First-in-human experience of left atrial appendage occlusion with the steerable FuStar sheath

Abstract

Background: Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first-in-human experience of LAAO with the FuStar sheath.

Methods: Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA₂ DS₂ -VASc score: 5.0 ± 2) with non-valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers.

Results: Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm² ± 3835.3, respectively.

Conclusion: This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

Keywords: atrial fibrillation; left atrial appendage occlusion; steerable FuStar sheath; stroke prophylaxis.