Intracardiac echocardiography-guided implantation of the Watchman FLX left atrial appendage closure device

Background The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia. Objective To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation. Methods A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events. Results The study included 30 patients: age 75 +/- 8 years, 53% men, CHA(2)DS(2)-VASc 4.6 +/- 1.6, and HAS-BLED 3.4 +/- 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 +/- 3.1 and 25.7 +/- 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 +/- 15 ml contrast used. The final device size was 29.2 +/- 4.7 mm with 21.6 +/- 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak >= 5 mm. Major safety events occurred in 6.6% (2/30). Conclusion The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE.