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


"A-Fib.com is a great web site for patients, that is unequaled by anything else out there."

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

"Jill and I put you and your work in our prayers every night. What you do to help people through this [A-Fib] process is really incredible."

Jill and Steve Douglas, East Troy, WI 

“I really appreciate all the information on your website as it allows me to be a better informed patient and to know what questions to ask my EP. 

Faye Spencer, Boise, ID, April 2017

“I think your site has helped a lot of patients.”

Dr. Hugh G. Calkins, MD  Johns Hopkins,
Baltimore, MD


Doctors & patients are saying about 'Beat Your A-Fib'...


"If I had [your book] 10 years ago, it would have saved me 8 years of hell.”

Roy Salmon, Patient, A-Fib Free,
Adelaide, Australia

"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

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient, 
Rome, Italy

"Within the pages of Beat Your A-Fib, Dr. Steve Ryan, PhD, provides a comprehensive guide for persons seeking to find a cure for their Atrial Fibrillation."

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


Stroke Risk

The Impact of Race on Stroke Risk Among Atrial Fibrillation Patients

It’s well reported that African Americans have a lower risk of developing A-Fib as compared to Caucasians.

But it’s a different story regarding strokes. A new study has found that compared with whites, blacks are at increased risk of developing an ischemic stroke either before or after a diagnosis of atrial fibrillation (A-Fib).

A new University of Pennsylvania study found that such strokes may occur even before the patient is aware of having the heart-rhythm problem, and that this risk is higher for black patients. In many cases, the stroke was the red flag that led to the patient’s A-Fib diagnosis.

African Americans and Heart Disease

Heart disease tends to occur earlier in African American patients than in white counterparts.

The death rate from heart-related causes is higher, too, largely due to a higher rate of heart attacks, sudden cardiac arrest, heart failure, and stroke, according to the American Heart Association

The Penn Study: Looking Back and Monitoring Forward

Researchers used a centralized pool of patient data from across the University of Pennsylvania Health System, which was comprised of 56,835 patients without a history of atrial fibrillation or a remote history of stroke.

Of these patients, the authors identified 3,507 patients who developed A-Fib. Upon diagnosis, they checked each patient’s medical history for the prior six months to document any history of stroke.

Going forward, the authors monitored these A-Fib patients for strokes for a median of 3.6 years.

Unique Design: The study design was unique in that researchers had a time point that represented the initial diagnosis of atrial fibrillation.

This approach provided an opportunity to examine the risk of stroke during a six-month period prior to a formal, clinical diagnosis of atrial fibrillation. Until now, no prior study has examined stroke risk in this period prior to a diagnosis of atrial fibrillation.

Study Findings

Out of 538 strokes occurring in the study periods, nearly half, 254, occurred before diagnosis with atrial fibrillation.

The authors suspect that in many of those 254 cases, the patients already had A-Fib but were undiagnosed.

Blacks had an independently higher risk of stroke both before and after being diagnosed with A-Fib, as compared with whites.­

Prior Six Months Findings: For the strokes that occurred in the six months before A-Fib diagnosis, the rate in black patients was about one-third higher than the rate in white patients.

Findings after A-Fib Diagnosis: For the strokes that occurred in the years following an A-Fib diagnosis, the rate in black patients was two-thirds higher than in white patients — a 2.5 percent chance of stroke per year in black patients compared with a 1.5 percent chance for whites.

Blood-Thinning Medicines: The increased stroke risk for black patients (with A-Fib) was especially high among those who did not have prescriptions for blood-thinning medicines (i.e., warfarin or NOACs).

But even the black patients with prescriptions had a somewhat higher risk of stroke than their white counterparts. (Note: The study authors did not examine whether patients took the medicines, only if they had been given a prescription.)

Editor’s Comments

It’s well reported that African Americans have a lower risk of developing A-Fib as compared to Caucasians. But until now, there was little data on the additional risks that come with A-Fib for each race.

The new findings build on previous studies examining the impact of race on the risk of developing atrial fibrillation.

More Facts About Strokes in African Americans: On his website, Dr. Greg Hall, who specializes in urban health and the clinical care of African Americans shared these sobering facts about strokes in African Americans:

“Most strokes in African Americans occur due to high blood pressure, and a much higher number of African Americans have uncontrolled blood pressure.
quarter of all strokes occur in the presence of atrial fibrillation (a fib). And while representing 13 percent of the US population, African Americans experience almost twice that percentage of all strokes (26%).
Strokes are worse in Blacks. And when a stroke occurs, African Americans have them earlier in life and present with more severe and disabling conditions. “

To learn more, see Dr. Hall’s post: Atrial Fibrillation in African Americans

A-Fib Stroke Risk Greater for Blacks: This is obviously a very important study for black patients. If you’re African American, you have less chance of developing A-Fib. 

Blacks have almost twice the percentage of all strokes (26%) while making up only 13% of the U.S. population.

But if you do develop A-Fib, your stroke risk is much greater than for Caucasians. As Dr. Hall points out, African Americans experience almost twice the percentage of all strokes (26%) while making up only 13% of the U.S. population.

“Silent” A-Fib Stroke Risk Greater for Blacks: An even more disturbing fact is that in this study, half of the strokes occurred before an African American patient was diagnosed with A-Fib. Silent A-Fib is a danger for all A-Fib patients, but the stroke risk was nearly one-third higher in black patients.

Blacks Urgently Need Monitoring for Silent A-Fib: Most strokes in African Americans occur because of high blood pressure which is more prevalent in blacks. But from a public health aspect, it’s even more important to test black patients for silent A-Fib. Monitoring for silent A-Fib needs to become Standard Operating Procedure for blacks reaching middle age.

If you are African American, you should be monitored or get yourself a DIY A-Fib monitor to make sure you don’t have silent A-Fib.

(For recommended DIY heart monitors, see my article, Do-It-Yourself ECG: A Review of Consumer Handheld ECG Monitors.) 

Resources for this article
Patel PJ, et al. Race and stroke in an atrial fibrillation inception cohort: findings from the Penn Atrial Fibrillation Free study [published online February 19, 2018]. Heart Rhythm. doi:10.1016/j.hrthm.2017.11.025.

Avril, T. Black patients with a-fib at higher risk of stroke, Penn study finds, Health/The Inquirer, Daily News, Philly.com. Feb. 20, 2018. http://www.philly.com/philly/health/a-fib-stroke-penn-atrial-fibrillation-black-african-20180220.html

African Americans with Atrial Fibrillation at Significantly Higher Risk for Stroke Compared to Caucasians with the Disease.  Press Release. Newswise.com. Article ID: 689679, Released: 16-Feb-2018. https://www.newswise.com/articles/african-americans-with-atrial-fibrillation-at-significantly-higher-risk-for-stoke-compared-to-caucasians-with-the-disease

Ischemic Stroke Risk in Atrial Fibrillation Varies by Race. Cardiolog Advisor, February 28, 2018. https://www.thecardiologyadvisor.com/atrial-fibrillation/ischemic-stroke-risk-in-atrial-fibrillation-varies-by-race/article/745853/

Roger VL, Go AS, et al. Heart Disease and Stroke Statistics—2012 Update: A Report From the American Heart Association. Circulation. 2012;125(1):e2-e220. doi:10.1161/CIR.0b013e31823ac046. Strokes in African Americans.  October 22, 2017 by Dr Greg Hall. http://drgreghall.com/2017/10/22/strokes-african-americans/

 

Revised Article: Warfarin vs. Pradaxa and the Other New Anticoagulants (NOACs)

In May 2018, the FDA approval the reversal agent, Andexxa, for the NOACs Xarelto (rivaroxaban) and Eliquis (apixaban). Pradaxa (dabigatran) has had the reversal agent, Praxbind, since 2015.

