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Treatments

2023 AF Symposium: Live Case from Dublin using Pulsed Field Ablation and Multispline Catheter

LIVE live from Dublin, Ireland—it was like we were in the EP lab with Drs. Joseph Galvin and Gabor Szeplaki from Mater Private Hospital in Ireland.

They perform 800-900 ablations/year and have done 268 cases of Pulsed Field Ablation (PFA) using the Boston Scientific Farapulse system. Amazingly, these ablation average 40 minutes in length—a very short time to perform an ablation (and no complications).

The patient was a 66-year-old woman who had developed symptomatic paroxysmal A-Fib three years ago, medications were poorly tolerated.

The first thing we noticed was, instead of the typical Lead apron shields to protect against Fluoroscopy radiation, they were wearing what looked like plastic vests which were leadless (but did provide radiation protection).

As we watched from Boston… . Read my full blow-by-blow report, see Live Case Presentation from Dublin, Ireland. Pulsed Field Ablation for AF Using a Multispline Catheter.

A-Fib Patients with Sleep Apnea: Philips Respironics Recall of CPAP Devices

Background: A-Fib patients often have obstructive sleep apnea as well. Many use a Continuous Positive Airway Pressure (CPAP) device when sleeping to keep their air way open and unobstructed.

The FDA Safety Commission and NST Attorneys-at-Law report that Philips has recalled their CPAP devices because of “identified potential health risks related to the polyester-based polyurethane sound abatement foam component of these devices.” The foam in the machine can break down and then be swallowed or inhaled by the user.

According to Philips’ lab results, degraded polyurethane foam produced potentially harmful chemicals. These chemicals may then enter one’s body, reach the bloodstream, and travel to any body tissue and organ. Most of these harmful chemicals from the degraded foam can cause cancer.

All CPAP Users

If you use a different brand of CPAP device, check the tubing. Or talk to your supplier about how safe your device is in light of the Phillips recall.

If You Have a Philips CPAP Device

For detailed information about this recall, go the NST Attorneys-at-Law web site or Philips Voluntary Recall Information to:

  • Determine if your product is listed in the Philips recall notification
  • Learn how to Register Your Device For Recall and What To Expect Next

Talk to Your Doctor: The U.S. Food and Drug Administration (FDA) advises consumers to talk to their doctor to weigh the risks of continued use and decide on a suitable way to move forward.

A-Fib, Sleep Apnea and CPAP: What You Need to Know

If you have a Phillips CPAP device, learn if you have a model that has been recalled. If so, stop using it and talk with your doctor on how to proceed.

If you model has been officially recalled, Philips should give you a new one. But you may be safer switching to another CPAP manufacturer.

Visit the Philips Voluntary Recall Information website to stay current on your claim.

References
• UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due

• Voluntary Recall Information: Philips Respironics Sleep and Respiratory Care devices. https://www.usa.philips.com/healthcare/e/sleep/communications/src-update/information-for-patients-and-caregivers

• CPAP and Cancer. NST Attorneys-at-Law. https://www.nstlaw.com/cpap-and-cancer/

2023 AF Symposium: Challenging Case―An EP’s Nightmare

This is a tragic case of a 77-year-old male, a retired Cardiologist and a personal friend of the speaker for over 40 years. This case resonated emotionally with both the doctors, panelists and the audience who seemed to have experienced similar experiences with their patients.

Dr. Karl-Heinz Kuck of the University of Lubeck, Lubeck, Germany, described what lead up to a fatal climax.

The story starts in 2014 when his patient developed Persistent Atrial Fibrillation. He had a successful PVI (Pulmonary Vein Isolation/ablation) and roof line ablation in 2015.

A couple of weeks later, the patent had a repeat ablation including an isthmus line. He was doing well for 6 years. But then he came back with… Read the whole story at Challenging Case―An EP’s Nightmare.

2023 AF Symposium: Innovative A-Fib Ablation Plus LAA Closure in One Procedure

This report from the 2023 AF Symposium is about an innovative treatment for A-Fib patients―combining A-Fib ablation with the insertion of a Left Atrial Appendage (LAA) occlusion device in a combined procedure.

Closing off the Left Atrial Appendage has become an important topic for patients looking to be A-Fib free.

Many A-Fib stokes originate in the Left Atrial Appendage. And many recurrences of A-Fib come from the Left Atrial Appendage, too.

Inserting a Watchman occlusion device to close off the LAA has become a relatively simple and fast process. Combining it with a catheter ablation doesn’t add much time to the ablation procedure.

This treatment strategy is currently in use in many countries overseas, but isn’t yet common practice in the U.S.

