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


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

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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'...


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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

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


Treatments

2022 AF Symposium: Pulsed Field Ablation Using a Focal Electrode Catheter

I’ve written a new report from the 2022 AF Symposium. The presentation included a video of the speaker performing the Pulsed Field Ablation. Note: PFA is not yet approved by the FDA, but is in clinical trials.

Dr. Atul Verma of Southlake Regional Health Center in Toronto, Canada presented his talk in a somewhat unusual format. He showed a pre-recorded case of him performing a Pulsed Field Ablation (PFA). Then while the video was playing, he would lower the volume and comment live to the audience. Several panelists and audience members also joined in offering comments during his presentation.

The Patient: Was in early persistent A-Fib, with a normal heart and normal-sized atrium. The goal was to isolate the patient’s Pulmonary Veins (PVs) and posterior wall using Pulsed Field Ablation (PFA).

The Ablation System: Dr. Verma performed an ablation of a patient using the Galaxy Centauri system. The Galaxy system allows EPs to use the same focal catheters and mapping systems they now use when they ablate using point-by-point Radio Frequency (RF) energy However, the Centauri generator produces PFA pulses instead of RF.

On the video, when Dr. Verma would make a point-by-point dot lesion using PFA…to continue reading my report. go to: Pulsed Field Ablation Using a Focal Electrode Catheter by Dr. Atul Verma.

For the background, concepts and treatment strategies associated with the evolving technology of Pulsed Field Ablation, see my 2020 AF Symposium report: Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.

2022 AF Symposium: Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story

2022 AF Symposium

Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story

Luigi Di Biase MD

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”

Watchman Device Anticoagulation Protocol

The Watchman occlusion device to close off the Left Atrial Appendage (LAA) of Atrial Fibrillation patients was FDA approved in 2015 (PROTECT AF and PREVAIL clinical studies).

For how the LAA is closed off watch the VIDEO: Placement of the Watchman FLX™ Left Atrial Appendage Closure Device.

Dr. Di Biase explained how the standard anticoagulation protocol to prevent stroke after implementation was warfarin for 45 days followed by Dual Antiplatelet Therapy (DAPT) for six months. (DAPT combines aspirin with clopidogrel.) Then the patient was on aspirin for life.

NOACs (DOACs) Have Replaced Warfarin

In common practice today, NOACs (DOACs) (Direct Oral Anticoagulants) have replaced warfarin post-op. However, there are concerns about the DAPT protocol.

Dr. Di Biase gave the example of a patient who experienced a GI bleed 2 months after switching from a NOAC to the DAPT protocol (clopidogrel/aspirin). DAPT therapy may carry bleeding risks while providing sub-optimal stroke prevention. Genetic abnormalities may affect the efficacy of clopidogrel in as many as 25% of patients.

DRT (Device Related Thrombus) can occur in 3%-4% of cases. “In our opinion, DRT is more common with DAPT when compared to low dose NOAC.”

Low Dose NOAC Possibly Safer Than Aspirin For Life

He also pointed out that “in some cases, we feel low dose NOAC is safer than aspirin for life.”

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

What does this means for patients receiving the Watchman? Instead of switching to clopidogrel/aspirin after 45 days post-op, we can stay on uninterrupted NOAC but at low dose with lower risk of bleeding and better results.
This makes the installation of the Watchman device safer and more effective (it was remarkably effective before this).

If you find any errors on this page, email us. Y Last updated: Wednesday, February 23, 2022

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2022 AF Symposium Spotlight: Calculating Left Atrium Wall Thickness

2022 AF Symposium

Spotlight Sessions: These feature products or devices still in development or not yet FDA approved. They give us a glimpse into what the future of A-Fib treatment may look like. This year 17 Spotlight products and treatments were presented in 5 minute talks.

