European heart journal. Cardiovascular Imaging · 2026
Routine application of three-dimensional transesophageal echocardiography-based device selection for transcatheter closure of atrial septal defect without balloon sizing.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Lee Pil Hyung, Kim Ga Yun, Yu Jae Sung, Earm Inbae, Kwon Kyung Beom, Koo Hyung Il, Kim Tae Oh, Lee Sahmin, Sun Byung Joo, Kim Dae-Hee, Kang Duk-Hyun, Song Jae-Kwan, Song Jong-Min
Аннотация
AIMS: 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.
METHODS AND RESULTS: 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.
CONCLUSION: 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 NCT02097758).
METHODS AND RESULTS: 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.
CONCLUSION: 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 NCT02097758).