ABOUT 'BEAT YOUR A-FIB'...


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

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

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

Dr. Wilber Su Cavanaugh Heart Center, Phoenix, AZ

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

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



ABOUT A-FIB.COM...


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

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

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

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

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

Terry Traver, former A-Fib patient

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

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


Watchman device

The Watchman Device: My Top 5 Articles

You’re on a blood thinner for your increased stroke risk from A-Fib. But you hate it.

Is the monthly testing or diet restrictions a hassle? Is the increased risk of bleeding stressful?  Have you developed side effects, i.e., gastrointestinal problems or poor kidney function? Maybe you just don’t want a lifetime on meds.

Or, perhaps you’re unable to take a blood thinner for other medical reasons. What do you do?

WATCHMAN™ Occlusion Device: The Alternative to Blood Thinners

There is an alternative to taking blood thinners―closing off your Left Atrial Appendage (LAA) with the Watchman™, an occlusion device. The LAA, a small sack located at the top of your left atrium, is where 90-95% of A-Fib strokes originate.

Inserting the Watchman is a very low risk procedure that takes as little as 20 minutes to install. Afterward, you usually don’t need to be on a blood thinner.

Review these articles to learn more about the Watchman:

1. The Watchman™ Device: The Alternative to Blood Thinners

2. Clinical Trials Results: Watchman Better Than a Lifetime on Warfarin

3. A Watchman and Ablation Combo? Everything You Never Thought to Ask

4. Technology & Innovations: The Watchman Device 

5. Steve’s List of EPs Installing the Watchman Device

Bonus: Video about the Watchman

Video - Closure of the Left Atrial Appendage Technique

Click image for video.

Closure of the Left Atrial Appendage: The Watchman Device

Animation shows how the Watchman is inserted and positioned in the left atrial appendage (LAA) using a catheter; then how heart tissue grows over the Watchman, closing off the opening of the LAA trapping any blood clots. (1:04)

He’s Got A-Fib but Can’t Take Blood Thinners: What to Do?

We’ve posted a new personal A-Fib story. William F Covert tells about how in 2014 his A-Fib returned when he developed a serious lung problem. The new problem meant he could no longer take anticoagulants. So how was he going to deal with the increased risk of stroke due to having A-Fib?

William writes:

Personal A-Fib story of William Covert at A-Fib.com

William F Covert

“My A-Fib symptoms started in 2012 with dizziness and constant fatigue. Several trips to my family physician proved to be futile.

“Let Me Take a Quick Pulse Reading by Hand”

On my last exam, the doctor stopped me as we were walking out of the exam room and said, “Let me take a quick pulse reading by hand.” She did so, then performed an EKG and announced: “You have A-Fib. Can you go to a cardiologist right now?”

This was my introduction to the world of A-Fib!

The cardiologist put me on Xarelto and after an electrocardioversion, I was A-Fib free…for 15 months.

I Began to Cough up Drops of Blood

At first it was occasional. Then as time passed, it became more frequent and larger amounts. Doctors thought that the use of Xarelto was the probable cause of the bleeding and advised me to stop the anticoagulant for 6 weeks, and hopefully the bleeding would stop.

Unfortunately, it got worse. And I went back into A-Fib.” continue reading William’s story…

 

GPA Disease Means No Blood Thinners: How to Deal with A-Fib Stroke Risk?

A-Fib Patient Story #85

GPA Disease Means No Blood Thinners: How to Deal with A-Fib Stroke Risk?

By William F. Covert, May 2016

My symptoms started with dizziness and constant fatigue. Several trips to my family physician proved to be futile.

2012: “Let Me Take a Quick Pulse Reading by Hand”

Personal A-Fib story of William Covert at A-Fib.com

William F Covert

On my last exam, the doctor stopped me as we were walking out of the exam room and said, “Let me take a quick pulse reading by hand.” (Blood pressure machines normally do not detect irregular heartbeat.) She did so, then performed an EKG. “You have A-Fib. Can you go to a cardiologist right now?”

This was my introduction to the world of A-Fib!

I saw a cardiologist the same day (November 2012) who put me on Xarelto (a blood thinner) and scheduled me for an Electrocardioversion a month later.

It was successful and kept me A-Fib free…for 15 months.

After my cardioversion, I was prescribed Sotalol (an antiarrhythmic medicine) for 15 months. But when I went back into A-Fib, they discontinued the Sotalol. They felt that, since the Sotalol didn’t prevent me from relapsing into A-Fib, there was no use in taking it.

2014: Coughing Up Blood

I began to cough up drops of blood. At first it was occasional. Then as time passed, it became more frequent and larger amounts. Doctors thought that the use of Xarelto was the probable cause of the bleeding and advised me to stop the anticoagulant for 6 weeks, and hopefully the bleeding would stop.

Unfortunately, it got worse. A second CAT scan 4 weeks later revealed my lungs were full of blood.

A second CAT scan revealed my lungs were full of blood. I was diagnosed with a disease called Wegener’s (GPA) 

I was diagnosed with a disease called Wegener’s (GPA-Granulomatosis with Polyangiitis), an uncommon disorder that causes inflammation of certain blood vessels. I was never told that Xarelto triggered the Wegener’s, but it certainly could make the bleeding worse.

Back in A-Fib, but Can’t Take Blood Thinners

The Wegener’s (GPA) caused damage and bleeding to my lungs, and I went back into A-Fib on March 31, 2014.

I was subsequently taken off of blood thinners and put on a low dose aspirin regimen to provide some element of safety from an A-Fib-related stroke.

Because of the Wegener’s, I would not be able to take blood thinners like warfarin (Coumadin) or Xarelto on a long-term basis.

Stroke Risk: Alternatives to Blood Thinners

I was acutely aware of the potential stroke possibility, because of being in A-Fib and not being able to take blood thinners. With A-Fib you need blood thinners to prevent a stroke. But Wegener’s (GPA) is a disease that causes bleeding. Blood thinners would only exacerbate the problem.

I was acutely aware of the potential stroke possibility, because of being in A-Fib and not being able to take blood thinners.

My cardiologist discussed the various alternatives to blood thinners. Some were invasive and not recommended because of my age (79).

After a few visits, my cardiologist told me about a new procedure using the Watchman device which would both help protect me from an A-Fib stroke and afterwards not require me to take anticoagulants.

[The Watchman Device closes off the Left Atrial Appendage (LAA) where 90%-95% of A-Fib clots and strokes come from.]

The Watchman Device: Weighing the Odds

If I decided to have the Watchman device installed, I would be required to be on the anticoagulant warfarin for 45 days afterwards. Then I’d need to take Plavix (similar to aspirin) for 6 months after that.

Why Coumadin and Plavix After Installing the Watchman? 

In the U.S., the Food & Drug Administration (FDA) requires the use of warfarin after installing the Watchman because it takes about 45 days for the thin layer of heart tissue to grow over the device. This is to insure you won’t have any blood clots that could pass around it and cause a stroke.

You will have a Transesophageal Echocardiogram (TEE) to determine the progress at the 45-day period and again at 6 months until Plavix can be stopped. Plavix is another requirement of the FDA. Doctors have to follow the FDA guidelines. (Boston Scientific is the manufacturer of the Watchman.)

For someone like me with Wegener’s, even this short a time on warfarin and Plavix was risky. But the effects of a stroke would be for life or might kill me.

For someone like me with Wegener’s, even this short a time on warfarin and Plavix was risky. But the effects of a stroke would be for life or might kill me.

