ABOUT 'BEAT YOUR A-FIB'...


"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

"Your book [Beat Your A-Fib] is the quintessential most important guide not only for the individual experiencing atrial fibrillation and his family, but also for primary physicians, and cardiologists."

Jane-Alexandra Krehbiel, nurse, blogger and author "Rational Preparedness: A Primer to Preparedness"



ABOUT A-FIB.COM...


"Steve Ryan's summaries of the Boston 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

"I love your [A-fib.com] website, Patti and Steve! An excellent resource for anybody seeking credible science on atrial fibrillation plus compelling real-life stories from others living with A-Fib. Congratulations…"

Carolyn Thomas, blogger and heart attack survivor; MyHeartSisters.org

"Steve, your website was so helpful. Thank you! After two ablations I am now A-fib free. You are a great help to a lot of people, keep up the good work."

Terry Traver, former A-Fib patient

"If you want to do some research on AF go to A-Fib.com by Steve Ryan, this site was a big help to me, and helped me be free of AF."

Roy Salmon Patient, A-Fib Free; pacemakerclub.com, Sept. 2013


Dr. Michele Haissaguerre

Catheter Ablation: The Bordeaux Group Procedures & Costs

“I’ve heard good things about the French Bordeaux group. Didn’t Prof. Michel Häissaguerre invent catheter ablation for A-Fib? Where can I get more info about them? How much does it cost to go there?”

Prof. Häissaguerre and his colleagues invented catheter ablation for A-Fib (Pulmonary Vein Isolation). the Bordeaux group at the Cardiologic Hospital of Haut-Lévêque is still considered one of the top A-Fib centers in the world. (They cured my A-Fib back in 1998. I was their first U.S. patient. Read my story.)

In particular they are doing cutting edge research using ECGI (CardioInsight) to map and ablate persistent A-Fib. ECGI will probably revolutionize how ablations are mapped and performed.

How to Contact the Hôpital Cardiologique du Haut Lévêque-(CHU) de Bordeaux 

Links to University Hospital of Bordeaux, Cardiology and Electrophysiology services (June 2016):

• Cardiology and Electrophysiology and Pacing ServicesHead of department: Pr Jean-Michel Haïssaguerre

• Electrophysiology and Ablation, Head of Unit: Prof. Pierre Jais

• Patient Care: Services and Appointment Request – online form

Bordeaux Procedures and Costs

Here is something they wrote a few years ago which explains their methodology and the costs of being treated at Bordeaux (2010). Published as: Are you a good candidate? http://Are you a good candidate?

CATHETER ABLATION OF ATRIAL FIBRILLATION

Currently the only treatments that cure atrial fibrillation (AF) are:

a) Surgery (such as the Cox Maze operation and its variations)
b) Catheter Ablation

The main goals of catheter ablation of AF are to:

1) restore the heart to normal sinus rhythm, thereby eliminating the symptoms of AF.
2) relieve the patient from the associated risks of AF, such as blood clot formation, stroke, cardiac failure, and increased mortality. (It has not been proven that a successful Catheter Ablation will achieve these goals in all A-Fib patients.)

In the catheter ablation procedure a catheter, a soft, thin, flexible tube with an electrode at the tip, is inserted through a large vein in the groin and moved into the heart. This catheter delivers Radiofrequency (RF) energy to cauterize and eliminate the sources or spots in the heart (ectopic foci or wavelet circuits) that are triggering or maintaining the episodes of AF. These sources or spots in the heart are usually found in the pulmonary vein openings. The catheter also makes linear lines or lesions to segment the atrial tissue, thereby interrupting the errant electrical waves responsible for maintaining AF.

This isolation of the pulmonary veins cures the intermittent (paroxysmal) form of AF in 80% of patients (without having to take any medications). An additional 10% of patients are improved—an antiarrhythmic drug keeps them is sinus rhythm without the need for blood thinners.

For patients with permanent or persistent AF (lasting more than 48 hours or who have had Electrocardioversion), isolation of the pulmonary veins is less effective and should be combined with linear lines or lesions. This is because the longer one has episodes of AF, the more the sources or spots in the heart which produce AF signals tend to spread outside the pulmonary veins.

Ablated heart tissue has a tendency to heal itself and recover. For this reason and to increase the success rate to 90%, more than one procedure is required after 1-3 months of follow-up.

Pre-ablation Management

For safety reasons (to avoid clot formation during the catheter ablation procedure) the patient should take oral anticoagulation (coumadin, not aspirin) at an optimal therapeutic range (INR 2-3) for at least 1-2 months before the procedure. In addition, a transesophageal echocardiogram should be performed a few days before hospitalization to make sure there are no clots in the heart, particularly in the left atrial appendage. If clots are found, the procedure must be postponed a few days until these clots can be dissolved by blood thinners.

Anticoagulants should be interrupted 48 hours before the day of the procedure. If the patient is taking antiarrhythmic drugs, they should be stopped on admission.

Catheter Approaches

General anesthesia is rarely performed on adult patients, in order to minimize the associated risks of anesthetic drugs. The patient is slightly sedated and a local anesthetic is applied to the groin area. Usually three catheters for mapping and ablation are inserted through one or two femoral veins in the groin and moved up into the heart.

The mapping catheters have multiple electrodes mounted in a longitudinal or circumferential shaft. (Other configurations including investigational designs may be used for individual situations.) The ablation catheter has an irrigated tip to prevent local clot formation and to allow greater energy delivery if needed (at thick parts of the cardiac tissue). To insert these catheters into the left atrium, it is usually required to make a puncture of the transseptal wall between the two upper chambers (atria) at what is called the foramen ovale. After the ablation procedure, this foramen ovale closes back up and heals over. (In 20% of patients this foramen ovale hole never closes up completely and remains open, creating a pathway between the two atria chambers.)

