ABOUT 'BEAT YOUR A-FIB'...


"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su Cavanaugh Heart Center, Phoenix, AZ

"Your book [Beat Your A-Fib] is the quintessential most important guide not only for the individual experiencing atrial fibrillation and his family, but also for primary physicians, and cardiologists."

Jane-Alexandra Krehbiel, nurse, blogger and author "Rational Preparedness: A Primer to Preparedness"



ABOUT A-FIB.COM...


"Steve Ryan's summaries of the Boston A-Fib Symposium are terrific. Steve has the ability to synthesize and communicate accurately in clear and simple terms the essence of complex subjects. This is an exceptional skill and a great service to patients with atrial fibrillation."

Dr. Jeremy Ruskin of Mass. General Hospital and Harvard Medical School

"I love your [A-fib.com] website, Patti and Steve! An excellent resource for anybody seeking credible science on atrial fibrillation plus compelling real-life stories from others living with A-Fib. Congratulations…"

Carolyn Thomas, blogger and heart attack survivor; MyHeartSisters.org

"Steve, your website was so helpful. Thank you! After two ablations I am now A-fib free. You are a great help to a lot of people, keep up the good work."

Terry Traver, former A-Fib patient

"If you want to do some research on AF go to A-Fib.com by Steve Ryan, this site was a big help to me, and helped me be free of AF."

Roy Salmon Patient, A-Fib Free; pacemakerclub.com, Sept. 2013


Pradaxa

My 2015 Top Five List: A Review of Advancements in the Treatment of A-Fib

2015 in Review at A-Fib.comWith the beginning of a new year, we often look back and measure how far we’ve come. In 2015, I found five significant advancements in the treatment of Atrial Fibrillation.

1. FDA Approves the Watchman Device

The Watchman occlusion device

The Watchman is positioned via catheter

Anticoagulant Alternative: Because A-Fib patients are at high risk of stroke and clots, a blood thinner (anticoagulant) like warfarin is often prescribed. If you can’t or don’t want to be on blood thinners, you had few options.

That was until March 2015 when the US Food and Drug Administration (FDA) approved the Watchman device. There’s now an option to blood thinners! The Watchman device (Boston Scientific) is inserted to close off the Left Atrial Appendage (LAA), the origin of 90%-95% of A-Fib clots.

It’s not an absolute guarantee you will never have a stroke―but neither is taking warfarin or the newer anticoagulants. For more, see Watchman Device: An Alternative to Blood Thinners.

2. Research: Watchman Better Than a Lifetime on Warfarin

Warfarin - Coumadin tablets various dosages

Warfarin (Coumadin)

The Watchman device isn’t simply an alternative to taking warfarin, clinical trials show it’s actually better. Patients with the Watchman had fewer hemorrhagic strokes and less bleeding compared to patients on warfarin. (Warfarin and other anticoagulants work by causing bleeding and are inherently dangerous.)

It’s too early to say the same about the newer anticoagulants like Pradaxa, Xarelto, Eliquis and Savaysa/Lixiana with their short history but one would expect the same general principles to apply. For more, see Watchman Better Than Warfarin.

3. Antidote for Pradaxa

Praxbind - antidote to Pradaxa

Praxbind: Pradaxa antidote

Up to now, patients on Pradaxa have been bleeding to death in the emergency room while doctors were powerless to stop their bleeding and could only stand by and watch them die. See Stop Prescribing or Taking Pradaxa.

In October 2015, the FDA granted “accelerated approval” to Praxbind, the reversal agent (antidote) to Pradaxa (Boehringer Ingelheim). Praxbind (idarucizumab) is given intravenously to patients and reverses the anticoagulant effect of Pradaxa within minutes.

Note: The reversal agent, Andexanet Alfa, is on FDA fast track and is expected to be approved by mid-2016 as an antidote for Xarelto and Eliquis (Factor Xa inhibitors).

4. Life Style Changes Can Make Some People A-Fib Free

Weightloss

Weightloss

Weight Loss: A weight loss program and counseling in Australia has worked so well that some patients have become A-Fib free.

In his Adelaide clinic, Dr. Prashanthan Sanders convinces his overweight A-Fib patients to buy into the program, lose weight, and keep it off.  This holistic approach to health has also been successfully applied to other A-Fib contributing factors such as diabetes, sleep apnea, hypertension, binge drinking and smoking. See Weight Loss Key to Reverse Atrial Fibrillation, Improve Ablation Success.

Exercise

Exercise

Exercise: But not everyone can lose weight and keep it off. And other risk factors like hypertension and diabetes are more difficult to permanently change.

The same Australian researchers found that exercise improves A-Fib (even obese A-Fib patients benefit from exercise). Supervised aerobic and strength exercises reduced A-Fib by 84%.

Combine for Best Results: Exercise and weight loss together produced the best results. An astounding 94% of obese patients who both lost weight and exercised regularly were A-Fib free after rhythm control therapy (i.e., antiarrhythmic drugs and/or catheter ablation).

Couch Potato Warning: If you don’t exercise regularly, you’re almost guaranteed to stay in A-Fib. Even with rhythm control (antiarrhythmic drugs and/or ablation), 83% of the low-fitness obese patients had A-Fib.

5. Research Studies: Preventing Fibrosis

Fibrotic cells - 2008 Boston A-Fib Symposium Kottkamp

Fibrotic cells

A-Fib produces fibrosis, and up to now, was considered permanent and irreversible. Fibrosis is fiber-like scar tissue that stiffens and weakens the heart muscle which reduces pumping efficiency and leads to other heart problems.  (See Fibrosis and A-Fib).

Dr. Jose Jalife’s experimental studies with sheep found that a Gal-3 inhibitor (GM-CT-01) actually reduced or prevented fibrosis. Better yet, instead of having to wait years for possible FDA approval, a natural supplement, Pecta-Sol C (Modified Citrus Pectin) works like a Galectin-3 inhibitor.

For A-Fib patients, this may provide the means to avoid fibrosis or repair fibrotic heart tissue. (See Galectin-3 Inhibitor Prevents A-Fib).

A Personal Prediction

WATCHMAN device at A-Fib.com

WATCHMAN device

On a personal note, I’m excited about the great potential of the Watchman device to significantly reduce or eliminate the threat of strokes—especially in the elderly―even if they don’t have A-Fib.

Imagine a world where stroke risk could be eliminated by a simple 20-30 minute procedure. The Watchman device (and other occlusion devices) may change the way elderly medicine is practiced.

If you find any errors on this page, email us. Y Last updated: Thursday, January 21, 2016

Drug Watch: FDA Approves Reversal Agent Praxbind® for the Anticoagulant Pradaxa

The FDA granted “accelerated approval” to Praxbind®, a reversal agent (antidote) to Pradaxa®. Praxbind is given intravenously to patients who have uncontrolled bleeding or require emergency surgery.

The accelerated approval program is designed to provide patients with earlier access to new drugs.

Pradaxa (dabigatran), a novel oral anticoagulant (NOAC), reduces the risk of clots and stroke in patients with Atrial Fibrillation. The new NOACs are alternatives to warfarin (Coumadin).

Patients on Pradaxa Were Bleeding to Death in the ER

Patients on Pradaxa have been bleeding to death in the ER while doctors were powerless to stop their bleeding and could only watch them die. See Stop Prescribing or Taking Pradaxa.

Praxbind - antidote to Pradaxa

Praxbind®, reversal agent for Pradaxa®

In clinical trials, 5gs of Praxbind (idarucizumab) reversed the anticoagulant effect of Pradaxa within minutes (which is significantly faster than the current antidotes for warfarin). In one ongoing trial, the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within four hours. This effect lasted at least 24 hours.

Praxbind works by binding to Pradaxa to neutralize its effect (measured as unbound Pradaxa plasma concentration). The most common side effects of Praxbind were headache, low potassium, confusion, constipation, fever and pneumonia.

Boehringer Ingelheim (a privately-held German company), which manufactures both Pradaxa and Praxbind, will be required to submit additional clinical information after approval to confirm the clinical benefit of Praxbind.

After Praxbind, Get Back on Anticoagulants ASAP!

Boehringer Ingelheim recommends that patients resume their anticoagulant therapy as soon as medically appropriate. In the clinical trials of Praxbind, five patients suffered strokes after reversal. They were not receiving anticoagulant therapy at the time of their stroke.

Other NOACs Will Soon Have a Reversal Agent

Pradaxa was the first NOAC to win FDA approval, but now there are three other new anti–blood clotting drugs available to doctors and patients.

Despite its newly approved reversal agent, Pradaxa’s advantage over the other NOACs will probably be short lived.

• Xarelto® (rivaroxaban) by Bayer Pharma/Janssen Pharmaceuticals
• Eliquis® (apixaban) by Pfizer/Bristol-Meyers Squibb (tested the best with the best safety record)
• Lixiana®/Savaysa® (edoxaban) by Daiichi-Sankyo (newest NOAC to be approved by the FDA)

The other NOACs will soon have a reversal agent, Andexanet Alfa, which has done well in clinical trials and is also on fast track FDA approval. It’s being developed by Portola Pharmaceuticals.

Despite its newly approved reversal agent, Pradaxa’s advantage over the other NOACs will probably be short lived.

References for this article

Warfarin vs. Pradaxa and the Other New Anticoagulants

by Steve S. Ryan, PhD, Update July 2014, June 2015, October 2015
red-heart-negative 150 pix by 96 res

“I’ve read about people bleeding to death in the ER because they are on the new anticoagulant Pradaxa. Doctors can’t stop the bleeding, even from minor cuts. Is that true? Doesn’t Coumadin carry the same risk? What about the other new anticoagulants Xarelto and Eliquis?”

You’re correct about Pradaxa and the reported bleeding deaths (See “Stop Prescribing or Taking Pradaxa: Suspect in 542 deaths.”) None of the new anticoagulants (including Xarelto and Eliquis) has a proven, reliable antidote or reversal mechanism. But, Pradaxa, in particular, has been associated with tragic deaths in the ER where doctors are helpless and can only watch as someone bleeds to death.

 Stroke Prevention

Most would agree that the worst thing that can happen to a patient with A-Fib is a life-altering stroke. A stroke often causes death or permanent disability. Thus the importance of anticoagulation therapy for A-Fib patients.

For many years, there was only one proven therapy for stroke prevention in A-Fib patients at high or intermediate risk for stroke: the anticoagulant Coumadin (warfarin). It’s readily available and inexpensive.

But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking Coumadin).

But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking it).

Frequent blood tests are required to regulate the dose. Coumadin also has many interactions with other drugs, herbs, and food sources. If taken incorrectly, Coumadin can increase your risk of dangerous bleeding (yes, just like with Pradaxa).

In addition, Coumadin taken over several years may lead in microbleeds in the brain and dementia. (Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy )

For patients at low or intermediate risk of stroke (including younger patients without any additional stroke risk factors) aspirin may be prescribed, or no anticoagulation therapy at all.

Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy

 The NOACs Trials

For over 20 years there have been extensive efforts to replace warfarin with other drugs. In the US, we have four new anticoagulants to consider: Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban), (added January, 2015) and the recently approved (January, 2015) Savaysa (edoxaban)).

The data on the new anticoagulant come from three randomized controlled trials involving more than 50,000 A-Fib patients:

RE-LY (dabigatran)1
• ROCKET-AF (rivaroxaban)2
• ARISTOTLE (apixaban)3

Each study compared one drug against warfarin (not against each other). Taken together, these studies consistently revealed that A-Fib patients who took the non-warfarin blood thinners suffered fewer strokes, intracranial bleeds, and serious bleeds than those who took warfarin.

All of these drugs are at least as good as warfarin for preventing stroke and all are better than warfarin in reducing your risk of serious bleeding in the brain. But none have antidotes or reversal agents (at this time).

Note: Each of these NOAC trials had a questionable bias toward the new drug when compared against warfarin. Warfarin users are notoriously non-compliant, up to 50% are inconsistent in managing their diet, monitoring their INR levels and taking the correct dosage.4 Each of the three trials compared a group of compliant patients against a group of inconsistent warfarin patients. So results should be viewed with a critical eye.

For a more in-depth look at the clinical trials of the new NOACs, see 2013 BAFS: The New Anticoagulants (NOACs).

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 Three Notable Concerns

The new anticoagulants offer several advantages over warfarin. They are fast acting. And when stopped (i.e., for surgery), they just as quickly clear your body (a short “half-life). There’s a broad therapeutic window (wide range of safe use), and they have minimal drug or dietary interactions. They can be administered in fixed doses without monitoring, making them potentially more convenient to use than warfarin.

Remember: The goal of anticoagulation therapy is to reduce your risk of life-altering stroke.

Enthusiasm for the new anticoagulants, (NOACs), however, must be tempered by three notable concerns in patients taking these drugs:

1. No readily available means for assessing the degree of anticoagulation
2. No readily available reversal strategy
3. Life-threatening bleeding complications can occur after an injury
(Added May, 2015) Dr. Stephen Kimmel of the Un. of Pennsylvania discusses a fourth concern—stomach problems and gastrointestinal bleeding. “If you have a history of stomach problems or gastrointestinal bleeding, you may want to avoid Pradaxa and Xarelto—both medications have the highest risk for those complications.”5

 No Way to Measure Effectiveness

One of the problems with the newer anticoagulants (NOACs) is we don’t have a good way to measure how effective they are or how much of an anti-clotting effect there is at a given point in time. (For example, in treating trauma patients, ER doctors can only use the elapsed time from the last dose to estimate the clotting effect.)

With Coumadin (warfarin), on the other hand, we can measure how effective it is by its level in the blood stream measured in INR (International Normalized Ratio). A person not on anticoagulants will have an INR slightly above 1 (the author’s INR is 1.1). Someone with A-Fib on Coumadin should have an INR between 2.0 and 3.0. At this INR level a person will bleed more than someone with an INR of 1.0, but the blood will still clot.

With an INR below 2.0 you are more in danger of having an ischemic (clotting) stroke, the kind that most often occurs in A-Fib. With an INR of 4.0 and above, there is much more risk of blood not clotting and of developing a hemorrhagic stroke.

But the INR blood test doesn’t work with the new anticoagulants which affects only one particular stage in the anticoagulation process. Pradaxa, for example, is a direct thrombin inhibitor, whereas Coumadin affects nearly every stage in the anticoagulation process. (Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound.)

The lack of a readily available method to determine the degree or current level of anticoagulation is a major challenge for ER physicians and staff treating trauma patients.

Medical ID: If you’re on any blood thinner, it’s a good idea to carry some kind of medical ID. (See our Resources and Links for MedIDs free medical ID wallet card generator.) If you have an accident involving bleeding, EMTs don’t normally carry anticlotting meds. But they can call ahead to the ER and get the staff ready to help you.

 Are the NOACs Too Effective?

Pradaxa, in particular seems to work almost too well.

Pradaxa, in particular seems to work almost too well.

In some patients there is excessive bleeding that is catastrophic (usually in older or weaker patients). Pradaxa has been associated with some deaths in the ER where doctors currently have no antidote to stop people from bleeding to death.

Coumadin on the other hand has several proven, time-tested reversal or antidote strategies.6

Pradaxa (dabigatran) won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and consequently captured a significant share of the anticoagulant market. Pradaxa comes in two doses in the United States, 150 mg twice daily or 75 mg twice daily. It’s large and harder to swallow, comes in a bottle with a 30-day shelf life once opened (or in blister packs which eliminates the shelf-life problem.) And it’s expensive.7 In the RELY trial, Pradaxa was not only equal to warfarin, but it proved to be superior to it in preventing stroke. Bleeding rates in the head were lower with Coumadin. However, bleeding from the stomach or bowels was higher. The most common side effect was stomach pain.

In addition to the bleeding deaths in the ER mentioned above, Pradaxa’s own fact sheet states common side effects of Pradaxa include:8

• Indigestion, Upset Stomach, or Burning
• Stomach Pain

[These statements don’t capture the actual human toll—burning throat, roiling intestines, diarrhea, burning anus, lasting intestinal damage, etc. that Pradaxa can produce in some people.]

 Xarelto and Eliquis Test Better

Xarelto (rivaroxaban) was the second drug available in the United States. Xarelto comes in two doses, 20 mg daily or 15 mg daily. In contrast to Pradaxa, it is a small pill taken once-a-day that doesn’t seem to cause a lot of intestinal problems. In the Rocket AF trial, Xarelto also significantly lowered the risk of bleeding in the brain and head compared to Coumadin. Like the other new anticoagulants, Xarelto also doesn’t have a reversal agent; but anecdotally we don’t seem to see a lot of deaths in the ER from Xarelto.

Eliquis (apixaban) was third to be approved, comes in two doses, 5 mg twice daily or 2.5 mg twice daily (the lower for A-Fib patients with kidney dysfunction). Similar to Xarelto, the risk of bleeding in the brain and head was lower versus Coumadin. However, this drug was unique in that bleeding from other sites including the stomach, bowels, and bladder was less. In the Aristotle trial, Eliquis was at least as good and tended to be better than warfarin at preventing stroke.  Eliquis is the only drug that can claim that survival improved with its use compared to warfarin.

Xarelto and Eliquis, just like Pradaxa, are also very expensive.

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 Bleeding Complications

The reported bleeding events tend to occur mainly in elderly patients (median age of 80) which raises a question regarding safe dosing and monitoring in older patients. Elderly patients often have mild to moderate renal impairment, which can cause plasma levels of the NOAC to increase to up to three times those in normal renal function.

“One-size-fits-all” dosage of these new anticoagulants may need to be re-examined for elderly patients. (The FDA rejected the lower 110-mg twice-daily dose of Pradaxa (dabigatran) tested in the RE-LY trial, instead approving a 75-mg twice-daily dose just for patients with severe renal impairment.)

Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff.

 Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff and emergency physicians treating injured and often unstable patients (as does the lack of a readily available method to determine the degree or current level of anticoagulation). Currently, the only reversal option is emergency dialysis. The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages is an incredible challenge, even at the best trauma centers.

With a relatively short elimination half-life, for now, time may be the most important antidote for NOACs.

 Adverse-Events Analysis

Eliquis Earns Best Safety Score

Through an analysis of data from the FDA Adverse Event Reporting System by AdverseEvents, Inc., Eliquis has received an “RxScore” safety score of 39.45 on a 100 point scale, with 100 representing the highest risk. In comparison, warfarin had a score of 67.57. Pradaxa (dabigatran) had a score of 67.15, Xarelto (rivaroxaban) 67.08.9,10

The FDA’s database comprises all the reports made by doctors, patients and other healthcare providers, which means it’s not a “scientific” finding with the authority of a clinical trial. AdverseEvents applies logic, math and software to the database to sift out the important data.

For Eliquis, “the rate of suspect cases was lower in every type of adverse-event report, from hospitalization to death.” For example, among Eliquis patients reporting side effects, only 21% cited hospitalization, while Pradaxa had 39%, Xarelto 43% and warfarin 50%.

The results all point to the same general conclusion: Eliquis may be a safer choice among the new NOACs.

 Update May 2014: Pradaxa

Since it was approved for use in 2010, Pradaxa has been linked to more than 500 patient deaths. More than 1,600 individuals have filed lawsuits in state and federal courts in the United States alleging they suffered bleeding events caused by the drug.

In May 2014, Boehringer-Ingelheim, the privately held German company that makes Pradaxa, settled 4,000 Pradaxa lawsuits and will pay $650 million. The lawsuit states that Pradaxa can cause bleeding events that cannot be controlled and are sometimes fatal.11

Pradaxa has generated $1 Billion in revenue for Boehringer-Ingelheim. So, will this $650 million settlement hurt BI’s bottom line and affect its marketing of Pradaxa? (BI’s revenues in 2012 were $1.5 billion). Probably not.

 Author’s Recommendations

If you’re conscientious and are pretty good at staying in the proper INR range, stick with Coumadin if you can. It may not be as convenient and easy to use as the newer anticoagulants, but we know Coumadin works if you stay within the proper INR range. And there are proven reversal agents for Coumadin, unlike for the newer anticoagulants. The cost of Coumadin is significantly lower when compared to the new anticoagulants.12

Update June 2015: Instead of the above statement, I suggest you talk with your doctor about switching from warfarin (Coumadin) to the NOAC Eliquis (apixaban). Studies show that warfarin produces arterial calcification and plaque which damage your heart over time. (See Stop Taking Warfarin! Switch to Eliquis.) Eliquis doesn’t block Vitamin K like warfarin, it tested better than the other NOACs and is safer.

If you struggle with staying in the proper INR range13, can’t juggle the diet restrictions or monthly monitoring, you should talk with your doctor about switching to Eliquis. It has no interactions with food (not even spinach) and requires NO monitoring (no more finger stick checks). Though be aware of Eliquis’  much higher monthly price.14 You will need to judge if the benefits outweigh the costs.

When choosing an anticoagulant, you need to consider which is worse: the risk of uncontrolled bleeding or the risk of a debilitating stroke.

Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16

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Return to Index of Articles: Drug Therapies (Medicines)

Last updated: Saturday, March 26, 2016

 

References    (↵ returns to text)
  1. Connolly SJ, et al. RE-LY Steering Committee and Investigators.  Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51. Last accessed July 10, 2014 URL: http://www.ncbi.nlm.nih.gov/pubmed/19717844
  2. Patel MR, et al. ROCKET AF Investigators.  Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.  N Engl J Med. 2011;365(10):883-91. Last accessed July 10, 2014, http://www.ncbi.nlm.nih.gov/pubmed/2183095
  3. Granger CB, et al. ARISTOTLE Committees and Investigators.  Apixaban versus warfarin in patients with atrial fibrillation.  N Engl J Med. 2011; 365(11):981-92 Last accessed July 10, 2014
  4. Ansell J, et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the interactional study of anticoagulation management (ISAM) J Thromb Thrombolysis 2007; 23: 83—91. Last accessed July 10, 2014
  5. Kimmel, Stephen. The Truth About Blood Thinners, Bottom Line/Health, May 2015, p. 11
  6. Coumadin reversal or antidote strategies: Vitamin K antagonist, Fresh Frozen Plasma, Prothrombin Complex Concentrate (PCC), and the newly FDA-approved Kcentra.
  7. Pradaxa costs about $250 a month; By comparison, warfarin (Coumadin) costs about $60-$80/month when you add in INR monitoring once a month. Last accessed July 10, 2014
  8. Pradaxa: Highlights of Prescribing Information. Boehringer-Ingelheim website. Last accessed March 13, 2014 URL: http://tinyurl.com/PraxadaInfo
  9. Examining the Comparative Safety of Blood Thinners: An Analysis Utilizing AdverseEvents Explorer, February 2014, Special Report Download. http://info.adverseevents.com/special-report-blood-thinner Last accessed July 10, 2014
  10. Staton, Tracy. Eliquis earns best safety score in its class in analysis of FDA adverse event reports. FiercePharma, February 26, 2014. Last accessed July 10, 2014, http://www.fiercepharma.com/story/eliquis-earns-best-safety-score-its-class-analysis-fda-adverse-event-report/2014-02-26
  11. Feeley, Jef. Boehringer Pays $650 Million to End Blood-Thinner Cases. May 28, 2014. Bloomberg.com. Last accessed July 10, 2014, URL: http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html
  12. Your insurance provider will have a direct say into which drug you take.
  13. Consider a warfarin sensitivity test. About a third of the people who take warfarin are at a higher risk of bleeding because their genes make them more sensitive to warfarin. If a family member experienced side effects, talk to your doctor about taking a genetic warfarin sensitivity test.
  14. For those in the US and on Medicare with Part D coverage, the monthly cost may range from $30 to $50.
  15. Marzo, Kevin. Blood thinner Antidote. Bottom Line Health, Volume 29, Number 9, September 2015, p. 1.
  16. Mundell, E.J.. Drug May Be Antidote to Bleeding Tied to Blood Thinner Pradaxa. Medline Plus. Monday, June 22, 2015. http://www.nlm.nih.gov/medlineplus/news/fullstory_153206.html

The Year in Review: Highlights and Achievements

By Steve S. Ryan, PhD

When I think about the field of atrial fibrillation in 2013, several thoughts come to mind. There were technical advancements, some new drug therapies, and additions to our understanding of Atrial Fibrillation (and a few accomplishments for our A-Fib.com website).

Heart Imaging And Mapping Systems

Perhaps the most important technical innovations in 2013 for A-Fib patients were the introduction of two new heart imaging and mapping systems. A third system, the Bioelectronic Catheter, represents a whole new technology with tremendous potential for A-Fib patients.

Patients wearing 'vest' lies down for the ECGI.

The ECGI System

The ECGI system, combined with a CT scan, produces a complete 3-D image of your heart along with identifying all the A-Fib-producing spots. Think of it as an ECG with 256 special high resolution electrodes rather than 12. It greatly reduces your ablation time and your radiation exposure.

A day before your ablation, you simply don a special vest with 256 electrodes covering your upper torso, and lay down. The 3-D image created is a road map of your heart with all the focal and rotor areas (A-Fib-producing spots) identified. During your ablation your EP simply ablates the “guilty” areas. Read more of my article…

Topera-FIRMap catheter - three sizes

The FIRM System

The FIRM system uses a different approach to mapping the heart and the A-Fib producing spots. It uses a basket catheter inside the heart to map large areas in a single pass and reveal the location of foci and rotors. Read more of my article…

Why are these two technologies important? ECGI allows your imaging & mapping to be performed the day prior to your ablation, rather than during your ablation. This shortens the length of your ablation procedure.  In addition it reduces your radiation exposure and produces remarkably accurate 3D images of your heart and identifies where A-Fib signals are coming from. The FIRM system, though performed during an ablation rather than before it, may be a significant improvement over the Lasso catheter mapping system now in current use. Both systems may mark a new level of imaging/mapping for A-Fib.

Flexible Biomechanical Balloon Catheter - photo credit: Dae-Hyeong Kim-University of Illinois

Stretchable Electronics Meets the Balloon Catheter

The merging of living systems with electronic systems is called “bioelectronics”. Key is a flexible, pliable circuit made from organic materials—the carbon-based building blocks of life. Bioelectronics have entered the EP lab with a prototype of a ‘bioelectronic catheter’, the marriage of a pliable integrated circuit with a catheter balloon.

In a mapping application, the deflated bioelectronic balloon catheter is slipped into the heart, then pumped up. The inflated integrated circuit conforms to the heart’s grooves and makes contact with hard-to-reach tissue. It can map a hundred electrical signals simultaneously, across a wider area and in far greater detail than had been previously possible. And it’s being developed to function in reverse. For ablation applications, instead of detecting current, it can apply precise electrical burns. This is a potentially breakthrough technology that may well change the way catheter mapping and ablation are performed. (Thanks to David Holzman for calling our attention to this ground-breaking research article.)

This is a remarkable time in the history of A-Fib treatment. Three very different technologies are poised to radically improve the way A-Fib is detected, mapped and ablated. We’ll look back at 2013 as a watershed year for A-Fib patients.

Three New Anticoagulants

In 2013 we saw three new anticoagulants, a welcome development for A-Fib patients. Note: the new anticoagulants are very expensive compared to the proven anticoagulant warfarin.

pradaxa_logo 150 pix 96 res Eliquis apixiban logo 150 pix 96 res Xarelto logo 150 pix 96 res

How do they compare to warfarin?

Warfarin seems to have a slightly higher chance of producing intracranial bleeding.
In general stay away from Pradaxa. There are horrible ER reports of patients bleeding to death from even minor cuts, because there is no antidote or reversal agent. Read more about my Pradaxa warning

Eliquis, in general, tested better than Xarelto in the clinical trials, but it’s so new we don’t have a lot of real-world data on it yet. And, as with Pradaxa, neither have antidotes or reversal agents.
In addition, there was what some consider a major problem with the clinical trials comparing the new anticoagulants to warfarin. ‘Compliance’ rates by warfarin users were poor (many either weren’t taking their warfarin or weren’t in the proper INR range). Did this skew the results?

And finally, unlike warfarin where effectiveness can be measured with INR levels, we don’t have any way to measure how effectively the new blood thinners actually anticoagulate blood. Read more of my article Warfarin vs. Pradaxa and the Other New Anticoagulants“.

Keep in mind: ‘New’ doesn’t necessarily mean ‘better’ or ‘more effective’ for You.

A-Fib with high blood pressure?

High Blood Pressure with Your A-Fib? Is Renal Denervation a solution?

As many as 30% of people with A-Fib also have high blood pressure which can’t be lowered by meds, exercise, diet, etc. There was hope that Renal Denervation would help.

With Renal Denervation, an ablation catheter is threaded into the left and right arteries leading to the kidneys, then RF energy is applied to the nerves in the vascular walls of the arteries, hopefully reducing ‘Sympathetic Tone’, lowering high blood pressure and reducing A-Fib. For many people Renal Denervation seemed the only realistic hope of lowering their high blood pressure. However, the Medtronic Simplicity-3 trial indicated that renal denervation doesn’t work. Read more of this article…  For 2014 news on this topic, read more…

A Study of Obesity and A-Fib: A-Fib Potentially Reversible

Apple and tape measure - weight loss 200 pix by 96 resObesity is a well known cause or trigger of A-Fib, probably because it puts extra pressure and stress on the Pulmonary Vein openings where most A-Fib starts.

In 2013 A research study report focused on obese patients with A-Fib. Those who lost a significant amount of weight also had 2.5 times less A-Fib episodes and reduced their left atrial area and intra-ventricular septal thickness.

Good news! Losing weight can potentially reverse some of the remodeling effects of A-Fib. Related article: Obesity in Young Women Doubles Chances of Developing A-Fib.

Data collected in a typical sleep study

Obstructive Sleep Apnea and A-Fib

Obstructive Sleep Apnea (OSA) is another well recognized cause or trigger of A-Fib. Anyone with A-Fib should be tested for sleep apnea.

Earlier studies have shown approximately two-thirds (62%) of patients with paroxysmal or persistent A-Fib suffer from sleep apnea. In 2013, research reports showed that the worse one’s sleep apnea is, the worse A-Fib can become. In addition, sleep apnea often predicts A-Fib recurrence after catheter ablation.