My doctors would not offer their okay for me to be on warfarin and Plavix, even for that short a time.

Getting a Second Opinion: I also visited the Mayo Clinic in Rochester, MN for a second opinion. The pulmonologist (specialist in lungs and respiratory system) said that, because my Wegener’s was then in remission, a short course of blood thinners would be OK. However, the cardiologist told me he did not recommend doing this.

Bottom line: It had to be my decision.

2016: Chooses the Watchman (at Age 79)

After researching and reading the reports about all the clinical trials in the U.S. and the Watchman success stories in Europe, I decided, “This is for me!” I would go for the Watchman. This was better odds for me.

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

Catheter placing Watchman in LAA

The procedure to insert the Watchman device took less than 2 hours at Ochsner Hospital, New Orleans, LA, January 20, 2016 by Dr. Stephen Ramee, Interventional Cardiologist.

I was on warfarin for a total of 45 days, and now I’m on Plavix for 6 months―till the middle of September 2016.

So far everything is going fine with me―but I’ll be glad when I’m finished with the Plavix.

I Still Have A-Fib, But It doesn’t Keep Me Down

I have A-Fib symptoms all the time. I feel the fibrillation, and it causes dizziness and fatigue. But I am better in the AM and get more fatigued around 2:00 PM. This doesn’t keep me down. I take care of our yard, play golf and travel, etc. My blood pressure medicine has been adjusted to assist in decreasing the light-headedness and fatigue. However, the GPA (Wegener’s) medication that I have to take can also cause these types of reactions.

I am now taking 100 mg of metoprolol daily which seems to be controlling my heart rate, although erratically. My heart rate is usually between 65-75 beats per minute.

Lessons Learned graphic with hands 400 pix sq at 300 resLessons Learned

If you have A-Fib and have other heart issues that will not allow blood thinners, consider the Watchman device implant.

I have never looked back and believe it was a great decision for me.

[William invites you to email him with your questions about Wegener’s disease and the Watchman device.]

William F. Covert, New Orleans, LA
covach(at)cox.net

Editor’s comments
Kudos to William for being proactive, educating himself, getting a second opinion and dealing with a very difficult situation.
William’s dilemma is not unique. Many people with A-Fib can’t tolerate or react badly to anticoagulants. Without anticoagulants, they are 4-5 times more likely to suffer an A-Fib stroke. With 90%-95% of A-Fib clots coming from the Left Atrial Appendage (LAA), the Watchman device (and other occlusion devices) are a welcome alternative to anticoagulants.
Guarantee Against Stroke? Does the Watchman Device guarantee William will never have an A-Fib or other kind of stroke? No. Like anticoagulants, the Watchman device basically reduces William’s stroke risk to that of a normal heart-healthy person (but they can have a stroke, too). There is nothing on the market that will absolutely guarantee you will never have a stroke. However, the Watchman Device comes close and it’s better than a lifetime on warfarin. (Be advised that clots and stroke can develop in other areas than just the LAA.)
William Can Still Have a Catheter Ablation: While William is protected from A-Fib stroke, he still has A-Fib. If he so chooses, he can have a catheter ablation to fix his A-Fib. Many EPs routinely perform a catheter ablation on people who have had a Watchman device installed, especially in Europe where they have been using the Watchman device since 2004. See: A Watchman and Ablation Combo? Everything You Never Thought to Ask.
Be proactive! Learn from William’s story. If he hadn’t done his own research and got second opinions, he might already have suffered an A-Fib stroke.
For more about the Watchman, see my two articles: Watchman Device Option to Blood Thinners and Watchman Better Than a Life on Warfarin.

Back to the Top

Return to Patient A-Fib Stories

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

Become your own best patient advocate - horizontal Blue 400 x 328 pix at 300 res

Read other stories of A-Fib patients dealing with Atrial Fibrillation: see Personal A-Fib Stories.

65 and Older: 99% Have Microbleeds—So Are Anticoagulants Risky?

In a  recent study, 99% of subjects aged 65 or older had evidence of microbleeds; and closer examination of the cranial MRI images revealed an increased number of detectable microbleeds (i.e., the closer they looked, the more microbleeds they found).

Microbleeds in the brain are thought to be a precursor of hemorrhagic stroke.

Cerebral microbleeds (MBs) are small chronic brain hemorrhages of the small vessels of the brain.

If Microbleeds Cause Hemorrhagic Stroke, Should I be on a Blood Thinner?

The fact that almost everyone 65 or older has microbleeds is astonishing and worrisome, particularly if you have A-Fib and have to take anticoagulants. Anticoagulants cause bleeding. That’s how they work.

In plain language, this study indicates that cerebral microbleeds lead to or cause hemorrhagic stroke. It’s not surprising then that some doctors are reluctant to prescribe heavy-duty anticoagulants to older A-Fib patients.

Being older and already having microbleeds only makes taking anticoagulants all the more worrisome.

Risks of Taking Anticoagulants (Blood Thinners)

Taking most any prescription medication has trade-offs. Older A-Fib patients find themselves between a rock and a hard place.

In the case of anticoagulants, on one hand you get protection from having an A-Fib stroke (which often leads to death or severe disability), but on the other hand you have an increased risk of bleeding.

For those over 65 who already have microbleeds, … Continue reading this report…->

A Watchman and Ablation Combo? Everything You Never Thought to Ask

by Steve S. Ryan, PhD

The Watchman device closes off the Left Atrial Appendage (LAA), the source of most clots and A-Fib strokes.

The Watchman has been available in other countries since 2009, but only since 2015 in the US.

Research tells us that the Watchman device is not only as good as but is actually better for A-Fib patients than being on the blood thinner warfarin.  (See my post: Clinical Trials Results: Watchman Better Than a Lifetime on Warfarin)

Answers From Australia

A five-year study in Australia by Dr. Karen Phillips and her colleague, Dr. TW Walker, gives us ‘real world’ data and insights. Specifically, she studied combining the Watchman device with a catheter ablation for treating Atrial Fibrillation patients.

I’ve corresponded with Dr. Karen Phillips to help me answer your questions about the Watchman device.

“Can the Watchman be installed at the same time as my ablation?“

Yes.  Dr. Karen Phillips and several Electrophysiologists (EPs) in Europe have been doing this for over five years with no complications. She hasn’t seen any downside to doing the two procedures together. There’s very little, if any, experience in the US of combining a PVI with a Watchman device (US approved in 2015).

Should the Watchman be installed at the same time as my ablation?“

First answer: should the LAA be closed off? (Surgeons, unlike EPs, routinely remove the LAA in A-Fib surgery.) But the LAA isn’t a useless appendage and it has several functions. Younger people, especially the athletic, might be compromised by having their LAA closed off. (See LAA Important for Heart health.) There are many arguments for not routinely closing off the LAA in everyone. … Continue reading this report…->

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

Looking back over 2015, I found five significant developments for those ‘living’ with A-Fib and those seeking their ‘cure’. My ‘Top Five List’ focuses on the Watchman device, a Pradaxa antidote and research findings about lifestyle choices, and reducing fibrosis.

1. FDA Approves the Watchman Device

The Watchman occlusion device

The Watchman is positioned via catheter

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

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

To read my complete Top Five List…go to My 2015 Top Five List: A Review of Advancements in the Treatment of A-Fib->.

