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


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

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

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

Jill and Steve Douglas, East Troy, WI 

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

Faye Spencer, Boise, ID, April 2017

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

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


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


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

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

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

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

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

Dr. Wilber Su,
Cavanaugh Heart Center, 
Phoenix, AZ

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

Ira David Levin, heart patient, Rome, Italy

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

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



Left Atrial Appendage Closure

My Top 5 Articles: Surgical Treatment Options for Atrial Fibrillation

When drug therapies fail or if not a candidate for catheter ablation, patients look to surgical treatments to reduce the risk of stroke, to ease symptoms or to cure their Atrial Fibrillation.

Here are my top 5 articles about the Maze & Mini-maze surgeries and role of the left atrial appendage:

  1. The Cox-Maze & Mini-Maze Surgeries and the Hybrid Surgery/Ablation
  2. Advantages of the Convergent (Hybrid) Procedure
  3. Considering a Mini-Maze? Don’t Destroy the Ganglionic Plexus
  4. The Role of the Left Atrial Appendage (LAA) & Removal Issues
  5. The Watchman™ Device: The Alternative to Blood Thinners

BONUS VIDEO
Mini-Maze Surgery with Cardiac Surgeon Dr. Dipin Gupta

See our library of videos about Atrial Fibrillation

Cardiothoracic surgeon Dipin Gupta, MD, discusses this surgical treatment for persistent atrial fibrillation. The Mini-Maze is done without open-heart surgery and using a small incision on the side of the chest. Published by MedStar and Cleveland Clinic. March, 2015 (4:35) Go to video->

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

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

An alternative to anticoagulants, the Watchman occlusion device closes off the LAA. FDA approved, it’s a very low risk procedure that takes as little as 20 minutes to install. Afterward, you would usually not need to be on blood thinners.

CT brain with Ischemic stroke at A-Fib.com

CT brain with Ischemic stroke

Effects of a Lifetime on Warfarin

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

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

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

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

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

What About the New Anticoagulants (NOACs)?

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

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

Caveat—Long-Term Effects of Watchman?

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

Catheter placing Watchman in LAA

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

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

EPs Installing the Watchman Device

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

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

References for this article

Updated Steve’s List: US Doctors Installing the Watchman Device

If you are at high risk for stroke but can’t or don’t want to take anticoagulants, your doctor may suggest closing off the Left Atrial Appendage using an occluder such as the FDA approved Boston Scientific WATCHMAN™.

Steve’s List of Specialists Installing the Watchman: My original list of doctors installing the Watchman was limited to those EPs participating in the clinical trials. In 2015 the FDA approved the Watchman for use in the U.S. Since then my list of doctors installing the Watchman has expanded. (Internationally, the Watchman has been available since 2009.)

Watchman device - A-Fib.com

Watchman occlusion device by Boston Scientific

How to Find a Specialist: Today, you can visit the Boston Scientific website to find medical centers installing the Watchman device; just enter a state or postal code.

Use Steve’s List instead: When looking to install a Watchman device, I recommend you seek an electrophysiologist (EP) who is certified in “Clinical Cardiac Electrocardiography”. Use my list which is organized by state and city. Go to, Steve’s List of Specialists Installing the Watchman Device.

To learn more about the Watchman, see: The Watchman Device: My Top 5 Articles.

2017 AF Symposium: LIVE VIDEO! Two Procedures—Different Left Atrial Appendage (LAA) Occlusion Devices

AF Symposium 2017

LIVE VIDEO! Two Procedures—Different Left Atrial Appendage (LAA) Occlusion Devices

This live streaming video session from Milan, Italy, featured two Left Atrial Appendage occlusion devices: the Amplatz Amulet from St. Jude Medical and the LAmbre from LifeTech Scientific.

