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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
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.
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.
• 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
Other A-Fib patients have been where you are right now. Dozens have shared their personal A-Fib experience (starting with the Steve Ryan) on this site and in my book.
Originally published in Beat Your A-Fib, ‘The Top 10 List of A-Fib Patients’ Best Advice’ is a consensus of valuable advice from fellow patients who are now free from the burden of Atrial Fibrillation.
We hope these hard-learned lessons will help you also find your A-Fib cure or best outcome for you.
This 10-part series of posts expands on each lesson learned on the Top 10 List. To read each post, just click on a link:
Q: I have A-Fib and since I turned 65, I’ve been covered by Medicare. What about Medicaid? Can I qualify for Medicaid, too? Should I?
A: As a U.S. citizen, yes, you may qualify. One in five Americans is eligible for Medicaid as well as Medicare. This is known as “dual eligibility”. If you qualify and choose to enroll in both programs, the two can work together to help cover most of your health care costs. (Medicare is the primary coverage and pays first. Medicaid pays second for anything that isn’t covered.)
Updated 7/17/22Did you know after almost any type of cardiac surgery, it’s all too common to develop Post-Operative Atrial Fibrillation (POAF)? POAF occrus in 15%-42% of patients following cardiac surgery. (Other major surgeries can lead to Post-Operative A-Fib as well.)
Beware! If you or a loved one are having surgery, anticipate developing post-operative A-Fib. Some consider it an inevitable complication of surgery.
Both Short and Long-Term Consequences
Post-Operative A-Fib (POAF) is associated with prolonged hospital stays, higher healthcare-related costs, increased mortality, increased risk of cerebrovascular accidents (CVA), and re-hospitalization.
If you do develop A-Fib after cardiac surgery, both your short-term and long-term prognosis is poor. Increased short and long-term mortality is likely caused by heart failure, cerebrovascular accidents (CVA), and bleeding complications. Even after 10 years, you can develop “late recurrent A-Fib”.
The most common cardiac surgery in the U.S. is bypass surgery with more than 200,000 surgeries performed annually. And what’s the most frequent complication? If you guessed A-Fib, you’d be right. Rates of post-operative A-Fib after surgery range from 10%-to-50%. Those aren’t very good odds.
The Research: Post-Operative A-Fib is Dangerous
Post-operative A-Fib can be really nasty. (Don’t listen to people who say POAF is harmless and goes away soon.)
From Finland(Waterford and Ad), in a study of cardiac surgery, POAF produced a 36.5% occurrence of stroke.
In another study of over 2 million patients, POAF was associated with increased risk of early and late mortality. POAF is a strong predictor of long-term development of A-Fib (9-fold increase of the development of A-Fib more than 30 days after surgery).
From the Netherlands(Kuar, H. et al), in a small study, researchers used implantable loop recorders in cardiac surgery patients to record both early and late post-operative A-Fib (POAF). (Early POAF=within 5 days, POAF=after this period.) Over an average follow-up of 29 months, 34% of patients had early POAF, while 67% experienced late POAF.
From the University of Pittsburgh (Bianco et al), in a study involving 12,227 cardiac patients, 4,300 developed post-operative A-Fib (35.2%). These patients had significantly higher rates of re-operation, transfusions, sepsis, prolonged ventilation, pneumonia, renal failure and dialysis. On long-term follow-up, they had worse morbidity, lower survival, and more readmissions for heart failure.
From Weill Cornell Medicine, New York (Goyal et al)
“Post-operative A-Fib (POAF) occurs in up to 40% of patients undergoing heart surgery and 2% of patients undergoing non-cardiac surgery,” In an observational retrospective study of nearly 3 million patients at 11 acute care hospitals across the U.S.,18.8% of patients who underwent heart surgery developed post-operative A-Fib. “…and the risk of hospitalization for heart failure increased by a third compared to patients who did not develop AF.” Doctors tend to view POAF as a benign event, triggered by the stress of the surgery. But accoring to the authors of this study, “evidence is emerging that post-operative A-Fib is linked to longer term problems such as stroke and death from any cause.”