Dr. Walid Saliba of the Cleveland Clinic Foundation in Cleveland, OH explained how patient selection is important in this combined procedure. To learn more read my report…

 

2023 AF Symposium: Live Case from Dublin, Ireland. Pulsed Field Ablation for AF Using a Multispline Catheter

2023 AF Symposium

Dr. Joseph Galvin, Dublin, Ireland

Live Case Presentation from Dublin, Ireland. Pulsed Field Ablation for AF Using a Multispline Catheter

The presenters of this live presentation were Drs. Joseph Galvin and Gabor Szeplaki from Mater Private Hospital in Ireland. They perform 800-900 ablations/year and have done 268 cases of Pulsed Field Ablation (PFA) using the Boston Scientific Farapulse system.

As we watched this live ablation, they used the optimized biphasic wave form for the PFA ablations. Dr. Szeplaki did the actual ablation while Dr. Galvin commented.

Dr. Gabor Szeplaki, Dublin, Ireland

No Lead Aprons

The first thing one noticed was that, instead of the typical Lead apron shields to protect against Fluoroscopy radiation, they were wearing what looked like plastic vests which were leadless. (Zero Gravity system by Biotronik.) These shields attach via a magnet to the operator who wears a vest with a magnet at the front.

66-Year-Old Female with Common Right Atrium

The patient was a 66-year-old woman who had developed symptomatic paroxysmal A-Fib three years ago. She had been taking Sotalol but tolerated it poorly. They also had tried dronedarone, but she had symptoms.

Her CHA2DS2-VASc score was 3. She had hypertension. Her left atrium was otherwise healthy. She had a somewhat unusual pulmonary vein anatomy with what looked like a huge common right ostium. They used general anesthesia rather than conscious sedation.

Ablation Procedure

NOACs (Novel Oral Anticoagulants) were discontinued the morning of the procedure.

A TEE (Transesophageal Echocardiogram) was used to make sure there was no thrombus (clot) in the heart.

They used Ultrasound to position the catheter to puncture the vein. In the heart they used a single transseptal puncture to access the left atrium. They used the Orion catheter for 3-D mapping and paced from the Coronary Sinus.

The mapping software was integrated into the Farapulse system in real time, which is a great help to the EPs. The catheter sheaths were transparent so that they could better see and eliminate bubbles on the catheters.

Farapulse catheter Open-Basket configuration

Farapulse catheter – Five Petal Flower configuration

Each vein to be ablated received four basket and four petal ablations rotating the catheter each time for better coverage. (For a more detailed description of the Farapulse system, see my 2020 report, Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.) 

They made sure that both exit and entrance block were achieved in each vein. As they ablated, the heart tissue on the screen changed from light red to dark red.

Even with the large common right ostium, they still used the 31mm catheter rather than the larger size. The patient was successfully ablated and returned to normal sinus rhythm.

Overall their results in their center are 96% vein isolation and 84% curable PVI.

Dr. Galvin commented that when they first started, PFA ablations were taking 6-7 hours. But now they are doing them in 40 minutes.

Editor's CommentsEditor’s Comments

PFA Ablation Easy, Safe and Effective: The Farapulse ablation protocol has become relatively easy and safe to do. The operators in Ireland seemed very proficient, confident, and experienced. For them this was no big deal and almost routine. This is great news for patients. 40 minutes is a very short time to perform an ablation. And with no complications.
PFA Not Yet Approved in U.S.―But Will Be Soon. PFA ablation is not yet approved in the U.S., but has been approved overseas and has been in use for some time. Panelists from Germany pointed out that PFA ablation is now done on an out-patient basis with no need to stay in a hospital overnight. This is all good news for U.S. patients with Atrial Fibrillation.
Transparent Radiation Shields Great Advance: And using these transparent shields to protect against radiation exposure is a huge advance for EPs doing ablations.

I’ve been in operating rooms and had to wear those lead aprons used today by most EPs. They are really heavy and wear you down by the end of the day. All too many EPs develop slipped disks or other back problems. And reducing or eliminating radiation exposure improves EPs health and peace of mind. Good news for EPs!

If you find any errors on this page, email us. Y Last updated: Saturday, August 12, 2023

Return to 2023 AF Symposium Reports

2023 AF Symposium: Challenging Case―Ablates Hot Spots in Low Voltage Areas

2023 AF Symposium

Dr John Day, Salt Lake City, UT

Challenging Case―Ablates Low Voltage High Frequency Areas

Dr. John Day of the Heart Center of St. Mark’s Hospital in Salt Lake City, UT presented the case of a 56-year-old young man in otherwise good health. His BMI was normal. He had had an ablation but was still in A-Fib, according to his Apple watch. “Doc, I’m still having A-Fib. You’ve got to fix it.” He had mild or moderate left atrium enlargement but no clear A-Fib triggers. He didn’t want to be on drugs. He had tried Flecainide which lowered his heart rate too much. He couldn’t exercise on Flecainide.

