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[Atrial septal defect percutaneous transvenous occlusion with the buttoned device]
Insights
The Sideris device safely and effectively closes atrial septal defects (ASDs) in selected patients. While some residual shunts may occur initially, they often resolve over time, leading to improved patient outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Atrial septal defects (ASDs) are congenital heart conditions requiring intervention.
- Percutaneous transvenous occlusion offers a less invasive alternative to surgical repair.
- Evaluating novel devices for ASD closure is crucial for improving patient care.
Purpose of the Study:
- To assess the clinical experience and outcomes of using the Sideris device for percutaneous transvenous occlusion of atrial septal defects (ASDs).
Main Methods:
- A total of 36 ASD occlusion procedures were performed in 32 patients (27 female, 5 male; mean age 16 years).
- Patients had secundum ASDs with clinical and hemodynamic compromise, with specific size criteria met.
- Both the basic and self-centered Sideris device models were used, employing direct implant or over-the-wire techniques.
Main Results:
- Successful occlusion was achieved in 90.63% of patients (29/32).
- Three patients required surgical removal of the device due to inadequate position or embolization, with no associated morbidity or mortality.
- Trivial residual shunts were observed in 9.4% immediately post-procedure, decreasing to 4.5% at 12-month follow-up.
Conclusions:
- The Sideris device demonstrates safety and efficiency for ASD occlusion in appropriately selected patients.
- Initial residual shunts are common but tend to resolve, not hindering clinical or hemodynamic improvement.
- The Sideris device represents a viable option for percutaneous ASD closure.
Purpose:
To analyse the experience with the use of Sideris' device for percutaneous transvenous occlusion of atrial septal defect (ASD).
Methods:
Thirty six procedures of ASD occlusion were performed in 32 patients; 27 (84.4%) female and five (15.6%) male, mean age of 16 years (4-61). All patients had secundum atrial septal defects with clinical and hemodynamic compromise. The ASD diameter measured < 31 mm and occupied less than 50% of the septal length in all cases. The basic device was used in 28 (87.5%) patients and the self centered model in four (12.5%). The direct implant technique was employed in 15 (41.7%) procedures while in the other 21 (58.3%) an over a wire technique was used. The size of the device was selected according with the Sideris' normogram.
Results:
Occlusion of the defect was achieved in 29 patients (90.63%). In two (6.25%) the position of the device was not adequate and in one (3.12%) the device embolized to the pulmonary artery. In these three cases the device was removed surgically during the defect closure. There was neither morbidity nor mortality in this series. Trivial or small residual shunt was detected with color flow mapping in three (9.4%) patients immediately after the procedure. In 22 patients with 12 months follow-up, trivial residual shunt was present in only one (4.5%). Structural modification of the device was detected in one patient, however with complete ASD occlusion and neither clinical nor hemodynamic disturbance.
Conclusion:
The Sideris' device is safe and efficient for ASD occlusion in selected patients. Although there is a relatively high incidence of residual shunt immediately after the procedure, the shunt itself tends to become smaller or disappear during the follow-up and it does not preclude clinical and hemodynamic improvement.