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AF Symposium & other medical conferences articles

2020 AF Symposium: Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation

2020 AF Symposium

Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation

by Steve S. Ryan

This article on Pulsed Field Ablation (PFA) may be challenging to read. But it’s worth it. As an emerging technology, there are many concepts and treatment strategies that will be brand new to you (they were for me). I expect PFA will change the way catheter ablations are done and will become an innovative and most effective treatment option for A-Fib.

The video presentations at the AF Symposium are always well attended. Usually these cases are presented live via streaming video. But this time the case was a pre-recorded video.

This emerging technology, Pulsed Field Ablation, and how it works was presented on video by Dr. Vivek Reddy from Mount Sinai Medical Center in New York City and Dr. Petr Neuzil from Homolka Hospital in Prague, Czech Republic.

Dr. Reddy provided live commentary from the podium while the recently recorded patient procedure played on the screen behind him.

Pulsed Field Ablation (PFA) and Electroporation

Pulsed Field Ablation (PFA) from Farapulse, Inc. creates an instantaneous electrical field to open tiny doors (nanopores) in nearby cells, a process called ‘electroporation’ (electro-POR-ation).

Electroporation is a microbiology technique in which an electrical field is applied to cells in order to increase the permeability of the cell membrane.
Shortly thereafter, the contents of the cell exit through these doors and the cell dies.

Unlike current methods of ablation (i.e., radiofrequency and cryo) which rely on cooking or freezing tissue, PFA retains the cell’s original structure even after death and does not rely on thermal effects.

More importantly, PFA works on the selected cell types while leaving others alone.

Video Presentation: Pulsed Field Ablation Case

On the video, we saw Dr. Reddy use fluoroscopy to move the Farapulse catheter (Farawave) to the opening of the Left Superior Vein, a position similar to where one would place a balloon catheter.

Farapulse Five Petal Flower at A-Fib.com

Farapulse catheter: Five Petal Flower Configuration

The configuration of the catheter looked like a flat five-petal flower. He was also able to change the configuration to a more spherical “basket” shape. Each of the five splines contained four separate electrodes which delivered the PFA energy. The fully deployed flower-shaped configuration had a diameter of 31 mm.

Those same electrodes that delivered the PFA energy also recorded signals from the heart to show that the ablation was effective. They could switch back and forth during the ablation procedure.

Direct Contact Not Necessary

We watched how they delivered one application of PFA, then 10 seconds later they rotated the five-spline catheter a few degrees and delivered another application to optimize coverage and proximity.

Farapulse catheter: Open-Basket Configuration at A-Fib.com

Farapulse catheter: Open-Basket Configuration

Dr. Reddy explained that they perform two paired deliveries with the basket configuration, then two more with the flower configuration with occasional rotation of the catheter. They didn’t seem to worry about achieving direct, hard contact with the Pulmonary Vein (PV) openings.

Someone from the audience asked, “How much contact do you need?” Dr. Reddy replied, “You definitely need proximity. Do you actually need  contact? No. But you need proximity, to be within a couple of millimeters of the targeted tissue.”… “We’re not going to cause PV stenosis with this.”

We saw how the electrograms of A-Fib signals disappeared as the PFA applications progressed. The application process seemed to move very fast. Dr. Reddy stated that he could vary the size and shape of the configurations to fit individual anatomies.

Affects Heart Tissue but Not the Esophagus

Dr. Reddy added (enthusiastically),“What is really exciting about it is tissue selectivity.” He talked about how each tissue seems to have a different threshold for necrosis (cell death) which makes PFA very tissue selective.

PFA can affect heart tissue (cardiomyocytes) while not affecting nerve fibers or the esophagus. We watched as he ablated the Right Superior PV which seemed very close to the Phrenic Nerve. Dr. Reddy described how in 120 cases to date, he has never seen Phrenic Nerve paralysis or even palsy.

Left-RF ablation with damaged Esophagus; Center-CryoBalloon ablation with damaged Esophagus; Right-Pulse Field ablation with Normal Esophagus. Source: Dr. Vivek Reddy

Posterior Wall Ablation

Using the flower configuration, Dr. Reddy then ablated the posterior wall by simply making overlapping flower-shaped petal lesions, two sets of lesions in each location. This also seemed to go very fast.

Cavo-Tricuspid Isthmus Line

He also showed how he made a Cavo-Tricuspid Isthmus line (to ablate Flutter from the right atrium) by switching to a catheter with a small basket used as a focal catheter.

After the video ended, Dr. Reddy said they have already performed 126+ ablations using PFA. (Certainly seems ready for ‘prime time’.)

Characteristics of Pulsed Field Ablation (PFA)

Tissue Selective and Safer

The underlying process of Pulsed Field Ablation called “Irreversible Electroporation” is tissue selective. Cardiomyocytes (heart tissue) happen to have a particularly low threshold to these electrical fields which don’t affect other surrounding non-heart tissue such as the esophagus or phrenic nerve. In practical terms, this means that PFA is much safer than current ablation energy sources.

Very Fast and Precise

Pulsed Field Ablation is a non-thermal energy system that uses a series of ultra-short electrical pulses to ablate heart tissue. This series of pulses, or the “waveform”, makes a long-lasting lesion in a manner of seconds. PFA can be  delivered in seconds or minutes compared with hours for radiofrequency.

PFA is not only very fast but very precise as well. The Farapulse generator, which creates the waveform, can be programmed to deliver therapy through different PFA catheters.

Doesn’t Require Direct Contact

PFA catheter does not require actual physical contact but only needs proximity to the tissue.

Unlike standard ablation energy sources such as RF (heat) and Cryo (freezing), the PFA catheter does not require actual physical contact but only needs proximity to the tissue to be ablated. And it doesn’t cause scarring or char formation.

Doesn’t Produce Stenosis

Clinical trials have shown that direct application of PFA to pulmonary veins does not seem to result in PV stenosis (swelling) which can occur from heating (RF) or cooling (cryo).

FDA ‘Breakthrough Device’ Designation for PFA

U.S. Food and Drug Administration logoThe FDA gave PFA (Farapulse, Inc.) their Breakthrough Device designation May 8, 2019. This FDA Program is designed to “help patients receive more timely access to breakthrough technology which has the potential to provide more effective treatment and diagnosis for life-threatening or irreversibly debilitating diseases and  conditions.”

Translation: The FDA recognized how PFA can potentially change the nature of catheter ablation and become a major innovative improvement in the treatment of patients with A-Fib.

PFA Ablation: A Few Years Away for A-Fib Patients

As Dr. Jais and others commented at the end of the presentation, it will probably take 3-5 years for PFA to be available for A-Fib patients worldwide.

Assuming eventual FDA approval (very likely), the small start-up company Farapulse, Inc. will probably have to be bought by a major device manufacturer with a world-wide manufacturing, marketing and distribution network. That’s probably the only way to produce and distribute the Farapulse Pulsed Electrical Field generators in quantities sufficient to treat large numbers of A-Fib patients.

Disclosure: Dr. Vivek Reddy of Mount Sinai Medical Center in New York city has invested in and owns stock in Farapulse, Inc. This is an indication of the confidence he has in PFA technology.

Editor’s Comments

Note: All forward-looking statements and claims regarding safety and effectiveness are those of the author alone.
PFA Ablation: A True Game Changer: Everyone at the AF Symposium was in awe at how fast, easy and effective PFA ablation seemed to be.
I predict that Pulsed Field Ablation will supersede all other types of catheter ablation for A-Fib. But it will probably take 3-5 years for PFA ablation to become standard and available for most A-Fib  patients.
But Don’t Wait for PFA: If you are asking yourself if you should wait 3-5 years for PFA ablation to be available, the answer is no. Today’s ablation techniques are very good and effective, though not apparently as good as PFA. And waiting 3-5 years for an ablation could do serious harm to your heart.
In fact, read about my second Ablation in 2019, 20 years after the first.
Thanks to Farapulse, Inc who provided technical content and images for this report. For anyone interested in investing in PFA and Farapulse, Inc., it’s a privately held company with no stock currently available.

Read More About Pulsed Field Ablations (PFA)

See my summaries of five abstracts (one-page descriptions of A-Fib research) distributed at the Symposium as a printed digest.

• Lesion Durability and Safety Outcomes of Pulsed Field Ablation

• Pulsed Field Ablation with CTI Lesions Terminates Flutter in a Small Study

• Durability of Pulsed Field Ablation Isolation Over Time: Preliminary Study

• Pulsed Field Ablation vs RF Ablation: A Study in Swine 

• Using MRI to Check Pulsed Field Ablations (PFA)

If you find any errors on this page, email us. Y Last updated: Saturday, May 2, 2020

Return to 2020 AF Symposium Reports

AF Symposium 2020: My New A-Fib Reports

This year the 25th AF Symposium was held January 23-25th in Washington DC (for this fellow from Malibu it was cold but no snow ).

Atrial Fibrillation: I attended over 75 presentations including Spotlight (short) sessions, learning luncheons and panel discussions with Q/A. The Symposium lets me learn about advances in research and treatments of A-Fib directly from the most eminent medical researchers, scientists, cardiologists and cardiac electrophysiologists.

There are many interesting topics including the controversy of closure of the Left Atrial Appendage. But the many presentations about the new “Pulsed Field Ablation” technology dominated the Symposium.

Read My First Report: Overview: The 25th Annual International AF Symposium 2020 by Steve S. Ryan, PhD

Steve Ryan at 2020 AF Symposium in Washington DC in January.

Steve Ryan at 2020 AF Symposium in Wash, DC.

More reports are coming: I’ve finished a number of my summary reports and will be posting several each week.

Check the menu list on the left for 2020 AF Symposium and click to go to my latest posts.

Remember: All my reports are written in plain language for A-Fib patients and their families. (I’ve done the heavy lifting for you!)

P.S. You may want to browse my reports from the 2019 AF Symposium or the archive to my AF Symposiums Summaries by Year.

