Author + information
- Received April 3, 2020
- Revision received June 18, 2020
- Accepted June 20, 2020
- Published online August 26, 2020.
- Kasper Korsholm, MD, PhD,
- Athanasios Samaras, MD,
- Asger Andersen, MD, PhD,
- Jesper Møller Jensen, MD, PhD and
- Jens Erik Nielsen-Kudsk, MD, DMSc∗ ()
- ↵∗Address for correspondence:
Dr. Jens Erik Nielsen-Kudsk, Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.
Objectives The aim of this study was to investigate the procedural efficacy and safety of the novel Watchman FLX (Boston Scientific, Marlborough, Massachusetts) device for left atrial appendage occlusion (LAAO) and to assess the feasibility of intracardiac echocardiography (ICE) to guide implantation.
Background The Watchman FLX device for transcatheter LAAO was introduced for a simplified implantation in a wider range of LAA anatomies.
Methods This single-center study included consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and January 2020 (N = 91). Patients underwent cardiac computed tomography (CT) imaging for pre-procedural planning. Initial procedures were guided by transesophageal echocardiography (TEE; n = 8) and thereafter by ICE (n = 83) from the left atrium. TEE and cardiac CT imaging were performed at 8 weeks’ follow-up.
Results Technical success was achieved in 90 (99%) patients, with the first device implanted in 86 (96%) procedures. Procedural success was 93.4%. Peri-procedural complications occurred in 5 (5.5%), with pericardial effusion being the most common (2.2%). Only 3.3% had a peri-device leak on TEE follow-up. No device-related thrombosis occurred. The mean device compression rate at end of procedure was 18.3 ± 7.7%, compared with 12.2 ± 7.8% by TEE at 8 weeks’ follow-up (p < 0.001) and 5.8 ± 8.8% by cardiac CT imaging at follow-up (p < 0.001).
Conclusions The Watchman FLX device was suitable for closure of a wide range of LAA anatomies, including shallow appendages. The follow-up closure rate was higher than previously reported with other devices. ICE from the left atrium was used, with high procedural success and a low complication rate, comparable to previous studies on LAAO.
This study was funded by an unrestricted research grant from Boston Scientific and by the Novo Nordisk Foundation (NNF17OC0024868 and NNF17OC0029510). Dr. Korsholm has received speaker honorarium from Abbott; and a travel grant from Boston Scientific. Dr. Nielsen-Kudsk is a proctor/consultant for Abbott and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received April 3, 2020.
- Revision received June 18, 2020.
- Accepted June 20, 2020.
- 2020 American College of Cardiology Foundation
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