Doctors & patients are saying about 'A-Fib.com'...


"A-Fib.com is a great web site for patients, that is unequaled by anything else out there."

Dr. Douglas L. Packer, MD, FHRS, Mayo Clinic, Rochester, MN

"Jill and I put you and your work in our prayers every night. What you do to help people through this [A-Fib] process is really incredible."

Jill and Steve Douglas, East Troy, WI 

“I really appreciate all the information on your website as it allows me to be a better informed patient and to know what questions to ask my EP. 

Faye Spencer, Boise, ID, April 2017

“I think your site has helped a lot of patients.”

Dr. Hugh G. Calkins, MD  Johns Hopkins,
Baltimore, MD


Doctors & patients are saying about 'Beat Your A-Fib'...


"If I had [your book] 10 years ago, it would have saved me 8 years of hell.”

Roy Salmon, Patient, A-Fib Free,
Adelaide, Australia

"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su,
Cavanaugh Heart Center, 
Phoenix, AZ

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient, 
Rome, Italy

"Within the pages of Beat Your A-Fib, Dr. Steve Ryan, PhD, provides a comprehensive guide for persons seeking to find a cure for their Atrial Fibrillation."

Walter Kerwin, MD, Cedars-Sinai Medical Center, Los Angeles, CA


Catheter Ablation

Can One Have a Stroke If A-Fib Free? Years After Successful Ablation, He has TIAs

Steve from Minnesota had a successful catheter ablation in 2016 at the Mayo Clinic. He remained in normal sinus rhythm (NSR), off all medications and felt very good. He walked every day and felt well.

TIA symptoms are the same as a stroke, and usually begin suddenly. The difference is the symptoms only last for a few minutes or hours as the blockage is temporary.

Recently he wrote to me that in the fall of 2018, he had a TIA (Transient Ischemic Attack, a temporary stroke) where his left arm went limp for about 30-60 seconds. Then in March 2019, another TIA caused him to lose complete vision in his left eye for 2-3 minutes.

In response, his electrophysiologist (EP) put him on the anticoagulant Eliquis. He wore a loop monitor which showed he was in normal sinus rhythm with only a single “5-beat atrial tachycardia” (only one irregular beat). All the usual tests came back showing no heart problems.

How can Steve have TIAs if he doesn’t have any A-Fib?

Unfortunately for A-Fib patients, clots and stroke can also be non-A-Fib related, such as vascular strokes or hypertensive lacunar stroke. (Vascular and cerebrovascular disease can produce a heart attack or coronary event as well as a clot or stroke.)

With A-Fib patients, clots more often come the Left Atrium and Left Atrial Appendage (LAA). But stroke can originate from other areas. For example, plaque deposits in the arteries can break loose and form clots.

Also, if Minnesota Steve developed some fibrosis while he was in A-Fib, his left atrium may not be contracting properly making clot formation more possible. And sometimes if the LAA is electrically isolated during the ablation, it may not be contracting properly and can develop clots.

(Doctors may want to check Minnesota Steve for Patent Foramen Ovale and Atrial Septal Defect where a hole in the septum can permit clots to pass to the brain. Though, normally, this problem would have been found when performing Steve’s original ablation.

A transient ischemic attack (TIA) occurs when part of the brain experiences a temporary lack of blood flow. This causes stroke-like symptoms that resolve within 24 hours. Unlike a stroke, a ministroke on its own doesn’t cause permanent disabilities.

Would a Watchman device to close off the LAA prevent these TIAs?

Not necessarily. For patients with A-Fib, clots tend to form in the Left Atrial Appendage (LAA) because blood tends to stagnate there. But if blood is being pumped properly in the left atrium, it’s harder for clots to form in the LAA. (And other areas of clot formation can occur in the left atrium besides the LAA.)

What should Steve do now? What can he do to guarantee that he will never have a stroke?

Having TIAs is a warning sign. Often, but not always, TIAs precede a major stroke. To help guard against clots and stroke, Minnesota Steve will likely have to be on an anticoagulant, such as Eliquis, for life.

What’s Next for Steve?

Minnesota Steve and his doctor should concentrate on treating vascular risk factors such as blood pressure, diabetes, cholesterol control, (CHADs2-VASc) and if needed, stop smoking. And, of course, continue monitoring for A-Fib.

Fibrosis makes the heart stiff, less flexible and weak, overworks the heart and reduces pumping efficiency.

Minnesota Steve probably should have an MRI done to measure for fibrosis in his heart. In addition, his Left Atrial Appendage (LAA) should be checked with a echocardiograph (TEE) to see if it is emptying properly.

His doctor may also want to determine how much plaque Minnesota Steve has in his arteries. How likely is it to break off and form clots? (Some doctors may suggest antiplatelet therapy in addition to the anticoagulant Eliquis, but usually the two are not combined effectively.)

I’ll continue to track Minnesota Steve’s progress and write an update if I get more information on his health status.

No Absolute Guarantee Against Stroke

While anticoagulants significantly lower the risk of an A-Fib stroke, they but do not totally eliminate it.

While anticoagulants significantly lower the risk of an A-Fib stroke, but they do not totally eliminate the risk.

A close friend of ours with A-Fib was on Coumadin at the ideal INR range (2.5) and still had a major stroke.

After a successful catheter ablation such as Minnesota Steve had, one’s stroke risk generally drops down to that of a normal person. But normal people have strokes and TIAs, too.

There is no therapy that will absolutely guarantee one will never have a stroke.

Share Your Views at A-Fib.comMinnesota Steve is blessed to have no permanent damage from those TIAs. But they are warning signs which must be heeded, probably by life-long anticoagulation. No one wants to be on anticoagulants for life. But he may not have any other choice.

Share your insights: Without a lot of current definitive research, this is a difficult subject to discuss. If anyone has any suggestions, criticisms, or comments to share on this most important topic, please email me.

A special thanks to Steve from Minnesota for asking this question and sharing his TIA experiences.

Your Nearest ‘Certified Stroke Center’ Could Save Your Life

or avert the debilitating effects of an A-Fib stroke.
But only if you get there within four hours.

Use my article to find your nearest certified or ‘Advanced Comprehensive Stroke Center’. Read my article.

Tony Rejects Drug Therapy: Says to Ask Questions, None are Stupid

Tony Hall, Evansville, IN, was 54 years old when he develped Atrial Fibrillation in January 2014. After confirming his diagnosis at the hospital, he wrote:

“I sit in the passenger seat feeling like a pet heading to a kennel. Suddenly things are different. I no longer have that “healthy as a horse” attitude.”

