Background:  Left atrial appendage (LAA) occlusion (LAAO) is an established alternative to oral anticoagulation (OAC) for stroke prevention in patients with high stroke risk and con­traindications to long-term oral anticoagulation. LAAO remains a challenging procedure due the wide variability of left atrial appendage morphology. The steerable FuStar sheath was designed to facilitate transseptal access and delivery of percutaneous devices.

Aims: The aim of the study was to evaluate the feasibility and safety of the FuStar sheath. We report first-in-human experience of LAAO with the FuStar sheath.

Methods:  Patients with atrial fibrillation and contraindications to oral anticoagulation were scheduled at this study. The indication for LAAO was made based on current guidelines and recommendations. In all LAAO procedures the FuStar sheath was used. Th sheath is available with 45° single or 45° x 30° double curves. The delivery system provides full recapturing and multiple repositioning of the device. After the procedure, all patients received dual antiplatelet therapy with aspirin and clopidogrel for 3 months, followed by aspirin alone

Results: 20 patients (76.6 ± 8.4 years; 12 (60%) men; CHA2DS2-VASc: 5.0 ± 2) with atrial fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath. Successful device implantation was achieved in all patients (100%). Figure 1-3 presents the successful device implantation using the FuStar sheath. In 3 (5%) patients, resizing of the device was necessary. No peri-procedural 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 feasibility and safety of the steerable FuStar sheath for LAAO.

Figure 1-3: The Figure presents the sucessful device implantation using the FuStar sheath