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Updated: Mar 15, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left atrial appendage closure: A single center experience and comparison of two contemporary devices
Filippo Figini1,2, Patrizio Mazzone1, Damiano Regazzoli1
1Interventional Cardiology Department, San Raffaele Hospital, Milan, Italy.
Insights
Left atrial appendage (LAA) closure using percutaneous devices is safe and effective for stroke prevention in atrial fibrillation patients. Both Amplatzer Cardiac Plug (ACP) and Watchman systems showed comparable clinical outcomes, with ACP and 3D-TEE reducing leaks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous left atrial appendage (LAA) occlusion is an emerging stroke prevention strategy for atrial fibrillation.
- Real-world applicability of randomized trial results and direct device comparisons remain unclear.
Purpose of the Study:
- To compare indications and clinical outcomes of two contemporary LAA percutaneous closure systems.
- Evaluate real-world effectiveness and safety of LAA closure devices.
Main Methods:
- Retrospective analysis of 165 patients undergoing LAA closure between 2009-2015.
- Operators chose device (Amplatzer Cardiac Plug or Watchman) and indications.
- Routine clinical and transesophageal echocardiography (TEE) follow-up was performed.
Main Results:
- Low incidence of ischemic events (1 TIA, 0 strokes) over a median 15-month follow-up.
- 23% of patients had leaks ≥1 mm, less common with Amplatzer Cardiac Plug (ACP) and 3D-TEE.
- Clinical outcomes were comparable between ACP and Watchman systems.
Conclusions:
- LAA closure demonstrates excellent safety and efficacy in high-risk patients, regardless of device.
- ACP and 3D-TEE use minimized residual leaks.
- Clinical significance of small peri-device flow requires further investigation.
Objectives:
To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population.
Background:
Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared.
Methods:
We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed.
Results:
One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices.
Conclusions:
Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc.

