Why the study?
The Amplatzer Steerable Delivery Sheath was designed to improve ease-of-use and procedural results of LAAC, but procedural outcomes compared with the standard sheath needed evaluation.
Does the Amplatzer Steerable Delivery Sheath improve procedural results and safety compared to the standard sheath in patients undergoing left atrial appendage closure?
Does the Amplatzer Steerable Delivery Sheath improve procedural results and safety compared to the standard sheath in patients undergoing left atrial appendage closure?
The use of a steerable delivery sheath for left atrial appendage closure is feasible and safe, achieving high procedural success and sealing rates comparable to the standard sheath, though it may involve an initial learning curve.
Answers are grounded in this paper and cite their sources.
Steerable sheath yields comparable LAAC metrics to standard; leaves open any advantage in randomized trials.
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.
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Mezger et al. (2024) studied this question.
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