In September, I was the only patient invited to present at MAM 2016 in Zurich, Switzerland. After dinner the first night, I spoke to over 200+ surgeons and electrophysiologists (EPs).
I tried to describe for the doctors what it’s like to live in Atrial Fibrillation. Here is what I told them.
You Never Forget Your First A- Fib Attack
“As most A-Fib patients will testify, you never forget your first A- Fib attack.
Mine was 19 years ago, but I can remember it like it was yesterday. All of a sudden my heart started going crazy! It felt like my heart was trying to jump out of my chest or like there was a live fish flopping around in there. I can still feel the sheer terror, fear, confusion, anxiety and worry it created.
I remember thinking, “Am I going to die?” “Is this a heart attack?” It was one of the most terrifying experiences of my life.
Most symptomatic A-Fib patients have a similar story.
Psychological and Emotional Effects of A-Fib
A-Fib doesn’t just affect you physically, it affects you emotionally as well.A-Fib affects not just your heart—but also your head—and your quality of life.
It affects not just your heart—but also your head—and your quality of life.
By the way, I’ve never been to a medical conference where this aspect of A-Fib was studied. (Today is a first, I guess.)
I wish there were some way to give you a one-minute episode of A-Fib. It would change your perception of A-Fib forever. The psychological and emotional aspects of A-Fib can be as bad as or even worse than the physical.
Living in Fear (and Anger)—A-Fib Wrecked My Life
In my case, I lived in fear of the next A-Fib attack. I went through all the emotional gamut—anxiety, fear, worry, confusion, uncertainty, frustration, depression, and finally anger at my own heart.I went through all the emotional gamut—anxiety, fear, worry, confusion, uncertainty, frustration, depression, and finally anger at my own heart.
I’m a passionate runner. I used to run along Venice Beach. But my heart would go crazy and beat too fast. I’d have to stop and walk back to our apartment. Talk about frustration!
And A-Fib affected my work. I had a great job on the soap opera “Days Of Our Lives” as part of the technical crew. But I’d get dizzy and light headed and nearly lost my job. A-Fib wrecked my life!
Research—Then Going to Bordeaux for an Ablation
To make a long story short, I locked myself in a medical library and read everything I could find about Atrial Fibrillation. During this time, I tried every drug known to man including the dreaded amiodarone which made me cough up blood. Nothing worked.
I found that doctors in Bordeaux, France, had discovered how to make people A-Fib free.
One of the doctors who treated me with catheter ablation is here today, Dr. Dipen Shah. Thanks to him, Dr. Haissaguerre and Dr. Jais I’ve been A-Fib free for 18 years. I was their first US patient.
My Challenge to Doctors treating A-Fib Patients
Today I want to challenge you. Just ask yourself:
What are you doing to help your patients deal with the Fear and Anxiety of A-Fib?
What are you doing to help them cope with the Psychological and Emotional effects of A-Fib?
Helping Your Patients Deal With Stress and Anxiety
Knowledge is Power and Control! Learning about A-Fib relieves worry and anxiety. Two ways to help your patients:
1. Reference books and websites. Give your patients a short list of web sites and books which you have read and recommend. If you do this, think of how much better informed your patients will be! Knowledge is Power and Control! Learning about A-Fib relieves worry and anxiety.
Hint: For distribution, list your recommendations on the back of a business card. If it comes from you, your patients will devour them.
2. Counseling and medication. You should have a list you can give out of several psychiatrists who understand A-Fib and how it affects patients.
You’ll know who needs this kind of help. Men, especially, may not admit to themselves that they need help.
Thanks for Making Us A-Fib Free
Finally, I want to thank you on behalf of all the patients you’ve made A-Fib free. There are few medical procedures as transformative and life changing as going from A-Fib to Normal Sinus Rhythm.
There is simply no comparison between living in A-Fib and being A-Fib free! Normal Sinus Rhythm is wonderful!
There’s nothing like having a heart that beats normally again. No more tiredness, dizziness. being light headed. Your body feels alive. Your brain works. You can run and exercise again. [See the photo at right of me doing the high jump at age 75!]
Thank you for giving me my life back!”
After my talk I received enthusiastic complements and ‘fist bumps’.
I think I really made an impression. I don’t think anyone had ever talked to these doctors like that before.