This news sent us searching A-Fib.com for NOAC articles that might need to be updated. One such article is Warfarin vs. Pradaxa and the Other New Anticoagulants.CT scan - Ischemic Stroke - NOAC and Warfarin at A-Fib.com

In the end we revised the entire article, which was originally written in 2015 with periodic revisions in 2016, 2017 and earlier this year.

Stay Informed. Know Your Choices.

Warfarin vs. Pradaxa and the Other New Anticoagulants is a good review of your anticoagulant choices, the risks and benefits of each, costs, and recent research on the side-effects of long time use of these blood thinners.

Partner with your doctor: Whether or not to go on an anticoagulant, and which one, is one of the most difficult decisions you and your doctor have to make. Stay up-to-date. Then you can partner with your doctor on a plan that meets your treatment goals.

Don’t forget: Your anticoagulant treatment choice may change over time (with lifestyle changes, interaction with other medications, getting older, etc). Go to: Warfarin vs. Pradaxa and the Other New Anticoagulants.

Educate yourself.
Become your own best patient advocate.

Good News for A-Fib Patients!―FDA Approves Reversal Agent for the NOACs Xarelto and Eliquis

Background: One of the problems for Atrial Fibrillation patients taking anticoagulants is the risk of life threatening or uncontrolled bleeding, particularly if one is injured. Since the introduction of the NOAC anticoagulants, there’s been an increase of hospital admissions and deaths related to bleeding, one of the major complications of anticoagulation.
In the U.S. alone in 2016, there were about 117,000 hospital admissions attributed to factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month. An estimated 4 million people are taking factor Xa inhibitors.

Anticoagulant Reversal Agents

Up to now, only the anticoagulants Pradaxa (dabigatran) and Coumadin (warfarin) had a reversal agent or antidote.

As an example, if you were taking Pradaxa and were injured in an auto accident, doctors in the ER could administer ‘Praxbind’ (idarucizumab), the Pradaxa reversal agent, to stop any uncontrolled bleeding and (probably) save your life.

Many patients with Atrial Fibrillation were put on Pradaxa rather than Xarelto and Eliquis because Pradaxa has had a reversal agent since 2015.

Andexxa: Antidote for Xarelto and Eliquis

Now both Xarelto (rivaroxaban) and Eliquis (apixaban) have the FDA-approved reversal agent Andexxa (Portola Pharmaceuticals) as of May 7, 2018. It probably won’t be available till early June.

Andexxa rapidly and significantly reverses ‘anti-factor Xa’ activity which is the anticoagulant mechanism of both Xarelto and Eliquis.

Should you Switch From Pradaxa?

If you are taking Pradaxa, you may want to discuss with your doctor whether you should switch to another NOAC. (Note: Eliquis tested the best and is the safest of the new anticoagulants. See my article: Pradaxa and the Other New Anticoagulants.)

Are you tolerating Pradaxa well ? Nearly two out of five people (35%) couldn’t― that’s a high rate of adverse reactions. A large number of patients on the 150mg dose of Pradaxa had an increased incidence of gastrointestinal adverse reactions (35%/yr) compared to warfarin (24%/yr). For more see my article: The New Anticoagulants.

Pradaxa’s own fact sheet states common side effects of Pradaxa include:

• Indigestion, Upset Stomach, or Burning
• Stomach Pain

Note: 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.

Even if you seem to tolerate Pradaxa well, it may cause permanent GI damage over time.

Anticoagulants are Still Considered High Risk Drugs

FAQs A-Fib afibEven though Xarelto and Eliquis join Pradaxa with an antidote reversal agent, they are all still considered high-risk drugs.

Taking an anticoagulant is not like taking a multi-vitamin.

Anticoagulants work by causing or increasing bleeding. Though they are certainly better than having an A-Fib stroke, they carry their own risks. Read more: Bleeding Risk of Anticoagulants.

Resource for this article
Wending, P. FDA Approves First Factor Xa Inhibitor Antidote, Andexxa. Medscape Medical Nrews, May 4, 2018. https://www.medscape.com/viewarticle/896182

Anticoagulants Increase Risk of Hemorrhagic-Type Strokes as Well

Background: Of late we’ve written a lot about A-Fib stroke and the risk of Ischemic stroke which occurs when a clot blocks an artery to the brain.
While it is by far the most common kind of stroke among A-Fib patients, there is another type of stroke threat, an Intracerebral Hemorrhagic stroke. An ICH stroke is caused by a leaked or ruptured blood vessel in the brain. Although less common in A-Fib patients, an ICH stroke can be just as devastating, even deadly.

Anticoagulants and Intracerebral Hemorrhage Stroke (ICH)

For A-Fib patients, anticoagulants are used for the prevention of clots and stroke. But according to Dr. M. Edip Gurol, anticoagulants may actually increase the risk of Intracerebral Hemorrhagic (ICH) stroke.

While Intracerebral Hemorrhagic (ICH) stroke is less common than Ischemic stroke, it is a more deadly and disabling type of stroke. Although accounting for only 15 percent of all strokes, hemorrhagic strokes are responsible for about 40 percent of all stroke deaths.

Dr, M. Edip Gurol

Dr. M. Edip Gurol’s comments are published in the March 18, 2018 issue Cardiac Rhythm News. A stroke neurologist specialist at Mass. General Hospital, he has a particular expertise in the care of patients at high risk for ischaemic (blockage type) strokes and haemorrhages.

According to Dr. Gurol, over 50% of patients sustaining a warfarin-related intracerebral hemorrhagic [ICH] stroke die within the first three months.

Are the outcomes any better for patients on the newer NOACs (New Oral Anticoagulants) who have an ICH? No, the outcomes are just as dismal, similar to patients having a warfarin-related ICH stroke.

The Link With Cerebral Microbleeds (CMBs)

Growing evidence suggests a link between cerebral microbleeds (small chronic brain hemorrhages of the small vessels of the brain) and increased risk of intracerebral hemorrhage stroke (ICH).

This has led to concerns about the safety of administering anticoaglulant drugs in patients with cerebral microbleeds (CMBs).

About cerebral microbleeds, Dr. Gurol warns:

“The presence of one or more CMBs [cerebral microbleeds] conferred a five to six times higher ICH (hemorrhagic stroke) risk,”
OACs [anticoagulants] are not benign medications in patients with CMBs even without a history of brain bleed.”

LEFT: Brain MRIs of two microbleeds in the same older adult with A-Fib taking an NOAC (red arrows point to tiny microbleed dots). RIGHT: Two years later, the patient had a hemorrhagic stroke and died. The right MRI shows the fatal hemorrhage.

How Common are Cerebral Microbleeds?

Long-term research studies using Magnetic Resonance Imaging (MRIs), show cerebral microbleeds are already present at middle age and their prevalence rises strongly with increasing age. Microbleeds rarely disappear.

One recent MRI study found evidence of microbleeds in 99% of subjects aged 65 or older, and that increasing the imaging strength increased the number of detectable microbleeds.

Anticoagulants are not benign medications in patients with CMBs [cerebral microbleeds] even without a history of brain bleed. Dr. M. Edip Gurol

Are You at Risk?

Should A-Fib patients over age 65 be taking anticoagulants for the rest of their lives? According to Dr. Gurol and his research, probably not.

In the decades-long population-based Rotterdam Study, the risk of intracerebral hemorrhage stroke was found to increase as the number of microbleeds increased.