LAA Closure Using the Amplatz Amulet (St. Jude Medical)

Amplatz Amulet occlusion device by St. Jude Medical - A-Fib.com

Amplatz Amulet occlusion device by St. Jude Medical

Live from Milan, Drs. Claudio Tondo, Antonio Dello Russo, Gaetano Fassini, and Massimo Moltrasio inserted an Amplatz Amulet (St. Jude Medical) into the Left Atrial Appendage of a 78-year-old women who had a high risk of bleeding. (The LAA is the origin of 90%-95% of Atrial Fibrillation-related clots).

Model of Patient’s LAA: These doctors did something I had never seen before. They made a physical model of the woman’s LAA, then showed how the Amplatz Amulet fit into the model. This isn’t done in all cases of LAA occlusion, but was very helpful for the AF Symposium attendees to see how the Amplatz Amulet actually worked.

Illustration of placing the Amplatz Amulet (St. Jude Medical) in the left atrial appendage

Illustration of placing the Amplatz Amulet (St. Jude Medical) in the left atrial appendage

The doctors also demonstrated how they could easily retract and recapture the device (which isn’t easy to do with the Watchman occlusion device [Boston Scientific]).

Like the Watchman device, the Amulet also has hooks to hold the device in place.

VIDEO ANIMATION: showing how the Amplatz Amulet device is installed (1:14 min.) from St. Jude Medical.
Watchman device - A-Fib.com

Watchman occlusion device by Boston Scientific

It seemed very easy to insert the Amplatz device. It closed off the LAA opening with the bottom part completely covering the LAA opening into the left atrium.

For most patients, this might be an advantage of the Amplatz device over the Watchman occlusion device which doesn’t have this overlap and can sometimes leak around the edges.

But, on the other hand, once the Amplatz device is in place, the overlap of the LAA would prevent ablation and electrical isolation of the LAA should that be necessary. But in most cases, this isn’t often required.

Second LAA Closure Using the LAmbre (LifeTech Scientific)

LAmbre (LifeTech Scientific) occlusion device at A-Fib.com

LAmbre (LifeTech Scientific) occlusion device

Later in the session when the moderators cut back to the live video stream from Milan, the EPs inserted a LAmbre (LifeTech Scientific) device in the LAA of a second patient. She was a 50-year-old woman who had a very small LAA. She had suffered two ischemic strokes within a month of each other, but she had bleeding problems when she took warfarin and dabigatran (Pradaxa).

[She was definitely between a rock and a hard place. Ischemia refers to a restriction or blocking of blood supply as by A-Fib clots. She needed to be on blood thinners to prevent A-Fib clots from forming particularly in her LAA, but couldn’t tolerate blood thinners which caused her bleeding problems. An LAA occlusion device was pretty much her only option.]

The LAmbre LAA occlusion device (LifeTech Scientific) seems similar to the Amplatz (St. Jude Medical) as both are fully recapturable and repositionable within the LAA. But each has its own anchor design to hold the device in place. But the LAmbre can fit into smaller size Left Atrial Appendages.

Both the Amplatz Amulet and the LAmbre occlusion devices are approved for use in Europe, but neither is approved yet in the U.S. (Not surprising since the U.S. approval  of the Watchman device also lagged the European approval.)

I predict the Amplatz Amulet from St. Jude Medical will soon be approved by the FDA for use in the U.S.

Return to 2017 AF Symposium Reports
If you find any errors on this page, email us. Last updated: Monday, June 12, 2017

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 almost 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…->

Curing Long-standing Persistent A-Fib: Ablating the Left Atrial Appendage is Key

Patients with long-standing Atrial Fibrillation are often the hardest to make A-Fib free. Because of having been in A-Fib for so long, they may have developed many A-Fib producing spots in their heart besides in the Pulmonary Veins (PVs).

Patients with long-standing Atrial Fibrillation are often the hardest to make A-Fib free

To make them A-Fib free, the electrophysiologist (EP) must ablate (isolate) not only the Pulmonary Veins, but also many non-PV triggers. Isolating the Left Atrial Appendage (LAA) significantly increased the success of catheter ablation in long-standing persistent A-Fib patients.

