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Updated: Jun 18, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion
Daniel J Friedman1, Chengan Du2, Sarah Zimmerman2
1Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (D.J.F., S.V., A.S.K., J.P.P.).
Insights
Higher hospital and physician WATCHMAN volumes improve left atrial appendage occlusion success. The newer WATCHMAN FLX device shows better outcomes and less volume-outcome variation.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Health Services Research
Background:
- Volume-outcome relationships are established for many cardiovascular procedures, guiding minimum volume thresholds.
- The specific association between procedural volume and outcomes for left atrial appendage occlusion (LAAO) remains poorly understood.
- This study investigates the impact of hospital and physician procedural volume on LAAO success.
Purpose of the Study:
- To determine the relationship between hospital and physician volume and the success of WATCHMAN left atrial appendage occlusion procedures.
- To evaluate this relationship specifically for the WATCHMAN FLX device.
Main Methods:
- Analysis of 87,480 WATCHMAN procedures from the National Cardiovascular Data Registry LAAO Registry (January 2019 to October 2021).
- Utilized three-level hierarchical generalized linear models to assess adjusted relationships.
- Procedural success defined as device release with peridevice leak <5 mm and no in-hospital major adverse events.
Main Results:
- Overall procedural success rate was 94.2% across 693 hospitals.
- Lower hospital volumes (Q1, Q2) were associated with significantly lower procedural success compared to the highest volume quartile (Q4).
- Lower physician volumes (Q1, Q2, Q3) were also significantly associated with reduced procedural success compared to Q4.
- The WATCHMAN FLX device showed attenuated volume-outcome relationships with modest outcome differences across volume quartiles.
Conclusions:
- Higher hospital and physician volumes for WATCHMAN procedures are linked to increased procedural success.
- The transition to the WATCHMAN FLX device correlated with improved procedural success and reduced outcome variability across volume levels.
- Understanding device-specific volume-outcome relationships is crucial for optimizing left atrial appendage occlusion procedures.
Background:
Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device.
Methods:
We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events).
Results:
Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA2DS2-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles.
Conclusions:
In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices.
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