The Watchman FLX Device: First European Experience and Feasibility of Intracardiac Echocardiography to Guide Implantation.
LAA closure
clinical research
other imaging modalities
Journal
JACC. Clinical electrophysiology
ISSN: 2405-5018
Titre abrégé: JACC Clin Electrophysiol
Pays: United States
ID NLM: 101656995
Informations de publication
Date de publication:
14 12 2020
14 12 2020
Historique:
received:
03
04
2020
revised:
18
06
2020
accepted:
20
06
2020
entrez:
18
12
2020
pubmed:
19
12
2020
medline:
19
8
2021
Statut:
ppublish
Résumé
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. The Watchman FLX device for transcatheter LAAO was introduced for a simplified implantation in a wider range of LAA anatomies. 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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 33334441
pii: S2405-500X(20)30599-5
doi: 10.1016/j.jacep.2020.06.028
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1633-1642Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Author Disclosures 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 has received 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.