Spotlight Session: Calculating Left Atrium Wall Thickness

Dr. Saman Nazarian

In this session Dr. Saman Nazarian of the University of Pennsylvania in Philadelphia, PA presented on “Personalization AF Ablation Based on CT Wall Thickness” by the company Circle Cardiovascular Imaging. [CT stands for Computerized Tomography.]

Left Atrium Wall Thickness: The left atrium wall thickness varies from 1 mm to over 5 mm in the roof area. If one applies too much RF ablation power to a thin wall, this can produce steam pops, esophagus damage, or phrenic nerve damage. If too little RF energy is applied to thicker left atrium wall areas, this can lead to Pulmonary Veins (PV) reconnection.

 Measuring Wall Thickness: Using Computed Tomography (CT) to measure atrium wall thickness, Circle Cardiovascular Imaging, Inc. proposes to “ablate by LAW” (Left Atrium Wall thickness).

It uses computed tomography to measure wall thickness, segmentation, and calculates the distance between endo and epicardial layers.

These measurements can be incorporated into mapping systems. An ablation index value is developed based on Left Atrial wall thickness. The proper amount of RF energy can than be applied to various parts of the left atrium.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

The concept of measuring left atrium wall thickness certainly seems like an improvement in RF catheter ablation.

But looking to new developments, one wonders if or how it would apply to Pulsed Field Ablation―the future of A-Fib catheter ablation.

If you find any errors on this page, email us. Y Last updated: Tuesday, February 22, 2022

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2022 AF Symposium Abstract: Trial II of InCarda Orally Inhaled Flecainide

2022 AF Symposium

Abstract: Trial II of InCarda Orally Inhaled Flecainide

Background: 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.

Flecainide is a Class IC anti-arrhythmic that is prescribed daily in tablet form for many A-Fib patients. It can also be used as a “Pill in the Pocket” therapy.

The InCarda inhaler from InCarda Therapeutics, Inc., is a different delivery system, is portable, and used only as needed.

Inhaler For Rapid Absorption of Flecainide

When an A-Fib patient self-administers the InCarda inhaler, it produces a flecainide-containing aerosol when 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.

The InCarda inhaler can be used like a Pill-In-The-Pocket therapy. This would free many A-Fib patients from daily use of Flecainide. This is a good thing, because Flecainide, like most antiarrhythmic drugs, can have bad side effects and be poorly tolerated over time.

Phase II Trials

InCarda inhaler from InCarda Therapeutics, Inc.

In a Phase II clinical trial of the inhaler, 97 patients received 120 mg of flecainide acetate oral inhalation solution (FleclH) during an 8-minute inhalation period.

Inhalation Safety Measures: Safety was evaluated based on peak plasma concentrations of flecainide, maximum QRS prolongation, cardiovascular events (CVEs) and adverse events. (Patients who did not convert to sinus were offered alternative treatment. They didn’t experience any adverse consequences.)

The Conversion Rate: At 90 minutes post-dose, the conversion rate to normal sinus rhythm was 47.5%, and the median time to conversion was 14.6 minutes from start of inhalation.

There were no significant safety differences in patients converting to normal sinus rhythm and those who didn’t.

The authors concluded, “Inhalation of 120 mg of flecainide (FleclH) was safe, and the efficacy was similar to that reported for oral and IV administration.”

Editor’s Comments

This InCarda inhaler is an incredible medical innovation for A-Fib patients! Imagine having an A-Fib episode and just using your flecainide inhaler to get you out of it in just 8 to 14 minutes! Think of how liberating that would be!
In clinical trial, the flecainide inhaler is testing just as effective as the tablet form−but currently the inhaler only works for patients about 50% of the time.
Many A-Fib patients would say that’s still a lot better than having to take flecainide as a tablet every day.
I’m hoping the dosage and formula will be adjusted to work better and more consistently.
Other Possibilities: Can the InCarda system be eventually used with other anti-arrhythmic drugs? Can it be used for anticoagulant delivery as well? The possibilities seem endless.