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

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

1. FDA Approves the Watchman Device

The Watchman occlusion device

The Watchman is positioned via catheter

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

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

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

2. Research: Watchman Better Than a Lifetime on Warfarin

Warfarin - Coumadin tablets various dosages

Warfarin (Coumadin)

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

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

3. Antidote for Pradaxa

Praxbind - antidote to Pradaxa

Praxbind: Pradaxa antidote

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

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

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

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

Weightloss

Weightloss

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

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

Exercise

Exercise

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

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

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

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

5. Research Studies: Preventing Fibrosis

Fibrotic cells - 2008 Boston A-Fib Symposium Kottkamp

Fibrotic cells

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

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

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

A Personal Prediction

WATCHMAN device at A-Fib.com

WATCHMAN device

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

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

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

Clinical Trials Results: Watchman Better Than a Lifetime on Warfarin

by Steve S. Ryan, PHD, October 2015, Updated January 26, 2016

According to recent studies, you are better off having a Watchman device installed than spending a lifetime on warfarin.

WATCHMAN device

WATCHMAN device for Left Atrial Appendage Closure

In two randomized clinical trials comparing Left Atrial Appendage Closure (LACC-Watchman Device) to warfarin, 1,261 patients from the PROTECT AF and PREVAIL trials were studied. The follow-up period was around 3.3 years. Patients receiving the Watchman compared to patients on warfarin had significantly fewer:

• Hemorrhagic strokes
• Cardiovascular/unexplained death
• Non-procedural bleeding
• All-cause stroke or systemic embolism was similar between both strategies.

There were more ischemic strokes in the Watchman device group, but this was balanced by a greater number of hemorrhagic strokes in the Warfarin group.

Warfarin - Coumadin tablets various dosages

Warfarin (Coumadin) various dosages

However, the patients in the control group of the PREVIAL trial were considered “unusual” in that, given their risk profile, they had a much lower ischemic stroke rate than ever observed in any clinical trial. See Getting FDA Approval for the Watchman Device.

(The U.S. Food and Drug Administration (FDA) approved Boston Scientific’s WATCHMAN™ LAA closure technology for use in the U.S. on March 13, 2015. It has been available internationally since 2009. The FDA approval of the WATCHMAN device is based on the clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The Watchman device will be available first at U.S. centers where it has been used in clinical studies.) 

What Patients Need to Know: Watchman Actually Better Than Warfarin

The Watchman device provides similar protection against having an A-Fib (ischemic) stroke as being on warfarin.

But the Watchman device isn’t simply an “alternative” to warfarin, but rather an improvement or advance or progression. One would intuitively expect that people receiving the Watchman device would also have less hemorrhagic strokes and bleeding compared to those on warfarin, which these studies do demonstrate.

Welcome Alternative to a Lifetime on Warfarin

Warfarin and other anticoagulants work by causing bleeding and are inherently dangerous. The Watchman device is not only a welcome alternative to a lifetime on warfarin, but is actually better than warfarin.

Long-term use of anticoagulants such as warfarin have been known to not only cause hemorrhagic strokes but also microbleeds in the brain which lead to dementia.

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 which lead to dementia. 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, and that increasing the imaging strength increased the number of detectable microbleeds. Microbleeds have been suggested to be predictive of hemorrhagic stroke.

According to current research, you are better off having a Watchman device installed than spending a lifetime on warfarin. (Of course, this assumes that the doctor performing the procedure is beyond his/her learning curve. That is, when operating doctors are first performing the procedure, there is a higher risk for procedural complications.)

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?

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.

CT Brain scan showing Ischemic Stroke

CT Brain scan showing Ischemic Stroke

Preventing Stroke in the Elderly—Even If They Don’t Have A-Fib!

One of the great potentials of the Watchman device is that it may someday be used to prevent stroke in the elderly even if they don’t have A-Fib. Imagine a world where you no longer live in fear of a stroke as you get older, where 90%-95% of stroke risk can be eliminated by a simple 20 minute procedure. The Watchman device (and other Left Atrium Occlusion Devices such as the Lariat and the surgical AtriClip) may change the way elderly medicine is practiced.

How many people turning 70 or 75 would welcome a device that would almost guarantee freedom from the most severe type of ischemic stroke (a cardioembolic stroke)? The Watchman device has the potential to greatly reduce or eliminate the threat of strokes in the elderly!

References for this article

Watchman Device Approved for Use in US

The WATCHMAN device from Boston Scientific

The WATCHMAN device

Good news for A-Fib patients who can’t or don’t want to be on blood thinners like Coumadin. The FDA recently approved Boston Scientific’s WATCHMAN™ technology for closure of the Left Atrial Appendage. (The Watchman has been available internationally since 2009.)

The FDA approval is based on the clinical program with numerous studies involving more than 2,400 patients and nearly 6,000 patient-years of follow-up. The Watchman device will be available first at U.S. centers where it has been used in clinical studies.

To learn more about the Watchman device and closure of the Left Atrial Appendage, see my three reports The Watchman™ Device: The Alternative to Blood Thinners, Technology & Innovations: The Watchman Device and The Role of the Left Atrial Appendage (LAA) & Removal Issues. Steve's Lists logo

In addition, for a list of US doctors installing the Watchman device, go to Steve’s Lists/Doctors Installing the Watchman Device.

Closure of the LAA: Why One Patient Chose the Lariat

Lariat II imageWhen closing off the Left Atrial Appendage (a small pocket of heart tissue located above the left atrium), you are typically looking at an occlusion device such as the Lariat or the Watchman (surgical removal is also an option). The Lariat is relatively new, so, how does it compare to the Watchman?

The Lariat device is a noose-like device which is slipped around the LAA. This ‘lasso’ is then tightened, and eventually the tissue dies and shrivels up like a grape into a raisin. Learn more and why one patient chose the Lariat.->

Getting FDA Approval for the Watchman Device

AF Symposium 2015

Getting FDA Approval for the Watchman Device

by Steve S. Ryan, PhD, February 2015

Vivek Reddy Mt Siani Hospital

Dr Vivek Reddy Mt Sinai Hospital

The Watchman device is in the last stages of the approval process from the FDA. This is a true “tipping point” in the development of devices to help A-Fib patients (The Watchman is approved everywhere else in the world).  If (or rather when) the Watchman is approved in the U.S., it will be because of the dedicated, thorough research of Dr. Vivek Reddy and his many colleagues and researchers.
(Added March 2015: The FDA approved the Watchman Device March 2015. See http://a-fib.com/my-2015-top-five-list-of-a-fib-advancements/)

Dr. Vivek Reddy of Mount Sinai Hospital gave a historically important talk entitled “5 Year Follow-Up Data On Watchman in Coumadin Eligible Patients.” He discussed the two major clinical trials of the Watchman device—PROTECT-AF and PREVAIL.

PROTECT-AF

In PROTECT-AF, patients who were followed for five years had less strokes (Primary Efficacy Endpoint) than those in the warfarin arm and there were less deaths. (Reddy, V. et al. JAMA. 312:1988 [2014])

PREVAIL

Reddy Watchman 1 500 pix at 96 resThe PREVIAL clinical trial was a smaller study designed to confirm the results of the PROTECT-AF trial and validate the safety of the implant procedure. With regards to the Primary Efficacy Endpoint (composite of all stroke, systemic embolism, and cardiovascular/unexplained death at 18 months), “non-inferiority was not achieved.” In other words, the Watchman group performed slightly worse than the warfarin control group.