Since almost everyone over age 65 has microbleeds, it’s all too easy for long-term anticoagulants to expand those microbleeds into full blown Intracerebral hemorrhagic strokes (ICHs).

Are There Alternatives to a Lifetime on Anticoagulants?

Yes, there are alternatives to having to take anticoagulants for the rest of your life. Read my articles: Watchman Better Than Warfarin and Are Anticoagulants Risky if Over Age 65?

Or…get your A-Fib cured so you don’t need to take an anticoagulant at all.

Resources for this Article
Gurol, M Edip. Brain MRI scans can inform the choice between OACs and LAA closure for non-valvular AF. Cardiac Rhythm News. March 18, 2018, Issue 40. p. 9. https://cardiacrhythmnews.com/brain-mri-scans-can-inform-the-choice-between-oacs-and-laa-closure-for-non-valvular-af/

Janaway BM, et al. Brain haemosiderin in older people: pathological evidence for an ischaemic origin of magnetic resonance imaging (MRI) microbleeds. Neuropathol Appl Neurobiol. 2014 Apr;40(3):258-69.

Akoudad, S., et al Cerebral Microbleeds are Associated With an Increased Risk of Stroke: The Rotterdam Study. Circulation. 2015;CIRCULATIONAHA.115.016261. https://doi.org/10.1161/CIRCULATIONAHA.115.016261.

Poels MM, et al.Prevalence and risk factors of cerebral microbleeds: an update of the Rotterdam scan study. Stroke. 2010 Oct;41(10 Suppl):S103-6. doi: 10.1161/STROKEAHA.110.595181. PubMed PMID: 20876479.

Wang, Z., et al. Cerebral Microbleeds: Is Antithrombotic Therapy Safe to Administer? Stroke. 2014;45:2811-2817, originally published July 15, 2014.  https://doi.org/10.1161/STROKEAHA.114.004286

Intracranial Hemorrhage, Cerebral Hemorrhage and Hemorrhagic Stroke, Cleveland Clinic. Health Library / Disease & Conditions.  https://my.clevelandclinic.org/health/diseases/14480-intracranial-hemorrhage-cerebral-hemorrhage-and-hemorrhagic-stroke

A-Fib Produces More Ischemic Strokes, Despite Improvements in Stroke Prevention

A good friend of ours with A-Fib recently had a crippling ischemic stroke, even though her INR on Coumadin was 2.5, right in the middle of the desired range. Her left side is paralyzed. It’s heartbreaking to eat dinner with her and watch food dribble from the side of her mouth.  She’s getting good care and physical therapy, but she will probably never recover fully.

A-Fib Ischemic Stroke All Too Common

A recent retrospective study of more than 930,000 stroke patients found that 20% of acute ischemic stroke patients had A-Fib in 2014, up from 16% in 2003.

CT brain with Ischemic stroke at A-Fib.com

CT brain with Ischemic stroke

And despite recent improvements in stroke treatment outcomes (and stroke prevention), the negative effect of A-Fib was pretty much the same over the 12-year period of the study. Nearly 10% of A-Fib stroke patients died (“mortality”), compared to about 6% for patients without A-Fib.

According to co-author Dr. Mohamad Alkhouli of West Virginia University in Morgantown,

…the prevalence of A-Fib among patients admitted with acute ischemic stroke is rising, especially among white and elderly patients.

A-Fib stroke patients in this study were older (82 versus 70 years), more likely to be female (59.3% versus 51.8%, and Caucasian (80.6% versus 67.3%). (Females on average live about 5 years longer than males. Increased stroke probably relates to the fact that females live longer than males rather than female gender. See Being a Woman Not a Risk Factor for Stroke)

A-Fib Ischemic Stroke Worse Than “Normal” Stroke

The authors found that A-Fib patients were more likely to receive thrombolytic therapy. But even so, they showed worse outcomes, with 9.9% dying versus 6.1% of the non-A-Fib patients. And the A-Fib group had a higher rate of acute kidney injury, bleeding, infectious complications, and severe disability. They had longer hospital stays, higher costs of care, and more non-home discharges.

Danger of Hemorrhagic Stroke

This study didn’t investigate hemorrhagic stroke which is more likely to happen with increased age. 99% of people over age 65 have microbleeds in the brain. Taking anticoagulants to decrease the risk of an ischemic stroke can turn these microbleeds into full hemorrhagic strokes. Older A-Fib patients are between a rock and a hard place. See Anticoagulants Risky over Age 65.

Don’t Just Live With Your A-Fib

Living with A-Fib, especially as you get older, is often a death sentence. Don’t settle for a life on meds. Seek your cure!

Resources for this Article
Alkhouli M, et al “Burden of atrial fibrillation associated ischemic stroke in the United States” JACC Clin Electrophys 2018; DOI: 10.1016/j.jacep.2018.02.021.

George, Judy. Afib Found in Growing Proportion of Strokes―And despite improved stroke care, worse outcomes persist in Afib. Medpage Today. May 2, 2018. https://www.medpagetoday.com/neurology/strokes/72659

A-Fib-Related Stroke Risk: Watchman Better Than a Lifetime on Warfarin

Background: The most prescribed anticoagulant, warfarin, reduces the A-Fib-related risk of stroke by 60% to 70%. Most A-Fib clots (90%-95%) come from the Left Atrial Appendage (LAA).

An alternative to anticoagulants, the Watchman occlusion device closes off the LAA. FDA approved, 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.

CT brain with Ischemic stroke at A-Fib.com

CT brain with Ischemic stroke

Effects of a Lifetime on Warfarin

Warfarin (brand name Coumadin) and other anticoagulants work by causing bleeding and are inherently dangerous.

Among other bad side effects, long-term use of anticoagulants such as warfarin have been known to not only cause hemorrhagic strokes, but also microbleeds in the brain leading to dementia. (For more, see Patient on Anticoagulation Therapy for 10 Years Develops Microbleeds and Dementia).

A 2015 study found evidence of microbleeds in 99% of subjects aged 65 or older. When imaging strength was magnified, even more microbleeds were detected. Microbleeds are thought to be predictive of hemorrhagic stroke.

Conclusion: according to current research, to reduce microbleeds, ditch the anticoagulants. You’d do better having a Watchman device installed than spending a lifetime on warfarin.

Note: there’s no guaranteed way to avoid a stroke altogether.

What About the New Anticoagulants (NOACs)?

Does this research apply to the new anticoagulants like Pradaxa, Xarelto, Eliquis and Savaysa/Lixiana? Technically no. This research only applies to warfarin.

But intuitively one would expect the same general principles to apply. All anticoagulants cause bleeding. That’s how they work.

Caveat—Long-Term Effects of Watchman?

Catheter positioning the Watchman occlusion device at the mouth of the Left Atrial Appendage

Catheter placing Watchman in LAA

What are the long-term effects of leaving a mechanical device like the Watchman inside the heart? We know that, after a few months, heart tissue grows over the Watchman device so that the LAA is permanently closed off from the rest of the heart.

It seems unlikely that complications would develop after a long period of time as has happened with warfarin. But we can’t say that for sure until enough time has passed. The first clinical trial installation of the Watchman device in the US was in 2009 and in Europe in 2004. So far, no long-term complications have developed.

EPs Installing the Watchman Device

Want to learn more about the Watchman? See my article, The Watchman™ Device: The Alternative to Blood Thinners.

To find EPs installing the Watchman, I highly recommend selecting an electrophysiologist (EP) who is certified in “Clinical Cardiac Electrophysiology”. For a list of EPs meeting this criteria, see Steve’s Lists of A-Fib Doctors by Specialty: Doctors Installing the Watchman.

