Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes

Abstract

Objectives: This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE).

Background: Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus.

Methods: The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months.

Results: A total of 15 patients (age 71.3 ± 10.8 years, 33% men, CHA2DS2-VASc 4.1 ± 1.7, HAS-BLED 3.4 ± 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak ≤5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients.

Conclusions: This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (The Conformal Prague Study; NCT04193826).

Keywords: Watchman FLX; amulet; intracardiac echocardiography; left atrial appendage occlusion; stroke prevention.

Conflict of interest statement

Funding Support and Author Disclosures Conformal Medical, Inc, provided funding for this study. Dr Neuzil has received grants from Conformal Medical Inc and Biosense Webster Inc. Dr Dukkipati has received a grant from Biosense Webster. Dr Reddy has served as an unpaid consultant to Conformal Medical Inc and Biosense Webster Inc; has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Middlepeak, Nuvera, Sirona Medical, and Valcare unrelated to this work; has served as a consultant for Abbott, Axon, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, EBR, Impulse Dynamics, Medtronic, Philips, Pulse Biosciences, Stimda, and Thermedical unrelated to this work; and has equity in Manual Surgical Sciences, Newpace, Surecor, and Vizaramed unrelated to this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2022. Published by Elsevier Inc.