FEops HEARTguide Patient-Specific Computational Simulations for WATCHMAN FLX Left Atrial Appendage Closure: A Retrospective Study.

Background

Three-dimensional transesophageal echocardiography (3D-TEE) is the primary imaging tool for left atrial appendage closure planning. The utility of cardiac computed tomography angiography (CCTA) and patient-specific computational models is unknown.

Objectives

The purpose of this study was to evaluate the accuracy of the FEops HEARTguide patient-specific computational modeling in predicting appropriate device size, location, and compression of the WATCHMAN FLX compared to intraprocedural 3D-TEE.

Methods

Patients with both preprocedural and postprocedural CCTA and 3D-TEE imaging of the LAA who received a WATCHMAN FLX left atrial appendage closure device were studied (n = 22). The FEops HEARTguide platform used baseline CCTA imaging to generate a prediction of device size(s), device position(s), and device dimensions. Blinded (without knowledge of implanted device size/position) and unblinded (implant device size/position disclosed) simulations were evaluated.

Results

In 16 (72.7%) patients, the blind simulation predicted the final implanted device size. In these patients, the 3D-TEE measurements were not significantly different and had excellent correlation (Pearson correlation coefficient (r) ≥ 0.90). No patients had peridevice leak after device implant. In the 6 patients for whom the model did not predict the implanted device size, a larger device size was ultimately implanted as per operator preference. The model measurements of the unblinded patients demonstrated excellent correlation with 3D-TEE.

Conclusions

This is the first study to demonstrate that the FEops HEARTguide model accurately predicts WATCHMAN FLX device implantation characteristics. Future studies are needed to evaluate if computational modeling can improve confidence in sizing, positioning, and compression of the device without compromising technical success.

Informations de copyright

© 2022 The Authors.

Déclaration de conflit d'intérêts

Dr Vahl has received institutional funding to Columbia University Irving Medical Center from Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers; and has personally received consulting fees from Abbott Vascular, Boston Scientific, and Siemens Healthineers. Dr Sommer is a trainer for Boston Scientific’s Watchman device; is an investigator for the following Boston Scientific trials: OPTION and CHAMPION-AF; and is the National Principal Investigator on for two Gore trials: ASSURED and RELIEF. Dr Khalique is part of a corelab contracting with JenaValve, but has not received any direct compensation; has received consulting fees from Abbott Structural and Boston Scientific; and has received Speakers bureau fees from Edwards Lifesciences. Dr Hamid is part of a corelab contracting with JenaValve, but she has not received any direct compensation. Drs Bavo and De Beule are employees of FEops. Dr Hahn has received speaker fees from Abbot Vascular, Baylis Medical, Edwards Lifescience, and Philips Healthcare; institutional consulting contracts with no direct compensation for Abbott Structural, Edwards Lifesciences, Medtronic, Novartis, and Philips Healthcare; and equity with Navigate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.