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Catheter Ablation

2022 AF Symposium: Spherical Array Catheter Case with Video

Note: This was a very early, first-in-human use of this Spherical Array PFA catheter not yet approved by the FDA.

Dr. Vivek Reddy from Mount Sinai Medical Center in New York City, NY, showed a fascinating video of how the spherical PFA catheter emerged from the catheter sheath and formed itself into a spherical array, then locked itself into shape.

Click image to see Spiral Array catheter open

It was like watching a magic trick. How could they design a catheter sheath from which would emerge a complex spherical shaped catheter that would come together so smoothly?

On the video, we watched as Dr. Reddy and his team performed a Pulsed Field Ablation using the Spherical Array Catheter. The patient was a 31-year-old male diagnosed with paroxysmal A-Fib in 2020.

How the Spherical Array Catheter Works

Once fully deployed, the spherical PFA catheter has a diameter of 30 mm. It contains 122 gold-plated electrodes on 16 splines around the sphere. Continue reading about the Spherical Array catheter and the Pulsed Field Ablation for this patient.

2022 AF Symposium: Procedural Anticoagulation with LAA Closure Devices for A-Fib Patients

In this report from the 2022 AF Symposium, Dr. Luigi Di Biase of the Albert Einstein College of Medicine, Bronx, NY gave a presentation on “Peri and Post Procedural Anticoagulation with LAA Closure Devices―An Evolving Story”.

In particular, he is talking about the Watchman occlusion device to close off an A-Fib patient’s Left Atrial Appendage. His focus is on the anticoagulation protocol following the procedure involving, that is, the drug regime for patients in the months afterward. e.g., DOACs, aspirin and clopidogrel.

This is a short report, a quick read, go to Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story.

2022 AF Symposium: Challenging Cases: The Patient has the Last Say

My new report from the 2022 AF Symposium is about one of the “Challenging Cases” presentations. This is when some of the world’s leading Electrophysiologists (EPs) describe the most difficult Atrial Fibrillation cases they had to cope with through the year. Frankness prevails.

Normal Ejection Fraction should be 50 to 75 percent to indicate the heart is pumping well.

Dr. Erik Prystowsky of St. Vincent’s Hospital, Indianapolis, IN, described a 65-year-old man with Atrial Fibrillation, shortness of breath, and a critically low Ejection Fraction (10%). And a severely enlarged left atrium (5.4 cm).

The patient was offered a catheter ablation procedure but would not accept even after the most persuasive attempts to convince him—it would likely fix his A-Fib, improve his Ejection Fraction, and reduce the size of his left atrium. To learn how this patient’s health evolved over the next 5-6 years, read my full report: Challenging Cases—The Patient has the Last Say.

Browse our Personal A-Fib Stories of Hope

A-Fib Catheter Ablation Combined with Left Atrial Appendage (LAA) Closure

In the People’s Republic of China (and other countries) catheter ablation for Atrial Fibrillation is often combined with closure of the Left Atrial Appendage (LAA) in one procedure. This means A-Fib patients can have a Watchman occlusion device installed at the same time as their catheter ablation.

While it may be common practice in some locales, there is limited research data on this combined procedure and, in particular, with patients with prior stroke. That’s why this study in China was conducted.

There is limited research data on this combined procedure and, in particular, with patients with prior stroke.

Aim of this Study: To compare the safety and efficacy of combined catheter ablation with closure of the Left Atrial Appendage (LAA), especially for A-Fib patients who have had a prior stroke.

Study Design: This retrospective study enrolled 296 patients who underwent combined procedures of A-Fib catheter ablation and LAAC. Patients were divided into two groups: 81 patients with prior stroke (Stroke group) and 215 patients without prior stroke (Control group).

Combined procedures were successfully performed in all the patients.

Follow-up Findings: The researchers followed-up with patients at a mean of 20 months.

Both the Stroke group and the Control group (without prior stroke) were relatively A-Fib free after catheter ablation. (Stroke group: 64.2%, the non-stroke control group: 68.4%).

The relative risk reductions in stroke and bleeding were around 80% in the stroke group and 62% in the control non-prior stroke group.

Conclusion: The researchers wrote: “The combination of catheter ablation and LAAC (Left Atrial Appendage Closure) is safe and effective in selected AF patients with prior stroke.”

