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Updated: Feb 24, 2026
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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
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Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry
Sergio Berti1, Gennaro Santoro2, Elvis Brscic3
1UO Cardiologia Diagnostica ed Interventistica, Fondazione Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy.
International Journal of Cardiology
|August 12, 2017
Summary
Left atrial appendage occlusion (LAAO) using AMPLATZER™ devices is safe and effective for preventing strokes in non-valvular atrial fibrillation (NVAF) patients. This large study shows high success rates and reduced thromboembolic events with these devices.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Left atrial appendage occlusion (LAAO) is a proven stroke prophylaxis for non-valvular atrial fibrillation (NVAF).
- Assessing AMPLATZER™ devices in a large, multicenter cohort of high-risk NVAF patients is crucial.
Purpose of the Study:
- To evaluate the safety and efficacy of AMPLATZER™ devices for LAAO in NVAF patients.
- To analyze procedural success, complication rates, and long-term outcomes.
Main Methods:
- A multicenter, single-nation study involving 613 NVAF patients from December 2008 to April 2015.
- Data collected included baseline characteristics, imaging, procedural details, and follow-up outcomes.
- No restrictions on institutional protocols for indications, planning, implantation, or follow-up.
Main Results:
- Successful AMPLATZER™ device implantation in 95.4% of cases.
- Major complications occurred in 6.2% (major bleeding 3.3%, pericardial tamponade 2.0%).
- Mean follow-up of 20 months showed a 66% reduction in stroke/TIA rates; annual stroke/thromboembolic event rates were 1.67%/2.90%.
Conclusions:
- LAAO with AMPLATZER™ devices demonstrates high procedural success and early safety.
- The study confirms mid-term efficacy in preventing NVAF-related thromboembolism.
- AMPLATZER™ devices offer a viable option for stroke prevention in high-risk NVAF patients.
