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. 2022 Nov 15;2(6):780-783.
doi: 10.1016/j.jacasi.2022.08.003. eCollection 2022 Nov.

First-in-Human Experience of Using a Universal Steerable Sheath in Implanting Left Atrial Appendage Closure Devices

Sheng-Nan Chang  1 , Fu-Chun Chiu  1 , Jien-Jiun Chen  1 , Pang-Shuo Huang  1 , Ting-Tse Lin  2 , Hsiao-Liang Cheng  3 , Chin-Feng Tsai  4 , Yi-Chih Wang  5 , Chia-Ti Tsai  5
Affiliations

First-in-Human Experience of Using a Universal Steerable Sheath in Implanting Left Atrial Appendage Closure Devices

Sheng-Nan Chang et al. JACC Asia. .

Abstract

Left atrial appendage (LAA) closure (LAAC) device implantation may be challenging in cases with difficult LAA anatomy. A deflectable sheath to approach multiple LAA positions may be helpful. We used a deflectable sheath to implant LAAC devices in 20 patients and included 60 cases using the standard sheaths for comparison. The procedures were successful in all patients without peri-procedural complications. After a median follow-up of 1.52 (IQR: 0.76-2.33) years, none of the patients in the deflectable sheath group had peri-device leak ≥3 mm and experienced thromboembolic stroke. In the standard sheath group, after follow-up of 2.03 (IQR: 0.87-3.19) years, 2 had peri-device leak ≥3 mm and 1 experienced thromboembolic stroke. We first proved the idea of using a universal steerable sheath for LAAC device implantation in difficult LAA anatomy, which also allows rapid switching of different LAAC devices.

Keywords: AF, atrial fibrillation; LAA, left atrial appendage; LAAC, left atrial appendage closure; deflectable sheath; left atrial appendage closure device; steerable sheath.

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Conflict of interest statement

The work was supported by grants from the Ministry of Science and Technology in Taiwan (MOST 109-2314-B-002-244-MY3 and MOST 110-2314-B-002-198 -MY3). The Ministry of Science and Technology had no role in the conduct of this study. All authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Angiography Angiography showing different trans-septal puncture positions in performing LAAC device implantation. (A) The sheath location is too low relative to the LAA ostium (or too high LAA). (B) The sheath location is too high relative to the LAA ostium (or too low LAA). In most of the scenarios, the trans-septal puncture is too high or the LAA is low. Then the sheath could be bent downward to achieve a good coaxiality between the sheath and the LAA. Arrowheads indicate the distal marker of the steerable sheath. LAA = left atrial appendage; LAAC = left atrial appendage closure.
Figure 2
Figure 2
Implantation Implantation of the first LAAC using the steerable sheath. (A) The loaded LAAC device is advanced distally and the distal tip of the device should be aligned with the distal tip of the steerable sheath (asterisk). Then dye injection shows that the proximal border of the loaded device (arrowheads) is close to the LAA ostial plane (arrow and white dashed line). (B) After deployment, the proximal waist of the device (arrowheads) remains in the same position and is close to the LAA ostial plane (arrow). Abbreviations as in Figure 1.
See this image and copyright information in PMC

References

    1. Holmes D.R., Reddy V.Y., Turi Z.G., et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374:534–542. - PubMed
    1. Chang S.N., Lai L.P., Chiang F.T., Lin J.L., Hwang J.J., Tsai C.T. C-reactive protein gene polymorphism predicts the risk of thromboembolic stroke in patients with atrial fibrillation: a more than 10-year prospective follow-up study. J Thromb Haemost. 2017;15:1541–1546. - PubMed
    1. Kleinecke C., Gomez Monterrosas O., Scalone G., et al. First-in-human experience of left atrial appendage occlusion with the steerable FuStar sheath. J Interv Cardiol. 2018;31:532–537. - PubMed

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