Before an ablation, Dr. Sidney Peykar of the Cardiac Arrhythmia Institute in Florida, requires all his A-Fib patients be tested for sleep apnea. If they have sleep apnea, they must use CPAP therapy after their ablation procedure.

A-Fib.com: Our New Website’s First Year

A-Fib_com logo The original A-Fib.com web site was created using the phased out software MS FrontPage. Thanks to a  “no strings attached” grant from Medtronic, A-Fib.com was reinvented with a more up-to-date but familiar look, and features more functionality (built on an infra-structure using Joomla and WordPress). We can now grow the site and add features and functions as needed.

It involved a tremendous amount of work. A special thanks to Sharion Cox for building the new site and for technical support. My wife, Patti Ryan, designed the look and all graphics. (I can’t thank Patti enough; I’m so lucky!)

A-Fib.com Project:
Update the Directory of Doctors & Facilities

Steve and A-Fib.com bulk mailing to update the A-Fib.com Directory of Doctors and Facilities

Back when I started A-Fib.com in 2002, there were less than a dozen sites performing ablations for A-Fib. Today our Directory of Doctors and Facilities lists well over 1,000 centers in the US, plus many sites worldwide.

Increasingly, doctors were writing me asking why they weren’t included, or why their info was incorrect since they had moved, etc. To update our records and our service to A-Fib patients, starting in July 2013, we prepared and mailed letters to over 1,000 doctors/facilities. We asked each to update/verify their listing (and include a contact person for our use).

Note to Doctors! If you haven’t updated your listing in our A-Fib.com Directory of Doctors and Facilities, just use our Contact Us form to email me and I’ll send you the form to fill in and return.

The response to our bulk mailing was great. The data input started in October and continued for several months (as time allowed). Recently, we cut over to the ‘new’ Directory menu and pages.

 


2014 PREVIEW A-Fib.com

What’s Ahead for A-Fib.com in 2014

2014 Boston AFib Symposium Reports: Check out my new reports from the 2014 Boston A-Fib Symposium (BAFS) held January 9-11, 2014 in Orlando FL.

The first two reports are posted. Look for more reports soon. I usually end up with 12-15 reports in total.

Steve and bulk mailing to update the A-Fib.com Directory of Doctors and Facilities

Our a-Fib.com Directory of Doctors & Facilities: Work on updating our listings is still underway. We need to contact those who did not respond to our request for verification or updating of their listing. (Shall we write again or maybe make phone calls?)Beat Your A-Fib by Steve S Ryan, PhD

Amazon Best Sellers list:  Our book sales continue to grow. Did you know that our book ‘Beat Your A-Fib’ has been on Amazon’s Best Sellers list continually in two categories (Disorders & Diseases Reference and Heart Disease) since its debut in March 2012? Visit Amazon.com and read over 40 customer reviews.

Help A-Fib.com Become Self-sustaining: We plan to step up our efforts to make A-Fib.com a self-sustaining site. (Since 2002, Steve and Patti Ryan have personally funded A-Fib.com with an occassional reader’s donation.)


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Visit our shop at Spreadshirt.com.

In our efforts toward sustainabiliy, several years ago we added a PayPal ‘Donate’ button (you don’t need a PayPal account to donate) and invited donations toward our onlline maintenance costs.

Then, a year or so ago, we added a portal link to Amazon.com. When you use our Amazon.com link, A-Fib.com receives a small commission on each sale (at no extra cost to you).

Our newest effort is our ‘A-Fib can be Cured! shop with T-shirts and more at Spreadshirt.com. With each shirt purchase $2 goes to support A-Fib.com. (We will roll out new designs every quarter or so).

Posted February 2014

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Last updated: Wednesday, February 11, 2015

New A-Fib Patient Story: Serious Pradaxa Side Effects

Jeff Patten, Ashby, MA

Jeff Patten, Ashby, MA

Jeff Patten’s A-Fib started briefly in 2000, then returned in 2010 when his father-in-law died. The emotional upset, high summer heat, stress and accumulated age, followed closely by a bout with appendicitis, put him back into A-Fib .

In 2012, came a successful CryoBalloon ablation. But Jeff’s post-ablation recovery on Pradaxa turned into “alimentary torture” and burning diarrhea. Later came a Right Atrium Catheter Ablation for PACs/PVCs. Learn how Jeff emerged in 2015 healthy and A-Fib free.

 

Jeff Patten A-Fib Patient Story

A-Fib Patient Story #78

Jeff Patten

15 years in A-Fib: CryoBalloon Ablation, Pradaxa Problems, Second Ablation (RF) for Flutter

By Jeff Patten, Ashby, MA, January 2015

My A-Fib started about fifteen years ago.

That warm September day in 2000, I was tired, had a lot of coffee and was trying to finish a heavy shrub transplanting job. Sweating and breathing heavily, I noticed my heart was not doing what it should.

Alarming! Dehydration?? A couple of hours in ER and it normalized on its own.

After a couple more brief episodes, I decided to get back in better shape – slowly and judiciously! I’d always been active and couldn’t understand why the ole’ ticker was failing me now. They called it lone paroxysmal atrial fibrillation, so there was nothing else wrong.

Flecainide “Pill-In-The-Pocket,” Propafenone, Then CryoBalloon Ablation

The next decade saw no more episodes.

Then, in 2010, my father-in-law died. The recipe of emotional upset, high summer heat, stress (there was a lot of heavy “estate” to handle), and―as they tell me―accumulated age put me back on the A-Fib merry-go-’round.

My A-Fib was very symptomatic with erratic chest pounding, weakness and breathlessness. I took Life easier, and the A-Fib eased―until that autumn’s bout with appendicitis!

My EP put me on flecainide as a pill-in-the-pocket. That seemed to work for a while―until it didn’t

Time to see an electrophysiologist. My newly acquired EP put me on flecainide as a pill-in-the-pocket. That seemed to work for a while―until it didn’t. Episodes got worse. I was put on propafenone and warfarin while waiting for my ablation.

In December 2012, I had a pulmonary vein isolation (PVI). My EP used the newly approved CryoBalloon catheter.

Recovery: A-Fib free, but Pradaxa “Alimentary Torture” and Burning Diarrhea, Switch to Xarelto

After my ablation, I was put on a double dose of the proton pump inhibitor omeprazole (Prilosec), which is done on the theory it will help prevent the very unusual but deadly side effect of PVI known as atrioesophageal fistula by reducing erosive inflammation.

Since my INR numbers on warfarin were hard to control and there was concern about warfarin’s deleterious effect on vascular calcium through its action on vitamin K, I was put on dabigatran (Pradaxa) as an alternative.

Pradaxa comes in a special container to control moisture. The pills must be tossed if not used in four months once opened. They are awkwardly large. They must be taken twice a day. They are formulated with tartaric acid to help absorption. Everyone who takes Pradaxa must contend with all this.

Pradaxa was alimentary torture. Burned on the way down. Burned in my stomach and belly. Burned with diarrhea on the way out.

For me, Pradaxa was alimentary torture. Burned on the way down. Burned in my stomach and belly. Burned with diarrhea on the way out. The label suggests you’ll accommodate.

After six days I called for help and was switched to rivaroxaban (Xarelto). This is a small pill. Tiny, really. No particular moisture issues. No unusual expiration. Once a day. No burning. But the diarrhea continued for more than a couple of months.

Lymphocytic Colitis: From Taking Omeprazole (Prilosec) and/or Pradaxa?

As soon as my ablation was deemed ‘successful’, meaning that I was able to come off my doses of propafenone and Xarelto and omeprazole, I had a colonoscopy to check out the continuing diarrhea.

Diagnosis: lymphocytic colitis. I did a bit of research on this and discovered that very little is conclusively known about this increasing public problem. It is understood that there is an association between this colitis and the use of proton pump inhibitors among other meds such as non-steroidal anti-inflammatories. The diarrhea gradually subsided.

This Pradaxa/omeprazole story is one anecdote. No scientific conclusions can be drawn. I know what I personally conclude about it, however!

Ectopic Beats Turn into Flutter, RF Ablation

The ectopic beats following the ablation got worse.

PACs and PVCs are supposed to be normal and benign. Sometimes mine seemed to string themselves together for a bit. Then in July 2013, they didn’t quit. A heart rate of 130 at rest sent me to the E.R. where I got a diagnosis of atrial flutter, a successful cardioversion, and an appointment for another ablation.

An ablation in August addressed three flutter ‘circuits’. Careful electrical mapping was used this time, and RF-energy was used to break the ‘circuits’.  Apparently flutter such as this often follows on the heels of an A-Fib ablation. Not fully understood.  Yet.

So far, so good. I’ll let you know if anything more of interest happens.

Jeff Patten
jedapatten@yahoo.com

Editor’s Comments
Pradaxa and Stomach Problems: It’s unfortunately not unusual to experience the intestinal tract problems Jeff had when taking Pradaxa. Pradaxa’s own fact sheet states the common side effects of Pradaxa include:
• Indigestion, Upset Stomach, or Burning
• Stomach Pain
In Pradaxa’s clinical trials, nearly two out of five people (35%) could not tolerate Pradaxa, which is a high rate of adverse reactions. In an earlier post I wrote “Based on the clinical trial data, there is a danger that Pradaxa over time may cause long-term damage to the gastrointestinal system.” (See The New Anticoagulants [NOACs], 2013 Boston Atrial Fibrillation Symposium). This may be what happened to Jeff when he developed lymphocytic colitis, but we can’t say this for sure.
It’s unusual to be put on a double dose of omeprazole (Prilosec).
Switch from Pradaxa to Eliquis or Go Back to Warfarin: I’d recommend to anyone taking Pradaxa to switch to a different anticoagulant or go back to warfarin if it worked for you. Not only is Pradaxa associated with intestinal tract problems, but it’s been associated with people bleeding to death in the ER. There’s no reversal agent or antidote for Pradaxa as there is for warfarin. (See Stop Prescribing or Taking Pradaxa). Eliquis tested better than the other new anticoagulants and is safer.
With the new anticoagulants (NOACs) now available, no one probably should be taking warfarin anymore. Warfarin produces arterial calcification, and also puts patients at increased risk of osteoporosis and bone fractures. (See Stop Taking Warfarin [Coumadin]!!! Switch to Eliquis [Apixaban].)
Flutter after A-Fib ablation: Many EPs include a Flutter ablation along with an A-Fib PVI. It’s relatively easy to do compared to a left atrium PVI and only adds around 10 minutes to the ablation procedure. It involves making an ablation line in the right atrium (Caviotricuspid Isthmus line) either before or after entering the left atrium. But other EPs are reluctant to make any ablation burns in the heart that aren’t medically necessary. If someone isn’t in right atrium flutter, they wouldn’t do a Flutter ablation. (Personally if I had a choice, I’d ask the EP to do a right atrium Flutter ablation as long as they were already ablating inside my heart anyway.)
However, Jeff had three Flutter circuits which probably meant that some of these Flutter circuits did come from the left atrium. Flutter can develop after an A-Fib ablation or be found later after the inflammation of the ablation scarring settles down. That’s why Jeff needed a second ablation which was RF rather than CryoBalloon.