In an editorial by Melissa Middeldorp and Christine Albert (Cedars Sinai, Los Angeles), they suggest that POAF “is not just a transient response to surgery but may be reflective of underlying atrial and myocardial structural changes that not only predispose to the acute AF event but to other potentially related adverse events, such as Heart Failure hospitalization.”
The most disturbing point of this study is that A-Fib may itself contribute to heart failure, “post-operative AF is associated with future heart failure hospitalizations.”
Patients with A-Fib undergoing noncardiac surgery (NCS) were associated with higher risks of mortality, heart failure, and stroke. The study included 8,635,758 Medicare patients admitted for noncardiac surgery and focused on 16.4% of these patients who had A-Fib at the time of their surgery. “Pre-existing AF is independently associated with postoperative adverse outcomes after NCS.” (Prasadam S, et al) (Thanks to David Holzman for calling our attention to this research.)
Protocol to Prevent Post-Operative A-Fib
In the post-operative period, anticoagulants aren’t enough. Anticoagulation after cardiac surgery can be dangerous with a high risk of bleeding and thromboembolism (stroke).
A better stroke prevention strategy is to prevent the occurrence of POAF in the first place.
The researchers, Waterford and Ad, state that preoperative oral amiodarone is the single most powerful intervention to dramatically reduce rates of POAF.
Protocols to prevent POAF:They recommend a protocol of 400 mg oral amiodarone per day for 3 days prior to surgery, followed by 200 mg per day for 10 days through and following the operation regardless of whether or not POAF developed. They also recommend that a patient be on a beta-blocker or a statin whenever possible.
They also advise limiting blood transfusions. Red blood cell transfusion is associated with an increased rate of POAF. The mechanism is likely that red blood cell transfusion induces a pro-inflammatory state, which is known to underlie POAF.
Other Protocols: Some doctors use a beta blocker protocol before surgery such as propranolol and carvedilol plus N-acetyl cysteine which work by “attenuating the sympathetic tone.”
Study results showed that both amiodarone and beta blocker protocols had similar results in reducing poet-operative A-Fib, and that their combined use was more effective than just beta blockers (Tzoumas, A. et al).
Treatment of Post-Operative A-Fib: Some surgeons routinely discharge patients while they are still in A-Fib or Flutter. But others insist on discharging patients in sinus rhythm using electrical cardioversion. The authors, Waterford and Ad, state that electrical cardioversion “should be used more liberally.”
Editor’s Comments
Our Friend’s Bypass Surgery: On a personal note, a friend of ours recently had bypass surgery. We drove him to the hospital and were with him whenever we could. He had a hard time. He had to be put on a ventilator and was in a medically induced coma for 5 days. But he recovered and is now doing well!
I warned him about the chances of developing A-Fib after cardiac surgery, which is exactly what happened to him. But after the surgery, his surgeon got him on an amiodarone protocol which did help.
The surgeon did not use pre-operative amiodarone treatment to prevent him from developing A-Fib in the first place. That’s unfortunately what most cardiac surgical patients experience.
A-Fib After Surgery Not Benign and Transient: In the past, A-Fib after surgery was considered benign and transient. But we now know better. As described in the above research, post-operative A-Fib causes many health problems and even death.
Amiodarone Effective But Toxic and Dangerous: Amiodarone, though effective, is a very toxic drug that should only be used for a short time and under close monitoring.
Why Do So Few Surgeons Use Pre-Operative Protocols? Almost every surgeon knows that surgery often causes and/or predisposes patients to develop A-Fib. Then why do so few use pre-operative protocols to prevent post-operative A-Fib? Numerous studies show that post-operative A-Fib can be dramatically reduced by pre-operative oral amiodarone (53% to 25%) (Waterford and Ad)
Sending Patients Home in A-Fib: It’s shocking that surgeons often send their patients home while still in A-Fib! WHAT? How can they cause and/or be responsible for their patients developing a serious, dangerous heart illness like A-Fib and not do anything about it? Will your surgeon protect you from developing post-op A-Fib?
