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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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
Magnesium Works in ERs to Reduce Risk of A-Fib or Return to Normal Sinus Rhythm
In the United Kingdom, it is common practice in critical care (E.R.) to administer serum magnesium to prevent A-Fib or to return patients to normal sinus rhythm.
This isn’t commonly done in the U.S.
UK ER Study: Magnesium Used in the ER to Prevent A-Fib
Research published in 2022 describes a study done of an adult critical care unit/emergency department (casualty) at the University College London Hospital between January 2016 and December 2017.
This single center observational study examined the preferences of critical nurses using Mg in patients who had undergone non-cardiac surgery.
Of 9,114 opportunities to administer intravenous Magnesium (Mg), there were significant variation practices depending on the individual nurses.
But still, intravenous Mg was associated with a 3% decrease in the relative risk of getting A-Fib after non-cardiac surgery.
Austrian ER Study: IV Magnesium Returns Normal Sinus Rhythm
A study from Vienna, Austria, looked at 2,546 episodes of non-permanent A-Fib in the emergency room (ER). Admission of Intravenous Magnesium (145.8 mg) and Potassium (24 mEq) were compared to no administration of either supplement.
Researchers found that Intravenous Magnesium and Potassium was associated with increased odds of returning patients to normal sinus rhythm (19.2% vs 10.4%) (but didn’t affect A-Flutter.)
Editor’s Comments
Though the above studies differ, they both show that administering Intravenous Magnesium in the ER is an effective tool in avoiding A-Fib or in returning A-Fib patients to normal sinus rhythm.
Some ERs in the U.S. do use Magnesium to return patients to normal sinus rhythm. (But many doctors still consider Magnesium [and most supplements] as little more than snake oil.)
This research is encouraging and indicates that Magnesium can be a useful tool with critical care patients. More research is needed.
What This Means for A-Fib Patients: If you wind up in the emergency room or urgent care for your Atrial Fibrillation, ask if they intend to administer an IV of Magnesium. (If not, why?)
For more about Magnesium, see my article, Cardiovascular Benefits of Magnesium: Insights for Atrial Fibrillation Patients.
Parlay an Ablation to Keep Dementia Away
I have written about studies documenting that A-Fib leads to or causes dementia. How A-Fib doubles the risk of dementia. And that there’s a direct cause and effect relationship, independently relating A-Fib to cognitive decline and dementia.
Good news! A recent research study tells us there’s a way to break that link.
Observational Study: Ablation Reduces Dementia
In a fascinating observational study from Turin, Italy, catheter ablation for A-Fib was associated with a nearly 50% reduction in dementia during a 4.5-year follow-up.
The researchers looked at four observational studies from 2020-2021 that included 40,146 patients of whom 11,312 had catheter ablation for A-Fib.
Compared to patients who developed dementia, they found having a catheter ablation for A-Fib reduced the risk of developing dementia by 50%!
Researchers concluded: ”Correct management of the arrhythmia holds the potential to delay or avoid cognitive decline occurrence.”
Important Research Findings for Patients with A-Fib!
We know that going from A-Fib to normal sinus rhythm increases and improves blood flow to the brain. So it’s intuitive to suppose that improving brain function would reduce the risk of dementia.
A-Fib patients who have a catheter ablation may now add another benefit to becoming A-Fib free, they may also significantly reduce the risk of developing dementia!
Seek Your Cure and a Two-For-One
If you have A-Fib, don’t settle for a life on meds. Don’t just “manage” your A-Fib. Seek your Cure.
A two-for-one! If your path to a cure includes a catheter ablation, you may also be reducing your risk of developing dementia. That’s a double whammy!
New Anticoagulant with less Bleeding Risk―Asundexian Factor XI (Bayer)
Today’s anticoagulants (DOACs-Direct Oral Anticoagulants) have a residual risk of major bleeding of 1.5-3.6%/year. That means that after stopping a DOAC anticoagulant, the effects can continue to affect you for 1½ to 3½ years afterward.
The result is you continue to be at a higher risk of major bleeding even though you are no longer taking the anticoagulant.
Alarming, bleeding events remain a high risk for you.
These bleeding events are associated with increased mortality, high costs, and compromised adherence to treatment. Especially for patients 65 and older, anticoagulants increase the risk of hemorrhagic-type strokes. (For more about anticoagulants, see my post: Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.)