If you find any errors on this page, email us. Y Last updated: Tuesday, February 22, 2022

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2022 AF Symposium: Pulsed Field Ablation Systems

At A-Fib.com, we first described the new technology called Pulsed Field Ablation (Farapulse, Inc.) in the beginning of 2021. See my report: Pulse Field Ablation—Emerging Tech for Atrial Fibrillation. Since then, Farapulse, Inc. has been acquired by Boston Scientific.

Today many companies with different Pulse Field Ablation systems have entered the market. All are still in various stages of investigation, none have been FDA approved.

In my report, In Development: Systems for Pulsed Field Ablation (PFA), I summarize comments by Dr. Moussa Mansour of Massachusetts General Hospital in Boston, MA, in his presentation, “Technology and Regulatory Status of Current Systems for Pulsed Field Ablation (PFA).”

He gave an overview of the various companies and their PFA systems in development and in clinical trials. You’ll find my 2022 AF Symposium report here: Pulsed Field Ablation. You can also see my other reports at 2022 AF Symposium.

2022 AF Symposium: Pulsed Field Ablation Using a Focal Electrode Catheter by Dr. Atul Verma

2022 AF Symposium

Pulsed Field Ablation Using a Focal Electrode Catheter by Dr. Atul Verma

Note: Pulsed Field Ablation (PFA) is not yet approved by the FDA; Clinical trials are underway.

Dr. Atul Verma of Southlake Regional Health Center in Toronto, Canada presented his talk in a somewhat unusual format. He showed a pre-recorded case of him performing a Pulsed Field Ablation (PFA). Then while the video was playing, he would lower the volume and comment live to the audience. Several panelists and audience members also joined in offering comments during his presentation.

PFA with the Galaxy Centauri System

Dr Atul Verma

Dr Atul Verma

Dr. Verma performed an ablation of a patient using the Galaxy Centauri system. The Galaxy system allows EPs to use the same focal catheters and mapping systems they now use when they ablate using point-by-point Radio Frequency (RF) energy However, the Centauri generator produces PFA pulses instead of RF.

Pulsed Field Ablation (PFA) is not yet approved by the FDA; Clinical trials are underway.

The Patient: Was in early persistent A-Fib, with a normal heart and normal-sized atrium.

Dr. Verma’s goal was to isolate the patient’s Pulmonary Veins (PVs) and posterior wall using Pulsed Field Ablation (PFA).

Equipment: He used a standard Carto system and a SMARTTOUCH irrigated catheter to apply the PFA pulses. He also used an irrigated tip catheter (though as he and other panelists acknowledged, Pulsed Field Ablation may not need irrigated catheters). He also used atrial pacing to make sure the patient’s heart rate stayed over 50.

Video of the PFA

On the video, when Dr. Verma would make a point-by-point dot lesion using PFA, the catheter would disappear from the screen but would come back later. He explained that his current Carto system wasn’t designed to handle very large PFA pulses going through the catheter creating an error.

As with RF lesions, dots would appear where a PFA pulse was applied. Dr. Verma stated that, as with RF, the dots do need to be contiguous to avoid gaps.

Dosage: The Galaxy Centauri system can adjust the dose based on patient response (titrate). Medium dosage was 22 amps, high 25 amps. Dr. Verma used the medium dosage on the posterior wall which is thinner. Commenting from the panel, Dr. Vivek Reddy thought the high PFA dosage could be used all the time.

The PFA pulses didn’t create thermal damage, eliminating the danger of the dreaded atrial esophageal fistula.

Esophagus Temperature: We watched the video as Dr. Verma positioned the PFA catheter directly over the esophagus and applied high power PFA signals. The temperature in the esophagus before the ablation was 34.7°C and was the exact same temperature after the PFA pulses were applied―demonstrating how safe PFA ablation is.

The PFA pulses obviously didn’t create thermal damage to the esophagus, thereby eliminating the danger of the dreaded atrial esophageal fistula. He also showed ablating the carina ridge area where he used greater contact force and more power.