Two or three physicians usually perform the catheter ablation procedure. They are involved in positioning the catheter, and in the collection, analysis and interpretation of heart signals obtained during conventional or computerized mapping.

RF ablation is performed around the openings of the pulmonary veins, one by one or two by two, using a limited level of energy to avoid swelling of the pulmonary vein openings or atrial perforation. Isolation of the pulmonary vein openings is successfully performed in 100% of cases.

In paroxysmal (occasional) AF, PV isolation cures AF in 60-70% of cases. Ablation of the appropriate site in the right atrium (Cavotricuspid Isthmus) is also performed to prevent right atrial flutter. Linear block here is successfully achieved in 99% of cases.

In persistent AF (lasting more than 48 hours or with a history of electrical cardioversion), PV isolation is rarely sufficient. Additional RF applications are required to eliminate spots of AF activity outside the pulmonary veins. In the most resistant cases (usually long lasting AF), linear ablation similar to surgical incision is performed in the left atrium between the two superior PV and/or from the vein to the mitral annulus (mitral “isthmus”). This achieves linear block in 90% of cases. The success depends on achieving continuous and coalescent cauterizing lesions to create a complete barrier. Any gap in the lesion line, even of a millimeter size, allows AF signals to cross thereby keeping the heart in AF. A gap in the lesion line is due either to a too thick atrial wall or recovery of atrial tissue during the 1-4 week healing process following ablation.

Pain and discomfort associated with ablation are controlled by Midazolam and Morphine. Because there are no nerve endings in the smooth tissue of the heart and veins, the pain and discomfort are minimal and usually well tolerated.

Duration of Operation and Hospital Stay

The duration of the procedure varies from one to five hours depending on individual conditions:

• the number of ectopic sources in the atrial tissue (outside the pulmonary veins) may require more mapping time.
• successful lineal ablation lines depend on the thickness of the heart wall which varies from one patient to another and can not be precisely determined by pre-ablation imaging.

The end point or goal of the procedure is the achievement of local block in all targeted structures (veins and isthmuses) so that no AF signals travel through the heart. In addition, after the ablation multiple pacing maneuvers are used to try to induce sustained AF. In paroxysmal AF, multiple pacing maneuvers do not induce AF in 90% of cases.

A second procedure may be needed within 3-5 days in 25% of AF patients due to partial recovery of ablated tissue and/or secondary AF sources not ablated in the original procedure. In difficult cases of multiple or unmapable ectopic foci (heart tissue generating AF signals), a second linear ablation may be required in the left atrium.

Patients are hospitalized 4 to 6 days depending on the number of procedures required. Typically they return to the normal care

unit after ablation and are ambulatory 12 to 24 hours later. They are monitored by telemetry during the next 3 days when any recurrence of arrhythmia is most likely to occur. The likelihood of recurrence decreases over the next month.

Patients are usually admitted on Monday and can leave the hospital for the week-end, if there are no complications. They must stay in the region during the week-end and must return the following Monday for outpatient evaluation, which could result in re-hospitalization if needed.

The occurrence of complications may increase the duration of the hospitalization and therefore the cost. In our experience, this happens to 2.5% of patients.

If AF symptoms do not reoccur, patients can return home and resume normal activities. Anticoagulants are recommended for at least 1-3 months after ablation, and can then be stopped if there is no AF or other risk factors. In persistent AF, antiarrhythmic medications are recommended for 1-3 months after ablation to enable the atria to return to normal (this process is called “remodeling.”)

Population of Patients

Catheter ablation of AF has been performed since 1994 in Bordeaux. As of October 2009, over 6,000 patients have been treated. At least 15 cases of atrial fibrillation or flutter are treated every week. The clinical characteristics of patients cover a wide spectrum of age (15-84 years old, average 52 years old). 78% of patients are male, while 22% are female. 80% have paroxysmal (occasional) AF, 20% have persistent AF. All patients were resistant to or intolerant of an average of 4 antiarrhythmic drugs and experienced at least weekly episodes of AF at their referral.

Some patients had documented pauses in their sinus heart beat after an attack of AF. They were cured by AF ablation, and thus avoided pacemaker implantation. 12% reported a previous embolic event (stroke), most in the circulation of the brain.

In patients with heart failure and permanent AF, the restoration of sinus rhythm (normal heart beat) is associated with a significant improvement of ventricular function in 80% of the patients.

Risks Associated with AF Catheter Ablation

Currently no one has died of a catheter ablation procedure in our department. Compared to other catheter procedures a 0.1% risk of death is a reasonable estimation.

The other risks of catheter ablation of AF are:

• bleeding in the pericardial sac surrounding the heart and requiring drainage (0.5-1%)
• embolic event (stroke) (0.2%)
• groin access hematoma (bruising) (4%)

There is no risk of sinus node or AV node damage by ablation which would require implanting a pacemaker.
World-wide there have been deaths reported by the use of high wattage catheters (50 watts or higher) creating a fistula (burn through) to the esophagus, usually 2 days after the procedure. We have not observed this complication.
Pulmonary vein narrowing (stenosis), if it did occur, would not usually cause symptoms. Out of 6,000 patients treated in our institution, 7 developed symptoms due to PV narrowing (>70% of lumen [opening] diameter) and required angioplasty and stenting.

The above risks compare very favorably with the risks involved in living with untreated AF. The risks of catheter ablation also compare very favorably with the risks involved in taking antiarrhythmic drugs and anticoagulants.

