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AF Symposium & other medical conferences articles

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

If you find any errors on this page, email us. Y Last updated: Monday, March 11, 2019

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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

If you find any errors on this page, email us. Y Last updated: Thursday, March 14, 2019

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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, especially, it’s no fun having to use a Foley catheter to pee.)

A Solution: VASCADE MVP Vascular Closure Device

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

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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: Tuesday, February 12, 2019

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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.

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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

2018 AF Symposium My Last 2 Live Procedures Reports

The Left Atrial Appendage was a popular topic at the 2018 AF Symposium. My last live case reports present two more ways for isolating the Left Atrial Appendage, one an occlusion device and the other using a CryoBalloon catheter.

Amplatzer Anulet

Installing an Amplatzer™ Amulet™ LAA Occluder

Dr. Claudio Tondo from Milan, Italy, demonstrated an LAA closure by inserting the Amplatzer Amulet LAA closure device. Because of the patient’s history of major bleeding, Dr. Tondo decided to close off her LAA first while postponing a PVI until later. (In Europe, a LAA occluder can be inserted at the same time as a catheter ablation). (See also, Installing a Coherex WaveCrest LAA Occlusion Device.)

The Amplatzer has two lips which close over both the outside and the inside of the LAA―like a sandwich…Continue reading this report->

CryoBalloon catheter

CryoBalloon catheter

CryoBalloon Catheter for Isolation of the LAA

To isolate the Non-PV triggers originating in the patient’s Left Atrial Appendage, Dr. Knight used a CryoBalloon catheter in order to penetrate deeper into the LAA tissue.

Using the CryoBalloon Catheter for this procedure is an “off-label use”, i.e., a new use not described in the FDA approved device labeling. (Also see, Isolating the Left Atrial Appendage using RF Energy) Dr. Knight used a 28mm CryoBalloon catheter… Continue reading this report>

Read My Other Live Case 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: more to come

2018 AF Symposium Live Case: CryoBalloon Catheter for Isolation of the LAA

by Steve S. Ryan, PhD.

B. Knight MD

During this live streaming video, Dr. Bradley Knight from Northwestern Un. in Chicago, IL demonstrated the use of a CryoBalloon Catheter to isolate the Left Atrial Appendage (an off-label use, i.e. a new use not described in the FDA approved device labeling.).

Patient background: His patient was a 72-year-old man with hypertension and persistent A-Fib. He had an ablation in 2013. His ejection fraction was low but improved after a cardioversion to 40%. July 15, 2017 he had a right atrium Flutter ablation. He was on amiodarone which had to be stopped because of thyroid problems.
He developed severe Left Atrium enlargement and his ejection fraction went down to 30%. His PVs was were very large and hard to isolate. It was recommended to do both a repeat PVI and to isolate the LAA.
Live Streaming Video from AF Symposium at A-Fib.com

Isolating the Left Atrial Appendage

To isolate the Non-PV triggers originating in the patient’s Left Atrial Appendage, Dr. Knight used a 28 mm CryoBalloon catheter in order to penetrate deeper into the LAA.

A second freeze was performed and then a third freeze was necessary because the LAA was still generating A-Fib signals. Before we could see this third freeze, the allotted time slot ran out.

The use of the CryoBalloon catheter appeared to be an effective treatment (though an off-label use) to isolate the LAA.

Editor’s comments:
I was surprised that two CryoBalloon lesions didn’t effectively isolate the patient’s LAA and a third lesion was necessary.
On the other hand, the use of the CryoBalloon catheter to isolate the LAA is in the very preliminary stage of research.
From watching Dr.Knight’s live case, it doesn’t seem like the CryoBalloon catheter will emerge as a viable method of electrically isolating the LAA.

If you find any errors on this page, email us. Y Last updated: Saturday, February 16, 2019

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

by Steve S. Ryan, PhD

John Hummel MD

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

Focal impulse and rotor modulation (FIRM)

Note: REAFFIRM stands for “Randomized Evaluation of Atrial Fibrillation Treatment with Focal Impulse and Rotor Modulation Guided Procedures” (REAFFIRM).
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 CTI (Cavo Tricuspid Isthmus Ablation for atrial flutter) and extra non-PV trigger ablations. Irrigated catheters were used in all cases, but not all used contact force sensing catheters.

