Multicenter nit-occlud® PDA-R patent. Ductus arteriosus occlusion device trial: Initial and six-month results

• Published in: Catheterization and cardiovascular interventions Vol. 86; no. 2; pp. 258 - 263
• Main Authors: Granja, Miguel A., Trentacoste, Luis, Rivarola, Marcelo, Barbosa, Jesus Damsky, Lucini, Victorio, Peirone, Alejandro, Spillman, Ana
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.08.2015; Wiley Subscription Services, Inc
• Subjects: Adolescent; Argentina; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Child; Child, Preschool; Ductus Arteriosus, Patent - diagnosis; Ductus Arteriosus, Patent - physiopathology; Ductus Arteriosus, Patent - therapy; Female; Hemodynamics; Humans; Infant; Male; patent ductus arteriosus; PDA-R occluder; percutaneus closure; Pilot Projects; Prospective Studies; Prosthesis Design; Pulmonary arteries; Radiography, Interventional; Septal Occluder Device; Time Factors; Treatment Outcome; Argentina; PDA-R occluder; percutaneus closure; patent ductus arteriosus
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.24912

Background Transcatheter closure of a moderate to large patent ductus arteriosus (PDA) using conventional techniques is challenging. The Nit‐Occlud® PDA‐R trial can close a PDA up to 8 mm in diameter. We sought to report procedural and six‐month efficacy and safety results of the multicenter Nit‐Occlud® PDA‐R trial. Methods From June 2010 to February 2011, 43 patients were enrolled in three centers from Argentina. Median age was 4.5 (range 1.4–18.4 years) years old at catheterization, 70% were females and weight was 17.7 (range 10–67 kg). Results PDAs mean diameter was 2.98 ± 1.03 and ranged from 2 to 6.19 mm. About 11.6% were large (≥4 mm), whereas 32.6% were <2.5 mm. Median pulmonary artery mean pressure was 17 mm Hg (range 9–26 mm Hg). The device was implanted successfully in all patients. By echocardiography, trivial residual shunt was observed in 42% at the end of the procedure, in 28% at 24 hr, in 12.1% at one week, and none at three‐months. There was one case of embolization (due to undersizing), that was treated successfully with a larger study device. There were no major short‐ or long‐term complications. Conclusions PDAs ranging from 2 to 6 mm can be effectively and safely closed using the Nit‐Occlud® PDA‐R device, with good procedural and six‐month results. The Nit‐Occlud® PDA‐R emerges as an optimal alternative for closure of small to moderate PDAs. © 2015 Wiley Periodicals, Inc.