Procedure Costs (2010)

This cost is fixed by the public health administration.  The cost for a private service (operators: Drs. M. Haissaguerre/P. Jais/ M. Hocini) is 5000 euros (around $6,000) (hospital and physician charges). The total cost of AF catheter ablation depends on the duration of one’s stay in the hospital, which depends on the difficulty of individual ablation cases.

The typical hospital stay of 5 days with an ablation including pulmonary vein isolation and ablation of the right and left atria would cost about 10,328 euros (around $12,600). One day more or less would be 2044 Euros (around $2,500).

The total costs of a 5 day stay and ablation would be 17,600 euros (around $21,500).
For patients accompanied by a family member and without local accommodations, a meal, bed and breakfast is provided in the same room 27,10 euros/day (around $33.00).

The current waiting time for a procedure is 2 months.

Patients should come with personal clothes, since it is possible to walk outside. Patients are generally expected to wear their own clothes, including pajamas. Since the hospital only provides small towels, you may wish to bring your own towels.

(Costs updated 6/2/2010.)

Information about the Hospital

Cardiologic Hospital of Haut-Lévêque is a 300 bed hospital entirely dedicated to medical and surgical cardiology. It is located in Pessac and is a 20 minute drive from the airport, and a 20-30 minute drive from the center of Bordeaux and the TGV station.

Languages spoken: English and Spanish

The web site is: http://www.chu-bordeaux.fr/LES-HOPITAUX-ET-SITES-DU-CHU/Groupe-hospitalier-Sud/Hôpital-Haut-Lévêque/.

Dr. Carlo Romero A-Fib Patient Story

Dr Carlo Romero from The Philippines

Dr Carlo Romero
from The Philippines

A-Fib Patient Story #79

Philippino Dr. with A-Fib Has Amiodarone Problems—Then ECGI & Ablation at Bordeaux

By Dr. Carlo Romero, The Philippines, February 2015

I am a 49-year-old male from the Philippines. I was diagnosed with A-Fib in 2007 at age 42. It happened after I was dehydrated playing golf. The A-Fib resolved by itself after a few hours. But after a few months, I had another attack. When I went to the ER, an ECG documented the AFIB. I was not given any medication but was advised to stay away from triggers which I did. I even stayed away from cigarettes, drinking, chocolates, food with monosodium glutamate.

After Three Years, Severe Pain Triggers A-Fib—Amiodarone Works, But Thyroid Problems

 I did not have any attacks for a year, but my thyroid hormones were becoming abnormal due to the amiodarone.

I had no known A-Fib attacks for three years until I was operated on for a herniated disc in 2010. The severe pain and the medications probably triggered the A-Fib again as I had several attacks. I was referred to an electrophysiologist in Manila which is an hour and half plane ride from our province. This time I was given amiodarone and Coumadin. I did not have any attacks for a year, but my thyroid hormones were becoming abnormal due to the amiodarone. I was shifted to 100mg flecainide bid which again limited my A-Fib to probably one attack per year.

A-Fib Attacks Become More Frequent—Decides To Go To Bordeaux

At this time I was already doing research about what other options were available, because I know that in time, the medications will stop working. In 2010, I was already in touch with Steve Ryan and had already heard of ablation. I had written several big centers and inquired about ablation procedures and cost. I wrote emails to Bordeaux and to the secretary of Dr. Natale. But since the attacks were few and far between, I decided to stick to medication which controlled the symptoms.

 It was a choice between having the ablation in San Francisco or the Bordeaux group…The cost made me decide on Bordeaux, because it cost half that of San Francisco.

However mid-2014, after a bout of flu, the A-Fib symptoms recurred and the attacks became more frequent. I learned that at this time that there was an ablation center here in Manila, but it is still in the infancy stage. So, I decided to go abroad. It was a choice between having the ablation in San Francisco or the Bordeaux group since they have been the most talked about ablationists in the forums. The cost made me decide on Bordeaux, because it cost half that of San Francisco.

Arriving at Bordeaux Hospital

Carlo Romero in Bordeaux hospital room 500 pix at 96 res

Carlo Romero in Bordeaux, France, hospital room

In August 2014, I wrote Bordeaux emails, and they made me answer a questionnaire to determine my status. I sent my reply and was told I would be a good candidate. I was given an ablation date Nov 3, 2014, more than 2 mos. from the time I inquired. I was instructed to do some blood tests and a TEE 2-3 weeks prior to my ablation and to settle the payment for the procedure 1 month before the ablation date. I complied with all of these requirements, got a medical visa from the French Embassy, plane ticket, hotel booking and was all set. I arrived in Bordeaux on Oct 29, 2014. Since we still had time, we first went to Lourdes, France and then back to Bordeaux the next day.

Nov 3, 2014, Monday, I was told to be at the Hospital at 8am. To be sure that we didn’t get lost, we took a cab which cost around 45 euros coming from the center of Bordeaux near the opera house. Admission was a breeze, and I made sure we had internet which you can get in the Admitting section (ask them about it because the nurses are not familiar with it). I made sure of the internet connection to be able to use the app I downloaded which helps me to communicate in French. (Translate App) When you type in English, the app will translate it to French.

I was attached to a holter monitor whose signals were transmitted to the nurse’s station. The first day was spent getting X-rays, lab exams, preparation and shaving of the groin area. They also started injecting heparin. I was told to stop amiodarone 5 days prior to ablation. But since I learned from Steve Ryan that amiodarone has a long half-life, we asked Dr. Jais thru email if the instruction was right. He was able to correct it to 10 days prior to ablation and pradaxa 48 hours prior to ablation.

Ablation with ECGI

Carlo Romero with nurse preparing the ECGI before ablation

Carlo Romero with nurse preparing the ECGI before ablation

The next day, I received IV fluids and was brought down to the CT scan area. I laid down on a bed and was given a vest which I learned later was an ECGI. It’s the new procedure which, according to Dr Haissaguerre, is not yet in use in the US. But they have found it very useful and promising.

His explanation is that it is like an ECG. But instead of 12 leads, it has 252 leads (attached in the vest) The ECGI vest represents the future of the mapping procedure, and according to him will shorten the OR time since they can map out the heart prior to the procedure. (For a further explanation of how the ECGI mapping system works, see “How ECGI [Non-Invasive Electrocardiographic Imaging] Works.”)

I think I was the 2nd case that day since I was brought down at the theatre at 1 pm. I did not see Dr Haissaguerre at that time nor prior to the procedure which made me a little bit anxious. But I was assured by his assistant that He will be doing the ablation. The assistant doctor asked me if it was ok that he start with the insertion of the catheter and that Dr Haissaguerre will be the one doing the ablation later, to which I agreed.

I must have dozed off. Because when I became aware again, I heard that we were about to be finished. Although during the ablation there were instances where I felt my heart going very fast, then they would later massage my neck area. And then after a while, there were two more cycles like that. I was told later that, since I was not in A-Fib, they had to induce me several times. My procedure took almost 4 hours.

After the Ablation—Time With Dr. Haissagguerre

Wednesday, when I woke up, I had a fever of about 39 degrees and had a difficult time breathing. The nurses upon instruction from the doctor gave me paracetamol which lowered the fever, but I was still in pain if I breathed. I was really worried at that time and kept on reminding the nurses to ask the doctor when will they see me so I can talk with them about these symptoms.

That night, a young doctor came to my room with a portable 2d echo and, after examination, concluded I had fluid around my heart and that the fever and the difficulty of breathing were related to that. I was given an anti-inflammatory which relieved the symptoms in 2 days. At this time my abdomen was black and blue due to the round-the-clock injection of heparin. Towards the evening , I was allowed to start with soup and yogurt and later solid foods if I could tolerate them.

Thursday, the fever and the difficulty of breathing diminished. The nurses also advised me to start pradaxa after my last dose of heparin. I was allowed to sit up already and go to the bathroom. In the afternoon, Dr Haissaguerre was able to visit me which was the first time I met him face-to-face. My wife told me that he visited a few hours after my procedure, but I was mostly asleep at that time. He had an aura of confidence in him that made me feel that I was talking to a very knowledgeable person. He explained that I had 3 problematic areas. 1 in the atrial septum and 2 near the pulmonary veins. He added that since I was not in A-Fib, they had to induce it with isoproterenol.

Dr Haissaguerre stayed in the room for almost an hour explaining to us what was done and what to expect in the future. I asked him how many international patients they have. He informed that they accept only 2 international patients per week.

They started with the atrial septum focus which made the A-Fib stop after they had ablated it. But since they knew that I had 3 problematic areas even before the procedure, they induced me again and ablated the 2 remaining areas near the pulmonary veins. After that I was told they could no longer induce my A-Fib.

Dr Haissaguerre stayed in the room for almost an hour explaining to us what was done and what to expect in the future. I asked him how many international patients they have. He informed that they accept only 2 international patients per week. And I was told that I was the first Filipino patient he had. I was also able to meet for the first time Laurence Bayle, the secretary of the doctors with whom I was in contact most of the time. Sometimes it would take a day or two for my emails to be answered, sometimes a week. But despite that, I was able to arrange and carry out my ablation. Probably the volume of the inquiries made it impossible for them to answer immediately.

Dr. Michele Haissagguerre with Dr. Carlo Romero

Dr. Michele Haissagguerre with Dr. Carlo Romero

Discharge—Questions For Dr. Haissaguerre

The next day, Friday, I was told that I would be discharged. I was given all the instructions. While waiting for our Dr Haissaguerre to meet us prior to discharge, we were able to go around the hospital and outside it. From what I understand, it’s a big hospital building which caters solely for heart patients. We were sent to the admitting section to settle our accounts, but we were told that we would have no additional payments, as everything is included in the package.

When Dr. Haissaguerre arrived to see us in the afternoon, I informed him about skipped beats which bothered me post op. He told me that it was normal for an ablated heart to skip beats especially since I had a pericardial effusion, but that they will go away in time. (the skipped beats slowly went away in a month’s time).

I went back to the hospital in November 10, 2014 for my final check-up prior to being allowed to go home. The next few days, we opted to go to Paris and spent some vacation time just in case there was still a need to see Dr. Haissaguerre prior to our flight back home to the Philippines.

Lessons Learned

The whole “healing journey” was very memorable. I cannot believe that I really went out of country just to have the procedure, but everything went as planned. A lot of anxious moments and hesitancy, but I made it through. A few hitches here and there, but nothing that couldn’t be handled.

In this age of the Internet, we as patients have the power to learn more about our disease and act accordingly. We can opt to just live with it which is not really a bad choice as a lot of A-Fib patients have done successfully. Or we can be proactive about it. Of course the ablation procedure is not 100% curative nor 100% safe, But I made my decision based on my goal that I still wanted to practice my profession as a doctor. I owe it to my patients to try to heal myself by the best possible means so that I can render the best medical service to them.

I am now exactly 100 days post ablation. I’m still on anticoagulants, but am A-Fib free. In the last conversation I had with Dr Haissaguerre, I asked him if there are things that I am prohibited to do or food that I am not allowed to eat, and he told me no prohibitions.

