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Updated: Oct 2, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety
Mohit K Turagam1, Petr Neuzil2, Pavel Hala2
1Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: https://twitter.com/mohitkturagam.
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).
