February 8, 2023JACC: Cardiovascular InterventionsOpen Access

Intracardiac Echocardiography to Guide Watchman FLX Implantation

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Why the study?

Intracardiac echocardiography is increasingly used to guide left atrial appendage closure, but the efficacy and safety of ICE-guided LAAC with the Watchman FLX device required investigation.

Does intracardiac echocardiography (ICE)-guided left atrial appendage closure with the Watchman FLX device prevent significant peridevice leaks in patients with clinical indications for LAAC?

Structured PICO

Does intracardiac echocardiography (ICE)-guided left atrial appendage closure with the Watchman FLX device prevent significant peridevice leaks in patients with clinical indications for LAAC?

Population

Patients with CHA2DS2-VASc scores ≥2 and clinical indications for left atrial appendage closure (LAAC)

Intervention

Intracardiac echocardiography (ICE)-guided left atrial appendage closure (LAAC) with the Watchman FLX device

Outcome

Rate of significant peridevice leaks (>5 mm) at 45-day transesophageal echocardiography (TEE)surrogate

Intracardiac echocardiography can safely and effectively guide LAAC with the Watchman FLX device, achieving 100% technical success and 0% significant peridevice leaks at 45 days.

Implication

May support ICE-guided Watchman FLX LAAC in selected patients; leaves open need for randomized trials versus TEE.

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: -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: -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).