心房中隔欠損症のバルーンサイジングなし経カテーテル閉鎖のための3次元経食道心エコー検査に基づくデバイス選択のルーチン適用

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 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 minutes, 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.

Preprocedural 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 NCT02097758).