He started drug therapy. Then came a cardioconversion, but that didn’t keep him in normal sinus rhythm for long. He was in and out of A-Fib, and by August was in persistent A-Fib.

Learning His Treatment Options

Tony didn’t passively accept everything he was hearing from doctors and others.

He and his wife, Jill, read as much as they could and critically waded through the information they found. (I’m continually amazed at how much mis-information there is about A-Fib on the internet and in the media.)

5-months post-ablation, Tony and Jill after 10K race.

After doing his research, educating himself about treatment options and learning what his health insurance would cover, he chose to have a catheter ablation at the Mayo Clinic in December 2014.

During his three month blanking period, he had some sporadic fluttering and early on a couple of brief A-Fib episodes.

Off all medication and A-Fib-free, in March 2015 he completed a 10K race beating his time from the previous year by a fraction.

Becoming his Own Best Patient Advocate

Tony and Jill are great examples for all A-Fibbers of how to become your own best patient advocate. He rejected endless trials of various drug therapies. Instead he opted for a catheter ablation just shy of a year after his initial A-Fib diagnosis.

In his A-Fib story, he shares this advice to others considering a catheter ablation:

“Make sure, if you desire to have an ablation, that your reasoning is sound and that you have a good argument as to why drug therapy is not the way you want to go.
Having an ablation as front line treatment for A-Fib is not embraced by every EP, and many are reluctant to ablate until drug therapy has failed.
Be persistent and move on [to another doctor] if you are met with resistance.”

For Tony Hall’s personal experience story, see: Very Active 54-Year Old Became His Own Patient Advocate; Chose Ablation as First Line Treatment.

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

If you find any errors on this page, email us. Y Last updated: Friday, February 8, 2019

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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.

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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5-Year CABANA Trial: Compares Catheter Ablation with Antiarrhythmic Drug Therapy

The catheter ablation procedure for Atrial Fibrillation has been around for 20+ years.

In a randomized controlled trial, the 5-year CABANA study is the largest to compare the A-Fib treatments of catheter ablation (PVI) and antiarrhythmic drug therapy (AAD).

CABANA stands for Catheter Ablation versus Antiarrhythmic Drug Therapy.

CABANA Trial Design

Worldwide, 2,204 patients with new onset or undertreated Atrial Fibrillation were randomized between two treatments: catheter ablation (PVI) or antiarrhythmic drug (AAD) therapy. Patient participants were followed for nearly 5 years.

Patients details: Many patients had concurrent illnesses with Atrial Fibrillation: cardiomyopathy (9%), chronic heart failure (15%), prior cerebrovascular accidents or TIAs (mini-strokes) (10%).

Over half of participants (57%) had persistent or long-standing persistent A-Fib [i.e. harder types of A-Fib to cure].

Drug details: Antiarrhythmic drug (AAD) therapy was mostly rhythm control (87.2%), some received rate control drug therapy.

Anticoagulation drug therapy was used in both groups.

CABANA Trial Results

Crossover a Major Problem: Many in the AAD therapy arm decided to have a catheter ablation instead (27.5%). And some in the ablation arm decided not to have an ablation (9.2%). [One can not blame patients or their doctors for making these life-impacting choices.] 

The CABANA results showed catheter ablation was significantly better than drug therapy for the primary endpoint (a composite of all-cause mortality, disabling stroke, serious bleeding or cardiac arrest). [See Additional Research Findings below.] Mortality and death rate were also significantly better for catheter ablation.

CABANA Findings: Ablation vs AAD Therapy

▪ Catheter Ablation significantly reduced the recurrence of A-Fib versus AAD therapy.

▪ Catheter Ablation improved ‘quality of life’ (QofL) more than AAD therapy, though both groups showed substantial improvement.

▪ Catheter Ablation patients had incremental, clinically meaningful and significant improvements in A-Fib-related symptoms. This benefit was sustained over 5 years of follow-up.

▪ Catheter Ablation was found to be a safe and effective therapy for A-Fib and had low adverse event rates.

Take-Aways for A-Fib Patients

Ablation Works Better than Antiarrhythmic Drugs: Rather than a life on antiarrhythmic drug therapy, the CABANA trial and other studies show that a catheter ablation is the better choice over antiarrhythmic drug therapy.

For related studies, see CASTLE AF: Live Longer-Have a Catheter Ablation and AATAC AF: Catheter Ablation Compared to Amiodarone Drug Therapy.

In an editorial in the Journal of Innovations in Cardiac Rhythm Management, Dr. Moussa Mansour, Massachusetts General Hospital, wrote about the CABANA trial:

“It confirmed our belief that catheter ablation is a superior treatment to the use of pharmacological agents, and corroborates the findings of many other radomized clinical trials.” 

Lower Recurrence: What’s also important for patients is the lower risk of recurrence of A-Fib versus AAD therapy.

Reduced Ablation Safety Concerns: Ablation significantly improved overall mortality and major heart problems.

Immeasurable Improvement in Quality of Life! Perhaps even more important for patients on a daily basis, catheter ablation significantly improved quality of life.

Don’t Settle for a Lifetime on Drugs

Over the years, catheter ablation for A-Fib has become an increasingly low risk procedure with reduced safety concerns. (Ablation isn’t surgery. There’s no cutting involved. Complication risk is similar to tubal ligation or vasectomy.)

An ablation can reduce or entirely rid you of your A-Fib symptoms, make you feel better, and let you live a healthier and longer life (for people who are older, too). A catheter ablation significantly improves your quality of life (even if you need a second “re-do ablation” down the road).

For many, many patients, A-Fib is definitely curable. Getting back into normal sinus rhythm and staying in sinus rhythm is a life-changing experience, as anyone who’s free from the burden of A-Fib can tell you.

See also:  Does a Successful Catheter Ablation Have Side Benefits? How About a Failed Ablation?

Additional Study Findings
Primary endpoints: Results of the primary endpoints were not significant. This is probably due to the crossovers and the lower than expected adverse event rates (5.2% for ablation versus 6.1% for AAD therapy).

Deeper Analysis of Data: The researchers performed sensitivity analyses on the primary results using “treatment received” and “per protocol” rather than “intent to treat”.

Research Terms: Primary endpoint—specific event the study is designed to assess. Intent to treat—all assigned to the AAD group compared to the assigned ablation group (even though 1/4 crossed over to the ablation group). Treatment received—compared all who received an ablation to all who received AAD therapy.
References for this article
• Packer, Douglas. CABANA trial provides important new data on clinical and quality of life effects of ablation for atrial fibrillation. Cardiac Rhythm News: October 18, 2018, Issue 42. P. 1.