My hope is that the effects of my talk will trickle down to helping others with Atrial Fibrillation.
If you find any errors on this page, email us. ♥ Last updated: Thursday, October 6, 2016
P.S. This week in the U.S., we celebrate the founding of our country with the July 4, 1776 signing of our Declaration of Independence. (BTW: Patti found this photo and writes: “Our family’s Fourth of July picnic celebrations always include a cold slice of watermelon.”)
22. “In case I have an A-Fib-related stroke, what does my family need to know to help me? (I’m already on a blood thinner.) What can I do to improve my odds of surviving it?
Stroke is the most dreaded effect of having A-Fib. And an A-Fib-related stroke is usually worse because the clots tends to be larger. They often result in death or permanent disability.
Here are some basic facts and steps you and your family can take to prepare for and what to do if stroke strikes any member of your family.
Prepare Your Plan: The 4 Steps
For your own and your family’s peace of mind, you need to create a ‘Stroke Action Plan’.
Step 1: Learn the Signs of a Stroke
Make it a family affair. Discuss the most common signs of stroke: sudden weakness of the face, arm or leg, most often on one side of the body. Stroke may be associated with a headache, or may be completely painless. Each person may have different stroke warning signs.
Step 2―Ask Your Doctor
Discuss with your doctor what actions to take in case of stroke. For example, some doctors recommend aspirin to help avoid a second ischemic stroke (A-Fib). If so, ask what dosage.
Step 3―Locate Your Nearest ‘Certified Stroke Center’
Why a Certified Stroke Center? If a stroke victim gets to a Certified Stroke Center within four hours, there is a good chance specialists can dissolve the clot without any lasting damage.
Only a fraction of the 5,800 acute-care hospitals in the U.S are certified as providing state-of-the-art stroke care.
A certified or ‘Advanced Comprehensive Stroke Center’ is typically the largest and best-equipped hospital in a given geographical area that can treat any kind of stroke or stroke complication.
A Certified Stroke Center will have drugs such as Tissue Plasminogen Activator (tPA) to dissolve the clot. Can use Clopidogrel or acetylsalicylic acid (ASA) to stop platelets from clumping together to form clots. Or use anticoagulants to keep existing blood clots from getting larger.
So do your homework. To find the nearest certified or ‘Advanced Comprehensive Stroke Center’ check these listings:
Step 4―Post Your ‘Stroke Action Plan’
Write up the three components of your plan (i.e., the signs of stroke, aspirin dosage and location of the nearest Certified Stroke Center).
What about your workplace? Locate the nearest Certified Stroke Center to your job, too, and post a copy.
Also, print handouts with the name and address of the nearest Certified Stroke Center (Advanced Comprehensive Stroke Center) for EMS responders. Keep a bottle of aspirin nearby.
Store your ‘Stroke Action Plan’ in a special binder or post so that family can easily find the information.
If a Stroke Strikes: Work the Plan
1. Immediately call your emergency medical services (EMS)―even if the person having the stroke doesn’t want you to. (e.g., 911 in US and Canada, 0000 in Australia, 999 in the UK.)
Note: DO NOT try to diagnose the problem by yourself, and DO NOT wait to see if the symptoms go away on their own.
2. While waiting for EMS, administer aspirin in the proper dosage (if advised by your doctor before hand) to help avoid a second stroke.
Note: The emergency operator might connect you to a hospital that gives you instructions based on symptoms.
3. When EMS arrives, tell them to take the patient to your nearest Certified Stroke Center (give them a handout with the name and address).
Note: If necessary, be firm, insist they go to your choice of Certified Stroke Center. (Realize that some paramedics and ambulance services have side deals with hospitals to take patients to their hospitals, even if it’s not the right hospital for stroke victims.)
The Wrap Up
A ‘Stroke Action Plan’ with specific steps is reassuring during a medical emergency and helps everyone stay calm. Your family will be confident they’re supporting you in taking the right action at the right time.
The only guarantee of not having an A-Fib stroke is to no longer have A-Fib.
Know that quickly going to a certified or ‘Advanced Comprehensive Stroke Center’ may save you from the debilitating effects of an A-Fib stroke, or even death.
For additional reading, see Ablation Reduces Stroke Risk to that of a Normal Person.