BELIEF Trial—LAA Isolation 76% Success Rate

In a randomized study (BELIEF trial), 173 patients with persistent A-Fib either received standard ablation plus LAA isolation or standard ablation alone. (If patients continued to have A-Fib, they could have a repeat ablation which included LAA isolation.)

At 2 years, 76% of patients who had received standard ablation plus LAA isolation were free of arrhythmia vs 56% of patients who had received only a standard ablation.

Dr. Luigi Di Biase, who presented the findings at the European Society of Cardiology 2015 Congress, stated “We do believe (LAA isolation) should be the standard of care in patients with longstanding AF.

Isolating the LAA improved long-term freedom from persistent A-Fib.

But 52% Had Impaired LAA Function

Isolating the LAA can cause problems. If many burns have to be made at the LAA to achieve isolation, they may reduce the ability of the LAA to contract properly. … 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…->

2016 AF Report: 2 Challenging, Difficult Catheter Ablation Cases with LAA Closure

AF Symposium 2016

Steve Ryan at 2016 AF Symposium

Steve Ryan at 2016 AF Symposium

Two Challenging, Difficult Catheter Ablation Cases with LAA Closure

by Steve S. Ryan, PhD

One of the most interesting and practical sessions was “Challenging Cases in Catheter Ablation and LAA Closure for AF”.  Featured were a panel with some of the world’s ‘master’ Electrophysiologists (EPs). Each presented one or two cases of their most challenging and difficult cases from the past year. The panelists were:

• Dr. David Keane, St. Vincent’s University Hospital, Dublin, Ireland (Moderator).
• Dr. Moussa Mansour, Massachusetts General Hospital, Boston, MA.
• Dr. Andrea Natale, Texas Cardiac Arrhythmia Institute, Austin, TX
• Dr. Douglas Packer, Mayo Clinic, Rochester, MN
• Dr. Vivek Reddy, Mount Sinai Hospital, New York, NY
• Dr. Miguel Valderrabano, Houston Methodist Hospital, Houston, TX
• Dr. David Wilber, Loyola University Medical Center, Chicago, IL

Two cases of Persistent A-Fib stood out as significant for readers of A-Fib.com. To learn why, see my ‘Take Away’ comments that follow each case description.

Electrically Dead Left Atrium

Dr. Miguel Valderrabano

Dr. Miguel Valderrabano

Dr. Valderrabano presented the case of a 48-year-old female patient with symptomatic Persistent A-Fib. She had been cardioverted several times and had tried several antiarrhythmic drugs including amiodarone. She had had Pulmonary Vein Isolations (PVI) by other EPs before being referred to Dr. Valderrabano.

Her left atrium was enlarged. Dr. Valderrabano ablated her again but couldn’t isolate her Left Atrial Appendage (LAA) where A-Fib signals were still coming from. He used the Lariat (SentreHeart, Inc.), a noose-like suture delivery device, to close off and electrically remove her LAA.

After these steps, she had a leak from her closed-off LAA which had to be plugged. She was A-Fib free but developed Atrial Flutter which had to be ablated.

After all these ablations, she was finally in sinus rhythm. But at what cost? All the extensive ablations and scarring had made her Left Atrium electrically dead and unable to contract normally (“Stiff Left Atrium”).

The patient knew she might lose contraction of her left atrium, but was most happy to be in sinus rhythm after years of symptomatic A-Fib.

TAKE-AWAYS FOR PATIENTS

Lariat to Prevent A-Fib Signals from the LAA: The Lariat is an occlusion device, and like the Watchman, is normally used for closing off the Left Atrial Appendage (LAA) to prevent A-Fib clots breaking loose and causing a stroke. It’s particularly useful for people who can’t or don’t want to take anticoagulants.

In this case, the LAA was the source of non-Pulmonary Vein (PV) signals (and often is). By removing it, patients can often be restored to sinus rhythm. (Master EPs now consider the LAA the most important source of non-PV triggers. Unfortunately, many EPs are unaware of the LAA’s importance and don’t check it for non-PV triggers during an ablation.)

