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Updated: Aug 22, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices
Matthew J Price1, Daniel J Friedman2, Chengan Du3
1Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
Insights
The Watchman FLX device demonstrated significantly lower in-hospital major adverse events (MAE) compared to the Watchman 2.5, improving procedural safety for transcatheter left atrial appendage occlusion (LAAO). This advancement may enhance the risk-benefit profile for stroke prevention in atrial fibrillation patients.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Procedural complications of transcatheter left atrial appendage occlusion (LAAO) can limit clinical benefits.
- Next-generation devices aim to enhance procedural safety, but their impact requires evaluation.
Purpose of the Study:
- To compare in-hospital outcomes between the Watchman FLX and the predicate Watchman 2.5 device.
- To assess the safety and efficacy of the next-generation Watchman FLX in LAAO procedures.
Main Methods:
- Utilized the National Cardiovascular Data Registry LAAO Registry for patient data.
- Compared in-hospital outcomes between Watchman FLX and Watchman 2.5 groups, including propensity score matching.
- Primary endpoint was in-hospital major adverse events (MAE), a composite of critical safety outcomes.
Main Results:
- Watchman FLX showed significantly lower in-hospital MAE rates (1.35% vs. 2.40%) compared to Watchman 2.5.
- Reduced rates of pericardial effusion, mortality, major bleeding, cardiac arrest, and device embolization were observed with Watchman FLX.
- Propensity score matching confirmed lower MAE rates for the Watchman FLX device.
Conclusions:
- Transcatheter LAAO with Watchman FLX is associated with reduced in-hospital MAE compared to the Watchman 2.5.
- The improved safety profile of Watchman FLX may enhance its risk-benefit balance for stroke prevention in atrial fibrillation.
- These findings support the clinical utility of next-generation LAAO devices.
Background:
Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described.
Objectives:
The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.
Methods:
The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX.
Results:
The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001).
Conclusions:
Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.