If you find any errors on this page, email us. Y Last updated: Wednesday, April 27, 2016
We met Emmett Finch, The Malibu Poet, when we researched his personal A-Fib story for our book, Beat Your A-Fib. (“40-Year Battle With A-Fib Includes AV Node Ablation With Pacemaker” on pp. 166-169.) Now in his 90s, Emmett’s story illustrates the evolution of A-Fib treatments from drug therapy to PVIs, and from AV Node ablation/Pacemaker to the Watchman device.
Emmett honored us with a special poem ‘A-Fib’s Demise’. It’s for people of faith who look for hope and help from the Divine but also see doctors, medicines, supplements, etc. as manifestations of the “creative power we call God.”
We hope ‘A-Fib’s Demise’ will inspire you to Seek Your Cure!
Note: Want a hard copy? Download and print the PDF.
Neville (from Australia) wants to share his experience with our A-Fib.com readers:
“I recently bought cardiologist Stephen Sinatra’s book, “The Healing Kitchen” from Amazon.com using your [A-Fib.com portal] link.
I recommend it to your readers as a big help in finding foods that promote heart health and avoiding those that are harmful. There is a wealth of useful advice in the book including information on clinical studies that back up his arguments.”
Thanks, Neville, for sharing your book recommendation. And thank you for using the A-Fib.com portal link to Amazon.com to make your purchase. Each sale generates a small commission which we apply to the monthly costs of publishing A-Fib.com. All at no extra cost to you.
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The Facts About Women with A-Fib: Mother Nature and Gender Bias—Or—Get Thee to an EP ASAP
by Patti J. Ryan, August 2015
Several studies have established that the symptoms and consequences of A-Fib are more profoundly felt in women.
Mother Nature and A-Fib Symptoms in Women
Females tend to develop A-Fib at a later age than men. They are also more likely to seek medical attention, are usually more symptomatic, and have higher heart rates. A-Fib tends to affect their physical quality of life more severely.
While men as a group develop A-Fib twice as often as women, there are twice as many females as males in the age group with the highest percentage of A-Fib.
Cardiovascular mortality rates are 2.5-fold greater for women with A-Fib. Women have a 4.6-fold higher rate of stroke. A-Fib is the most frequent cause of disabling stroke in elderly females.
Remember: you don’t have to live with A-Fib! Seek your cure.
What can you do about it? As a female with A-Fib, you may have more symptoms, quality of life issues and are at greater risk of an A-Fib-related stroke. But you don’t have to live with A-Fib. As soon as practical, get a referral to a heart rhythm specialist (a cardiologist with a specialty in electrophysiology). Early diagnosis means less damage to your heart and more treatment options.
Drug Therapies for Women with A-Fib and Risk of Stroke
Women fail more antiarrhythmic drugs therapies than men. Women don’t do well on some antiarrhythmic drugs (estrogen may prolong the QT interval).
Antiarrhythmic drug therapy in women with hypertension is associated with more major cardiovascular events. (Some research indicates that women may have more hypertension than men, 55.2% vs 40%).
What this means to patients: “Drugs don’t cure A-Fib but merely keep it at bay,” says heart rhythm specialist, Dr. Dhiraj Gupta. Antiarrhythmic drugs only work for about 50% of patients, and often stop working after a period of time. Many can’t tolerate the side effects.
Don’t spend a year in A-Fib trying different medications or combinations of medications only to find none work for you. In addition, anticoagulants, like warfarin, for your increased stroke risk, have their own health risks. Don’t live a life on medication. Seek your cure.
Differences in Catheter Ablation for Females with A-Fib
Women, in general, have smaller cardiac chambers so that catheter manipulation is more of a challenge (40.6 mm on average for women vs 44.6 mm for men). (However, since research data shows there is a significant delay in referral for ablation in women, it is feasible that they may have larger left atrial sizes due to remodeling, making this a moot point.)
Run, don’t walk to the best heart rhythm specialist (an electrophysiologist) you can find.
Females have more non-PV triggers and have lower ablation success rates.
Females tend to have more ablation complications like pericardial tamponade and vascular complications.
What can you do about it? Don’t delay. “Run, don’t walk” to the best heart rhythm specialist (an electrophysiologist) you can find, advises former A-Fib patient Sheri Weber. A-Fib is a progressive disease. Consult an EP after your diagnosis. Don’t wait for your A-Fib to get worse. (A-Fib rarely gets better.)