2020 AF Symposium: Reports for Patients by Steve S. Ryan, PhD

AF Symposium 2020

My Summary Reports Written for A-Fib Patients

by Steve S. Ryan, PhD

Now in its 25th year, the annual AF Symposium is one of the most important scientific conferences on A-Fib in the world. (I attended my first AF Symposium in 2003.)

Each year at the Symposium, I learn about advances in research and treatments directly from the most eminent medical researchers, scientists, cardiologists and cardiac electrophysiologists. 

As always, I do this to offer A-Fib.com readers the most up-to-date research and developments that may impact their treatment choices.

All my reports are written in plain language for A-Fib patients and their families.

REPORT TITLE PRESENTER (S) DATE POSTED
20. Challenging Case: 75-Year-Old, A-Fib Increases, Develops Bradycardia, 12-sec Heart Pause Dr. Eric Prystowsky, St. Vincent Hospital, Indianapolis, IN May 2,2020
19. Abstract: Combination Device to Both Electrically Isolate and Occlude the Left Atrial Appendage (LAA) John Thompson, MD, MBA, MSC AuriGen Medical May 1, 2020
18. Abstract: High Hemorrhagic Risk Factors from NOACs Massachusetts General Hospital May 1, 2020
17. Terminate Persistent A-Fib by Ablating Higher Frequency Modulation Areas Dr. Jose Jalife, University of Michigan, Ann Arbor, MI May 1, 2020
16. Protecting the Esophagus by Cooling It Dr. Mark Gallagher from St. George’s University Hospital in London, United Kingdom April 28, 2020
15. For A-Fib Patients Under Age 40: Genetic Testing Before Your Catheter Ablation? Dr. Patrick Ellinor of Massachusetts General Hospital April 28, 2020
14. After Diagnosis, How Soon Should an A-Fib Patient Get an Ablation? Dr. Karl-Heinz Kuck of St. Georg Hospital in Hamburg, Germany April 28, 2020
13. Virtual Heart” Assists Actual Ablations Prof. Natalia Trayanova of Johns Hopkins Un. in Baltimore, MD. April 26, 2020
12. Device-Detected AF and Stroke Risk as a Function of AF Burden-Clinical Implications  Dr. Daniel Singer, Massachusetts General Hospital in Boston, MA April 26, 2020
11. Live Case: LAA Closure with New  Watchman FLX Dr. John Foran, Royal Brompton Hospital in London, UK April 24, 2020
10. Live Case: Convergent AF Ablation Drs. Andrew Makati and Andrew Sherman, St. Joseph’s Hospital, Tampa, FL April 22, 2020
9. Live Case: Ultra-Low Temperature Cryoablation Dr. Tom De Potter, OLV Hospital, Aalst, Belgium April 21, 2020
8. PFA Abstract:
Lesion Durability and Safety Outcomes of Pulsed Field Ablation 
Dr. Vivek Reddy, Mount Sinai Medical Center, New York City April 17, 2020
7. PFA Abstract:
Pulsed Field Ablation with CTI Lesions Terminates Flutter in a Small Study
Dr. Ante Anic, University Hospital Center Split, Croatia April 17, 2020
6. PFA Abstract:
Durability of Pulsed Field Ablation Isolation Over Time: Preliminary Study 
Researchers at Mount Sinai Hospital in New York April 17, 2020
5. PFA Abstract:
Pulsed Field Ablation vs RF Ablation: A Study in Swine
Dr. Jacob Koruth, Mount Sinai Medical Center, New York City April 17, 2020
4. PFA Abstract:
Using MRI to Check Pulsed Field Ablations (PFA)
The French Bordeaux Group April 17, 2020
3. Live Case: Difficult A-Fib Ablation of Atypical Flutter Dr. Kevin Heist from Massachusetts General Hospital April 10, 2020
2. Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation Dr. Vivek Reddy, Mount Sinai Medical Center, New York City, USA; Dr. Petr Neuzil, Homolka Hospital in Prague, Czech Republic. April 6, 2020
1. Overview: The 25th Annual International AF Symposium 2020 by Steve S. Ryan, PhD – – – March 2020
Archive: Link to all my AF Symposiums Summaries by Year

J. Ruskin

“Steve Ryan’s summaries of the A-Fib Symposium are terrific. Steve has the ability to synthesize and communicate accurately in clear and simple terms the essence of complex subjects. This is an exceptional skill and a great service to patients with atrial fibrillation.” — Dr. Jeremy Ruskin of Mass. General Hospital and Harvard Medical School

If you find any errors on this page, email us. Y Last updated: Saturday, May 2, 2020

Overview of the 2020 International AF Symposium

By Steve S. Ryan, PhD, March 2020

The attendance at the 25th Annual AF Symposium seemed much higher than that of last year in Florida. Perhaps being in Washington, DC made it easier for people to attend.

The weather was chilly, but no snow. There was some rain on Saturday.

Conference Venue: Gaylord National Hotel

Gaylord National Hotel, atrium; Wash DC

The Gaylord National Hotel (actually located in Maryland) was a great venue. It featured an incredible Atrium covered lobby with plants and walkways which felt like you were outside. It had a comfortable and friendly feeling. There were plenty of shops and restaurants (and bathrooms!) But it was quite a distance from the Washington DC airports with no hotel shuttle service.

The exhibit area was right next to the presentation hall which saved a lot of walking time and facilitated interaction with the exhibitors.

The General Mood

As the Symposium progressed, it began to feel like we were entering a new era of A-Fib treatment (i.e. Pulsed Field Ablation!). One could feel the excitement in the air.

Most Talked About

The most talked about topic was the new ablation treatment called Pulsed Field Ablation (PFA) by Farapulse, Inc.

Regarding PFA:“Both the efficacy and the safety…are significantly superior to the current standard of RF or cryo.” – Dr. Pierre Jais, Bordeaux University Hospital (Bordeaux, France)

There were three Pulsed Field Ablation (PFA) presentations, one pre-recorded patient case, and a special luncheon at the product theater that was packed (I couldn’t get a seat and missed some of the speakers’ talks.)

In addition, there were five abstracts on PFA included in the 53 presented in the AF Symposium brochure. There were so many presentations and so much attention on Pulse Field Ablation/Electroporation (PFA) that it justifiably dominated the Symposium.

Another important topic was Left Atrial Appendage closure (seven presentations).

A-Fib Experts’ Presentations, Discussions and Q&A

There were 72+ different talks presented over the  course of the 3-day AF Symposium. All talks were 10 minutes long with time for audience Question & Answer and discussion. The exceptions were the live cases which were usually 30 minutes and the Spotlight Session talks which were 5 minutes long. (As far as I could tell, not one presenter went over their minute limit.)

Each topic was moderated by leaders in the A-Fib field. Speakers included 2 representatives from the FDA.

As in previous Symposiums, attendees were given the opportunity to interact and answer questions posed by the presenters, this time via text. But the response by cell phone text was so poor that by the end presenters were just asking for a show of hands in response to their questions.

Spotlight Sessions, Lunchtime Learning and Late Breaking Clinical Trials

In addition to the scheduled talks, the AF Symposium featured 17 short talks on new and innovative technologies (14 on devices, 2 on drugs, and 1 on FDA approaches). These Spotlight Sessions were exciting and all too brief. (Last year there were 8 of these Spotlight Sessions, indicating how rapidly innovation and interest in the A-Fib field are progressing.)

There were two lunchtime learning sessions (not part of the official CME presentations). The first was on Pulsed Field Ablation and was so crowded that I couldn’t get in at first and missed part of the talk. The second was on Optimizing AF Management.

The last session of Friday featured Late Breaking Clinical Trials and First Report Clinical Investigations. One of the great things the AF Symposium does is include in their brochure abstracts of studies and clinical trials that are or could be important to the A-Fib field.

There were 53 such studies this year. Many of these studies were also presented in posters hung up just outside the presentation area.

Sponsored Sessions

I was surprised that there were two sponsored sessions, one by Abbott focused primarily on their HD Grid and the second by Biosense-Webster which was more broadly focused but featured their mapping system. Both were non-CME because of their sponsorship.

I frankly don’t know what to make of sponsors determining or so heavily influencing presentations, even if they are listed as non-CME. One presenter in particular seemed to go slavishly overboard in promoting a particular mapping system (it was embarrassing listening to this person).

Worldwide Live Patient Cases Via Streaming Video

The live cases sessions were again worth the price of admission and were the most well attended. We observed six live and one pre-taped presentation from:

• Royal Brompton Hospital, London, United Kingdom
• OLV Hospital, Aaist, Belgium
• Oxford University Hospitals, Oxford, United Kingdom
• St. Joseph’s Hospital, Tampa, Florida
• Texas Cardiac Arrhythmia Institute, Austin, Texas
• Massachusetts General, Boston, MA
• Homolka Hospital, Prague, Czech Republic and Mount Sinai Medical Center, New York, NY (pre-recorded)

I was amazed at how they were able to switch back and forth between various centers and overcome the inevitable technical challenges involving so many live presentations from around the world. In addition to the invaluable content, the technical achievement of so many live presentations was really impressive.

Talks on Left Atrial Appendage (LAA) Closure

There were six talks and one Live Case presentation on closing off the Left Atrial Appendage (LAA).

I was surprised that there was very little discussion of the functions of the LAA and whether or not it should be closed off in the first place.

In this context, Dr. Jais from the Bordeaux Group made what was probably the most important, quotable statement in the AF Symposium:

“We have ablated too much…Those patients when they have the (Left Atrial) Appendage taken out, they have very poor residual LA (Left Atrium) function. I don’t want that to happen anymore. If we can avoid it, I think we should.”

Dr. Jais later added:

“Sinus rhythm is by definition superior to persistent A-Fib. But the best ablation strategy is the one that restores sinus rhythm at the least tissue cost, thereby preserving as much as possible the LA function.”

Editor’s comment: Personally, even though I’m old (79 years young), I would not give up my LAA without a fight! I enjoy running/sprinting too much, especially in Masters Track Meets. I need all the heart pumping ability my heart can deliver. Read more at LAA Role and Removal Issues.

