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


Treatments

New FAQ: What is Atypical Flutter?

“I have Atrial Flutter that my EP describes as “atypical”. What does that mean? Is it treated differently than typical Flutter? (I’ve had two ablations, many cardioversions, and a Watchman installed to close off my LAA.)”

Atrial Flutter is similar but different from Atrial Fibrillation. Atrial Flutter is characterized by rapid, organized contractions of individual heart muscle fibers (see graphic below).

In general, there are two types of Atrial Flutter:

• Typical Flutter (from the right atrium)
• Atypical Flutter (can come from anywhere)

Typical Flutter originates in the right atrium (whereas A-Fib usually comes from the left atrium).

Atypical Flutter can come from anywhere and is one of the most difficult arrhythmias to map and ablate.

To learn more, read my full answer, go to: I have Atrial Flutter that my EP describes as “atypical”. What does that mean?”

A-Flutter usually comes from the right atrium (A-Fib usually comes from the left atrium).

2020 AF Symposium: Protecting the Esophagus by Cooling It

2020 AF Symposium

Protecting the Esophagus by Cooling It

Mark Gallagher. MD

“We know that most strategies (to prevent fistula) don’t work,” Says Dr. Mark Gallagher from St. George’s University Hospital in London, United Kingdom.

At the 2020 AF Symposium, he described an innovative strategy he and his colleagues developed to prevent fistula. He presented the completed IMPACT study which investigated whether Attune Medical’s ensoETM esophageal cooling system could effectively reduce the incidence and severity of thermal injuries to the esophagus during cardiac ablation.

What is Atrial Esophageal Fistula?
Atrial-Esophageal Fistula is the worst complication of a catheter ablation. Unlike most other ablation complications, this can kill you.

What is Atrial Esophageal Fistula? During an ablation, heat from the RF catheter applied to the back of the heart can damage the esophagus which often lies just behind the posterior wall of the left atrium. (This can also happen to some extent with Cryo ablation.)

How Atrial Esophageal Fistula can kill You: If RF heat damages the esophagus, ulcer-like lesions form in the esophagus. Then 2-3 weeks post-ablation, gastric acids (reflux) can eat away at these lesions creating a fistula (hole) from the esophagus into the heart. Without major intervention, blood can pump from the heart into the esophagus leading to death.

IMPACT Double Blind Randomised Controlled Trial

In their clinical trial, Dr. Mark Gallagher and colleagues divided 120 patients into two groups: a control group and a experimental group.

IMPACT stands for Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation.

The Control Group: The control group received only standard care, in this case a temperature probe in the esophagus. If the temperature in the esophagus went too high, they would stop the ablation till the temperature went back down (current practice).

This would often lead to the EP not being able to effectively isolate all A-Fib signal areas in the heart which were too close to the esophagus. And often, by the time the temperature went up, damage had already been done to the esophagus.

The Experimental Group: Patients in the second (experimental) group instead received a 3-foot long silicone soft tube in their esophagus connected to what was basically a refrigerator. This closed loop system pumped cooled water (25  ͦ F) down one loop of the tube, then back through another loop to the console whenever the EP worked near the esophagus. The EP controls the temperature.

Double-Blind for Both Operators and Evaluators

This was a double-blind study. The EP doing the ablation didn’t know if they were working on a Control or Experimental patient. And the doctors evaluating the procedure for possible esophagus damage also were blinded.

After 7 days, an endoscopy was performed on each patient’s esophagus (an endoscopy examines the inside of an organ). They were looking for lesions and for gastroparesis (delayed emptying of the stomach).

IMPACT Study Results

The Control group who received the standard temperature probe had multiple epithelial lesions, while the Experimental group who experienced the closed loop cooling system had only one minor lesion.

The Experimental group also needed less fluoroscopy (X-ray) time. And, more importantly, the EP was able to ablate longer in areas near the esophagus (such as the posterior wall of the left atrium). That improved the success rate of the ablation and ablation efficacy.

Editor’s Comments

Most fistula patients die. And for those who live through the emergency treatment, they are often compromised for life. But with the esophageal cooling system, patients and doctors may never again have to worry about the dreaded complication Atrial-Esophageal Fistula!
Cooling the Esophagus, a Major Medical Breakthrough! Cooling the esophagus is simple and relatively easy to do. And, barring future research findings, it seems full proof.
The Attune Medical’s ensoETM esophageal cooling system is certainly cheaper than having to care for patients with a fistula.
The Attune Medical ensoETM esophageal cooling system can provide both cooling during RF ablation, and heating during Cryo ablation.
Probably among the major proponents of the esophagus cooling system will be hospital administrators. Treating patients with a fistula is a huge expense and a nightmare for hospital staff.
A fistula is an all-hands-on-deck emergency involving not just the EP department but surgeons and many hospital staffers. A surgeon may have to perform emergency surgery to insert stents in the esophagus in order to close off the fistula, or the surgeon may have to cut out part of the damaged esophagus, which is particularly risky
(I remember one EP describing how he and his staff were running down a hospital corridor with their fistula patient close to dying, in order to get the patient to an operating surgeon.).
Esophageal Cooling Means Better Ablations: And as a bonus, using the esophageal cooling system enables EPs to do a more thorough better job. They can ablate all areas of the heart rather than avoiding areas too close to the esophagus or using lower power with shorter duration or less contact force.
When Will Esophageal Cooling be Available? For catheter ablation application, probably not soon. In the U.S and probably worldwide, Attune Medical’s ensoETM esophageal cooling system is already in use and approved for specific purposes, for example, in cases of brain damage where a patient needs to have their whole body cooled down. But not for catheter ablation
In the United Kingdom, it will first have to be approved by NHS. In the U.S., it may not need to go through the FDA approval process again. (But this is a very speculative observation.)