References for this article
Holmes, Jr. DR et al. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation. J Am Coll Cardiol. 2015;65(24):2614-2623. http://content.onlinejacc.org/article.aspx?articleid=2323039 doi: 10.1016/j.jacc.2015.04.025

Best, Ben. The 2015 International Stroke Conference, September 2015. Life Extension Magazine. http://www.lifeextension.com/magazine/2015/9/the-2015-international-stroke-conference/page-01

Janaway BM, Simpson JE, Hoggard N, et al. Brain haemosiderin in older people: pathological evidence for an ischaemic origin of magnetic resonance imaging (MRI) microbleeds. Neuropathol Appl Neurobiol.2014 Apr;40(3):258-69.

Finding the Right Doctor for You and Your A-Fib

Caduceus at A-Fib.com

Seek your cure!

by Steve S. Ryan, Last updated: March 24, 2018

When your family doctor first suspects you have A-Fib, they will probably send you to a cardiologist, a doctor who specializes in the heart.

The cardiologist will want to put you on different medications (called Drug Therapy) over the next six months to a year or more to see if any of these medications will stop or control your A-Fib. 

But current A-Fib medications are not very effective. They work for only about 40% of patients and frequently stop working over time. Many people can’t tolerate the bad side effects.

Know that time is of the essence in treating A-Fib. The longer you have A-Fib, the more your A-Fib may “remodel” your heart (i.e., change it physically and electrically).

“…Once the diagnosis of atrial fibrillation is made, it’s important not to spend too much time trying to keep a patient in normal rhythm with medical (drug) therapy…before referring them to catheter ablation.” Dr. Oussama Wazni, Co-Director of the Center for Atrial Fibrillation at the Cleveland Clinic.

With this information in mind, drug therapy may not be the best option for you.

 How to Start Your Search

To seek treatments beyond medications, you may need to change doctors.

Since Atrial Fibrillation is an electrical problem, you should see a Cardiac Electrophysiologist (EP)a cardiologist who specializes in the electrical activity of the heart and in the diagnosis and treatment of heart rhythm disorders.

A-Fib is an electrical problem. Patients should see an Electrophysiologist, an EP, a cardiologist who specializes in the electrical activity of the heart.

The EP’s primary concern is creating a ‘treatment plan’—an organized path to finding your A-Fib cure or best outcome.

To find the right doctor for you, seek recommendations from your General Practitioner (GP) and from other A-Fib patients (see Resources/Bulletin Boards for a list of online discussion groups).

If you know nurses or support staff who work in the cardiology field or in Electrophysiology (EP) labs, they can be great resources.

When you go to an A-Fib centers with several EPs, be aware that the office will tend to assign you to the newest, least experienced EP on staff. You should instead do your research first and ask for a particular EP you know is more experienced; for example, someone with the initials FHRS after his name or a Castle Connolly Top Doctor.

Finding a Heart Rhythm Specialist’ Online

To find a local Electrophysiologist yourself, we recommend the Heart Rhythm Society website and their feature called ‘Finding a Heart Rhythm Specialist’. ‘Check’ the box “to limit the results to Fellows of the Heart Rhythm Society (FHRS)”. (EPs with the FHRS designation have been recognized by their peers and are experienced heart rhythm professionals working in the field of electrophysiology and/or pacing).

When you type in a U.S. city and state (or country), the site gives you a list of Electrophysiologists in your area. Check for their list of specialties (not all EPs perform catheter ablations, for example; some focus on pacing/pacemakers, or clinical research, etc.). Look for additional information such as which medical insurance they accept.

 Our A-Fib.com Directory

This A-Fib.com Directory of Doctors and Facilities is an evolving list of the physicians and medical centers who treat patients with atrial fibrillation. Our directory is offered as a service and convenience to A-Fib patients.

It’s divided into sections: U.S. Doctors and Centers by state/city and International listings by country or geographic region. In addition, I’ve compiled several rosters, called  Steve’s Lists’ of doctors by specialty.

 Organize Your Research

My A-Fib records at A-Fib.com

To find the right doctor to cure your A-Fib, start your research with a notebook and a three-ring binder or a file folder. Learn Why You Need an A-Fib Notebook and 3-Ring Binder.

You need to organize the information you will be collecting: printouts of information from the internet, copies of documents from your local public library or medical center library, notes from phone calls, and answers to “interview” questions during doctor consultations.

Your 3-ring binder, or file folder is also where to collect copies of all your lab tests, notes from doctor visits, doctor correspondence, etc.

Obtain Copies of Your Medical Records, Tests, and Images

If you need to request copies of some medical records, read our article, How to Request Copies of your Medical Records. We give you three ways to request your medical records from your doctors and healthcare providers.

Later, when you are ready to interview new doctors, you will want to send each office a packet with your medical records, test results, and images or X-rays. (As a back-up, bring your three-ring binder with the originals.)

We strongly encourage you to get in the habit of keeping a copy of every test result you get in a designated three-ring binder. Don’t leave your doctor’s office or hospital without a copy of every test they perform. Or if the test result isn’t immediately available, have them mail it to you.

Back to top

 Researching Doctors and Centers

Don’t rely on a single online source when researching and selecting doctors. Be cautious of all doctor informational listings you find on web sites (yes, including this one).

Doctors may be listed or appear most prominently because they pay for that privilege (but not so at A-Fib.com). Read my article, Don’t be Fooled by Pay-to-Play Online Doctor Referral Sites.

Don’t depend on websites of patient’ ratings of doctors or with patient surveys. They lend themselves to manipulation. Ratings often reflect how well-liked a doctor is, not competency. Consult several sites.

 How to Find the Information

You must do your own homework. To narrow down your list of prospective doctors you will want to scrutinize their credentials. To research each doctor, consult the internet or your local library. One or more of the following online resources may be helpful.

Credential Acronyms: For an explanation of the acronyms following a physician’s name, see Physician Credentials.

The Heart Rhythm Society ‘Find a Specialist searchable directory for a doctor’s specialties, insurance accepted, etc.;
The American Board of Medical Specialists (ABMS) Directory of Board Certified Medical Specialists;
The American Board of Internal Medicine; Check a doctor’s certification;
The Cardiothoracic Surgeon’s Network Directory of Surgeons;
Vitals, an independent healthcare ratings organization; provides physician’s profile, education, awards & recognition, insurance accepted, hospital affiliations, and info on malpractice and sanctions.

 Your Consultation Appointments

Narrow down your list to the top three doctors. Now you are ready to set up a consultation appointment with each doctor. Think of this as an interview. Don’t worry, doctors are also ‘interviewing’ you to determine if they can help you. What to say:

1. You have Atrial Fibrillation, and what kind (paroxysmal, persistent or long-standing persistent);

2. You want to consult with the doctor about your treatment goals, for example, you are seeking to cure your A-Fib, not just manage it with drugs.

Note: some EPs have a “referrals only” policy, which means they won’t talk to you directly. You have to be referred by a cardiologist or a family doctor.

Send Your Medical Records Beforehand

Before your appointment, send each doctor a packet with your A-Fib-related medical records. To learn what to include in your packet of medical records, read Why You Need an A-Fib Notebook and 3-Ring Binder and Your Personal A-Fib Medical Summary.

Download our worksheet

Questions to Ask: Use Our Free Worksheet

To help you scrutinize prospective doctors, we’ve written a set of 10 interview questions to help get you started. Download the FREE PDF and save to your hard drive. Then, print a worksheet for each doctor you interview. 

Prepare and add your own list of questions for each prospective doctor.

During Your “Interview”

Never see a doctor aloneWhen you arrive at the doctors offices’, make sure they have indeed received your medical records. (As a back-up, bring your own originals from your three-ring A-Fib binder.)