But for some reason the warfarin control group performed much better than in any other trial. The Ischemic Stroke Rate per 100 patient-years was 1.1 in PROTECT-AF, while in PREVAIL it was only 0.3. In other words, the warfarin control group in PREVAIL overperformed compared to any other clinical trial.

Dr. Reddy pointed out to the FDA panel October, 2014 that the longer-term follow-up of the PROTECT-AF trial confirmed the efficacy of the Watchman therapy, even though the PREVAIL trial trended negative compared to the warfarin control group. But this particular PREVAIL warfarin control group was “unusual” and performed much better than expected.

Looking at other adverse events, the hemorrhagic stroke rate was 0.4% for the Watchman arm and 0.7% for the warfarin control group.

The Cardiovascular Death rate was 1.4% for the Watchman vs. 2.3% for warfarin.

Combining PROTECT-AF and PREVAIL

Reddy Watchman 2 500 pix wide by 96 resWhen you combine the PROTECT-AF and PREVAIL studies even with the “unusual” PREVAIL warfarin control arm results, “All Stroke” is non-inferior or about the same for both arms.

Also, as one would expect, after 6-months post implant, the Watchman arm had significantly less bleeding events than warfarin.

Early Safety Endpoint Achieved

The Early Safety Endpoint in PREVAIL was achieved.

• There was a significant increase in inplant success rate (95.1%) compared to PROTECT-AF (90.9%). There was no significant difference in complication rates between experienced and new implanters, demonstrating the success of the physician training program. Following successful implantation, 99.3% of patients were able to discontinue warfarin after 12 months.

• There was a 52% reduction in procedure/device related vascular complications (1.9% in PREVAIL vs, 4.0% in PROTECT-AF).

• There was a 52% reduction in pericardial effusions requiring intervention and at a rate comparable to other left atrial procedures.

Editor’s Comments:
Because of a freak statistical accident, the warfarin arm in the PREVAIL trial performed much better than expected and much better than in any previous trials. Perhaps if the PREVAIL trial were longer or had more subjects, the results might approach the longer PROTECT-AF trial. One shouldn’t interpret the results of PREVAIL as negating the conclusive results of the longer PROTECT-AF trial. In PREVIAL the Watchman device performed just as well as in PROTECT-AF. Only the warfarin control arm was different.
The most significant finding of PREVAIL was the the Early Safety Endpoints were achieved. That was the primary reason the FDA wanted the PREVAIL study in the first place.
Thanks to the excellent research and presentation by Dr. Reddy and his colleagues before the FDA, I’ll go out on a limb and predict the FDA will approve the Watchman device, probably by the middle of 2015.
The Watchman device closes off the LAA where 90-95% of A-Fib strokes come from. It’s a very low risk procedure that takes as little as 20 minutes to install. Afterward, you would usually not need to be on blood thinners. (For more, see my article, The Watchman Device: The Alternative to Blood Thinners).
If the FDA were to not approve the Watchman, this would be a major setback in the treatment of A-Fib in the US. The Watchman is approved everywhere else in the world. One would have to go to Canada or overseas to get the Watchman installed.
NOTE: Dr. Reddy also discussed this topic in February at the 2015 International Symposium on Left Atrial Appendage (ISLLA) held in Marina Del Rey, CA.

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Last updated: Friday, November 11, 2016

International Symposium on Left Atrial Appendage (ISLAA) 2015

Internation Symposium LAA 2015 logoby Steve S. Ryan, PhD, February 2015

The heart’s Left Atrial Appendage (LAA) has emerged as an important factor in the source of A-Fib signals. So much so, that doctors and researchers from around the world gathered for a two-day Symposium devoted exclusively to the LAA on February 6-7 at the Marina del Rey Marriott Hotel in Marina del Rey, CA.

Overview—First Impressions & Brief Reports

“Closing Off the LAA Has No Adverse Effects”

This Symposium was unique in that Electrophysiologists, Interventionalists and Surgeons were featured speakers and attendees. Dr. James Cox, inventor of the original Cox Maze operation, both presented a report and participated in a debate “Who Should Perform LAA Occlusion/Exclusion Procedures? A 3-Way Debate with a Surgeon, EP and Interventionalist.” In Dr. Cox’s talk he stated that cutting out the LAA has no adverse effects. This is a very powerful statement coming from someone with his years of experience.

AtriClip In Action

AtriClip being positioned

Dr. Cox said that the AtriClip closure device was the safest compared to staples and sutures. We were privileged to see two recorded operations using the AtriClip which were fascinating to watch. The surgeon opened up the pericardium sack and inserted the AtriClip over the LAA. In the first case he used what looked like two pencil eraser probes to poke and prod the LAA into the jaws of the AtriClip.

In the second case the surgeon inserted sutures into the LAA and used them to pull the LAA through the AtriClip opening. Once the AtriClip closed off the LAA, the closure looked very complete and secure. Both surgeons did not sew up and close the pericardium opening they had made to get to the LAA. This was surprising to me, but I later learned that this is standard procedure during such surgery to not close or stitch up the pericardium sack.

The Watchman occlusion device

The Watchman occlusion device

Watchman May Win FDA Approval

In my earlier brief reports on the Orlando AF Symposium, based on the recent research and the FDA presentation, I said the Watchman device probably won’t be approved in the US.

I’m happy to say that I am most likely wrong. The Watchman may be approved by the middle of this year. One presenter described how the FDA chairman talked with several people who were going to Canada to have the Watchman device installed. He seemed embarassed that the Watchman was available everywhere in the world but not in the US and said that it has to be approved.

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

Lariat II imageLariat Live Case

We were privileged to watch a live case from Cedars Sinai in which Dr. Saibal Kar and his colleagues inserted a Lariat device to close off the LAA in a patient. From outside the heart Dr. Kar inserted a magnet-tipped catheter through the diaphragm so that it arrived at the base of the LAA. Then from inside the heart he inserted another magnet-tipped catheter to the base of the LAA where the magnets joined and formed a rope-like structure.

Using this rope-like link he inserted a catheter with the Lariat II device which followed this rope-like link till it reached the LAA. He then unfurled the Lariat snare or noose-like device which he manipulated over the base of the LAA. But there were problems. It was hard to get all the folds or pouches of the LAA in the Lariat snare.

In most Lariat procedures, they use a balloon inside the heart to expand the LAA so that the lariat noose can more easily fit over it. Inserting the Lariat seemed like a somewhat tricky procedure to me, and is certainly more complicated than inserting a Watchman device.

Having to work from both outside and inside the heart and using balloons and catheters with magnet tips isn’t something the average EP or Interventionalist is used to doing. As Dr. Andrea Natale commented, the Lariat procedure needs skill and expertise. Though Dr. Natale didn’t say this, there are few centers and doctors with the experience, skill and expertise necessary to successfully insert the lariat device.

LAA Structures are Different and UniqueLAA 1.500 pix wide at 96 res

Previous research has postulated that the LAA has four basic structures:

1. Chicken-wing (48%)

2. Windsock (19%)

3. Cactus (30%)

4. Califlower (3%)

The Chicken-wing is the easiest to tie off with the Lariat, while the Califlower can be quite difficult. Also, sometimes the LAA is virtually inaccessible, because it is buried behind other heart structures.

LAA 3 500 pixel wide at 96 resDr. Jacqueline Saw of Vancouver General Hospital certainly surprised me by showing five more different LAA shapes which she named:

5. Elephant trunk

6. Serpiginous

7. Seahorse

8. Whale’s tail

9. Trousers

It seems that every LAA is different and unique in structure, like snowflakes. This may be very important in our understanding of the LAA.

