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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: Initial experience with the ultraseal device.
Ander Regueiro1, Mathieu Bernier1, Gilles O'Hara1
1Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
Summary
The Ultraseal device offers a safe and feasible option for percutaneous left atrial appendage (LAA) closure in patients with nonvalvular atrial fibrillation (NVAF). Initial results show successful implantation without major complications, indicating potential for stroke risk reduction.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Left atrial appendage (LAA) closure is an alternative to oral anticoagulation for stroke prevention in nonvalvular atrial fibrillation (NVAF) patients at high risk of bleeding.
- The Ultraseal device is a novel LAA closure prosthesis designed for high conformability to diverse LAA anatomies.
Purpose of the Study:
- To report the initial clinical experience and evaluate the safety and feasibility of percutaneous LAA closure using the Ultraseal device.
Main Methods:
- Twelve consecutive patients with NVAF underwent LAA closure with the Ultraseal device.
- Clinical and transesophageal echocardiography (TEE) assessments were performed at baseline and 45 days post-procedure.
Main Results:
- Successful device implantation was achieved in all patients, with no periprocedural complications.
- No instances of bleeding, stroke, pericardial effusion, or device embolization were reported at 45-day follow-up.
- One patient developed a device-related thrombus without clinical sequelae; no significant residual leaks were observed.
Conclusions:
- Initial experience with the Ultraseal LAA closure device suggests preliminary safety and feasibility.
- Larger studies with extended follow-up are necessary to further validate these findings.