Be sure you have your worksheets and list of other questions, a notepad and pen to take lots of notes.

Audio Recording: In addition, consider using an audio recorder to help you remember things. (Most doctors don’t mind, but always ask permission beforehand.) Many cell phones can be used to make a recording.

Take Along a Trusted Friend: You may want to take along a trusted friend or family member. As needed, your ‘personal advocate’ can question the doctor for you and verify your list of questions have been answered. It’s hard to be on top of your game when you feel ill and anxious. Studies show that patients immediately forget up to 80% of what’s discussed during a doctor visit, and get about half of the remainder wrong.

Afterwards, your patient advocate friend can help you evaluate the doctor’s answers, discuss anything that’s unclear and comment on the doctor’s demeanor.

Afterwards: How to Interpret the Answers You Received

Back home, study your notes about each doctor. To ‘interpret’ the doctors’ answers, see our article, “Choosing the Right Doctor: 10 Questions You’ve Got to Ask (And What Their Answers Mean)“.  We’ve included the various responses you might receive, and what each response means to you when searching for the right doctor for you and your treatment goals.

Also Assess the Doctor’s Manner and Personality

Warning - cautionYou’ll also want to assess the doctor’s manner and personality. Is this someone who will work with you? Someone who listens to how A-Fib makes you feel? Does this doctor inspire confidence? Is this someone you feel comfortable with and trust with your health care?

Your relationship with your doctor is important. See our post: ‘Do you Like’ Your Doctor, Do You ‘Connect’?…How it Affects Your Health

Rudeness, bad temper, boorish behavior, etc. from a doctor, no matter how highly recommended, should be a red flag for you. That kind of behavior is not just personally offensive but can be dangerous for your health.

Gender bias: Does he/she respect you? Women in particular should be wary of condescending behavior. ReadIt’s All In Your Mind” Her MD Said. Women in the US often don’t receive the proper diagnosis and treatment of their A-Fib.

Does the poor behavior also extend to how the doctor treats his staff? Patients of doctors “who don’t show respect for their medical staff have much higher rates of adverse effects, than patients of their more congenial colleagues,” according to Gerald B. Hickson, MD of Vanderbilt University Medical Center.

If your doctor is condescending or dismisses your concerns, you’re getting poor care. If a doctor is too busy to talk with you and answer your concerns, he’s probably too busy to take care of you properly.

But do give the doctor a break. They may be having a bad day or may have heard your questions too many times before. So say something, speak up! Or contact the patient-relations representative at the medical center. They want to know if a doctor is rude (those patients are more likely to sue!). Once a doctor’s bad behavior is called to his attention, they are likely to do better. And you’ll feel better, too.

 Evaluate the Consultations

After seeing your top three doctors, compare their answers. Did one doctor stand out?  If not, you may want to go back to your research list for number four and five on your list and set up appointments with them too.)

 Directory of Doctors and Medical Centers

Steves Lists and Directory of Doctors at A-Fib.com

Click for Steve’s Lists

The A-Fib.com Directory of Doctors lists US & international physicians and medical centers treating Atrial Fibrillation patients. This evolving list is offered as a service and convenience to A-Fib patients. (Unlike other directories, we accept no fee to be included.) The directory is divided into three categories.

US Doctors and Medical Centers (by state/city)
International: Doctors and Medical Centers (by country or region)

For a list of EPs doing Catheter Ablation procedures, see Steve’s Lists/US EPs with FHRS-designation performing A-Fib ablations by US State/City.

 For surgeons performing Maze/Mini-Maze operations, see Doctors & Facilities/Steve’s Lists Doctors by Specialties and more specifically, US Surgeons performing Maze and Mini-Maze operations.

Resources for this article
Shannonhouse, R. “Is Your Doctor a Bully?” Bottom Line Health, September 2013, p. 2.

Fellowship in the Heart Rhythm Society (FHRS) Information. Heart Rhythm Society website. Accessed April 8, 2014. URL:http://www.hrsonline.org/Membership/FHRS-Information

Makary, Marty. “7 Things Your Hospital Won’t Tell You (That Could Hurt You)” Bottom Line Personal, Volume 34, Number 2, January 15, 2013. p1.

Hussein, AA, et al. Radiofrequency Ablation of Persistent Atrial Fibrillation: Diagnosis-to-Ablation Time, Markers of Pathways of Atrial Remodeling, and Outcomes. Circulation: Arrhythmia and Electrophysiology. 2016;9:e003669. https://doi.org/10.1161/CIRCEP.115.003669.

McDaniel, Susan H. The Right Way to Ask Your Doctor Questions. Bottom Line Health. Volume 31, Number 4, April 2017, p. 14. 

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Last updated: Saturday, March 24, 2018

 

Why & How to Create Your ‘A-Fib Episode Action Plan’

Support A-Fib.com

Do your loved ones know how to help you during an A-Fib episode? That’s the topic of this email we received from the spouse of an A-Fib patient:

My husband’s A-Fib is getting worse. When should I call Emergency and/or take him to the hospital? I’m petrified with fear for him. Our doctors say don’t worry unless he shows signs of a heart attack or stroke.”

For your family’s peace of mind, you need to create an ‘A-Fib Action Plan’. During an A-Fib episode, having an action plan is reassuring to you and your loved ones, and helps everyone stay calm.

Your A-Fib Action Plan

To develop your A-Fib Action Plan, you need to team up with your doctor. Discuss the following with your healthcare providers. Your A-Fib Action Plan A-Fib.comYou should know:

• When to contact your doctor’s office
• Your doctor’s cell number and email address for emergencies
• What symptoms or criteria should send you to the emergency room
• When at the ER, if you should call your doctor
• When at the ER, if your doctor will call and talk with the ER staff
• When you should “just ride out” the episode
• How to recognize the signs of stroke

Write Up and Post Your PlanKeep Calm and Follow Your A-Fib Action Plan - A-Fib.com

Write up the answers to these questions. Add other helpful information, i.e., name of your local Emergency Room, directions, map, and phone numbers, etc. Store the original of your A-Fib Action Plan in your A-Fib binder or folder.

Post a copy in a prominent place your family can find easily. Discuss your A-Fib Action Plan with your loved ones and answer their questions.

Consider: What about your workplace? Should you discuss your Action Plan with your co-workers as well? Should you post a copy at work?

Be Confident & Stay Calm

During an A-Fib attack, an A-Fib Action Plan with specific steps is reassuring and helps everyone stay calm. Your family will be confident they’re supporting you in taking the right action at the right time.

You may want to also read the FAQ: 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.

Note: If your doctor is reluctant to develop a specific action plan or your Atrial Fibrillation is getting worse, it may be time to change doctors.

Have a Contribution to Make?

Do you have ideas for other content that should be included in an A-Fib Action Plan? I welcome your input. Send me an email with your thoughts.

Warfarin vs. Pradaxa and the Other New Anticoagulants

by Steve S. Ryan, PhD, Last Updated June 2018
CT scan - Ischemic Stroke - NOAC and Warfarin at A-Fib.com

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.

Low-Risk Patients: 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.

Stroke Prevention With warfarin

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 warfarin (Coumadin). It’s readily available and inexpensive.

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

But maintaining correct warfarin 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.

Higher Risk of Bleeding Gene? 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.

Drug Interactions: Warfarin also has many interactions with other drugs, herbs, and food sources. If taken incorrectly, warfarin can increase your risk of dangerous bleeding.

Warfarin: Notable Concerns

Taking warfarin over several years may lead to microbleeds in the brain and dementia.

