Congenital heart diseaseCohort study
Routine application of three-dimensional transesophageal echocardiography-based device selection for transcatheter closure of atrial septal defect without balloon sizing
- prospective atrial septal defect (ASD)_3D_Device_Size registry
- consecutive patients
Authors' 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 NCT 02097758)
Study context
- Population
- Consecutive patients undergoing transcatheter ASD closure with device size determined prior to the procedure by a 3D transesophageal echocardiography (TEE)-based formulapatients included between September 2016 and May 2024
- Participants
- 748 patients
Main finding
As reported in the abstract
Median procedural time
18.0 min
Median fluoroscopy time
3.7 min
Observational data: associations, not effects.
Further findings
Procedure success rate
- Procedure success rate
- 99.5%
Intraprocedural device size reselection
- Patients requiring intraprocedural device size reselection
- One patient (0.1%)
Follow-up
- Median clinical follow-up
- 1.6 years
Oval ASDs and long axis orientation
- Oval ASDs
- 186 (24.9%)
- Long axis orientations were diverse
Computational simulation of balloon sizing in fluoroscopic antero-posterior projection
- Greatest underestimation of maximal diameter, in horizontally oriented oval ASDs
- 34.9%
Safety
Device embolization
- Device embolization
- three (0.4%) patients
- two of these cases were attributed to delivery system malfunction
Device malposition
- Device malposition, underwent surgery
- one (0.1%) patient
Cardiac erosion requiring surgery · During follow-up
- Patients requiring surgery for cardiac erosion
- one patient
Original publication
Summarised from the published abstract; every number is checked against it