Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM.J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.PMID: 37587183
Take Home Points
- Overall survival at 3-year follow-up for the entire cohort was 95.3% and for patients ≤2 Kg at the time of implant was 92.9%.
- 9 patients died following device placement but causes of death were reviewed independently by the clinical events committee and no deaths were adjudicated as device or procedure related.
- Beyond 6 months there were no additional device or procedure replated complications.
- An increase in tricuspid regurgitation (TR) was reported in 5 patients but none required intervention to repair or replace the tricuspid valve at 3-year follow-up.
- Echocardiography follow-up demonstrated effective patent ductus arteriosus (PDA) closure achieved in 97.4% of patients at 30 days post implant, 99.4% at 6 months and 100% through 3-years.
Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan)
Transcatheter patent ductus arteriosus (PDA) closure is the mainstay of therapy in older children and adults though controversy has persisted about the optimal approach to PDA closure in preterm infants. The Amplatzer Piccolo Occluder (Abbott Structural Heart, Plymouth, MN) was approved for commercial use in the United States by the Food and Drug Administration in 2019 for PDA closure in patients ≥700. Patients began enrollment in June 2017 for the prospective single arm multicenter pre-marked study to characterize the safety and effectiveness of the Amplatzer Piccolo Occluder in children ≥700g and ≥3 days of age at the time of implant. The procedural outcomes and 6-month clinical data were previously published. This study reports the 3-year clinical outcomes in this cohort of patients.
A total of 200 patients were enrolled in the study and the entire cohort was split evenly by weight ≤2 Kg (n=100) and ≥2 Kg (n=100). The mean weight of infants referred from the NICU was 0.85 +/- 0.29 Kg and had a mean gestational age of 26 +/- 3 weeks. There were 9 unsuccessful implants, 5 patient deaths prior to 6-month follow up and an additional 4 patient deaths after six months leaving 182 patients available for analysis at 3-year follow up.
Overall patient survival at 3 years was 95.3% and for children ≤2 Kg was 92.9%. Beyond 6-months there were no additional device or procedure related adverse events. All patient deaths were independently reviewed by the clinical events committee and found to be unrelated to the procedure or device. Only 33 echocardiograms were available at 3-year follow-up but all (33/33) demonstrated complete PDA closure with no residual defect. There was no late cases of aortic obstruction and no cases of LPA obstruction requiring intervention at 3-year follow up. An increase in TR was reported in 5 patients with four available for analysis at 3-year follow up and none required intervention or repair of the tricuspid valve.
The authors conclude that transcatheter PDA closure with the Amplatzer Piccolo Occluder is safe and effective and with 3-year follow up there is 100% successful closure and >95% survival. They concede, however, that although a high rate of technical success and low rates of complications are achieved, the impact on the clinical course of patients treated with this device requires ongoing investigation.