Dr. Shaw also described how the LAA Orifice Opening can have very different shapes:

1. Oval (68.9%)LAA 2 500 pix wide at 96 res

2. Triangular (7.7%)

3. Foot-like (10%)

4. Waterdrop-like (7.7%)

5. Round (5.7%)

She also described how Cardiac Computed Tomography Angiography [CCTA]) imaging is used to measure the diameter and depth of the LAA. Addition measurements include the internal LAA structures such as lobes, muscle ridges, trebeculations and sharp bends.

These internal structures may influence or hinder the placement of LAA occlusion devices.

CCTA imaging can also be used after an occlusion device (i.e. Lariat or Watchman) is implanted to inspect and detect gaps or leaks.

References for this article

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Last updated: Friday, March 6, 2015

 

Closure of the LAA: Why One Patient Chose the Lariat Over the Watchman Device

By Steve S. Ryan, PhD, February 2015

When closing off the Left Atrial Appendage, a small pocket of heart tissue located above the left atrium, you are typically looking at an occlusion device such as the Lariat or the Watchman (surgical removal is also an option). The Lariat is relatively new, so, how does it compare to the Watchman?

About the Lariat

Lariat II image

The Lariat occlusion device

The Lariat device is a noose-like device which is slipped around the LAA. This ‘lasso’ is then tightened, and eventually the tissue dies and shrivels up (like a grape into a raisin). In effect, the Lariat chokes off the LAA and eliminates it as a source of A-Fib signals. (For more on the Lariat see my article: Tech & Innovations: Lariat II.)

A serious problem with the Lariat is described as “the gunny-sack effect”. The LAA heart tissue between the lariat lasso atrophies and becomes thinner. As with a gunny sack, the multiple tight folds begin to loosen and unravel slightly leaving a hole. If the hole is large enough, blood may flow into and out of the dead LAA possibly carrying with it dead tissue remnants into the blood stream which can cause clots and strokes. The number of clot/strokes reported so far is very small compared with the total Lariat cases worldwide.

Easily Fixed if Discovered

Once this hole or leak is discovered, it’s relatively easy for the EP to fix by closing it off using one of several occluder devices.

About the Watchman Device

The Watchman occlusion device

The Watchman occlusion device

The Watchman device, in contrast, is basically a plug that closes off the LAA from the inside of the LAA. It’s inserted via catheter, positioned and inflated. It ‘screens’ any clots from leaving the LAA. Eventually, heart tissue grows over the area.

But due to the typical non-symmetrical opening of the LAA, there can be leakage when the Watchman is installed due to the ‘edge effect’ (the device not always fitting perfectly). The leakage, though, isn’t generally large enough to permit clots to escape from the LAA into the heart. The incidence of leaks is around 30% to 35% depending on which research you look at.

Clots can also form on the surface of the device site. Therefore, after the Watchman is installed, patients are put on blood thinners for some time. (The risk of clot formation on the device site is around 4.5%, which is comparable to the risk of patients on oral anticoagulation.)

Eventually heart wall tissue grows over the occluded surface. Though this does not necessarily block electrical activity coming from the LAA, so the edges of the LAA may have to be ablated (which can be challenging).

Solution: Ablation First, Then Watchman

To avoid this last scenario (A-Fib triggers coming from the LAA), your EP will typically recommend you first get a catheter ablation to isolate the LAA. Later, after the ablations scars (lesions) have healed, the Watchman can then be installed, if necessary.

The Watchman device and the Lariat are FDA approved.

Why One Patient Chose the Lariat

Shannon Dickson, editor of THE AFIB REPORT, says he chose the Lariat “after already having had a successful LAA isolation ablation a year earlier which had eliminated the last remaining trigger source of a periodic LAA-based tachycardia. The reason I chose the Lariat in spite of having no more arrhythmia at all after that LAA isolation procedure, was to not only be able to stop all OAC drugs, but to add an extra measure of insurance that my LAA could never again become a source of any future arrhythmia. The prior successfully ablated LAA trigger source could never reconnect at some point and start the whole mischief again.

By fully ligating the LAA with a successful Lariat or AtriClip procedure, the added bonus of full electrical isolation of the LAA is added to the obvious vascular isolation as well.

The Watchman is designed to prevent LAA-based thromboembolic events, but does not electrically isolate the LAA. As such, any Watchman candidates who still have active LAA-based triggering should strongly consider getting an LAA isolation ablation prior to the Watchman procedure.”

Shannon considers the LAA “the most lethal appendage in the human anatomy.”

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Questions About the Lariat

The Lariat is a relatively new procedure with many questions from patients. Here are several of these questions with my thoughts after each one.

Q: “What are the long-term effects of leaving dead heart tissue to dissolve and become reabsorbed on the left atrium and in the pericardium sack?” These are yet to be fully studied. Most of the time the LAA remnant shrinks and becomes a fibrous, hardened tissue.

Preliminary data suggests that the hormones normally produced by the LAA are eventually re-produced by the Right Atrial Appendage (RAA) (it’s not talked about much, but yes, there is a Right Atrial Appendage too) and other parts of the heart.

Q: “If there is any type of hole left, will blood from the heart eventually leak into the pericardium sack once the LAA is gone?”

Most likely not. This hasn’t been an issue in all the years of surgical staple or suture ligation of the LAA. When the LAA shrinks and dissolves, it may form a permanent cap over any remaining hole. The perfect analogy here may be the umbilical cord after it is tied. The blood flow ceases and it becomes a hardened, fibrous structure.

Q: “What actually happens to the LAA when it dies and deteriorates?”

We know that the LAA shrivels up (like a grape into a raisin) and eventually disintegrates. On the inside of the heart where the LAA mouth was, heart tissue eventually grows over this now-closed mouth or opening.

Q: “How long does this process take?”

In general it takes around three to six months for heart tissue inside the heart to grow over the closed-off mouth of the LAA. On the outside of the heart, the LAA shrinks to a final-state cap over the closed-off LAA mouth in about a year or slightly longer and is somewhat variable per person.

Q: “How does this dead tissue affect the rest of the heart and body?”

Most likely this dead LAA tissue won’t have a bad effect on the rest of the heart and body. In the experience of surgical stapling or sutures to close off the LAA, there hasn’t been a body of evidence of late issues or complications. Though again, it’s too early in the experience of the Lariat procedures to say this definitively.

Q: “Some say the LAA dead tissue is simply absorbed by the body. How does this happen?”

More study needs to be done to identify and define the actual processes and time table, but previous surgical studies and autopsies indicate that the dead LAA disintegrates and is eventually re-absorbed by the body.

The Bottom Line

The Lariat’s “Gunny-sack” effect described above is relatively rare and is easily fixed. It shouldn’t be a major concern if you need to have a lariat device installed to close off your Left Atrial Appendage. Just make sure your EP checks the Lariat for leaks every three months during the first year after you get it installed. If your doctor doesn’t or won’t do that, find someone else to install the Lariat.

In spite of the small risk of clotting with the Lariat, if you can’t tolerate taking anticoagulants, it’s still the procedure of choice (the Watchman device requires 6 weeks of anticoagulants post-procedure). But it’s a more complicated procedure than installing a Watchman. You should only go to an EP experienced at installing the Lariat.

People chose the Lariat because it’s a welcome alternative to a lifetime on blood thinners (anticoagulants). 90%-95% of A-Fib clots come from the LAA. Closing off the LAA isn’t an absolute guarantee one will never have an A-Fib clot or stroke, but it comes close. (Neither are today’s anticoagulants.)

