Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial)

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Atrial septal defects (ASDs) are common congenital heart conditions requiring closure.
• Transcatheter closure offers a less invasive alternative to surgical repair.
• The buttoned device is a novel technology for ASD closure.

Purpose of the Study:

• To evaluate the safety and efficacy of the buttoned device for transcatheter closure of ostium secundum ASDs.
• To assess device performance and complication rates during and after implantation.
• To determine the long-term outcomes of ASD closure using this device.

Main Methods:

• A clinical trial involving 57 patients (aged 1-62 years) with ostium secundum ASDs.
• Transcatheter implantation of the buttoned device.
• Assessment of procedural success, device stability, and hemodynamic parameters (Qp/Qs).
• Follow-up evaluation for shunt presence, complications, endocarditis, and thromboembolism.

Main Results:

• Successful device implantation in 46 of 50 patients (92%) where closure was attempted.
• Effective closure achieved in 45 of 57 patients (79%) overall.
• Significant reduction in Qp/Qs from 1.8 to 1.1 (p < 0.0001) immediately post-procedure.
• 98% of patients had no or trivial residual shunt at follow-up (1-20 months).
• Complications included device unbuttoning (4 patients) and transient valve regurgitation (4 patients).
• No cases of endocarditis or thromboembolism reported in 350 patient-months.

Conclusions:

• The buttoned device is an effective option for transcatheter closure of ostium secundum ASDs.
• High rates of successful closure and minimal residual shunts were observed.
• While complications like device unbuttoning occurred, overall safety and efficacy were demonstrated.
• Further investigation may be warranted to optimize device design and implantation techniques.