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Updated: Sep 6, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Randomized Trial of Surgical Left Atrial Appendage Closure: Protection Against Cerebrovascular Events
Christoffer V Madsen1, Jesper Park-Hansen2, Susanne J V Holme3
1Department of Cardiology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark; Department of Biomedical Science, University of Copenhagen, Copenhagen, Denmark.
Insights
Routine left atrial appendage closure during open-heart surgery may reduce long-term stroke risk. This procedure appears safe and effective, regardless of prior atrial fibrillation or oral anticoagulant use, warranting further investigation.
Area of Science:
- Cardiology
- Neurology
- Surgical Innovation
Background:
- Atrial fibrillation and stroke are common complications following open-heart surgery.
- Left atrial appendage (LAA) closure is a potential strategy to mitigate ischemic stroke risk.
- The efficacy of routine LAA closure in preventing long-term cerebrovascular events requires further evaluation.
Purpose of the Study:
- To assess the long-term effectiveness of routine left atrial appendage closure (LAAC) in preventing cerebrovascular events after open-heart surgery.
- To determine if LAAC provides protection independently of pre-existing atrial fibrillation, stroke risk scores, or oral anticoagulation use.
Main Methods:
- Prospective, randomized, open-label trial (NCT02378116) with long-term follow-up.
- Patients undergoing elective open-heart surgery were randomized to either LAAC plus standard care or standard care alone.
- Stratification by oral anticoagulation status and adjudication of cerebrovascular events by blinded neurologists.
Main Results:
- The LAAC group showed a trend towards fewer cerebrovascular events (intention-to-treat analysis: 11 vs 19, P=0.033).
- Mean follow-up duration was 6.2 years.
- LAAC was found to be safe in the long-term follow-up period.
Conclusions:
- Left atrial appendage closure as an adjunct to open-heart surgery appears safe and may reduce long-term cerebrovascular events.
- The benefits of LAAC may extend to patients regardless of their pre-surgery atrial fibrillation status or oral anticoagulation use.
- Further large-scale randomized trials are needed to confirm these findings, particularly in patients without atrial fibrillation and high stroke risk.
Abstract:
Following open-heart surgery, atrial fibrillation and stroke occur frequently. Left atrial appendage closure added to elective open-heart surgery could reduce the risk of ischemic stroke. We aim to examine if routine closure of the left atrial appendage in patients undergoing open-heart surgery provides long-term protection against cerebrovascular events independently of atrial fibrillation history, stroke risk, and oral anticoagulation use. Long-term follow-up of patients enrolled in the prospective, randomized, open-label, blinded evaluation trial entitled left atrial appendage closure by surgery (NCT02378116). Patients were stratified by oral anticoagulation status and randomized (1:1) to left atrial appendage closure in addition to elective open-heart surgery vs standard care. The primary composite endpoint was ischemic stroke events, transient ischemic attacks, and imaging findings of silent cerebral ischemic lesions. Two neurologists blinded for treatment assignment adjudicated cerebrovascular events. In total, 186 patients (82% males) were reviewed. At baseline, mean (standard deviation (SD)) age was68 (9) years and 13.4% (n = 25/186) had been diagnosed with atrial fibrillation. Median [interquartile range (IQR)] CHA2DS2-VASc was 3 [2,4] and 25.9% (n = 48/186) were receiving oral anticoagulants. Mean follow-up was 6.2 (2.5) years. The left atrial appendage closure group experienced fewer cerebrovascular events; intention-to-treat 11 vs 19 (P = 0.033, n = 186) and per-protocol 9 vs 17 (P = 0.186, n = 141). Left atrial appendage closure as an add-on open-heart surgery, regardless of pre-surgery atrial fibrillation and oral anticoagulation status, seems safe and may reduce cerebrovascular events in long-term follow-up. More extensive randomized clinical trials investigating left atrial appendage closure in patients without atrial fibrillation and high stroke risk are warranted.
