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Multicenter Study
. 2023 Oct;43(10):1238-1244.
doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams

Brian H Morray  1 , Shyam K Sathanandam  2 , Thomas Forbes  3 , Matthew Gillespie  4 , Darren Berman  5 , Aimee K Armstrong  6 , Shabana Shahanavaz  7 , Thomas Jones  8 , Toby Rockefeller  9 , Henri Justino  10 , David Nykanen  11 , Courtney Weiler  12 , Dan Gutfinger  12 , Evan M Zahn  13
Affiliations
Multicenter Study

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams

Brian H Morray et al. J Perinatol. 2023 Oct.

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). 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.

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Conflict of interest statement

BHM is a consultant and proctor for Abbott Structural Heart; SS: proctor/consultant Abbott; TF: proctor/consultant Abbott, Edwards, AcuNav/Biosence Webster, B. Braun Medical, Siemens, Medtronic; MG: proctor/consultant Abbott, Medtronic, W.L. Gore & Assoc; DB: proctor/consultant Abbott, Edwards, Medtronic; AKA: proctor/consultant Abbott, Edwards, Medtronic, Cook Medical; S. Shahanavaz: proctor Abbott, Medtronic, and Edwards; TJ: research grant, proctor/consultant Abbott, Edwards, Medtronic, W.L. Gore & Assoc.; BM: Consultant Medtronic, proctor Abbott; TR: proctor Abbott; HJ: proctor/consultant Abbott, Baylis Medtech, Chiesi USA, Edwards Lifesciences, Medtronic, Clinical trial executive committee Janssen Pharmaceutical, Co-founder PolyVascular, scientific advisory board Pediastent; DN: proctor Abbott, consultant and independent data reviewer W.L. Gore & Assoc, expert witness Glaxo Smith Kline; CW: full-time Abbott employee; DG: full-time employee Abbott; EMZ: consultant/proctor Abbott, Edwards, Medtronic, National PI ADO II AS IDE Trial and Alterra/S3.

Figures

Fig. 1
Fig. 1. Flow chart of study enrollment and follow-up for both the IDE and CAP cohort through the three-year study period.
A total of 182 patients were available for study follow-up of which 156 (85.7%) completed three-year follow-up.
Fig. 2
Fig. 2. Three year study cohort survival curves.
Overall survival for the entire cohort was 95% at three years. Kaplan-Meier survival analysis demonstrated no significant difference in three-year survival between patients >2 kg and ≤ 2 kg.
Fig. 3
Fig. 3. Postmortem histopathology following PDA occlusion with the Amplatzer Piccolo™ Occluder.
A, B Term infant with a history of congenital heart block and respiratory failure died 66 days post-implant (Patient #9). Aortic (A) and Pulmonary Artery (B) views demonstrate complete endothelialization and intraductal device placement. C, D Preterm infant with a history of coarctation requiring stent placement and respiratory failure died 141 days post-implant (Patient #3). Aortic (C) and Pulmonary Artery (D) views demonstrate complete endothelialization and intraductal device placement.
Fig. 4
Fig. 4. All patients with echocardiographic follow-up through three years demonstrated complete ductal occlusion with no residual shunt.
At six-month follow-up there was one patient with a significant residual shunt.
See this image and copyright information in PMC

References

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