“Live a Normal life” and that’s what I plan to do.

Carlo Romero
Email: cadromero1170@yahoo.com

Editor’s Comments:
Because Dr. Carlo had been in A-Fib for some time, his ablation probably was more challenging. It took four hours which was longer than usual considering that the mapping had been done already by the ECGI system. He had a minor pericardial effusion which is often unavoidable in more extensive ablations.
The ablation Dr. Carlo had represents a radical, transformative change in ablation therapy and may alter the way ablations are done. Normal catheter ablation for A-Fib usually starts with isolating the pulmonary vein openings. But Dr. Haissaguerre instead started with the atrial septum area as indicated by the ECGI system. Only later did he go to the pulmonary vein areas. ECGI will certainly change the way catheter ablations are performed.
Dr. Carlo Romero is a great example of a proactive A-Fib patient who educated himself about A-Fib, researched all his options, found the right doctor for him, and wouldn’t settle for less than the opportunity for a complete cure of his A-Fib.

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If you find any errors on this page, email us. Y Last updated: Sunday, July 17, 2016

AF Symposium 2015 Brief Reports by Steve S. Ryan, PhD

20th Annual AF Symposium

by Steve S. Ryan, PhD

This overview should give you a sense of the topics floating through the three days in Orlando and the over sixty presentations by fifty A-Fib experts and researchers. (Most recent brief reports listed first)

AF Symposium: My Brief Reports

 The Novel Oral Anticoagulants: Xarelto Best Seller; Dr. Daniel Singer
 Stimulating the Front Ear Flap Inhibits A-Fib—Research by Dr. Warren Jackman
 Dr. Ruskin Asked: Can Anyone in A-Fib Really Be Asymptomatic?
 The Rhythmia 3-Dimensional Mapping System (Live from Leipzig via Satellite) 
 LAA Occlusion Devices: Is the Watchman Device Dead in the Water?
 FDA ‘Easy Feasibility Study’ (EFS 
 Reversal Agents for the New Anticoagulants (NOACs)? 
 Female Gender: Is it a Risk Factor for Stroke?
 Living in A-Fib More Dangerous Than Having an Ablation
 Rotors! Rotors! Rotors! Sizzling Topic but No Consensus
 Holistic Approach to Health: Great Results Dealing with Obesity
 Atrial Esophageal Fistula: A Case Study
 Anticoagulation Case Study: Dilemma for 92-year-old With Paroxysmal A-Fib
 Ablation Without X-Ray or Fluoroscopy (Live via Satellite)
 From Beijing: Strange Chinese Case (Live via Satellite)
 Ablation & Closing Off the Left Atrial Appendage in the Same Procedure (Live via Satellite)
 Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)
 Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight
 Fibrosis and A-Fib: Continuing Research on Sheep

The Rhythmia 3-Dimensional Mapping System (Live from Leipzig via Satellite)

Rhythmia 3-Dimensional Mapping image

Image from Rhythmia 3-Dimensional Mapping system by Medtronic

Live Via Satellite TV icon(Please be advised that the Symposium organizers go to great lengths not to identify or unfairly publicize one device over another. When writing these reports I often have to do a good deal of research to correctly identify and describe particular devices that are demonstrated, as a service to readers. But this in no way implies or suggests that one device is superior to another.)

Dr. Gerhard Hindricks of the University of Leipzig in Germany gave a dynamic presentation of a catheter ablation of a 46-year-old female with paroxysmal A-Fib using the Rhythmia 3-dimensional multipolar mapping system by Boston Scientific. Along with his colleagues Drs. Andreas Bollmann and Jedrzej Kosiuk, they used the Rhythmia special basket catheter to generate a 3-D map of electrogram voltages and activation times. To me it seemed amazingly fast. The eight-splined bidirectional catheter produced 1,000 data points per minute. In what seemed like only a few passes, they produced a 3-D color reconstruction of the patient’s left atrium.

The actual ablation was routine. They terminated the A-Fib into sinus rhythm without having to use Electrocardioversion. But they found that the PV isolation was incomplete. Using the same Rhythmia 3-D mapping catheter, they were easily and quickly able to locate the gap in the Left Superior PV and ablate it.

LAA Occlusion Devices: Is the Watchman Device Dead in the Water?

Dr. Vivek Reddy from Mount Sinai School of Medicine in New York City gave a very well referenced and persuasive presentation on the Watchman device which closes off the Left Atrial Appendage to prevent clots and strokes. The theory behind the Watchman device is that most A-Fib clots originate in the Left Atrial Appendage (LAA). The Watchman closes off the LAA where 90-95% of A-Fib strokes come from. It’s a very low risk procedure that takes as little as 20 minutes to install. Afterward, you would usually not need to be on blood thinners. (For more, see my article, The Watchman Device: The Alternative to Blood Thinners).

Dr. Reddy certainly persuaded me that the FDA should approve the Watchman device. Dr. Reddy, earlier in Washington, had made the same persuasive arguments before the FDA.

Dr. Andrew Farb from the FDA took the bull by the horns and gave his perspective on the various LAA Closure (Occlusion) Devices. But as one would expect, he didn’t indicate how the FDA would rule on the Watchman device, since deliberations were still ongoing.

After his presentation, I asked him several pointed questions about this, but he was, of course, careful not to comment about current FDA deliberations. My guess? If body language, momentum, mood of the presentations, and more importantly recent research indicate anything, the Watchman device probably will not be approved by the FDA.

There was a palpable sense of sadness at the end of these presentations. The attendees realized that the game may be over for the Watchman device. I hope I am wrong, since the Watchman device would be an important tool to help A-Fib patients. Once the FDA rules and the current clinical trials of the Watchman device end, you will probably have to go to Canada or overseas to get a Watchman device installed.

