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Updated: Sep 27, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States
Matthew J Price1, David Slotwiner2, Chengan Du3
1Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
Insights
This study reports 1-year outcomes for transcatheter left atrial appendage occlusion (LAAO) in the US. The procedure showed a 1.53% rate of ischemic stroke and 6.93% rate of major bleeding in real-world patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter left atrial appendage occlusion (LAAO) is an alternative to anticoagulation for stroke prevention in atrial fibrillation.
- Real-world, 1-year clinical outcome data for LAAO are limited, particularly following commercial availability.
Purpose of the Study:
- To report 1-year clinical outcomes after commercial transcatheter left atrial appendage occlusion (LAAO) in a large, national cohort within the United States.
- To provide data for shared decision-making between clinicians and patients regarding LAAO therapy.
Main Methods:
- Analysis of patients undergoing the Watchman procedure between January 1, 2016, and December 31, 2018, enrolled in the National Cardiovascular Data Registry LAAO Registry.
- Primary endpoint: ischemic stroke. Secondary endpoints: ischemic stroke or systemic embolism, mortality, and major bleeding.
- Kaplan-Meier method used for 1-year event rate estimations.
Main Results:
- The study included 36,681 patients with a mean age of 76 years and high CHA2DS2-VASc and HAS-BLED scores.
- 1-year Kaplan-Meier estimates: ischemic stroke 1.53%, ischemic stroke or systemic embolism 2.19%, mortality 8.52%, and major bleeding 6.93%.
- Most major bleeding events occurred within 45 days post-procedure.
Conclusions:
- This study provides crucial 1-year outcome data for transcatheter LAAO in a diverse, real-world US patient population.
- The findings support informed clinical and patient decision-making regarding the use of LAAO for stroke prevention.
Objectives:
The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.
Background:
The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported.
Methods:
Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.
Results:
The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.
Conclusions:
This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.
