Routine application of three-dimensional transesophageal echocardiography-based device selection for transcatheter closure of atrial septal defect without balloon sizing

There is no standardized global framework for device size selection in transcatheter atrial septal defect (ASD) closure. We aimed to evaluate outcomes and insights from the routine application of a device selection strategy based on 3D transesophageal echocardiography (TEE) in consecutive patients undergoing ASD closure.

The study population was derived from a prospective ASD_3D_Device_Size registry, in which device sizing was exclusively determined prior to the procedure by a 3D TEE-based formula. All patients were clinically followed for a median of 1.6 years after the procedure. Between September 2016 and May 2024, a total of 748 patients were included. Median procedural and fluoroscopy times were 18.0 and 3.7 min, respectively. Procedure success rate was 99.5%. One patient (0.1%) required intraprocedural device size reselection. Device embolization occurred in three (0.4%) patients; two of these cases were attributed to delivery system malfunction. Device malposition was found in one (0.1%) patient, who underwent surgery. During follow-up, one patient required surgery for cardiac erosion. Among 186 (24.9%) oval ASDs, long axis orientations were diverse. Computational simulations demonstrated that, when balloon sizing was assumed to be performed in the fluoroscopic antero-posterior projection, the greatest underestimation of maximal diameter, with a discrepancy of 34.9%, occurred in the horizontally oriented oval ASDs.

Pre-procedural determination of device size based on 3D TEE provides a safe and useful framework in routine clinical practice. Because of the diversity in maximal diameter orientation, balloon sizing using a fixed fluoroscopic angle may underestimate the true maximal diameter of an ASD.

(ClinicalTrials.gov number NCT 02097758)