Daily Schedule: Topics Discussed

Thursday, January 23

♥ Risk Factors for Atrial Fibrillation – Pathophysiology, Clinical Impact and Therapeutic Strategies (4 talks)
♥ Spotlight Session: Early Stage and Emerging New Technologies and Drugs in Cardiac EP (17 talks)
♥ Abbott sponsored presentations, (non-CME). Novel Techniques and Technologies for Catheter Ablation of AF (6 talks)
♥ Stroke Prevention in AF: Session I – Screening and Anticoagulation (5 talks)
♥ Stroke Prevention in AF: Session II – Left Atrial Appendage Closure and Carotid Protection (4 talks). This session also included a 30 minute Live Case presentation featuring the real time installation of the Watchman FLX.
♥ Stroke Prevention in AF: Session II – Left Atrial Appendage Closure (Continued) (3 talks)

Friday, January 24

♥ Real-Time Case Transmissions: New Directions in Imaging, Mapping and Ablation – Panel and Audience Discussions (All Cases 30 Minutes). (The most well attended session.) (3 presentations)
♥ Real-Time Case Transmissions: New Directions in Imaging, Mapping and Ablation – Panel & Audience Discussions (cont.) (2 live cases, 1 pre-recorded)
♥ Biosense Webster sponsored presentations, (non-CME), State of the Art in Advanced Mapping and Catheter Ablation for AF: Improving Efficacy and Efficiency (4 talks)
♥ Advances in Pulmonary Vein Isolation (Session I) (7 talks)
♥ Advances in Pulmonary Vein Isolation (Session II) (Pulsed Field Ablation) (3 talks)
♥ Late Breaking Clinical Trials and First Report Clinical Investigations
♥ Best Abstract Award and Presentation

Saturday, January 25

♥ Beyond PVI – Anatomical vs Electrophysiological Targets for AF Ablation (Session I) (6 talks)
♥ Beyond PVI – Anatomical vs Electrophysiological Targets for AF Ablation (Session II) (3 talks)
♥ Improving the Safety, Effectiveness and Efficiency of AF Ablation (2 talks)
♥ Outcome Trials in Atrial Fibrillation Ablation (6 talks)
♥ Challenging Cases in AF Management: Anticoagulation, Arrhythmic Drugs and Catheter Ablation for AF (5 case presenters)

Why I Attend: Expect My Reports

I’ve been attending the AF Symposium for 16 years. This year’s presentations were some of the best, most exciting I’ve experienced, especially on Pulse Field Ablation. The AF Symposium provides info and discussions on A-Fib unlike any other conferences.

It’s a privilege to be able to attend presentations by the best clinicians and researchers working in A-Fib today. I learn more in three days than in a year of reading the various A-Fib research reports.

I’m especially blessed by being able to ask questions of the presenters and converse one-to-one with them. (I especially admire their patience when answering some of my questions.)

More to Come

Look for more of my reports from the 2020 AF Symposium in the next weeks and months. I will share the current state of the art in A-Fib research and treatments and what’s relevant to patients with Atrial Fibrillation.

And, as always, my reports will be written in plain language for A-Fib patients and their families.

P.S. WhY the Short List of Reports for 2019 AF Symposium

You may have noted the short number of reports for the 2019 AF Symposium. I apologize for not writing very many reports on last year’s AF Symposium.

2018 Malibu Fires and Floods: We came all too close to losing our home during the November 2018 Malibu fires and floods. The Malibu fire burned down both sides of our property all the way to the highway. The floods sent an avalanche of mud that blocked our driveway. We were over a month without electricity and eventually ran our home off of a generator.

But we are not complaining! We still love living in Malibu and will stick it out. Thanks to all for your messages of concern for us. Read about our experiences during the Malibu fires.

If you find any errors on this page, email us. Y Last updated: Sunday, April 26, 2020

Return to 2020 AF Symposium Reports

Updated: What is the Annual ‘AF Symposium’ and Why it’s Important to Patients

I’ve updated my page about the What is the Annual ‘AF Symposium’ and Why it’s Important to Patients. If you are new to reading my reports and summaries from this annual presentation and learning event, you’ll want to take a look.

The most important point I make is that this conference provides me with a unique opportunity to learn about advances in research and therapeutics directly from many of the most eminent investigators in the field.

I use this newly gained insight to share those findings that are relevant to A-Fib patients and their families. And I do it in plain language, filtering out as much medical jargon as possible.

In 2002 I started Atrial Fibrillation: Resources for Patients, A-Fib.com, to spare others the frustration, depression and anxiety I went through to find my cure. (Read Steve’s storyPersonal A-Fib story #1). I continue this mission through my reports from the AF Symposium.

My goal is to provide you with the most up-to-date research and developments in the treatment of Atrial Fibrillation that may affect your choices of medical care.

Go to: What is the Annual ‘AF Symposium’ and Why it’s Important to Patients.

Remember: You must educate yourself to find
your A-Fib cure or best outcome for you!

AF Symposium New Report: Live! Convergent Hybrid Ablation for Atrial Fibrillation

Background: The Convergent Hybrid Ablation is currently used for patients with persistent and longstanding persistent atrial fibrillation.
The Hybrid is performed under general anesthesia. First the surgeon accesses the outside (epicardial) of the heart and creates lesions on the posterior left atrial wall and around the pulmonary veins (PVs). Next, the EP performs a standard PV catheter ablation from inside (endocardial) the heart, uses mapping systems to detect any gaps in the surgical ablation lines, and completes the surgeon’s lesion set, if needed.

Via live streaming video, AF Symposium attendees got to watch a Convergent Hybrid operation/procedure performed from Emory Heart and Vascular Center at Saint Joseph’s Hospital, Atlanta, GA.

PATIENT DESCRIPTION: A DIFFICULT CASE

The patient was a 62-year-old man who had been in A-Fib for 21 years, 10 years of those in persistent A-Fib. He was also very tall. He also complained of being very fatigued.

They didn’t know the amount of fibrosis the patient had developed. They mentioned that they hoped the fibrosis was localized rather than diffuse and that the patient did not have a Utah 4 or a Strawberry-type of large fibrosis area. (About Utah and fibrosis, see High Fibrosis at Greater Risk of Stroke and Precludes Catheter Ablation)

The patient had been on rate control drugs and the antiarrhythmic Sotalol. It was not mentioned if anyone had ever tried a normal catheter ablation on this patient before going to the Convergent operation/procedure.

Phase I: SURGERY ON OUTSIDE OF HEART

In this version of the hybrid, the cardiothoracic surgeon accesses the outside posterior of the heart through the subxiphoid process cutting through the central tendon of the soft tissue of the diaphragm making a 2-3 cm incision.

Important: Read my extensive Editor’s Comments at the end of this report.

The surgeon achieves direct vision of the posterior cardiac structure with a miniature camera (from EnSight by AtriCure). (The xiphoid process is a cartilaginous section at the lower end of the sternum.)… Continue reading my new report from the 2019 AF Symposium->

2019 AF Symposium: Live! Convergent Hybrid Ablation for Atrial Fibrillation

by Steve S. Ryan

Convergent surgical lesions pattern

Background: The Convergent Hybrid Ablation is currently used for patients with persistent and longstanding persistent atrial fibrillation.
The Hybrid is performed under general anesthesia. First the surgeon accesses the outside (epicardial) of the heart and creates lesions on the posterior left atrial wall and around the pulmonary veins (PVs).
Next, the EP performs a standard PV catheter ablation from inside (endocardial) the heart, uses mapping systems to detect any gaps in the surgical ablation lines, and completes the surgeon’s lesion set, if needed.

Live Case from Atlanta: Sequential Endocardial and Epicardial Operation/Procedure

Symposium attendees got to watch a Convergent Hybrid operation/procedure performed Live from Emory Heart and Vascular Center at Saint Joseph’s Hospital, Atlanta, GA. Presenting doctors were cardiothoracic surgeon Dr. Michael Halkos and cardiac electrophysiologists (EPs) Dr. David DeLurgio and Dr. Kevin Makati.

Patient Description: a Difficult Case

The patient was a 62-year-old man who had been in A-Fib for 21 years, 10 years of which were in persistent A-Fib. He was also very tall. He also complained of being very fatigued.

They didn’t know the amount of fibrosis the patient had developed. (One would think someone in A-Fib for such a long time would have developed a significant amount of fibrosis.) They did not measure the patient’s amount or type of fibrosis. They mentioned that they hoped the fibrosis was localized rather than diffuse and that the patient did not have a Utah 4 or a Strawberry-type large fibrosis area. (About Utah and fibrosis, see High Fibrosis at Greater Risk of Stroke and Precludes Catheter Ablation)

The patient had been on rate control drugs and the antiarrhythmic Sotalol. It was not mentioned if anyone had ever tried a normal catheter ablation on this patient before going to the Convergent operation/procedure.

Surgery on Outside of Heart

In this version of the hybrid, the cardiothoracic surgeon accesses the outside posterior of the heart through the subxiphoid process cutting through the central tendon of the soft tissue of the diaphragm making a 2-3 cm incision. The surgeon achieves direct vision of the posterior cardiac structure with a miniature camera (from EnSight by AtriCure). (The xiphoid process is a cartilaginous section at the lower end of the sternum.)

Size comparison: Atricure EPI-Sense device size vs. ablation catheter

Convergent Catheter vs. PVI Ablation Catheter: The catheter used to make the burns in the Convergent operation is unlike a standard point-by-point RF catheter with force sensing.

The Atricure EPi-Sense Guided Coagulation System with VisiTrax® technology: How it works.

Instead it is a long linear catheter with multiple RF coils on its side which is placed horizontally to make long, large burns on the heart.(AtriCure EPi Sense Coagulation Device).

The burns are normally 90 seconds long at 30 watts. This catheter can also be used for pacing, sensing, and to produce electrograms. Impedance drops (10%) are used to verify lesion effectiveness. The catheter has a notch on the top which can be used to orient the catheter.

Phase I: Live Surgical Operation

When starting, the Symposium audience watched as the surgeon, Dr. Michael Halkos, accessed the outside of the heart through the diaphram. Then he identified the left inferior and right inferior PVs.