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

“Oral anticoagulants…increase the risk of intracerebral hemorrhages (ICH), a less common but more deadly and disabling type of stroke. Over 50% of patients sustaining a  warfarin-related ICH die within the first three months.” (NOAC-related intracerebral hemorrhages outcomes are similar to warfarin.)

GI intestinal bleeding is another potential risk of Warfarin. “The risk of warfarin related GI bleeds can range from between 0.8% and 1.5% in patients on long term anti-coagulation.”

Stroke Prevention: NOACs

Novel Oral AntiCoagulants (NOACs) are alternatives for vitamin K antagonists (e.g., Warfarin) for stroke prevention.

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) and Savaysa (edoxaban)).

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

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

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.

Questionable Trials Bias: 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. 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).

But NOACs are not like taking vitamins. They work by causing or increasing bleeding and are considered high risk meds. “For patients with atrial fibrillation, NOACs still pose a major bleeding risk,” according to Dr. Shang-Hung Chang and his colleagues at Chang Gung Memorial Hospital in Taiwan.

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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. Life-threatening bleeding complications can occur after an injury
3. Stomach problems and gastrointestinal bleeding

According to Dr. Stephen Kimmel of the Un. of Pennsylvania: “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.”

NOACs: 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 warfarin (Coumadin), 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 Warfarin 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 affect only one particular stage in the anticoagulation process. Pradaxa, for example, is a direct thrombin inhibitor, whereas warfarin 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. If you have an accident involving bleeding, EMTs can call ahead to the ER and get the staff ready to help you. To print your own I.D. see: Print a free Medical Alert I.D. Wallet Card

Pradaxa: Too Effective?

Pradaxa, in particular seems to work almost too well.

Pradaxa won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and thus captured a significant market share. 

In some patients there is excessive bleeding that is catastrophic (usually in older or weaker patients). Pradaxa has been associated with deaths in the ER before doctors had Praxbind, the Pradaxa reversal agent, to stop people from bleeding to death. (Warfarin on the other hand has several proven, time-tested reversal or antidote strategies.)

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.

Questionable Trials Bias: Each of these NOAC trials had a questionable bias toward the new drug when compared against warfarin.

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 than with Warfarin. 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:

• 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

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 warfarin. 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 warfarin.

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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NOAC Reversal Agents and Bleeding Complications

As of May 2018, there are now FDA-approved NOAC reversal agents: Praxbind for Pradaxa (dabigatran) and Andexxa for the NOACs Xarelto (rivaroxaban) and Eliquis (apixaban). See FDA Approves Antidote for Xeralto and Eliquis).

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 with 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.)

 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.

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.

Choosing Your anticoagulant

If you’re conscientious and are pretty good at staying in the proper INR range, stick with warfarin (Coumadin) if you can. It may not be as convenient and easy to use as the newer anticoagulants, but we know warfarin works if you stay within the proper INR range. And there are proven reversal agents for warfarin. The cost of warfarin is significantly lower when compared to the new anticoagulants. (Your insurance provider may have a direct say about which drug you take.)

Note: There’s no guaranteed way to avoid a stroke altogether.

If you have trouble staying within the proper INR range, can’t juggle the diet restrictions or monthly monitoring, I suggest you talk with your doctor about switching from warfarin (Coumadin) to the NOAC Eliquis (apixaban). Eliquis doesn’t block Vitamin K like warfarin, has no interactions with food (not even spinach), and requires NO monitoring (no more finger stick checks).

Compared the other NOACs, Eliquis tested better and has the best RxScore safety score. Like all the NOACs, be aware of Eliquis’ much higher monthly price. (For those in the US and on Medicare with Part D coverage, the monthly cost may range from $30 to $50.) You will need to judge if the benefits outweigh the costs.

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

Resources for this article
• Gurol, M Edip. Brain MRI scans can inform the choice between OACs and LAA closure for non-valvular AF. Cardiac Rhythm News. March 18, 2018, Issue 40. p. 9

• Lakkireddy, Dhanunjaya. Octreotide enables left atrial appendage closure in AF patients with GI bleeding. Cardiac Rhythm News, May 31, 2018, Issue 40. P.1.

• Chang SH et al. Association Between Use of Non–Vitamin K Oral Anticoagulants With and Without Concurrent Medications and Risk of Major Bleeding in Nonvalvular Atrial Fibrillation. JAMA. 2017; doi:10.1001/jama.2017.13883.

• Piccini, JP. Interaction between newer anticoagulants, certain drugs increases major bleeding in AF. Perspective. Arrhythmia Disorders. Healio/Cardiology Today. Oct 2017. https://www.healio.com/cardiology/arrhythmia-disorders/news/online/%7B48813250-e3e1-4a0b-81bc-b2471691e666%7D/interaction-between-newer-anticoagulants-certain-drugs-increases-major-bleeding-in-af

• 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

• 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

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Last updated: Thursday, June 21, 2018

 

2013 BAFS: The New Anticoagulants (NOACs)

2013 BOSTON ATRIAL FIBRILLATION SYMPOSIUM

The New Anticoagulants (NOACs)

by Steve S. Ryan, PhD

After the excitement of last year’s Boston A-Fib Symposium where three new anticoagulants were introduced, this year’s presentations on anticoagulants and stroke prevention were somewhat anticlimactic. After nearly 40 years of warfarin as virtually the only anticoagulant choice, it’s a wonderful thing to have three new anticoagulants to choose from. But it’s also a challenge. (The new anticoagulants are now collectively referred to as “NOACs” Novel Oral Anticoagulants.) The new anticoagulants (NOACs) are:

  1. Dabigatran (brand name Pradaxa by Boehringer Ingelheim); a direct thrombin inhibitor
  2. Rivaroxaban (brand name Xarelto by Bayer); a direct factor Xa inhibitor
  3. Apixaban (brand name Eliquis by Bristol-Meyers Squibb & Pfizer); a direct factor Xa inhibitor

(Plus, in the near future Edoxaban by Daiichi Sankyo; a direct factor Xa inhibitor)  

Note: Warfarin is a vitamin K antagonist, and is still one of the most widely prescribed medicines in the world.

Which New Anticoagulant is the Best?

The most important question for both doctors and A-Fib patients is: which of the three new anticoagulants is the best, or which is better for particular patients? None of the presenters addressed this question directly or unequivocally. But I’ll put my neck on the line and try to draw conclusions from the data presented. Here’s the short version of my conclusions (in case you don’t want to read through all the data below).

  • Stay away from dabigatran (Pradaxa) until ‘the smoke clears’.

  • The clear winner of the clinical trials sweepstakes was Apixaban (Eliquis). But this anticoagulant was only recently approved by the FDA (December, 2012); there’s little real-world data on it yet.

CostS

The new anticoagulants’ cost is approximately $250.00/month. Compared to the cost of warfarin use at around $4.00/month plus about $55.00/month for monitoring INR levels, at about $60/month, warfarin is still more economical.

History of Warfarin

Dr. Daniel Singer began his presentation by recalling how warfarin was something of a wonder drug when it was first introduced. It reduced the risk of an A-Fib stroke by 70% which is all the more remarkable since many of the people in the early studies weren’t maintaining warfarin at proper INR levels (or sometimes weren’t taking it at all). According to Dr. Singer, “This corresponded to a complete prevention of additional risk of A-Fib for stroke.” Since A-Fib produces a 4-5 times increased risk of stroke, “a relative reduction of this magnitude is effectively removing it.” Warfarin’s risk of producing a hemorrhagic stroke is around 0.3%/year. The rate of strokes prevented by warfarin versus intracranial bleeding (hemorrhagic stroke) was around 15-1.

Should Everyone with A-Fib Be Taking Anticoagulants?