Overall, most people who have a Lariat installed are older with long-term persistent A-Fib, or with long-term paroxysmal A-Fib with the LAA as the prime driver of their arrhythmia.

If you are worried about what happens to your LAA when it dies and disintegrates, and how it might affect your body and overall health, we have no evidence or experience that it is a long-term health risk.

Which is Better―The Lariat or the Watchman?

There haven’t been any head-to-head comparisons of the Lariat and Watchman. So far, reaching conclusions about the superiority of one device versus the other cannot be made at this time. The choice of device has to be made based on the individual needs of a particular patient.

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Last updated: Friday, August 28, 2015

Removing or Closing Off the Left Atrial Appendage

Source: Boston Scientific Inc. educational brochure

Technology & Innovations

Removing or Closing Off the Left Atrial Appendage

For more recent articles, see The Role of the Left Atrial Appendage (LAA) & Removal Issues and Left Atrial Appendage May be Important for Heart Repair

Removing or closing off the Left Atrial Appendage (LAA) may affect how well the heart pumps and is of special concern to athletes and to those with heart pumping problems. In canine studies the LAA provided 17.2% of the whole left atrial volume of blood pumped. It’s possible that removing or closing off the LAA may lead to heart pumping problems and exercise intolerance.)

Though still in clinical trials, the Watchman Device is available for most people. For a list of US doctors installing the Watchman Device, go to Doctors Installing the Watchman Device. (Posted 2011)

Hondo T. et al. “The Role of the left atrial appendage. A volume loading study in open-chest dogs.” Jpn Heart J 1995 Mar;36(2):225-34. http://www.ncbi.nlm.nih.gov/pubmed/7596042

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Last updated: Sunday, February 15, 2015

The Watchman Device

Technology & Innovations 

The Watchman Device

The Watchman occlusion device

The Watchman occlusion device

An important recent innovation for patients is the Watchman Device. The theory behind the Watchman Device is most A-Fib clots originate in the Left Atrial Appendage (LAA). The Watchman Device closes off the LAA where 90-95% of A-Fib strokes come from. It’s a relatively low risk procedure compared to open heart surgery. It takes only a short time to install. Then you would usually not need to be on blood thinners.

Here’s how it works:

Once a patient’s Left Atrial Appendage is measured, a wide-sheathed catheter with a spline is used to insert the Watchman device which has a self-expanding Nitinol (a special metal) open-ended circular frame. The atrial surface of this frame is covered with a thin, permeable 160 μm (micron) pore filter made of polyester material (Polyethylene Terephthalate known as Dacron or PET). This filter allows blood to pass through while stopping clots. Little hooks or anchors called fixation barbs at the middle of the device make sure it is attached firmly to the LAA wall. The Watchman device comes in multiple sizes from 21mm to 33mm to accommodate the different sizes of LAAs.

Before the catheter is removed (which fixes the Watchman device in place), contrast agents are used to make sure the Watchman device is stable and entirely closes off the LAA opening. Over time heart tissue grows over the polyester (PET) material so that it completely closes off the LAA with mooth heart tissue similar to other heart surfaces. In this Occlusion slide, heart tissue has completely covered the Watchman device after only nine months.

Some doctors are inserting the Watchman device in as little as 20 minutes. There is no surgery or ablation involved.

Patients on Coumadin continue to take it for six weeks after the Watchman device is inserted. They are then examined using a TEE (Transesophageal Echocardiogram) to make sure there is complete closure of the LAA. At that time they are taken off of Coumadin.

VIDEO: A 3 minute animation of how the Watchman device is deployed (or watch at https://www.youtube.com/watch?v=1GWXBs-ly2k)

Coumadin reduces but does not totally eliminate the risk of stroke. Even with the proper INR levels of Coumadin, a small number of people with A-Fib have had strokes. The Watchman device also reduces but does not totally eliminate the risk of stroke. Like Coumadin, the Watchman is not an absolute guarantee one will never have a stroke. It basically reduces the risk of stroke similar to that of a person with a normal heart.

Those of us who hate having to take Coumadin or blood thinners will be able to go in for a procedure that takes as little as 20 minutes, and replace Coumadin and blood thinners with the Watchman. This is incredibly good news for many of us.

Even while we are waiting for or trying to decide on having a Pulmonary Vein Ablation, we can have the Watchman inserted and reduce our risk of stroke similar to that of a person with a normal heart.

The Watchman device may become part of most catheter ablation procedures. If the catheter ablation procedure were unsuccessful or in case of silent A-Fib attacks after ablation, patients would still be protected from an A-Fib stroke by the closing off of the Left Atrial Appendage. The Watchman Device may become standard therapy not just for people with A-Fib, but also for anyone at risk of a stroke.

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Last updated: Sunday, March 29, 2015

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

20th Annual AF Symposium

by Steve S. Ryan, PhD

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

AF Symposium: My Brief Reports

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

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

Rhythmia 3-Dimensional Mapping image

Image from Rhythmia 3-Dimensional Mapping system by Medtronic

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

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

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

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

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

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

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

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

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

(Happily I was wrong on this prediction. Update: The U.S. Food and Drug Administration (FDA) approved Boston Scientific’s WATCHMAN™ LAA closure technology for use in the U.S. on March 13, 2015. It has been available internationally since 2009. The FDA approval of the WATCHMAN device is based on the clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The Watchman device will be available first at U.S. centers where it has been used in clinical studies.)

Watchman May Win FDA Approval

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

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

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

FDA ‘Easy Feasibility Study’ (EFS)

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

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

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

Reversal Agents for the New Anticoagulants (NOACs)?

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

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

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

Female Gender: Is it a Risk Factor for Stroke?

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

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

Living in A-Fib More Dangerous Than Having an Ablation

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

Rotors! Rotors! Rotors! Sizzling Topic but No Consensus

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

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

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

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Holistic Approach to Health: Great Results Dealing with Obesity

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

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

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

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

Atrial Esophageal Fistula: A Case Study

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

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

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

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

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

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

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

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

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

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

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

From Beijing: Strange Chinese Case (Live via Satellite)

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

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

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

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Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)

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

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

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

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

Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight

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

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

Fibrosis and A-Fib: Continuing Research on Sheep

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

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

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

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Last updated: Friday, November 18, 2016 

Steve’s Lists of A-Fib Doctors by Specialty

Steve's Lists of Doctors by Specialty - Atrial Fibrillation, afib, a fib, A-Fib

Doctors by Specialty

Steve’s Lists of A-Fib Doctors by Specialty 

Steve has prepared these lists of doctors treating atrial fibrillation patients by specialty to help you find doctors with a particular expertise.

  1. US EPs with FHRS-designation performing A-Fib ablations: Listed by State/City
  2. US EPs Using Cryoballoon Ablation
  3. US EPs Installing the Watchman Device
  4. US Surgeons performing Maze and Mini-Maze operations
  5. US Centers performing the Hybrid Surgery/Ablation procedure
  6. EPs Specializing in Persistent/Long-Standing Persistent A-Fib (US and International)
  7. EPs using Contact Force sensing catheters

Return to Directory of Doctors Treating A-Fib: Medical Centers and Practices

Notice: unlike other directories, A-Fib.com offers no preferential listings or placement. No doctor or facility pays, provides services, etc. to be listed. We accept no fee, benefit or value of any kind for listing a specific doctor or medical center. A-Fib.com is not affiliated with any practice, medical center or physician.