Illustration of surgical lesions to outside of heart

Using these benchmark structures, he then started to ablate the whole of the posterior left atrium including any other areas of the posterior left atrium he could access.

The burns can overlap and can be repeated. (We only saw them make 2 burns, but usually 20 to 40 burns are made.)

We also saw the surgeon use a suction catheter to remove any blood and liquid from the area being worked on. Note: The pericardium sac is filled with saline to help prevent damage to the esophagus.

Phase II: EP Procedure

Because of time constraints, we didn’t get to see Dr. David DeLurgio, the cardiac electrophysiologist (EP) work on this patient after he was wheeled into the EP lab.

Dr. DeLurgio was scheduled after the surgery phase to later perform a PVI ablation and ablate the right atrium Cavo-tricuspid Isthmus (CTI) to prevent Flutter.

His tasks would also include using mapping technology to check the surgeon’s lesions and fill in any gaps.

Editor’s Comments
Who should consider a Hybrid Ablation for Atrial Fibrillation? Patients with persistent and/or longstanding persistent atrial fibrillation. Specifically, the Hybrid Surgery/Ablation might be an effective option for:
  • highly symptomatic patients with persistent atrial fibrillation and longstanding persistent atrial fibrillation who have failed one or two catheter ablations,
  • for someone with a significantly enlarged left atrium, or
  • for someone who is morbidly obese (making it difficult to create imaging maps necessary for catheter ablations).
This 62-year-old Patient:  It was not mentioned if anyone had ever tried a normal catheter ablation on this patient before going to the Convergent operation/procedure.
I hope for this 62-year-old male patient that he was treated first with a less invasive PV catheter ablation (or two). If the ablation(s) failed, only then would his doctors recommende the much more invasive and riskier convergent surgery.
This was a “sequential” Hybrid approach. There is also a “non-synchronous” or two-staged version where the surgeon and the EP work on the same patient but at different times and/or places.
“Minimally invasive”: Though called “minimally invasive,” the Convergent operation is still major heart surgery. It’s invasive, traumatic, complicated, requires considerable surgical skills and experience, and is potentially risky.
My Bias: Please be advised that I am personally biased against the Convergent Hybrid operation/procedure. Whenever I see it, I get nauseous and sick to my stomach watching them burn the whole of the posterior left atrium wall. To me this is overkill.
The outside posterior left atrium is turned into dead, fibrotic tissue. There is no more blood flow, transport and contraction function no longer work, nerve transmission is destroyed, normal heart muscle fibers turn into non-contracting scar tissue. The ability of the left atrium to contract risks being hindered.
The surgeon does tremendous damage to the outside posterior left atrium which can never be restored. This may weaken the heart and contribute later to heart problems like congestive heart failure.
I can’t imagine having my outside posterior left atrium wall destroyed like that. All too many patients today suffer from weak hearts due to heart muscle damage.
Difference between Surgeons and EPs: Cardiac Electrophysiologists (EPs) do often ablate in the inside posterior left atrium such as by creating a box lesion set. But they try to do as little permanent damage to the heart as possible.
Similar ablation techniques are called ‘hybrid ablation technique’, ‘convergence process’, ‘Convergent Maze Procedure’ and ‘Convergent Ablation”’
.
Whereas surgeons in the Convergent operation try to do as much damage as possible. Their goal is durable posterior wall isolation.
My concern: Is it really necessary to completely obliterate the outside left atrium posterior wall to make a patient A-Fib free? Perhaps. In some patients this may indeed be necessary. But is this necessary in every patient having a convergent operation?

For more about the Hybrid approach, see my article: Advantages of the Convergent Procedure and the VIDEO: The Hybrid Maze/Ablation for Atrial Fibrillation for Persistent A-Fib Includes animation and on-camera interviews. Published by Tenet Heart & Vascular Network. Length 4:30

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AF Symposium Two New Reports: Ablation Without Touching Heart and New RF Balloon Catheter

I’ve posted two of my reports from the 2019 AF Symposium.

Automated Robotic Ultrasound Ablation

From the Czech Republic via streaming video, a catheter ablation using an incredible new technology―Ultrasound Mapping and Ablation (Low-Intensity Collimated Ultrasound, LICU) from Vytronus, Inc. The catheter never touches the tissue!

From Vytronus VIDEO: Ultrasound Mapping and Ablation

The EP created a robotic lesion path for the ultrasound catheter to follow. Using electromagnetic navigation, the catheter automatically went to the spots and path the operator drew.

We watched as the catheter hovered over the heart surface while the highly directional ultrasound energy beam created the lesion lines—never touching the tissue. It was amazing to watch!

To learn more...go to my full report: Ablation Without touching the Heart Surface Using Ultrasound―Live Case from Prague.

Multi-Electrode Radio-Frequency (RF) Balloon Catheter

Multi-Electrode Radio-Frequency (RF) Balloon Catheter from Biosense Webster

The new irrigated Multi-Electrode RF Balloon Catheter from Biosense Webster is a “one-shot” delivery of RF energy and can burn lesions to isolate the Pulmonary Veins in minutes. And because the electrodes can be programmed to deliver less energy levels (for example near the esophagus), the RF Balloon Catheter can be safer and more effective than traditional RF point-by-point ablation.

It has 10 gold surface electrodes or heating bars which can be turned on and off or set to deliver different energy levels simultaneously. Each electrode is powered by its own generator.

While the AF Symposium audience watched the RF ablation live, the EP took just 7 seconds to isolate a particular vein―quite remarkable compared to the time involved for traditional RF.

To read my full report, go to: Multi-Electrode RF Balloon Catheter―Live Case from Boston Mass. General

2019 AF Symposium: Common Fluoroscopy Technology Converted to Real-Time 3D Images

Fluoroscopy is a type of medical imaging that shows a continuous 2D X-ray image on a monitor, (like an X-ray movie).

by Steve S. Ryan

Another medical breakthrough at this year’s AF Symposium featured an innovative mapping technology which turns normal fluoroscopy into real-time 3D imagery.

During a live CryoBalloon ablation from Milwaukee, WI, the system was used by Drs. Sabir Jra and Dr. Mohamed Hani of Aurora Health Care.

The Navik 3D Cardiac Mapping System from APN Health was FDA approved in 2016 and was first clinically used in March 2018. Dr. Jra is also the developer.

Real-Time Converting 2D to 3D: How the System Works

Commonly found in most every Electrophysiology lab is equipment for fluoroscopy. It’s a type of medical imaging that shows a continuous 2D X-ray image on a monitor (like an X-ray movie).

Monitor images Navik 3D system

The genius of Dr. Jra’s system is converting the familiar fluoroscopy into 3D real-time images.

The Navik 3D Cardiac Mapping System uses a complex mathematical formula and fast processor calculations to locate any opaque object (such as a catheter or a pulmonary vein opening) within regular X-ray fluoroscopy and turn it into a 3D image.

The Navik system uses real-time 2D, single-plane fluoroscopy images along with body surface ECG data and intracardiac echo signals to create a synchronized, real-time 3D visual map.

Real-Time 3D Images

As AF Symposium attendees watched the live CryoBalloon ablation, the mapping seemed to be very fast. It created and displayed real-time 3D maps of the cardiac chambers during the ablation, though the images appeared somewhat different from images from other 3D mapping systems.

Dr. Jra’s system can be integrated into a normal electrophysiology lab using typical procedure equipment. During the live procedure, his lab looked like other EP labs I’ve seen.

Editor’s Comments
3D Huge Improvement over Fluoroscopy: Dr. Jra’s work is innovative and a true medical breakthrough. It’s incredible—being able to convert, in real-time, fluoroscopic images into 3D images. Any electrophysiologist (EP) using fluoroscopy could, in theory, use Dr. Jra’s system.
Instead of X-ray images which are 2D and not all that clear, 3D images are a potentially huge improvement and would make the EP’s work more easily and clearly viewed.
Easy to Install and Use: The Navik 3D Cardiac Mapping System seems relatively easy and cost-effective to install. It doesn’t require major changes to an existing EP lab. But does require one addition piece of equipment, a body surface ECG system under the patient exam table.
Will 3D Fluoroscopy Become Widely Accepted and Used? Considering how many different excellent mapping and ablation systems are now being used, one wonders if Dr. Jra’s 3D fluoroscopy system will become accepted in today’s A-Fib marketplace, I’ll watch the rollout of the Navik 3D Cardiac Mapping System and report on its progress.
References for this article
Djelmami-Hani, M. Novel Approach to Cardiac 3-D Mapping. EP Lab Digest, Vol 18. Issue 9, Sept. 2018. URL: https://www.eplabdigest.com/novel-approach-cardiac-3d-mapping.

APN Health Receives FDA Clearance for Navik 3D Cardiac Mapping System. Diagnostic and Interventional Cardiology, February 29, 2016. URL: https://www.dicardiology.com/product/apn-health-receives-fda-clearance-navik-3d-cardiac-mapping-system

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AF Symposium: New Product Vascular Closure Device for Catheter Ablations

I just got off the phone with Andy who was telling me about his RF Ablation and his post-op experience. He had to lie on his back for 15 hours before his groin incision stopped bleeding and he was safe to go home. He said it was quite painful to be immobile that long.

Delivery disc of the  ASCADE MVP implants the collegan plug

My first report from the 2019 AF Symposium is about a new product used during catheter ablations and is designed to help patients like Andy go home sooner after their ablation.

The problem? Post-op bleeding from the catheter insertion point in the groin. Typically, the patient lies on their back for about 6 hours while the insertion point heals and stops bleeding enough so they can be discharged. (For guys, especially, it’s no fun having to use a Foley catheter to pee.)

Cardiva Medical has solved this problem. A simple, ingenious device closes off the insertion point(s) in the groin with a “collagen plug”.

Collagen plug like a cork in a bottle

How it’s used: After completing the ablation, the EP withdraws the ablation catheter, then replaces it with the VASCADE MVP which has a expandable/collapsible delivery disc to implant a collagen plug. This plug acts like a cork in a bottle and stops all bleeding leakage. (The FDA was so impressed with the VASCADE that it approved it within weeks.)

