3-year Follow-up of a Prospective, Multicenter Study of the Amplatzer Piccolo™ Occluder for Transcatheter Patent Ductus Arteriosus Closure in Children ≥700 grams

Abstract

Abstract Objective This study describes 3-year follow-up of 200 infants weighing ≥700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder. Study Design Between June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). Patients were evaluated for PDA closure, survival, and device- or procedure-related events for 3-years post-implant. Results The implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Overall survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and increased tricuspid regurgitation (5). No intervention was required for tricuspid valve regurgitation. Conclusions This follow-up study demonstrates high rates of PDA closure, low complication rate, and survival >95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants.