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[Transcatheter closure of atrial septal defects with the CardioSEAL occluder]
R Kaulitz1, H Bertram, M Peuster
1Medizinische Hochschule Hannover Abteilung Pädiatrische Kardiologie und Pädiatrische Intensivmedizin Carl-Neuberg-Str. 1 30625 Hannover, Germany.
Insights
Transcatheter closure of atrial septal defects using CardioSEAL devices is effective for various morphologies. Medium-term follow-up shows good occlusion rates and safety, supporting its use beyond typical defects.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Limited mid- and long-term follow-up data exist for newer devices used in secundum-type atrial septal defect (ASD) closure.
- Transcatheter closure offers a less invasive alternative to surgical repair for ASDs.
Purpose of the Study:
- To evaluate the effectiveness and safety of transcatheter closure for various atrial septal defect morphologies using CardioSEAL and CardioSEAL-Starflex occluders.
- To assess mid-term outcomes in patients with non-centrally located secundum-type ASDs.
Main Methods:
- Retrospective study of 91 patients (age 1.5-71 years) who underwent transcatheter ASD closure.
- Devices used: CardioSEAL and CardioSEAL-Starflex occluders.
- Follow-up included transesophageal and transthoracic echocardiography, and fluoroscopy.
Main Results:
- Overall occlusion rate increased from 66% immediately post-implantation to 86% at 24 months.
- Patients with isolated secundum-type ASDs had a higher primary closure rate (76%) compared to those with varied morphologies.
- No device-related thrombus, sustained atrial arrhythmia, or infective endocarditis occurred; minor device positioning issues and fatigue fractures were noted.
Conclusions:
- Transcatheter closure with CardioSEAL double umbrella devices is effective and safe for medium-term follow-up in secundum-type ASDs.
- The technique can be successfully applied to a range of atrial septal defect morphologies, not limited to centrally located defects.
Abstract:
Data on mid- and long-term follow-up for the recent devices for closure of secundum-type atrial septal defects are limited. The purpose of our retrospective study was to report the effectiveness of transcatheter closure in patients with various morphological types of atrial septal defect other than centrally located defects within the oval fossa using the CardioSEAL and CardioSEAL-Starflex occluder. A total of 91 patients (age 1.5-71 years, median 6 years) underwent transcatheter closure. On the transesophageal echocardiogram, defect size varied from 6 to 18 mm with an estimated stretched diameter of 11 to 24 mm, median 15 mm; the ratio of the stretched diameter to septal length ranged from 0.28 to 0.68. Mean follow-up was 28.7 +/- 11,9 months (range 3-46 months). Isolated secundum-type defects were present in 59 patients (65%), multiple septal defects including patients with perforated atrial septal aneurysms and defects with deficient atrial rim in 32 patients (35%). Occlusion rate using device diameters from 23 to 40 mm increased from 66% (60/91 patients) immediately after implantation to 86% (48/56 patients) 24 months after implantation. Patients with isolated secundum-type defects presented with a significantly higher primary closure rate (45/59 patients, 76%) compared to patients with various defect morphology. Closure rate did not depend on the type of implanted device modification. No thrombus formation, sustained atrial arrhythmia or infective endocarditis occurred. Serial transthoracic echocardiographic findings revealed protrusion of one left-sided arm onto the right atrial aspect in 5 patients; malposition of one right-sided superior arm of the device was observed in 7 patients. Fluoroscopy showed single fatigue fracture in 7 patients (7.7%) within the first 6 months after implantation. These results demonstrate that transcatheter closure with the double umbrella device was effective and safe on medium-term follow-up and could be extended to atrial septal defects of various morphology.