Patients were monitored for 12 months with Holter and implantable monitors. The patients were primarily white males 65+ years old. There were no significant differences in the two groups of patients.

Trial Results: No Significant Difference in FIRM+PVI vs. PVI Alone

Prediction: It was anticipated that the control arm (PVI alone) would have a freedom from A-Fib success rate of 40% versus the treatment arm (FIRM+ PVI) would have a success rate of 75%.

Actual: At 12 months the success rate of the treatment (FIRM+ PVI) was 78%, while the control group with PVI alone had a success rate of 70%. This was a non-significant difference (not what the researchers had expected).

Translation: The control arm of the trial (PVI alone) did much better than anticipated. The researchers are trying now to look more closely at the details of the non-FIRM trial to identify why it did so well.

What this Trial Means for Patients

The REAFFIRM trial was a well designed study which showed that FIRM is not significantly better that a standard well-performed PVI ablation.
This is not the first study to call into question the effectiveness of the FIRM system. Critical Analysis of the FIRM Mapping System (2015) and More FIRM Research: Mapping System Falls Short (Again) (2016).
Unless and until the smoke clears and we have further research, the FIRM system probably won’t be an effective player long-term in the world of A-Fib ablation.
Bottom line: Don’t go out of your way to find a center or EP using the FIRM mapping system.

If you find any errors on this page, email us. Y Last updated: Wednesday, February 28, 2018

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2018 AF Symposium Live Case: Installing a Coherex WaveCrest LAA Occlusion Device

by Steve S. Ryan, PhD.
Background: The Coherex WaveCrest Left Atrial Appendage (LAA) occlusion device is not yet approved by the FDA for use in the U.S. The WaveCrest is similar in purpose to the Boston Scientific Watchman™ LAA Closure Device (which is FDA approved).

Tom De Potter MD

Dr. Tom De Potter of Aalst, Belgium, presented a live case in which he installed a Coherex WaveCrest Left Atrial Appendage (LAA) occlusion device in an 84-year-old female with longstanding A-Fib and a bleeding problem.

The WaveCrest has roll-out anchors which are then fixed into the sides of the LAA. It comes in three sizes to fit different LAA openings.Live Streaming Video from AF Symposium at A-Fib.com

He spent a good deal of time and attention washing and immersing the WaveCrest in water to make sure there were no bubbles.

When the device is expanded inside the LAA, it can be repositioned and recaptured. Dr. Potter seemed to tug and firmly push and pull the device to anchor it.  After insertion, it requires 2 months of dual antiplatelet therapy.

WaveCrest is from Coherex Medical, Inc., a subsidiary of Biosense Webster/Johnson & Johnson.

Coherex WaveCrest Video

Video still frames of Coherex WaveCrest occlusion device positioned in LAA.

Video animation is available: The Coherex Medical website has a short (35-second) showing the installation of the Coherex WaveCrest Left Atrial Appendage (LAA) occlusion device. Go to video on the Coherex website->

Editor’s Comments:
To me the WaveCrest seemed similar to Boston Scientific Watchman LAA Closure Device which did all the heavy lifting to be the first LAA occlusion device to get U.S. FDA approval.
I didn’t see major significant advantages of the WaveCrest. Though it’s always good for EPs to have a choice of devices when closing off the LAA.
For more on the Watchman, see  my article, The Watchman™ Device: An Alternative to Blood Thinners. 

If you find any errors on this page, email us. Y Last updated: Wednesday, February 28, 2018

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2018 AF Symposium Live Case: Installing an Amplatzer™ Amulet™ LAA Occluder

by Steve S. Ryan, PhD.

Illustration: Amplatzer Amulet in LAA

On the Thursday session on Left Atrial Appendage Closure, two live cases were presented via streaming video from around the world.

