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Left Atrial Appendage Closure

Abbott’s LAA Closure Device Amplatzer Amulet FDA Approved for A-Fib

Atrial Fibrillation patients now have a second effective way to close off the Left Atrial Appendage (LAA) to prevent strokes and to no longer be required to take anticoagulants for life. Abbott’s Amplatzer Amulet Left Atrial Appendage closure device was approved by the FDA in August 2021.

Amulet Clinical Trial

In a clinical trial sponsored by Abbott, the Amplatzer Amulet was compared head-to-head with the earlier version of the Watchman device, (not with the more recent Watchman FLX commonly in use today).

Amplatzer Amulet Occluder device positioned in Left Atrial Appendage (LAA)

The Amplatzer Amulet device features a lobe which fills the body of the Left Atrial Appendage (LAA) and a disc to close off the opening into the LAA.

In the Amulet LAA Occluder clinical trial, 80% of Amulet patients were discharged without anticoagulant therapy. Only 20% were discharged on anticoagulants (usually dual antiplatelet therapy, clopidogrel plus aspirin). The FDA-approved label recommends this to prevent clot formation before the device is completely closed off by heart tissue growing over the device (reendothelialization).

In this study most Watchman patients (82%) were discharged requiring anticoagulant therapy. The Watchman usually requires a short course (45 days) of warfarin followed by dual antiplatelet therapy anticoagulants (usually clopidogrel plus aspirin) until 6 months after LAA closure.

Major Advantage of Amulet Over Watchman

Why is the Amulet important for some Atrial Fibrillation patients? The Amulet doesn’t usually require the use of anticoagulants after it is inserted. (Some patients can’t take anticoagulants, others don’t want to be on anticoagulants, even for a short period.)

No Data Yet on Amulet vs. Newest Watchman FLX

The Amulet did close off the LAA better than the 2015 version of the Watchman, but not by much (98.9% vs. 96.8%).

We don’t have data comparing the current Watchman FLX to the Amulet.

Editor's Comments about Cecelia's A-Fib story

Editor’s Comments

Atrial Fibrillation patients considering an Amulet should probably wait till after they are free of Atrial Fibrillation and after a thorough mapping and isolation of all non-PV triggers, especially those coming from the LAA.
Metal Exposure: The Watchman FLX features reduced metal exposure, whereas the Amulet outside disc is a large protruding piece of metal inserted into the heart. (I personally would not want that huge piece of metal disc in my heart.)
Occluders: Watchman on left; Amplatzer Amulet on right

Occluders: Watchman on left; Amplatzer Amulet on right

What if one’s LAA continues to produces A-Fib signals? It’s difficult or impossible to isolate the LAA if the Amulet disc covers the LAA opening. The Watchman doesn’t protrude into the heart like the Amulet does.

No or Reduced Need for Anticoagulants with Amulet: The Amulet doesn’t usually require anticoagulants. This is great news for those who can’t tolerate anticoagulants. One of the major motivations to getting one’s LAA closed off is to no longer have to take anticoagulants which are high risk drugs.

It’s Great for A-Fib Patients to Now Have a Choice of LAA Closure Devices: It’s amazing how research has improved for patients with A-Fib. Who would have thought that we would now have two effective ways to close off the LAA to prevent strokes−with no requirement of anticoagulants therapy for life?
Which is Better―the Amulet or Watchman? Which Should I Choose? Unless you can’t tolerate anticoagulants for 6 months, stick with the Watchman FLX. We know it works in the real world after years of experience. While the Amulet is used in Europe, it has just been FDA approved in the US. We need more real-world experience with it.

On a Personal Note: As many readers know after 21 years, my A-Fib returned. Not to worry. I’m once again A-Fib free after two catheter ablations by Dr. Shephal Doshi and Dr. Andrea Natale. But Dr. Natale did recommended I close off my Left Atrial Appendage (LAA). So in a few months, I’ll be getting the Watchman FLX occlusion device. I’ll write about the experience.

Additional reading: Don’t Want to Take Anticoagulants? Three Alternatives for A-Fib Patients; and Anticoagulants Increase Risk of Hemorrhagic-Type Strokes

● Lakkireddy, D. et al. Amplatzer amulet left atrial appendage occluder versus watchman device for stroke prophylaxis (amulet ide): a randomized controlled trial. Circulation, august 30, 2021.

● Todd. FDA Approves Next-Generation Watchman FLX Device for LAA Occlusion. TCTMD News, July 22, 2020.

My A-Fib’s Back: Need a Touch-Up This Week

On August 19 I’m scheduled for a touch-up ablation by Dr. Andrea Natale at Los Robles hospital in Thousand Oaks, CA.

Dr. Shephal Doshi and Steve Aug 1 2019

I’m symptom free. But my Medtronic Reveal LINQ loop recorder shows I still have some A-Fib after a catheter ablation by Dr. Shephal Doshi at St. John’s hospital in Santa Monica 24 months ago (August 2019).

Background: My first catheter ablation was in 1998 by Drs. Michel Haïssaguerre, Pierre Jais, and Dipen Shaw in Bordeaux, France. Though it was relatively primitive compared to what EPs are doing today, it kept me A-Fib free for 21+ years.

Steve with Dr Häissaguerre who cured Steve in 1998.