Dr. Verma then used a Lasso catheter to make sure the Pulmonary Veins (PVs) were isolated. Then he disconnected the Lasso catheter to prevent what he called possible “arcing”.

Procedure Duration: Dr. Verma completed the PFA ablation in 1½ hours which included a 20-minute waiting period.

Experts Panel Discussion

Barium Paste in Esophagus: Dr. Verma raised eyebrows among the panelists when he stated that he used barium paste in the esophagus to better locate and map it.

Dr. Hugh Calkins pointed out that in the past barium paste was aspirated into the lungs and now isn’t used much today. However, Dr. Verma mentioned that he was only using 5 cc of barium, and that this does not affect the lungs at all. Other panelists said that one of the big advantages of PFA is it is unlikely to damage the esophagus, thereby rendering Barium paste unnecessary.

Skeletal Muscle Stimulation: Dr. Verma expressed concern about stimulating skeletal muscle (the vertebrate muscle system) which he avoided by using bi-phasic PFA delivery, breaking PFA pulses into different packets, using a narrower PFA pulse width, and optimizing the PFA wave form. This also avoided generating microbubbles and prevented thermal reaction (heat damage).  

PFA and Coughing: Dr. Verma also described another occurrence which other panelists have noticed as well―patient coughing. Does PFA generate coughing? He asked the panel and attendees if this coughing during PFA comes from J receptors in the PVs or from the bronchi? Can or should this coughing be eliminated by more sedation or by pulling the catheter back? Dr. Andrea Natale suggested that, with PFA, general anesthesia isn’t needed.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

The Galaxy Centauri ablation system is probably not ready for prime time yet. Who would want to go back to having to use point-by-point ablation?
Most of the other PFA systems in development don’t need to use point-by-point ablation. They are faster, easier to use, more efficient and safer. However, the Galaxy system is undergoing further refinement, and this is an early concept.
Most labs and EPs would want to use the new catheters with an ablation system designed for PFA, not their traditional catheters. But there are some labs where minimal investment in new systems to get PFA may be an advantage, particularly outside the U.S. to get PFA may be an advantage, particularly outside the U.S.
One approved by the FDA, I expect PFA will change the way catheter ablations are done and will become an innovative and most effective treatment option for A-Fib patients.
We are grateful to both Dr. Verma and to all the other doctors for their creativity and hard work toward development of Pulsed Field Ablation systems.

For the background, concepts and treatment strategies associated with the evolving technology of Pulsed Field Ablation, see my 2020 AF Symposium report: Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.

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See all my reports at: 2022 AF Symposium.

2022 AF Symposium Challenging Cases in AF Management: The Patient has the Last Say

2022 AF Symposium

Challenging Cases: The Patient has the Last Say

In the “Challenging Cases” presentations, some of the world’s leading Electrophysiologists (EPs) describe the most difficult Atrial Fibrillation cases they had to cope with through the year. I find it one of the best learning experiences of the AF Symposium. (But for reasons I frankly don’t understand, it’s always the least attended. This year was no exception.)

Frankness prevails. The presenters don’t hesitate to discuss challenging situations, possible mistakes, or embarrassing moments. I’m always surprised to see such a lack of ego among this group of the best Electrophysiologists in the world.

The panelists this year were:

▪ Dr. David Keane of St. Vincent’s Hospital, Dublin, Ireland, Moderator
▪ Dr. John Camm of St. George’s Medical Center, London, UK
▪ Dr. John Day of the Intermountain Heart Institute, Murray, UT
▪ Dr. Young-Hoon Kim of Korea University Medical Center, Seoul, South Korea
▪ Dr. Gregory Michaud of Vanderbilt University Medical Center, Memphis, TN
▪ Dr. Eric Prystowsky of St. Vincent’s Hospital, Indianapolis, IN

Dr. Erik Prystowsky: The Patient Has the Final Say

One of the most challenging type of case EPs have to deal with was recalled by Dr. Erik Prystowsky of St. Vincent’s Hospital, Indianapolis, IN.