Will Ablation Centers Implement? It will probably require a great deal of marketing to make EPs and ablation centers aware of and actually start using the esophageal cooling system. And because Atrial-Esophageal Fistula is such a rare complication, centers may not be willing to invest in an esophageal cooling system.

References
If you are looking for Dr. Mark Gallagher’s talk in the AF Symposium brochure, it was not listed. It was presented on Friday, January 24, 2020 in the session “Advances in Pulmonary Vein Isolation (Session II.)”

See also Zagrodzky, J. et al. Fluoroscopy Reduction During Left Atrial Ablation After Implementation of an Esophageal Cooling Protocol. AFS2020-03 AF Symposium brochure abstract, p. 28. St. David’s South Austin Medical Center, 2020.

Late-Breaking Clinical Study Evaluates Attune Medical’s ensoETM for Use During Cardiac Ablation Procedures. EPDigest. February 3, 2020. https://www.eplabdigest.com/late-breaking-clinical-study-evaluates-attune-medicals-ensoetm-use-during-cardiac-ablation-procedures

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2020 AF Symposium: After Diagnosis, How Soon Should an A-Fib Patient Get an Ablation?

2020 AF Symposium

After Diagnosis, How Soon Should an A-Fib Patient Get an Ablation?

by Steve S. Ryan

When you were diagnosed with A-Fib, did your doctor say, “Let’s wait a year or two and try different drugs before we send you for a catheter ablation.” Is this attitude justified by current research?

Karl-Heinz Kuck, MD

Dr. Karl-Heinz Kuck of St. Georg Hospital in Hamburg, Germany discussed this most important topic for patients in his presentation “ATTEST Trial―Impact of Catheter Ablation on Progression from Paroxysmal to Persistent AF.”

Heavy Decision for Electrophysiologists (EPs): When to Ablate

Dr. Kuck started by describing how he personally is affected by the strategic decisions he has to make every day. As an EP, “when should we ablate a patient with A-Fib?” Should we just look at symptoms (not considering anything that is caused by A-Fib).

Will this decision contribute to a patient moving into persistent forms of A-Fib?

This happens all too often―within one year, 4% to 15% of paroxysmal A-Fib patients become persistent.

Persistent A-Fib Patients at Higher Risk

Patients who progress to persistent A-Fib are at a higher risk of dying, they have more risk of stroke, it’s more difficult to restore them to normal sinus rhythm.

In the Rocket AF trial, the mortality rate of persistent A-Fib was triple that of paroxysmal patients.

ATTEST stands for “Atrial Fibrillation progression randomized control trial“

ATTEST: RF Ablation vs Antiarrhythmic Drugs

The ATTEST clinical trial included 255 paroxysmal patients in 36 different study locations. They were older than 60 years and had to have been in A-Fib for at least 2 years (mean age 68). They had failed up to 2 antiarrhythmic drugs (either rate or rhythm control).

Patients were randomized to two groups: radiofrequency ablation (RF) (128) or antiarrhythmic drugs (127). They were followed for 3 years (ending in 2018).

ATTEST Findings: RF Ablation vs Antiarrhythmic Drugs

At 3 years, the rate of persistent A-Fib or atrial tachycardia was lower (2.4% ) in the RF group vs the antiarrhythmic drug group (17.5%).

The RF group was approximately 10 times less likely to develop persistent A-Fib compared to the antiarrhythmic drug group.

For patients in the antiarrhythmic drug group, 20.6% progressed to persistent A-Fib or atrial tachycardia compared to only 2.2% in the RF group.

Recurrences occurred in 49% of the ablation group vs. 84% in the drug group. Repeat ablations were done on 17.1% of the ablation group.

Dr. Kuck’s Conclusion

Early radiofrequency ablation was superior to antiarrhythmic drugs to delay the progression to persistent atrial fibrillation among patients with paroxysmal A-Fib.

His advice: “Ablate as early as possible.”

Editor’s Comments

Don’t Leave Someone in A-Fib―Ablate as Early as Possible: Dr. Kuck’s ingenious research answers once and for all whether or not A-Fib patients should be left in A-Fib, whether seriously symptomatic or not (e.g., leaving A-Fib patients on rate control drugs but still in A-Fib.)
These patients are 10 times more likely to progress to persistent A-Fib. That’s why today’s Management of A-Fib Guidelines list catheter ablation as a first-line choice. That is, A-Fib patients have the option of going directly to a catheter ablation.
Know Your Rights—Be Assertive: I occasionally hear of Cardiologists who refuse to refer patients for a catheter ablation, who tell patients a catheter ablation is unproven and dangerous.
When you hear something like that, it’s time to get a second opinion and/or change doctors.
As an A-Fib patient, you should know your rights and be assertive—that according to the guidelines, you have a right to choose catheter ablation as your first choice.
Your doctor may try to talk you into first trying antiarrhythmic meds before offering you the option of a catheter ablation. That is so wrong!
 Why risk progressing into persistent A-Fib? There are so many bad things that can happen to you when left in A-Fib. As Dr. Kuck points out, you’re at a higher risk of dying, there’s more risk of stroke, it’s more difficult to restore you to sinus.
And we haven’t even talked about heart damage from fibrosis, the risk of electrical remodeling of the heart and, the all-too-real dangers of taking antiarrhythmic drugs over time.
Thanks for Sharing, Dr. Kuck! I am particularly grateful to Dr. Kuck for sharing his own anxieties and decision-making strategies when trying to determine when a patient should get a catheter ablation, how this affects him personally.
Making decisions about patients whom one cares about isn’t always easy. But Dr. Kuck’s research should now make these decisions easier both for EPs and for patients.