Left Atrial Appendage: During the touch-up ablation, my Left Atrial Appendage (LAA) may have to be electrically isolated. If that’s done, and my LAA doesn’t empty of blood properly, I may have to have a Watchman device inserted to mechanically close off my LAA. As an enthusiastic runner/sprinter, I don’t want to have my LAA closed off as it can reduce blood flow. But at 80 years old, I may have little choice. I’ll post again after my redo ablation.

A “re-do” catheter ablation is nothing to be frightened of. My procedure this week, like last time, will be as an out-patient. For my 2019 touch-up procedure, I arrived at the hospital at 5am and was back home at 5pm. In and Out. Lickety-split!

2020 AF Symposium Abstract: Combination Device to Both Electrically Isolate and Occlude the LAA

2020 AF Symposium Abstract

Combination Device to Both Electrically Isolate and Occlude the Left Atrial Appendage (LAA)

by Steve S. Ryan

Heart showing location of Left Atrial Appendage (LAA)

Researchers in this study described the Left Atrial Appendage (LAA) as the 5th Pulmonary Vein. It plays a similar role as the PVs in generating A-Fib signals, but is the source of many clots that lead to stroke. Currently implanting an LAA occlusion device is a stand-alone procedure.

How the AuriGen Combination Device Works

An abstract by AuriGen Medical described a study with dogs of a very innovative device which both closes off and electrically isolates the Left Atrial Appendage (LAA) in a one-shot procedure.

The AuriGen Ablation, Delivery and Occlusion System consists of an LAA implant which closes off the LAA with a PET (polyethylene terephthalate) membrane, and an RF Ablation System to circumferential ablate the ostium of the LAA with an RF electrical array.  Once implanted, the catheter electrodes are removed through a self-closing access conduit, leaving the occluder in play.

On day 7, the dogs underwent surgery to open the chest (thoracotomy) and observed that the LAA occluder device hadn’t moved. This also indicated that the ablation may have resulted in permanent electrical isolation of the LAA.

Editor’s Comments:

One can’t help but admire how A-Fib researchers and device manufacturers are developing innovative devices to improve A-Fib patient treatment.
From a patient’s perspective, it’s important that doctors and researchers recognize the importance of the LAA as a source of A-Fib signals (potentials). It seems to me that all too many EPs either ignore or put a low priority on mapping and ablating the LAA. Whereas other EPs such as Dr. Andrea Natale, after ablating the PVs, then focus on the LAA before examining any other areas of the heart. They recognize that the LAA often plays a major role in triggering A-Fib signals
Brilliant Idea to Combine LAA Closure with Electrical Isolation: The AuriGen combination occluder/LAA ablation device probably won’t be used in simple, recent onset, paroxysmal A-Fib cases because just isolating the PVs is usually enough to return patients to normal sinus rhythm (NSR).
Instead, the AuriGen combination device would be very useful in more complex cases where patients have had A-Fib for longer periods or who are more at risk of developing LAA clots. The AuriGen device can both close off and isolate the LAA in one procedure.
Practical Use by EPs: It’s is a long way from being available for A-Fib patients.
When and if the AuriGen device becomes available for patients, in practice EPs will probably first do a PVI to isolate the PVs, then proceed to use the AuriGen combination device to close off and isolate the LAA in the same procedure.

This will increase the effectiveness of ablation particularly in cases of persistent A-Fib. And, more importantly for patients, both procedures can be done at the same time.

Thompson, J,  et al. Pre-Clinical Evaluation of the AuriGen Medical Combination Device Designed to Electrically Isolate and Occlude the Left Atrial Appendage. Aurigen Medical. Abstract AFS2020-09 in the AF Symposium 2020 brochure, p. 34.

If you find any errors on this page, email us. Y Last updated: Wednesday, August 26, 2020

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2020 AF Symposium Live Case: LAA Closure with New Generation Device

John Foran MD

AF Symposium 2020

Live Case: LAA Closure with New Generation Device

In this live case Dr. John Foran from Royal Brompton Hospital in London, implanted the Watchman FLX to close off the Left Atrial Appendage (LAA) (Boston Scientific). It was in conjunction with several presentations on Left Atrial Appendage Closure (LAAC) devices.

The moderator for this live case was Dr. Walid Saliba of the Cleveland Clinic. The Panelists were Dr. Jacqueline Saw of Vancouver General Hospital and Dr. Dhanunjaya Lakkireddy of the Kansas City Heart Rhythm Institute.

Patient History

This male patient with persistent A-Fib had recently suffered a hemorrhagic (bleeding) stroke. He had been in A-Fib for 20 years and had a long history of hypertension. He had a CHADS-VASc score of 4 and a HAS-BLED score of 3. He was formerly on warfarin for 17 years, then switched to edoxaban (Savaysa) for one year when he had his “catastrophic” cerebral bleed. Happily, he eventually made a good recovery.

Dr. Foran would not state that his patient’s hemorrhagic stroke came from his years of being on anticoagulants. He raised the alternative possibility that the man’s stroke could have come from a hypertension bleed. Dr. Foran said he tries to insert a Watchman device as soon as possible after a cerebral stroke.

Patient Drug Treatments

His doctors stopped his anticoagulant when he was approved for Left Atrial Appendage Closure. He was put on Apixaban (Eliquis) 2/day for a short period of time.