Watchman May Win FDA Approval

Updated March 13, 2015: The Watchman Device by Boston Scientific finally wins FDA approval

In my earlier brief reports on the Orlando AF Symposium, based on the recent research and the FDA presentation, I said the Watchman device probably won’t be approved in the US. I’m happy to say that I am most likely wrong.

At the LAA Symposium 2015 in Marina del Rey, CA, it was suggested that the Watchman device may be approved by the middle of this year. One presenter described how the FDA chairman talked with several people who were going to Canada to have the Watchman device installed. He seemed embarrassed that the Watchman was available everywhere in the world but not in the US and said that it has to be approved.

Other doctors I talked with at the LAA Symposium were of the same opinion. Presenters described how clinical trials for other LAA closure devices were on hold so that they could get approved in comparison to the Watchman (Non-Inferiority Trials). Dr. Dhanunjaya Lakkireddy of the University of Kansas Medical Center said that we are at a “tipping point” for the (A-Fib) industry.

FDA ‘Easy Feasibility Study’ (EFS)

As everyone, including the FDA, is well aware, A-Fib innovations usually start in Europe where they are more easily approved. Then only later do they move to the US for FDA approval, since the FDA generally requires more data than European regulators.

Drs. Jun Dong and Andrew Farb from the FDA described the FDA’s ‘Easy Feasibility Study’ (EFS) program where medical device innovations could be evaluated  in the US without having to go to Europe first. He encouraged researchers and attendees to take advantage of the new EFS program. This is major news and may make the development of A-Fib innovations much easier to accomplish in the US.

For further information, contact: Andrew Farb, Email: Andrew.farb@fda.hss.gov. 301-796-6317

Reversal Agents for the New Anticoagulants (NOACs)?

Dr. Luigi Di Biase from the Albert Einstein College of Medicine in the Bronx, NY and Dr. Daniel Singer from Massachusetts General Hospital in Boston each described potentially great developments in reversal agents for apixaban (Eliquis) and rivaroxaban (Xarelto).

Dr. Di Biase described studies where leaving people on uninterrupted rivaroxaban and apixaban before, during and after an ablation dramatically reduced the amount of silent thromboembolic lesions and were as safe as warfarin with regards to stroke and TIAs. (This didn’t work with dabigatran [Pradaxa].) But if patients develop bleeding or effusion during the ablation, they are in trouble because there is no direct reversal agent as there is for warfarin. He has used Factor IV as an indirect reversal agent. Dr. Singer also described how Factor IV was used as a reversal agent for apixaban.

But there are new reversal agents for apixaban and rivaroxaban which promise to completely reverse the effects of these two drugs in less than four minutes. The FDA is speeding up studies on these reversal agents. But one never knows when or if the FDA will approve them.

Female Gender: Is it a Risk Factor for Stroke?

Dr. John Day of the Intermountain Heart Institute in Murray, UT (and recently elected president of the Heart Rhythm Society) may be the first A-Fib leader to publicly question whether women should be given one point on the stroke risk CHA2DS2-VASc scale just because of their gender. Many doctors have said this in a circumspect way. Dr. Eric Prystowsky in a presentation at last year’s AHS meeting thought that most doctors would agree with Dr. Day, “as long as there wasn’t a camera focused on them.” He gave the example of a 45-year-old woman in good health and a 45-year-old man with hypertension who according to current guidelines should both be given one point on the stroke risk CHA2DS2-VASc score.

Editor’s Comments:
As readers of A-Fib.com, you know that’s been my opinion ever since the original European guidelines came out. Women in their child-bearing years are much less at risk of stroke because of the blood-thinning effect of losing blood each month. And even after menopause women have less risk of stroke. But eventually they do have more strokes. But not because of an innate inferiority, but because women live longer than men. Stroke is age related. An observational Danish registry study documents this.
For more, see The Denmark Study: Women in A-Fib Not at Greater Risk of Stroke Contrary to CHA2DS2-VASc Guidelines!) (Be advised that the original European guidelines were written by doctors with major conflicts of interest.) These guidelines may be a not so very subtle form of gender bias.

Living in A-Fib More Dangerous Than Having an Ablation

Living in A-Fib is more dangerous than having an ablation, according to Dr. Josef Kautzner from Prague, the Czech Republic. Studies have documented that the adverse effects of living in A-Fib, having to take A-Fib drugs and anticoagulants for life are both pragmatically and statistically worse than having an ablation. Dr. Kautzner discussed how A-Fib can cause or is associated with silent brain lesions and dementia. Any time you go into a hospital is a risk. And no one would say that a catheter ablation is a walk in the park. But an ablation is a low risk procedure, though not risk free. The risk is similar to having your tubes tied. The possible adverse effects of an ablation procedure (like bleeding at the groin) are generally temporary, unlike the lasting, permanent damage you can do to your heart, body and brain by living in A-Fib for years.

Rotors! Rotors! Rotors! Sizzling Topic but No Consensus

The most hotly discussed topic at this year’s symposium was rotors. The opinions expressed about rotors were at times very heated, more than I had ever seen at an AF Symposium. Dr. Shih-Ann Chen of Taipei, Taiwan disagreed with Dr. Sanjiv Narayan of Stanford, CA about the basic concepts of rotors and how they should be defined. Dr. Ravi Mandapati of UCLA and Loma Linda University disagreed with Dr. Narayan which was all the more striking in that he had worked with Dr. Narayan when he was at UCLA. Dr. Pierre Jais of Bordeaux, France said that the FIRM mapping system misses 40% of the atrium area.

