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


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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

2022 AF Symposium Spotlight: Innovation in Development to Seal the Left Atrial Appendage

The CLASS LAAO

Sometimes the method to close off the Left Atrial Appendage, doesn’t make a complete closure. It can leak. I’m very excited about this new product. Dr. Jamie Kim of the Catholic Medical Center in Manchester, NH, presented one of the most innovative and promising new developments for patients to close off their LAA.

Instead of relatively hard, rigid structures which don’t always conform perfectly to the LAA opening and thus may leak, the CLASS LAAO system from Conformal Medical, Inc. uses a different type of conformable foam-based fabric to seal off the LAA. Read this short Spotlight summary for more about this promising new device.

Go to my 2022 AF Symposium page with all my reports.

A-Fib Catheter Ablation Combined with Left Atrial Appendage (LAA) Closure

In the People’s Republic of China (and other countries) catheter ablation for Atrial Fibrillation is often combined with closure of the Left Atrial Appendage (LAA) in one procedure. This means A-Fib patients can have a Watchman occlusion device installed at the same time as their catheter ablation.

While it may be common practice in some locales, there is limited research data on this combined procedure and, in particular, with patients with prior stroke. That’s why this study in China was conducted.

There is limited research data on this combined procedure and, in particular, with patients with prior stroke.

Aim of this Study: To compare the safety and efficacy of combined catheter ablation with closure of the Left Atrial Appendage (LAA), especially for A-Fib patients who have had a prior stroke.

Study Design: This retrospective study enrolled 296 patients who underwent combined procedures of A-Fib catheter ablation and LAAC. Patients were divided into two groups: 81 patients with prior stroke (Stroke group) and 215 patients without prior stroke (Control group).

Combined procedures were successfully performed in all the patients.

Follow-up Findings: The researchers followed-up with patients at a mean of 20 months.

Both the Stroke group and the Control group (without prior stroke) were relatively A-Fib free after catheter ablation. (Stroke group: 64.2%, the non-stroke control group: 68.4%).

The relative risk reductions in stroke and bleeding were around 80% in the stroke group and 62% in the control non-prior stroke group.

Conclusion: The researchers wrote: “The combination of catheter ablation and LAAC (Left Atrial Appendage Closure) is safe and effective in selected AF patients with prior stroke.”

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

There are several limitations to this study. This is a single-center retrospective study with a moderate sample size.
Despite the limitations of this study, for A-Fib patients the combination of catheter ablation and Left Atrial Appendage (LAA) closure appears safe and effective.

Currently, U.S. patients have to wait 3 months after a catheter ablation to have a Watchman inserted. Why must patients wait, why endure months of anticoagulants usage? But, more research is needed to confirm the conclusions of these researchers.

Reference
Mo, B et al. Combined Catheter Ablation and Left Atrial Appendage Closure in Atrial Fibrillation Patients with and without Prior Stroke. Journal of Interventional Cardiology, Volume 2021, Article ID 2138670. https://www.hindawi.com/journals/jitc/2021/2138670/ https://doi.org/10.1155/2021/2138670

 

Spotlight Session: Clinical Experience with the CLASS LAAO System

2022 AF Symposium

Spotlight Sessions: Features products or devices usually still in development or not yet FDA approved. They give us a glimpse into what the future of A-Fib treatment may look like.

Spotlight Session: Clinical Experience with the CLASS LAAO System

Dr. Jamie Kim

Dr. Jamie Kim of the Catholic Medical Center in Manchester, NH, presented one of the most innovative and promising new developments for patients to close off their Left Atrial Appendage (LAA).

The CLASS LAAO

Instead of relatively hard, rigid structures which don’t always conform perfectly to the LAA opening and thus may leak, the CLASS LAAO system from Conformal Medical, Inc. uses a different type of conformable foam-based fabric to seal off the LAA.

Complete Seal

The CLASS is designed to conform to a broader range of LAA sizes and shapes.

In the animation we saw, the foam-like material expanded from the insertion catheter to fill the interior of the irregularly shaped LAA. Dr. Kim says the seal made by the CLASS is complete.

Easier To Use, Wider Applicability

The CLASS LAAO system catheter

The CLASS device is soft which allows for both easier positioning when inserted and greater conformability. It also didn’t seem to have any metal protrusions as one sees in the Watchman.

It comes in only two sizes. It also uses rows of anchors to lock the device in place in the LAA. It’s designed with a flexible Nitinol under skeleton. It can be re-captured, if necessary.