If you know the name of the doctor or practice, use the “Search our site” box (upper right on this page) to get to the right Directory page. Then, open your browser’s ‘Find on Page’ feature (‘CTRL+F’) to locate the name on the page.

Disclaimer: this directory is provided for informational purposes only. We make no endorsement of a specific physician or medical facility. Choosing a physician is an important decision and should be based upon your own investigation of each physician’s training, education and experience. These listings offer you the opportunity to locate and contact a healthcare professional directly. 

A-Fib.com is your independent source of unbiased information about Atrial Fibrillation, resources and treatments.

Last updated: Tuesday, September 6, 2016

Watchman Occlusion Device – Blood Thinners Alternative

The Watchman device placed in opening to the Left Atrial Appendage

Illustration: The Watchman device placed in opening to the Left Atrial Appendage

The Watchman™ Device: The Alternative to Blood Thinners

By Steve S. Ryan, PhD, updated March 2015

Do you hate having to take Coumadin or other blood thinners? Hate the side effects? Or are you allergic to them? A replacement to taking blood thinners is the Watchman, an occlusion device.

The theory behind the WATCHMAN™ LAA closure technology is that most A-Fib clots originate in the Left Atrial Appendage (LAA). The Watchman closes off the LAA where 90-95% of A-Fib strokes come from. It’s a very low risk procedure that takes as little as 20 minutes to install. Afterward, you would usually not need to be on blood thinners.

Boston Scientific's WATCHMAN™ LAA closure technology

Boston Scientific’s WATCHMAN™ LAA closure technology

How It Works

The Watchman device comes in multiple sizes from 21mm to 33mm to accommodate the different sizes of LAAs. Once a patient’s Left Atrial Appendage is measured, a wide-sheathed catheter with a spline is used to insert the Watchman device which has a self-expanding Nitinol (a special metal) open-ended circular frame.

The atrial surface of this frame is covered with a thin, permeable 160 μm (micron) pore filter made of polyester material (Polyethylene Terephthalate known as Dacron or PET). This filter allows blood to pass through while stopping clots. Little hooks or anchors called fixation barbs at the middle of the device make sure it is attached firmly to the LAA wall.

Before the catheter is removed (which fixes the Watchman in place), contrast agents are used to make sure the Watchman is stable and entirely closes off the LAA opening. Over time heart tissue grows over the polyester (PET) material so that it completely closes off the LAA with smooth heart tissue similar to other heart surfaces.

In this Occlusion image, heart tissue has completely covered the Watchman device after only nine months. 

Anatomical View of the WATCHMAN Device in the LAA 9 months after implantation.

Patients on Coumadin continue to take it for six weeks after the Watchman device is inserted. They are then examined using a TEE (Transesophageal Echocardiogram) to make sure there is complete closure of the LAA. At that time they are taken off of Coumadin and put on a different type of blood thinner called clopidogrel (Plavix) until six months after the implant procedure. 

Think of the Watchman as a replacement for blood thinners; both reduce but do not totally eliminate the risk of stroke. The stroke risk is reduced to that of a person with a normal heart.

Even while you are waiting for or trying to decide on having a Pulmonary Vein Ablation, you can have the Watchman inserted and reduce your stroke risk to that of a person without A-Fib.

The Future

Just as closing off the LAA is standard practice in the Cox Maze/Mini-Maze operations, in the future, the Watchman device could become part of most catheter ablation procedures. If included with the ablation procedure, the Watchman would protect the patient from blood clots even if the catheter ablation procedure was unsuccessful. The Watchman device may become standard therapy for anyone at risk of a stroke, not just for people with A-Fib.

For a list of US doctors installing the Watchman device, go to Steve’s Lists/Doctors Installing the Watchman Device.

Update: The U.S. Food and Drug Administration (FDA) approved Boston Scientific’s WATCHMAN™ LAA closure technology for use in the U.S. on March 13, 2015. It has been available internationally since 2009. The FDA approval of the WATCHMAN device is based on the clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The Watchman device will be available first at U.S. centers where it has been used in clinical studies. 
Reference for this Article

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US Doctors Installing the Watchman Device – a List by A-Fib.com

Steves List logo 200 pix at 96 resUS EPs Installing the Watchman Device – by US State

If you are at high risk for stroke but can’t take anticoagulants, your doctor may suggest closing off the Left Atrial Appendage using an occluder such as the Watchman Device.

Update: After extensive clinical studies, the FDA approved Boston Scientific’s WATCHMAN™ LAA closure technology for use in the U.S. on March 13, 2015 (it has been available internationally since 2009). Boston Scientific has an excellent web site which lists centers implanting the Watchman device http://www.bostonscientific.com/en-US/products/laac-system/watchman-device/implanting-hospitals.html. On the far right hit the button “Find Implanting Center”. Doctors are listed only by the hospitals they work at rather than by their office and their normal contact phone number. (I had to use a magnifying glass to read the copy.)
However, this Boston Scientific site doesn’t distinguish between Electrophysiologists (EPs) certified in “Clinical Cardiac Electrophysiology” and Internists/Interventionalists who normally do not work inside the heart. These doctors are usually only certified in “Cardiovascular Disease,” “Internal Medicine,” or “Interventional Cardiology.” (They usually work primarily with pacemakers and/or stents and usually don’t perform A-Fib ablations.)

The following table lists only EPs who have passed their “Clinical Cardiac Electrophysiology” (CCE) certification. Though installing the Watchman Device is normally a relatively simple procedure, it might be advisable to have the Watchman Device installed only by EPs who have their CCE. They are usually more experienced at working inside the heart.

HOW TO FIND THE CONTACT INFO

STATE CITY DOCTOR Phone Number Center
Alabama Birmingham Dr. Jose Osorio 205-939-0073 Alabama Cardiovascular
Arizona Phoenix/Peoria/Chandler Dr. Vijendra Swarup (Clinical Trial Participant) 602-456-2342 Arizona Heart Rhythm Center
Arizona Phoenix Dr. Marwan M. Bahu 602-952-0002 Biltmore Cardiology
Arizona Phoenix Dr. Ashish Sadhu 602-307-0070 Heart & Vascular Center
California Santa Monica Dr. Shephal Doshi (Clinical Trial Participant) 310-829-6889  St. John’s
California Los Angeles Dr. Michael Shehata 310-423-3336 Cedars-Sinai
California Los Angeles Dr. Ivan Ho 213-977-0419 Good Samaritan
Florida Atlantis Dr. Mark A. Freher 561-434-0353 Florida Electrophysiology Assoc.
Florida Bradenton Dr. Daniel E. Friedman 941-748-2277 Bradenton Cardiology
Forida Lakeland Dr. Neal G. Kavesh 863-680-7000 Watson Clinic
Florida St. Petersburg Dr. Robert C. Sheppard 727-490-2136 Heart & Vascular Institute
Florida St. Petersburg Dr. Shalin S. Shah 727-544-1441 Bay Area Heart Center
Florida Sarasota Dr. Robert E. Eckart 941-917-4250 Heart Specialists of Sarasota
Florida Sarasota Dr. Dilip J. Mathew (Lariat) 941-486-6758 Heart Rhythm Consultants
Florida Tallahassee Dr. Farhat S. Khairallah 850-216-0120 Southern Medical Group
Florida Tampa Dr. Kevin J. Makati (Lariat) 813-229-9292 Tampa Cardiac Specialists
Georgia Atlanta Dr. Angel Leon (Clinical Trial Participant) 404-686-2504  Emory Univ. Heart Center
Georgia Atlanta Dr. David DeLurgio (Clinical Trial Participant) 404-686-2504  Emory Univ. Heart Center
Georgia Atlanta Dr. Mikhael F. El-Chami 404-686-2504 Emory Univ. Heart Center
Georgia Atlanta Dr. Michael Hoskins 404-712-4063 Emory Univ. Hospital
Illinois Naperville/Winfield Dr. Moeen A. Saleem 630-687-9451 Midwest Heart Specialists
Illinois Springfield Dr. Ziad F. Issa (Clinical Trial Participant) 217-788-0706 Prairie Cardiovascular Consultants
Kentucky Lexington Dr. Gery Tomassoni (Clinical Trial Participant) 859-277-5887 Lexington Cardiology at Central Baptist
Massachusetts Boston Dr. Moussa Mansour (Clinical Trial Participant) 617-726-5557 Massachusetts General Hospital
Massachusetts Burlington Dr. Bruce G. Hook 781-744-8863 Lahey Clinic
Massachusetts Burlington Dr. Jonathan S. Silver 781-744-8863 Lahey Clinic
Massachusetts Fall River Dr. Nitesh A. Sood 508-679-7262 Southcoast Healthcare