Stiff Left Atrium: No one wants to lose their Left Atrium’s ability to contract and pump. But in extreme cases, this may happen.

I talked to one of the most experienced EPS in the world who has had to do several ablations which restored a patient to sinus but also rendered their left atrium electrically dead and unable to contract normally. [Note: the Left Ventricle does most of the heavy-duty pumping work.]

His patients, even though they knew the risks, were overjoyed to finally be in normal sinus rhythm. After years of symptomatic A-Fib, they had their life back again.

FIRM Advantages and Problems

Dr. Vivek Reddy, Mt Siani Hospital

Dr Vivek Reddy, Mt Siani Hospital

Dr. Vivek Reddy presented the case of a 63-year-old male in Persistent A-Fib who had had several ablations before being referred to him. After wearing a Holter monitor for one-week, the data showed an A-Fib burden of 27%, i.e., his A-Fib was very symptomatic and burdensome.

Dr. Reddy did a FIRM-guided ablation, but the patient was still in A-Fib.

Upon closer examination and manual mapping, the ‘renegade’ A-Fib signal source was found and ablated, which restored the patient to sinus rhythm.

Dr. Reddy had discovered the A-Fib signal in the area where the FIRM basket catheter didn’t map. As mentioned in other Symposium presentations, due to design problems, the FIRM basket catheter maps only slightly more than ½ of the left atrium. (New basket catheters to correct this problem are being developed by the manufacturer, Abbott/Topera.)

TAKE-AWAYS FOR PATIENTS

Limited but Extensive Data with Fast Results: Even though the FIRM mapping and ablation system seems to currently have built-in limitations, master EPs still use the FIRM basket mapping catheter because it provides a great deal of important information very quickly. It is especially useful in cases of Persistent A-Fib where it identifies non-PV triggers such as rotors and focal drivers. As Dr. Reddy stated earlier, this is the future of A-Fib ablation.

Choose an EP Who Can Compensate for FIRM Limitations: When choosing an EP to do your ablation, it isn’t enough to select someone who uses the FIRM system. You need an EP who knows the limitations of the FIRM system and how to find and ablate non-PV triggers the FIRM system may miss. The fact that an EP uses the FIRM system is not a guarantee you will have a successful ablation.

Wrap Up

The two cases I chose to write about were the most informative for those A-Fib patients seeking to understand the most current treatment options. This Saturday afternoon session was the last of the 2016 AF Symposium.

For more about the Lariat occlusion device, see my brief article: Lariat II Suture Delivery Device.
For more about the FIRM mapping system, see my brief article: FIRM Mapping System—Should Ablation Patients Avoid It?

Return to 2016 AF Symposium Reports reby Steve Ryan, PhD

If you find any errors on this page, email us. Y Last updated: Monday, February 15, 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.

AF Symposium New Report: Should the Left Atrial Appendage be Removed

Dr. Dhanunjaya Lakkireddy

Dr. Dhanunjaya Lakkireddy

In 30% of A-Fib patients, the LAA was the only structure that had A-Fib signals.

In his presentation, Dr. Dhanunjaya Lakkireddy said after the Pulmonary Veins (PV)s, “the LAA is the most common source of (A-Fib) focus triggers and other A-Fib signals.” He further stated that in patients over 70 years old, especially women, the LAA plays a more important role as the source of A-Fib signals. Removing or closing off the LAA reduces the pumping volume of the left atrium by 15% to 30%…Read more.

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.->

Alert: Patients with Lariat Device for Left Atrial Appendage Closure

By Steve S. Ryan, PhD, February 2015

If you’ve had your Left Atrial Appendage (LAA) closed off using the Lariat device from SentreHeart, Inc., you must schedule follow-up tests at 3 months and one year intervals to check for total LAA closure with no gaps or leakage. Talk to your doctor about a TEE (Trans-esophageal Echocardiogram) or preferably a 3-D TEE. In a small number of reported cases the Lariat failed to fully seal off the LAA allowing tissue remnants to loosen, enter the blood stream and cause clot and stroke. (See Shannon Dickson’s first-hand story below.)