I give it a try: In the Exhibitors Hall, Michael Gebauer of Cardiva Medical demonstrated it to me. It takes a whole 5 seconds to insert the VASCADE MVP.

Continue reading (for how to get the cork out of the bottle, and more)go to my full report: Cardiva Medical ASCADE MVP Vascular Closure Device.

About the Annual International AF Symposium

What is the Annual ‘AF Symposium’ and Why it’s Important to Patients

by Steve S. Ryan, PhD
first published Jan. 2014, updated Jan 2015  Last updated: February 6, 2019

Introduction

The past two decades have witnessed dramatic advances in all areas of A-Fib research with major progress in our understanding of atrial fibrillation and the development of safer and more effective strategies for the treating and curing of atrial fibrillation.

The annual international AF Symposium (formerly called the Boston AF Symposium) is one of the most important conferences on A-Fib in the world. The Symposium is a major scientific forum at which health care professionals have a unique opportunity to learn about advances in research and therapeutics directly from many of the most eminent investigators in the field.

This intensive and highly focused three-day symposium brings together the world’s leading medical scientists to share the most recent advances in the field of atrial fibrillation.

Steve Ryan with Dr Michel Häissaguerre (inventor of the PVI ablation for A-Fib) at the 2019 AF Symposium presentation hall

Why I attend the Symposium

Each year I attend the Symposium to learn and ‘absorb’ the presentations and research findings.

Attending the annual AF Symposium gives me a thorough and practical view of the current state of the art in the field of A-Fib. I then apply this newly acquired knowledge and understanding to the publishing of A-Fib.com.

Look for My Reports

On the plane ride home I start writing summaries of significant presentations and important research findings that are relevant to A-Fib patients and their families.

I strive to ‘translate’ as much of the medical jargon into everyday language. I add my own comments and insights to help interpret the information for A-Fib.com readers.

In the months following the Symposium, I write and post three or four reports each month usually ending up with about 12–20 articles. (Why does it take so long? I send each of my summaries to the presenter inviting their feedback, so it takes some time to get each article written, reviewed, and posted.)

I announce each posting on my A-Fib News Blog with a link to each article.

For the readers of A-Fib.com

My goal is to offer the most up-to-date A-Fib research findings and developments that may impact the treatment choices of patients seeking their A-Fib cure.

Caution: If you haven’t read and understood most of the articles on A-Fib.com, it may be difficult reading. (Hint: our Glossary of Terms may be helpful.)

 Return to AF Symposium Archives by Year
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2019 AF Symposium: Multi-Electrode RF Balloon Catheter―Live Case from Mass. General

by Steve S. Ryan

Live streaming video-2019 AF Sympoium; A-Fib.comMassachusetts General Hospital in Boston, MA was the origination site for an ablation using a new irrigated Multi-Electrode Radiofrequency (RF) balloon catheter from Biosense Webster. Live via streaming video, were Drs. Moussa Mansour, Andrea Natale and Kevin Heist.

Multi-Electrode RF Balloon Catheter from Biosense Webster

While the AF Symposium audience watched the RF ablation live, the EP took just 7 seconds to isolate a particular vein―quite remarkable compared to the time involved for a traditional RF point-by-point ablation.

Multi-Electrode RF balloon catheter from Biosense Webster; A-Fib.com

Multi-Electrode RF balloon catheter from Biosense Webster

Catheter design: This new irrigated Multi-Electrode RF balloon catheter has 10 gold surface electrodes or heating bars which can be turned on and off or set to deliver different energy levels simultaneously. Each electrode is powered by its own generator.

In addition, rather than a fixed size, the 28 mm balloon is “compliant” and can fit into different-sized and shaped pulmonary vein openings.

Balloon catheters: This is the first RF balloon catheter in use for pulmonary vein (PV) ablation. Up to now balloon catheter technology has been used mainly with Cryoablation of the PV veins and the Laser Balloon catheter.

Approvals: In Europe, 200 patients have been treated with the Multi-Electrode RF balloon catheter. It is in trials in the U.S. and hasn’t yet been approved by the FDA.

Balloon Catheter also Creates 3-D Mapping

The 10 electrodes in the balloon also function as a circular mapping catheter to produce a 3-D map of the atrium and can pace the heart as well.

The liquid used to cool the RF burns flows at 35 nl/min. The RF is unipolar and heats at a maximum of 15 watts. RF lesions are made for 60 seconds, but the time can be reduced to 20 seconds when working on areas such as the posterior wall near the esophagus.

 RADIANCE stands for “PV Isolation with a Novel Multi-electrode Radiofrequency Balloon Catheter that Allows Directionally-Tailored Energy Delivery”

RADIANCE multicenter study: The RADIANCE study was a multicenter study conducted between Dec. 2, 2016 and March 8, 2017 in Europe. A total of 39 patients with paroxysmal atrial fibrillation were treated with the Biosense Webster multi-electrode radio frequency (RF) balloon catheter at four centers with nine different operators from both the U.S. and Europe.

In the RADIANCE study, 100 percent of the treated pulmonary veins were electrically isolated without the need for “touch-up” lesions with a RF focal catheter (referred to as “one-shot” delivery).  The study showed the RF balloon catheter could deliver directionally-tailored energy using multiple electrodes for efficient acute PVI in patients with paroxysmal A-Fib. For more about the RADIANCE Study see Multi-Electrode RF Balloon Efficient for Acute Pulmonary Vein Isolation Study.

Editor’s Comments
Advantages of the new RF Balloon Catheter:
It is difficult with an RF point-by-point catheter to produce a solid circular lesion around the PVs in a beating heart. It can take hours.
By comparison, this new irrigated RF Balloon Catheter is a “one-shot” delivery of energy and can isolate (burn lesions) in the PVs in minutes. And because the electrodes can be programmed to deliver less energy levels (for example near the esophagus), the RF Balloon Catheter can be safer and more effective than traditional point-by-point ablation.
Compared to CryoBalloon Ablation: The question from a patient’s perspective is which is better or more effective? The newer RF Balloon catheter ablation (when FDA approved in the U.S.), or the current, already proven CryoBalloon ablation? Right now, there isn’t enough data to answer this question.
The RF Balloon ablation does have an advantage over traditional CryoBalloon ablation. It can deliver different energy levels to prevent deeper ablation damage. (Currently, potential damage to the esophagus is handled with displacement tools which move the esophagus away from ablation sites. For more on this, see Esophageal Displacement Tool.)
Bottom Line for Patients: Promising! I’m excited about the Multi-Electrode Radiofrequency (RF) balloon catheter from Biosense Webster. I’ll report on it again, hopefully when it receives FDA approval for use in the U.S.
Reference for this article
Fornell, D. Multi-Electrode RF Balloon Efficient for Acute Pulmonary Vein Isolation. Study presented at the Heart Rhythm Society’s 2017 Late-Breaking Clinical Trials Section. DAIC, May 17, 2017. https://www.dicardiology.com/article/multi-electrode-rf-balloon-efficient-acute-pulmonary-vein-isolation

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AF Symposium 2019: Live from Prague—Ablation Without touching the Heart Surface Using Ultrasound

By Steve S. Ryan

On the second day of the AF Symposium attendees viewed, live from the Czech Republic, a catheter ablation using an incredible new technology―Ultrasound Mapping and Ablation (Low-Intensity Collimated Ultrasound, LICU) from Vytronus, Inc.

“Collimated” refers to focusing ultrasound rays so that they are parallel and spread out minimally with minimum divergence.

The procedure was via live streaming video from Na Homolce Hospital in Prague. The doctors performing the A-Fib ablation were cardiac electrophysiologists Jan Petru, Moritoshi Funasako, and Petr Neuzil.

Near-Real Time Ultrasonic Imaging of the Heart

The system first robotically scanned the left atrium and Pulmonary Veins (PVs) to create a 3-D global image of the heart anatomy in near-real time using the same dual-purpose transducer tip that makes the ablation lesions. (Later the same process was used to verify ablation lesions and the effectiveness of the ablation.)

Automated Robotic Ultrasound Ablation

In this automated robotic ablation, the LICU ultrasound catheter with a dual-purpose transducer tip didn’t touch the heart surface to make ablation lines.

The EP created a robotic path for the ultrasound catheter to follow. Using electromagnetic navigation, the catheter automatically went to the spots and path the operator drew.

We watched as the catheter hovered over the heart surface while the highly directional ultrasound energy beam created the lesion lines.

It was amazing to watch!

If the heart surface was thicker, the ultrasound catheter slowed down thereby increasing the ultrasound dose and energy delivered. This made the continuous lesions deep enough and transmural. The catheter didn’t touch or make contact with the heart surface.

Flowing Blood in the Heart Doesn’t Affect the Ultrasound Beam

The choice of ultrasound frequency (approximately 10 MHz) means that the ultrasound beam is affected very little by blood in the heart. Blood is “transparent” to the ultrasound beam.

This also means that the distance from the catheter tip to the targeted tissue isn’t critical and can vary. Also, the ultrasound catheter tip is irrigated to cool the tissue and prevent the formation of char or thrombus.

Color-Coded Range Map

The system uses a color-coded ultrasound-generated range map which displays how far the tip of the catheter is from the tissue to be ablated in order to create good lesions.

If the operator sees purple, blue or green, the catheter is within therapeutic ablation range. Yellow, orange and red indicate the catheter is beyond therapeutic range. The therapeutic range can vary from 5 mm to 50 mm.

During the live ablation, the EP said that dark blue is the best, while purple may be too close.

VIDEO: Product Animation. Ultrasound Mapping and Ablation (Low-Intensity Collimated Ultrasound, LICU) from Vytronus, Inc. (2:22 min.)

Video playback controls: Controls are located in the lower right portion of the frame: Click on arrow icon to select.