 

Michigan Detroit Dr. Claudio D. Schuger 313-916-2417 Henry Ford Hospital
Michigan Grand Rapids Dr. Musa I. Dahu 616-885-5000 Frederik Meijer Heart
Michigan Royal Oak Dr. David E. Haines 248-898-4198 William Beaumont Hospital
Minnesota Minneapolis Dr. William Katsiyiannis (Clinical Trial Participant)  612-863-3900 Minneapolis Heart Institute
Minnesota Rochester Dr. Douglas L. Packer 507-284-3994 Mayo Clinic
Minnesota Rochester Dr. Samuel J. Asirvatham 507-284-3994 Mayo Clinic
Minnesota Rochester Dr. Thomas M. Munger 507-284-3994 Mayo Clinic

 

Mississippi Tupelo Dr. Karl J. Crossen 662-620-6800 Cardiology Assoc of Northern Mississippi
Mississippi Tupelo Dr. Keith Kyker 662-620-6800 Cardiology Assoc of Northern Mississippi
Missouri Kansas City Dr. Alan Wimmer (Clinical Trial Participant) 816-931-1883 Mid America Heart Institute
Missouri Saint Louis Dr. Amit A. Doshi 314-256-5240 Heart Health Center
Missouri Saint Louis Dr. J. Mauricio Sanchez 314-993-6969 Heart Health Center
New Hampshire Manchester Dr. Connor J. Haugh 603-669-0413 Catholic Medical Center
New Hampshire Manchester Dr. Jamie H. Kim 603-669-0413 Catholic Medical Center
New Jersey Asbury Park Dr. Ashish B. Patel 732-663-0300 Monmouth Cardiology
New Jersey Camden Dr. Zoltan Turi 856-968-7096 Cooper Univ. Hospital
New Jersey Neptune Dr. Mark A. Mascarenhas 732-776-8535 Monmouth Cardiology
New Jersey Neptune Dr. Mark J. Hansalia 732-776-8500 Shore Heart Group
New Jersey Parlin Dr. Zyan Younan 732-727-0400 K. George Younan, MD
New York New York Dr. Vivek Reddy (Clinical Trial Participant) 212-241-7114 Mount Sinai
New York Manhasset Dr. Stuart J. Beldner 516-562-2300 North Shore Univ. Hospital
New York New Hyde Park Dr. Bruce G. Goldner 718-470-7330 Long Island Jewish Medical
New York New Hyde Park Dr. Apoor Patel 718-470-7330 Long Island Jewish Medical
New York New York Dr. Srinivas R. Dukkipati 212-241-7114 Mount Sinai
New York New York Dr. Jacob Koruth 212-241-7114 Mount Sinai
New York Staten Island Dr. Marcin Kowalski 718-663-7000 Staten Island Univ. Hospital
North Carolina Charlotte Dr. John W. Holshouser 704-373-0212 Sanger Heart & Vascular
Ohio Cleveland Dr. Mohamed Kanj 216-444-9162 Cleveland Clinic
Ohio Cleveland Dr. Walid Saliba 216-444-9162 Cleveland Clinic
Ohio Cleveland Dr. Oussama M. Wazni 216-444-9162 Cleveland Clinic
Ohio Columbus Dr. James M. Kleman 614-262-6772 OhioHealth Heart
Tennessee Nashville Dr. Robert A. “Drew” Pickett 615-329-5144 Saint Thomas Midtown
Tennessee Nashville Dr. W. David Thompson 615-269-4545 Saint Thomas West
Tennessee Nashville Dr. Christopher R. Ellis 615-322-2318 Vanderbilt Heart Center for Atrial Fibrillation
Texas Austin Dr. Rodney Horton (Clinical Trial Participant) 512-807-3150 Texas Cardiac Arrhythmia Institute
Texas  Austin Dr. Andrea Natale 512-807-3150 Texas Cardiac Arrhythmia Institute
Texas  Austin Dr. J. David Burkhardt 512-807-3150 Texas Cardiac Arrhythmia Institute
Texas Austin Dr. Patrick M. Hranitzky 512-807-3150 Texas Cardiac Arrhythmia Institute
Texas Austin Dr. David R. Tshopp 512-458-1006 Austin Heart
Texas Fort Worth Dr. Syed Nayyar Shah 817-334-2800 Heart Center of North Texas
Texas Fort Worth Dr. Senthil K. Thambidorai 817-334-2800 Heart Center of North Texas
Texas Houston Dr. Nadim Nasir, Jr. 713-791-1978 Methodist DeBakey Heart
Texas Houston Dr. Miguel Valderrabano 713-791-1978 Methodist DeBakey Heart
Texas San Antonio Dr. Kiran N. Jayaram 210-614-5400 Cardiology Clinic of San Antonio
Utah Murray Dr. J. Peter Weiss 801-507-3513 Intermountain Heart
Virginia Richmond Dr. John R. Onufer (Clinical Trial Participant) 804-288-4494 Virginia Cardiovascular Specialists
Virginia Norfolk Dr. Ian Woollett 757-597-9294 Sentara Cardiovascular Research
Washington  Seattle Dr. Adam Zivin 206-861-8550 Swedish Heart & Vascular
Washington Seattle Dr. Jordan Prutkin 206-598-4300 UW Medicine Regional Heart Clinic

Return to Steve’s Lists of A-Fib Doctors by Specialty

NOTICE: we offer no preferential listings. We accept no fee, benefit or value of any kind for listing a specific doctor or medical center. A-Fib.com is not affiliated with any practice, medical center or physician.

HOW TO FIND CONTACT INFO: Use the “Search our site” box (upper right on this page) to get to the right Directory page. Then, open your browser’s ‘Find on Page’ feature (‘CTRL+F’) to locate the name on the page.

Disclaimer: this directory is provided for your convenience only.  We make no endorsement of a specific physician or medical facility. Choosing a physician is an important decision and should be based upon your own investigation of each physician’s training, education and experience. This directory offers you the opportunity to locate and contact a healthcare professional directly.

A-Fib.com is your source of unbiased information about Atrial Fibrillation and its treatment options.

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Last updated: Saturday, May 21, 2016

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