Pacific-AF clinical trials
Drug to Reduce Bleeding Event in Clinical Trial
Currently the PACIFIC-AF clinical trials is studying Asundexian, a new anticoagulant. Asundexian is an oral factor XI (FXIa inhibitor). Early clinical results indicate that FXIa inhibition works to prevent stroke with reduced bleeding risk. Clinical trials and phases are continuing.
If FXIa inhibition proves to be safer and as effective as existing DOACs, it would be a major advance in stroke-prevention therapy.
Study of Dementia Risk: Catheter Ablation for A-Fib Versus Drug Therapy Alone
Historically, dementia in patients with A-Fib was attributed to strokes.
Recently it has become clear that A-Fib is associated with multiple forms of dementia even in the absence of stroke.
As anyone with an aging loved one suffering from dementia can tell you, dementia is a major health problem. In the U.S., dementia is predicted to affect more than 10.5 million Americans by 2050.
Research: Risks of Ablation vs. Drug Therapy
In an observational study, researchers compared A-Fib patients who had a catheter ablation to those treated with drug therapy alone.
They used the 2010 to 2021 data from a large, nationally representative claims database (Optum Clinformatics Data) to identify 19,088 A-Fib patients. They then divided these patients into two groups: those receiving a catheter ablation vs those receiving anti-arrhythmic drug (AAD) therapy alone.
Findings: Risks of Dementia and Mortality
Dementia Risk: They found that catheter ablation for A-Fib was associated with a 41% lower risk of dementia compared to patients treated only with anti-arrhythmic drug therapy. This dementia risk reduction held across both males and females.
Mortality Risk: Though not studied as a primary outcome, researchers found patients treated with catheter ablation also had a 49% lower rick of mortality compared with anti-arrhythmic drug therapy only.
What This Means to Patients
Catheter Ablation, by reducing the risk of dementia by 41%, is a major advance in our knowledge about health care for A-Fib patients.
This is yet another reason to get a catheter ablation ASAP in order to be A-Fib free.
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.
(Finally) A Head-to-Head Comparison of Anticoagulants for A-Fib: Eliquis vs Xarelto
The most commonly prescribed direct-acting anticoagulants (DOACs) for A-Fib patients are Eliquis (generic name: apixaban) and Xarelto (generic name: rivaroxaban).
Direct-acting anticoagulants (DOACs) were introduced in the early 2010s, but most of the testing has been against warfarin, not against other DOACs. Finally, thanks to the researchers of two retrospective studies, A-Fib patients now have a head-to-head comparison of Eliquis versus Xarelto.
Study 1: Stroke and Bleeding Risks
A recent retrospective study (Fralick, M. et al) looked at 6 years of prescription data for atrial fibrillation patients from the Nationwide Healthcare Claims Database (NPIC). A-Fib patient group sizes were matched (39,351 each). Mean age was 69 years, 40% were women and follow up was 288–291 days.
Significant Findings
1. Eliquis patients had significantly lower rates of stroke or systemic embolism (6.6 vs 8.0 events per 1000 person-years) compared to Xarelto.
2. Eliquis patients had a significantly lower incidence of major bleeding, defined as gastrointestinal bleeding or intracranial hemorrhage (12.9 vs 21.9 events per 1000 person-years).
Researchers Conclusion (Fralick, M. et al): In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban.
Study 2: Stroke and Bleeding Risks
A second retrospective study (Ray, W. et al) looked at 581,451 atrial fibrillation patients 65 years or older who were enrolled in Medicare from 2013–2018. A-Fib patient group sizes were Rivaroxaban, 227,572 and Apixaban, 353,879. Follow up was for 4 years, through November 30, 2018. Mean age was 77.0 years; 50.2% were women (291 966).
Significant Findings
1. Xarelto patients had more hemorrhagic events including fatal extracranial bleeding (1.4 vs 1.0 per 1000 person-years)
2. Xarelto had more nonfatal extracranial bleeding (39.7 vs 18.5 per 1000 person-years)
3. Xarelto had more fatal ischemic/hemorrhagic events (4.5 vs 3.3 per 1000 person-years)
4. Xarelto had more “total mortality” (44.2 vs 41.0 per 1000 person-years)
Researchers Conclusions and Relevance (Ray, W. et al): Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.
Eliquis vs Xarelto…and the Winner is…
Eliquis (apixaban)! In routine care, Eliquis was found to be both more effective and safer than Xarelto.
