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Updated: May 31, 2026
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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study
Wei Zhou1,2, Qian Tang2,3, Anning Zeng4
1Department of Clinical Medicine, Guizhou Medical University, No. 9 Beijing Road, Yunyan District, Guiyang, Guizhou 550004, China.
Summary
Simplified left atrial appendage occlusion (sLAAO) using fluoroscopy alone is a safe and effective alternative to conventional procedures. This approach demonstrates high success rates and low complication risks, making it suitable for resource-limited settings.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Conventional left atrial appendage occlusion (LAAO) often requires transesophageal echocardiography and general anesthesia, limiting its use in resource-constrained environments.
- Simplified LAAO (sLAAO) guided solely by fluoroscopy presents a more accessible alternative for patients with non-valvular atrial fibrillation.
Purpose of the Study:
- To evaluate the safety, efficacy, and short-term outcomes of sLAAO using the WATCHMAN FLX device under exclusive fluoroscopic guidance.
- To assess the feasibility of sLAAO in a real-world, multicenter setting.
Main Methods:
- Prospective, multicenter, single-arm registry (ROSE-FLX study) of 400 patients with non-valvular atrial fibrillation.
- All patients underwent sLAAO under local anesthesia and exclusive fluoroscopic guidance.
- Procedural success, complications, and follow-up outcomes were analyzed; predictors of adverse events were identified using Cox regression.
Main Results:
- 100% procedural success with low major complication rates: pericardial effusion (0.5%), access-site complications (1.3%), and major bleeding (0.8%).
- Median follow-up of 194.5 days showed low rates of all-cause mortality (0.8%), transient ischemic attacks (3.3%), and device-related thrombosis (0.3%).
- Chronic obstructive pulmonary disease and higher CHA2DS2-VASc scores were independent predictors of adverse events.
Conclusions:
- Exclusive fluoroscopy-guided sLAAO with the WATCHMAN FLX device is feasible, safe, and resource-efficient.
- The procedure achieves high success and low complication rates.
- This approach may be considered in centers lacking advanced echocardiographic or anesthetic support, pending further comparative studies.
