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2018 AF Symposium Live Case: Installing an Amplatzer™ Amulet™ LAA Occluder
by Steve S. Ryan, PhD.
Illustration: Amplatzer Amulet in LAA
On the Thursday session on Left Atrial Appendage Closure, two live cases were presented via streaming video from around the world.
Here, I cover the first live case featuring the Amplatzer™ Amulet™ Left Atrial Appendage (LAA) occlusion device. (For my report on the other occluder, see: Installing a Coherex WaveCrest LAA Occlusion Device.)
Note: The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder, is not yet approved by the FDA for use in the U.S. It is similar in purpose to the Boston Scientific Watchman™ LAA Closure Device (which is FDA approved). The Amplatzer™ Amulet™ is from Abbott (formerly St. Jude Medical).
Patient Background: An 81-year-old lady with acute hypertension was in permanent A-Fib since 2016. Her CHADS2VASc score was 5 (at the top of the risk range), her HAS-BLED score was 4 (high for one year risk of major bleeding). She had suffered syncope (fainting) episodes and had a history of major bleeding on anticoagulants (the reason for the LAA closure). On the positive side, her Ejection Fraction was a healthy 61%.
Live From Milan, Italy
Claudio Tondo, MD
Dr. Claudio Tondo from Milan, Italy, demonstrated an LAA Closure by inserting an Amplatzer LAA closure device.
In Europe, a LAA occluder can be inserted at the same time as a PVI (catheter ablation). But for the AF Symposium live session, only the Amplatzer Amulet™ was inserted. (Because of her history of major bleeding, Dr. Tondo decided to close off her LAA first while postponing a PVI till later.)
Amplatzer Amulet Features
Amplatzer™ Amulet™
The Amplatzer has two lips which close over both the outside and the inside of the LAA―like a sandwich. It comes in different sizes to fit better into different sized LAAs.
One advantage of the Amplatzer is less risk of leaking because the inside and outside lips overlap the opening of the LAA. Over time, heart tissue grows over the implant, becoming part of the heart.
Inserting the Amplatzer LAA Occluder
The primary imaging technology used to insert the Amplatzer was Intracardiac Echo, though fluoroscopy was used as an adjunct to help the audience follow the procedure. In the Echo you could see the Amplatzer being positioned and inserted into the LAA. (I could follow the fluoroscopy but found it hard to follow the Echo.)
Dr. Tondo described her LAA shape as “chicken wing” which is usually an LAA shape easier to close off. It appeared relatively easy to insert the device into the patient’s LAA, then fit it snugly into the LAA opening.
Dr. Tondo and his team used a type of dye pumped in behind the Amplatzer to see if there was any blow back or leaking. Once that was done, they simply disconnected the catheter used to insert the Amplatzer.
Amplatzer™ Amulet™ Video
A short animation from Abbott (formerly St. Jude Medical) illustrates insertion of the Amplatzer™ Amulet™ LAA Occluder (1:14). To watch the video, go to Abbott webpage->
Editor’s Comments:
About this patient: This 81-year-old lady was in a very difficult, risky situation. Her stroke risk was very high, but she couldn’t take anticoagulants to prevent a stroke because they caused her bleeding. By inserting the Amplatzer Amulet device to close off her Left Atrial Appendage (LAA), Dr. Tondo would significantly lower her risk of an A-Fib stroke which mostly comes from the LAA.
Her persistent A-Fib was very symptomatic with dangerous fainting episodes. She needed a catheter ablation to get her back into normal sinus rhythm. Dr. Tondo planned to perform the PVI as soon as possible after her LAA closure.
Two LAA occluder devices
About the Amplatzer Amulet: Having previously watched the Watchman Device procedure, to me the Amplatzer Amulet seemed simpler to insert. Though both are relatively easy to install.
One potential problem with an Amulet might occur if a subsequent catheter ablation requires the LAA to be mapped and isolated. It will be harder to do so because the lips of the Amulet cover the LAA opening.
In Europe, the Amplatzer Amulet is used to close holes in the septum (called ‘patent foramen ovale’, i.e. a hole in the heart that didn’t close the way it should after birth.).
Once approved in the U.S. by the FDA, it will probably become a competitor or an alternative to the Watchman Device.
If you find any errors on this page, email us. Y Last updated: Saturday, February 16, 2019
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