The Bottom Line for Patients: It’s safer to have an ablation than to not have one. For more see my article Live Longer―Have a Catheter Ablation!

References
ESC 2019: Catheter ablation may be up to 10 times more effective than  drug therapy alone at delaying AF progression.  Cardiac Rhythm News. September 2, 2019, 3634.

Dobkowski, Darlene. ATTEST: Radiofrequency ablation superior to antiarrhythmic drugs for AF progression. October 10, 2019. Healio, Cardiology Today. https://www.healio.com/cardiology/arrhythmia-disorders/news/online/%7B5fa2c711-a459-4c62-bb46-8fad6c69c9ea%7D/attest-radiofrequency-ablation-superior-to-antiarrhythmic-drugs-for-af-progression

Kuck, K-H. Late-Breaking Science in Atrial Fibrillation 1. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019;

Paris Peykar, S. Atrial Fibrillation. Cardiac Arrhythmia Institute/Sarasota Memorial Hospital website. Last accessed Jan 5, 2013. URL:http://caifl.com/arrhythmia-information/atrial-fibrillation/↵

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2020 AF Symposium: “Virtual Heart” Assists Actual Ablations

AF Symposium 2020

“Virtual Heart” Assists Actual Ablations

by Steve S. Ryan

We have previously described the innovate, exciting work of Prof. Natalia Trayanova of Johns Hopkins Un. in Baltimore, MD. See ‘3D Virtual Heart’ Predicts Location of Rotors (2017 AF Symposium) and The Virtual Heart Computerized Simulation (2015 AF Symposium).

N. Trayanova, MD

At the 2020 AF Symposium, Prof. Natalia Trayanova of Johns Hopkins University presented “Computationally Guided Personalized Targeted Ablation for Persistent AF.” This computerized model is used to simulate an individual patient’s heart. This ‘Virtual Heart’ can then be used to guide an individual patient’s therapy.

Significant for Persistent A-Fib: For patients with Persistent Atrial Fibrillation, this computerized model is especially important. In a simple case of A-Fib, ablating/isolating the Pulmonary Veins (PVs) is usually all that’s necessary to restore a patient to sinus.

But with persistent A-Fib, it’s frequently required to do more than isolate the PVs. Persistent A-Fib patients often have fibrosis (fibrotic substrate) which perpetuates re-circulating electrical waves (rotors). The Virtual Heart identifies these fibrotic areas which sustain A-Fib.

How the Virtual Heart Works

Dr. Trayanova and her team start by doing an MRI scan. Then they hyper-enhance segments which correspond to areas of fibrotic remodeling in a patient’s heart.

The next step is to develop a computational mesh that incorporates representations of ion channels, calcium cycling and other electrophysical aspects of an individual’s atria. All this is incorporated into patient-specific geometry of the model.

Virtual-Heart-OPTIMA-approach-flowchart.

What the Model Can Reveal: They run the model to see what the arrhythmia looks like.

• Does the fibrotic substrate anchor rotors in particular locations?
• What are the spatial characteristics of the regions where they are located?
• Can these spatial metrics guide where the proper ablation should be?
• Can we reliably predetermine ablation targets?

Dr. Trayanova’s team merges these virtual atria with an advanced imaging technology (CARTO 3 System) to predict where the catheter should ablate.

The “Virtual Heart” Identifies Rotors: Prof. Trayanova found that re-entrant drivers (rotors) persisted in areas of higher fibrosis density and entropy (lack of order or predictability). They didn’t persist in regions of non-fibrotic sites and regions of deep fibrosis. The Virtual Heart is designed to completely eliminate the ability of the fibrotic substrate to sustain A-Fib.

Dr. Trayanova compared the predictive ability of her models to actual ECGI mapping cases from the Bordeaux group. Overall, her prediction of where rotors would be found coincided with where rotors were actually found by ECGI.

First-In-Human Virtual Ablation

Dr. Trayanova made major news when she announced the first-in-human clinical study of her Virtual Heart system! The first ten patients were part of an FDA approved clinical study of 160 persistent A-Fib patients called OPTIMA―Optimal Target Identification via Models of Arrhythmogenesis.

These ten patients had MRI heart scans which showed the fibrosis/scarring in their hearts.

This is a personalized approach tailored for each patient. The amount and structure of fibrosis is different in each individual.

Schematic summarizing the process of importing OPTIMA ablation targets into CARTO.

Creating Digital 3-D Models: Dr. Trayanova and colleagues then created digital 3-D models (Carto) and duplicated digitally the substrate and areas of fibrosis in individual patients.

They filled this model with digital virtual heart cells which mimicked and became a computerized duplicate heart. This digital heart behaved just like that individual patient’s real heart.

This digital heart behaved just like that individual patient’s real heart.