Drs. Haissaguerre and Jais from Bordeaux and Dr. Sebastien Knecht of Brussels, Belgium gave presentations on how they were using the CardioInsight body surface mapping vest to perform ablations of “drivers” at many different centers, while Dr. Karl-Heinz Kuck from Hamburg, Germany using a different body surface mapping system said that he couldn’t ablate rotors. Dr. Narayan says the FIRM system finds a maximum of 2-3 rotors in the atria, while other systems find as many as seven. The FIRM system says rotors are usually relatively stable and can last as long as 30 seconds while others say they rotate in one fixed spot for only one or two rotations, that they tend to migrate within a certain area.

The presenters obviously didn’t share a consensus of basic concepts of what rotors are, how they work, their importance in A-Fib, how they should be correctly identified, used, and ablated. (It seems to me the Bordeaux group has the best understanding and pragmatic use of rotors. They refer to “rotors” and focal sources as “drivers.”) But the CardioInsight system Bordeaux uses isn’t currently available or isn’t being tested in the US.

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Holistic Approach to Health: Great Results Dealing with Obesity

Obesity was one of the most often discussed topics. There is a growing consensus among EPs that it isn’t enough to just give obese patients a catheter ablation while not dealing with their obesity. If the obesity isn’t dealt with, their A-Fib is very likely to re-occur. A-Fib will develop in other spots that haven’t been ablated. The condition (obesity) that triggered or caused the A-Fib will trigger or cause it again, if it isn’t taken care of.

Dr. Prashanthan Sanders of Adelaide, Australia described the great results he is getting in his clinic which includes a weight loss program and counseling. He convinces his overweight patients to buy into the program, lose weight, and keep it off. The program works so well that just by losing weight patients become A-Fib free. This program is a holistic approach to health and also is developed to work for diabetes, sleep apnea, hypertension, binge drinking and smoking.

Dr. Sanders foresees a world where some patients become A-Fib free simply by changing their life style, where they don’t have to have a catheter ablation to become A-Fib free.

Many other doctors commented that A-Fib treatment at many centers today includes or should include much more than A-Fib ablation and drugs. A-Fib centers should have nutritionists, exercise therapists, sleep apnea specialists, etc. as part of their A-Fib program.

Atrial Esophageal Fistula: A Case Study

Dr. John Day of the Intermountain Heart Institute in the Challenging Cases Discussion described his experience with the dreaded Atrial Esophageal Fistula. Though very rare, this is one of the few possible complications of a catheter ablation that can kill you. An ablation, if not done with caution, can irritate and damage the esophagus which often lies right next to the heart. Over 2-3 weeks stomach acid can eat through this damaged area to produce a hole or fistula from the esophagus into the heart.

As soon as Dr. Day saw this patient, he knew it was a fistula and immediately called surgeons and a GI doctor. All the surgeons were doing operations and didn’t want to do the surgery in the EP lab. Dr. Day described how he and his colleagues ran down the hospital hallway to the operating room while giving the patient a transfusion and at the same time pumping out the blood escaping from his heart.

The GI doctor got there first and put in a stent in the esophagus to plug the hole. There was lots of discussion as to whether this was the best approach, but it worked. The patient survived but had to spend a month in the hospital.

This cautionary and very dramatic tale certainly got the attention of all the attendees. No matter how rare a fistula is, every EP and A-Fib center must have an established protocol in place to deal with it. I remember Dr. Hugh Calkins in a previous Symposium advising, “There are only two kinds of EPs—those who have not had an Atrial Esophageal Fistula and those who have!” (Dr. Calkins’ patient with fistula also survived.)

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Anticoagulation Case Study: Dilemma for 92-year-old With Paroxysmal A-Fib

Dr. Peter Kowey of Lankenau Hospital in Winnewood, PA described a case that illustrates the kind of dilemma both doctors and patients often have to face. A 92-year-old woman with paroxysmal A-Fib who had been treated for many years with warfarin had some bruising and nuisance bleeding, but never anything major.

Dr. Kowey thought that ethically he should tell her about the different new anticoagulants which may be superior to warfarin, then see if she wanted to change. She went with apixaban (Eliquis), then six months later had a stroke even though she was taking apixaban properly and conscientiously. Happily, she made an almost full recovery. She returned to warfarin which had worked for her in the past and which she was comfortable using.

Editor’s Comments:
One of the reasons Dr. Kowey discussed the new anticoagulants with his 92-year-old patient was because warfarin is considered more apt to cause bleeding in older patients. The newer anticoagulants in clinical trials caused less bleeding. But we don’t have much data from the clinical trials on people over 90 years old.
Can we say that apixaban didn’t work or was ineffective? No. Anticoagulants reduce but do not totally eliminate the risk of an A-Fib stroke. Just because she had a stroke doesn’t mean apixaban didn’t work.
Dr. Jeremy Ruskin pointed out that there has never been and probably never will be a head-to-head comparison of the three new anticoagulants. But in my opinion apixaban (Eliquis) appears to have tested better and is safer than the others
For more, see my 2013 BAFS articles, The New Anticoagulants (NOACs) and Warfarin vs. Pradaxa and the Other New Anticoagulants.

Ablation Without X-Ray or Fluoroscopy (Live via Satellite)

Live Via Satellite TV iconIn the satellite case live presentations, Drs. Rodney Horton and Amin Al-Ahmad from the Texas Cardiac Arrhythmia Institute in Austin, TX surprised us by doing an ablation without wearing the standard lead aprons to prevent fluoroscopy exposure. Even more surprising was one of the lab assistants who was pregnant. She could work on the ablation because no fluoroscopy was used. The doctors did the whole ablation using ICE (Intracardiac Echo) and 3D mapping. They showed for example how ICE can be used to thread the catheter up into the heart and into the left atrium. Dr. Horton said that not having to wear those heavy lead aprons would probably add 5-10 years to his ablation career.