• Mansour, Moussa. Letter from the Editor in Chief. The Journal of Innovations in Cardiac Rhythm Management, June 2018. DOI: 10.19102/icrm.2018.090609.

After 18 years in A-Fib, Triathlete Mike Jones Asked, “Could I Be so Fortunate?”

In his A-Fib story, Mike Jones writes that he’d been a very physically active middle age man who competed in running, triathlons and handball. It was difficult for him to accept that “something was wrong”.

In fact, he had paroxysmal A-Fib episodes for at least three years before his official diagnosis. Over the many years, he had been on various drug therapies, but nonetheless, his A-Fib episodes become very debilitating. He shares:

Mike Jones

“For many years, surgical intervention was out of reach, and financially out of the question for me. And, in those days, there was only the “Maze”. Along the way, I read a little bit about the Mini Maze, which did not inspire me much either.
It wasn’t until I found “A-Fib Resources for Patients” [A-Fib.com] that I began to take a real interest in researching PVI/PVA [Pulmonary Vein Isolation/Ablation] .”

Mike recalls the day after his life-changing catheter ablation:

“On the drive home the following afternoon, I thought about all those years that I had spent….with all of the drugs, and all of the depressing hours, with all of the sacrifices, and all of the fear…nearly 15 years of it.
Then, my long-awaited PVI procedure. In a 2 day period of time, with little discomfort (and within my budget!) all of that might now be behind me.
Could I be so fortunate?
I feel a little foolish now, a little sheepish, that I had made such a big thing out of getting this procedure done.”

Life After His Ablation

In the ten months following his ablation, Mike writes that he only had two episodes early on and that he continues to take soaks in Epson salts once a week to keep his magnesium levels up.

He writes about his life now that it is free of A-Fib:

 “I do not take any blood thinners, and no heart medication whatsoever. In my 70’s now, I won’t be running any endurance races, and my conditioning level is too low for any serious handball (yet).
But my energy level is high enough that I live a very normal life. I am a hobby woodworker, and I typically spend anywhere from 4 to 6 hours a day in my shop. I walk, swim, cut wood, and, when nobody is looking…I dance.
“I walk, swim, cut wood, and, when nobody is looking…I dance.”
I understand that the A-Fibs might one day return, but I would have no hesitation in returning for a tune up if, or when, that day should ever arrive.”

―Mike Jones, Redding, CA, Now A-Fib free after an ablation using both CryoBalloon and RF methods 

A-Fib is a Progressive Disease

It’s really remarkable that Mike could live in paroxysmal A-Fib for 18 years and not progress to Persistent or Longstanding Persistent A-Fib. In one study over half the people who developed paroxysmal A-Fib turned Persistent after only one year. Perhaps Mike’s athleticism and fitness kept his A-Fib from getting worse.

In most people, A-Fib is a progressive disease that remodels the heart and gets worse over time. To avoid this happening to you, aim to be A-Fib free as soon as you can.

For more about Mike, read his A-Fib story, Triathlete 18 years in A-Fib, on Amiodarone for eight years―then A-Fib free after ablation by Dr. Padraig O’Neill.

For more A-Fib stories to encourage and inspire you, go to Personal A-Fib Stories of Hope.

“Normal” Has a New Meaning for Jim After His Ablation

Before you developed Atrial Fibrillation, did you lead an active lifestyle? Has A-Fib robbed you of your energy and replaced it with fatigue? That’s what happened to Jim. After years of drug therapy that didn’t work, read how Jim recovered his active lifestyle post-ablation.

Three years after his ablation, Jim McGauley of Macclenny, FL, shared his personal A-Fib story with our A-Fib.com readers. His atrial fibrillation had been detected several years earlier but was not controlled effectively with drug therapy.

Jim underwent a catheter ablation in the summer of 2009. His procedure was performed without complications by Dr. Saumil Oza and his team at St. Vincent’s Medical Center, Bridgeport, CT.

He writes that, after a brief period of recuperation, he resumed normal activity.  In his story, After Years in A-Fib, New Energy and Improved Life, Jim shares: 

“Within a matter of days [of my ablation], I realized that “normal” had a new meaning.
I had lived with the atrial fibrillation for years, and it took the ablation and resulting corrected heart rhythm to bring about a marked surge in my energy level with less fatigue and an overall sense of “fitness”.
I have always maintained an active lifestyle, but post-ablation I was able to increase significantly my exercise regimen. I now run 2-3 miles three times a week and include modest weight training to keep my upper body toned.”
Jim McGauley, Publisher, The Baker County Press, Macclenny, FL. After failed drug therapy, now A-Fib free via catheter ablation.

Catheter Ablation Can Have Life-Altering Effects

Atrial Fibrillation patients seeking a cure and relief from their symptoms often have many questions about catheter ablation procedures. To learn more, see:

• VIDEO: When Drug Therapy Fails: Why Patients Consider Catheter Ablation (3:00 min., includes transcript)
• Treatments/Catheter Ablation
• Frequently Asked Questions: Catheter Ablation, Pulmonary Vein Isolation, CyroBalloon Ablation

About the ablation experience itself, Jim went on to share:

“The ablation itself is minimally invasive considering that it is correcting an abnormality inside the heart itself, and the recovery period was brief and generally comfortable.

I would readily recommend it… to anyone qualifying as a candidate to correct atrial fibrillation.”

―Jim McGauley, now A-Fib free after catheter ablation 

Diet and Nutrition: ‘The China Study’ and Other Diet Plans With Dr. Joseph Mercola

After Saul Lisauskas of Encinitas, CA was diagnosed with Atrial Fibrillation, he was disappointed by doctors who offered only drug therapy with no advice about improving his symptoms through diet and nutrition. He decided to educated himself on the topic: In his A-Fib story Saul wrote:

Saul Lisauskas

“I read a few books on the subject of food and the interaction with our body. The best book was The China Study. It will give you an education about food, its sources and dangers.”

The China Study Book and its Critics

The China Study by T. Colin Campbell & Thomas M. Campbell II was first published in 2004. The book’s title comes from the China-Cornell-Oxford Project, a 20-year study that began in 1983 and was conducted jointly by the Chinese Academy of Preventive Medicine, Cornell University, and the University of Oxford.

By Campbell & Campbell II

Conflicting opinions: There has been criticism of some of the conclusions drawn in The China Study (mostly focused on data collection, collection bias and data analysis).