Are You Having Any Kind of Surgery? Before you have surgery, you have to ask your surgeons if they do anything to prevent you from developing A-Fib after the surgery. If you’re not confident or satisfied with their response, find another surgeon. Don’t hesitate to travel if necessary.
Developing Post-Operative A-Fib doesn’t have to be a roll of the dice. Talk to your surgeon about protocols to prevent it. you should settle for nothing less.
References
• Waterford and Ad. 7 Pillars of Postoperative Atrial Prevention. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. Editorial. November 25, 2021. https://pubmed.ncbi.nlm.nih.gov/34823388/ doi: 10.1177/15569845211043485.
• Develops A-Fib After Appendectomy Surgery; Lifestyle Changes and Meds Restore Normal Sinus Rhythm. Personal A-Fib story. A-Fib.com https://a-fib.com/after-appendectomy-surgery-develops-a-fib-amiodarone-damages-thyroid/
• Tzoumas, A. et al. Atrial fibrillation following coronary artery bypass graft: Where do we stand? Cardiovascular Revascularization Medicine, December 16, 2021. https://www.sciencedirect.com/science/article/abs/pii/S1553838921008046
• Kaur, H. et al. New-onset perioperative atrial fibrillation in cardiac surgery patients: transient trouble or persistent problem? EP Europace, euab316, December 24, 2021. https://academic.oup.com/europace/advance-article-abstract/doi/10.1093/europace/euab316/6482023 https://doi.org/10.1093/europace/euab316
• Bianco, V. et al. The Long-Term Impact of Thoracic and Cardiovascular Surgery. Science Direct, February 1, 2022. https://www.jtcvs.org/article/S0022-5223(22)00103-9/fulltext DOI:https://doi.org/10.1016/j.jtcvs.2021.10.072
• Goyal, P. et al. AF after surgery is linked to an increased risk of heart failure hospitalization. Cardiac Rhythm News, June 29, 2022. https://tinyurl.com/yc5mm2tu
• Prasadam S. et al. Preoperative Atrial Fibrillation and Cardiovascular Outcomes After Noncardiac Surgery. JACC Journals, Vol. 79 No. 25. https://www.jacc.org/doi/10.1016/j.jacc.2022.04.021
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.)
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.
Sometimes I just can’t understand some of the research studies done about Atrial Fibrillation such as this one. I can not wrap my head around this recent study from the Netherlands (APACHE-AF).
They studied A-Fib patients who survived intracerebral hemorrhage after being treated with anticoagulation for atrial fibrillation. Their hemorrhagic stroke was “anticoagulant-associated”. Seven to 90 days after their hemorrhage, patients were either put back on anticoagulation (50 patients) or avoided anticoagulation.
WHAT?! How can you put someone back on an anticoagulant which probably caused their hemorrhagic stroke in the first place?
These researchers certainly knew the alternative options to taking anticoagulants.
This study was done at 16 hospitals in the Netherlands but was nevertheless very small. Most patients who did suffer a hemorrhagic stroke either died or were severely disabled. Few survived. That’s why there were so few patients in the study.
Further Damage From Anticoagulation
Not surprisingly, after a minimum follow-up of 6 months (a very short follow-up), 26% of the apixaban group had non-fatal strokes or vascular death. The patients on antiplatelet therapy (26) or no anticoagulation didn’t do very well either.
The researchers themselves concluded, “Patients with atrial fibrillation who had an intracerebral hemorrhage while taking anticoagulants have a high subsequent annual risk of non-fatal stroke or vascular death.”
Did I Miss Something?
How can you put someone back on an anticoagulant, even Eliquis, when anticoagulants probably caused their hemorrhagic stroke in the first place? This seems both ethically wrong and wrong-headed.
Did I miss something important? If anyone wants to share their view of this study with me, send me an email.
Reference
Schreuder, F. et al. Apixaban versus no anticoagulation after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation in the Netherlands (APACHE-AF): a randomized, open-label, phase 2 trial. The Lancet Neurology, November 2021. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(21)00298-2/fulltext DOI:https://doi.org/10.1016/S1474-4422(21)00298-2
Sometimes the method to close off the Left Atrial Appendage, doesn’t make a complete closure. It can leak. I’m very excited about this new product. Dr. Jamie Kim of the Catholic Medical Center in Manchester, NH, presented one of the most innovative and promising new developments for patients to close off their LAA.
