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Multicenter nit‐occlud ® PDA‐R patent. Ductus arteriosus occlusion device trial: Initial and six‐month results
Author(s) -
Granja Miguel A.,
Trentacoste Luis,
Rivarola Marcelo,
Barbosa Jesus Damsky,
Lucini Victorio,
Peirone Alejandro,
Spillman Ana
Publication year - 2015
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.24912
Subject(s) - medicine , ductus arteriosus , pulmonary artery , embolization , occlusion , surgery , multicenter study , shunt (medical) , multicenter trial , nuclear medicine , randomized controlled trial
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.