Then, they stimulate/pace the virtual heart electrically in many different locations to see where a stimulus produces an irregular heartbeat or rotor.

Rounds of Virtual Ablation: At this point, they performed several rounds of virtual ablation to digitally ablate those areas. Again, they tested to see if the digital ablation scars generated sites of emergent activity.

By the third round, there are no more hidden areas that can cause abnormal electrical signals. “We repeat the process till the substrate is no longer inducible for AF.” This also targets latent atrial arrhythmias, such as those that might emerge following initial ablation.

The Patient’s Digital Model: Finally, they export the digital model of the patient’s heart with all the A-Fib sites/rotors marked for the EP doing the actual ablation. In the EP lab, the EP uses this map to guide the catheter to the areas that need to be ablated.

Success of First Ten Patients

Persistent A-Fib patients, in general, are the most difficult to return to normal sinus rhythm. Around 50% of these patients have recurrences and have to return for additional ablations (which often cause yet more scar tissue).

Of Dr. Trayanova’s first 10 persistent patients in the OPTIMA procedure, only one patient had to return for a Flutter ablation (this was mostly because they ran out of time during the first ablation). In particular, all the rotor sites were correctly identified and ablated.

Editor’s Comments:

Persistent A-Fib patients are perhaps the most difficult to make A-Fib free.
Today, it’s common for even the best Master EPs to bring back persistent A-Fib patients for a second and even a third ablation before restoring them to sinus.
This may change with deployment of the Virtual Heart system.
The Virtual Heart system extensively and repeatedly maps where all A-Fib signals are coming from in a particular patient’s heart. With this mapping, the EP knows exactly where to ablate, including “hidden” areas which could emerge after a preliminary ablation, and areas that would cause electrical misfiring in the future.
Very important, with the Virtual Heart ablation there is no or very little recurrence of A-Fib.
The Virtual Heart system represents a major breakthrough in the treatment of persistent A-Fib patients.
The potential of Dr. Trayanova’ s research for A-Fib patients is incredible!
Imagine getting an MRI and knowing where your A-Fib is coming from, how your A-Fib affects and works in your heart both now and in the predictive future, how various A-Fib drugs can be expected and predicted to affect your heart, how much and what kind of fibrosis you have, how you can expect your fibrosis to progress and affect you over time, what therapies should be done in your particular case.
Imagine…if you need a catheter ablation, your EP knows exactly where to ablate in your heart.
Imagine…being able to accurately predict whether or not or how fast you will progress from paroxysmal to persistent A-Fib.
Imagine…all based on computer models that mirror your own heart.

Dr. Trayanova’s research has the potential to radically change the way A-Fib is treated. Almost all the uncertainties EPs and A-Fib patients now have to deal with can potentially be eliminated with the virtual computer reconstruction of individual A-Fib hearts.

References
Trayanova, N. A. Custom Cardiology: A Virtual Heart for Every Patient; Personalized computer models will let cardiologists test life-saving interventions. IEEE online, 28 Oct 2014. Accessed Feb 26, 2015, URL: http://www.ieee.org/about/index.html

Scudellari, Megan. Personalized Virtual Hearts Could Improve Cardiac Surgery―Digital replicas of patients’ hearts can identify hidden, irregular heart tissue for surgeons to destroy. IEEE Spectrum, August 22, 2019 / 12:00 GMT https://spectrum.ieee.org/the-human-os/biomedical/imaging/virtual-hearts-improve-cardiac-surgery

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2020 AF Symposium Live Case: LAA Closure with New Generation Device

John Foran MD

AF Symposium 2020

Live Case: LAA Closure with New Generation Device

In this live case Dr. John Foran from Royal Brompton Hospital in London, implanted the Watchman FLX to close off the Left Atrial Appendage (LAA) (Boston Scientific). It was in conjunction with several presentations on Left Atrial Appendage Closure (LAAC) devices.

The moderator for this live case was Dr. Walid Saliba of the Cleveland Clinic. The Panelists were Dr. Jacqueline Saw of Vancouver General Hospital and Dr. Dhanunjaya Lakkireddy of the Kansas City Heart Rhythm Institute.

Patient History

This male patient with persistent A-Fib had recently suffered a hemorrhagic (bleeding) stroke. He had been in A-Fib for 20 years and had a long history of hypertension. He had a CHADS-VASc score of 4 and a HAS-BLED score of 3. He was formerly on warfarin for 17 years, then switched to edoxaban (Savaysa) for one year when he had his “catastrophic” cerebral bleed. Happily, he eventually made a good recovery.

Dr. Foran would not state that his patient’s hemorrhagic stroke came from his years of being on anticoagulants. He raised the alternative possibility that the man’s stroke could have come from a hypertension bleed. Dr. Foran said he tries to insert a Watchman device as soon as possible after a cerebral stroke.

Patient Drug Treatments

His doctors stopped his anticoagulant when he was approved for Left Atrial Appendage Closure. He was put on Apixaban (Eliquis) 2/day for a short period of time.

As of April 2020, the Watchman FLX device is not yet approved for use in the U.S.

Dr. Foran said, “we always anticoagulate in the lead-up to an implant procedure.” The apixaban was continued through the procedure.

Post-op, the patient will be given apixaban as well as aspirin during six weeks after the procedure. Then he will be on apixaban for 6 months.

The Next Generation: Watchman FLX Occlusion Device

Dr. Foran displayed the earlier Watchman 2.5 version (left) and compared it to the new Watchman FLX (right).

