What does this research mean for the field?

Left atrial appendage occlusion using the steerable FuStar delivery sheath is feasible and safe, achieving 100% acute procedural success with no periprocedural complications. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

March 26, 2018Journal of Interventional CardiologyOpen Access

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

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Non-valvular atrial fibrillation (n=20). Intervention: Left atrial appendage occlusion with the LAmbre device using the FuStar steerable sheath. Primary outcome: Successful device implantation.

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Key result

Steerable FuStar sheath achieves 100% successful LAAO implantation with zero periprocedural complications.

n=20

Why the study?

Left atrial appendage occlusion remains challenging due to wide variability in left atrial appendage morphology, motivating evaluation of the steerable FuStar sheath.

Study Design

Type

Observational (n=20)

Multicenter

Yes

PICO

Population

20 patients (mean age 76.6) with non-valvular atrial fibrillation and contraindications to oral anticoagulation undergoing LAAO with a novel steerable sheath.

Intervention / Comparator

Left atrial appendage occlusion with the LAmbre device using the FuStar steerable sheath

Primary Outcome

Successful device implantation

Implication

Feasibility shown in small series; leaves open safety and efficacy for randomized confirmation before practice change.

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; CHA2DS2‐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.

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Cite This Study

Kleinecke et al. (2018) conducted an observational in Non-valvular atrial fibrillation (n=20). Left atrial appendage occlusion with the LAmbre device using the FuStar steerable sheath was evaluated on Successful device implantation. Left atrial appendage occlusion using the steerable FuStar sheath achieved successful device implantation in 100% of patients with no periprocedural complications.

synapsesocial.com/papers/6acb06f20792ac03dd5da5a7 https://doi.org/10.1111/joic.12509