Background: Surgical repair is the procedure of choice for atrial septal defect correction. Even though surgical mortality is low (< 1%), morbidity is significant (anesthesia, thoracotomy, cardiopulmonary bypass, longer hospitalization and intensive care unit monitoring). Transcatheter methods to occlude atrial septal defects have been in development during the last two decades. We report our experience in Italy with the Sideris buttoned double-disk device.
Methods: From March 1992 to April 1993, 14 patients aged 20 months to 52 years, weight 10 to 82 kg, underwent transcatheter atrial septal defect occlusion with the Sideris buttoned device. The buttoned device is a miniaturized two disk device introduced through small venous sheaths (8-9 F). The diameter of atrial septal defects by echocardiography varied between 9 and 23 mm, while the balloon stretched diameter of the defects varied between 13 and 24 mm. The devices selected were 19 +/- 4 mm larger than the stretched diameter of the defect, but less than the total length of the septum (33-56 mm) by echo.
Results: Pulmonary-to-systemic flow ratio varied between 1.5 to 4.0. Mean pulmonary artery pressure varied between 10 and 24 mmHg (mean value 17 +/- 3.5 mm Hg). The relationship between different atrial septal defect measurements (echo, shunt flow, stretched diameter) was statistically analysed: transthoracic echo diameter had a good correlation with the balloon stretched diameter (r = 0.63, p < 0.001). The atrial septal defect was occluded in 12 patients (86% success rate). There was one early "unbuttoning" which was surgically corrected with success. The other patient underwent surgical correction 3 months later because of unsuitability for transcatheter closure. Minimal residual shunt detected by color flow mapping at 1 month follow-up was seen in 4 patients (33%). No complications occurred in any of our patients.
Conclusions: This initial experience with the Sideris buttoned double-disk device demonstrated that transcatheter closure of atrial septal defect is feasible and effective. It can be accomplished through small introducing sheaths. Further clinical trials are justified. This method could become the procedure of choice for the correction of small ASDs.
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