DOI: 10.1038/s41372-023-01741-1; PMCID: PMC10541325
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). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study.
RESULTS: The implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. 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 tricuspid regurgitation (5), for which no interventions were required.
CONCLUSIONS: This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants.
CLINICALTRIALS: gov identifier: NCT0305585.
Journal of perinatology : official journal of the California Perinatal Association
Infant; Humans; Child; Follow-Up Studies; Ductus Arteriosus, Patent; Prospective Studies; Cardiac Catheterization; Septal Occluder Device; Treatment Outcome
Follow-Up Studies; Patent Ductus Arteriosus; Prospective Studies; Cardiac Catheterization; Septal Occluder Device; Treatment Outcome
Morray BH, Sathanandam SK, Forbes T, et al. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams. J Perinatol. 2023;43(10):1238-1244. doi:10.1038/s41372-023-01741-1