Instead of relatively hard, rigid structures which don’t always conform perfectly to the LAA opening and thus may leak, the CLASS LAAO system from Conformal Medical, Inc. uses a different type of conformable foam-based fabric to seal off the LAA. Read this short Spotlight summary for more about this promising new device.
Go to my 2022 AF Symposium page with all my reports.
In this report from the 2022 AF Symposium, Dr. Luigi Di Biase of the Albert Einstein College of Medicine, Bronx, NY gave a presentation on “Peri and Post Procedural Anticoagulation with LAA Closure Devices―An Evolving Story”.
In particular, he is talking about the Watchman occlusion device to close off an A-Fib patient’s Left Atrial Appendage. His focus is on the anticoagulation protocol following the procedure involving, that is, the drug regime for patients in the months afterward. e.g., DOACs, aspirin and clopidogrel.
In a study from Australia (ACTIVE-AF), a six-month exercise program helped maintain normal heart rhythm and reduced the severity of symptoms in patients with atrial fibrillation.
In the ACTIVE-AF study, 120 symptomatic paroxysmal or persistent A-Fib patients were randomly assigned to a six-month exercise program or a program of usual care (control group). The average age of patients in the study was 65 years and 43% were women.
The exercise program included supervised exercise weekly for three months, then every two-weeks for three months.
The exercise group also had an individualized weekly exercise plan to follow at home. The goal was to increase aerobic exercise up to 3.5 hours a week. The six-month exercise program was followed up by another six months of observation.
Study Results
According to lead author was Dr. Adrian Elliott of the University of Adelaide, Adelaide, Australia, the A-Fib recurrence rate was significantly lower in the exercise group (60%) vs the control group (80%).
Patients in the exercise group also had a significant reduction in the severity of their symptoms at 12 months compared to the control group (less severe palpitations, shortness of breath, and fatigue).
ACTIVE-AF Conclusions
“The ACTIVE-AF trial demonstrates that some patients can control their arrhythmia through physical activity, without the need for complex interventions such as ablation or medications to keep their heart in normal rhythm,” said study author Dr. Adrian Elliott.
Recommendations for patients with symptomatic paroxysmal or persistent A-Fib:
• Aerobic exercise should part of the treatment plan, alongside the use of medications and the management of obesity, hypertension, and sleep apnea; • Patients should strive to build up to 3.5 hours per week of aerobic exercise; • Some higher intensity activities should be incorporated to improve cardiorespiratory fitness.
Editor’s Comments
We know from many other studies that exercise is recommended for patients with coronary heart disease and heart failure, but also for overall heart fitness and health.
This small study shows that exercise is good for A-Fib patients as well. Though sometimes it just isn’t possible with symptomatic A-Fib. (e.g., When I had A-Fib years ago, my heart rate would get very high when I’d try to jog. I’d have to stop and walk home.)
Relying on exercise to “cure” A-Fib is probably a false hope. Exercise alone won’t eliminate your A-Fib. But for those who are symptomatic, exercise can improve your A-Fib symptoms and reduce “recurrence” of your A-Fib (i.e., after being symptom-free for a period of time).
Take Away for A-Fib Patients: Aerobic exercise to improve cardiorespiratory fitness should become a regular habit. Even after one is cured of A-Fib (i.e., by catheter ablation, etc.) because exercise helps prevent recurrence of A-Fib.
References
• Exercise maintains normal heart rhythm in patients with atrial fibrillation. European Society of Cardiology. August 23, 2021. https://www.medscape.com/viewarticle/957322
• ESC 2021: ACTIVE-AF finds benefits for exercise programme in AF patients. Cardiac Rhythm News. 23rd August 2021. https://cardiacrhythmnews.com/esc-2021-active-af-finds-benefits-for-exercise-programme-in-af-patients/.