Oct 2015: FDA Aproves Reversal Agent Praxbind® for the Anticoagulant Pradaxa

The FDA granted “accelerated approval” to Praxbind®, a reversal agent (antidote) to Pradaxa®. Praxbind is given intravenously to patients who have uncontrolled bleeding or require emergency surgery.

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If you find any errors on this page, email us. Y Last updated: Sunday, July 17, 2016

AF Symposium 2015 Brief Reports by Steve S. Ryan, PhD

20th Annual AF Symposium

by Steve S. Ryan, PhD

This overview should give you a sense of the topics floating through the three days in Orlando and the over sixty presentations by fifty A-Fib experts and researchers. (Most recent brief reports listed first)

AF Symposium: My Brief Reports

 The Novel Oral Anticoagulants: Xarelto Best Seller; Dr. Daniel Singer
 Stimulating the Front Ear Flap Inhibits A-Fib—Research by Dr. Warren Jackman
 Dr. Ruskin Asked: Can Anyone in A-Fib Really Be Asymptomatic?
 The Rhythmia 3-Dimensional Mapping System (Live from Leipzig via Satellite) 
 LAA Occlusion Devices: Is the Watchman Device Dead in the Water?
 FDA ‘Easy Feasibility Study’ (EFS 
 Reversal Agents for the New Anticoagulants (NOACs)? 
 Female Gender: Is it a Risk Factor for Stroke?
 Living in A-Fib More Dangerous Than Having an Ablation
 Rotors! Rotors! Rotors! Sizzling Topic but No Consensus
 Holistic Approach to Health: Great Results Dealing with Obesity
 Atrial Esophageal Fistula: A Case Study
 Anticoagulation Case Study: Dilemma for 92-year-old With Paroxysmal A-Fib
 Ablation Without X-Ray or Fluoroscopy (Live via Satellite)
 From Beijing: Strange Chinese Case (Live via Satellite)
 Ablation & Closing Off the Left Atrial Appendage in the Same Procedure (Live via Satellite)
 Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)
 Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight
 Fibrosis and A-Fib: Continuing Research on Sheep

The Rhythmia 3-Dimensional Mapping System (Live from Leipzig via Satellite)

Rhythmia 3-Dimensional Mapping image

Image from Rhythmia 3-Dimensional Mapping system by Medtronic

Live Via Satellite TV icon(Please be advised that the Symposium organizers go to great lengths not to identify or unfairly publicize one device over another. When writing these reports I often have to do a good deal of research to correctly identify and describe particular devices that are demonstrated, as a service to readers. But this in no way implies or suggests that one device is superior to another.)

Dr. Gerhard Hindricks of the University of Leipzig in Germany gave a dynamic presentation of a catheter ablation of a 46-year-old female with paroxysmal A-Fib using the Rhythmia 3-dimensional multipolar mapping system by Boston Scientific. Along with his colleagues Drs. Andreas Bollmann and Jedrzej Kosiuk, they used the Rhythmia special basket catheter to generate a 3-D map of electrogram voltages and activation times. To me it seemed amazingly fast. The eight-splined bidirectional catheter produced 1,000 data points per minute. In what seemed like only a few passes, they produced a 3-D color reconstruction of the patient’s left atrium.

The actual ablation was routine. They terminated the A-Fib into sinus rhythm without having to use Electrocardioversion. But they found that the PV isolation was incomplete. Using the same Rhythmia 3-D mapping catheter, they were easily and quickly able to locate the gap in the Left Superior PV and ablate it.

LAA Occlusion Devices: Is the Watchman Device Dead in the Water?

Dr. Vivek Reddy from Mount Sinai School of Medicine in New York City gave a very well referenced and persuasive presentation on the Watchman device which closes off the Left Atrial Appendage to prevent clots and strokes. The theory behind the Watchman device is that most A-Fib clots originate in the Left Atrial Appendage (LAA). The Watchman closes off the LAA where 90-95% of A-Fib strokes come from. It’s a very low risk procedure that takes as little as 20 minutes to install. Afterward, you would usually not need to be on blood thinners. (For more, see my article, The Watchman Device: The Alternative to Blood Thinners).

Dr. Reddy certainly persuaded me that the FDA should approve the Watchman device. Dr. Reddy, earlier in Washington, had made the same persuasive arguments before the FDA.

Dr. Andrew Farb from the FDA took the bull by the horns and gave his perspective on the various LAA Closure (Occlusion) Devices. But as one would expect, he didn’t indicate how the FDA would rule on the Watchman device, since deliberations were still ongoing.

After his presentation, I asked him several pointed questions about this, but he was, of course, careful not to comment about current FDA deliberations. My guess? If body language, momentum, mood of the presentations, and more importantly recent research indicate anything, the Watchman device probably will not be approved by the FDA.

There was a palpable sense of sadness at the end of these presentations. The attendees realized that the game may be over for the Watchman device. I hope I am wrong, since the Watchman device would be an important tool to help A-Fib patients. Once the FDA rules and the current clinical trials of the Watchman device end, you will probably have to go to Canada or overseas to get a Watchman device installed.

Watchman May Win FDA Approval

Updated March 13, 2015: The Watchman Device by Boston Scientific finally wins FDA approval

In my earlier brief reports on the Orlando AF Symposium, based on the recent research and the FDA presentation, I said the Watchman device probably won’t be approved in the US. I’m happy to say that I am most likely wrong.

At the LAA Symposium 2015 in Marina del Rey, CA, it was suggested that the Watchman device may be approved by the middle of this year. One presenter described how the FDA chairman talked with several people who were going to Canada to have the Watchman device installed. He seemed embarrassed that the Watchman was available everywhere in the world but not in the US and said that it has to be approved.

Other doctors I talked with at the LAA Symposium were of the same opinion. Presenters described how clinical trials for other LAA closure devices were on hold so that they could get approved in comparison to the Watchman (Non-Inferiority Trials). Dr. Dhanunjaya Lakkireddy of the University of Kansas Medical Center said that we are at a “tipping point” for the (A-Fib) industry.

FDA ‘Easy Feasibility Study’ (EFS)

As everyone, including the FDA, is well aware, A-Fib innovations usually start in Europe where they are more easily approved. Then only later do they move to the US for FDA approval, since the FDA generally requires more data than European regulators.

Drs. Jun Dong and Andrew Farb from the FDA described the FDA’s ‘Easy Feasibility Study’ (EFS) program where medical device innovations could be evaluated  in the US without having to go to Europe first. He encouraged researchers and attendees to take advantage of the new EFS program. This is major news and may make the development of A-Fib innovations much easier to accomplish in the US.

For further information, contact: Andrew Farb, Email: Andrew.farb@fda.hss.gov. 301-796-6317

Reversal Agents for the New Anticoagulants (NOACs)?

Dr. Luigi Di Biase from the Albert Einstein College of Medicine in the Bronx, NY and Dr. Daniel Singer from Massachusetts General Hospital in Boston each described potentially great developments in reversal agents for apixaban (Eliquis) and rivaroxaban (Xarelto).

Dr. Di Biase described studies where leaving people on uninterrupted rivaroxaban and apixaban before, during and after an ablation dramatically reduced the amount of silent thromboembolic lesions and were as safe as warfarin with regards to stroke and TIAs. (This didn’t work with dabigatran [Pradaxa].) But if patients develop bleeding or effusion during the ablation, they are in trouble because there is no direct reversal agent as there is for warfarin. He has used Factor IV as an indirect reversal agent. Dr. Singer also described how Factor IV was used as a reversal agent for apixaban.

But there are new reversal agents for apixaban and rivaroxaban which promise to completely reverse the effects of these two drugs in less than four minutes. The FDA is speeding up studies on these reversal agents. But one never knows when or if the FDA will approve them.

Female Gender: Is it a Risk Factor for Stroke?

Dr. John Day of the Intermountain Heart Institute in Murray, UT (and recently elected president of the Heart Rhythm Society) may be the first A-Fib leader to publicly question whether women should be given one point on the stroke risk CHA2DS2-VASc scale just because of their gender. Many doctors have said this in a circumspect way. Dr. Eric Prystowsky in a presentation at last year’s AHS meeting thought that most doctors would agree with Dr. Day, “as long as there wasn’t a camera focused on them.” He gave the example of a 45-year-old woman in good health and a 45-year-old man with hypertension who according to current guidelines should both be given one point on the stroke risk CHA2DS2-VASc score.

Editor’s Comments:
As readers of A-Fib.com, you know that’s been my opinion ever since the original European guidelines came out. Women in their child-bearing years are much less at risk of stroke because of the blood-thinning effect of losing blood each month. And even after menopause women have less risk of stroke. But eventually they do have more strokes. But not because of an innate inferiority, but because women live longer than men. Stroke is age related. An observational Danish registry study documents this.
For more, see The Denmark Study: Women in A-Fib Not at Greater Risk of Stroke Contrary to CHA2DS2-VASc Guidelines!) (Be advised that the original European guidelines were written by doctors with major conflicts of interest.) These guidelines may be a not so very subtle form of gender bias.