Gender Bias Also Plays a Role
Women are referred to A-Fib specialists three times less often than men. Men with A-Fib are managed more aggressively (such as more cardioversions) prior to seeking a catheter ablation.
Women often have developed a larger left atrium because of being referred to EPs later in their treatment plan than men (60 months for females vs 47 months for males).
Women are referred to A-Fib specialists three times less often than men.
Women are referred for catheter ablation less frequently and later into their treatment plan than men. When referred, they are older on average than men (61.6 years old vs 56.9 years old for men).
Consequently, they have more complex symptoms, and their procedure success rate is lower with more complications.
What can you do about it? When you go to your GP or cardiologist with your A-Fib symptoms or complaints, anticipate gender bias! Don’t let it deter you. A-Fib is a progressive disease. Don’t waste time. Don’t let your A-Fib worsen over time by remodeling or enlarging your heart. Request a referral to a heart rhythm specialist―an electrophysiologist (EP). Until you consult an EP, you may not be getting the best and most up-to-date A-Fib treatment advice. You deserve nothing less.
Don’t just take your meds and get used to being in A-Fib.
Why is there Gender Bias in the Treatment of Women with A-Fib?
In many cultures and societies, doctors are more conservative in their treatment of women with A-Fib. Some doctors, concerned with safety, may be reluctant to perform or recommend any invasive procedures in women.
Social and family pressures may delay medical consultation and treatment (“I can’t be sick. My family needs me.”) Access to health care may be limited for some women.
And, of course, there’s plain ol’ bias by male doctors against female patients. “Your symptoms are all in your mind.” or “Just take your meds and get used to being in A-Fib.” (These are actual quotes from A-Fib.com readers about their doctors’ advice.)
What can you do about it? Be prepared for your doctor appointment with a list of questions or concerns. Don’t leave until you have answers. Don’t be afraid to ‘fire’ your doctor. Get a second, or third opinion. Find a doctor who will partner with you to find your cure or best outcome. (For help, use the Finding the Right Doctor for You resources on A-Fib.com.)
Good News: EPs Less Likely to Have Gender Bias
Research indicates female gender bias tends to disappear when a woman sees an electrophysiologist (EP), particularly concerning catheter ablation. This suggests that treatment bias may be more at the primary care level, i.e., your GP or general cardiologist.
What this means to patients: It’s reassuring to be in the care of someone who regularly treats A-Fib patients. A-Fib is an electrical problem. Don’t waste you time. Don’t settle for just ‘managing’ your A-Fib. See a heart rhythm specialist, an electrophysiologist, a cardiologist who specializes in the electrical function of your heart. An EP will discuss all your treatment options. EPs want to free you from the burden of A-Fib.
About the author: Patti J. Ryan is editor of A-Fib.com and regularly contributes her writing and graphics expertise. She is also publisher of Beat Your A-Fib: The Essential Guide to Finding Your Cure by Steve S. Ryan, PhD (BeatYourA-Fib.com), an Amazon.com Top 100 Seller in two health-related categories.
Stanford University psychologist Kelly McGonigal, PhD, author of The Upside of Stress: Why Stress Is Good for You, and How to Get Good at It, has challenged the conventional view that stress is bad for you. I found a few insights from her book encouraging for A-Fib patients.
Researchers who followed 30,000 US Americans for eight years found that the risk for death from any cause rose by 43% among participants who had high levels of stress. But that number applied only to people who believed that the stress they were experiencing was bad for their health.
Study participants who reported similar levels of stress but who did not consider it to be bad for their health, had survival rates that were actually better than those of people with relatively stress-free lives.
Dr. McGonigal recommends telling yourself “I’m excited” rather than stressed. Try to look at stress as simply your body’s response when something you care about is at stake. The pounding heart or faster breathing is your body’s way of heightening your senses so that you are mentally focused and motivated to do well.
Look at stress as a challenge rather than a looming threat.
So What Does this Mean for A-Fib Patients? Stress, by itself, is not usually a trigger for an A-Fib attack. (You could be totally stress-free, lounging on a swing on a tropical isle and still have an A-Fib attack.)
But stress can play a role in the intensity and duration of your A-Fib attacks.
Beyond the physical, A-Fib has psychological and emotional effects as well. Recent research indicates that “psychological distress” worsens the severity of A-Fib symptoms.
