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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

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