Comparison of Watchman 2.5 (left) and Watchman FLX (right)

The Watchman FLX has a closed cell architecture with no sharp points at the top. The threaded insert is much smaller with less metal visible. (In the older Watchman device, it was found that thrombi (clots) could form on the metal insert visible after the Watchman was inserted.)

The Watchman FLX is designed to conform better to individual anatomies.

Watchman FLX -18 J-hooks in 2 rows

It uses 18 hooks offset in two different planes as compared to the older Watchman 2.5 which had 10 hooks. This allows the FLX to hook deeper into the LAA.

Dr. Foran said the older Watchman had sharp points at the top which meant you couldn’t push it forward very hard into the heart tissue̶-particularly in someone with a small LAA (like this patient).

Because the Watchman FLX is more flexible, he no longer uses the earlier Watchman 2.5 version.

Inserting the Watchman FLX

When the Symposium audience joined the live ablation, the patient had already been prepped in the EP lab. The catheters were already in place in the heart.

Illustration of Watchman inserted into Left Atrial Appendage

We watched as Dr. Foran, using fluoroscopy (x-ray) and echocardiogram, inserted the Watchman FLX into the opening of the LAA. He used saline and color flow for contrast to show where the sheath was.

Dr. Foran showed how there were air bubbles inside the sheath which he flushed out with saline.

Next, he opened up the Watchman FLX inside the LAA. He pushed in the Watchman FLX for 10 seconds to better imbed the device’s hooks. He then tugged on it a couple of times to make sure the anchors were well seated.

To complete the procedure, he then released the Watchman FLX and withdrew the sheath.

Editor’s Comments

My own electrophysiologist (EP), Dr. Shephal Doshi at Pacific Heart in Santa Monica, CA, told me it normally takes him only around 20 minutes to insert a Watchman. The new Watchman FLX appears to be even easier to install.
The biggest improvement in the Watchman FLX, in my opinion, is the smaller threaded insert with much less metal visible. Patients will likely have significantly reduced risk of clots forming on metal, which was an annoying problem that sometimes occurred with the earlier Watchman.
Approved in Europe but Not in U.S.:  In Europe, Boston Scientific received CE Mark certification in March 2019 and initiated a limited market release of the Watchman FLX™ in the European Economic Area (EEA).
In the U.S., clinical trials of the Watchman FLX are under way in 29 U.S. medicals centers. The trials close in Feb. 2021. I expect eventual approval by the U.S. Food and Drug Administration (FDA).
About 85% of A-Fib strokes are ischemic strokes; this A-Fib patient had a hemorrhagic stroke which is less common.
The Patient’s Hemorrhagic Stroke: Did anticoagulants cause or contribute significantly to this patient’s bleeding stroke?
We simply can’t say for sure whether being on anticoagulants for so many years caused or contributed to this patient’s cerebral hemorrhage (bleeding stroke).
As Dr. Foran pointed out, the patient’s hypertension may have been a factor in his stroke.
But anticoagulants are not like taking vitamins. They work by causing or increasing bleeding. However, they are certainly better than having an A-Fib ischemic (blocking blood flow) clot and stroke.

A-Fib Patients and Hemorrhagic Stroke: Recent research indicates that the risk of a hemorrhagic stroke, particularly in older A-Fib patients, should be considered carefully and can be very dangerous. For more about A-Fib and Hemorrhagic stroke, see my article, Anticoagulants Increase Risk of Hemorrhagic-Type Strokes

Reference for this report
Das, A.S et al. Etiology and Imaging Risk Markers of Non-Vitamin K Antagonist Oral Anticoagulant-Related Intracerebral Hemorrhage. AFS2020-17. AF Symposium 2020 brochure, p. 42.

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2020 AF Symposium Live Case: Ultra-Low Temperature Cryoablation

AF Symposium 2020

Live Case: Ultra-Low Temperature Cryoablation

Background: The Adagio Medical iCLAS catheter is a Cryo catheter that uses ultra-low temperatures and is unlike anything currently on the market. To learn more about the iCLAS catheter, see my earlier report from the 2018 AF Symposium: Innovative iCLAS Cyro Catheter by Adagio Medical.
Note: The Adagio Medical iCLAS is not yet FDA approved. The U.S. IDE study trial is active and enrolling. The clinical trial started in December 2019. https://clinicaltrials.gov/ct2/show/NCT04061603.

Live Ablation Via Streaming Video

Tom DePottee, MD

Live from Belgium, Dr. Tom De Potter and his colleagues from OLV Hospital performed an ablation using Adagio Medical’s ultra-low temperature cryoablation catheter.

When the Symposium audience joined the live ablation via streaming video, Dr. De Potter and his colleagues had already performed a single transseptal puncture and were working in the left atrium.

Several catheter configurations possible with the Adagio Medical system.

To produce temperatures as low as (minus) –196° Celsius, Adagio Medical uses what they call Near Critical Nitrogen (NCN) which is far lower than current CryoBalloon technologies.

Producing Continuous Linear Ablations

Adagio catheters produce continuous linear ablations and can also be configured to do focal (single point) catheter lesions. Dr. De Potter also showed how the same Adagio Medical catheter can also do cryo mapping.

As we watched, Dr. De Potter encircled the Left Superior Pulmonary Vein (PV) with a double loop catheter. Then applied the cryo energy and froze the ostium area to isolate the PV. The catheter stylus included a loop of the freezing section and a loop with electrodes which recorded/mapped the A-Fib signals.

