Related Experiment Video
Updated: Jun 11, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries
Emily P Zeitler1, Boyang Bian2, Robert I Griffiths
1Dartmouth Health and The Dartmouth Institute, Lebanon, NH (E.P.Z.).
Insights
Long-term outcomes after WATCHMAN left atrial appendage occlusion show significant mortality and bleeding risks in older, sicker Medicare patients, but a relatively low annual ischemic stroke rate.
Area of Science:
- Cardiology
- Medical Devices
- Public Health
Background:
- Long-term outcomes of left atrial appendage occlusion (LAAO) are not well-established outside clinical trials.
- Real-world data collection was mandated for US market authorization of the WATCHMAN device.
- This study evaluates stroke, bleeding, and mortality rates in Medicare beneficiaries post-LAAO.
Purpose of the Study:
- To assess the long-term safety and effectiveness of the WATCHMAN device in a large, real-world Medicare population.
- To identify outcomes in important patient subgroups.
- To provide data for post-market surveillance and clinical decision-making.
Main Methods:
- Analysis of Medicare fee-for-service beneficiaries aged 65+ who underwent LAAO (April 2016 - August 2020).
- Utilized ICD-10 and CPT codes for patient identification and outcome assessment.
- Calculated cumulative incidence of mortality, ischemic stroke, and major bleeding over a 5-year follow-up period.
Main Results:
- 48,763 WATCHMAN recipients (median age 77) had 5-year outcomes: 44% mortality, 15% major bleeding, 7% ischemic stroke.
- Outcomes were worse in older and frailer patients, including those with prior stroke or bleeding.
- Male patients had higher mortality but similar stroke/bleeding rates compared to females.
Conclusions:
- Medicare beneficiaries receiving WATCHMAN were older and sicker than trial participants.
- High long-term mortality and bleeding rates reflect the patient population's high-risk profile.
- The annual ischemic stroke rate remained relatively low (<1.5% per year).
Background:
Long-term outcomes following left atrial appendage occlusion outside clinical trials and small registries are largely unknown. Collecting these data was a condition of US market authorization of the WATCHMAN device. The aim of this analysis was to evaluate the rates of stroke, bleeding, and death among Medicare beneficiaries following left atrial appendage occlusion implantation during initial commercial availability of the WATCHMAN left atrial appendage occlusion device overall and in important subgroups.
Methods:
All Medicare fee-for-service beneficiaries ≥65 years of age who underwent left atrial appendage occlusion from April 1, 2016, to August 31, 2020, were included based on the International Classification of Diseases, Tenth Revision, and Current Procedural Terminology codes. Over a 5-year follow-up period, the cumulative incidence over time of mortality, ischemic stroke, and major bleeding were calculated using the International Classification of Diseases, Tenth Revision, diagnosis codes for the full study cohort and within important prespecified subgroups.
Results:
WATCHMAN recipients (n=48 763) were a median of 77 (interquartile range, 72-82) years of age, 42% female, and mostly White (93%). The median CHA2DS2VASc score was 4 (interquartile range, 3-5) with prior major bleeding in 42% and prior stroke in 12%. At 5 years, death occurred in 44%, bleeding in 15% (with higher risk early following implantation), and ischemic stroke in 7%. Each of these end points was more common with greater baseline age. Male patients had greater 5-year mortality than female patients (46.9% versus 40.6%), but there was no difference between sexes in the rates of ischemic stroke (6.6% versus 7.5%) or major bleeding (14.9% for both). WATCHMAN recipients with prior ischemic stroke or a major bleeding event were older and frailer; these groups had higher rates of ischemic stroke, major bleeding, and death.
Conclusions:
Compared with patients enrolled in the pivotal clinical trials, Medicare beneficiaries undergoing WATCHMAN implantation were older, more female, and had more comorbid conditions. Substantial long-term mortality and major bleeding following WATCHMAN reflect the high-risk nature of the patient population, while the ischemic stroke rate was relatively low (<1.5% per year).
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