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

There are several limitations to this study. This is a single-center retrospective study with a moderate sample size.
Despite the limitations of this study, for A-Fib patients the combination of catheter ablation and Left Atrial Appendage (LAA) closure appears safe and effective.

Currently, U.S. patients have to wait 3 months after a catheter ablation to have a Watchman inserted. Why must patients wait, why endure months of anticoagulants usage? But, more research is needed to confirm the conclusions of these researchers.

Reference
Mo, B et al. Combined Catheter Ablation and Left Atrial Appendage Closure in Atrial Fibrillation Patients with and without Prior Stroke. Journal of Interventional Cardiology, Volume 2021, Article ID 2138670. https://www.hindawi.com/journals/jitc/2021/2138670/ https://doi.org/10.1155/2021/2138670

 

AF 2022 Symposium: Pulsed Field Ablation—Integrated Mapping-Ablation Spherical Array Catheter for A-Fib

2022 AF Symposium

Pulsed Field Ablation for AF Using an Integrated Mapping and Ablation Spherical Array Catheter

Note: This was a very early, first-in-human use of this Spherical Array PFA catheter not yet approved by the FDA
Dr. Vivek Reddy, Mt Siani Hospital

Dr Vivek Reddy

Dr. Vivek Reddy from Mount Sinai Medical Center in New York City, NY and Dr. Petr Neuzil of Homolka Hospital, Prague, Czech Republic presented a pre-recorded case on “Pulsed Field Ablation for AF Using an Integrated Mapping and Ablation Spherical Array Catheter.”

The patient was a 31-year-old male diagnosed with paroxysmal A-Fib in 2020. His left atrium diameter measured 39 mm (normal size). His Ejection Fraction was 65% (normal). His CHA2DS2-VASc score was zero.

Innovative Spherical Array

Dr. Reddy showed a fascinating demo of how the spherical PFA catheter emerged from the catheter sheath and formed itself into a spherical array, then locked itself into shape. It was like watching a magic trick. How could they design a catheter sheath from which would emerge a complex spherical shaped catheter that would come together so smoothly? Kudos to whomever designed this innovative system (Kardium Globe).

How the Spherical Array Catheter Works

Once fully deployed, the spherical PFA catheter has a diameter of 30 mm. It contains 122 gold-plated electrodes on 16 splines around the sphere. Behind each electrode is a thermocouple to measure heat. (The system was originally designed for RF ablation. But this spherical catheter was not irrigated.) Because of the high number of electrodes, it also  produces high quality 3D activation maps of the left atrium. It can also be used for pacing.

Spiral Array Catheter at opening to Pulmonary Vein

As we watched, Dr. Reddy easily rotated and moved the Spherical Array catheter. It can map and ablate anywhere is the left atrium and produce continuous lesions. It doesn’t have to be manipulated as much as a point-by-point RF catheter. The next generation catheter will be smaller.

The system is bi-polar and biphasic in that the PFA signal is delivered using an electrode on one spline along with another electrode on an adjacent spline. Usually, Dr. Reddy said, he only required a 3-second PFA ablation to isolate a PV.

They used general anesthesia, but acknowledged that this system could work under simple conscious  sedation.

Single-Shot, Omni-Directional, Needs Tissue Contact

Dr. Reddy described it as a single shot system in that one PFA application should isolate an area. It is omni-directional in that the sphere can be positioned in any direction as long as there is contact, and the sphere is touching tissue. The system seemed to easily produce a voltage map of the left atrium. The system uses GPS 3D navigation and mapping to track the precise location of the Globe catheter inside the atrium.

“Flow” and “Contact” Mapping: Where to Apply the PFA Pulse

Dr. Reddy described the system as using two types of contact mapping: “Flow” Map and “Contact” Mapping.

The Flow Map gets contact info relatively fast by sensing how quickly the electrodes cool when electricity is applied to them, while Contact Mapping takes 10-15 seconds and calculates how high the temperature rises. If it touches tissue, the temperature should become higher. “Contact” mapping provides more high-fidelity info than “Flow” mapping.

Click image to see Spiral Array catheter open

Dr. Reddy would use both systems one after the other to determine where the actual PFA pulse should be applied. Dr. Reddy said that the Spherical Array catheter is in one sense a large focal catheter while also more forgiving in terms of precise positioning. When a green area appeared, this meant contact. While white represented areas not yet ablated. Blue areas represented completed PFA lesions.

