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Doctors & patients are saying about 'Beat Your A-Fib'...


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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 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. 

• 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

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