Efficiency and Predictability for Pulmonary Vein Isolation With the Goal of Same-Day Discharge

Discussion With Celso Acevedo, MD, and Nguyen Phan, MD, on Their Use of the HeartLight X3 System

The HeartLight X3 System (CardioFocus) is a visually guided laser balloon technology for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). It consists of an ultra-compliant balloon, a motor-controlled laser energy source, and a 2 French camera for direct visualization of the pulmonary vein, making it ideal for pulmonary vein isolation (PVI). The HeartLight X3 System is developed and manufactured by CardioFocus, Inc, in Marlborough, Massachusetts. More than 14,000 patients have been treated worldwide. In this feature interview, EP Lab Digest speaks with Drs Celso Acevedo and Nguyen Phan about their experience with the HeartLight X3 System. Dr Acevedo is with Florida Heart and Lung in Ocala, Florida. Dr Phan is with the Ascension Medical Group in Milwaukee, Wisconsin.

How and why is efficiency and predictability in your AF procedures important to you, your staff, and administration? What has been your experience with the HeartLight X3 System, and how has it changed your AF treatment strategy and workflow?

Phan: Efficiency became especially important to us during the start of the COVID-19 pandemic, when a lot of hospitals were shutting down. About 6 months into the pandemic, our hospital began allowing us to perform complex cases again, but only if we could send patients home same day. This was due to concerns about the risk of infection as well as issues with staffing. In the past, when we performed radiofrequency (RF) ablation for AF, we kept most patients overnight because a lot of them were returning either that night or the next day to the emergency department (ED) with symptoms of pericarditis or chest pain.

With the HeartLight X3 System, we are seeing a lot less patients return with chest pain or pericarditis. That is why we were comfortable telling administration that we could do these cases in the morning and send patients home by 4:00 PM. We had to promise that a significant number (almost 90%) of patients would be discharged home the same day, and the only ones who would stay would be due to some unforeseen complication. Letting us continue to do complex AF cases during COVID-19 was important, as we would not have been able to achieve this with any other modality.

Acevedo: Shorter procedure times are not only convenient for the operator, because less time is needed, but they also enhance safety, as there is decreased radiation exposure to the patient. You also have the capability, especially when this technology is combined with a vascular closure device, to send patients home right after the procedure. So if you are able to expedite cases and perform them efficiently, those patients can go home the same day. Even the last case of the day can be discharged early without a prolonged observation or hospital admission. Efficiency can be misconstrued with being hurried or rushed. Our main goal is to provide patients with the safest and most effective procedure to treat their arrhythmia. It is not about trying to get things done within an hour to maximize throughput. It is about that one individual and their experience. When using the HeartLight X3 System, it is truly a first-pass isolation of the pulmonary veins (PVs). That also helps improve efficiency, because you are able to achieve isolation of all 4 PVs consistently and predictably, in most, if not all cases.

What feature of the HeartLight Laser Balloon has made the biggest impact in the way you perform PVI?

Acevedo: In the past, I used RF ablation only. I never considered cryoballoon ablation, because most PVs are different sizes and shapes, and the cryoballoon only comes in 2 sizes. The RF platform was very flexible, because it allowed me to isolate different PVs with relative ease.

What I like about the HeartLight X3 system is that it combines that flexibility of being able to treat different veins with direct visualization of tissue contact and lesion placement. The platform is a compliant balloon that will accommodate different vein sizes, anywhere from 7-41 mm, as well as an endoscope that allows the operator to look directly inside the PV, so no assumptions have to be made. When you use a mapping system, you are using data that was taken at the beginning of the case and making assumptions during mid to late case. The HeartLight Laser Balloon is fixed to the PV so there is no guesswork—it takes away that uncertainty.

Since the laser balloon is compliant, when you have good contact and the balloon accommodates around the vein, you are able to go more antral. Typically, it is a little trickier to go antral with the cryoballoon, but with the laser, you are able to do a wide circumferential lesion. In addition, laser energy does not disrupt the endothelium as much, and there is data to show there is less inflammation. Because the laser preserves the endothelium, it does not cause a lot of pericarditis. I have also noticed that antiarrhythmic drugs are not needed as often after ablation. I am less wary about not using antiarrhythmics, which was the standard of care for many years. A lot of patients are discharged on anticoagulation for a couple of months, but not all of them require antiarrhythmic drugs. Some RF patients also need anti-inflammatory agents postablation, but I rarely, if ever, see that with a laser.

Phan: It makes the procedure a lot simpler. We are able to quickly cannulate the vein and isolate with the laser balloon to directly visualize where we are ablating. We no longer need three-dimensional mapping to tell us where we are—we can see the vein and know exactly where to ablate. This significantly cuts down on time, as we are able to do cases in half the time that it previously took us. So those are the 2 key features that have made the biggest impact—we are able to ablate much faster and the procedure is safer because we can see exactly where we are going.