To compare the Watchman with the CLASS, see my report: The Watchman Device. There’s also a brief animation of how the Watchman is installed: The Watchman FLXTM Device: Closure of the Left Atrial Appendage.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

Barring any problems in the clinical trials, the CLASS LAA closure device is a major medical advance for patients. The CLASS LAA closure device will likely become the choice of most EPs and will supersede both the Watchman and Amulet devices.

How Does LAA Closure for Atrial Fibrillation Affect Heart Pumping Ability?

Left Arial Appendage (LAA) closure is the cornerstone of stroke prevention in surgical treatment of A-Fib. The Left Atrial Appendage is closed off, cut out, stapled shut, or shut off with a clip. How does this affect the heart’s ability to pump blood?

Small Study to Directly Measure Pumping Effect of LAA Closure

In a very small study of the hybrid operation/ablation, seven patients were measured for cardiac output and left ventricular stroke volume just before the hybrid operation, directly after, then ten minutes later.

The hybrid operation/ablation, learn more at The Cox-Maze & Mini-Maze Surgeries and the Hybrid Surgery/Ablation

The researchers pointed out that “the LAA also has a contractile function and takes part in the LA contraction process, especially in patients in SR (sinus rhythm)”.

But five of the seven patients were in A-Fib and already had reduced ejection fraction (EF) (26%). (Normal EF is 50% to 75%.) Even in the patients in SR, their EF was only 46%.

Ejection fraction (EF) is a percentage of blood that is pumped out of the heart during each beat. A range of 50%-75% indicates your heart is pumping well, delivering an adequate amount of blood to the body and brain.

LAA Closure Lowers Pumping Pressure Long Term

The researchers pointed out that LAA closure “can result in lower systolic blood pressure on the long term” according to previous research. (“Systolic” is the top number in your blood pressure measurement and is the pumping force your heart exerts.)

The researchers also pointed out that the LAA is the predominant site of atrial natriuretic peptide (ANP) in the heart which can affect heart pumping “volume overload”.

No Significant Difference

The researchers found no significant differences in various pumping measurements, but the Left Ventricular Stroke Volume (LSCI) was affected (28 mLm² to 24 mLm², P-value 0.066).

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

Patients with Poor EF: In patients with poor heart pumping and contracting ability (EF below 50%) to begin with, this study suggests they aren’t affected much by losing their LAA. They probably wouldn’t even notice it was gone. But the jury is still out on how losing the LAA affects even A-Fib patients with poor Ejection Fraction (EF) long term.
Patients with Normal EF: However, this may not be the case with A-Fib patients with a normal EF. The LAA does have a contractile function, particularly in patients with larger size LAAs. (Do athletes have larger size LAAs due to their exercise?)  This small study did not address the cases of A-Fib patients with normal EFs.

What This Means for A-Fib Patients

This small study didn’t measure patients with a normal Ejection Fraction (EF) who had their Left Atrial Appendage (LAA) closed off or removed. Most likely the heart’s pumping ability is affected by losing one’s LAA. (In dogs, the LAA provides 17.2% of the volume of blood pumped by the left atrium.)
If you are an active exerciser or athlete, you may want to consider keeping your LAA if possible. But for most people, losing your LAA probably won’t affect you very much. You may not even notice your LAA is gone.

What this Means to Me: A Watchman in my Future

Personally, I love to run, do sprints, etc. But after two recent ablations (after 21 years of being A-Fib free), my Medtronic Reveal LINQ loop recorder recently picked up a full day of Silent A-Fib signals. (Reports are sent wirelessly to my EP each night by the bedside transmitter.)

This wasn’t a big surprise. In my last ablation, my LAA was ablated to stop A-Fib signals, but it also electrically affected the LAA from pumping out properly. My EPs warned me that I would likely need to close-off my LAA sometime in the future.

With this recent data, my two EPs (Drs. Doshi and Natale) recommended I close-off my LAA with a Watchman device.

Even though it might affect my pumping ability, at age 81, stopping my A-Fib signals is more important to me. After my Watchman implant, I’ll write more. 

