Evaluating the New Watchman FLX Pro 40 mm Device: A Case Study Series.

BACKGROUND

Left atrial appendage closure (LAAC) is a well-established alternative for stroke prevention in patients with atrial fibrillation (AF) who are not suitable for long-term anticoagulation. The WATCHMAN FLX Pro 40 mm device is a novel advancement featuring a fluoropolymer coating to enhance thromboresistance and a size expansion to accommodate larger left atrial appendages (LAA). However, clinical data on this new device remains limited.

OBJECTIVE

This study presents the first case series evaluating the procedural success, safety, and early outcomes of the 40 mm WATCHMAN FLX Pro device.

METHODS

A total of nine patients underwent LAAC with the 40 mm WATCHMAN FLX Pro between July and November 2024. Pre-procedural imaging, intraoperative guidance, procedural outcomes, and follow-up imaging were analyzed. Procedural success was defined by the successful deployment of the device meeting "PASS" criteria, with no major complications.

RESULTS

The study demonstrated a 100% procedural success rate, with all patients undergoing same-day discharge. No procedural or periprocedural complications were observed. Follow-up imaging at 4 months (available for 88.9% of patients) revealed no high-grade device-related thrombus (DRT), though some cases exhibited peridevice leaks, predominantly minor subfabric leaks.

CONCLUSION

The 40 mm WATCHMAN FLX Pro expands LAAC treatment options for patients with larger LAA anatomy, demonstrating a favorable safety and efficacy profile in this early experience. Larger studies with long-term follow-up are needed to validate these findings.