The Lariat Device

The Lariat device from SentreHeart, Inc.

The Lariat device from SentreHeart, Inc.; open and closed

When closing off the Left Atrial Appendage (LAA), surgeons may use the Lariat II device, a noose-like device which is slipped around this small pocket of heart tissue. The ‘lasso’ is then tightened, and eventually the tissue dies and shrivels up like a grape. In effect, the Lariat II 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.)

The Problem: The ‘Gunny-Sack’ Effect

In what is described as “the gunny-sack effect”, the LAA heart tissue between the lariat lasso atrophies and becomes thinner. As with a gunnysack, 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 (necrotic) tissue remnants into the blood stream. These dead tissue remnants can cause clots and strokes. Normal blood thinners don’t work on them. Any hole over 2mm can create such leaks. It’s estimated that holes greater than 2mm occur in 6% of Lariat cases, but not all cause clots and strokes. The number of clot/strokes (embolic events) reported so far is very small compared with around 2,500 total Lariat cases worldwide to-date.

Easily Fixed if Discovered

Once this hole or leak is discovered, it’s relatively easy for your surgeon to fix by closing it off with an Amplatzer Atrial Septal Occluder, an Amplatzer Duct Occluder II, or a Gore Helix Septal Occluder.

Lariat II – Should Include Short-Term Anticoagulation

And even when the LAA is completely closed off, there is still a small chance (around 2%) of clots forming inside the heart at the LAA closed off location primarily during the first 4-8 weeks. This is probably related to tissue inflammation and blood platelet “clumping” at the site. It’s therefore important for you and your doctor to consider short term anticoagulation for 6-8 weeks to reduce the risk of clot forming at the closure site. (For those patient who can not take oral anticoagulation or antiplatelet agents, there will be a small temporary risk of stroke at the LAA site while the area heals.)

Shannon W. Dickson: Tells of Clots and a Stroke After Lariat II Installed

If you’d like to read a well-written first-person account of someone who experienced clots and a stroke after having a Lariat occluder installed, Shannon W. Dickson published his experience in The AFIB Report, Number 133, August/September 2014.

(Shannon Dickson says he got the Lariat II because his A-Fib was producing loads of spots in his LAA. Even after an LAA isolation ablation a year earlier (effectively disconnecting electrically from the LAA), Shannon chose the added reassurance a successful Lariat ligation can bring. Permanently removing the LAA from the ‘AFIB/Flutter equation’ insures his LAA could never again reconnect and be a source of more arrhythmia.)

Shannon is the new managing editor of The AFIB Report; a one-year subscription to The AFIB Report is $29.00.

Editor’s Comments:
Don’t let this risk of a leak and stroke scare you away from having a Lariat device installed if you need it. If a hole or leak does form, and it’s discovered, it’s very easily fixed. Just make sure your doctors check for leaks!

Return to Index of Articles: Maze, Mini-Maze, Convergent, LAA Closure Surgeries

Last updated: Friday, October 14, 2016

References for this Article
   

Should the Left Atrial Appendage (LAA) be Removed in Patients With A-Fib?

Dr. Dhanunjaya Lakkireddy

Dr. Dhanunjaya Lakkireddy

AF Symposium 2015

Should the Left Atrial Appendage (LAA) be Removed in Patients With A-Fib?

by Steve S. Ryan, PhD

Leading doctors and researchers have pointed out the importance of the Left Atrial Appendage (LAA) particularly when ablating persistent A-Fib. In the Bordeaux group’s Five-Step Ablation Protocol for Chronic A-Fib, after isolating the Pulmonary Veins (PVs), their next step is to look for A-Fib signals coming from the LAA. In 2010, Dr. Andrea Natale and his colleagues showed that in 30% of A-Fib patients, the LAA was the only structure that had A-Fib signals. (Circulation 2010.)

