Objectives: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. Background: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. Methods: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. Results: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. Conclusions: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier:

Background Patent ductus arteriosus (PDA) is common in extremely low birth weight (ELBW) infants. The objectives of this study were to describe our early clinical experience of transcatheter PDA closure (TCPC) in ELBW infants, compare outcomes with surgical ligation of PDA (SLP), and identify risk factors for prolonged respiratory support. Methods A retrospective review was performed comparing infants born <27 weeks, weighing <1 kg at birth and < 2 kg during TCPC with 2:1 propensity‐score matched group of infants that underwent SLP. Change in respiratory severity scores (RSS) immediately post‐procedure and the time taken for return to pre‐procedure RSS for TCPC versus SLP was compared. Factors contributing to prolonged elevation of RSS were identified. Results Eighty ELBW infants (median procedure weight: 1060 [range 640–2000] grams) that underwent successful TCPC were compared with 40 infants that underwent SLP (procedure weight 650–1760 g). There was greater increase in RSS following SLP compared to TCPC (76% vs. 18%; P < 0.01). It took longer for RSS to return to pre‐procedural scores post‐SLP compared to post‐TCPC (28 vs. 8.4 hr; P < 0.01). Elevated pulmonary artery pressure (PAP) and TCPC at >8 weeks of age were associated with prolonged (>30‐days) elevation of RSS ≥ 1 (OR = 5.4, 95%CI: 2.2–9.4, P < 0.01 and OR = 2.86, 95%CI: 1.5–4.2, P = 0.05 respectively). Overall complication rate for TCPC was 3.7%. Conclusions TCPC is feasible in infants as small as 640‐2000 g and can be performed safely in the majority. TCPC may offer faster weaning of respiratory support compared to SLP when performed earlier in life, and before the onset of elevated PAP.

The MVP is a new, large-diameter vascular embolization device that may be useful for the occlusion of PDA in extremely small, premature infants. © 2016 Wiley Periodicals, Inc.