Publisher of Cholesterol-and-Health.com Christopher Masterjohn, PhD has written: “Only 39 of 350 pages are actually devoted to the China study…[The China Study] would be more aptly titled, A Comprehensive Case for the Vegan Diet, and the reader should be cautioned that the evidence is selected, presented, and interpreted with the goal of making that case in mind.”

The Cornell-Oxford-China Study: A Critique (Jesse and Julie Racsh Foundation) states: “After performing regression analyses, the data does not justify the indictment of all animal foods as risk factors for chronic degenerative disease.” Read the report online or download the PDF.

A Critical Look at ‘The China Study’ and Other Diet Plans: Dr. Mercola Interviews Denise Minger

Dr J. Mercola

A jam-packed, up-to-date article for those interested in improving current health problems and long-term health through diet and nutrition.

Denise Minger

Published in July 2018, natural health expert and Mercola.com founder Dr. Joseph Mercola interviewed Denise Minger, most noted for her comprehensive rebuttal of “The China Study” (The China Study: Fact or Fallacy?) some eight years ago. She’s heavily vested in the vegan versus omnivore battle, having cycled through vegetarianism and raw veganism, finally coming full circle to being an omnivore.

Topics covered in a Critical Look at ‘The China Study’ and Other Diet Plans:

• Raw Veganism Took a Toll on Health
• Debunking ‘The China Study’
• The Case for Lowering Protein Intake
• Protein Cycling
• Macronutrient Cycling — An Overlooked Component of Optimal Health
• Cyclical Ketogenic Diet Is Ideally Combined With Cyclical Fasting
• Focus on Nutrient Density
• How Minger’s Diet Has Changed Over the Years
• Critiquing the Blood Type Diet
• Awesome Omnivore
• Plant-Based Paleo
• Lifelong Learning Is Key to Staying Ahead

Go to A Critical Look at ‘The China Study’ and Other Diet Plans.

VIDEO: Highlights from Dr. Joseph Mercola’s interview with Denise Minger (2:28)


YouTube video playback controls are located in the lower right portion of the frame: closed captions,
speed/quality, watch on YouTube website and enlarge video to full frame.

Additional Resources About Diet and Nutrition

Download the full transcript of Dr. Mercola’s interview with Denise Minger. Read Debra Minger’s The China Study: Fact or Fallacy?.

Read The China Study for Free: The 2006 edition is available to read online or download.

The 2017 edition of The China Study is available at Amazon.com and other bookstores.

See my article: The Effect of Diet & Nutrition on Your A-Fib: My Top 5 Articles.

Resources for this article

• The China Project: Studying the Link Between Diet and Disease. Study room provides a general overview and introduction to the Cornell-China-Oxford project. Accessed August 7, 2018 URL: http://www.cornell.edu/video/playlist/the-china-project-studying-the-link-between-diet-and-disease

• Cornell-Oxford-China Study: A Critique. Jesse and Julie Racsh Foundation. Accessed August 7, 2018 URL: http://www.raschfoundation.org/wp-content/uploads/Cornell_Oxford_China-Study-Critique.pdf

• Masterjohn, C. The Truth About the China Study. Cholesterol and Health.com Accessed August 7, 2018 URL: http://www.cholesterol-and-health.com/China-Study.html

• Mercola, J. A Critical Look at ‘The China Study’ and Other Diet Plans. Mercola.com, July 08, 2018. URL: https://articles.mercola.com/sites/articles/archive/2018/07/08/the-china-study-and-other-nutrition-plans.aspx

• Minger, D. The China Study: Fact or Fallacy? July 7, 2010. DeniseMinger.com. https://deniseminger.com/2010/07/07/the-china-study-fact-or-fallac/

No Way Am I Having an Ablation! Seeks Alternative Treatments

Saul Lisauskas of Encinitas, CA, was 62 years old when he first detected something wrong with his heart. After his A-Fib was diagnosed, he started to note his episodes were associated with stress and getting angry, along with dehydration, too much caffeinated coffee and foods containing MSG.

Saul Lisauskas

He was disappointed by doctors who offered only drug therapy with no advice about nutrition and the benefts of an improved, healthy diet. He decided to educated himself on the topic: Saul wrote:

“I read a few books on the subject of food and the interaction with our body. The best book was The China Study. It will give you an education about food, its sources and dangers.”

Looking for Alternative Treatments: A Vegetarian Diet

While avoiding his A-Fib ‘triggers’, he decided to go vegetarian but eating fish (a pescetarian) to reduce exposures to foods laced with unhealthy chemicals. (As a bonus, he lost 20 pounds in 3 months.) He was feeling better, but his A-Fib was still active. In his A-Fib story, Saul shares:

“The cardiologist explained to me that the real solution lay in having an Ablation procedure. I was willing to do anything to avoid that surgery.
“I was willing to do anything to avoid that surgery [catheter ablation].”
But with time, my A-Fib episodes increased along with longer periods of activity and stronger symptoms.”
During my ordeal leading up to my Ablation procedure, I was taking various meds in order to control my A-Fib.
However, the meds would make me dizzy and slow down my heart rate to dangerous levels to the point that such levels in fact were counterproductive. My system would compensate by sudden increases of adrenaline and consequently place me in A-Fib mode.
Consequently, I had a pacemaker installed to prevent low levels of heart rate.”

After nearly 8 years since his A-Fib diagnosis, Saul writes about his decision to have a catheter ablation:

“I was getting tired of and frustrated with all these meds.
After too many episodes of A-Fib forcing me to go to the ER, I capitulated against the Ablation surgery and had it done.
Today I am feeling well and doing my daily activities. …I feel that I may be cured well enough not to have to have another ablation.”

― Saul Lisauskas, Encinitas, CA, A-Fib free with pacemaker and catheter ablation

Since his ablation, Saul writes that he remains cautious not to run the risk of stress, dehydration, too much caffeinated coffee or getting angry.

To read more about Saul’s story, see No Way Am I Having an Ablation! But Diet and Meds Disappoint—A-Fib Free After Ablation.

Lessons Learned

When asked if he had any ‘Lessons Learned’ to share, Saul offers these insights:

”Doctors do not have a solution for everybody with A-Fib…We need to carefully educate ourselves as we follow the doctor’s recommendations and observe how our body reacts. Do not follow blindly the doctor’s recommendations.”

Saul certainly did everything he could to avoid having an ablation—identifying what triggered his A-Fib, a vegan diet with fish and all kinds of meds.

Saul certainly did everything he could to avoid having an ablation.