Dr. Day gave the audience the following choices and asked their opinion.

1. End the case [with no further treatment]

2. Change the antiarrhythmic.

3. Ablate again.

Mapping illustration: Low-voltage high frequency areas targeted for ablation

The consensus of the audience was to ablate again. And this was indeed how Dr. Day proceeded.

Second Ablation of Hot Spots

In this patient’s second ablation, all the PVs (pulmonary veins) remained isolated. A­-Fib was induced with pacing and Isoproterenol. Dr. Day used electrogram guided ablation.

When in both sinus rhythm and atrial fibrillation, the patient had low-voltage zones (suggestive of left atrial fibrosis) on the posterior wall of the left atrium.

Dr. Day targeted very high frequency signals (hot spots) appearing in low voltage areas. He remarked:

• “We only mark low voltage zones (diseased tissue) if it is low voltage in both sinus rhythm and atrial fibrillation.”
• “We only treat confirmed low voltage zones with high frequency signals…basically with this approach we are only treating diseased tissue with intense abnormal electrical activity which often corresponds to atrial fibrillation driver sites.”

Dr. Day admitted this doesn’t always work. But he has done over 5,000 ablations where this technique is effective.

The patient’s A-Fib didn’t terminate during the ablation, but it did later. Sometimes these patients have to be cardioverted to get them back into normal sinus rhythm.

This patient has been A-Fib free for 18 months and is off of Flecainide.

Editor's Comments

Editor’s Comments

Dr. Day and his colleagues may have developed a new method of making patients with difficult cases A-Fib free.

Innovation approach. Instead of looking for “potentials”, he ablates areas of low voltage and high frequency. This is an innovative approach and could help many patients with difficult cases.

If you find any errors on this page, email us. Y Last updated: Thursday, May 11, 2023

Return to 2023 AF Symposium Reports

2023 AF Symposium: Ablation Combines with LAA Closure in One Procedure

2023 AF Symposium

Ablation Combines with LAA Closure in One Procedure

Walid Saliba, MD

Dr. Walid Saliba of the Cleveland Clinic Foundation in Cleveland, OH, discussed an innovative treatment for A-Fib patients―combining A-Fib ablation with the insertion of a Left Atrial Appendage (LAA) occlusion device in a combined procedure. (This treatment strategy is currently in use in many countries overseas, but isn’t yet common practice in the U.S.)

Patient Selection

Dr. Saliba explained how patient selection is important in this combined procedure.

The idea patient with atrial fibrillation needing an ablation would also have a high risk of stroke but couldn’t tolerate anticoagulants because of a high risk of bleeding.

Advantages of Combining PVI with LAA Closure

While these two procedures (A-Fib ablation and LAA closure) are typically done separately, combining them in one procedure has many potential advantages. Both procedures:

• require access from the groin to the left atrium

• initiating oral anticoagulation around the time of the procedure

Dr. Saliba made the following points:

1.Combining these two procedures reduces the risk of complications. (For example, one only has to make a transseptal puncture once rather than at two different times.)

2. Patients prefer only having to have one procedure rather than the hassle of going to the hospital twice for two different steps.

3. Combining these two procedures reduces the potential risk of bleeding.

Reimbursement Problem in U.S.

Dr. Saliba described how in the beginning (2015) it was difficult to be reimbursed for combining two different procedures at the same time. But eventually he was able to convince the powers that be that this was good for certain patients and actually saved the hospital money.

Source of A-Fib Recurrences

Dr. Natale and Dr. Saliba discussed that many A-Fib recurrences come from the Left Atrial Appendage. Inserting an LAA occlusion device when performing an ablation might prevent the mapping and ablating of non-PV triggers in or around the LAA. (This is less of a problem with the Watchman than with the Amulet device which actually masks off the LAA area with a metal disc.)

High Success, Low Complication

Dr. Saliba and his colleagues at the Cleveland Clinic have performed this combined procedure on more than 240 patients with one-year follow-up. Their success rate is high with low complications. Patients stayed in the hospital for a day.  Over 95% of their patients are eventually off of anticoagulants.

Half of their patients received the original Watchman, while the other half got the Watchman FlX. Leaks around the Watchman were only around 2.2% and were less than 2mm. At 90 days leaks were around 25% with less than 3mm. Dr. Saliba hasn’t noticed any problems with LAA remodeling, pressure, or scarring of the Left Atrium wall.