In his presentation, Dr. Dhanunjaya Lakkireddy from the Un. of Kansas Hospital in Kansas City, MO, confirmed these findings. After the PVs, “the LAA is the most common source of (A-Fib) focus triggers and other A-Fib signals.”

In Older Patients the PVs Have No A-Fib Signals

He further stated that in patients over 70 years old, especially women, the LAA plays a more important role so much so that the PVs are often silent.

How Removing the LAA Affects Left Atrium Pumping Volume

Removing or closing off the LAA reduces the pumping volume of the left atrium by 15% to 30%. But after the LAA is removed, the overall left atrium volume improves.

Removing The LAA Reduces Natriuretic Peptides―But The Heart Compensates Over Time

The LAA is responsible for neuroharmonal changes such as natriuretic peptide levels (i.e., regulates the amount of sodium in the urine) which are important for bodily functions such as thirst. When the LAA is removed, natriuretic peptide levels go down. But Dr. Lakkireddy’s research shows that over time these levels normalize. Other heart areas such as the right atrium compensate and produce more natriuretic peptides to make up for what the LAA used to produce.

Removing the LAA Lowers Blood Pressure

Removing or closing off the LAA often improves blood pressure by dropping epinephrine (adrenaline) levels and lowering (“down-regulating”) the

renin-angiotensin system (hormone system that regulates blood pressure and fluid balance).

Removing the LAA Improves Recurrence Rates

Dr. Lakkireddy found that removing or closing off the LAA at the same time as a catheter ablation for A-Fib reduces recurrence rates by 29%.

Editor’s Comments:
Why LAA A-Fib Signal Sources in Older People—Why Do PVs Go Silent?
One of the most important findings of Dr. Lakkireddy’s research is that in older people the LAA is the most important source of A-Fib signals, so much so that the PVs are often silent. This is counter-intuitive and hard to understand. If, as we know from years of previous research, A-Fib usually starts and is most often found in the PVs, why do the PVs go silent and A-Fib activity mostly move to the LAA in older people? What is the physical or chemical mechanism that causes this major change?
Sea-Change in Ablation Strategy
Dr. Lakkireddy’s presentation was the most important and ground-breaking for older A-Fib patients. It should change the way ablations are performed on older people. If you are over 70 years old, in persistent A-Fib and aren’t very active, you must seek out EPs and centers who understand and ablate the LAA. Most EPs don’t even look at the LAA as possible A-Fib signal sources. Don’t rely on your local EP to learn about this research and adopt any requisite new ablation strategies.
In Older A-Fib Patients the LAA Should be Removed
It certainly looks like, in the case of older people with A-Fib, the LAA should be removed by an occlusion device (either the Lariat or by surgery [AtriClip]). In addition to the known benefit of reducing A-Fib stroke risk (90%-95% of A-Fib clots come from thee LAA), the LAA is a major and often the only source of A-Fib signals in older people.
Little Downside to Removing the LAA
And according to Dr. Lakkireddy, there is very little downside to removing the LAA.
Blood pressure goes down, over time natriuretic peptide levels return to their pre-LAA levels as the heart compensates, the lost LA pumping volume does improve, and recurrence rates are reduced when the LAA is removed.
Older people who are less active may not even notice the loss of LAA pumping volume or the reservoir or surge effect of the LAA. (On the other hand, an active athletic senior may be affected by the loss of pumping volume if the LAA is removed.)
LAA Can Be Removed Before or After an Ablation
In the case of a catheter ablation for A-Fib, it may not be necessary to remove the LAA at the time of the ablation. Since it is a safer procedure than even an A-Fib ablation, the LAA could be removed three months before or after a catheter ablation.

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Last updated: Friday, March 6, 2015

 

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

Return to Research & Innovations

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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Return to Index of Articles: Research & Innovations

Last updated: Friday, August 28, 2015

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