Living in A-Fib More Dangerous Than Having an Ablation

Living in A-Fib is more dangerous than having an ablation, according to Dr. Josef Kautzner from Prague, the Czech Republic. Studies have documented that the adverse effects of living in A-Fib, having to take A-Fib drugs and anticoagulants for life are both pragmatically and statistically worse than having an ablation. Dr. Kautzner discussed how A-Fib can cause or is associated with silent brain lesions and dementia. Any time you go into a hospital is a risk. And no one would say that a catheter ablation is a walk in the park. But an ablation is a low risk procedure, though not risk free. The risk is similar to having your tubes tied. The possible adverse effects of an ablation procedure (like bleeding at the groin) are generally temporary, unlike the lasting, permanent damage you can do to your heart, body and brain by living in A-Fib for years.

Rotors! Rotors! Rotors! Sizzling Topic but No Consensus

The most hotly discussed topic at this year’s symposium was rotors. The opinions expressed about rotors were at times very heated, more than I had ever seen at an AF Symposium. Dr. Shih-Ann Chen of Taipei, Taiwan disagreed with Dr. Sanjiv Narayan of Stanford, CA about the basic concepts of rotors and how they should be defined. Dr. Ravi Mandapati of UCLA and Loma Linda University disagreed with Dr. Narayan which was all the more striking in that he had worked with Dr. Narayan when he was at UCLA. Dr. Pierre Jais of Bordeaux, France said that the FIRM mapping system misses 40% of the atrium area.

Drs. Haissaguerre and Jais from Bordeaux and Dr. Sebastien Knecht of Brussels, Belgium gave presentations on how they were using the CardioInsight body surface mapping vest to perform ablations of “drivers” at many different centers, while Dr. Karl-Heinz Kuck from Hamburg, Germany using a different body surface mapping system said that he couldn’t ablate rotors. Dr. Narayan says the FIRM system finds a maximum of 2-3 rotors in the atria, while other systems find as many as seven. The FIRM system says rotors are usually relatively stable and can last as long as 30 seconds while others say they rotate in one fixed spot for only one or two rotations, that they tend to migrate within a certain area.

The presenters obviously didn’t share a consensus of basic concepts of what rotors are, how they work, their importance in A-Fib, how they should be correctly identified, used, and ablated. (It seems to me the Bordeaux group has the best understanding and pragmatic use of rotors. They refer to “rotors” and focal sources as “drivers.”) But the CardioInsight system Bordeaux uses isn’t currently available or isn’t being tested in the US.

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Holistic Approach to Health: Great Results Dealing with Obesity

Obesity was one of the most often discussed topics. There is a growing consensus among EPs that it isn’t enough to just give obese patients a catheter ablation while not dealing with their obesity. If the obesity isn’t dealt with, their A-Fib is very likely to re-occur. A-Fib will develop in other spots that haven’t been ablated. The condition (obesity) that triggered or caused the A-Fib will trigger or cause it again, if it isn’t taken care of.

Dr. Prashanthan Sanders of Adelaide, Australia described the great results he is getting in his clinic which includes a weight loss program and counseling. He convinces his overweight patients to buy into the program, lose weight, and keep it off. The program works so well that just by losing weight patients become A-Fib free. This program is a holistic approach to health and also is developed to work for diabetes, sleep apnea, hypertension, binge drinking and smoking.

Dr. Sanders foresees a world where some patients become A-Fib free simply by changing their life style, where they don’t have to have a catheter ablation to become A-Fib free.

Many other doctors commented that A-Fib treatment at many centers today includes or should include much more than A-Fib ablation and drugs. A-Fib centers should have nutritionists, exercise therapists, sleep apnea specialists, etc. as part of their A-Fib program.

Atrial Esophageal Fistula: A Case Study

Dr. John Day of the Intermountain Heart Institute in the Challenging Cases Discussion described his experience with the dreaded Atrial Esophageal Fistula. Though very rare, this is one of the few possible complications of a catheter ablation that can kill you. An ablation, if not done with caution, can irritate and damage the esophagus which often lies right next to the heart. Over 2-3 weeks stomach acid can eat through this damaged area to produce a hole or fistula from the esophagus into the heart.

As soon as Dr. Day saw this patient, he knew it was a fistula and immediately called surgeons and a GI doctor. All the surgeons were doing operations and didn’t want to do the surgery in the EP lab. Dr. Day described how he and his colleagues ran down the hospital hallway to the operating room while giving the patient a transfusion and at the same time pumping out the blood escaping from his heart.

The GI doctor got there first and put in a stent in the esophagus to plug the hole. There was lots of discussion as to whether this was the best approach, but it worked. The patient survived but had to spend a month in the hospital.

This cautionary and very dramatic tale certainly got the attention of all the attendees. No matter how rare a fistula is, every EP and A-Fib center must have an established protocol in place to deal with it. I remember Dr. Hugh Calkins in a previous Symposium advising, “There are only two kinds of EPs—those who have not had an Atrial Esophageal Fistula and those who have!” (Dr. Calkins’ patient with fistula also survived.)

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Anticoagulation Case Study: Dilemma for 92-year-old With Paroxysmal A-Fib

Dr. Peter Kowey of Lankenau Hospital in Winnewood, PA described a case that illustrates the kind of dilemma both doctors and patients often have to face. A 92-year-old woman with paroxysmal A-Fib who had been treated for many years with warfarin had some bruising and nuisance bleeding, but never anything major.

Dr. Kowey thought that ethically he should tell her about the different new anticoagulants which may be superior to warfarin, then see if she wanted to change. She went with apixaban (Eliquis), then six months later had a stroke even though she was taking apixaban properly and conscientiously. Happily, she made an almost full recovery. She returned to warfarin which had worked for her in the past and which she was comfortable using.

Editor’s Comments:
One of the reasons Dr. Kowey discussed the new anticoagulants with his 92-year-old patient was because warfarin is considered more apt to cause bleeding in older patients. The newer anticoagulants in clinical trials caused less bleeding. But we don’t have much data from the clinical trials on people over 90 years old.
Can we say that apixaban didn’t work or was ineffective? No. Anticoagulants reduce but do not totally eliminate the risk of an A-Fib stroke. Just because she had a stroke doesn’t mean apixaban didn’t work.
Dr. Jeremy Ruskin pointed out that there has never been and probably never will be a head-to-head comparison of the three new anticoagulants. But in my opinion apixaban (Eliquis) appears to have tested better and is safer than the others
For more, see my 2013 BAFS articles, The New Anticoagulants (NOACs) and Warfarin vs. Pradaxa and the Other New Anticoagulants.

Ablation Without X-Ray or Fluoroscopy (Live via Satellite)

Live Via Satellite TV iconIn the satellite case live presentations, Drs. Rodney Horton and Amin Al-Ahmad from the Texas Cardiac Arrhythmia Institute in Austin, TX surprised us by doing an ablation without wearing the standard lead aprons to prevent fluoroscopy exposure. Even more surprising was one of the lab assistants who was pregnant. She could work on the ablation because no fluoroscopy was used. The doctors did the whole ablation using ICE (Intracardiac Echo) and 3D mapping. They showed for example how ICE can be used to thread the catheter up into the heart and into the left atrium. Dr. Horton said that not having to wear those heavy lead aprons would probably add 5-10 years to his ablation career.

(They didn’t wear surgical masks during the ablation which was surprising to me. I will write them for an explanation.)

From Beijing: Strange Chinese Case (Live via Satellite)

Live Via Satellite TV iconThe live satellite case from Beijing, China was technically flawless and probably a first of its kind. But it wasn’t much of a learning experience for the attendees. The Chinese EPs only used one catheter and had to frequently pull out the mapping catheter and replace it with the ablation catheter, etc. When the expert panel asked them questions, the Chinese EPs either didn’t understand or simply didn’t answer them. They seemed very uncomfortable. It seemed like a throwback to ablation techniques of 20 years ago.

Ablation and Closing Off the Left Atrial Appendage in the Same Procedure (Live via Satellite)

Live Via Satellite TV iconDrs. Claudio Tondo, Gaetano Fassini, Massimo Moltrasio, and Antonio Dello Russo from Milan, Italy showed how they do a catheter ablation for A-Fib and install the Watchman device in the same procedure, when it’s needed. They do the ablation procedure first. Then when the patient is in sinus rhythm, they install the Watchman device. (This can’t be done in the US, because the Watchman device hasn’t received FDA approval. In later discussions including representatives of the FDA, there was an all too real possibility that the Watchman will never receive FDA approval.)

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Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)

Image of the TactiCath Quartz irrigated ablation catheter with EnSite Contact Force Module (Photo St. Jude Medical, Inc.)

TactiCath Quartz irrigated ablation catheter with EnSite Contact Force Module (Photo St. Jude Medical, Inc.)

Live Via Satellite TV icon Drs. Kevin Heist and Moussa Mansour from Massachusetts General in Boston showed in a live case how they used a Contact Force Sensing catheter combined with Jet Ventilation. (There are two Contact Force Sensing catheters approved by the FDA—the ThermoCool Smart Touch device by Biosense Webster (approved Feb. 24, 2014) and the TactiCath Quartz Contact Force Ablation Catheter by St. Jude Medical (approved Oct. 27, 2014). This live case used the TactiCath catheter but didn’t imply or suggest it is superior to the ThermoCool catheter. For a description of each, see my 2014 AF Symposium report The New Era of Catheter Ablation Technology: Force Sensing Catheters.

This combination of Force Sensing Catheter with Jet Ventilation for RF ablation probably represents the most advanced RF ablation strategy available today. Jet Ventilation doesn’t stop the heart from beating as in bypass surgery. But to this observer it seemed to put the heart in a type of slow motion with a lot less movement than when the heart is beating in normal sinus rhythm. You could really see a difference when they turned the Jet Ventilation off and on. Slowing down the heart like this helps the ablation doctor make lesions in hard-to-access areas and makes it easier to hold the catheter steady and apply the right contact pressure.

Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight

Drs. Michel Haissaguerre and Pierre Jais from Bordeaux/LYRIC gave presentations on the ECGI system. The day before their ablation, the patient lies down on his/her back and a technician places a vest-like device with 256 electrodes over his/her chest and stomach. These electrodes combine with rapid CT (Computed Tomography) scans to produce a very detailed 3D color map of the heart. (For a detailed description and discussion of the ECGI system, see 2013 BAFS: Non-Invasive Electrocardiographic Imaging [ECG]) The system automatically detects rotors and foci and computes them into a “Cumulative Map” or movie. These driver regions are ranked, based on statistical prevalence.

Then, Dr. Sebastien Knecht from CHU Brugmann, Brussels, Belgium, described the AFACART trial design and preliminary results using the CardioInsight ECGI system. Many centers in Europe including four in Germany are now using the CardioInsight. Requiring very little training, technicians and EPs using the CardioInsight system are getting similar great results like the Bordeaux group. Though these studies just started, it looks like the CardioInsight ECGI mapping and ablation system is poised to revolutionize the way EPs map and perform ablations.

Fibrosis and A-Fib: Continuing Research on Sheep

Dr. Jose Jalife of the University of Michigan in Ann Arbor, MI, continued his exciting research on fibrosis and A-Fib. In previous Symposiums Dr. Jalife demonstrated how A-Fib produces fibrosis. When he paced sheep into A-Fib, their hearts became fibrotic within a very short time. The markers of fibrosis (collagen and scarring) increased progressively as the sheep went from paroxysmal to persistent A-Fib. (See A-Fib Produces Fibrosis—Experimental and Real-World Data.)

Fibrosis is tissue that has fiber-like characteristics which develop in place of the normal smooth walls of the heart. Fibrotic tissue is scarred, immobile, basically dead tissue with reduced or no blood flow and no transport function. It results in a loss of atrial muscle mass. Over time it makes the heart stiff, less flexible and weak, overworks the heart, reduces pumping efficiency and leads to other heart problems. Fibrosis, up to now, was considered permanent and irreversible. But Dr. Jalife gave his sheep a Gal-3 inhibitor GM-CT-01 that actually prevented and reduced fibrosis! (For his previous presentations, see 2014 BAFS: The Holy Grail: Preventing A-Fib by a GAL-3 Inhibitor.)

In his continuing studies of sheep, Dr. Jalife found that fibrosis predicts recurrence, and that fibrosis can not be reversed if it is well established, even with GAL-3 Inhibitors.

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Last updated: Thursday, January 21, 2016 

FAQs A-Fib Treatments: Medicines and Drug Therapies

FAQs A-Fib Treatments: Medicines and Drug Therapies

Drug Therapies for Atrial Fibrillation, A-Fib, Afib

Drug Therapies for Atrial Fibrillation

Atrial Fibrillation patients often search for unbiased information and guidance about medicines and drug therapy treatments. These are answers to the most frequently asked questions by patients and their families. (Click on the question to jump to the answer.)

1. Which medications are best to control my Atrial Fibrillation?” “I have a heart condition. What medications work best for me?

2. “Is the “Pill-In-The-Pocket” treatment a cure for A-Fib? When should it be used?”

3. “I take atenolol, a beta-blocker. Will it stop my A-Fib.”

4. I’ve been on amiodarone for over a year. It works for me and keeps me out of A-Fib. But I’m worried about the toxic side effects. What should I do?”

5. Should everyone who has A-Fib be on a blood thinner like warfarin (Coumadin)?”

6. Which is the better anticoagulant to prevent stroke—warfarin (Coumadin) or aspirin?

7. What’s the difference between warfarin and Coumadin?

8. I’m on warfarin. Can I also take aspirin, since it works differently than warfarin? Wouldn’t that give me more protection from an A-Fib (ischemic) stroke?

9. “What are my chances of getting an A-Fib stroke?

10. “I’m worried about having to take the blood thinner warfarin (brand name Coumadin). If I cut myself, do I risk bleeding to death?

11. “I am on Coumadin (warfarin) to thin my blood and prevent A-Fib blood clots. Do I now need to avoid foods with Vitamin K which would interfere with the blood thinning effects of Coumadin?” UPDATED

12. “The A-Fib.com web site claims that an A-Fib stroke is often worse than other causes of stroke. Why is that? If a clot causes a stroke, what difference does it make if it comes from A-Fib or other causes? Isn’t the damage the same?

13. “I just had an Electrical Cardioversion. My doctor wants me to stay on Coumadin for at least one month. Why is that required? They mentioned something about a “stunned atrium.” What is that?

14. Are natural blood thinners for blood clot treatment as good as prescription blood thinners like warfarin?”

15. “How long do I have to be in A-Fib before I develop a clot and have a stroke?

16. I have to be on aspirin for stroke prevention. Which is better—the low-dose baby aspirin (81 mg) or a high dose (325 mg)? Should I take the immediate-release (uncoated) or the enteric-coated aspirin?

17. I don’t want to be on blood thinners for the rest of my life. I’ve had a successful catheter ablation and am no longer in A-Fib. But my doctor says I need to be on a blood thinner. I’ve been told that, even after a successful catheter ablation, I could still have “silent” A-Fib—A-Fib episodes that I’m not aware of.  Is there anything I can do to get off of blood thinners?

18. “My last cardiologist had me on Pradaxa. My new cardiologist wants me to switch to Eliquis. Is Eliquis easier to deal with if bleeding occurs?

19. “My doctor told me about the Tikosyn drug option that I want to consider in getting rid of my 5-month-old persistent A-Fib. That seems like something that should be discussed on your web site.

20. “I hate taking Coumadin. Is there a way to get off blood thinners all together? I know I’m at risk of an A-Fib stroke.”

21. “I”ve read about a new anticoagulant, edoxaban, as an alternative to warfarin (Coumadin) for reducing risk of stroke. For A-Fib patients, how does it compare to warfarin? Should I consider edoxaban instead of the other NOACs?

22. “Do you have information about Hormone Replacement Therapy (HRT) and if it might help or hinder my atrial fibrillation?

23. Are Anticoagulants and blood thinners the same thing? How do they thin the blood?

24. I have A-Fib, and my heart doctor wants me to take Xarelto 15 mg. I am concerned about the side effects which can involve death. What else can I do?

25. “Is the antiarrhythmic drug Multaq [dronedarone] safer than taking amiodarone? How does it compare to other antiarrhythmic drugs?”

Last updated: Wednesday, May 25, 2016

Back to FAQs by Patients with Atrial Fibrillation

A-Fib and Stroke: A Woman’s Perspective

A-Fib and Stroke: Women Under-Diagnosed & Under-Treated:
A Woman’s Perspective

By Lynn Haye

Clot blocking vein

Stroke prevention is the primary focus for all people with A-Fib; men and women, young and old – regardless of the type of A-Fib. Patients with A-Fib have a 5-fold increased risk of stroke. This risk factor increases steeply with age (1.5% at ages 50-59 to 23.5% at ages 80-89)1 In addition, since A-Fib is often asymptomatic and may go clinically undetected, the stroke risk attributed to A-Fib may be substantially underestimated.

The National Stroke Association estimates that at least 1 in 6 strokes are actually caused by A-Fib and that A-Fib strokes are more debilitating with higher rates of mortality. However, three out of four A-Fib strokes can be prevented in patients who have been diagnosed with A-Fib and are receiving appropriate treatment.2

  Her A-Fib Stroke Risk

Recent publications have highlighted the gender differences in stroke risk.3,4 Women have a higher lifetime risk of stroke from all causes, and this is probably related to both life expectancy and treatment variables. The question of female sex as a separate risk factor for stroke in A-Fib is a bit more complicated.

There are two stroke risk tools currently used by physicians to predict risk in A-Fib patients; CHADS2 in the US and the newer CHA2DS2-VASc in Europe.5  The newer tool adds an independent risk factor for female sex and lowers the age range to 65 for risk. (To read more about CHADS2 and CHA2DS2-VASc see our article: The CHADS2 Stroke-Risk Grading System.) This development puts younger women with A-Fib into consideration for anticoagulation medication. Because of the increased risk for bleeding on these medications, there is concern about putting more and younger patients on them.  Anticoagulants are not like taking vitamins. No one should be on anticoagulants unless there is a real risk of stroke.

A recent Danish study 6 found that while female sex increased stroke risk by 20% in A-Fib patients older than 75, it did not do so in female A-Fib patients age 65-74.  This suggests no increased risk for younger women, while older women remain at risk due to age. The current UK protocol in the GARFIELD study 7may answer this difference as they are evaluating the significance of female sex as an independent risk factor for A-Fib stroke in younger patients, age 65-74.

  Under-Diagnosed/Under-Treated

As with other cardiovascular disorders, women with arrhythmias in the US have been under-treated and under-referred.  This less aggressive and/or less effective treatment for A-Fib may put women at higher risk for stroke overall.  Studies have shown that women with A-Fib have been less likely to receive anticoagulation and ablation procedures compared to men, although their treatment benefits are comparable.4

  Elaine’s Stroke

Let’s take the example of Elaine, a college-educated professional who marries at age 25 to Bob, a 32-year-old accountant. They both lead busy but fulfilling lives and have two wonderful children. Elaine is naturally protected from a stroke during her child-bearing years by her menstrual cycle. The blood she loses every month thins her blood and makes her less susceptible to forming clots and having a stroke. But once Elaine enters menopause and no longer has her menstrual cycle, all too soon her risk of stroke becomes the same as her husband, Bob.

Bob unfortunately passes away at age 76 leaving Elaine a widow at age 69. (Women in the US live an average of five years longer than men.) As Elaine ages she becomes more limited in her physical activities. Her blood becomes thicker and less viscous. Clots can more easily form in her heart, especially in the Left Atrial Appendage (where 90-95% of A-Fib clots form). She may develop A-Fib which is more likely to happen as people get older. At age 81 Elaine has an A-Fib stroke.

Unfortunately this scenario is an all too common for women.

  Preventing Her A-Fib Stroke

Is there anything women can do to reduce their risk of stroke? Some things come to mind:

Recognize Important Signs

If you haven’t been formally diagnosed with A-Fib, be sure to take seriously signs such as palpitations, shortness of breath, fatigue, dizziness, chest pain and fainting.  These signs may be significant, not just moods or the result of an ‘off’ day.  Check your pulse for any irregularity – it’s the rhythm not the rate that should concern you here.  Remember, A-Fib stroke may be avoided with early diagnosis and treatment.