OPTION Trial Revelations to Come

The OPTION Trial is a clinical study of patients with non-valvular A-Fib. It compares outcomes of a combined ablation + LAA occlusion procedure versus catheter ablation alone followed with anticoagulation.

Specifically, the study is to determine if the WATCHMAN FLX occlusion device placed at the time of the ablation is a reasonable alternative to continuation of oral anticoagulation following catheter ablation. The results of this trial will be available in 2024.

Editor's Comments Editor’s Comments

Combining PVI with LAA Closure Medical Breakthrough! Combining a catheter ablation for A-Fib (PVI) with the insertion of a Watchman occlusion device seems a major improvement for patients, as well as reducing or eliminating a major source of worry for electrophysiologists (EPs).
One day, hopefully soon, everyone getting a catheter ablation will also have an occlusion device inserted in one procedure.
Free from Most Stroke Risk: Inserting a Watchman device to close off the LAA has become a relatively simple and fast process. Combining it with a PVI doesn’t add much time to the ablation procedure. And Dr. Saliba’s research demonstrated that it works!
The Left Atrial Appendage (LAA) is where most clots and strokes come from in patients with non valvular A-Fib. Patients getting a catheter ablation generally leave the hospital A-Fib free.
Nevertheless, they are still considered at some risk of stroke. Current guidelines dictate continuation of stroke prevention with oral anticoagulation despite a successful ablation. Having the LAA closure device offers protection against stroke without the ongoing bleeding issues of oral anticoagulation.
Patients Would Choose/Prefer This Combination Procedure: If you offered the average A-Fib patient the chance to be protected from a stroke at the same time they are made A-Fib free by a catheter ablation, most patients would choose the combination procedure.
They would only have to be hospitalized once and wouldn’t have to return weeks later to have their LAA closed off, as is common practice in the U.S. today.
They would have better peace of mind and quality of life knowing they are largely protected from having an A-Fib stroke.

And their doctor wouldn’t have to worry about them going off their anticoagulant and developing a clot in their LAA.

If you find any errors on this page, email us. Y Last updated: Thursday, May 11, 2023

Return to 2023 AF Symposium Reports

During A-Fib Ablation Cooling Esophageal Reduces Injury

One of the very rare and dreaded complications of catheter ablation is Atrial Esophageal Fistula (1 case in 500 to 2,000+). Unlike most other ablation complications which are generally minor, temporary and easily resolved, a fistula can kill you!

Atrial Esophageal Fistula

How does this happen? The esophagus often lies just behind the posterior wall of the left atrium. During an ablation, heat from the RF (radio frequency) catheter applied to the back of the heart can damage the esophagus. (This can also happen during a Cryo ablation.)

If RF heat damages the esophagus, ulcer-like lesions form in the esophagus. In the 2-3 weeks following the ablation (post-ablation), gastric acids (reflux) can eat away at these lesions creating a fistula (hole) leading from the esophagus into the heart. Without major intervention, stomach contents can pass from the esophagus into the heart, leading to bloodstream infection (sepsis) and death.

Established strategies used to prevent esophageal injury include:

1. Reduce power applied to the vulnerable regions (Lesions with lower power may not always be effective.).

2. Monitor Esophageal temperature, stopping the ablation when temperature rises. (Note: This is a reactive approach of limited efficacy. By the time temperature rises, serious damage may have already been done to the esophagus.)

3. Deviate the esophagus during the ablation to bend it away from the area being ablated. (Can cause Esophageal trauma and involve difficulties in use. And requires procedural pauses for device manipulation.)

Cooling the Esophagus

“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.

Illustration: Esophageal temperature management device

In an innovative and important research study reported at the 2020 AF Symposium, Dr. Mark Gallagher describes a cooling system used in the esophagus to prevent fistulas.

How does it work? In preparation for ablation of heart tissue, a 3-foot-long silicon soft tube is inserted into the patient’s esophagus. It’s connected to what is basically a refrigerator. Then whenever the EP (electrophysiologist) works near the esophagus, this closed loop system pumps cooled water (39.2 °F, 4 °C) down one loop of the tube, then back through another loop to the console. The EP controls the temperature.

Results of Using the Cooling System

A recent meta-analysis of esophageal cooling for the purpose of protecting the esophagus during RF ablation found a 61% reduction in high-grade lesion formulation in a total of 494 patients.

A recent randomized-controlled trial found a statistically significant 83% reduction in endoscopically identified lesions when using a dedicated cooling device compared to standard luminal esophageal temperature (LET) monitoring.