In his discussion of the diagnostic guidelines for when to prescribe anticoagulants (CHADS2 & CHA2DS2-VASc), Dr. Singer pointed out that according to the CHA2DS2-VASc risk stratification guidelines for estimating the risk of stroke in patients with A-Fib, 90%-95% of all A-Fib patients should be taking anticoagulants. “We should think about whether that is right or wrong.” (In other words, are we possibly doing more harm than good requiring or diagnosing that so many A-Fib patients take anticoagulants? How many actually have a real risk of stroke? Anticoagulants are not benign medications. They carry their own risk of bleeding, hemorrhagic stroke, stomach (GI) bleeding, etc.)

(The Cha2DS2-VASc diagnostic system has been adopted by the European Society of Cardiology. But the provision that simply being female is a risk factor for stroke isn’t confirmed by all scientific data. See “Women in A-Fib Not at Greater Risk of Stroke.)

Dabigatran (Pradaxa)

Dabigatran (Pradaxa) was the first new anticoagulant approved by the FDA in 2010 after the RE-LY clinical trial with 18,000 patients at 951 centers. Like all the new anticoagulants, dabigatran has a rapid onset (two hours) compared to warfarin which is slow on and slow off. Like the others, dabigatran has a “single key activated factor” (direct thrombin inhibitor) compared to warfarin which affects many different steps in the anticoagulant process. There’s no need to adjust the dosage, but also there’s currently no good way to monitor how much of an anticoagulant effect dabigatran is having. Whereas with warfarin one can measure the INR. Dabigatran has a half-life of 12-17 hours and is 80% excreted by the kidneys. (Anyone with weak kidneys probably shouldn’t be taking dabigatran.)

At the 150 mg dose taken twice a day (the only dosage approved by the FDA), dabigatran was statistically better at reducing ischemic stroke. (The 110 mg dose approved in Canada was non-inferior to warfarin.) But dabigatran also reduced hemorrhagic stroke compared to warfarin by 60-70%. However, there were more stomach (GI) bleeds and indigestion (dyspepsia). The Pradaxa fact sheet states “In addition to bleeding, Pradaxa can cause stomach upset or burning, and stomach pain.” Nearly two out of five people (35%) could not tolerate Pradaxa, which is a high rate of adverse reactions. Patients on Pradaxa 150mg had an increased incidence of gastrointestinal adverse reactions (35%/yr) compared to warfarin (24%/yr).

If you’re taking dabigatran (Pradaxa), watch out for indigestion, burning, stomach pain and weight loss. Based on the clinical trial data, there is a danger that dabigatran over time may cause long-term damage to the gastrointestinal system.

Currently there’s no antidote to dabigatran or to the other new anticoagulants. After a fall or serious injury, one could bleed to death before the anticoagulant effect wears off. There is an antidote for warfarin.

Update October 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.

In the studies which compared warfarin to dabigatran, only 64% of warfarin A-Fib patients maintained their INR levels in the 2-3 recommended range. 36% of warfarin patients didn’t have proper INR levels. At first glance that might seem to skew the results in favor of the new anticoagulants. But that’s pretty close to real world experience with warfarin. It’s very hard for doctors and patients to maintain proper INR levels which is one of the advantages of the new anticoagulants.

Pradaxa: 6.0 Adverse Reactions Pradaxa Label Information. DailyMed.nih.nih.gov Last accessed April 10, 2013. URL: http://tinyurl.com/praxada-dailymed

Add Aspirin to the new Anticoagulants?

Dr. Singer pointed out that adding aspirin to all the new anticoagulants increased the risk of bleeding by 40%-50% without any added benefit for patients.

Rivaroxaban (Xarelto)

Rivaroxaban is a once-a-day, fast acting anticoagulant 20 mg (15 mg for younger patients) that is less dependent on the kidneys for excretion (33% versus 80% for dabigatran). Rivaroxaban is also a “single key activated factor” anticoagulant, but unlike dabigatran it is a direct factor Xa inhibitor. In case of serious injury, there’s currently no antidote. The FDA also approved it for DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism).

The Rocket-AF clinical trial of rivaroxaban studied 14,000 A-Fib patients at increased risk of stroke. The CHADS2 overall score was around 3 ½, while the other trials were around 2. 55% had a prior stroke or TIA, 60% had heart failure, 90% had hypertension.

Note: The patients in this trial were sicker than those in the other trials. One problem with this trial is that, of the patients taking warfarin, only 55% were in the therapeutic range. (45% were not taking warfarin properly, which could have skewed the results in favor of rivaroxaban.)

Rivaroxaban was non-inferior to warfarin with regards to preventing ischemic stroke, but it reduced hemorrhagic stroke by 40%. It was safer than warfarin for intracranial hemorrhage.

Apixaban (Eliquis)

Like the other new anticoagulants, Apixaban is fast acting with no need for dosage monitoring. It has a short half-life and is the least dependent on the kidneys for excretion (25%). It is a direct factor Xa inhibitor. Like the other NOACs, there is no antidote in case of a fall or serious accident. In the Aristotle clinical trial 18,000 A-Fib patients took 5 mg daily and were followed for nearly two years. The mean CHADS2 score was 2.1. Apixaban was superior to warfarin in preventing ischemic stroke and hemorrhagic stroke. There was a 31% reduction in bleeding, 58% reduction in intracranial hemorrhaging, and no increase in GI problems.

Dr. Singer’s Conclusions

The new anticoagulants (NOACs) are clearly as good as or better than moderately controlled warfarin. The improvement in intracranial hemorrhaging is an unexpected but crucial benefit. But for people doing well on warfarin, there isn’t much to gain except convenience.

However, today 40%-50% of patients in A-Fib aren’t adequately anticoagulated. Maybe the added convenience of NOACs will enlarge the percentage of people protected from stroke. NOACs may be more attractive to the warfarin-reluctant patient. NOACs may be better for older people more prone to hemorrhagic stroke.

Dr. Singer (and Dr. Peter Kowey in the next presentation) said that there hasn’t been a major revolution or switch to NOACs. The percentage of people on anticoagulants hasn’t increased much. A small percentage of people starting out on anticoagulants have chosen NOACs over warfarin. But we only have data on dabigatran, while the other NOACs are very new with little data.

Editor’s Comments
The three clinical trials used somewhat different inclusion criteria, different definitions, had somewhat different populations, and reported data differently. But despite these differences, we can still draw conclusions that are very important to patients.
• Anyone over 70 with A-Fib should talk to your doctor about switching to the new anticoagulants. They reduce the risk of a hemorrhagic stroke. If you’re on warfarin, the risk of a hemorrhagic stroke increases as one gets older. But the new anticoagulants reduce the risk of a hemorrhagic stroke.
• If you’re doing OK on warfarin, all things considered, it’s probably better to stay on it (with the exception of the elderly).
• Dabigatran (Pradaxa) produced more stomach (GI) bleeds and indigestion (dyspepsia). Nearly two out of five people (35%) could not tolerate it which is a high rate of adverse reactions. Even in the case of people who don’t experience obvious symptoms, dabigatran over time may be causing long-term damage to one’s gastrointestinal system. And real-world data about dabigatran has raised red flags. For example, in a multi-center study of patients having a Pulmonary Vein Isolation procedure, those taking dabigatran had significantly higher major bleeding and clots than those taking warfarin. Doctors are now weaning patients off of dabigatran and on to warfarin before an ablation. See Steve’s report: Dabigatran (Pradaxa) Danger During Ablation—Switch to Warfarin
• Apixaban (Eliquis) produced the best results. It was superior to warfarin in preventing both ischemic stroke and hemorrhagic stroke. Rivaroxaban, however, was “non-inferior” to warfarin which isn’t as good as being significantly better than or superior to warfarin. And, unlike dabigatran, apixaban didn’t produce any increase in GI problems. But apixaban (Eliquis) is a brand new anticoagulant only recently approved by the FDA (December, 2012); there’s little real-world data on it yet.