Freezing Isolated the Vein

We could see the ice formation on the catheter itself and how the freezing isolated the vein.

Adagio catheter encircles PV and freezes to isolate the PV area.

It only took 30 seconds to isolate that vein, but Dr. De Potter continued the freeze for one minute. Then performed what he called a bonus freeze.

On the catheter monitor, we could see how that vein had PV potentials which were then isolated.

Then Dr. De Potter moved to the Right Pulmonary Veins. The phrenic nerve usually runs close to the ostia of the right PVs. He said they perform phrenic nerve pacing to prevent damage to the phrenic nerve. We saw how they performed phrenic nerve capture.

Monitoring the Phrenic Nerve

If they do find they might be damaging the phrenic nerve, they don’t ablate there or insert a different catheter stylus configuration which doesn’t affect that area.

They didn’t achieve isolation of the Right Interior PV, so they did a second ablation while slightly changing the stylus loop position. Dr. De Potter said that he usually achieves isolation with one pass, except for, as in this case, with the Right Interior PV which is more challenging.

Protecting the esophagus with the Adagio Medical Warming Balloon (right of heart)

CryoAblation is Reversible. Dr. De Potter showed how they first used low energy cryo in a 30 second ablation to see if the phrenic nerve was affected (if affected, the tissue can be de-frosted and returned to normal or reversed.) Then they applied the full cryo energy at the ultra-low temperature which is permanent. The speed of decrease in cooling is very fast at 300°C/sec.

Protecting the Esophagus

To protect the esophagus, Dr. De Potter showed how they insert a warming balloon with constantly circulating warm saline into the esophagus which prevents excessive cooling and damage to the esophagus.

He stated that the next generation of the warming balloon will also have temperature sensing. They can then have a much better idea of what the freezing will do to the esophagus, how much temperature affects will be seen in the esophagus.

Ablating the Posterior Wall 

Dr. De Potter also showed the Adagio Medical system ablating the posterior wall. “It’s very simple. We will make overlapping rings.”

We saw him make those overlapping ring ablations in three passes which blocked conduction over the posterior wall. But with a larger atria, he may use 6 applications. He mentioned that at this stage he hasn’t achieved consistent success making a Mitral Isthmus line.

The Key Benefit of Ultra-Low Temperature Cryoablation

According to Dr. De Potter:

“The key benefit of this technology is a different energy source in contrast to the CryoBalloon which uses a theoretical minimum of –80°C.

This system (Adagio Medical) uses liquid nitrogen which has a theoretical minimum of –196°C. When you consider that this –80°C is at the center of the balloon and not necessarily at the tissue, we think we have a far better margin for efficient energy delivery while providing for patient safety.”

Editor’s Comments:

When I visited the Adagio booth at the Symposium exhibit hall, I was fascinated to see how easily the catheter can be manipulated into many different configurations depending on the lesions which need to be made.
Using its full length, the catheter can produce ultra-low temperatures along its whole span (110mm). Its 20 electrodes can also produce cryo-mapping of the atria.
Why is the iCLAS Cryo catheter special and innovative? The iCLAS catheter produces ablation lesions like current CryoBalloon catheters but at lower temperatures (colder). One would expect that such ultra-low Cryo lesions would be deeper, more transmural, and more lasting.
In addition, the ability to produce unlimited shapes gives the iCLAS catheter a unique ability to position Cryo lesions in a variety of locations in the heart.

The Adagio Medical iCLAS cyro system will make ablations much simpler and easier for EPs. It may eventually supersede normal CryoBalloon ablation (which is already a very effective ablation strategy).

If you find any errors on this page, email us. Y Last updated: Saturday, May 23, 2020

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2020 AF Symposium: 5 Abstracts on Pulsed Field Ablation

The 2020 AF Symposium abstracts are one-page descriptions of A-Fib research, both published or unpublished. The abstracts are supplemental to the Symposium live presentations, panels discussions and spotlight sessions. This year the printed digest contained 55 abstracts. I choose only a few to summarize.

My Summaries of Select PFA Abstracts

Pulsed Field Ablation (PFA) was the single most important topic at this year’s Symposium. I summarized five of the PFA abstracts of most interest to A-Fib patients.

Lesion Durability and Safety Outcomes of Pulsed Field Ablation
The durability of PFA lesions is the focus of Dr. Vivek Reddy’s abstract. His research study followed 113 patients who each received a PFA ablation.

Pulsed Field Ablation with CTI Lesions Terminates Flutter in a Small Study
The use of Pulsed Field Ablation (PFA) may significantly improve CTI ablation lesions to block the Flutter signal. (CTI: Cavo-Tricuspid Isthmus)

Durability of Pulsed Field Ablation Isolation Over Time: Preliminary Study
Pulsed Field Ablation (PFA) is a new treatment. This study asked the question of whether PFA electrical isolation (lesions) regresses over time.

Pulsed Field Ablation vs RF Ablation: A Study in Swine 
PFA is “tissue-specific”. This study tested if surrounding non-heart tissue (the esophagus) would be affected. PFA ablation was compared to RF ablation. Swine (pigs) were used so tissue could be dissected and examined.

Using MRI to Check Pulsed Field Ablations (PFA)
Normally, during a RF or cryo ablation, doctors move the esophagus as far away as possible from where they are ablating. In this study they took no such precautions.