As of April 2020, the Watchman FLX device is not yet approved for use in the U.S.

Dr. Foran said, “we always anticoagulate in the lead-up to an implant procedure.” The apixaban was continued through the procedure.

Post-op, the patient will be given apixaban as well as aspirin during six weeks after the procedure. Then he will be on apixaban for 6 months.

The Next Generation: Watchman FLX Occlusion Device

Dr. Foran displayed the earlier Watchman 2.5 version (left) and compared it to the new Watchman FLX (right).

Comparison of Watchman 2.5 (left) and Watchman FLX (right)

The Watchman FLX has a closed cell architecture with no sharp points at the top. The threaded insert is much smaller with less metal visible. (In the older Watchman device, it was found that thrombi (clots) could form on the metal insert visible after the Watchman was inserted.)

The Watchman FLX is designed to conform better to individual anatomies.

Watchman FLX -18 J-hooks in 2 rows

It uses 18 hooks offset in two different planes as compared to the older Watchman 2.5 which had 10 hooks. This allows the FLX to hook deeper into the LAA.

Dr. Foran said the older Watchman had sharp points at the top which meant you couldn’t push it forward very hard into the heart tissue̶-particularly in someone with a small LAA (like this patient).

Because the Watchman FLX is more flexible, he no longer uses the earlier Watchman 2.5 version.

Inserting the Watchman FLX

When the Symposium audience joined the live ablation, the patient had already been prepped in the EP lab. The catheters were already in place in the heart.

Illustration of Watchman inserted into Left Atrial Appendage

We watched as Dr. Foran, using fluoroscopy (x-ray) and echocardiogram, inserted the Watchman FLX into the opening of the LAA. He used saline and color flow for contrast to show where the sheath was.

Dr. Foran showed how there were air bubbles inside the sheath which he flushed out with saline.

Next, he opened up the Watchman FLX inside the LAA. He pushed in the Watchman FLX for 10 seconds to better imbed the device’s hooks. He then tugged on it a couple of times to make sure the anchors were well seated.

To complete the procedure, he then released the Watchman FLX and withdrew the sheath.

Editor’s Comments

My own electrophysiologist (EP), Dr. Shephal Doshi at Pacific Heart in Santa Monica, CA, told me it normally takes him only around 20 minutes to insert a Watchman. The new Watchman FLX appears to be even easier to install.
The biggest improvement in the Watchman FLX, in my opinion, is the smaller threaded insert with much less metal visible. Patients will likely have significantly reduced risk of clots forming on metal, which was an annoying problem that sometimes occurred with the earlier Watchman.
Approved in Europe but Not in U.S.:  In Europe, Boston Scientific received CE Mark certification in March 2019 and initiated a limited market release of the Watchman FLX™ in the European Economic Area (EEA).
In the U.S., clinical trials of the Watchman FLX are under way in 29 U.S. medicals centers. The trials close in Feb. 2021. I expect eventual approval by the U.S. Food and Drug Administration (FDA).
About 85% of A-Fib strokes are ischemic strokes; this A-Fib patient had a hemorrhagic stroke which is less common.
The Patient’s Hemorrhagic Stroke: Did anticoagulants cause or contribute significantly to this patient’s bleeding stroke?
We simply can’t say for sure whether being on anticoagulants for so many years caused or contributed to this patient’s cerebral hemorrhage (bleeding stroke).
As Dr. Foran pointed out, the patient’s hypertension may have been a factor in his stroke.
But anticoagulants are not like taking vitamins. They work by causing or increasing bleeding. However, they are certainly better than having an A-Fib ischemic (blocking blood flow) clot and stroke.

A-Fib Patients and Hemorrhagic Stroke: Recent research indicates that the risk of a hemorrhagic stroke, particularly in older A-Fib patients, should be considered carefully and can be very dangerous. For more about A-Fib and Hemorrhagic stroke, see my article, Anticoagulants Increase Risk of Hemorrhagic-Type Strokes

Reference for this report
Das, A.S et al. Etiology and Imaging Risk Markers of Non-Vitamin K Antagonist Oral Anticoagulant-Related Intracerebral Hemorrhage. AFS2020-17. AF Symposium 2020 brochure, p. 42.

If you find any errors on this page, email us. Y Last updated: Wednesday, August 26, 2020

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Considering a LAA Occlusion Closure? Watch Out for Nickel Allergy

Approximately 8% of us have a nickel allergy. If you’ve had your ears pierced (or some other body part) and had to use “hypoallergenic” jewelry, you most likely have a nickel allergy. (My wife, Patti, says gold earrings also work for her nickel allergy but are more costly.) It is one of the most common causes of metal sensitivities in people. It’s estimated that 15% to 20% of women in the U.S. are allergic to nickel due to jewelry exposure.

For more info on Nickel allergy, go to Two Cents About Nickel from American Academy of Allergy, Asthma & Immunology.

If you’re one of the many A-Fib patients looking to close off their Left Atrial Appendage, be aware if you have a nickel allergy, you have limited choices of an occlusion device.

Thanks to Frances Koepnick for alerting us to this problem. She had to cancel having a Watchman implanted because of her nickel allergy.

