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Updated: Jun 21, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left atrial appendage closure for patients with atrial fibrillation at high intracranial haemorrhagic risk
Avia Abramovitz Fouks1, Shadi Yaghi2, Elif Gokcal1
1Neurology, Massachussets General Hospital, Harvard Medical School, Boston, MA, USA.
Insights
Left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and high intracranial hemorrhage (ICH) risk shows promising safety and efficacy. This procedure demonstrated a low incidence of recurrent ICH and thromboembolic events in a recent study.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Left atrial appendage closure (LAAC) is increasingly used in non-valvular atrial fibrillation (NVAF) patients at high risk for intracranial hemorrhage (ICH).
- Detailed neurological outcomes and indications for LAAC in this high-risk population are not well-documented.
Purpose of the Study:
- To assess the neurological indications for LAAC in patients with NVAF and high ICH risk.
- To evaluate the safety and efficacy of LAAC in this specific patient cohort.
Main Methods:
- A single-center study included NVAF patients undergoing LAAC between January 2015 and October 2021.
- Patients had prior ICH or high ICH risk imaging markers (e.g., cerebral microbleeds) on brain MRI.
- Primary outcomes were post-LAAC ICH and thromboembolic events.
Main Results:
- 146 NVAF patients underwent LAAC; 122 had prior ICH history, 24 had imaging markers only.
- Mean follow-up was 2.12 years. Recurrent non-traumatic ICH occurred in 0.32/100 patient-years, traumatic ICH in 1.61/100 patient-years, and ischemic stroke in 1.94/100 patient-years.
- 92% of patients were not on oral anticoagulants at 1 year post-procedure.
Conclusions:
- LAAC demonstrated a low risk of recurrent ICH and ischemic stroke in high-risk NVAF patients.
- The findings support LAAC consideration in clinical practice for high ICH risk populations, aligning with FDA approval and guidelines.
Background And Objectives:
Although left atrial appendage closure (LAAC) is performed in patients with non-valvular atrial fibrillation (NVAF) at increased risk of intracranial haemorrhage (ICH), outcome data are scarce. We assessed the detailed neurological indications for LAAC and outcomes after LAAC in high ICH risk patients.
Methods:
Study population included consecutive patients with NVAF who underwent LAAC in a single hospital network between January 2015 and October 2021 because of prior ICH or the presence of high ICH risk imaging markers on brain MRI (cerebral microbleeds (CMBs)). Primary safety and efficacy outcome measures were the occurrence of ICH and thromboembolic events, respectively, after LAAC.
Results:
Among 146 patients with NVAF who underwent LAAC for high ICH risk, 122 had a history of ICH, while 24 presented with high ICH risk imaging markers only. Mean age was 75.7±7.61, 42 (28.8%) were women. Mean CHA2DS2-VASc score was 5.23±1.52. Of 122 patients with ICH history, 58 (47.5%) had intraparenchymal haemorrhage (IPH), 40 (32.8%) had traumatic ICH (T-ICH) and 18 (14.7%) had non-traumatic subdural haemorrhage. Of 85 patients with brain MRIs including necessary sequences, 43 (50.6%) were related to cerebral amyloid angiopathy and 37 (43.5%) to hypertensive microangiopathy. While 70% of patients were discharged on oral anticoagulants (OAC), 92% were not taking OAC at 1 year. Over 2.12 years mean follow-up, one patient had recurrent non-traumatic IPH (incidence rate (IR) 0.32 per 100 patient-years), five had T-ICH (IR 1.61 per 100 patient-years) and six had an ischaemic stroke (IR 1.94 per 100 patient-years).
Conclusions:
Among patients with NVAF at high ICH risk, LAAC demonstrated a low risk of recurrent ICH or ischaemic stroke compared with previously published data. LAAC in high ICH risk populations should be considered in clinical practice per FDA approval and recent guidelines.
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