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Updated: Feb 24, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
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.
Insights
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.
Background:
Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding.
Methods:
From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset.
Results:
AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively.
Conclusions:
In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.