Editor’s Comments:
Background: In the past, high-intensity focused ultrasound (HIFU) caused esophageal injury and was withdrawn from clinical use. But Low-Intensity Collimated Ultrasound (LICU) operates at a lower acoustic intensity than the previous HIFU. Lesion formation occurs at a more gradual fashion.
Though not yet approved for use in the U.S., development of an ultrasound LICU ablation catheter and mapping system is a most important innovation for A-Fib patients.
Near-Real-Time Mapping: The ability of the ultrasound catheter to create 3-D images of the atrium and PVs at almost the same time as the ablation is a major advantage over other mapping systems. It creates more accurate rendering of the targeted heart features. In other systems there can be map drifts/shifts, inaccuracies from heart motion, respiratory motion, and volume-related chamber enlargement.
Non-Contact Ablation: In an ultrasound LICU ablation the catheter doesn’t touch the heart tissue. The EP doesn’t have to worry about “contact force” measurement, i.e., whether they are applying enough or too much force to make good transmural lesions.
Robotically Controlled Ablation Process: To me the robotic ultrasound LICU system seems easier to use. The ultrasound lesions were created automatically. As compared to standard point-by-point RF ablation or even CryoBalloon ablation, it’s remarkably simple and requires much less EP involvement and skill.
From a patient’s perspective, you aren’t as dependent on the skill and manual dexterity of the EP (or whether they are on top of their game that day).
A Breakthrough but Not Yet Available: It was obvious to everyone in the AF Symposium audience that we were witnessing the dawn of a potential new age in catheter ablation.
Though still investigational and not yet approved in the U.S., robotic low-intensity ultrasound mapping and ablation seems like a radical breakthrough in ablation treatment.
More Studies Needed: Many studies of its safety and efficacy need to be made before ultrasound ablation becomes available to patients. But low-intensity robotic ultrasound ablation looks really promising.
References for this article
Koruth, J.S. et al. Pre-Clinical Investigation of a Low-Intensity Collimated Ultrasound System for Pulmonary Vein Isolation in a Porcine Model. JACC: Clinical Electrophysiology, Vol. 1, No. 4, August 2015 http://electrophysiology.onlinejacc.org/content/1/4/306. DOI: 10.1016/j.jacep.2015.04.011

Vytronus, Inc. Ultrasound Mapping and Ablation (Low-Intensity Collimated Ultrasound, LICU),  the Vytronus LICU® system. URL: https://www.vytronus.com/technology/

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First Impressions: The 24th Annual International AF Symposium 2019

There was snow on the streets of Boston, Mass. when I arrived for the 2019 AF Symposium (an all too familiar site for a boy from Buffalo, NY). But the weather warmed up somewhat during the three-day event from January 24-26, 2019.

The most prominent topic at this year’s Symposium was the CABANA trial which had its own Thursday afternoon (January 24) session including a debate on its merits. Look for my report soon. (For background, see my January 2019 post: 5-Year CABANA Trial: Compares Catheter Ablation with Antiarrhythmic Drug Therapy)

Plethora of Future Technology

Steve Ryan at 2019 AF Symposium sign; A-Fib.com

Steve Ryan at 2019 AF Symposium

I have never seen so many future technology presentations at the AF Symposium including topics such as Quantum Mechanics, Artificial Intelligence, Technology and Ethics, Robotic Interaction, and Device Investment applied to the A-Fib field.

A-Fib Experts Presentations, Discussions and Audience Interaction

Within the 3-day Symposium, there were 65 different short presentations, followed by time for discussion and audience interaction. Each topic session was moderated by 2 or 3 leaders in the A-Fib field. The five live cases session Friday morning was again worth the price of admission by itself.

Expect My Reports

It’s a privilege to be able to attend presentations by the best clinicians and researchers working in A-Fib today. I learn more in three days than in a year of reading the various A-Fib research reports.

In the next weeks and months, I will share the current state of the art in A-Fib research and treatments and what’s relevant from a patient’s point-of-view. And all written in plain language for A-Fib patients and their families.

Link to my First Report

To read my first full report of the 2019 AF Symposium, go to: Overview of The 24th Annual International AF Symposium 2019.

AF Symposium 2019 logo at A-Fib.com

2019 AF Symposium: Vascular Closure Device-Great News for Ablation Patients!

When one gets a catheter ablation, often the most annoying part of post-op is having to lie still on one’s back for 6 hours while the insertion point(s) in the groin stops bleeding and heals enough to go home. (For guys, it’s no fun having to use a Foley catheter to pee, particularly when they remove it!) The risk of bleeding from the puncture site(s) is an all-too-common complication that can affect up to 20% of ablation procedures.

A Solution: VASCADE MVP Venous Vascular Closure System

Delivery disc of the VASCADE MVP inserts the collagen plug

Cardiva Medical has solved this problem. A simple, ingenious device closes off the insertion point(s) in the groin to stop any bleeding.

How it’s used: After completing the ablation, the EP withdraws the ablation catheter, then replaces it with the VASCADE MVP which has a expandable/collapsible delivery disc to implant a collagen plug. This plug or patch stops all bleeding leakage. (The FDA was so impressed with the VASCADE that it approved it within weeks.)

I give it a try: In the Exhibitors Hall, Michael Gebauer of Cardiva Medical demonstrated it to me. It takes a whole 5 seconds to insert the VASCADE MVP.

The tip expands into a disc which stops all blood flow. The collagen plug is located just behind the tip of the disc. It expands as blood from the surrounding tissue fills it blocking off the catheter insertion point.

Then after around 30 seconds, the tip is collapsed and closed up and the device removed. (It’s so simple and easy to use, I could probably do it.)

After about 30 days, the collagen plug naturally dissolves by itself. Nothing is left behind.

Spotlight Session

In the Spotlight Session Thursday morning and at a lunch meeting, doctors Amin Al-Ahmed, Andrea Natale and Suneet Mittal described the VASCADE MVP and the AMBULATE randomized clinical trial. (Link to the AMBULATE trial results)

In the clinical trial, the VASCADE MVP was compared to standard post-op care where a nurse had to apply pressure on the groin insertion site(s) to make sure bleeding or leakage didn’t occur, sometimes for as long as 6 hours. EPs also used a figure-8 suture to close off each insertion site. But the patient still needed 6-8 hours of bed rest and could still bleed through the sutures especially if they had to cough. And removing the sutures was painful.

AMBULATE Clinical Trial

The Cardiva Medical VASCADE MVP

Ambulatory after 1 hour: Patients receiving the VASCADE were able to walk around after about an hour. They also didn’t need pain meds to help them stay still for 6 hours, which was previously required after a catheter ablation (58% reduction in need for pain meds).

Less staff time and less meds: Nursing staff saved time not having to apply pressure to the patient’s groin site(s). The drug Protamine, which previously had to be used to counteract the effects of blood thinners administered during an ablation, was no longer necessary.

Substantial cost reduction: Each VASCADE device costs around $200-$250, which is considerably cheaper that the normal $1,000-$2,000 costs associated with standard post-op care.

Sooner patient discharge: It’s estimated that patients may no longer have to stay overnight to monitor their groin insertion sites but may be able to go home the day of their ablation. (But patients may need to stay longer than an hour to get over the effects of the anesthesia and wake up fully.)

Session presenters: Doctors Al-Ahmed and Andrea Natale are with Texas Cardiac Arrhythmia Institute in Austin TX, and Dr Suneet Mittal is with Arrhythmia & Cardiology Consultants, Paramus, NJ.

VIDEO: Cardiva® VASCADE MVP Vascular Closure Device Animation. Insertion device for collagen plug. 1:30 min.

Increased Satisfaction: Doctors, Staff and Patients

Dr. Natale described how he and all of his 10 fellow EPs at the Texas Cardiac Arrhythmia Institute quickly chose to change their established protocols and now use the VASCADE MVP . (Link to the AMBULATE trial results)

The nursing staff, he reported, appreciate the time saved not having to manually apply pressure to the patient’s groin.

And the patients are happy with use of the VASCADE MVP because they can go home sooner, and lying on one’s back for 6 hours is hard and sometimes painful. Male patients appreciate less time having to endure a Foley catheter to pee. No issues have arisen with the 1,000 patients who have been treated with the VASCADE MVP.

Editor’s Comments
Though the VASCADE MVP device may at first not seem like a big deal, it really is!
I just got off the phone with Andy who was telling me about his RF Ablation and his post-op experience. He had to lie on his back for 15 hours before his groin incision stopped bleeding and he was safe to go home. He said it was quite painful to be immobile that long.
I predict that the VASCADE will be rapidly adopted by most centers doing catheter ablations.
It’s simple to use, it greatly increases patient satisfaction, it may shorten the time a patient has to stay in a hospital, nursing and lab staff are happier and can do more productive work, EPs have one less thing to worry about, and it’s relatively inexpensive compared to standard post-op care.
(But one EP leader I talked to at the Symposium said he continues to use the figure-8 suture and isn’t about to switch to the VASCADE.)
From a patient’s perspective, the VASCADE MVP is probably the most important presentation at this year’s AF Symposium.
References for this article
AMBULATE study of VASCADE MVP system meets primary endpoint. Cardiac Rhythm News. 16th November 2018.  https://cardiacrhythmnews.com/vascade-mvp-meets-primary-endpoint/

The AMBULATE Trial: A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 – 12 Fr Sheath Sizes (AMBULATE). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03193021

Duytschaever, M & Ernst, S. Combining practical and scientific learning to meet educational needs at Europe’s largest atrial fibrillation symposium. Cardiac Rhythm News, March 2019, Issue 44, p. 7.

If you find any errors on this page, email us. Y Last updated: Thursday, February 20, 2020

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2019 AF Symposium: Reports for Patients by Steve S. Ryan, PhD

Steve Ryan at 2019 AF Symposium sign; A-Fib.com

Steve Ryan at 2019 AF Symposium

AF Symposium 2019

My Summary Reports Written for A-Fib Patients

by Steve S. Ryan, PhD

Now in its 24th year, the annual AF Symposium is one of the most important scientific conferences on A-Fib in the world. I attend to learn about advances in research and treatments directly from the most eminent medical researchers, scientists, cardiologists and cardiac electrophysiologists. (My first Symposium was in 2003.)