My Summary Reports

For more from the 2020 AF Symposium, go to My Summary Reports Written for A-Fib Patients. Remember, all my reports are written in plain language for A-Fib patients and their families.

2020 AF Symposium Abstract: Pulsed Field Ablation Follow-Up Study

2020 AF Symposium Abstract

Pulsed Field Ablation Follow-Up Study

Dr. Vivek Reddy, Mt Siani Hospital

Dr Vivek Reddy, Mt Sinai Hospital

Background: At the 2020 AF Symposium, Dr. Vivek Reddy demonstrated an ablation using Pulsed Field Ablation (PFA). Radically improving ablation treatment, PFA is:
• Tissue selective; affects heart tissue only and not other structures or organs.
• Very fast and precise; long-lasting lesions can be delivered in seconds.
• No direct contact needed only proximity, i.e., millimeters from the targeted tissue.
• Safer than current ablation energy sources, primarily because of its tissue selectivity.
• Offers two catheter shapes designed to fit into various areas of the heart.

But Does Pulsed Field Ablation Endure Long-Term?

The durability of PFA lesions is the focus of Dr. Vivek Reddy’s abstract, Lesion Durability and Safety Outcomes of Pulsed Field Ablation. His research study followed 113 patients who each received a PFA ablation.

Study Description: Patients were enrolled in 3 multi-center clinical trials which used a biphasic PFA waveform with a basket/flower catheter configuration.

Dwell time’ is the time transpiring from introduction of the ablation catheter into the body to the catheter’s removal.

Five EPs were chosen to do the PFA ablations. The 88 most recent patients were ablated. They were not under general anesthesia. PFA procedures required around 33 minutes of Left Atrium (LA) dwell time.

Follow-up Testing and Results: At 75-90 days, patients were invasively re-mapped.

Then, after 1 year, the Pulmonary Vein (PV) lesions were re-assessed and safety re-examined.

All PVs remained isolated. The primary safety event rate was 1.8% (1 pericardial tamponade, 1 groin hematoma).

The esophagus was carefully evaluated. There was no evidence of thermal esophageal lesions.

Cerebral MRI revealed no post-procedure swelling (ischemia). There was no PV stenosis. There were no latent safety issues. Invasive re-map procedures showed that lesion durability of the Pulmonary Veins reached 98%.

Study Conclusion

The researchers concluded that Pulsed Field Ablation (PFA) demonstrated:

• An excellent safety profile, no unexpected safety issues over a full year of follow-up.
• A very high rate of long-term Pulmonary Vein isolation (durable lesions).

So Does Pulsed Field Ablation Endure Long-Term? Yes!

Editor’s Comments

A year’s follow-up demonstrated that Pulsed Field Ablation (PFA) is a significant improvement over current ablation treatments. And these extraordinary results were obtained by 5 operators, which means that PFA is not dependent of the skill of a particular electrophysiologist.
I predict that Pulsed Field Ablation (PFA) will supersede all current ablation strategies. It’s almost too good to be true.

Unfortunately, it will probably take 3-5 years for PFA to be available for most A-Fib patients.

Reference for this report
Reddy, V. et al. Lesion Durability and Safety Outcomes of Pulsed Field Ablation in > 100 Paroxysmal Atrial Fibrillation Patients. AF Symposium 2020 brochure, Abstract AFS2020-19, p. 44. Ichan School of Medicine at Mount Sinai.

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

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2020 AF Symposium Abstract: Using MRI to Check Pulsed Field Ablations (PFA)

2020 AF Symposium Abstract

Using MRI to Check Pulsed Field Ablations (PFA)

by Steve S. Ryan

Background: Pulsed Field Ablation (PFA) is a new treatment for Atrial Fibrillation with some unique features. First, the ablations are tissue-specific, only affecting heart tissue and not the surrounding organs. Second, instead of direct contact to make lesions, as with RF ablation, all that’s necessary is proximity to the targeted tissue to make the ablation.

Pierre Jaïs, MD, The Bordeaux Group

In a remarkable statement that would strike terror in the heart of most Electrophysiologists (EPs), the French Bordeaux group stated about Pulsed Field Ablations:

Measures to alter lesion placement based on proximity of the esophagus and phrenic nerve were not taken.”

Normally, during a RF or cryo ablation, doctors move the esophagus as far away as possible from where they are ablating. In this study they took no such precautions.

Pulsed Field Ablation (PFA) study

Farapulse catheter – Five Petal Flower configuration

At this year’s AF Symposium, the French Bordeaux group presented an abstract of their study using Pulsed Field Ablation (PFA) with MRI.

Study Technique: With the Pulsed Field Ablation (PFA) waveform generator, they used a 5-spline 12F catheter to isolate the Pulmonary Veins (PVs). Then, they used MRI to check the PFA lesions to assess any extra-cardiac damage.

Study Results

NO DAMAGE TO THE ESOPHAGUS

Position of Esophagus behind the heart

In 17 patients, the esophagus was located directly behind and adjacent to PFA lesions at a distance of 0.5 to 2 mm. Post PFA ablation and using MRI imaging, they found no esophageal lesions.

They also found no discontinuities (gaps) in any isolated PV.

(With other energy ablation sources such as RF, the esophagus would be scarred, have ulcer-like damage, and fistula.)

NO PHRENIC NERVE DAMAGE

Phrenic nerve near heart

When they ablated the right PVs, they knew that they were right next to or close to the phrenic nerve.

