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Updated: May 12, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Percutaneous Left Atrial Appendage Occlusion Therapy: Evolution and Growing Evidence
Xinqiang Han1, David G Benditt2
1Cardiology Division of Reid Health, Indiana University School of Medicine, Richmond, IN 47374, USA.
Insights
Atrial fibrillation (AF) patients at risk of stroke can benefit from left atrial appendage occlusion (LAAO). This minimally invasive procedure offers an alternative to oral anticoagulation, especially for those with high bleeding risks.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Atrial fibrillation (AF) is a common arrhythmia increasing stroke risk, often originating from the left atrial appendage (LAA).
- Oral anticoagulation (OAC) is standard for stroke prevention but carries bleeding risks and compliance issues.
- Surgical LAA excision is invasive and limited in application; percutaneous LAA occlusion (LAAO) has emerged as an alternative.
Purpose of the Study:
- To systematically review the development and clinical evidence for percutaneous left atrial appendage occlusion (LAAO) in nonvalvular AF (NVAF).
- To evaluate US FDA and CE-Mark approved LAAO devices and summarize the current status of the therapy.
- To discuss future perspectives, knowledge gaps, and the impact of ongoing clinical trials in LAAO.
Main Methods:
- Systematic literature review focusing on the evolution of LAAO.
- Analysis of clinical evidence supporting LAAO in NVAF patients.
- Evaluation of approved LAAO devices and current therapeutic status.
Main Results:
- LAAO is increasingly performed as an alternative to OAC for stroke prevention in NVAF, particularly in high-bleeding-risk patients.
- Significant progress has been made in LAAO device technology and clinical application over the past two decades.
- Ongoing clinical trials are expected to further define the role and optimize the use of LAAO.
Conclusions:
- Percutaneous LAAO represents a significant advancement in stroke prevention for NVAF patients.
- The therapy is a viable alternative to OAC, especially for patients with contraindications or high bleeding risk.
- Future research and technological advancements will likely expand the utility and effectiveness of LAAO.
Abstract:
Atrial fibrillation (AF) is the most common cardiac arrhythmia and if untreated, significantly increases both the risk of intracardiac thrombus formation and ischemic stroke. In patients with nonvalvular AF (NVAF), the left atrial appendage (LAA) has been estimated to be the source of thrombus development in 91% to 99% of cases. Consequently, oral anticoagulation (OAC) to provide stroke prevention has become the standard of care for most AF patients; however, OACs are associated with a risk of bleeding and their efficacy depends on optimal patient compliance. In terms of alternative approaches to preventing embolic events, surgical LAA excision was attempted as early as in the late 1940s in patients with valvular AF; LAA excision remains a recommendation in surgical guidelines for NVAF patients who need open-heart coronary bypass or valvular replacement/repair surgeries. However, due to its invasive nature surgical LAA intervention has limited clinical application in present cardiology practice. Percutaneous LAA occlusion (LAAO) is increasingly being performed as an alternative to OAC for stroke prevention; this is particularly the case in patients at increased bleeding risk. Substantial progress has been made in percutaneous LAAO therapy since its inception some twenty years ago. Herein we systematically review both the critical literature that led to the development of LAAO, and the increasing clinical evidence supporting the application of this treatment strategy in NVAF. To this end we focus on recently published critical evaluations of United States Food and Drug Administration (US FDA) and Conformité Européenne (Commercial Sale of Licensed Product in the EU) (CE-Mark) approved LAAO devices, summarize the current status of LAAO therapy, and discuss the future perspectives regarding the knowledge and technology gaps in this area by recognizing the potential contributions of many ongoing but likely transformative clinical trials.
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