We watched as the PVs were isolated. He showed both pre and post voltage maps side-by-side to document that the PVs were isolated. Some microbubbles were produced, but previous RF ablations using this system didn’t produce any problems. Dr. Reddy said that they haven’t seen any reconnection. In this case they only isolated the PVs and made no attempt to isolate the posterior left atrium wall or other areas of the heart.

Removing the Spherical Array Catheter

At the end we watched as Dr. Reddy forced the catheter shaft back over the Spherical Array which collapsed back into a linear form and was easily removed (another fascinating technical achievement).

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

Though this Spherical Array catheter is in very early stages of development, it seems to me to have the potential to challenge current leaders in the PFA field.
A streaming video-on-demand of Dr. Reddy’s case and presentation is available at https://player.vimeo.com/video/676797282. 28:48 min. (Published by the 2022 AF Symposium.)

2022 AF Symposium: Pulsed Field Ablation Using a Focal Electrode Catheter

I’ve written a new report from the 2022 AF Symposium. The presentation included a video of the speaker performing the Pulsed Field Ablation. Note: PFA is not yet approved by the FDA, but is in clinical trials.

Dr. Atul Verma of Southlake Regional Health Center in Toronto, Canada presented his talk in a somewhat unusual format. He showed a pre-recorded case of him performing a Pulsed Field Ablation (PFA). Then while the video was playing, he would lower the volume and comment live to the audience. Several panelists and audience members also joined in offering comments during his presentation.

The Patient: Was in early persistent A-Fib, with a normal heart and normal-sized atrium. The goal was to isolate the patient’s Pulmonary Veins (PVs) and posterior wall using Pulsed Field Ablation (PFA).

The Ablation System: Dr. Verma performed an ablation of a patient using the Galaxy Centauri system. The Galaxy system allows EPs to use the same focal catheters and mapping systems they now use when they ablate using point-by-point Radio Frequency (RF) energy However, the Centauri generator produces PFA pulses instead of RF.

On the video, when Dr. Verma would make a point-by-point dot lesion using PFA…to continue reading my report. go to: Pulsed Field Ablation Using a Focal Electrode Catheter by Dr. Atul Verma.

For the background, concepts and treatment strategies associated with the evolving technology of Pulsed Field Ablation, see my 2020 AF Symposium report: Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.

2022 AF Symposium: Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story

2022 AF Symposium

Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story

Luigi Di Biase MD

Dr. Luigi Di Biase of the Albert Einstein College of Medicine, Bronx, NY gave a presentation on “Peri and Post Procedural Anticoagulation with LAA Closure Devices―An Evolving Story”

Watchman Device Anticoagulation Protocol

The Watchman occlusion device to close off the Left Atrial Appendage (LAA) of Atrial Fibrillation patients was FDA approved in 2015 (PROTECT AF and PREVAIL clinical studies).

For how the LAA is closed off watch the VIDEO: Placement of the Watchman FLX™ Left Atrial Appendage Closure Device.

Dr. Di Biase explained how the standard anticoagulation protocol to prevent stroke after implementation was warfarin for 45 days followed by Dual Antiplatelet Therapy (DAPT) for six months. (DAPT combines aspirin with clopidogrel.) Then the patient was on aspirin for life.

NOACs (DOACs) Have Replaced Warfarin

In common practice today, NOACs (DOACs) (Direct Oral Anticoagulants) have replaced warfarin post-op. However, there are concerns about the DAPT protocol.

Dr. Di Biase gave the example of a patient who experienced a GI bleed 2 months after switching from a NOAC to the DAPT protocol (clopidogrel/aspirin). DAPT therapy may carry bleeding risks while providing sub-optimal stroke prevention. Genetic abnormalities may affect the efficacy of clopidogrel in as many as 25% of patients.

DRT (Device Related Thrombus) can occur in 3%-4% of cases. “In our opinion, DRT is more common with DAPT when compared to low dose NOAC.”

Low Dose NOAC Possibly Safer Than Aspirin For Life

He also pointed out that “in some cases, we feel low dose NOAC is safer than aspirin for life.”

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

What does this means for patients receiving the Watchman? Instead of switching to clopidogrel/aspirin after 45 days post-op, we can stay on uninterrupted NOAC but at low dose with lower risk of bleeding and better results.
This makes the installation of the Watchman device safer and more effective (it was remarkably effective before this).

