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Updated: Jul 19, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Comparative Outcomes of Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients With
Amanda Nguyen1, Muhammad Zia Khan2, Waleed Alruwaili3
1Department of Medicine, University of California Davis Medical Center, Sacramento, California, USA.
Insights
Left atrial appendage occlusion (LAAO) in atrial fibrillation (AF) patients with lower stroke risk (CHA2DS2-VASc < 3) is linked to fewer complications and lower hospitalization costs. These findings suggest potential shifts in LAAO therapy indications for stroke prevention.
Area of Science:
- Cardiology
- Medical Devices
- Health Economics
Background:
- Current guidelines recommend oral anticoagulation for stroke prevention in atrial fibrillation (AF) patients with CHA2DS2-VASc score ≥2.
- Centers for Medicare & Medicaid Services (CMS) policy currently reimburses left atrial appendage occlusion (LAAO) for patients with a CHA2DS2-VASc score ≥3.
Purpose of the Study:
- To evaluate differences in outcomes and complications of LAAO therapy in AF patients stratified by CHA2DS2-VASc score (≥3 vs. <3).
- To assess the impact of stroke risk on LAAO procedural complications, inpatient outcomes, and resource utilization.
Main Methods:
- Utilized the National Inpatient Sample (NIS) database from 2016-2020, identifying LAAO device implantations using ICD-10 codes.
- Stratified the study population into two groups based on stroke risk: CHA2DS2-VASc score ≥3 and <3.
- Assessed endpoints including procedural complications, inpatient outcomes, and healthcare resource utilization.
Main Results:
- A total of 73,795 LAAO devices were implanted in patients with CHA2DS2-VASc ≥3 and 15,500 in patients with CHA2DS2-VASc <3.
- Patients with CHA2DS2-VASc <3 exhibited significantly lower crude overall (6.9% vs. 9.9%) and major (4.5% vs. 6.2%) complications.
- Multivariable analysis confirmed that CHA2DS2-VASc <3 was associated with reduced overall complications (aOR 0.84), major complications (aOR 0.90), and hospitalization costs (aOR 0.95).
Conclusions:
- LAAO device implantation in AF patients with a CHA2DS2-VASc score <3 is associated with lower complication rates and reduced hospitalization costs.
- These findings warrant further investigation in large randomized trials to inform clinical practice guidelines for LAAO use in stroke prevention.
- The data suggest a potential role for LAAO in lower-risk AF patient populations.
Background:
Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA2DS2-VASc score ≥2 for stroke prevention. However, Centers for Medicare & Medicaid Services (CMS) reimburses left atrial appendage occlusion (LAAO) for patients with CHA2DS2-VASc score ≥3. This study aimed to evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA2DS2-VASc score of ≥ 3 versus < 3.
Methods:
National Inpatient Sample (NIS) and International Classification of Diseases, Tenth Revision codes were used to identify LAAO device implantation in the U.S. from years 2016 to 2020. The study population was stratified by stroke risk into two groups, CHA2DS2-VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization.
Results:
A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA2DS2-VASc ≥ 3 and < 3, respectively. Compared to patients with CHA2DS2-VASc score of ≥ 3, patients with CHA2DS2-VASc < 3 had lower overall (6.9% vs 9.9%, P < 0.01) and major (4.5% vs 6.2%, P < 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA2DS2-VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 - 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99).
Conclusions:
Patients with CHA2DS2-VASc < 3 had lower complications and hospitalization costs after LAAO device implantation. These data, if redemonstrated in a large randomized trial, can have important clinical implications for stroke prevention in AF patients.
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