As patients, we should pay particular attention to the fact that Eliquis had significantly lower incidence of major bleeding (gastrointestinal bleeding or intracranial hemorrhage) than Xarelto (12.9 vs 21.9 events). And that Xarelto had increased nonfatal extracranial bleeding (39.7 vs 18.5 events) compared to Eliquis.
These differences in bleeding weren’t just “statistically significant” but were really alarming. Major, red flag warning important. Particularly for older people who are more prone to bleeding problems.
Be Your Own Best Patient-Advocate
Whether or not to take anticoagulants and which one is one of the most difficult decisions you and your doctor must make.
All the results cited above were “significant” and should be taken into account when choosing an anticoagulant.
If you are taking Xarelto, you should talk with your doctor about switching to Eliquis.
Learn all you can about your health conditions. A well-informed patient is welcomed by your doctors and healthcare caregivers. (If not, consider changing doctors.)
• Dawwas, G.K. et al. Apixaban Versus Rivaroxaban in Patients With Atrial Fibrillation and Valvular Heart Disease—A Population-Based Study. Annals of Internal Medicine, 18 October 2022. https://www.acpjournals.org/doi/10.7326/M22-0318 https://doi.org/10.7326/M22-0318
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
Return to 2022 AF Symposium Reports
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
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.
A-Fib & Anticoagulants: Bleeding Risk If combined with OTC meds, Supplements
More than a third (33%) of people taking anticoagulants also take at least one nonprescription drug daily or most days of the week. This combination can cause dangerous side effects.
If you are taking an anticoagulant, such as Eliquis, Xarelto, Pradaxa or Savaysa, be aware that taking it along with some over-the-counter drugs and supplements can cause dangerous internal bleeding.
These over-the-counter drugs include painkillers such as aspirin, Advil (ibuprofen), and Tylenol (acetaminophen) and dietary supplements such as fish oil, turmeric, ginger and other herbs.
Internal Bleeding Risk: NOACs/DOACs Hard to Measure
The older anticoagulant, warfarin, required regular blood tests of INR (International Normalized Ratio) to measure how much warfarin was actually working in a patient’s blood to prevent a stroke.
But the newer anticoagulants (NOACs, DOACs), such as Eliquis, Xarelto, Pradaxa or Savaysa, aren’t normally measured by anticoagulation clinics or health care professionals using standardized tests such as INR. (The FDA, under pressure for new anticoagulants, approved the NOACs without there being any established or universally recognized method of determining their clot preventing effectiveness.)
Be aware that your doctor probably doesn’t test to see how much your NOAC is actually working in you. They hope it is, but doesn’t know for sure. Blood levels of your NOAC depends on factors such as how well or how poorly your kidneys are functioning.
Not all of your NOAC may actually be working for you. Pradaxa, for example, is 80% cleared by the kidneys. This means there may be lower anticoagulant levels in your blood stream, and a lot of your clot prevention is being flushed away by your kidneys. (Eliquis, Xarelto and Savaysa fare better with only 25%, 33% and 35% being cleared by the kidneys, respectively.)
Check With Your Doctor About Increased Internal Bleeding Risk
If you take an anticoagulant along with over-the counter drugs and supplements, ask your doctor which combinations to avoid. But be aware that many doctors are clueless about natural dietary supplements.
(Don’t ask them how effectively your NOAC is working in you. They probably don’t know and can’t easily test for that.)
Magnesium IV to Stop A-Fib
We have long advocated the benefits of Magnesium for A-Fib. (See Magnesium Long-Life Insights for A-Fib Patients.)
Intravenous Delivery: A recent randomized controlled double-blind study found that Magnesium delivered directly into the bloodstream (Intravenous, i.e., IV) can produce both rate and rhythm control when used for A-Fib patients in the emergency room (ER).
The Good News: This study from the University of Monastir, Tunisia, found Magnesium IV is the fastest way to improve Magnesium levels and is very effective in restoring A-Fib patients to normal sinus rhythm.
The Bad News: In U.S. emergency rooms, Magnesium IV is not a standard treatment for A-Fib patients (though it may be used prior to cardioversion). (Dr. Julian Whitaker in Newport Beach, CA performs this therapy (www.drwhitaker.com).)
One of our Advisory Board members wrote me about his large facility’s experience with Magnesium IVs, “A few years ago we tried and stopped because of futility.”
Bottom Line: So it’s an interesting research study, but don’t look for a Magnesium IV if you end up in the ER with an A-Fib episode.
