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.