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2023 AF Symposium Spotlight: Ground-Breaking LAA Elimination Device
For A-Fib patients, perhaps the most innovative and potentially ground-breaking presentation at this year’s AF Symposium was by Dr. Saibal Kar of Cardiovascular Associates at Los Robles Hospital in Thousand Oaks, CA.
In a Spotlight Session on Friday, he described a new device for closing off (“eliminating”) the Left Atrial Appendage (LAA). The LAA is where 90%-95% of Atrial Fibrillation clots and strokes come from.
The Laminar LAA elimination device is a potential medical breakthrough innovation! It takes little time to insert, it could be positioned at the same time as a catheter ablation. This could revolutionize the way LAAs are closed off today.. Learn all about it in my report: Spotlight Session: Laminar LAA Closure/Elimination Device.
2023 AF Symposium: Innovative A-Fib Ablation Plus LAA Closure in One Procedure
This report from the 2023 AF Symposium is about an innovative treatment for A-Fib patients―combining A-Fib ablation with the insertion of a Left Atrial Appendage (LAA) occlusion device in a combined procedure.
Closing off the Left Atrial Appendage has become an important topic for patients looking to be A-Fib free.
Many A-Fib stokes originate in the Left Atrial Appendage. And many recurrences of A-Fib come from the Left Atrial Appendage, too.
Inserting a Watchman occlusion device to close off the LAA has become a relatively simple and fast process. Combining it with a catheter ablation doesn’t add much time to the ablation procedure.
This treatment strategy is currently in use in many countries overseas, but isn’t yet common practice in the U.S.
Dr. Walid Saliba of the Cleveland Clinic Foundation in Cleveland, OH explained how patient selection is important in this combined procedure. To learn more read my report…
2023 AF Symposium: Ablation Combines with LAA Closure in One Procedure
2023 AF Symposium
Ablation Combines with LAA Closure in One Procedure
Walid Saliba, MD
Dr. Walid Saliba of the Cleveland Clinic Foundation in Cleveland, OH, discussed an innovative treatment for A-Fib patients―combining A-Fib ablation with the insertion of a Left Atrial Appendage (LAA) occlusion device in a combined procedure. (This treatment strategy is currently in use in many countries overseas, but isn’t yet common practice in the U.S.)
Patient Selection
Dr. Saliba explained how patient selection is important in this combined procedure.
The idea patient with atrial fibrillation needing an ablation would also have a high risk of stroke but couldn’t tolerate anticoagulants because of a high risk of bleeding.
Advantages of Combining PVI with LAA Closure
While these two procedures (A-Fib ablation and LAA closure) are typically done separately, combining them in one procedure has many potential advantages. Both procedures:
• require access from the groin to the left atrium
• initiating oral anticoagulation around the time of the procedure
Dr. Saliba made the following points:
1.Combining these two procedures reduces the risk of complications. (For example, one only has to make a transseptal puncture once rather than at two different times.)
2. Patients prefer only having to have one procedure rather than the hassle of going to the hospital twice for two different steps.
3. Combining these two procedures reduces the potential risk of bleeding.
Reimbursement Problem in U.S.
Dr. Saliba described how in the beginning (2015) it was difficult to be reimbursed for combining two different procedures at the same time. But eventually he was able to convince the powers that be that this was good for certain patients and actually saved the hospital money.
Source of A-Fib Recurrences
Dr. Natale and Dr. Saliba discussed that many A-Fib recurrences come from the Left Atrial Appendage. Inserting an LAA occlusion device when performing an ablation might prevent the mapping and ablating of non-PV triggers in or around the LAA. (This is less of a problem with the Watchman than with the Amulet device which actually masks off the LAA area with a metal disc.)
High Success, Low Complication
Dr. Saliba and his colleagues at the Cleveland Clinic have performed this combined procedure on more than 240 patients with one-year follow-up. Their success rate is high with low complications. Patients stayed in the hospital for a day. Over 95% of their patients are eventually off of anticoagulants.
Half of their patients received the original Watchman, while the other half got the Watchman FlX. Leaks around the Watchman were only around 2.2% and were less than 2mm. At 90 days leaks were around 25% with less than 3mm. Dr. Saliba hasn’t noticed any problems with LAA remodeling, pressure, or scarring of the Left Atrium wall.
OPTION Trial Revelations to Come
The OPTION Trial is a clinical study of patients with non-valvular A-Fib. It compares outcomes of a combined ablation + LAA occlusion procedure versus catheter ablation alone followed with anticoagulation.
Specifically, the study is to determine if the WATCHMAN FLX occlusion device placed at the time of the ablation is a reasonable alternative to continuation of oral anticoagulation following catheter ablation. The results of this trial will be available in 2024.
Editor’s Comments
Combining PVI with LAA Closure Medical Breakthrough! Combining a catheter ablation for A-Fib (PVI) with the insertion of a Watchman occlusion device seems a major improvement for patients, as well as reducing or eliminating a major source of worry for electrophysiologists (EPs).
One day, hopefully soon, everyone getting a catheter ablation will also have an occlusion device inserted in one procedure.
Free from Most Stroke Risk: Inserting a Watchman device to close off the LAA has become a relatively simple and fast process. Combining it with a PVI doesn’t add much time to the ablation procedure. And Dr. Saliba’s research demonstrated that it works!
The Left Atrial Appendage (LAA) is where most clots and strokes come from in patients with non valvular A-Fib. Patients getting a catheter ablation generally leave the hospital A-Fib free.
Nevertheless, they are still considered at some risk of stroke. Current guidelines dictate continuation of stroke prevention with oral anticoagulation despite a successful ablation. Having the LAA closure device offers protection against stroke without the ongoing bleeding issues of oral anticoagulation.
Patients Would Choose/Prefer This Combination Procedure: If you offered the average A-Fib patient the chance to be protected from a stroke at the same time they are made A-Fib free by a catheter ablation, most patients would choose the combination procedure.
They would only have to be hospitalized once and wouldn’t have to return weeks later to have their LAA closed off, as is common practice in the U.S. today.
They would have better peace of mind and quality of life knowing they are largely protected from having an A-Fib stroke.
And their doctor wouldn’t have to worry about them going off their anticoagulant and developing a clot in their LAA.
If you find any errors on this page, email us. Y Last updated: Thursday, May 11, 2023
Return to 2023 AF Symposium Reports
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.
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.
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
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.
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
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 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
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
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. Patients taking DOACs present a residual risk for major bleeding of 1.5-3.6%/year.
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
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.
• Sandro Ninni, Stanley Nattel. Factor xia inhibition in atrial Fibrillation: insights and knowledge gaps emerging from the PACIFIC-AF trial. Cardiovascular Research, cvac196. January 25, 2023, https://academic.oup.com/cardiovascres/advance-article/doi/10.1093/cvr/cvac196/7005367. https://doi.org/10.1093/cvr/cvac196
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
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
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
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!