A 65-year-old man had Atrial Fibrillation and shortness of breath. His Ejection Fraction was an astonishingly 10% (critically low). He was on a beta-blocker and was cardioverted successfully.

Dr Eric Prystowsky

Dr Eric Prystowsky

He was sent to Dr. Eric Prystowsky and became his patient. The patient was put on amiodarone and for several months was asymptomatic. His Ejection Fraction actually improved to 50%. He was found to have a severely enlarged left atrium (5.4 cm).

Questions Posed To the Panel: Dr. Prystowsky posed the following questions concerning this patient and asked panelists’ opinion about the best strategy for treating him:

1. Catheter ablation?
2. Switch from amiodarone to dofetilide (Multaq)? (Dr. Prystowsky said he does this frequently, probably because of the long-term toxicity of amiodarone.)
3. Continue on amiodarone?

The general consensus seemed to be to offer the patient a catheter ablation. (This would likely fix his A-Fib, improve his Ejection Fraction, and reduce the size of his left atrium.)

Offered a Catheter Ablation

The patient was offered a catheter ablation procedure. But the patient would not accept an ablation even after the most persuasive attempts to convince him otherwise. (Dr. Prystowsky practices in Indiana, where perhaps people are more conservative in medical choices.)

Dr. Prystowsky continued the patient on amiodarone but had him return to the office every six months.

Two Years Later…

Two years pass. The patient is now symptomatic and had sinus bradycardia (slow heart rate). He still refused a catheter ablation but did get a dual chamber pacemaker for his slow heart rate.

…Three Years After That

Three more years pass and his pacemaker now showed his Atrial Fibrillation had progressed to Persistent A-Fib. His Ejection Fraction was in the 25%-30% range (low). His heart rate was 150 bpm (high). He was again cardioverted back to sinus, but this only lasted a week. So he was once again cardioverted and put on lisinopril (an ACE inhibitor used primarily for high blood pressure and heart failure).

Another Year Later…

The cardioversion lasted about a year with a slightly improved Ejection Fraction, and he was asymptomatic. He complained of lightheadedness. He seemed to improve with an adjustment to his pacemaker taking him off of bi-ventricular pacing. After all this, he still refused to have a catheter ablation.

Bottom Line: The Patient has the Final Say

Dr. Prystowsky talked to the panel and attendees about the dangers of Tachymyopathy (impairment of left ventricular function) which many people never recover from. He stressed how important it was to try to keep patients in normal sinus rhythm, even in difficult cases like this.

In spite of all his problems, this patient feels relatively well and is still adamant about not having a catheter ablation.

As Dr. Prystowsky stated, “The patient has the final say!”

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

Dr. Prystowsky is one of smartest, most persuasive EPs around. But as frustrating as it must have been for him, he had to let this patient make the final decision.
This is a life-lesson all too many EPs have to come to grips with during their careers. No matter how much education and experience an EP has, even though they know how to fix problems like this patient has, there is only so much an EP can do.
After all, the patient does have the final say.

See all my reports at: 2022 AF Symposium.

If you find any errors on this page, email us. Y Last updated: Tuesday, February 22, 2022

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How Does LAA Closure for Atrial Fibrillation Affect Heart Pumping Ability?

Left Arial Appendage (LAA) closure is the cornerstone of stroke prevention in surgical treatment of A-Fib. The Left Atrial Appendage is closed off, cut out, stapled shut, or shut off with a clip. How does this affect the heart’s ability to pump blood?

Small Study to Directly Measure Pumping Effect of LAA Closure

In a very small study of the hybrid operation/ablation, seven patients were measured for cardiac output and left ventricular stroke volume just before the hybrid operation, directly after, then ten minutes later.

