Co-Author(s):
Petr Neuzil, MD
Srinivas Dukkipati, MD
Vivek Reddy, MD
Mount Sinai Hospital
1, Gustav L. Levy Street, New York, NY-10029
Introduction | Objectives: Transcatheter left atrial appendage closure (LAAC) has evolved as an important stroke prevention strategy in AF patients. Limitations of current LAAC devices include the need for precise coaxial delivery into the LAA, potential for traumatic implantation, incomplete LAA seal, and device-related thrombus (DRT). We report, the feasibility and safety of ICE-guided Conformal Left Atrial Appendage Closure Device (Conformal Medical, Inc ) implantation.
Methods: The Conformal Left Atrial Appendage Closure implant 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 Conformal device was delivered under fluoroscopic and ICE guidance. (Figure ) After positioning, TEE was placed to confirm ICE findings prior to device release. After closure, dual antiplatelet therapy was given for 6 months.
Results: Fifteen patients underwent LAAC (age 71.3±10.8 yrs, 33% male, CHA2DS2-VASc 4.1±1.7, LAA diameter 21.7±4.5). Implantation was 100% successful, taking 55.1±20.6 min, using 41.5±14.5 cc contrast. TEE evaluation prior to final release revealed adequate seal in all patients. There were no procedure/device-related complications. In 11 patients (4 missed TEE due to COVID-19), TEE at 45-days revealed adequate seal (9 pts-no leak; 1pt-1mm; 1pt-2mm) and no DRT. In 9 patients (6 missed TEE due to COVID-19), TEE at 6 months revealed adequate seal (8 patients-no leak; 1patient-1mm) and 1 patient had DRT. Death occurred in 1 patient which was unrelated to the procedure.
Conclusions: The Conformal Left Atrial Appendage Closure Device can be safely implanted with intraprocedural ICE imaging instead of TEE
AFS 2021-54