Upon examination, PFA lesions were found in the area of the phrenic nerve but no damage was seen (despite the fact that there was consistent phrenic nerve capture during PFA delivery).

LESS THAN 60 SECONDS PER PATIENT

And even more remarkably, the total energy delivery time per patient was less than 60 seconds. This is much less time than with other types of ablation.

Editor’s Comments:
I expect Pulsed Field Ablation (PFA) will revolutionize catheter ablation for A-Fib. This is incredibly good news for patients and will make the EP’s job much easier requiring less time in the EP lab.

Better for Patients

Atrial-Esophageal Fistula No Longer a Threat: These are remarkable results! When using Pulsed Field Ablation (PFA), EPs don’t have to worry about damaging the esophagus, even though the PFA catheter may be very close to the esophagus. The dreaded complication Atrial-Esophageal Fistula will become a thing of the past! The same holds for Phrenic Nerve damage.
PFA is Tissue Selective: Instead of direct tissue contact as with RF ablation, all that’s necessary with PFA is to position the catheter in proximity to the targeted tissue. Because PFA is tissue selective, it’s easier and faster to make lesions without gaps.

Better for EPs

PFA Allows More A-Fib Patients to be Treated: Because PFA takes so little time, patients won’t have to wait for months to schedule an ablation. EPs will be better able to handle today’s epidemic of A-Fib cases. (One wonders how many PFA ablations a skilled EP will be able to do during a day?)
Better for Health of EPs: PFA may add years to an EP’s career and health. EPs no longer will have to wear those heavy lead shields for long periods of time to prevent fluoroscopy radiation damage.

But Not Ready Yet

It will probably take 3-5 years for PFA to be available for most A-Fib patients.

Reference for this report
Jais, P. et al. Lesion Visualization of Pulsed Field Ablation by MRI in an Expanded Series of PAF Patients. IHU Liryc, University de Bordeaux. AF Symposium 2020 brochure, Abstract AFS2020-37, p. 62.

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

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2020 AF Symposium Abstract: PFA+CTI Lesions Terminates Flutter in a Small Study

2020 AF Symposium Abstract

Pulsed Field Ablation With CTI Lesions Terminates Flutter in a Small Study

Illustration of right atrium, cavotricuspid isthmus (CTI) and tricuspid valve annulus.

Definition: Cavotricuspid isthmus (CTI) is part of the right atrium located between the inferior vena cava (IVC) ostium and the tricuspid valve.

Typical Atrial Flutter comes from the right atrium and is usually terminated by what is called a Cavo-Tricuspid Isthmus (CTI) lesion ablation line which blocks the Flutter. But for a CTI lesion to work, the Electrophysiologist (EP) using RF has to make small continuous lesions which require intense concentration to be gap free.

Even though a CTI lesion is one of the safest ablation procedures, there are some risks. Damage can be to the right coronary artery or to the AV Node and His bundle signal pathways.

PFA Makes Flutter Ablation Easier and More Effective

Ante Anic, MD, U. Hospital Center, Croatia

An abstract distributed at the 2020 AF Symposium by Dr. Ante Anic showed how the use of Pulsed Field Ablation (PFA) may significantly improve CTI ablation lesions.

Pulsed Field Ablation is fast, contact forgiving, and only affects cardiac muscle cells (cardiomyocyte).

In a small PFA study (3 patients), a continuous, non-conducting line of CTI lesions was made with a deployable 4-spline, multi-electrode basket-shaped tip catheter.

Study Results: Right atrium Typical Flutter was successfully blocked with bidirectional block (BDB) confirmed. Moreover, these CTI lesions required little time to make (3, 4, & 6 minutes).

Unlike with standard radio-frequency (RF), the Pulsed Field Ablation catheter required few ablation sites (4, 3, and 6 respectively). In effect, making a CTI ablation line with PFA was much easier and required much less precision and concentration.

After a 15 minute waiting period, bidirectional block (BDB) was confirmed in all three patients to make sure there were no Flutter signals. They also used adenosine in one patient to try to stimulate that patient back into Flutter with no success.

Overall, they found that the PFA lesions were persistent and completely blocked the Flutter.

Editor’s Comments:
Pulsed Field Ablation (PFA) has different catheter shapes which enable the operator (EP) to easily work in all areas of the heart.

PFA catheter shapes: (L) Basket catheter (R) Flower Petal catheter.

In this limited study, a Cavo-Tricuspid Isthmus (CTI) lesion was used to eliminate typical Atrial Flutter. The electrophysiologist (EP) used a basket configuration to make linear, focal lesions. PFA seems well suited to any heart configuration an EP may encounter.
Furthermore, EPs don’t have to worry about precisely positioning the PFA catheter for direct contact. Proximity is all that’s needed. PFA is fast and tissue specific. It won’t damage surrounding nerves and organs.
Though a small study, this abstract from Croatia opens up new frontiers for the use of PFA.

I see Pulsed Field Ablation (PFA) as a radically superior treatment for right atrium typical Flutter.

Reference for this article
Antic, A. et al. Acute Experience with Pulsed Field Ablation for Typical Flutter. University Hospital Center Split, Croatia. AF Symposium 2020 brochure, AFS 2020-26, p. 51.

If you find any errors on this page, email us. Y Last updated: Wednesday, August 26, 2020 Return to 2020 AF Symposium Reports

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