, every time you do an exchange, I think it introduces the possibility of introducing air into the LA. We know air embolism is a major issue with procedures, especially as we transition to larger bore catheters. So, if you can eliminate all those things with the simplified system, save time, reduce the likelihood of inadvertent loss of LA access, and minimize the likelihood of air embolism, I think that is a real win-win for everyone involved. (Figure 2) 

The transcripts were edited for clarity and length.

Disclosure: Dr Mittal has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. He reports payment or honoraria from Boston Scientific for lectures, presentations, speakers bureaus, manuscript writing, or educational events.

This content was published with support from Boston Scientific.