Nickel in Occlusion Devices

Heart illustration showing the Left Atrial Appendage at

Heart illustration showing the Left Atrial Appendage

Watchman occlusion device (Boston Scientific): The Watchman contains Nitinol, a metal that is approximately 50% nickel and 50% titanium. The manufacturer states that individuals with a nickel allergy are ineligible for a Watchman implant.

Amplatzer Amulet occlusion device (St. Jude Medical-Abbott): The Amulet also contains nitinol and, therefore, has the same implications for nickel allergy.

Hyper-sensitivity Diagnostic Test Results

Standard skin/patch testing is considered unreliable for metal allergy testing. “Metal-LLT (Lymphocyte Transformation Testing)” is a diagnostic test used by allergists to measure hypersensitivity responses.

Below is a sample of test results showing nickel sensitivity:

Metal ChallengeStimulation Index Range (percentile based)
Aluminum0.9Normal (Non-Reactive)

For LAA Closure: What To Do About a Nickel Allergy?

Right now Frances seems to have two options: the Lariat II device (SentraHEART Inc) and a surgical approach using the second generation AtriClip  which does not contain nickel, and as such, is suitable for LAA closure in individuals with nickel allergies.

The Lariat II does contain Nitinol, but it is gold plated. The gold plating acts as a barrier to nitinol/nickel exposure. Though formerly approved by the FDA, the Lariat II device is currently in a second (extended) “Amaze”clinical trial which is due to be completed in December 2019. For more about the SentraHeart Lariat device, see my article, Lariat II Suture Delivery Device.

The AtriClip is traditionally used during open-heart, Maze, or Mini-Maze surgery to close off the LAA. But it can be used as a stand-alone secondary heart surgery, which is traumatic and risky. The first generation AtriClip is essentially a “rectangle” placed around the LAA. Then it’s collapsed to close off the LAA. It does contain nitinol (50% titanium + 50% nickel) to provide felxibility for insertion. One major advantage of the AtriClip is it removes (closes off) the LAA which also eliminates electrical activity (A-Fib signals) that the LAA may have been producing.

The second generation AtriClip is more like a “hair clip”. Once the clip is correctly placed around the LAA, it’s then “triggered” by a type of spring-loading which doesn’t require the flexibility of nitinol.

Additional warning: today’s pacemaker leads may also contain nickel.

Be very careful selecting a surgeon to install the AtriClip. As a stand-alone surgery, it can be somewhat challenging. Make sure your surgeon has a lot of experience and verifiable success results.

The Watchman Occlusion Device and Risk of Device-Related Blood Clot

The Watchman is an occlusion device that closes off the Left Atrial Appendage (LAA) to prevent clots from getting into the heart. For those with A-Fib, 90%–95% of clots and strokes come from the LAA.

The Watchman device is considered an alternative or an improvement to a lifetime of taking anticoagulants including warfarin and the NOACs. See Watchman Alternative to Coumadin and Watchman Better Than Warfarin.

2018 HRS Report: Clots Can Form on the Watchman

A new meta-analysis of clinical trials and registries of the Watchman device is believed to be the largest to date of Device-Related Thrombi (blood clot) following left atrial appendage closure.

Size comparison of the Watchman occlusion device

The study shows that in about 3.7 percent of patients a blood clot forms on a metal screw on the face of the device. The clot can form many months, even a year after installation.

“While not frequent, when present, thrombus on the face of an LAA occluder is associated with a high rate of ischemic stroke,” said study presenter Vivek Y. Reddy of Mount Sinai Hospital in New York City. (Dr. Reddy was one of the original investigators of the Watchman clinical trials.) These findings were presented at the 2018 Heart Rhythm Society meeting.

Device-related thrombi (DRTs) are troublesome because they increase the risk of ischemic stroke by over 3 fold. However, no significant association with mortality emerged.

This risk, Dr. Reddy said, calls for aggressive management of patients at risk for device-related blood clots.

The Study: Finds Device-Related Thrombi (DRTs)

To better understand the mechanism of stroke after LAA closure, Dr. Vivek Reddy and his colleagues, looked at the incidence, predictors and clinical outcomes of device-related thrombus (DRT).

Watchman device: inserted (L) and progression of proper tissue growth (R)

The meta-analysis study looked at data on 1,739 patients who were successfully implanted with the Watchman device as part of four prior clinical studies. Patient follow-ups included a transesophageal echocardiography (TEE).

Findings: Among those patients receiving a Watchman, the investigators found 65 patients (3.74%) had DRT. Most were detected after anticoagulation had been discontinued at 45 days post-insertion. Some DRTs first showed up at the 1-year TEE.

“A majority of Watchman patients with an identified DRT (74% of the 65 patients) did not have a stroke.” Dr. Vivek Reddy

Dr. Reddy reported that despite these findings, a majority of Watchman patients with an identified DRT (74% of the 65 patients) did not have a stroke. And in Watchman patients who did have stroke, 87% occurred in the absence of a DRT.

Implications: There is a strong case for rethinking the timing of planned follow-up TEE examinations of Watchman patients. The standard protocol is a TEE at 45 days after placement, when routine anticoagulation usually stops, and then a second TEE 12 months after placement.