The hybrid operation/ablation, learn more at The Cox-Maze & Mini-Maze Surgeries and the Hybrid Surgery/Ablation

The researchers pointed out that “the LAA also has a contractile function and takes part in the LA contraction process, especially in patients in SR (sinus rhythm)”.

But five of the seven patients were in A-Fib and already had reduced ejection fraction (EF) (26%). (Normal EF is 50% to 75%.) Even in the patients in SR, their EF was only 46%.

Ejection fraction (EF) is a percentage of blood that is pumped out of the heart during each beat. A range of 50%-75% indicates your heart is pumping well, delivering an adequate amount of blood to the body and brain.

LAA Closure Lowers Pumping Pressure Long Term

The researchers pointed out that LAA closure “can result in lower systolic blood pressure on the long term” according to previous research. (“Systolic” is the top number in your blood pressure measurement and is the pumping force your heart exerts.)

The researchers also pointed out that the LAA is the predominant site of atrial natriuretic peptide (ANP) in the heart which can affect heart pumping “volume overload”.

No Significant Difference

The researchers found no significant differences in various pumping measurements, but the Left Ventricular Stroke Volume (LSCI) was affected (28 mLm² to 24 mLm², P-value 0.066).

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

Patients with Poor EF: In patients with poor heart pumping and contracting ability (EF below 50%) to begin with, this study suggests they aren’t affected much by losing their LAA. They probably wouldn’t even notice it was gone. But the jury is still out on how losing the LAA affects even A-Fib patients with poor Ejection Fraction (EF) long term.
Patients with Normal EF: However, this may not be the case with A-Fib patients with a normal EF. The LAA does have a contractile function, particularly in patients with larger size LAAs. (Do athletes have larger size LAAs due to their exercise?)  This small study did not address the cases of A-Fib patients with normal EFs.

What This Means for A-Fib Patients

This small study didn’t measure patients with a normal Ejection Fraction (EF) who had their Left Atrial Appendage (LAA) closed off or removed. Most likely the heart’s pumping ability is affected by losing one’s LAA. (In dogs, the LAA provides 17.2% of the volume of blood pumped by the left atrium.)
If you are an active exerciser or athlete, you may want to consider keeping your LAA if possible. But for most people, losing your LAA probably won’t affect you very much. You may not even notice your LAA is gone.

What this Means to Me: A Watchman in my Future

Personally, I love to run, do sprints, etc. But after two recent ablations (after 21 years of being A-Fib free), my Medtronic Reveal LINQ loop recorder recently picked up a full day of Silent A-Fib signals. (Reports are sent wirelessly to my EP each night by the bedside transmitter.)

This wasn’t a big surprise. In my last ablation, my LAA was ablated to stop A-Fib signals, but it also electrically affected the LAA from pumping out properly. My EPs warned me that I would likely need to close-off my LAA sometime in the future.

With this recent data, my two EPs (Drs. Doshi and Natale) recommended I close-off my LAA with a Watchman device.

Even though it might affect my pumping ability, at age 81, stopping my A-Fib signals is more important to me. After my Watchman implant, I’ll write more. 

For my first-hand account of having a Medtronic Reveal LINQ loop recorder, go to Has My A-Fib Returned? I Get an Insertable Wireless Monitor

Reference
Heuts, S. et al. Does Left Atrial Appendage Exclusion by an Epicardial Clip influence Left Atrial Hemodynamics? Pilot Results of Invasive Intra-Cardiac Measurements. JAFIB Journal of Atrial Fibrillation. http://www.jafib.com/PMC/XML/Inprogress/FullIssue/2021-06-30.pdf#page=64

Catheter Ablation: Long-Term A-Fib Symptom Reduction and Improved Quality of Life

In an observational study from Sweden, researchers examined the long-term effects of catheter ablation after 5 years. They wanted to know if undergoing a catheter ablation would affect both A-Fib symptoms and health-related Quality of Life (HRQoL).

