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Updated: Apr 6, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left Atrial Appendage Closure -The WATCHMAN Device
Abhilash Akinapelli, Ojas Bansal, Jack P Chen
1Boston Scientific, Marlborough, MA, USA. Dongming.Hou@bsci.com.
Insights
Atrial fibrillation (AF) patients face high stroke risk. The WATCHMAN device offers a safe, effective alternative to warfarin for percutaneous left atrial appendage closure, reducing stroke risk.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Atrial fibrillation (AF) is a common arrhythmia, significantly increasing stroke risk, especially in older adults.
- Warfarin, while effective, has limitations like narrow therapeutic windows and bleeding risks, necessitating alternative treatments.
- The left atrial appendage is a primary source of thrombus in non-valvular AF, making it a target for intervention.
Purpose of the Study:
- To review the preclinical and clinical evidence for the WATCHMAN device.
- To evaluate the WATCHMAN device as an alternative to warfarin for stroke risk reduction in non-valvular AF.
- To discuss the next generation of left atrial appendage closure devices.
Main Methods:
- Review of preclinical studies and prospective randomized clinical trials.
- Analysis of data from over 2,400 patients with nearly 6,000 patient-years of follow-up.
- Evaluation of the FDA-approved WATCHMAN Left Atrial Appendage Closure (LAAC) Device.
Main Results:
- The WATCHMAN device has demonstrated safety and efficacy in reducing stroke risk in non-valvular AF patients.
- Clinical trials support the WATCHMAN device as a viable alternative to long-term warfarin therapy.
- The device has received FDA approval based on robust clinical data.
Conclusions:
- Percutaneous left atrial appendage closure with the WATCHMAN device is an effective stroke risk reduction strategy for high-risk non-valvular AF patients.
- The WATCHMAN device provides a valuable alternative for patients who cannot tolerate or are not suitable for long-term warfarin therapy.
- Ongoing research and next-generation devices continue to advance left atrial appendage closure technology.
Abstract:
Atrial fibrillation (AF) is one of the most common arrhythmias seen in clinical cardiology practice. Patients with non-valvular AF have an approximately 5-fold increase in the risk of stroke, with an exponential increase with advancing age. Cardioembolic strokes carry a high mortality risk. Although the potential of warfarin to reduce systemic embolization in AF patients is well established, its use is difficult due to narrow therapeutic windows and additional complications (e.g. increased risk of bleeding), especially for aging patients. Therefore, alternative means of treatment to reduce stroke risk in these patients are needed. The left atrial appendage is the major source of thrombus formation in patients with non-valvular AF. The WATCHMAN device (Boston Scientific, MA) is a percutaneous left atrial appendage closure device which has been tested prospectively in multiple randomized trials. It offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. Based on the robust WATCHMAN clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up, the WATCHMAN LAAC Device is approved by FDA. In this article we reviewed the preclinical studies and clinical trials, as well as the next generation of the device.