From a patient care perspective, what has changed from your previous PVI modality to using the HeartLight X3 System?

Phan: We immediately noticed 2 things. First, patients seem to tolerate this procedure much better and do not return as much with chest pain or pericarditis. Our mid-level providers who take these triage calls experienced a significant decrease in the number of patient calls to the office the next day with symptoms of chest pain. Our success rate has also increased compared to other modalities.

Acevedo: After a first ablation pass, you often see that demarcation where the laser isolated the PVs, so that is a very early indicator of outcome. Other reasons that helped me become an early adopter of this technology include having stability of contact on the ridge and the ability to titrate energy. The ridge between the left atrial appendage and PVs is a lot thicker, so it is typically difficult to get good contact in this area with RF. Ultrasound studies have also looked at thickness of the PV and ridge segments, and demonstrated that it is one of the thicker areas of the PV. I have no issue getting contact there using the laser balloon. You can titrate power output with laser, so we use higher output in that segment. With RF, I have seen a few left atrial flutters looping around that ridge. I have not seen that with a laser, because I can deliver more power in that area.

Before adopting this technology, I was always intrigued by it and had looked at the clinical trial data. At Heart Rhythm 2022, I was able to share my experience with the laser system during a Rhythm Theater presentation.¹ One of our colleagues from Prague presented data on PVI with laser in 110 patients. At 1 year, they saw 94% rhythm control in paroxysmal AF and 81% in persistent AF. I think the reason it is so effective in persistent AF is that you can go more antral with a laser and not be as close to the PV.

A recent publication from Gao et al² showed less edema with the HeartLight Laser Balloon compared to RF energy. What has been your experience with observing pericarditis in patients treated with laser vs RF energy for AF?

Acevedo: That was also noted in my first 15-25 cases with the balloon. I also noticed that I was getting less postop phone calls for chest pain. After RF ablation, I would sometimes prescribe patients colchicine if they developed postop chest pain. Early on during my transition from RF to laser, I began seeing decreased inflammation, pericarditis, and complaints of postop chest pain.

Phan: In the last couple of years that we have been using laser energy for AF, we have had only a small number of patients—maybe 1 or 2 that I can remember—who have returned to the ED or were readmitted with pericarditis. When we were doing RF, a significant percentage of our patients either came back to the ED next day with chest pain (not necessarily pericarditis) or were urgently seen in clinic within a week postprocedure for similar pain. That means we needed to have unexpected manpower to cover those clinics, often bringing them in short notice and scheduling additional testing based on their diagnostic stats from the ED. These patients often ended up needing an echocardiogram to evaluate for pericardial effusion or a computed tomography (CT) scan to look for pulmonary embolism. In our experience, we have seen a significant change with use of the HeartLight Laser Balloon.

Has COVID-19 increased your desire for same-day discharge? If so, what characteristics do you look for in an AF ablation device that make it ideal for same-day discharge?

Phan: Many hospitals are now experiencing a subsequent staffing shortage, so it is important that we are able to send patients home same day for most procedures. We are even contemplating sending patients home after ventricular tachycardia ablation. But for AF, same-day discharge is expected.

We take into consideration the following criteria to ensure same-day discharge. First, the procedure has to be fairly quick. If a patient is under general anesthesia for 3-4 hours during a procedure, we cannot discharge them home same day. Second, we have to be able to send them home with a low risk of them returning to the hospital or ED that night or the next day, because that would defeat the purpose of sending them home early. We do not want these patients to flood the ED and burden staff. Third, it needs to be a safe procedure. We have been able to meet these 3 criteria with CardioFocus.

Acevedo: COVID-19 changed the way we thought about many things. We had already been thinking about adopting a same-day discharge approach based on our overall ablation experience. These procedures are safe and we now have better technology. In conjunction with a vascular closure device, we are now seeing less postop pericarditis, chest pain, and postop arrhythmias. I am now discharging most of my AF ablation patients home same day. 

This article was published with support from CardioFocus.

Disclosures: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Acevedo and Phan have no conflicts of interest to report regarding the content herein.

References

1. Funasako M. Rhythm Theater 2: Consistent, predictable, and efficient PVI with the HeartLight X3 Endoscopic Ablation System. Presented at: Heart Rhythm 2022; April 30, 2022; San Francisco, CA.

2. Gao X, Chang D, Bilchick KC, et al. Left atrial thickness and acute thermal injury in patients undergoing ablation for atrial fibrillation: laser versus radiofrequency energies. J Cardiovasc Electrophysiol. 2021;32(5):1259-1267. doi:10.1111/jce.15011