Here, I cover the first live case featuring the Amplatzer™ Amulet™ Left Atrial Appendage (LAA) occlusion device. (For my report on the other occluder, see: Installing a Coherex WaveCrest LAA Occlusion Device.)

Note: The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder, is not yet approved by the FDA for use in the U.S. It is similar in purpose to the Boston Scientific Watchman™ LAA Closure Device (which is FDA approved). The Amplatzer™ Amulet™ is from Abbott (formerly St. Jude Medical).

Patient Background: An 81-year-old lady with acute hypertension was in permanent A-Fib since 2016. Her CHADS2VASc score was 5 (at the top of the risk range), her HAS-BLED score was 4 (high for one year risk of major bleeding). She had suffered syncope (fainting) episodes and had a history of major bleeding on anticoagulants (the reason for the LAA closure). On the positive side, her Ejection Fraction was a healthy 61%.

Live From Milan, Italy

Claudio Tondo, MD

Dr. Claudio Tondo from Milan, Italy, demonstrated an LAA Closure by inserting an Amplatzer LAA closure device.

In Europe, a LAA occluder can be inserted at the same time as a PVI (catheter ablation). But for the AF Symposium live session, only the Amplatzer Amulet™ was inserted.  (Because of her history of major bleeding, Dr. Tondo decided to close off her LAA first while postponing a PVI till later.)

Amplatzer Amulet Features

Amplatzer™ Amulet™ illustration at A-Fib.com

Amplatzer™ Amulet™

The Amplatzer has two lips which close over both the outside and the inside of the LAA―like a sandwich. It comes in different sizes to fit better into different sized LAAs.

One advantage of the Amplatzer is less risk of leaking because the inside and outside lips overlap the opening of the LAA. Over time, heart tissue grows over the implant, becoming part of the heart.

Inserting the Amplatzer LAA Occluder

Live Streaming Video from AF Symposium at A-Fib.com

The primary imaging technology used to insert the Amplatzer was Intracardiac Echo, though fluoroscopy was used as an adjunct to help the audience follow the procedure. In the Echo you could see the Amplatzer being positioned and inserted into the LAA. (I could follow the fluoroscopy but found it hard to follow the Echo.)

Dr. Tondo described her LAA shape as “chicken wing” which is usually an LAA shape easier to close off. It appeared relatively easy to insert the device into the patient’s LAA, then fit it snugly into the LAA opening.

Dr. Tondo and his team used a type of dye pumped in behind the Amplatzer to see if there was any blow back or leaking. Once that was done, they simply disconnected the catheter used to insert the Amplatzer.

Amplatzer™ Amulet™ Video

A short animation from Abbott (formerly St. Jude Medical) illustrates insertion of the Amplatzer™ Amulet™ LAA Occluder (1:14). To watch the video, go to Abbott webpage->

Editor’s Comments:
About this patient: This 81-year-old lady was in a very difficult, risky situation. Her stroke risk was very high, but she couldn’t take anticoagulants to prevent a stroke because they caused her bleeding. By inserting the Amplatzer Amulet device to close off her Left Atrial Appendage (LAA), Dr. Tondo would significantly lower her risk of an A-Fib stroke which mostly comes from the LAA.
Her persistent A-Fib was very symptomatic with dangerous fainting episodes. She needed a catheter ablation to get her back into normal sinus rhythm. Dr. Tondo planned to perform the PVI as soon as possible after her LAA closure.

Two LAA occluder devices

About the Amplatzer Amulet: Having previously watched the Watchman Device procedure, to me the Amplatzer Amulet seemed simpler to insert. Though both are relatively easy to install.
One potential problem with an Amulet might occur if a subsequent catheter ablation requires the LAA to be mapped and isolated. It will be harder to do so because the lips of the Amulet cover the LAA opening.
In Europe, the Amplatzer Amulet is used to close holes in the septum (called ‘patent foramen ovale’, i.e. a hole in the heart that didn’t close the way it should after birth.).
Once approved in the U.S. by the FDA, it will probably become a competitor or an alternative to the Watchman Device.

If you find any errors on this page, email us. Y Last updated: Saturday, February 16, 2019

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