For my first-hand account of having a Medtronic Reveal LINQ loop recorder, go to Has My A-Fib Returned? I Get an Insertable Wireless Monitor

Reference
Heuts, S. et al. Does Left Atrial Appendage Exclusion by an Epicardial Clip influence Left Atrial Hemodynamics? Pilot Results of Invasive Intra-Cardiac Measurements. JAFIB Journal of Atrial Fibrillation. http://www.jafib.com/PMC/XML/Inprogress/FullIssue/2021-06-30.pdf#page=64

Closure of the Left Atrial Appendage (LAA) vs Anticoagulants

The Left Atrial Appendage (LAA) is the source of many non-pulmonary vein A-Fib signals. So, when irregular heart rhythm signals persist after a catheter ablation, Atrial Fibrillation patients (like myself) look to closure or removal of the Left Atrial Appendage (LAA) rather than spending a lifetime on anticoagulants. Is this the wiser choice?

 The term “non-inferior” is used in a study to mean the new treatment is not worse than an active treatment.

Prague Research Study

A four-year study from Prague (PRAGUE-17) determined that Left Atrial Appendage (LAA) closure was “non-inferior” (i.e., not worse in comparison) to Novel Oral Anticoagulants (NOACs) for preventing major neurological, cardiovascular, or bleeding events in high-risk patients with A-Fib.

Two LAA occlusion devices

The anticoagulant most used in the study was apixaban (Eliquis) in 95% of cases. To close off the Left Atrial Appendage (LAA), electrophysiologists (EPs) used either the Amplatzer™ Amulet™ LAA Occluder or the Boston Scientific Watchman occlusion device.

The study also examined device-related complications finding “significant procedure/device-related complication was similar between the two treatment groups” (NOAC vs LAA Closure).

Bleeding risks: Furthermore, subsequent non-procedural bleeding was significantly reduced with LAA closure.

Anticoagulant risks: Patients taking anticoagulants for four years had a significantly greater risk of bleeding complications.

Danish Study Confirms Prague Results

NOACs vs DOAC? The term Novel oral anticoagulants (NOACs) is no longer “novel”; Preferred term is “DOAC,” which stands for direct oral anticoagulant.

In a study from Denmark using the Danish National Patient Registries, patients receiving the Amulet Left atrial appendage (LAA) closure device with a history of ischemic stroke were compared to similar patients receiving DOACs.

Risk of major bleeding events: The risk of major bleeding and all-cause mortality was significantly lower in the Amulet group. This study indicated similar stroke prevention effectiveness but significantly lower risk of major bleeding events with Left atrial appendage occlusion (LAAO) therapy compared with DOAC.

Editor's Comments about Cecelia's A-Fib storyEditor’s Comments

LAA Closure as Effective as Anticoagulants…Studies show that LAA Closure is just as effective as anticoagulants in preventing A-Fib stroke and other cardiovascular problems (stroke, transient ischemic attack, cardiovascular death, and clinically-relevant bleeding).
But Anticoagulants Increase Bleeding: As one would expect, having to take anticoagulants for four years did increase bleeding. For more, see Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.
The Bottom Line: If you have a choice, this research indicates a Left Atrial Appendage closure device like the Watchman is better than having to take anticoagulants for the rest of your life.

Many people hate taking anticoagulants. Now you don’t have to! LAA occlusion devices like the Watchman are a most welcome alternative to having to take anticoagulants for life.

Steve Ryan with Dr. Natale and surgical nurse, before ablation August 2021.

On a Personal Note: A Watchman is in my future.

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 and Dr. Doshi both 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.

References
• Osmancik, P. et al. Left Atrial Appendage Closure versus Non-Warfarin Oral Anticoagulation in Atrial Fibrillation: 4-Year Outcomes of PRAGUE-17. J Am Coll Cardiol. 2021 Oct 27;S0735-1097(21)07895-5 https://pubmed.ncbi.nlm.nih.gov/34748929/ doi: 10.1016/j.jacc.2021.10.023.

• Korsholm, K. et al. TCT-94 Clinical Outcomes of Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation Patients With Previous Ischemic Stroke. J Am Coll Cardiol. 2021 Nov, 78 (19_Supplement_S) B39. https://www.jacc.org/doi/full/10.1016/j.jacc.2021.09.944. 

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

References
● 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. https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.121.057063

● Todd. FDA Approves Next-Generation Watchman FLX Device for LAA Occlusion. TCTMD News, July 22, 2020. https://www.tctmd.com/news/fda-approves-next-generation-watchman-flx-device-laa-occlusion

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.

Resource
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.

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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.

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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 A-Fib.com

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)
Nickel4.2Reactive
Iron0.7Normal

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.

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