Another research study led by Dr. Marcela M. Montoya of Silico Science & Engineering S.A.S, Medellin, Colombia, found  “the rapidly growing use of esophageal cooling during ablation has resulted in the publication or presentation of data on thousands of patients. Well over 10,000 ablations have now been completed with no Atrioesophageal fistula (AEF) formation yet reported and only a single pericardio-esophageal injury is known to have occurred.” (Pericardio-esophageal injury is a rarer and less severe subset of fistula formation.)

These various research studies show that cooling the esophagus works and is a major advance in the ablation of A-Fib.

Update 5/8/23:
Attune Medical reports that over 25,000 cooling devices were used in ablation procedures without a reported atrioesophageal fistula, and only a single pericardio-esophageal fistula known.

Editor's Comments about Cecelia's A-Fib story

Editor’s Comments

Fistula Is a Major Emergency: 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.).
Treating patients with a fistula is a huge expense and a nightmare for both EPs and hospital staff.
No More Threat of Fistula! 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 is a Major Medical Breakthrough! Cooling the esophagus is simple and relatively easy to do. And, barring future research findings, the system seems near foolproof, at least with typical ablation technique.
Esophageal Cooling Means Better Ablations:  And as a bonus, using the esophageal cooling system enables EPs to do a 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. And procedure time is reduced, resulting in fewer complications.

List of Hospitals and Medical Centers using Esophageal Cooling

To assist you in seeking facilities offering esophageal cooling during Catheter Ablation for Atrial Fibrillation, I’ve compiled a list from my reference sources
This list is not an endorsement of any center, and is only offered for your convenience. Refer to Steve’s Directory of Doctors and Facilities for more information about a specific medical center or hospital.

Go to Steve’s List of Hospitals and Medical Centers using Esophageal Cooling

References
• Zagrodzky, J. et al. Cooling or Warming the Esophagus to Reduce Esophageal Injury During Left Atrial Ablation in the Treatment of Atrial Fibrillation. Journal of Visualized Experiments, 3/15/2020. (157), e60733. https://www.jove.com/pdf/60733/jove-protocol-60733-cooling-or-warming-esophagus-to-reduce-esophageal-injury-during-left. DOI: doi:10.3791/60733.

• Leung LWM, Toor P, Akhtar Z, et al. Real-world results of oesophageal protection from a temperature control device during left atrial ablation [published online ahead of print, 2023 Apr 25]. Europace. 2023;euad099. doi:10.1093/europace/euad099

• Montoya, M. M. et al. Proactive esophageal cooling protects against thermal insults during high-power short-duration radiofrequency cardiac ablation. Int J Hyperthermia. 2022;39(1): 1202-1212. https://pubmed.ncbi.nlm.nih.gov/36104029/ DOI: 10.1080/02656736.2022.2121860

2022 AF Symposium Abstract: Inhaler Can Stop A-Fib Attack in Minutes

This abstract further elaborates on an 2021 AF Symposium Spotlight session by Dr. Jeremy Ruskin of Massachusetts General Hospital. He showed safety data from the InCarda Phase 2 study (INSTANT) which he thought very promising. This abstract details a small clinical trial.

This InCarda inhaler is an incredible medical innovation for A-Fib patients! (It’s still in development.)

Imagine: A patient is having an A-Fib episode. The patient self-administers the InCarda inhaler, it produces a flecainide-containing aerosol which the patient inhales. This results in a rapid absorption of flecainide via the lungs into the heart.

It can terminate an A-Fib attack in as little as 8 minutes. (The tablet form of Flecainide takes around 1−3 hours to work.)

For more read my short report: Trial II of InCarda Orally Inhaled Flecainide.

2022 AF Symposium: Spherical Array Catheter Case with Video

Note: This was a very early, first-in-human use of this Spherical Array PFA catheter not yet approved by the FDA.

Dr. Vivek Reddy from Mount Sinai Medical Center in New York City, NY, showed a fascinating video of how the spherical PFA catheter emerged from the catheter sheath and formed itself into a spherical array, then locked itself into shape.

Click image to see Spiral Array catheter open

It was like watching a magic trick. How could they design a catheter sheath from which would emerge a complex spherical shaped catheter that would come together so smoothly?

On the video, we watched as Dr. Reddy and his team performed a Pulsed Field Ablation using the Spherical Array Catheter. The patient was a 31-year-old male diagnosed with paroxysmal A-Fib in 2020.

How the Spherical Array Catheter Works

Once fully deployed, the spherical PFA catheter has a diameter of 30 mm. It contains 122 gold-plated electrodes on 16 splines around the sphere. Continue reading about the Spherical Array catheter and the Pulsed Field Ablation for this patient.

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