Intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion: Design and rationale of the ICE-TEE trial

Abstract

Left atrial appendage occlusion (LAAO) has emerged as an alternative to long-term anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation deemed high risk for bleeding. LAAO is performed via a transseptal approach with the placement of an occlusion device in the left atrial appendage (LAA) to seal it. Intraoperative imaging with echocardiography is needed to guide and complete the procedure. Historically, Transesophageal echocardiography (TEE) has been the most frequently used modality for intraprocedural guidance. Recently, there has been a growing interest in the use of intracardiac echocardiography (ICE) as an adjunct to, or even an alternative to, transesophageal echocardiography (TEE), with several unique advantages and potential challenges. Several publications have highlighted the safety and feasibility of ICE in LAAO (Hemam et al., 2019; Morcos et al., 2022; Zhang et al., 2023 [2, 5, 7]). The most recent SCAI/HRS consensus statement recommends using TEE or ICE in procedural guidance (Saw et al., 2023 [8]). To date, no prospective randomized controlled trials have addressed the safety and feasibility of ICE-guided LAAO, compared to TEE guidance. The ICE TEE trial is a single-center, prospective, randomized, parallel-controlled, open-label clinical trial that will assess the efficacy and safety of ICE-guided LAAO compared to traditional TEE-guided LAAO. Patients are randomized in a 1:1 fashion. The primary endpoint of the study is the procedural success of LAAO device implantation, defined as the appropriate device implantation as per the IFU, without device-related complications, and no peri-device leaks >5 mm on color Doppler, according to the Munich consensus. Secondary endpoints include periprocedural complications, procedural characteristics, and cost of hospitalization. Patients will be assessed at 45 days with a TEE to evaluate for any peri-device leak (PDL). The trial aims to assess the efficacy and potential complications of using ICE to guide the implantation of percutaneous left atrial appendage occlusion (LAAO) devices compared to the traditional transesophageal echocardiography (TEE)- guided LAAO.

Keywords: Anesthesia; ICE; LAAO; PDL; Pericardial effusion; Safety; Sedation; Stroke; TEE.