His experience with meds was unfortunate. The meds Saul was taking slowed his heart rate to the point where his doctor had to insert a pacemaker to keep his heart rate normal. It’s crazy to think about it. If this happens to you, talk to your doctor about changing meds (or change doctors).

Unfortunately, once the heart starts to produce A-Fib signals, it’s hard to turn them off. Saul faced the decision that many people have to make. He bit the bullet and had a catheter ablation―with successful results. He’s now A-Fib free!

What’s the Best Treatment Options For You?

A-Fib is not a one-size-fits-all disease. Your Atrial Fibrillation is unique to you. Along with various treatments, you may need to address concurrent medical conditions (i.e, hypertension, diabetes, obesity, sleep apnea). Likewise, you may need to make lifestyle changes (e.g., diet, exercise, caffeine, alcohol, smoking).

In addition, your heart is a resilient muscle that tends to heal itself, so you may need a repeat procedure.

To learn about options for Atrial Fibrillation patients, see our pages under Treatments for A-Fib. Then go to: Decisions About Treatment Options. And remember…

Always Aim for a Cure!

NEW VIDEO: What Should I Expect After my A-Fib Catheter Ablation Procedure?

What to expect post-ablation

We have posted a new video that features Cardiac Electrophysiologist Dr. Darryl Wells.

He talks about judging the success of your ablation, why it’s difficult to predict which patients will be completely cured after one ablation procedure and why some require two procedures.

He discusses safety of the procedure and the appropriate age range for patients to receive the ablation procedure. (3:17)

Published by Swedish Heart and Vascular Institute. Go to video->

PVCs Aren’t Always Benign, and He Didn’t Want to Live with Them

Do NOT listen when doctors say PVCs are harmless, writes John Thorton from Sioux Falls, SD. Besides A-Fib and A-Flutter, his PVCs were destroying his life and driving him crazy.

Premature Ventricular Contractions (PVCs) are premature beats that occur in the ventricles, i.e., the heart’s lower chambers. (Premature beats that occur in the atria, the heart’s upper chambers, are called premature atrial contractions, or PACs.) In his A-Fib story, John writes:

John & Marcia T.

“The local MDs (about a half dozen different ones), cardiologists, EPs, and other local specialists, all told me stuff like: “Everyone has PVCs” and “PVCs are benign,” and “It is just anxiety,” and “You just need to learn to live with it”.
Which was completely WRONG.
Being his Own Patient Advocate

In his A-Fib story, PVC-Free After Successful Ablation at Mayo Clinic, John advises: Be assertive, even aggressive.

“I had to set up my own appointment at Mayo Clinic to get evaluated there. It was a lot of work, by me alone, to get in to see the doctors at Mayo, but it was worth it.
I honestly believe that had I not gone to Mayo, I would have suffered some major heart event, or possibly death.”

PVCs Aren’t Always Benign

Especially for people with A-Fib, PVCs should be taken seriously. Often they precede or predict who will develop A-Fib. They can increase chances of a fatal heart attack or sudden death. The good news: sites in the heart that produce PVCs can be mapped and ablated just like A-Fib signals.

To learn more about PVCs, see my article: FAQs Coping with A-Fib: PVCs & PACs

Don’t be Afraid to Fire Your Doctor!

Kudos to John for being his own best patient advocate, for taking the bull by the horns and dealing with his PVCs. In spite of what he heard from everyone else, he persevered and went to probably the best center in the US for treating PVCs—the Mayo Clinic. Now John’s A-Fib free and only has occasional PVCs.

Like John, don’t be afraid to fire your doctor! To learn how to interview doctors, see our page: Finding the Right Doctor for You and Your A-Fib.

VIDEO: What Should I Expect After an Atrial Fibrillation Ablation Procedure?

Atrial Fibrillation videos at A-Fib.comCardiac electrophysiologist Dr. Darryl Wells talks about judging success of your ablation, why it’s difficult to predict which patients will be completely cured after one ablation procedure and why some require two procedures, safety and the appropriate age range for patients to receive the ablation procedure. (3:17)

Published by Swedish Heart and Vascular Institute.

YouTube video playback controls: When watching this video, you have several playback options. The following controls are located in the lower right portion of the frame: Turn on closed captions, Settings (speed/quality), Watch on YouTube website, and Enlarge video to full frame. Click an icon to select.

If you find any errors on this page, email us. Y Last updated: Wednesday, February 6, 2019
Return to Instructional A-Fib Videos and Animations

VIDEO: The Hybrid Maze/Ablation for Atrial Fibrillation for Persistent A-Fib

For persistent or long-standing persistent atrial fibrillation, the Hybrid Maze/Ablation (also called the Hybrid Convergent Procedure) combines the complementary efforts of both the cardiothoracic surgeon and the cardiac electrophysiologist. The surgeon works on the outside the heart and the EP on the inside of the heart to eliminate the Atrial Fibrillation signals.

In this video, two cardiac EPs and a cardiothoracic surgeon describe the advantages, safety and effectiveness of the Hybrid approach and who is a good candidate. Includes animation and on-camera interviews.

Published by Tenet Heart & Vascular Network. Length 4:30. 

YouTube video playback controls: When watching this video, you have several playback options. The following controls are located in the lower right portion of the frame: Turn on closed captions, Settings (speed/quality), Watch on YouTube website, and Enlarge video to full frame. Click an icon to select.

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

Return to Instructional A-Fib Videos and Animations

A Tale of Two Ablations and Why All EPs Are Not Equal

I just received an email and O.R. (Operating Room) reports from Louis who in 2014 had a successful catheter ablation by Dr. David Wilber at Loyola in Chicago. Dr. Wilber is nationally known for both his ablation skills and experience, as well as for his research.

First Ablation with Dr. David Wilber

Dr. Wilbur’s ablation of Louis was textbook. Louis’ A-Fib terminated during his ablation procedure, which is considered the ideal outcome.

But Dr. Wilber didn’t stop there.

Dr. Wilber didn’t stop there; he found A-Fib signals coming from the Superior Vena Cava (SVC).

He used isoproterenol (IV medication) to try to induce non-PV triggers and found A-Fib signals coming from the Superior Vena Cava (SVC). He isolated the SVC and could no longer induce any arrhythmias in Louis. (Some EPs would not work that hard, and would have trouble finding and ablating non-PV triggers.)

Relocation, Then Second Ablation―Failure!

But later Louis did develop A-Fib/Flutter again. He had relocated to a distant state so he selected a second EP and had a second ablation there. This ablation was a failure.

