Left atrial appendage closure guided by fusion of 3D computational modelling on real-time fluoroscopy: A multicenter experience.

BACKGROUND

Patient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported.

OBJECTIVES

To assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective.

METHODS

We included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization.

RESULTS

A total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired.

CONCLUSIONS

Fusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Informations de copyright

Copyright © 2024. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of competing interest P. Garot is medical director and shareholder of CERC, a CRO dedicated to cardiovascular research. He is proctor for Abbott and has received Advisory/speaker's fees from Abbott, Biosensors, Boston Scientific, Cordis, GE Healthcare, and Terumo outside the submitted work. C. Skurk has received speakers fees from Abiomed and Boston Scientific. A. Gautier has received consulting fees from Abbott, Boston Scientific, GE HealthCare, Medtronic and Terumo outside the submitted work. A.M. Bavo is an employee of FEops. R. Vaillant is an employee of General Electric HealthCare. J. Horvilleur is proctor for Abbott. X. Freixa is proctor for Abbott, Boston Scientific and Lifetech Medical. J. Saw is Consultant and Proctor for Abbott and Boston Scientific. O. De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. The other co-authors have nothing to disclose.