Catheter Ablation: Eliminated or Reduced A-Fib Symptoms

From 2011 through 2019, 1521 A-Fib patients had RF PVI catheter ablations at Swedish hospitals using primarily the Carto system. After 5 years, 52% reported freedom from symptoms, 18% reported a greater than 50% symptom reduction, 14% had a minor reduction, while 18% reported no effect or a worsening of symptoms. Over half of the patients who had a catheter ablation were free from arrhythmia-related symptoms.

Symptom Reduction: Of those A-Fib patients still reporting symptoms, more than 80% experienced a symptom reduction. Altogether, more than 80% of the study participants experienced an improved arrhythmia-related situation. Researchers wrote: “The positive effect of CA [catheter ablation] on symptoms is long-lasting.”

Re-Ablation Option: Some of those who did not improve or whose symptoms worsened were accepted for re-ablation at follow-up. After five years, the most commonly reported symptoms were: breathlessness during activity, weakness/fatigue, and tiredness.

Independent predictors: Of those who reported no or worse A-Fib effects at follow-up, independent predictors were:

• Female gender
• Obesity (Body mass index ≥ 35)
• Ischemic Heart Disease (IHD) (narrowed arteries).

At follow-up in the study, the researchers didn’t find any gender differences.

More About Women with A-Fib: In my article, Women with A-Fib: Mother Nature and Gender Bias, I discuss how women have a higher symptom burden and often experience a more negative Quality of Life.

Dramatic Improvement in Quality of Life After Catheter Ablation

Quality of life (HRQoL) was evaluated both before the catheter ablation and after 5 years.

I found the Quality of Life questionnaire (ASTA) to be comprehensive, well written, and easy for patients to fill out.

Patients reported Quality of Life by using a 13-item scale divided into a 7-item physical subscale and a 6-item mental subscale. (HRQoL scale score values ranged from 0 to 100. Higher scores reflected both a higher symptom burden and a worse effect on Quality of Life.)

Quality of Life score was significantly lower [better] 5 years after catheter ablation (36.7 vs 13.1).

Quality of Life was obviously influenced by A-Fib symptoms which can cause psychological and emotional effects. At baseline at the beginning of the study, the most commonly reported negative influences on Quality of Life (HRQoL) were physically related: impaired physical ability, deteriorated life situation, and feeling unable to carry out daily activities.

Patients also reported worry, uncertainty about potential side-effects of medication, risk of recurrence, and the possible need for repeat procedures.

These negative effects improved dramatically over five years. The negative influences on HRQoL were primarily in those still reporting the presence of arrhythmia.

The Elderly had the Same Improvement as Younger Patients

Older A-Fib patients (over age 75) reported the same significant improvement in the symptoms scale score as younger ones. Quality of Life (HRQoL) improved significantly over 5 years, without any differences found between gender or age group.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments:

Being “Elderly” Shouldn’t Stop You from Having a Catheter Ablation: Unfortunately, some centers have an age cutoff for catheter ablation at age 75 or 80. This Swedish study instead found that “patients with AF should not be excluded from CA solely because of age.” To learn more see my FAQs A-Fib Ablations: Is 82 Too Old for a PVA?
Catheter Ablation Produces Better Results Today: A-Fib is one of the easiest heart diseases to “cure”. Catheter Ablation (CA) today is one of the safest, most effective, life-transforming procedures you can have in a hospital (CA isn’t surgery, there is no cutting involved.)
Today’s advanced catheter ablation treatments and mapping would probably produce greater symptom reduction than in this study.
Important Study on Quality of Life: The authors are to be commended for studying how catheter ablation influences Quality of Life (HRQoL). (Anyone who has become A-Fib free can testify how transformative and life-changing it is to go from A-Fib to normal sinus rhythm, such as myself.)
For many A-Fib patients, the impact on Quality of Life is just as important as their symptoms.
When doctors talk with patients about catheter ablation, they usually concentrate on A-Fib symptoms.
Instead, more emphasis should be put on how catheter ablation can radically improve Quality of Life. In this Swedish study, the strongest, most dramatic results for patients were in improved Quality of Life.
For many A-Fib patients, the challenges and impact on Quality of Life are just as important as their symptoms.