(They didn’t wear surgical masks during the ablation which was surprising to me. I will write them for an explanation.)

From Beijing: Strange Chinese Case (Live via Satellite)

Live Via Satellite TV iconThe live satellite case from Beijing, China was technically flawless and probably a first of its kind. But it wasn’t much of a learning experience for the attendees. The Chinese EPs only used one catheter and had to frequently pull out the mapping catheter and replace it with the ablation catheter, etc. When the expert panel asked them questions, the Chinese EPs either didn’t understand or simply didn’t answer them. They seemed very uncomfortable. It seemed like a throwback to ablation techniques of 20 years ago.

Ablation and Closing Off the Left Atrial Appendage in the Same Procedure (Live via Satellite)

Live Via Satellite TV iconDrs. Claudio Tondo, Gaetano Fassini, Massimo Moltrasio, and Antonio Dello Russo from Milan, Italy showed how they do a catheter ablation for A-Fib and install the Watchman device in the same procedure, when it’s needed. They do the ablation procedure first. Then when the patient is in sinus rhythm, they install the Watchman device. (This can’t be done in the US, because the Watchman device hasn’t received FDA approval. In later discussions including representatives of the FDA, there was an all too real possibility that the Watchman will never receive FDA approval.)

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Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)

Image of the TactiCath Quartz irrigated ablation catheter with EnSite Contact Force Module (Photo St. Jude Medical, Inc.)

TactiCath Quartz irrigated ablation catheter with EnSite Contact Force Module (Photo St. Jude Medical, Inc.)

Live Via Satellite TV icon Drs. Kevin Heist and Moussa Mansour from Massachusetts General in Boston showed in a live case how they used a Contact Force Sensing catheter combined with Jet Ventilation. (There are two Contact Force Sensing catheters approved by the FDA—the ThermoCool Smart Touch device by Biosense Webster (approved Feb. 24, 2014) and the TactiCath Quartz Contact Force Ablation Catheter by St. Jude Medical (approved Oct. 27, 2014). This live case used the TactiCath catheter but didn’t imply or suggest it is superior to the ThermoCool catheter. For a description of each, see my 2014 AF Symposium report The New Era of Catheter Ablation Technology: Force Sensing Catheters.

This combination of Force Sensing Catheter with Jet Ventilation for RF ablation probably represents the most advanced RF ablation strategy available today. Jet Ventilation doesn’t stop the heart from beating as in bypass surgery. But to this observer it seemed to put the heart in a type of slow motion with a lot less movement than when the heart is beating in normal sinus rhythm. You could really see a difference when they turned the Jet Ventilation off and on. Slowing down the heart like this helps the ablation doctor make lesions in hard-to-access areas and makes it easier to hold the catheter steady and apply the right contact pressure.

Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight

Drs. Michel Haissaguerre and Pierre Jais from Bordeaux/LYRIC gave presentations on the ECGI system. The day before their ablation, the patient lies down on his/her back and a technician places a vest-like device with 256 electrodes over his/her chest and stomach. These electrodes combine with rapid CT (Computed Tomography) scans to produce a very detailed 3D color map of the heart. (For a detailed description and discussion of the ECGI system, see 2013 BAFS: Non-Invasive Electrocardiographic Imaging [ECG]) The system automatically detects rotors and foci and computes them into a “Cumulative Map” or movie. These driver regions are ranked, based on statistical prevalence.

Then, Dr. Sebastien Knecht from CHU Brugmann, Brussels, Belgium, described the AFACART trial design and preliminary results using the CardioInsight ECGI system. Many centers in Europe including four in Germany are now using the CardioInsight. Requiring very little training, technicians and EPs using the CardioInsight system are getting similar great results like the Bordeaux group. Though these studies just started, it looks like the CardioInsight ECGI mapping and ablation system is poised to revolutionize the way EPs map and perform ablations.

Fibrosis and A-Fib: Continuing Research on Sheep

Dr. Jose Jalife of the University of Michigan in Ann Arbor, MI, continued his exciting research on fibrosis and A-Fib. In previous Symposiums Dr. Jalife demonstrated how A-Fib produces fibrosis. When he paced sheep into A-Fib, their hearts became fibrotic within a very short time. The markers of fibrosis (collagen and scarring) increased progressively as the sheep went from paroxysmal to persistent A-Fib. (See A-Fib Produces Fibrosis—Experimental and Real-World Data.)

Fibrosis is tissue that has fiber-like characteristics which develop in place of the normal smooth walls of the heart. Fibrotic tissue is scarred, immobile, basically dead tissue with reduced or no blood flow and no transport function. It results in a loss of atrial muscle mass. Over time it makes the heart stiff, less flexible and weak, overworks the heart, reduces pumping efficiency and leads to other heart problems. Fibrosis, up to now, was considered permanent and irreversible. But Dr. Jalife gave his sheep a Gal-3 inhibitor GM-CT-01 that actually prevented and reduced fibrosis! (For his previous presentations, see 2014 BAFS: The Holy Grail: Preventing A-Fib by a GAL-3 Inhibitor.)

In his continuing studies of sheep, Dr. Jalife found that fibrosis predicts recurrence, and that fibrosis can not be reversed if it is well established, even with GAL-3 Inhibitors.

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Last updated: Thursday, January 21, 2016 

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