Dr. Reddy suggests a better schedule might be to perform the first TEE at 3-4 months after placement when oral anticoagulant therapy stops. This gives time for a potential DRT to form.

What this Means For Those Patients With a Watchman

“Prevention and management of DRT may require that each [Watchman] patient receive a tailored regimen of anticoagulation and surveillance,” said B. De Lurgio, MD, a cardiac electrophysiologist at Emory Healthcare commenting on Reddy’s report.

If you have a Watchman device, you and your EP should discuss “aggressive surveillance” to find any clots on the face of your Watchman. Usually these can be resolved by taking a course of anticoagulants.

If Closing the LAA: An Alternative Occlusion Device

Lariat placement: lasso around opening to LAA

With no metal involved, another occlusion device is the Lariat II 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).

But there has been a reported problem with the Lariat, too. For more on the Lariat see my article: Alert: Patients with Lariat Device for Left Atrial Appendage Closure.

A Challenge to Install: Compared to the Watchman, the Lariat is more challenging to install and is currently used less often than the Watchman. Not all EPs install and have experience with the Lariat II. You may need to do research to find an EP experienced and good at installing the Lariat. For more about the Lariat, see Lariat II Suture to Close the Left Atrial Appendage.

Watchman Still As Effective As Warfarin

Regarding this DRT data, Dr. Reddy said he didn’t think this data takes away from the argument that the Watchman is a reasonable strategy. “It doesn’t add or detract from the previous data.”

Clots can form on any foreign body as well as inside the heart.

Comparing stroke risks: In cases where no treatment was applied (neither anticoagulants nor the Watchman), the overall ischemic stroke rate is 6.0% per year.

Contrast that 6% rate to the stroke rates of 1.77% per year in people with the Watchman device and 1.71% per year for those on oral anticoagulation.

The Watchman is still a viable option against stroke risk.

Resources for this article
Dukkipati, SR et al. Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation. 2018; May 11: (Epub ahead of print)

Perriello, B. HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant. May 11, 2018.

Andrew D. Bowser. Device-related thrombus associated with ischemic events. Cardiology News. May 14, 2018.

FAQ: I am considering closure of the LAA. What do I need to know?”

FAQ: Closure of the LAA

“I don’t want to be on a blood thinner for years and years. My doctor is talking about closure of the Left Atrial Appendage. What is an occlusion device?”

An occlusion device, like the FDA approved Watchman., is used to close off the Left Atrial Appendage (LAA), the source of most clots (90%-95%) and A-Fib-related strokes.

The Watchman is inserted in a very low risk procedure that takes as little as 20 minutes. Afterward, you would usually not need to be on a blood thinner (anticoagulant).

Closure of the LAA is often included in a Maze/Mini-Maze surgery and sometimes as part of a catheter ablation.

Side Effects: Closure of the LAA may compromise the ability of the Left Atrium to function fully. Serious athletes would probably miss the reduced blood flow from the left atrium. But most A-Fib patients would hardly notice.

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

Catheter placing Watchman in LAA

Long-Term Effects: 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 (compared to long-term use of the blood thinner, warfarin). But we can’t say that for sure until enough time has passed. The first clinical trials installation of the Watchman device in the US was in 2009 and in Europe in 2004. So far, no long-term complications have developed.

Other Occlusion Devices: Besides the Watchman from Boston Scientific, other occlusion devices include the Amplatz Amulet from St. Jude Medical and the LAmbre from LifeTech Scientific.

EPs Installing the Watchman Device: To find EPs installing the Watchman or other occlusion devices, 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.

Reference Articles: To learn more about the removal of the LAA, and the Watchman, see my articles, The Role of the Left Atrial Appendage (LAA) & Removal Issues and The Watchman™ Device: The Alternative to Blood Thinners.

Resource for this article
Holmes, Jr. DR et al. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation. J Am Coll Cardiol. 2015;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025

At 55, A-Fib After Underwater Hockey, Then 2 Failed Ablations & a 3rd Using the ECGI Vest

By Martin Johnson, Champaign, IL. March 2018
With a post-script by Dr. Phillip Cuculich, Barnes-Jewish/Washington Un.

Martin Johnson

“My first A-Fib attack that I noticed, occurred in 2003 when I was 55 years old during a game of underwater hockey, an extreme sport requiring swimming under water while pushing a lead puck from one end of the pool to the other.

At first, I thought “well I did just swim 25 yards under water as fast as I could, so maybe this is just normal”. It lasted about 20 seconds.

The attacks quickly increased their duration to a couple hours each over the next couple months. I was forced to give up the game I’d been playing since age 37. I switched sports to softball, but that soon became impossible too, as I got an A-Fib attack every single game (but oddly, never at a practice).

A-Fib Progresses―Attack Just Sitting at Desk

For the first couple of years I only got attacks after physical exertion. As time went on, less and less exertion was required to trigger one.

I had my first attack without any kind of physical exertion while sitting at my desk at work. It scared me enough to see the local EP who recommended that I get an ablation. I thought that was too aggressive and instead started to try various drugs.

“My EP’s prognosis was―’ever more often, ever longer attacks until I would be in permanent A-Fib’”.

After going through 6 different drugs, most of which had no effect, one of which almost killed me and another that modified my attacks, I had no net improvement. My EP’s prognosis was “ever more often, ever longer attacks until I would be in permanent A-Fib”.