Give Dr. McGonigal’s Advice a Try. So, when feeling stressed, try mentally ‘reframing’ the stress as a ‘challenge’ rather than as a looming threat. Tell yourself “I’m excited” rather than stressed. It may help lessen your A-Fib symptoms. (Let me know if this works for you! Email me.)
Sounds like this approach could help in many areas of our lives.
For other ways to cope with your stress, see our A-Fib.com article, Coping With the Fear and Anxiety of Atrial Fibrillation.
For more about stress from Kelly McGonigal, read her The Washington Post interview, or her book, The Upside of Stress: Why Stress Is Good for You, and How to Get Good at It.
by Steve S. Ryan, PhD, Update July 2014, June 2015, October 2015
“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.
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).
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:
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).
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.
Are the NOACs Too Effective?
Pradaxa, in particular seems to work almost too well.
Pradaxa, in particular seems to work almost too well.
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.
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.
With a relatively short elimination half-life, for now, time may be the most important antidote for NOACs.
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.
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
Last updated: Saturday, March 26, 2016
- 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↵
- 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↵
- 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↵
- 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↵
- Kimmel, Stephen. The Truth About Blood Thinners, Bottom Line/Health, May 2015, p. 11↵
- Coumadin reversal or antidote strategies: Vitamin K antagonist, Fresh Frozen Plasma, Prothrombin Complex Concentrate (PCC), and the newly FDA-approved Kcentra.↵
- 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↵
- Pradaxa: Highlights of Prescribing Information. Boehringer-Ingelheim website. Last accessed March 13, 2014 URL: http://tinyurl.com/PraxadaInfo↵
- 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↵
- 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↵
- 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↵
- Your insurance provider will have a direct say into which drug you take.↵
- 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.↵
- For those in the US and on Medicare with Part D coverage, the monthly cost may range from $30 to $50.↵
- Marzo, Kevin. Blood thinner Antidote. Bottom Line Health, Volume 29, Number 9, September 2015, p. 1.↵
- 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↵
FAQs: Mineral Deficiencies & Supplements for a Healthy Heart
A-Fib patients often look for non-drug approaches to ease or prevent the symptoms of their Atrial Fibrillation. Here we share answers to the most often asked questions about minerals deficiencies and the use of supplements.
4. “I tried to talk with my doctor about magnesium and other nutritional supplements. ‘There’s no proof that they work,’ was his response. Why are doctors so opposed to nutrition as a way of helping A-Fib.”
11. “Regarding Magnesium, can supplementing and restoring Mg to healthy levels reverse my A-Fib? I’m about to schedule a catheter ablation. But if supplementing can cure my A-Fib, why do an ablation?“
12. “Can I take the supplement CoQ10 while on Eliquis for Atrial Fibrillation? On your site it says CoQ10 could be helpful. But on my bottle of CoQ10, it says “do not take if you are on blood thinners.”
Last updated: Tuesday, June 14, 2016
Dr. Sam, a retired MD, wrote to caution A-Fib patients that local anesthesia containing epinephrine can trigger your A-Fib. Local anesthesia (with Epi or Adrenalin) is used by dentists and emergency room personnel.
Dr. Sam writes:
At the Dentist: “This past year I had to have a dental implant and bridgework requiring that I have Local Anesthesia several times. The dentist uses local anesthesia with Epinephrine (Epi or Adrenalin) to numb your mouth.
Epinephrine (Epi or Adrenalin) is one of the drugs EPs can use when completing a catheter ablation—they try to trigger A-Fib to check that their ablation scars for working. So dental local anesthesia with Epinephrine (Epi) potentially can trigger A-Fib. I found very little info online about this and no studies had been done about dental anesthesia with Epi & A-Fib.
My EP said he thought it would be OK to use. So I had it, and within 30 minutes I was in A-Fib which lasted about 20 minutes and then I went back into NSR.
From then on I requested my dentist use only local anesthesia without Epi, and I had no more A-Fib episodes. Dentists like to use local anesthesia with Epi because it lasts longer and reduces bleeding locally.
Discuss with your dentist if you think you’re sensitive. Tell him/her you have A-Fib.”