Considering a catheter ablation for your Atrial Fibrillation? Learn more on our Treatments for A-Fib page: Catheter Ablation: Pulmonary Vein Ablation (Isolation) 

Reference
Walfridsson, U. et al. Symptoms and health-related quality of life 5 years after catheter ablation of atrial fibrillation. Clinical Cardiology. Clinical Investigations. Dec 16, 2021 https://pubmed.ncbi.nlm.nih.gov/34913493/ doi: 10.1002/clc.23752

 

A-Fib Patients: Vazalore to Replace Aspirin

In 2014, Aspirin was removed from the AHA/ACC/HRS Guidelines for the Management of Patients with Atrial Fibrillation. (See my 2020 Update: Aspirin No Longer Recommended as First-Line Therapy for Stroke.)

There hasn’t been innovation in the mechanism of Aspirin delivery in over 50 years.

Not only is Aspirin proved relatively ineffective as an anticoagulant but it causes increased risk of gastrointestinal (GI) bleeding, ulcers, nose bleeds, wet macular degeneration, and hemorrhagic stroke.

For secondary prevention patients (after a heart attack), nearly 25% with a history of GI issues reported discontinuing aspirin against medical advice because of “stomach issues”.

Vazalore: Delivers Aspirin in a New Form

Vazalore Aspirin Therapy from PLx Pharma

In March 2021, the U.S. FDA approved the medication, Vazalore (PLx Pharma), a capsule containing aspirin and protective fatty substances called liposomes.

As liquid-filled capsules, Vazalore delivers Aspirin differently. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach.

Vazalore works four times faster than aspirin, with 71% less injury. It’s absorbed five times better than aspirin. It comes in low-dose (81 mg) and full-strength (325 mg) versions.

Aspirin Continues as “Secondary” Prevention

“Secondary prevention” refers to those who have already had a stroke or heart attack; the goal is to prevent another.

While no longer recommended as an anticoagulant for Atrial Fibrillation patients, Aspirin still has a roll to play in cardiac health.

Aspirin is recommended for a “secondary” prevention of recurrence of a heart attack. It significantly reduces the risk for a second heart attack or stroke. (Translation: If you’ve already had a heart attack or stroke, you may be on traditional Aspirin to prevent a second event.)

Editor’s Comments

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

It’s too early to tell how Vazalore compares to the use of DOACs (Direct-Acting Oral Anticoagulants).
But for those who have to take Aspirin (such as people with stents), Vazalore seems like a major game changer and medical breakthrough. It’s a way to get the benefits of aspirin without the bad side effects such as GI bleeding, ulcers, etc.
Now that Vazalore is FDA approved, let’s wait and see how it performs in practice as compared to clinical trials.
Are you on Vazalore? If you have been taking Vazalore for your Atrial Fibrillation, would you share your impressions? Email me and let me know about your experience.
References
• PLx Pharma Receives FDA Approval of SNDAs for Both VAZALORE 325 mg and 81 mg. March 1, 2021. PLx Pharma, Inc. press release. https://ir.plxpharma.com/news-releases/news-release-details/plx-pharma-receives-fda-approval-sndas-both-vazalore-325-mg-and

• Cryer, Byron. New form of aspirin is easier on the stomach. Bottom Line Personal. Volume 42, Number 21, November 1, 2021. p. 11.

• Moberg C, Naesdal J, Svedberg LE, Duchateau D, Harte N. Impact of gastrointestinal problems on adherence to low-dose acetylsalicylic acid: a quantitative study in patients with cardiovascular risk. Patient. 2011;4(2):103-113.

 

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