By 2010, I was getting approximately 24-hour long attacks approximately every four days plus occasional attacks triggered by physical exertion.

My First Ablation

I had my first RF ablation in July of 2010. I asked the EP if I should be in my natural A-Fib before the ablation, so that he could locate the problem cells. He said ‘no’. Instead, he induced A-Fib chemically. His approach was to isolate the PVs and draw several other lines in the left atrium. He then ablated the cells that he could detect taking part in the A-Fib that he induced.

He successfully got my heart back into Sinus Rhythm (SR), and was unable to further induce A-Fib. His OR report says that he expected this to have been a cure. (An O.R. [Operating Room] report describes what the EP did during the ablation.)

Two hours after the ablation, I was in A-Fib again.

In A-Fib Again―Leads to a Second Ablation

My A-Fib attack timing continued without letup— 24-hour-long attacks every 4 days. I agreed to a second ablation 6 months later.

“Two hours after the ablation, I was in A-Fib again.”

The OR Report for the second ablation was essentially the same as the first, and so were the results. After both ablations, I acquired new arrhythmias that annoyed me even while not in A-Fib. After about 6 months, the new arrhythmias abated, and my A-Fib pattern changed to 24 hours every 7 days—a small but welcome improvement.

Over the next five years, the attacks became longer and more frequent— by Jan 2016, I had 45 hours of A-Fib every 7 days.

Third Ablation? I Needed an Edge

Still I was not optimistic about a third ablation considering my previous poor results.

Medtronic ECGI vest

I decided I needed an edge—something that might be able to find whatever oddball A-Fib cause made me difficult to cure. The one thing that stuck out in my reading was the Medtronic ECGI vest used in Bordeaux, France by Dr Haissaguerre and others. [See How ECGI (Non-Invasive Electrocardiographic Imaging) Works.]

The 256 electrode ECGI vest enabled the graphic display of the electrical activity of the heart passively and totally non-invasively. Unfortunately, Dr Haissaguerre’s office would not respond to any of my attempts to contact him. And I learned that the FDA would not permit the use of the vest in the US as part of an ablation procedure.

Travel to St. Louis Where the ECGI Vest Was Invented

It seemed that all doors to the vest were shut. After some investigation, I discovered that the vest had actually been invented in the US at Washington Un. in St. Louis, MO. In January 2016

“I volunteered for a study…that might help me get use of the vest in spite of the FDA.”

I called up the inventor’s lab to get as much information as I could. I volunteered for a study with the hope of making connections that might someday help me get use of the vest in spite of the FDA.

In January 2017, I went to St Louis and got a CT scan and a vest recording for the study I had volunteered for. While there, I noticed a Dr. Cuculich come into the lab to borrow a vest. I immediately thought, this is the guy I need to keep track of.

FDA Approves Medtronic ECGI Vest―My New Hope!

Then the next month, Feb 2017, the FDA approved a commercial version of the vest made by Medtronic for use with A-Fib ablation.

By this time, I was having 48 hour attacks every 4 days. I called Medtronic to get a list of who in the US had bought the vest and who had any experience using it. To my relief, Barnes-Jewish Hospital in St Louis was one of only four buyers, and Dr Cuculich already had experience using the vest on non-A-Fib applications.

Now that I had located a possible vest practitioner, I still had to resolve other concerns. In particular, even Dr Haissaguerre in France didn’t use the vest on paroxysmal A-Fibbers. He only used the vest on patients with permanent A-Fib. I don’t know why. I was convinced that being in my natural A-Fib and not in chemically induced A-Fib, was essential to find the real causes. I also knew that I could put myself into A-Fib by physical exertion.

BisenseWebster Smart Catheter illustrations

Example of Contact force catheter (Biosense Webster)

Another Technology Edge: The Contact Force Catheter

Another technology that seemed important was the technique of dragging the catheter in order to burn a continuous line, rather than trying to burn individual dots. To help with this, a contact force catheter also seemed necessary. I first became aware of this due to a paper written by Dr Natale of Austin, TX. (see Resources below for article.)

A Concern: I Don’t Want to Lose My LAA

Another concern of mine was the insistence by some EPs to electrically isolate the Left Atrial Appendage (LAA).

“…in my mind…if the ablation worked, there would be no advantage to having closed off the LAA.”

During A-Fib, the blood in the LAA becomes stagnant, permitting the formation of clots.

But cutting off incompletely understood parts of one’s heart seemed exceedingly rash. Also, if the ablation worked, there would be no advantage to having closed off the LAA. So, closing off the LAA was just preparing for a failed ablation, in my mind.

About the Left Atrial Appendage (LAA)

What little is known about the LAA includes the fact that it is the source of heart stem cells needed for repair of the heart.

It was once thought that the heart cells you died with were the same ones you were born with. The latest belief is that about 40% of your heart is replaced during a full life.

This is a function I did not want to lose.

The LAA is also the source of a hormone which helps control blood pressure. The LAA also has a pumping function in parallel with the Left Atrium. And electrically isolating the LAA can often significantly reduce the contractile function of the LAA, thus making it a source of clots even when the heart is not in A-Fib.

Consulting Dr. Phillip Cuculich at Barnes-Jewish/Washington Un.

