Steerable Delivery Sheath for Optimized LAA Closure: First Experience and Procedural Outcomes

Background: The new Amplatzer Steerable Delivery Sheath is a delivery system designed to improve ease-of-use and procedural results of left atrial appendage closure (LAAC). We aimed to compare procedural results after switching our LAAC program at a tertiary care center with the Amulet device to the Steerable Delivery Sheath, with a control group of LAAC employing the standard sheath.

Methods: The first n = 32 consecutively treated patients at our site using the Amulet device with the Steerable Delivery Sheath were included in this retrospective analysis. As a control-group, n = 39 consecutive patients treated with the Amulet device before the switch to the new sheath were used.

Results: LAAC was successful in all patients in both groups (100%). Contrast use and fluoroscopy time were numerically higher in the steerable sheath group (steerable sheath vs. control group: contrast use 70 ± 23 vs. 55 ± 50 mL, p = 0.09, fluoroscopy time 12.7 ± 4.6 vs. 10.2 ± 6.6 min, p = 0.3). Fluoroscopy time and dose decreased after 3 months while contrast use remained unchanged. Complete sealing rate was high in both groups (steerable sheath vs. control group 97% vs. 95%, p > 0.9) and periprocedural complication rate was low, without any periprocedural stroke, vascular complications, or death in both cohorts.

Conclusions: LAAC with the Amplatzer Amulet steerable delivery sheath is feasible and safe. Fluoroscopy time and dose suggest a learning curve with the new sheath.