Efficacy, Safety and Characteristics of the Amplatzer Vascular Plug II and IV Utilization for Various Percutaneous Occlusions in Children under 10 Years

Abstract

Objectives: We aim to describe the efficacy, safety, and characteristics of the Amplatzer Vascular Plug (AVP) II and IV “off-label” use for multiple cardiovascular occlusions in children under 10 years. Methods: Observational retrospective multicenter (2007–2020, 6 centers) review of paediatric procedures using AVP II or IV. Results: A total of 125 children (49.6% aged ≤ 1 year, 147 lesions) underwent 136 successive procedures (success rate: 98.5%) using 169 devices (109 AVP IV, 60 AVP II). The mean device diameter was 7.7 ± 3.2 mm (4–20 mm). The median AVP size to vessel diameter ratio was 1.3 (0–2). The median age and weight at implantation were 1.0 year (0.01–9.98) and 8.4 kg (1–69). Procedures were heterogeneous (55 patent ductus arteriosus (PDA), 28 collaterals, 18 sequestrations, 22 arteriovenous/veinovenous/coronary fistulas, 6 vertical veins, 6 conduits, 5 ventricular septal defects, 7 miscellaneous). Day 1 and 6-month occlusion rates were respectively 94.8% and 98.5%. Major adverse events (MAE) occurred in 5.2% of cases (no procedure-related deaths), and more frequently in weight ≤ 5 kg (p = 0.01), younger patients (p = 0.03) during PDA closure (p = 0.02) of tubular types (p = 0.02) using larger devices (p = 0.03) and AVP II (p = 0.003). Independent predictor of MAE risk was a higher AVP diameter to patient weight ratio (Odds-ratio: 2.33, 95% confidence interval 1.31–4.13, p = 0.004, optimal cut off: 1.45). Conclusions: Both AVPs are safe and effective for percutaneous occlusions in children under 10. Such devices represent an alternative “off label” use for well selected paediatric patients.