See an Electrophysiologist (EP)

If you are newly diagnosed, have you followed up with a cardiologist or, better still, an electrophysiologist (EP)?  EPs see arrhythmias all the time and are usually more current on treatment options.  Sometimes it feels just ‘too’ serious or inappropriate to contact a ‘heart’ specialist, but it’s really more comforting when you are in the care of someone who regularly treats A-Fib.

If you need help locating an electrophysiologist in your area, check the provider list on this web site.

Be Aware—We Women Communicate Differently

Most women agree that we tend to communicate differently!  Contrary to some popular opinion, we often hesitate to complain or report symptoms – even when we know we should.  Some women still see heart problems as ‘masculine’ and can feel awkward presenting cardiac symptoms, particularly to a male physician. Just watch the comedic video by Elizabeth Banks at the American Heart Association website for a very insightful rendition of how we can minimize symptoms (AHA, Go Red for Women, “Just a Little Heart Attack”). It’s painfully funny….

Prepare for Your Electrophysiologist (EP) Appointment

Your physician may have limited time, so be prepared before going in for your appointment. It helps to take a list of questions or concerns to help you stay focused and make the best use of your time.  This also demonstrates the level of seriousness and concern that you bring to the session.

Importance of Blood Thinners for Women

Anticoagulation therapy is so basic to stroke prevention in A-Fib that any woman diagnosed with non-valvular A-Fib should make sure to discuss this with her physician at her first appointment.  But ‘Blood thinners’ carry the risk of bleeding, so your physician may check your risk on the HAS-BLED score.8 before prescribing blood thinners for you.

The newer, novel anticoagulants such as Pradaxa and Xarelto can make adherence easier for women. This is because the lack of dietary restrictions suits the diet of the typically ‘dieting’ woman.  However, the new, novel anticoagulants do not yet have reversal agents and should be used with caution. The other option, warfarin, requires frequent blood monitoring, and women are often very reluctant to add more required tasks to their already busy schedules.  There is a procedure for those who cannot tolerate anticoagulation medication. This procedure involves closing off the left atrial appendage and involves a more detailed and complex risk-benefit analysis.

Know the Symptoms of Stroke!

•  Sudden numbness or weakness of face, arm, leg—especially on one side of the body.
•  Sudden confusion, trouble speaking or understanding
•  Sudden trouble seeing in one or both eyes
•  Sudden trouble walking, dizziness, loss of balance or coordination
•  Sudden severe headache with no known cause

And the Other Symptoms Unique to women!

•  Sudden face and limb pain
•  Sudden hiccups
•  Sudden nausea
•  Sudden general weakness
•  Sudden chest pain
•  Sudden shortness of breath
•  Sudden palpitations

Call your emergency service (dial 911 in the US or 999 in the UK) if you have any of these symptoms, and make sure that your family and friends know that time is critical with stroke.  Everyone should know the simple test to act F.A.S.T.

F = FACE  Ask the person to smile. Does one side of the face droop?

A= ARMS  Ask the person to raise both arms. Does one arm drift down?

S= SPEECH  Ask the person to repeat a simple phrase. Is their speech slurred or strange?

T= TIME  If you observe any of these signs, call 911 immediately. 2

  Aim to be A-Fib Free

Probably the best thing to know about A-Fib stroke prevention is to not have A-Fib!  As Steve Ryan points out so well in his book, “Beat Your A-Fib”, the best preventive for A-Fib stroke is get rid of your A-Fib, to ‘Beat Your A-Fib’.

(posted October 2013)

Prevent an A-Fib stroke—first ‘treat’—then ‘beat’ your A-Fib!

Photo of Lynn Haye, PhD

Lynn Haye, PhD

LYNN HAYE, Ph.D.  is a clinical psychologist and former A-Fib patient. She studies and writes about current trends in the treatment and diagnosis of atrial fibrillation and has a special interest in women’s health issues. Dr. Haye and her family live in Orange County, CA.

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Last updated: Saturday, August 15, 2015

References    (↵ returns to text)
  1.  American Heart Association, Heart disease and stroke statistics 2013 update. www.heart.org
  2.  National Stroke Association www.stroke.org
  3. True Hills, M., ‘Gender Matters: Why Afib is More Fatal for Women’ EP Lab Digest 2013. www.eplabdigest.com/articles/Gender-Matters-Why-Afib-More-Fatal-Women
  4. Curtis, A.B., Narasimha, D., ‘Arrhythmias in Women’ Clinical Cardiology, 2012 Mar; 36(3)   www.ncbi.nlm.nih.gov/pubmed/22389121
  5. www.mdcalc.com/cha2ds2-vasc-score-for-atrial-fibrillation-stroke-risk/
  6. Mikkelsen, A., et al, ‘Female gender increases stroke risk in AF patients aged greater than 75 years by 20%’ European Society of Cardiology. 2012 www.escardio.org
  7. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. 2013 www.biomedcentral.com
  8. Curtis, A.B., Narasimha, D., ‘Arrhythmias in Women’ Clinical Cardiology, 2012 Mar; 36(3) www.ncbi.nlm.nih.gov/pubmed/22389121
  9. www.mdcalc.com/has-bled-score-for-major-bleeding-risk/
  10. National Stroke Association www.stroke.org

Stop Prescribing or Taking Pradaxa

Stop Prescribing or Taking Pradaxa: Suspect in 542 Patient Deaths

pradaxa_logo 150 pix 96 res

from Boehringer Ingelheim

by Steve S. Ryan, PhD, April 15, 2013; Updated October 2015

We’ve been reading heart-wrenching stories of people on Pradaxa bleeding to death in Emergency Rooms because there’s no antidote to reverse its blood-thinning effects. Pradaxa was identified as the primary suspect in 542 patient deaths reported to the FDA in 2011, as well as 3,781 serious adverse events.  Pradaxa “was linked to more reports of injury and death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices.” By comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period.

People taking Pradaxa were almost 5 times as likely to die from bleeding episodes than those taking warfarin.

Dr. Bryan A. Cotton, a trauma surgeon at Memorial Hermann-Texas Medical Center in Houston has said Pradaxa contributed to the bleeding deaths of at least eight patients at his hospital.

What a horrible way to die. Doctors and nurses in the ER try everything they can think of, but then have to watch as their patient dies from uncontrolled bleeding. How devastating for relatives and friends.

Why in the world would the FDA put blood thinners on the market that have no antidote or reversal agent, where people die because their bleeding can’t be stopped? Warfarin may not be perfect, but ER doctors at least have a fighting chance to stop someone from bleeding to death if they are taking warfarin.

Some doctors who receive consulting fees, etc. from Boehringer Ingelheim (the manufacturer of Pradaxa) are arguing that there was no evidence that the lack of an antidote contributed to the deaths of the Pradaxa takers who bled to death. (Try telling that to the ER doctors who had to watch their patients die from uncontrolled bleeding.)

Another argument is that 542 deaths is a small number compared to the number of people using Pradaxa. But many of these 542 deaths did not have to happen. Many deaths could probably have been prevented if there was a reversal agent like there is with warfarin.

Conclusions

We can’t expect the FDA to take Pradaxa off of the market or put any significant limits or safeguards on its use any time soon. The FDA tends to stand by any drug it approves. It’s embarrassing to them to admit they were wrong. (Some people go so far as to say the Drug Industry has a great deal of influence over the FDA.)

The solution is simple: Stop Prescribing or Taking Pradaxa. Go back to warfarin which isn’t as convenient as the new anticoagulants. But warfarin does work reasonably well if you stay in the proper INR range. And it does have reversal agents.

And there are alternatives to Pradaxa besides warfarin. The FDA has approved the anticoagulants Rivaroxaban (Xarelto) from Bayer & Johnson and Johnson and Apixaban (Eliquis) from Bristol-Meyers Squibb & Pfizer. However, “a European study also showed new blood thinners like Pradaxa can have 55% higher risks for internal bleeding.”

While these new anticoagulants also don’t have reversal agents, there is anecdotal evidence that Xarelto has fewer bleeding deaths than Pradaxa. The recently approved Eliquis tested better and is safer.

Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.
References for this article

Last updated: Thursday, January 21, 2016

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Dabigatran (Pradaxa) Danger During Ablation—Switch to Warfarin

Warning - cautionDabigatran (Pradaxa) Danger During Ablation—Switch to Warfarin

Dabigatran Danger During Ablation

by Steve S. Ryan, PhD

In an important multi-center study, A-Fib ablation patients on dabigatran (Pradaxa) were compared to ablation patients on warfarin. The dabigatran group had a significantly higher major bleeding and total bleeding rate, and a higher “thromboembolic complications” (clots, strokes) in those who had persistent A-Fib than the warfarin group.

The researchers went even further and said that dabigatran “was confirmed as an independent predictor of bleeding or thromboembolic complications.”

They concluded that “in patients undergoing A-Fib ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.”

Editor’s Comments: The researchers are basically saying that taking dabigatran before and during an ablation significantly raises your risk of developing bleeding problems and clots/stroke compared to warfarin. “Independent predictor” means there is a higher degree of certainty that taking dabigatran will lead to bleeding/stroke.
This is a very important finding for A-Fib patients. And this was no small, limited study. It enrolled 290 A-Fib patients at eight different high-volume centers in the US. The results were dramatically significant. Any A-Fib patient going in for an ablation needs to be aware of this research and act accordingly.
Consequences: Doctors are now weaning A-Fib patients off of dabigatran and on to warfarin before an ablation. If your doctor doesn’t do this, you should get a second opinion—even if your ablation is already scheduled.
In addition, this study raises much more serious red flags about dabigatran for all A-Fib patients, not just for those having an A-Fib ablation. Did the clinical trials of dabigatran miss something? If dabigatran has such bad effects during an ablation, does it have such bad effects in “normal” usage? Why does dabigatran have such bad effects during an ablation and not in “normal” usage? If you are taking dabigatran, you should pose these questions to your doctor. (Thanks of Carol Devenir for alerting us to this research and its importance.)
References for this Article

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Last updated: Wednesday, August 3, 2016

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