After touching up the right pulmonary veins (PVs), the second EP used adenosine and pacing to try to induce arrhythmia signals. He induced Flutter and isolated the right atrium by making a cavo-tricuspid isthmus line. He documented bidirectional block in the right atrium, but Louis still had Flutter.

The second EP didn’t map and track down the flutter.

Rather than map and track down the source of the Flutter, the EP simply Electrocardioverted Louis and stopped the ablation at that point. Then he put Louis on the dreaded antiarrhythmic drug amiodarone.

Still in Flutter―Amiodarone Side Effects

But after the second ablation, Louis still had A-Fib/Flutter.

On amiodarone, Louis developed the symptoms of loss of weight, thinning hair, extreme dry mouth, increased hand tremors, etc. Louis was taken off of amiodarone and is doing better. But he is still bothered by Flutter. See Amiodarone Effective but Toxic.

I’m working with Louis to get him to a “master” EP, a highly skilled EP with a high success rate with difficult A-Fib cases.

What Went Wrong with Louis’ Second Ablation?

From what can be deduced from Louis’ O.R. (Operating Room) report, there seems to be no mention of checking for entrance and exit block after ablating Louis’ pulmonary veins.

As a “crutch”, he put Louis on amiodarone, the most effective but also the most toxic of the antiarrhythmic drugs.

The second EP did use adenosine and pacing and induced a Flutter circuit. He ablated the right atrium and made a cavo-tricuspid isthmus line to make sure no Flutter came from the right atrium. But Louis still had Flutter.

Instead of using any of today’s advanced mapping and isolation strategies, Louis’ EP simply Electrocardioverted him to restore him to sinus. Then he stopped the ablation.

As a “crutch”, he put Louis on amiodarone, the most effective but also the most toxic of the antiarrhythmic drugs.

All EPs are Not Equal―It May Take Work to Find the Right EP

I’m sorry to say, the second EP Louis went to is indeed listed in our directory of EPs. He has all the proper credentials and is a member of the Heart Rhythm Society. But all EPs are obviously not equal. (See my editorial, Huge Growth in Number of EPs Doing Catheter Ablations, But All EPs Are Not Equal.)

Don’t just go to the EP whose office is near you. Go to the best, most experienced EP you can reasonably find. I know it’s a lot of effort. But you have to work at finding the right EP for you.

Do your due diligence. Seek recommendations from your General Practitioner (GP) and from other A-Fib patients (see our Resources/Bulletin Boards for a list of online discussion groups).

If you know nurses or support staff who work in the cardiology field or in Electrophysiology (EP) labs, they can be great resources.

Don’t rely on a single online source when researching and selecting doctors. Be cautious of all doctor informational listings you find on web sites (yes, including this one).

Be prepared to travel if that’s what it takes.

Learn How to Select Your EP

On our page Finding the Right Doctor for You and your A-Fib, we take you step-by-step to finding the right EP for you and your treatment goals.

Catheter Ablation vs Surgery For A-Fib: Finally an Apples-to-Apples Comparison

Update July 27, 2018 Which is better from a patient’s perspective―Catheter Ablation or Surgery (Mini-Maze)? A new study compares the two head-to-head.

An article in Cardiac Rhythm News (no author), describes the SCALAF trial (Surgical vs. Catheter Ablation of paroxysmal and early persistent Atrial Fibrillation).

SCALAF Trial Design

The SCALAF study is the first randomized control trial of patients with symptomatic A-Fib. In a 1:1 ratio, 52 patients received either a catheter ablation or surgery as their first invasive procedure. Follow-up data in all patients was collected for 2 years using implantable loop recorders (Medtronic Reveal XT).

The measurement of success was freedom from A-Fib (atrial tachyarrhythmia) and off antiarrhythmic drugs with safety measured by procedure-related complications.

PV Isolation Direct Comparison: The catheter ablation arm only isolated the PVs without additional lesion sets. The surgical arm (Mini-Maze) only isolated the PVs (and removed the left atrial appendage).

Trial Results

Efficacy: Catheter ablation vs. surgical patients (60% vs. 27%) were free from A-Fib without drugs.

Efficacy: After 2 years, a significantly greater number of catheter ablation patients (60%) were free from A-Fib without having to take A-Fib drugs compared to a much smaller number of surgical patients (27%).

Safety: Surgery patients had a higher procedure-related complication rate (34.8% vs. 11.1%) and a higher rate of major complications (22% vs. 0.0%) compared to catheter ablation patients. That’s about 1-in-4 surgical patients who had significant complications.

Safety: Surgery patients had a higher procedure-related complication rate (34.8% vs. 11.1%).

Hospital Stay: Hospitalization was longer for surgical patients with an average hospital stay of nine (6–10) days compared to three (2–3) days for catheter ablation.

Trial Conclusions

The investigators concluded that catheter ablation of the PVs in the treatment of paroxysmal and early persistent A-Fib is safer and results in higher long-term arrhythmia free survival compared to surgical (Mini-Maze) PV isolation. Follow-up with continuous monitoring using implantable loop recorders was important for true and accurate outcomes.

What Patients Need to Know

Don’t Make Surgery Your First Choice: Following the 2014 Guidelines for the Management of Patients with Atrial Fibrillation, your first treatment option should not be surgery (Mini-Maze).

Catheter Ablation Higher Success and Safer: Though this was a small study, this trial showed that catheter ablation is safer with better long-term freedom from A-Fib (and without medication) when compared head-to-head with surgical Mini-Maze. Follow-up monitoring of each patient with an implantable loop recorder (for 24/7, 365 days for two years) produced unbiased, non-disputable results.

The 2011 FAST Trial: The SCALAF trial results might be compared to the 2011 FAST Trial sponsored by AtriCure, Inc. The FAST trial compared AtriCure’s own system for Mini-Maze surgery to catheter ablation. The results favoring surgery don’t hold up under close scrutiny. More important was the high complication rate of the surgical approach. For more, see Surgical Versus Catheter Ablation―Flawed Study.

SCALAF: Catheter ablation is safer with better long-term freedom from A-Fib (and without medication) when compared head-to-head with surgical Mini-Maze.
 The Bottom Line: We now have an unbiased clinical trial comparing catheter ablation with surgery.

According to the SCAFAL trial, catheter ablation has higher success for long-term freedom from A-Fib than the surgery approach. Just as important, data from both FAST and SCAFAL demonstrate that catheter ablation is much safer than surgery.

Update July 27, 2018: In response to this post about the SCAFAL trial, we received this statement from surgeon Dr. John H. Sirak who performs the “5 box surgery” for A-Fib. Especially relevant is his statement that surgical PVI alone tends to produce Flutter. (The FAST study did compare more complex surgeries to catheter ablation.)

