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