My goal is to offer A-Fib.com readers the most up-to-date research and developments that may impact their treatment choices. And, as always, my reports are written in plain language for A-Fib patients and their families.

REPORT TITLE PRESENTER (S) DATE POSTED
6. Convergent Hybrid Ablation for Atrial Fibrillation―Live from Atlanta, GA

Drs. Michael Halkos,  David DeLurgio and Kevin Makati, Emory Heart and Vascular Center, St. Joseph’s Hospital, Atlanta, GA.

March 3, 2019
5. Common Fluoroscopy Technology Converted to Real-Time 3D Images―Live case from Milwaukee, WI

Drs. Sabir Jra and Mohamed Hani of Aurora Health Care, Milwaukee, WI

Feb 8, 2019
4. Multi-Electrode RF Balloon CatheterLive Case from Mass. General

Drs. Moussa Mansour, Andrea Natale and Kevin Heist, Mass. General, Boston, MA

Feb. 6, 2019
3. Ablation Without Touching the Heart Surface Using UltrasoundLive Case from Prague

Drs. Jan Petru, Moritoshi Funasako, and Petr Neuzil, Na Homolce Hospital in Prague,  the Czech Republic.

Feb. 5, 2019

2. New Product: Vascular Closure Device-Great News for Ablation Patients!

Drs. Al-Ahmed, Andrea Natale, Texas Cardiac Arrhythmia Institute in Austin TX; Dr Suneet Mittal, Arrhythmia & Cardiology Consultants, Paramus, NJ.

Jan 30, 2019

1. Overview: The 24th Annual International AF Symposium 2019 by Steve S. Ryan, PhD – – – Jan 30, 2019
Archive: Link to all my AF Symposiums Summaries by Year

Steve and Dr Michel Häissaguerre, The French Bordeaux group, who cured Steve’s A-Fib in 1998; AF Symposium 2019 presentations hall..

J. Ruskin

“Steve Ryan’s summaries of the A-Fib Symposium are terrific. Steve has the ability to synthesize and communicate accurately in clear and simple terms the essence of complex subjects. This is an exceptional skill and a great service to patients with atrial fibrillation.” — Dr. Jeremy Ruskin of Mass. General Hospital and Harvard Medical School

 If you find any errors on this page, email us. Y Last updated: Sunday, March 3, 2019

Overview: The 24th Annual International AF Symposium 2019

By Steve S. Ryan, PhD, January 30, 2019

There was snow on the streets of Boston, Mass. as world-renowned experts in the treatment of Atrial Fibrillation arrived for the 2019 International AF Symposium. (For a boy from Buffalo, NY, this was an all too familiar sight). But the weather warmed up somewhat during the three-day event from January 24-26, 2019.

Seaport World Trade Center, Boston, Mass.

For me, it felt like a kind of homecoming returning to the Seaport World Trade Center after 5 years of the AF Symposium meetings in Florida. (Unfortunately, the owner of the Seaport World Trade Center, Fidelity Investments, plans an ambitious remake of the complex that includes closure of the 120,000-square-foot exhibition space. Therefore, the 2020 AF Symposium will be held instead in Washington, DC.)

One disappointment: We were supposed to visit the John F. Kennedy Presidential Library and Museum. But due to the government shutdown, that had to be cancelled. (FYI: It reopened Jan. 29 after Congress restored funding.)

Instead we had a meet-and-greet supper meeting at the Seaport Hotel Thursday evening. (I probably bored everyone telling about our escape from the Malibu fires. A home down the street from us burned down, while ours was intact, except for one singed wall and melted PVC gutters. For the details, see Personal Update: Surviving the Woolsey/Malibu Fire.)

See my photo below with Dr Michel Häissaguerre (inventor of the PVI ablation for A-Fib) who cured my A-Fib in 1998 in Bordeaux, France.

Renewed friendships: It was great to renew friendships formed over many conversations about Atrial Fibrillation at the symposiums and continued by phone and email. I will often contact one or more of these experts to help with a difficult question from an A-Fib.com reader or on behalf of a patient needing the expertise of a master EP. (See our A-Fib.com Advisory Board for a partial list of specialists who advise me.)

The General Mood

“We’re getting better” seemed to be general feeling or mood of the 24th Annual AF Symposium in Boston, MA. Attendance was good with over 900 participants (up from last year).

Steve Ryan with Dr Michel Häissaguerre (inventor of the PVI ablation for A-Fib) at the 2019 AF Symposium presentation hall at A-Fib.com

Steve Ryan with Dr Michel Häissaguerre (inventor of the PVI ablation for A-Fib) at the 2019 AF Symposium presentation hall

Most Talked About

The most prominent topic was the CABANA trial which had its own Thursday afternoon (January 24) session including a debate on its merits. Look for my report soon. (For background, see my January 2019 post: 5-Year CABANA Trial: Compares Catheter Ablation with Antiarrhythmic Drug Therapy)

Plethora of Future Technology

I have never seen so many future technology presentations at the AF Symposium.

On Thursday morning there was a “Spotlight” session featuring 5-minute talks on innovative A-Fib developments (8 on devices, 2 on medicines).

Thursday also had a new, challenging session on “Emerging New Technologies” including topics such as Quantum Mechanics, Artificial Intelligence, Technology and Ethics, Robotic Interaction, and Device Investment applied to the A-Fib field.

The last session of the week on Friday featured five Late Breaking Clinical Trials which focused on new developments in A-Fib.

Two lunchtime learning sessions (not part of the official AF Symposium) featured sponsored talks on very innovative A-Fib developments.

Worldwide Live Patient Cases Via Streaming Video

The live cases session Friday morning was again worth the price of admission by itself. We saw live presentations from:

• Prague, the Czech Republic
• Mount Sinai Hospital in New York City
• Massachusetts General Hospital in Boston
• St. Luke’s Medical Center in Milwaukee, WI
• Emory Heart and Vascular Center in Atlanta, GA

The presentations were seamless and technically perfect. They would even switch back and forth between various centers during the live procedures.

A-Fib Experts Presentations, Discussions and Audience Interaction

Within the 3-day Symposium, there were 65 different short presentations, followed by time for discussion and audience interaction. Each topic session was moderated by 2 or 3 leaders in the A-Fib field. Attendees were given the opportunity to interact and answer questions posed by the presenters. Speakers included 2 representatives from the FDA.

Steve Ryan at 2019 AF Symposium sign; A-Fib.com

Steve Ryan at 2019 AF Symposium

The talks focused on the following subjects:

Thursday, January 24

  • Emerging New Technologies: Implications for the Future of Medicine and Cardiology
  • Spotlight Session: Early Stage & Emerging Technologies in Cardiac Mapping and Ablation
  • Novel Mapping and Ablation Technologies for Catheter Ablation off Atrial Fibrillation
  • CABANA: New Analyses, Long-Term Follow-Up and Debate – Interpretation and Implications for Clinical Practice
  • Challenging Cases in AF Management: Drugs, Anticoagulation, Ablation & LAA Closure

Friday, January 25

  • Real-Time Case Transmissions – New Imaging, Mapping and Ablation Technologies
  • New Trends in Catheter Ablation for Atrial Fibrillation: Improving Efficacy and Efficiency
  • New Technologies for Mapping and Ablation of Atrial Fibrillation
  • Stroke Prevention in AF: Current Issues in Anticoagulation, Ablation and LAA Closure
  • Left Atrial Appendage Closure

Saturday, January 26

  • Beyond PVI: Mechanisms and Targets for AF Ablation (Session I)
  • Beyond PVI: Mechanisms and Targets for AF Ablation (Session II)
  • How to improve the Safety of AF Ablation Procedures
  • Late Breaking Clinical Trials and First Report Clinical Investigations
    Best Abstract Award and Presentation

Why I Attend: Expect My Reports

As someone who has been attending the AF Symposium for 15 years, it’s unique and invaluable. It provides info and discussions on A-Fib unlike any other conferences. Each day one comes away with incredible insights into A-Fib.

After each day of the Symposium, one comes away with incredible insights into A-Fib.

It’s a privilege to be able to attend presentations by the best clinicians and researchers working in A-Fib today. I learn more in three days than in a year of reading the various A-Fib research reports.

I’m especially blessed by being able to ask questions of the presenters and converse one-to-one with them.

More to Come

Look for more of my reports from the 2019 AF Symposium in the next weeks and months. I will share the current state of the art in A-Fib research and treatments and what’s relevant to patients with Atrial Fibrillation.

And, as always, my reports will be written in plain language for A-Fib patients and their families.

AF Symposium 2019 logo at A-Fib.com

If you find any errors on this page, email us. Y Last updated: Monday, March 30, 2020

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I’m off to Boston: Attending the International AF Symposium 2019

To stay current about advances in the treatment of Atrial Fibrillation, each year I attend the annual International AF Symposium. The AF Symposium is one of the most important scientific conferences on A-Fib in the world. This year the conference is January 24-26, 2019 in Boston.

This intensive, highly focused three-day symposium brings together more than 50 of the world’s leading medical scientists, cardiologists and cardiac electrophysiologists (EPs) for a thorough and practical course on the current state of the art in the field of atrial fibrillation.

My goal is to offer A-Fib.com readers the most up-to-date research and developments in the treatment of A-Fib that may impact their treatment choices. 

This meeting has become a major scientific forum for health care professionals to learn about advances in research and therapeutics directly from many of the most eminent researchers, scientists and investigators in the field.

Reports for A-Fib.com: I usually attend all of the over 65 presentations, live procedures via video, and panel discussions. I then select the topics of most importance from a patient’s point of view and write summaries for patients with Atrial Fibrillation.

My goal is to offer A-Fib.com readers the most up-to-date research and developments that may impact their treatment choices. Look for my reports in the coming months.

My 2018 Summaries: In the meantime, you can review my reports from the 2018 AF Symposium.

