Key result
The Watchman-FLX left atrial appendage closure device demonstrated a 99.5% procedural success rate (0.5% failure vs 2% with Watchman 2.5) in a high-risk population.
Why the study?
Real-world experience with the innovative Watchman-FLX left atrial appendage closure device in experienced centers needed to be evaluated.
Does the Watchman-FLX device improve procedural success and safety compared to the first-generation Watchman 2.5 in high-risk patients requiring left atrial appendage closure?
Cohort (n=300)
Yes
Does the Watchman-FLX device improve procedural success and safety compared to the first-generation Watchman 2.5 in high-risk patients requiring left atrial appendage closure?
Absolute Event Rate: 0.5% vs 2%
The Watchman-FLX device demonstrates a high procedural success rate of 99.5% and a low complication profile in a high-risk real-world population.
Supports high FLX success in observational LAA closure; leaves open randomized confirmation of safety versus prior devices.
INTRODUCTION: The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise. METHODS: We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included. RESULTS: -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-related stroke and 0.6% fatal bleeding. CONCLUSION: Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period.
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Vizzari et al. (2022) conducted a cohort in High stroke and bleeding risk requiring left atrial appendage closure (n=300). Watchman-FLX left atrial appendage closure device vs. First-generation Watchman 2.5 device was evaluated on Procedural failure. The Watchman-FLX left atrial appendage closure device demonstrated a 99.5% procedural success rate (0.5% failure vs 2% with Watchman 2.5) in a high-risk population.
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