Back to the top

Return to 2013 AF Symposium Reports
Last updated: Saturday, March 24, 2018

Women in A-Fib Not at Greater Risk of Stroke!

Research icon Master-wider border REV 125 pix at 96 resby Steve S. Ryan, PhD, Last updated: March 24, 2018
April 2016 related article: The Controversy Continues: Women, Anticoagulants, CHA2DS2-VASc and Risk of Bleeding

Denmark Study—Being a woman not a risk factor for stroke

The new guidelines for stroke prevention in A-Fib (CHA2DS2-VASc) state that simply being a woman is a risk factor for stroke. But a recent comprehensive study from Denmark indicates this may not be true. (The guidelines were first adopted in Europe in 2012 and in the US in May 2014).

The Danes seem to have an effective health care system for everyone which includes, among other benefits, data on anyone with A-Fib. They looked at 44,744 women with A-Fib. Female gender did not increase the risk of stroke in patients aged less than 75 years. (According to most guidelines, being over 75 years old is a risk factor for stroke irrespective of whether one is female or male.) 

According to the study’s Dr. Anders Mikkelsen, “This suggests that female sex should not be included as an independent stroke/TE risk factor in guidelines or in risk stratification schemes used in treatment of patients with atrial fibrillation.”

Dr. Peter Nielsen added, that women with no additional risk factors had a 1-year stroke risk below 0.5%, “which is likely too low to warrant lifelong antithrombotic treatment.”

Israeli Study 2015

An Israeli observational study of 100,000 people came to the same conclusions as the above Denmark study. See Israeli Study—Being Female Not a Risk Factor for Stroke.

Dr. Day—Risks of Life-Long Anticoagulant Therapy

Dr. John Day, in a May 2014 editorial in The Journal of Innovations in Cardiac Rhythm Management, discusses the new CHA2DS2-VASc guidelines for anticoagulation therapy that call for many more people to be on anticoagulant therapy, particularly women. Dr. Day does not go so far as to say the new guidelines are in error (as I do), but he does ask,” What about the 35 year old woman with borderline hypertension and only one A-Fib recurrence each year? Should she now take anticoagulants for the rest of her life even if she has had a successful ablation?”

This editorial was very personal for Dr. Day. One of his patients, after a successful catheter ablation, was on anticoagulant therapy for 10 years and developed early onset dementia. A cranial MRI revealed many cerebral microbleeds. Both antiplatelet and anticoagulant therapy significantly increase the risk of cerebral microbleeds which are associated with dementia. Microbleeds are considered permanent and irreversible.

Dr. Day concludes, “Somehow I think we have lost sight of the total picture with the new A-Fib management guidelines. In my mind, I am not convinced that the long-term stroke risk of a CHA2DS2-VASc score of 1 or 2 (depending on which risk factors are present) justifies all of the risks of life-long anticoagulation therapy, particularly if the patient has had a successful ablation procedure.” For more of Dr. Day’s comments, see The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy.

Dr. John Mandrola echoes Dr. Day, “And if there is no A-Fib, there is no benefit from anticoagulation.”

Editor’s Comments: 

For additional insights, also see: Women with A-Fib: Mother Nature and Gender Bias—Or—Get Thee to an EP ASAP

Intuitively it doesn’t make sense that simply being a woman makes you more at risk of having an A-Fib stroke. This study seems to confirm what common sense would indicate and is most welcome news for women.

Anticoagulants Not Like Taking Vitamins

Women (and men) should be aware that anticoagulants increase the risk of bleeding disorders and should be given only to patients at a real risk of stroke. “In addition to bleeding, Pradaxa can cause stomach upset or burning, and stomach pain.” (Pradaxa Fact Sheet PX81802) (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.) According to Dr. David Graham of the FDA, the anticoagulant “Coumadin provides a benefit, but it is also responsible for probably more deaths than any single drug currently marketed.”
Many people have problems when taking anticoagulants and would prefer not to have to take them. One bruises easily, cuts take a long time to stop bleeding, one can’t participate in any contact sports or any activities like mountain climbing, bike riding, etc. If in an accident, one risks bleeding to death, because there is currently no practical way to reverse the anticlotting effect of the newer anticoagulants. When taking anticoagulants, there is an increased risk of developing an hemorrhagic stroke and gastrointestinal bleeding. And anticoagulants often have other bad side effects, make one feel sick, and diminish one’s quality of life.

Update October 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.

TV Ads for Anticoagulants

Recent advertising campaigns give the impression that you must take anticoagulants if you have A-Fib, that anticoagulants are the be-all and end-all for treating A-Fib, that if you take anticoagulants, then you will live happily ever after. (Actually anticoagulants are not a treatment for A-Fib, but for the risk of an A-Fib stroke). However, no matter how altruistic these national campaigns sound in trying to increase people’s awareness and knowledge of A-Fib, be advised that their primary purpose is to sell pharmaceuticals.

Gender Bias to Sell More Anticoagulants

If someone tells you that you must take anticoagulants because you are a woman, it may be time to get a second opinion. Don’t let a form of gender bias intimidate you into taking anticoagulants.
Realize also that adding a point to a person’s risk score translates into a huge increase in sales for pharmaceutical companies. The guidelines were written by doctors with major conflicts of interest.
However, if you know the risks and bad side effects of taking anticoagulants but still want to take them, that is certainly an option to discuss with your doctor.
(Thanks to David C. Holzman for calling our attention to this important study for women.)
References for this Article
• Day, John. Letter from the Editor in Chief. The Journal of Innovations in Cardiac Rhythm Management, 5 (2014), A6-A7. Last accessed May 15, 2014, URL: http://www.innovationsincrm.com/cardiac-rhythm-management/2014/may/586-letter-from-the-editor-in-chief

• Female gender increases stroke risk in AF patients aged >75 years by 20%, What about women? European Society of Cardiology press release. August 26 2012. Note: Press release accompanies both a presentation and an ESC press conference at the ESC Congress 2012. Last accessed March 22, 2013. URL: http://www.escardio.org/about/press/press-releases/esc12-munich/Pages/female-risk-stroke-atrial-fibrillation.aspx

• Loudon, Manette The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower. Natural News, Tuesday, August 30, 2005. http://www.naturalnews.com/011401_Dr_David_Graham_the_FDA.html• Mikkelsen, A. ESC Congress 2012 presentation materials (.PDF). Last accessed March 22, 2013. URL: http://www.escardio.org/The-ESC/Press-Office/Press-releases/Last-5-years/Female-gender-increases-stroke-risk-in-AF-patients-aged-75-years-by-20

• Pradaxa Fact Sheet PX81802. Last accessed March 22, 2013. URL: http://tinyurl.com/PradaxaFactSheetPX81802

• Mandrola, John. Atrial Flutter–15 facts you may want to know. In AF Ablation, Atrial fibrillation. August 5, 2013. http://www.drjohnm.org/2013/08/atrial-flutter-15-facts-you-may-want-to-know↵

• Nielsen PB et al. Female sex is a risk modifier rather than a risk factor for stroke in atrial fibrillation: should we use a CHA2DS2-VA score rather than CHA2DS2-VASc? Circulation. 2018;137:832-840. http://circ.ahajournals.org/content/137/8/832

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Last updated: Saturday, March 24, 2018

 

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