I called up Barnes-Jewish to inquire about my above listed concerns. Dr Cuculich called back and assured me that he was able and willing to meet all these requests:

1) Use the ECGI vest during ablation even though I’m paroxysmal;
2) To expect me to be in my organic A-Fib;
3) After getting me into Normal Sinus Rhythm, chemical induction of A-Fib was OK to track down more problems;
4) Use a contact force catheter and draw continuous lines rather than dots;
5) Leave my LAA electrically and physically intact.

Third Ablation―Running Up Flights of Stairs

The night before the scheduled ablation, I ran up and down a flight of stairs ten times which put me in my organic A-Fib in preparation for the following morning’s ablation.

On Nov 2, 2017, two Medtronic technicians fitted the 3-piece vest onto my torso. The ablation procedure took 5 hours—a lot longer than Dr Cuculich was planning on.

I woke up in NSR! The doctor noted that an A-Fib source in a pulmonary vein was active, but was already successfully being blocked by the ablation.

In Normal Sinus, But Short Bursts of A-Fib

Since the ablation 3.5 months ago, I have had about 15 A-Fib attacks totaling about 7 hours of A-Fib. [It’s not uncommon for A-Fib to reoccur during the three month ‘blanking period’ following an ablation.]

I believe every attack was triggered by drinking cold water. It took me a while to figure that out. I have not had an attack for the last month, during which I was able to remember ‘no cold water’!

Lessons Learned

For future reference: I read that Dr Cuculich was the lead investigator in a study of a totally non-invasive ablation procedure that uses the Medtronic vest to find the problems and ‘multi-beam focused radiation’ to ablate the errant heart cells.

I’m hoping that if my A-Fib comes back, that the FDA won’t have been as slow permitting this new method, as they were with the vest (see Resources below for link).

In light of my experience, I would recommend that no one get an ablation without the advantage of the Medtronic ECGI vest. Without it, the EP is only guessing.

Using canonical ablation patterns that might have worked on some group of A-Fibbers, or using the old fashioned way of dragging a sensing catheter along the entire inner surface of a beating heart looking for electrical anomalies, is laughable to me.

It’s no wonder that my first EP couldn’t find the A-Fib sources inside my coronary sinus and right atrium. I welcome your emails.”

Marty Johnson

Comments from Dr. Phillip Cuculic

Electrophysiologist Phillip Cuculich, MD

Phillip Cuculich, MD

“Thank you, Steve, for the chance to reply [to Martin’s A-Fib story]. And thank you, Martin, for sharing your story with the world. Brave patients and advocates like you are a powerful combination in today’s world of medicine.

Our understanding of any arrhythmia mechanism falls into two bins: the initiating event (triggers) and the sustaining circuit.

Over the past several decades, invasive procedures have identified common locations that harbor AF triggers, which is how pulmonary vein isolation has been an effective procedure to control AF for most patients. In general, we as a field have struggled in identifying reproducible non-PV triggers and the sustaining AF circuits.

One reason for our struggle is the tools with which we measure. A second reason is that each person’s AF is different, so the findings of one group of patients is not easily applicable to an individual patient that I meet for consultation.

Martin’s experience with noninvasive ECGI is a wonderful example of personalized medicine: treating an individual patient’s AF physiology. Credit for the development and clinical validation of this technology goes to the scientists, clinicians and industry development teams which include Dr. Yoram Rudy (Washington University), the amazing scientists who graduated from his lab, the intrepid clinical and investigational teams in Bordeaux, France, and the hard-working developers at CardioInsight and Medtronic.

Presently, thoughtful application of noninvasive ECGI is getting us closer to personalized AF treatment. Further development, testing, and refinement of the ECGI system is underway. While there is much more to accomplish in understanding the critical components of each individual patient’s AF, one cannot help but hear the hope dripping from the story that Martin shared.”

Editor’s Comments
I admire Martin’s tenacity in seeking his A-Fib cure after two failed catheter ablations. He educated himself about his disease and its treatments. Then he sought out an EP who would meet his needs, even drawing up a five-point check list to discuss before his third ablation. Well done, Martin!
Martin’s O.R. Report: Dr. Cuculich found all Martin’s PV’s were still not isolated or had re-connected. After his two previous ablations, all Martin’s PVs had connected/re-connected. Dr. Cuculich also found many gaps in Martin’s previous roof and mitral isthmus ablation lines.
ECGI Vest Found Hard-To-Map Drivers: The Medtronic ECGI Vest mapping system found Non-PV driver areas in Martin’s heart that easily could have escaped notice with routine mapping systems, areas such as the Coronary Sinus, Left Superior Pulmonary Vein and lateral Right Atrium.
During Dr. Cuculich’s ablation, Martin’s A-Fib/Flutter terminated when his Coronary Sinus was effectively ablated and isolated. This is considered the best outcome of an ablation. Most EPs would have stopped at this point. But because the Medtronic ECGI vest had indicated there were more A-Fib signal sources not yet ablated, Dr. Cuculich ablated those areas as well.
Medtronic ECGI Vest Very Effective! Martin’s A-Fib was a difficult case after two failed ablations. Instead of the usually 2-3-hour ablation, Martin’s took 5 hours, probably because the previous 2 ablation lesions made the third ablation more complicated.
The Medtronic ECGI Vest seems to be a major advance and improvement in the treatment of A-Fib. It certainly worked in Martin’s case. But at this time, few centers in the U.S. are using it and are only beginning to develop significant experience. This is because Medtronic wants the system to work as best as possible before making it more widely available.
What this means to patients: If you have persistent A-Fib or would be considered a potentially difficult case, try to find a center or EP with experience using the Medtronic ECGI Vest (even though you may have to travel.) It seems to be the next major advance and best mapping/ablation system on the market.