If you find any errors on this page, email us. Y Last updated: Wednesday, February 23, 2022

Return to 2022 AF Symposium Reports

2022 AF Symposium Spotlight: Calculating Left Atrium Wall Thickness

2022 AF Symposium

Spotlight Sessions: These feature products or devices still in development or not yet FDA approved. They give us a glimpse into what the future of A-Fib treatment may look like. This year 17 Spotlight products and treatments were presented in 5 minute talks.

Spotlight Session: Calculating Left Atrium Wall Thickness

Dr. Saman Nazarian

In this session Dr. Saman Nazarian of the University of Pennsylvania in Philadelphia, PA presented on “Personalization AF Ablation Based on CT Wall Thickness” by the company Circle Cardiovascular Imaging. [CT stands for Computerized Tomography.]

Left Atrium Wall Thickness: The left atrium wall thickness varies from 1 mm to over 5 mm in the roof area. If one applies too much RF ablation power to a thin wall, this can produce steam pops, esophagus damage, or phrenic nerve damage. If too little RF energy is applied to thicker left atrium wall areas, this can lead to Pulmonary Veins (PV) reconnection.

 Measuring Wall Thickness: Using Computed Tomography (CT) to measure atrium wall thickness, Circle Cardiovascular Imaging, Inc. proposes to “ablate by LAW” (Left Atrium Wall thickness).

It uses computed tomography to measure wall thickness, segmentation, and calculates the distance between endo and epicardial layers.

These measurements can be incorporated into mapping systems. An ablation index value is developed based on Left Atrial wall thickness. The proper amount of RF energy can than be applied to various parts of the left atrium.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

The concept of measuring left atrium wall thickness certainly seems like an improvement in RF catheter ablation.

But looking to new developments, one wonders if or how it would apply to Pulsed Field Ablation―the future of A-Fib catheter ablation.

If you find any errors on this page, email us. Y Last updated: Tuesday, February 22, 2022

Return to 2022 AF Symposium Reports

2022 AF Symposium: Pulsed Field Ablation Systems

At A-Fib.com, we first described the new technology called Pulsed Field Ablation (Farapulse, Inc.) in the beginning of 2021. See my report: Pulse Field Ablation—Emerging Tech for Atrial Fibrillation. Since then, Farapulse, Inc. has been acquired by Boston Scientific.

Today many companies with different Pulse Field Ablation systems have entered the market. All are still in various stages of investigation, none have been FDA approved.

In my report, In Development: Systems for Pulsed Field Ablation (PFA), I summarize comments by Dr. Moussa Mansour of Massachusetts General Hospital in Boston, MA, in his presentation, “Technology and Regulatory Status of Current Systems for Pulsed Field Ablation (PFA).”

He gave an overview of the various companies and their PFA systems in development and in clinical trials. You’ll find my 2022 AF Symposium report here: Pulsed Field Ablation. You can also see my other reports at 2022 AF Symposium.

2022 AF Symposium: Pulsed Field Ablation Using a Focal Electrode Catheter by Dr. Atul Verma

2022 AF Symposium

Pulsed Field Ablation Using a Focal Electrode Catheter by Dr. Atul Verma

Note: Pulsed Field Ablation (PFA) is not yet approved by the FDA; Clinical trials are underway.

Dr. Atul Verma of Southlake Regional Health Center in Toronto, Canada presented his talk in a somewhat unusual format. He showed a pre-recorded case of him performing a Pulsed Field Ablation (PFA). Then while the video was playing, he would lower the volume and comment live to the audience. Several panelists and audience members also joined in offering comments during his presentation.

PFA with the Galaxy Centauri System

Dr Atul Verma

Dr Atul Verma

Dr. Verma performed an ablation of a patient using the Galaxy Centauri system. The Galaxy system allows EPs to use the same focal catheters and mapping systems they now use when they ablate using point-by-point Radio Frequency (RF) energy However, the Centauri generator produces PFA pulses instead of RF.

Pulsed Field Ablation (PFA) is not yet approved by the FDA; Clinical trials are underway.

The Patient: Was in early persistent A-Fib, with a normal heart and normal-sized atrium.

Dr. Verma’s goal was to isolate the patient’s Pulmonary Veins (PVs) and posterior wall using Pulsed Field Ablation (PFA).