“I must be direct and say this study is next to worthless. First, it isn’t clear how the cohorts compare in terms of AF chronicity. Surgical PVI should at least be no worse than percutaneous. PVI is the most foolproof step of a surgical maze. If the randomization were truly accurate, why was the surgical arm so much smaller? My suspicion is that the surgical arm had a significantly higher number of non-paroxysmal patients. And who were the orangutans operating with a 35% complication rate? Along the same lines, since surgical PVI alone is now widely known to be fluttergenic and thus contraindicated, no reputable surgeon would offer a patient such an outdated operation! This study is not only pathetically executed, but also has no relevance to current standard-of-care practice.” 
Resources for this article
• Surgical treatment of atrial fibrillation results in higher complication rates when compared to catheter ablation. Cardiac Rhythm News (no author). May 18, 2018, Issue 41, p. 9.

• Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (SCALAF). ClinicalTrials.gov Identifier: NCT00703157. Sponsor: Medtronic Bakken Research Center Note: Principal Investigators are NOT employed by the organization sponsoring the study. https://clinicaltrials.gov/ct2/show/results/NCT00703157.

• AHA/ACC/HRS 2014 Guideline for the Management of Patients With Atrial Fibrillation. Circulation. published online March 28, 2014, 4.2.1. Antiplatelet Agents, p 29.doi: 10.1161/CIR.0000000000000041 Last accessed Nov 23, 2014.URL: From http://content.onlinejacc.org/article.aspx?articleid=1854230

Catheter Ablation Compared to Amiodarone Drug Therapy in Heart Failure Patients with A-Fib

Background: I previously reported on the ground-breaking CASTLE-AF study published in 2018 which compared treatment with conventional antiarrhythmic drugs (both rate and rhythm control) versus treatment with catheter ablation. I recently came across another, similar study. While the 2016 AATAC study pre-dates the CASTLE-AF study, it also contributes to our understanding of treatment choices for heart failure patients with A-Fib.

Treating Patients with Both Heart Failure and A-Fib

Heart failure is very common in patients with A-Fib (estimated at 42%). These are very sick patients. For people with advanced heart failure, nearly 90% die within one year.

In patients with both conditions, a cardiologist’s first treatment is most often drug therapy with an antiarrhythmic drug. But is this an effective strategy? Is this really in the patient’s best interest? A 2016 study says NO!

AATAC stands for: Ablation vs Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD

AATAC: Catheter Ablation vs. Amiodarone Antiarrhythmic Drug Therapy

In the powerful AATAC multicenter worldwide randomized trial, catheter ablation was compared to drug treatment with amiodarone (the most effective but also the most toxic of the antiarrhythmic drugs).

The 203 enrolled patients had persistent A-Fib and heart failure with an Ejection Fraction of less than 40%. Patients also all had either a dual-chamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator.

All patients in the AATAC study were given optimal medical therapy for congestive heart failure such as ACE inhibitors, etc.

Patients were randomized to receive either a catheter ablation or drug treatment with amiodarone.

Note: The AATAC study should be read in conjunction with the more significant CASTLE-AF study which found similar results.

Group 1: Catheter Ablation

The first group received a catheter ablation of the pulmonary veins (PVI) along with roof lines and extensive ablations on the left atrial posterior wall; if non-PV potentials were found, the superior vena cava was isolated. At their discretion, EPs could ablate complex fractionated electrograms and non-PV triggers.

A ‘re-do procedure’ could be performed during the 3-month blanking period.

Group 2: Amiodarone (AMIO) Drug Treatment

The Amiodarone (AMIO) group was given 400 mg twice a day for 2 weeks followed by 400 mg each day for the next 2 weeks, then they were given a maintenance dose of AMIO 200 mg/day for the balance of the 24 month study period.

Study Follow-up and Results

All patients were followed for a minimum of 24 months. Recurrence was measured by the implantable devices with device interrogation at 3, 6, 12, and 24 months follow-up. Key findings at the end of the trial period include:

Recurrence: 70% of patients in the ablation group were recurrence and A-Fib free (after an average of 1.4 procedures) vs. only 34% of the Amiodarone (AMIO) group.

PVI with/without posterior wall isolation: Higher success was reported in patients undergoing PVI with posterior wall isolation compared to PVI alone (79% vs. 8%).

Amiodarone therapy was found to be significantly more likely to fail.

Cardioversion: During the 3-month blanking period 51% of the Amiodarone (AMIO) group needed cardioversion vs. 3% of the ablation group.

The unplanned hospitalization rate was 31% in the ablation group vs. 57% in the AMIO group. This is a 45% relative risk reduction of hospitalization.

A significantly lower mortality was observed in the ablation group: 8% vs. AMIO 18%.

Summary: Catheter Ablation Superior to Amiodarone Drug Therapy

Heart failure and A-Fib are common cardiac conditions that often coexist.

The AATAC study, the first randomized study of heart failure patients with persistent A-Fib, found that catheter ablation is superior to amiodarone drug therapy in achieving freedom from A-Fib long-term.

In addition, treatment with catheter ablation improved mortality in these patients, increased exercise capacity and Quality of Life (QofL) along with reduced unplanned hospitalizations.

Acknowledging My Bias
I admit to being biased against amiodarone drug therapy due to personal experience and from what others have shared. (For example, see Karen Muccino’s A-Fib story.) I am horrified that anyone would be put on such a high initial dosage of amiodarone as in this study. I would never participate in such a study. But obviously all doctors don’t share my concerns.
If a less potent (and less dangerous) antiarrhythmic drug had been used, it’s probable the study results would have been even more favorable for the ablation group.

What This Means to A-Fib Patients

These patients were in persistent A-Fib along with heart failure. These are some of the most difficult patients to make A-Fib free.

The EPs and A-Fib centers in this study were some of the best in the world. That there was a 70% success rate and no recurrences after 2 years is a testimony to the advanced mapping and ablation skills of these EPs. It’s remarkable how far catheter ablation strategies have improved over the years.

On the downside, not all EPs are equal. The single procedure success rate varied greatly from 29% to 61%. (See Huge Growth in Number of EPs Doing Catheter Ablations, But All EPs Are Not Equal.)

Catheter Ablation Group: Improved Ejection Fractions

Among the 203 enrolled patients, it’s not surprising that there were 26 deaths during this study. These were very sick patients with congestive heart failure and Ejection Fraction below 40%. (An EF below 50% indicates a weakened heart muscle that is no longer pumping efficiently; an EF in the normal range is 50% to 75%.)