At the Opthamologist: “The drops that the eye doctor uses to dilate your eyes are similar to Adrenalin. Discuss with your eye doctor if you think you’re sensitive. Tell him/her you have A-Fib.”
At the Emergency Room: “In the ER doctors use local anesthesia with Epi to sew up lacerations and/or to do small surgical procedures requiring local anesthesia, because it reduces bleeding locally and lasts longer. Tell your doctor you have A-Fib and discuss your concern that the use of local anesthesia with Epi may trigger your Atrial Fibrillation.”
Thanks Dr. Sam for sharing this warning about Epinephrine containing products.
11. “What is the heart’s ejection fraction? As an A-Fib patient, is it important to know my EF?”
Ejection Fraction (EF) is a percentage of blood that is pumped out of the heart during each beat. Your EF is a key indicator of your heart health.
“Ejection” refers to the amount of blood that is pumped out of the heart’s main pumping chamber (the left ventricle) during each heartbeat. “Fraction” refers to the fact that, even in a healthy heart, some blood always remains within this chamber after each heartbeat. Therefore, an Ejection Fraction is a percentage of the blood within the chamber that is pumped out with every heartbeat.
EF is most commonly measured in your doctor’s office during an echocardiogram. Your EF should be between 50 to 75 percent to indicate the heart is pumping well and able to deliver an adequate supply of blood to the body and brain.
If your EF falls below 50%, this means your heart is no longer pumping efficiently to meet the body’s needs and indicates a weakened heart muscle. An EF of less than 35% increases the risk of life- threatening irregular heartbeats.
Your EF can go up and down, based on your heart condition and your treatment therapies.
What does this mean to you? Most likely your EF was measured when you were first diagnosed with A-Fib. Ask your doctor if your Ejection Fraction is above 50% and how often you should have it checked. Your EF can help your doctor determine the effectiveness of your A-Fib treatment plan.
Keep in mind that Ejection Fraction is just one measure of heart function.
9. “I’ve read about stem cells research to regenerate damaged heart tissue. Could this help cure A-Fib patients?”
Yes, this fascinating research, though not directed specifically to Atrial Fibrillation, may prove to be very important to A-Fib patients. These groundbreaking studies focus on using stem cells to regenerate damaged heart tissue.
Working with heart attack victims who had suffered major heart scarring, doctors infused into their damaged hearts, stem cells that had been harvested and grown from their own heart.
The results were astounding!
Scar tissue decreased—shrinking between 30% to 47%. New heart tissue was generated—the stem cell recipients grew the equivalent of 600 million new heart cells. Their ejection fraction increased from the low 30% range to almost normal. Patients who received these stem cells had significant improvements in heart function, physical capacity, and scored better on quality-of-life questionnaires. MRI and ultrasound imaging revealed that areas where stem cells were infused showed major improvement which continued for over a year.
Their heart damage was reversed without dangerous side effects.
What does this mean to A-Fib patients? For someone with Atrial Fibrillation, the research studies’ terms of ‘scar tissue’ and ‘heart damage’ translates to ‘fibrosis’, that is, tissue that becomes fibrous and inflexible. Fibrosis in A-Fib patients is linked to enlargement of the heart and the increased threat of stroke.
if injected stem cells can somehow signal the heart to repair itself, this may turn the A-Fib patient’s fibrosis and scarring back into normal heart muscle. The fibrosis and scarring associated with A-Fib would no longer be permanent and irreversible.
Maybe someday we could be cured of A-Fib through stem cell infusion rather than with ablation burns or surgery.
For more read my article: “Stem Cells Reverse Heart Damage—May Repair Fibrosis and Scarring in A-Fib”, and my reports: 2013 BAFS: A-Fib Produces Fibrosis—Experimental and Real-World Data, and BAFS 2014: High Fibrosis at Greater Risk of Stroke and Precludes Catheter Ablation: Lessons Learned from the DECAAF Trial.
9. “My surgeon wants to close off my LAA during my Mini-Maze surgery. Should I agree? What’s the role of the Left Atrial Appendage?”
The Left Atrial Appendage (LAA) is a pocket or sleeve-like structure on the outside left top of the left atrium which opens into the left atrium. It’s a complicated structure with often more than one lobe. From an embryonic perspective, the LAA is more related to the ventricles than to the smooth-walled atrium.
