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New device shows promise in closure of patent ductus arteriosus
A patent ductus arteriosus occluder had a high efficacy rate but with residual shunts in a cohort of patients undergoing patent ductus arteriosus closure in a prospective, nonrandomized pilot study.
The trial included 33 patients with patent ductus arteriosus accrued between November 2011 and April 2013 who underwent attempted transcatheter patent ductus arteriosus closure with the Occlutech PDA occluder (Occlutech). Exclusion criteria were weight less than 6 kg and the presence of associated cardiac anomalies requiring surgery. The median patient age was 2 years (6 months to 38 years) and the median weight was 9.3 kg (6-69.2 kg).
Clinicians conducted transthoracic echocardiography at 24 hours and 30, 90, 180 and 360 days after intervention. They assessed residual shunt, left pulmonary artery and descending aortic velocities.
The devices were delivered using 6F to 8F long sheaths. Standard techniques were employed for PDA closures. The researchers noted that 3 mm was the narrowest median diameter for patent ductus arteriosus (PDA; 1.8-5.8 mm).
Successful closure was achieved in all 33 patients. Complete closure immediately following the procedure was observed on angiography in 48.5% of patients, with a small residual shunt in 30.3%, moderate residual shunt in 12.1% and a significant residual shunt with soft systolic murmur in 9.1%. Doppler analysis at 24 hours indicated a complete closure rate of 81.8%, which increased to 97% at 30 days and 100% at 90 days.
Device embolization, hemolysis or obstruction to the left pulmonary artery or descending aorta did not occur. No patients required blood transfusion, and no patients experienced femoral arterial or venous complications, with one exception who had a mild, pre-existing coarctation.
“The new Occlutech PDA occluder is safe and effective for the closure of type A PDAs,” the researchers concluded. “In large PDAs, there is a tendency for residual shunts and delayed complete closure.” – by Rob Volansky
Disclosure: The researchers report no relevant financial disclosures.