The good news is that for many in the catheter ablation group, their ejection fraction was significantly improved and they were no longer in heart failure.

Catheter Ablation Outperforms Antiarrhythmic Drugs

We now have 2 studies which demonstrate that compared to antiarrhythmic drug therapy, catheter ablation lowers death rate among A-Fib patients (with heart failure), improves QofL and lets patients live longer and healthier lives. Other major benefits of ablation include reduced unplanned hospitalizations and increased exercise capacity.

Take-Away for A-Fib Patients

I think we can draw conclusions from the AATAC and the CASTLE AF studies that also apply to A-Fib patients (not in heart failure).

Rather than a life on antiarrhythmic drug therapy, the AATAC and CASTLE AF studies encourage A-Fib patients to seek a catheter ablation (including a second “re-do ablation”, if necessary.)

Bottom-line: Hard research data shows that a catheter ablation is the better choice over drug therapy. An ablation can rid you of your A-Fib symptoms, make you feel better, and let you live a healthier and longer life.

Don’t just live with A-Fib. Seek your cure.

 

Resources for this Article
Di Biase, L., et al. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device. Results From the AATAC Multicenter Randomized Trial. Circulation. 2016;133:1637-1644. March 30, 2016. http://circ.ahajournals.org/content/133/17/1637 DOI  https://doi.org/10.1161/circulationaha.115.019406

From My Mailbox: Catheter Ablation Complication Rate: Compared to What?

Frequently I get emails asking about the complication rate of catheter ablation.

I like the suggestion made by Dr. David Keane of St. Vincent’s University Hospital, Dublin Ireland. Complications from A-Fib ablation should be viewed in perspective, that is, compared to the alternative of a lifetime on antiarrhythmic drugs (AADs).

The following is based on his presentation from the 2014 Boston AF Symposium.

Meta-Analysis: RF Catheter Ablation vs. Antiarrhythmic Drugs

In what may be the first systematic literature review and meta-analysis of clinical studies of Radiofrequency Ablation (RFA) vs. Antiarrhythmic Drugs (AADs), the reviewers looked at studies from 1990 to 2007. [Note: RFA wasn’t in use until the mid-1990s.] Included were sixty-three RFA studies and 34 AAD studies.

RF Ablation: From 1990-2007, the single procedure success rate for Radiofrequency Ablation (RFA) without need of post-op Antiarrhythmic Drug (AAD) therapy was 57% [today’s success rates are in the 70%–85% range], multiple procedure success rates without post-op AADs were 71% [today’s success rates are closer to 90%], and the multiple procedure success rate with post-op AADs was 77%.

AAD Therapy: The success rate for AAD therapy alone was 52%.

Note: The meta-analysis included five AADs: amiodarone, dofetilide, sotalol, flecainide, and propafenone. Amiodarone was the most effective. [Amiodarone is the most toxic and dangerous of the five AADs and is usually prescribed only for short periods of time and under close supervision for bad side effects.]

Adverse Event: side effect or any undesirable experience associated with the use of a medical product in a patient. In the US, adverse events are reported to the FDA.

Side Effects Cause Patients to Stop Taking AADs: Because of adverse events (side effects), 10.4% of patients discontinued taking their AADs, 13.5% discontinued AADs because of treatment failure, and 4.2% just didn’t take the AADs.

The overall discontinuation rate of AADs was almost 30%.

Findings: Efficiency and Complications Rates

Based on the meta-analysis, reviewers found Radiofrequency Ablation (RFA) had a higher efficiency rate and a lower rate of complications than AAD Therapy.

Findings: Adverse Events Ablation vs AAD

As a point of reference, the complication rate of the common appendectomy is 18%.

This meta-analysis found adverse events for catheter ablation was 5% vs 30% for AAD studies.

More about AAD Therapy adverse events: The overall death rate for AAD therapy was 2.8% (i.e., sudden death 0.6%, treatment-related death 0.5%, non treatment-related death 1.3%). Other adverse events from AAD therapy were:

•  CV (cardiovascular) Events 3.7%
•  Bradycardia 1.9%
•  GI (Gastrointestinal problems) 6.5%
•  Neuropathy 5.0%
•  Thyroid Dysfunction 3.3%
•  Torsades 0.7%
•  Q-T prolongation 0.2%

Conclusions from Meta-Analysis

Most adverse events associated with antiarrhythmic drugs (AADs) are life altering and permanent. (For example, bradycardia requires a pacemaker.)

Whereas complications from catheter ablation are generally short term and not permanent. (For example, when tamponade is repaired, the heart usually returns to normal.)

While this meta-analysis covered 1990-2007, based on subsequent research the trends are continuing. In general, it appears it’s safer to have an ablation than to not have one while living a life-time on AAD therapy.

D. Keane MD

The Full Report: For the full summary of Dr. Keane’s 2014 Symposium presentation, see: Catheter Ablation Complications: In-depth Review and Comparison with Antiarrhythmic Drug Therapy.

What this Means to Patients

If you are age 70 or 80, antiarrhythmic drugs might be a realistic option.

But if you are younger, it’s inconceivable that you would spend the rest of your life taking AADs. In addition to not working well or losing their effectiveness over time, they can have bad, cumulative side effects as described above.

Today’s ‘Guidelines for the Management of Patients with Atrial Fibrillation’ reflect this fact and allow you to select a catheter ablation without having to spend time trying various antiarrhythmic drugs (while your A-Fib may be getting worse).

In general, research shows it’s safer to have an ablation than to not have one (and live a lifetime on AA drug therapy).

Resources for this Article
•  Deshmukh, A. et al. In-Hospital Complications Associated with Catheter Ablation of AF in US: 2000-2010. Analysis of 93,801 Procedures. Circulation. 2013;128:2104-2112. http://circ.ahajournals.org/content/128/19/2104.abstract

•  Haïssaguerre M. “Electrophysiological End Point for Catheter Ablation of Atrial Fibrillation Initiated From Multiple Pulmonary Venous Foci,” Circulation. 2000;101:p. 1409

•  Jais, P. “Ablation Therapy for Atrial Fibrillation: Past, Present and Future,” Cardiovascular Research, Vol. 54, Issue 2, May 2002, P. 343

•  Cappato R et al. “Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.” Circulation: Arrhythmia and Electrophysiology. 2010: 3:32-38.

•  AHA/ACC/HRS. 2014 Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2014; 130: e199-e267 DOI: 10.1161/CIR.0000000000000041.

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