AF Symposium participants with large presentation screens

2018 AF Symposium: Findings from the CASTLE-AF Clinical Trial

by Steve S. Ryan, PhD.
FAQs Understanding Your A-Fib A-Fib.comPersonal note: Most people who’ve had a successful catheter ablation can tell you how wonderful it feels to have a heart that beats normally again. There are few other procedures that so improve one’s quality of life. (I had my procedure back in 1998 and still treasure being in normal sinus rhythm!)
One would think intuitively that having normal blood flow to the brain and body would improve overall health and lead to longer life. But there haven’t been many studies documenting this result…until now!
The findings of the CASTLE AF clinical trial are one of the most important studies for patients in the last decade!

Dr. Nassir Marrouche & the CASTLE-AF Clinical Trial

CASTLE-AF stands for Catheter Ablation versus Standard conventional Treatment in patients with LEft ventricular dysfunction and Atrial Fibrillation.

I reported briefly on the CASTLE AF clinical trial last October [see CASTLE AF Study: Live Longer―Have a Catheter Ablation]. At the time, it was a late-breaking study with few details.

Nassir Marrouche MD

N. Marrouche MD

At the January 2018 AF Symposium Dr. Nassir Marrouche presented results of the full CASTLE-AF study.

CASTLE-AF is a multicenter, randomized, controlled trial of A-Fib patients with managed heart failure. The trial was to determine if catheter ablation lowers morbidity and mortality as compared with drug therapy (rate or rhythm control).

The Case of the 50-Year-Old Man with an Ejection Fraction of 24%

Dr. Marrouche started his presentation by describing one of his patients, a 50-year-old man with A-Fib for 6 years who had progressed from paroxysmal to persistent. He’d taken various antiarrhythmic drugs (AADs) such as Sotalol and amiodarone.

Ejection Fraction is a measurement of the blood leaving your heart each time it contracts. Normal rate is 50%-75%.

He had failed Electrocardioversions. His Ejection Fraction (EF) was 24%―dangerously low and considered a stage of heart failure. [To learn more about EF, read my FAQ: Understanding A-Fib and Ejection Fraction.]

After a catheter ablation procedure, Dr. Marrouche’s patient’s Ejection Fraction improved from 24% to 44%. [This is a huge improvement! This man’s life was basically saved.]

Rate vs Rhythm Control & Amiodarone Toxicity

Dr. Marrouche discussed older studies such as AFFIRM comparing rate control drug therapy to rhythm control drug therapy using antiarrhythmic drugs (AADs).

Even though people on AADs were often in normal sinus rhythm and felt better, mortality in the rate control group and the AAD group was about the same. This somewhat surprising result may have occurred because one of the AADs used was amiodarone which is known for its toxic effects. [The toxicity of amiodarone may have offset the improved mortality of being in normal sinus rhythm.]

For more on amiodarone, see Amiodarone: Most Effective and Most Toxic)

Description of the CASTLE-AF Study

The 9-year, multicenter CASTLE-AF trial started in 2008 and focused on patients with A-Fib and systolic heart failure. The 398 participants were at 31 sites in 9 countries across Europe, Australia and the U.S.

Heart Failure occurs when it’s unable to pump enough blood to the other organs to satisfy their need for oxygen and nutrients (not that the heart has suddenly stopped).

All patients had sick hearts. Study participants had A-Fib, advanced heart failure (i.e., low ejection fraction less than 35%) and dual chamber Implantable Cardioverter Defibrillators (ICDs). Patients were randomized to receive either radiofrequency catheter ablation or conventional drug treatment.

Of the conventional drug therapy group, 30% were on antiarrhythmic drugs (AADs) and the rest were on rate control drugs.  (Note: amiodarone was used around 35% of the time as the AAD.)

EPs performing the RF catheter ablations could use whatever ablation techniques or systems deemed appropriate. 51% of ablation patients had additional isolation burns, mainly ablation lines and mapping/targeting complex fractionated atrial electrograms (CFAEs).

The median follow-up period was 37.8 months, which is longer than most other A-Fib ablation trials.

Results―Ablation Saves Lives―47% Reduction in Death Rate

Dr. Marrouche listed key results of the CASTLE-AF Clinical Trial:

Catheter ablation lowered the death rate by 47% vs conventional therapy;
In the catheter ablation group: 60% improved their ejection fraction by more than 35%;
After 5 years, 60% of the ablation group were in normal sinus rhythm compared to only 22% receiving conventional drug therapy;
There was a 51% reduction in cardiovascular mortality in the catheter group;
Even though 94% of the patients were taking Coumadin, the catheter ablation group’s stroke rate was ½ of the conventional drug treatment group;
There was a 38% reduction in all cause mortality and hospital admissions in the catheter group. A-Fib burden (percentage of time in A-Fib) also improved;
Heart failure hospital admissions improved immediately within 6 months of the ablation.

Dr. Marrouche stressed that catheter ablation for A-Fib patients should be performed early, the earlier the better. “…Ablate them early on, very soon in the disease stage.”

CASTLE-AF: Ablation Improves Quantity, Not Just Quality of Life

Catheter ablation was previously known to improve Quality of Life (QofL). But in the CASTLE-AF study, it also improved life outcomes (the quantity of life, how long one lives).

After catheter ablation, the death rate of trial patients was lowered by an amazing 47%! Catheter ablation improved lower-than-normal ejection fraction and consequently cured a major component of heart failure.

Presentation Q & A and Insightful Comments

Dr. Hugh Calkins, AF Symposium

Dr. Hugh Calkins

During the question and answer session after Dr. Marrouche’s presentation, Dr. Hugh Calkins of Johns Hopkins expressed the sentiments of not just the attendees but of all A-Fib patients and their doctors.

“This is such an unbelievably fantastic study. This is the first study to show that AF ablation improves mortality and heart failure. Hats off to you for getting this done. All of us believed in this procedure. But people kept asking us for hard end points (which you have provided).”
Dr. Douglas Packer

Dr. Douglas Packer

In a bit of hyperbole, Dr. Douglas Packer from the Mayo Clinic added,

“CABANA people everywhere were screaming with delight when they saw the results of your paper.”

Dr. Marrouche also talked about how difficult it was to get this study done, to get and keep funding, to motivate everyone involved to continue over the years. He especially thanked Medtronic Inc. for never wavering in their support of this study.

Editor’s Comments
My Anecdotal Evidence: I recently heard from a 73-year-old man I had advised who had persistent A-Fib. One month after an ablation by Dr. Andrea Natale, he is in normal sinus rhythm and his ejection fraction improved from a low 35% to a normal 55% (normal range is 50–75%)!
Even though he’s only a month into his blanking period, he reports he’s feeling terrific.
Today’s Ablation Treatments Strategies Much Improved: If the CASTLE-AF were started today rather than in 2008, we would expect to see even better results. There’s been a tremendous improvement in ablation treatment strategies over the years, such as contact force sensing catheters, balloon catheters, and advanced mapping systems.
Hard Data―Ablation Lowers Death Rate: Thanks to Dr. Marrouche and his colleagues, we now have hard data that a catheter ablation doesn’t just feel good but lets us live a healthier, longer life. It actually lowered the death rate of these very sick patients by 47% which is unheard of! (If the hard data weren’t there, no one would believe it.)
Dramatic Improvement in Heart Failure: People with congestive heart failure (low ejection fraction) say it sometimes feels like they are suffocating. (For those with advanced heart failure, nearly 90% die within one year.) Can you imagine what patients in the CASTLE-AF study experienced when their ejection fraction went from less than 35% to a 60% improvement? It’s like someone was giving them their life back again.

Personal note: When last measured, my EF was 65% ―pretty good for a 77-year-old.

Improvement of Ejection Fraction to 35% = No or Reduced Heart Failure: Over time A-Fib weakens the heart and reduces ejection fraction (leading to heart failure). Whereas patients in the ablation group reversed this remodeling effect. The most astounding statistic of CASTLE-AF is that 60% of patients improved their ejection fraction by 35% after their catheter ablation.
That kind of improvement means that many patients no longer suffered from heart failure. This is an amazing development in medicine. For people in this study, it’s like a miracle. They can now live more normal lives.
Less Hospital Admissions: A-Fib and heart failure are expensive diseases. A-Fib on average costs patients around $8,700/year. (See The Costs and Consequences of Living with Atrial Fibrillation. It’s not inconsequential that successful catheter ablations reduce hospitalizations and trips to the ER.
Wider Adoption of Catheter Ablation: The CASTLE-AF study results could be a game changer for Atrial Fibrillation patients! Results could pave the way for wider adoption of catheter ablation and may prompt changes in current guidelines for treatment.
The Bottom Line: Becoming A-Fib free by a catheter ablation doesn’t just make you feel better and gets rid of your A-Fib symptoms. We now have hard data that an ablation lets you live a healthier and longer life.

Addition reference: Marrouche NF, et al. Catheter Ablation for Atrial Fibrillation with Heart Failure. N Engl J Med 2018; 378:417-427, Feb 01, 2018. http://www.nejm.org/doi/full/10.1056/NEJMoa1707855.

If you find any errors on this page, email us. Y Last updated: Sunday, June 17, 2018

Back to 2018 AF Symposium Reports

2018 AF Symposium: Kiss of Death for FIRM Mapping? The REAFFIRM Trial

In a late-breaking presentation, the interim results of the REAFFIRM trial were presented by Dr. John Hummel from the Ohio State University Wexner Medical Center.

Focal impulse and rotor modulation (FIRM)

FIRM stands for Focal impulse and rotor modulation (FIRM) and is used for mapping electrical signals of the heart.

The trial was intended to assess the safety and effectiveness of FIRM mapping used with conventional ablation (including PVI) versus a standard PVI procedure for the treatment of persistent atrial fibrillation.

REAFFIRM Trial Design

In a prospective multi-center trial, 350 patients with persistent or long-standing persistent A-Fib who had not had a previous ablation were randomized in a 1:1 fashion. The trial was designed to compare FIRM mapping used with standard catheter ablation (including PVI) versus PVI without use of FIRM mapping.

The non-FIRM ablation control group included…Continue reading this report->

Review All My Reports

To browse all my 2018 reports, go to my 2018 AF Symposium page (or use the link in the left menu column).

My 2018 reports

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