References for this Article

Kolata, G. A ‘Game Changer’ for Patients With Irregular Heart Rhythm. The, Dec. 13, 2017.

Cuculich, P. S., et al. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. December 14, 2017. N Engl J Med 2017; 377:2325-2336. DOI: 10.1056/NEJMoa1613773.

Ryan, S. The New Era of Catheter Ablation Technology: Force Sensing Catheters.

Ryan, S. The Role of the Left Atrial Appendage (LAA) & Removal Issues.

Natale, A., et al. Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter: Results of the Prospective, Multicenter SMART-AF Trial. Journal of the American College of Cardiology, 2014. ISSN: 1558-3597, Vol: 64, Issue: 7, Page: 647-56.

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If you find any errors on this page, email us. Y Last updated: Tuesday, July 28, 2020

2018 AF Symposium Live Case: CryoBalloon Catheter for Isolation of the LAA

by Steve S. Ryan, PhD.

B. Knight MD

During this live streaming video, Dr. Bradley Knight from Northwestern Un. in Chicago, IL demonstrated the use of a CryoBalloon Catheter to isolate the Left Atrial Appendage (an off-label use, i.e. a new use not described in the FDA approved device labeling.).

Patient background: His patient was a 72-year-old man with hypertension and persistent A-Fib. He had an ablation in 2013. His ejection fraction was low but improved after a cardioversion to 40%. July 15, 2017 he had a right atrium Flutter ablation. He was on amiodarone which had to be stopped because of thyroid problems.
He developed severe Left Atrium enlargement and his ejection fraction went down to 30%. His PVs was were very large and hard to isolate. It was recommended to do both a repeat PVI and to isolate the LAA.
Live Streaming Video from AF Symposium at

Isolating the Left Atrial Appendage

To isolate the Non-PV triggers originating in the patient’s Left Atrial Appendage, Dr. Knight used a 28 mm CryoBalloon catheter in order to penetrate deeper into the LAA.

A second freeze was performed and then a third freeze was necessary because the LAA was still generating A-Fib signals. Before we could see this third freeze, the allotted time slot ran out.

The use of the CryoBalloon catheter appeared to be an effective treatment (though an off-label use) to isolate the LAA.

Editor’s comments:
I was surprised that two CryoBalloon lesions didn’t effectively isolate the patient’s LAA and a third lesion was necessary.
On the other hand, the use of the CryoBalloon catheter to isolate the LAA is in the very preliminary stage of research.
From watching Dr.Knight’s live case, it doesn’t seem like the CryoBalloon catheter will emerge as a viable method of electrically isolating the LAA.

If you find any errors on this page, email us. Y Last updated: Saturday, February 16, 2019

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2018 AF Symposium Live Case: Installing a Coherex WaveCrest LAA Occlusion Device

by Steve S. Ryan, PhD.
Background: The Coherex WaveCrest Left Atrial Appendage (LAA) occlusion device is not yet approved by the FDA for use in the U.S. The WaveCrest is similar in purpose to the Boston Scientific Watchman™ LAA Closure Device (which is FDA approved).

Tom De Potter MD

Dr. Tom De Potter of Aalst, Belgium, presented a live case in which he installed a Coherex WaveCrest Left Atrial Appendage (LAA) occlusion device in an 84-year-old female with longstanding A-Fib and a bleeding problem.

The WaveCrest has roll-out anchors which are then fixed into the sides of the LAA. It comes in three sizes to fit different LAA openings.Live Streaming Video from AF Symposium at

He spent a good deal of time and attention washing and immersing the WaveCrest in water to make sure there were no bubbles.

When the device is expanded inside the LAA, it can be repositioned and recaptured. Dr. Potter seemed to tug and firmly push and pull the device to anchor it.  After insertion, it requires 2 months of dual antiplatelet therapy.

WaveCrest is from Coherex Medical, Inc., a subsidiary of Biosense Webster/Johnson & Johnson.

Coherex WaveCrest Video

Video still frames of Coherex WaveCrest occlusion device positioned in LAA.

Video animation is available: The Coherex Medical website has a short (35-second) showing the installation of the Coherex WaveCrest Left Atrial Appendage (LAA) occlusion device. Go to video on the Coherex website->

Editor’s Comments:
To me the WaveCrest seemed similar to Boston Scientific Watchman LAA Closure Device which did all the heavy lifting to be the first LAA occlusion device to get U.S. FDA approval.
I didn’t see major significant advantages of the WaveCrest. Though it’s always good for EPs to have a choice of devices when closing off the LAA.
For more on the Watchman, see  my article, The Watchman™ Device: An Alternative to Blood Thinners. 

If you find any errors on this page, email us. Y Last updated: Wednesday, February 28, 2018

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