Buttoned Device Occlusion of Patent Ductus Arteriosus

Area of Science:

• Cardiovascular Medicine
• Medical Devices
• Pediatric Cardiology

Background:

• Patent ductus arteriosus (PDA) is a common congenital heart defect requiring intervention.
• Transcatheter device closure is a preferred method for PDA treatment.
• Existing devices may have limitations in achieving complete occlusion or managing residual shunts.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel buttoned device for transcatheter closure of PDA.
• To assess the device's performance across various PDA anatomies.
• To report on the long-term outcomes, including residual shunt rates and reinterventions.

Main Methods:

• A large, multi-institutional study involving patients undergoing PDA closure with the buttoned device.
• Device implantation via small sheaths.
• Assessment of procedural success, hemodynamic changes (pulmonary-to-systemic flow ratio), and occlusion rates.
• Follow-up evaluation for residual shunts, hemolysis, and need for reintervention.
• Description of a modified device incorporating a folding plug for complete occlusion.

Main Results:

• Successful device implantation in 98% of patients.
• Effective occlusion achieved in 88% of patients, regardless of PDA morphology.
• Significant decrease in pulmonary-to-systemic flow ratio observed.
• Low reintervention rate (3%) for residual shunts, with spontaneous closure in many cases.
• Modified device demonstrated complete PDA occlusion at implantation.

Conclusions:

• The buttoned device is a safe and effective option for PDA closure across diverse anatomies.
• The modified device design successfully addresses the issue of residual shunts, enhancing safety.
• Transcatheter closure with this device offers a high success rate and favorable long-term outcomes.