Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study

Jens Erik Nielsen-Kudsk; Sergio Berti; Francesco Caprioglio; Federico Ronco; Dabit Arzamendi; Timothy Betts; Claudio Tondo; Thomas Christen; Dominic J Allocco

doi:10.1016/j.jcin.2022.10.024

Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study

JACC Cardiovasc Interv. 2023 Mar 27;16(6):643-651. doi: 10.1016/j.jcin.2022.10.024. Epub 2023 Feb 8.

Authors

Jens Erik Nielsen-Kudsk¹, Sergio Berti², Francesco Caprioglio³, Federico Ronco⁴, Dabit Arzamendi⁵, Timothy Betts⁶, Claudio Tondo⁷, Thomas Christen⁸, Dominic J Allocco⁸

Affiliations

¹ Aarhus University Hospital, Aarhus, Denmark. Electronic address: [email protected].
² Fondazione Toscana Gabriele Monasterio, Massa, Italy.
³ Ospedale San Bortolo, Vicenza, Italy.
⁴ Ospedale Dell Angelo, Mestre, Italy.
⁵ Hospital De La Santa Creu I Sant Pau, Barcelona, Spain.
⁶ John Radcliffe Hospital, Oxford, United Kingdom.
⁷ Heart Rhythm Center at Monzino Cardiac Center, IRCCS, Department of Biomedical, Surgical and Dentist Sciences, University of Milan, Milan, Italy.
⁸ Boston Scientific, Marlborough, Massachusetts, USA.

PMID: 36764917
DOI: 10.1016/j.jcin.2022.10.024

Abstract

Background: Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage closure (LAAC).

Objectives: The aim of this study was to investigate the efficacy and safety of ICE-guided LAAC with the Watchman FLX device.

Methods: The ICE LAA (I Can See Left Atrial Appendage) study was a prospective, multicenter study with independent adjudication of echocardiographic data by a core laboratory and clinical events by a clinical events committee. Patients with atrial fibrillation with CHA₂DS₂-VASc scores ≥2 and clinical indications for LAAC were eligible. Preplanning with either cardiac computed tomography or transesophageal echocardiography (TEE) within 7 days prior to LAAC was mandatory. Intraprocedural ICE was carried out from the left atrium. The primary outcome was the rate of significant peridevice leaks (>5 mm) at 45-day TEE.

Results: A total of 100 patients were enrolled. The mean age was 76 ± 8 years, the mean CHA₂DS₂-VASc score was 4.0 ± 1.5, and the mean HAS-BLED score was 2.5 ± 0.9. The incidence of the primary outcome of significant peridevice leak (>5 mm) was 0%; all patients evaluated by TEE at 45 days had effective LAAC. All patients received Watchman FLX devices, and technical success was 100%. The number of devices per case was 1.0 ± 0.1. ICE successfully guided the assessment of device release criteria, including device compression (19.2% ± 7.1%; recommended range: 10%-30%). No subject required conversion to TEE. Procedural complications were 4 access-site bleeds. There was no stroke, transient ischemic attack, systemic embolization, pericardial effusion, device embolization, or device-related thrombus during the procedure or 45-day follow-up.

Conclusions: ICE can be used to successfully guide LAAC with the Watchman FLX, with excellent procedural success, a high rate of effective LAAC, and minimal periprocedural complications. (I Can See Left Atrial Appendage [ICELAA] Clinical Study; NCT04196335).

Keywords: ICE; atrial fibrillation; intracardiac echocardiography; left atrial appendage; left atrial appendage closure; stroke prevention.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Atrial Appendage* / diagnostic imaging
Atrial Fibrillation* / complications
Atrial Fibrillation* / diagnostic imaging
Atrial Fibrillation* / therapy
Cardiac Catheterization
Echocardiography
Echocardiography, Transesophageal
Humans
Prospective Studies
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04196335