In the first trimester or two of our time in the womb, The Left Atrial Appendage (LAA) was originally our left atrium (LA). When the final real Left Atrium (LA) formed gradually from the conjunction and evolutionary development of the four pulmonary veins, the actual LA chamber grew and ballooned out, pushing the smaller remnant LA up to the left top of the Left Atrium where it became known as the Left Atrial Appendage (LAA) with its own functions and behaviors. But as we age and as heart disease/A-Fib, etc. start to set in, the LAA can turn into “the most lethal, no longer essential appendage in the human anatomy.” (Thanks to Shannon Dickson for these insights about the LAA.)
Sometimes during a difficult A-Fib catheter ablation case (persistent or long-standing persistent), the LAA has to be partially or completely electrically isolated from the rest of the heart. When the LAA is ablated, there is a 70% chance of significantly reducing its emptying volume. If the LAA emptying volume is reduced to less than 40 millileters/sec, the patient would have to be put on blood thinners for life or their LAA would have to be removed or closed off. Otherwise clots would form in the LAA because of low blood flow.
Functions of the Left Atrial Appendage
- The Left Atrial Appendage functions like a reservoir or decompression chamber or a surge tank on a hot water heater to prevent surges of blood in the left atrium when the mitral valve is closed. Without it there is increased pressure on the pulmonary veins and left atrium which might possibly lead to heart problems later.
- Cutting out or stapling shut the LAA reduces the amount of blood pumped by the heart and may result in exercise intolerance for people with an active life style. (In dogs the LAA provides 17.2% volume of blood pumped.)
- The LAA also has a high concentration of Atrial Natriuretic Factor (ANF) granules which help to reduce blood pressure. The LAA functions as a storage device for ANF. But recent preliminary research indicates that the Right Atrial Appendage compensates for the loss of the LAA by producing more ANF.
- The Left Atrial Appendage may also function as a reservoir of different types of stem cells which can stimulate the heart to repair itself (See
Left Atrial Appendage May be Important for Heart Repair http://a-fib.com/laa-important-for-heart-health-repair/
The LAA, Blood Clots and Stroke Risk: In A-Fib, blood stagnates in the LAA and clots tend to form. By closing off the Left Atrial Appendage, most but not all risk of stroke is eliminated even if you are still in A-Fib.
On the other hand, cutting out or stapling shut the LAA also reduces the amount of blood pumped by the heart and may result in exercise intolerance for people with an active life style.
One considered advantage of the Mini-Maze operations is that the Left Atrial Appendage (LAA) is routinely closed off.
The Controversy: Some question the need or benefit of removing the Left Atrial Appendage (LAA) if someone is no longer in A-Fib. For a patient made A-Fib free, would their heart function better or more normally if they still had their LAA?
Editor’s comment: If you are thinking of having a Cox Maze or Mini-Maze, discuss removing the LAA with the surgeon. Ask if they close off the Left Atrial Appendage and with what: sutures, stapler or the AtriClip, and their success rate of complete closure.
8. “A-Fib and Flutter—I have both. Does one cause the other?”
You can have A-Flutter without A-Fib. And of course, A-Fib without Flutter. But more often than not, they are linked.
If you have A-Flutter, A-Fib often lurks in the background or develops later.
But right now we can’t say for sure if one causes the other. We do know that A-Flutter usually comes from the right atrium, while A-Fib usually comes from the left atrium.
(When Electrophysiologists do a catheter ablation, the first stage of success is to convert A-Fib into A-Flutter, the second stage is to convert A-Flutter into tachycardia. When the tachycardia is stopped and can’t be re-induced, the ablation is considered finished. You can consider A-Flutter as a more organized form of A-Fib.)
Atrial Fibrillation patients often have loads of “Why?” and “How?” questions. Here are answers to the most frequently asked questions by patients and their families. (Click on the question to jump to the answer.)
5. “What is the difference between “Adrenergic” and “Vagal” Atrial Fibrillation? How can I tell if I have one or the other? Does it really matter? Does Pulmonary Vein Ablation (Isolation) work for Adrenergic and/or Vagal A-Fib?“
14. “I have paroxysmal A-Fib with “pauses” at the end of an event. Will they stop if my A-Fib is cured? My cardiologist recommends a pacemaker. I am willing, but want to learn more about these pauses first.” NEW!
Last updated: Monday, August 8, 2016