Equipment: He used a standard Carto system and a SMARTTOUCH irrigated catheter to apply the PFA pulses. He also used an irrigated tip catheter (though as he and other panelists acknowledged, Pulsed Field Ablation may not need irrigated catheters). He also used atrial pacing to make sure the patient’s heart rate stayed over 50.

Video of the PFA

On the video, when Dr. Verma would make a point-by-point dot lesion using PFA, the catheter would disappear from the screen but would come back later. He explained that his current Carto system wasn’t designed to handle very large PFA pulses going through the catheter creating an error.

As with RF lesions, dots would appear where a PFA pulse was applied. Dr. Verma stated that, as with RF, the dots do need to be contiguous to avoid gaps.

Dosage: The Galaxy Centauri system can adjust the dose based on patient response (titrate). Medium dosage was 22 amps, high 25 amps. Dr. Verma used the medium dosage on the posterior wall which is thinner. Commenting from the panel, Dr. Vivek Reddy thought the high PFA dosage could be used all the time.

The PFA pulses didn’t create thermal damage, eliminating the danger of the dreaded atrial esophageal fistula.

Esophagus Temperature: We watched the video as Dr. Verma positioned the PFA catheter directly over the esophagus and applied high power PFA signals. The temperature in the esophagus before the ablation was 34.7°C and was the exact same temperature after the PFA pulses were applied―demonstrating how safe PFA ablation is.

The PFA pulses obviously didn’t create thermal damage to the esophagus, thereby eliminating the danger of the dreaded atrial esophageal fistula. He also showed ablating the carina ridge area where he used greater contact force and more power.

Dr. Verma then used a Lasso catheter to make sure the Pulmonary Veins (PVs) were isolated. Then he disconnected the Lasso catheter to prevent what he called possible “arcing”.

Procedure Duration: Dr. Verma completed the PFA ablation in 1½ hours which included a 20-minute waiting period.

Experts Panel Discussion

Barium Paste in Esophagus: Dr. Verma raised eyebrows among the panelists when he stated that he used barium paste in the esophagus to better locate and map it.

Dr. Hugh Calkins pointed out that in the past barium paste was aspirated into the lungs and now isn’t used much today. However, Dr. Verma mentioned that he was only using 5 cc of barium, and that this does not affect the lungs at all. Other panelists said that one of the big advantages of PFA is it is unlikely to damage the esophagus, thereby rendering Barium paste unnecessary.

Skeletal Muscle Stimulation: Dr. Verma expressed concern about stimulating skeletal muscle (the vertebrate muscle system) which he avoided by using bi-phasic PFA delivery, breaking PFA pulses into different packets, using a narrower PFA pulse width, and optimizing the PFA wave form. This also avoided generating microbubbles and prevented thermal reaction (heat damage).  

PFA and Coughing: Dr. Verma also described another occurrence which other panelists have noticed as well―patient coughing. Does PFA generate coughing? He asked the panel and attendees if this coughing during PFA comes from J receptors in the PVs or from the bronchi? Can or should this coughing be eliminated by more sedation or by pulling the catheter back? Dr. Andrea Natale suggested that, with PFA, general anesthesia isn’t needed.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

The Galaxy Centauri ablation system is probably not ready for prime time yet. Who would want to go back to having to use point-by-point ablation?
Most of the other PFA systems in development don’t need to use point-by-point ablation. They are faster, easier to use, more efficient and safer. However, the Galaxy system is undergoing further refinement, and this is an early concept.
Most labs and EPs would want to use the new catheters with an ablation system designed for PFA, not their traditional catheters. But there are some labs where minimal investment in new systems to get PFA may be an advantage, particularly outside the U.S. to get PFA may be an advantage, particularly outside the U.S.
One approved by the FDA, I expect PFA will change the way catheter ablations are done and will become an innovative and most effective treatment option for A-Fib patients.
We are grateful to both Dr. Verma and to all the other doctors for their creativity and hard work toward development of Pulsed Field Ablation systems.

For the background, concepts and treatment strategies associated with the evolving technology of Pulsed Field Ablation, see my 2020 AF Symposium report: Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.

If you find any errors on this page, email us. Y Last updated: Tuesday, February 22, 2022

Return to 2022 AF Symposium Reports

See all my reports at: 2022 AF Symposium.

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