Efficacy, safety, and characteristics of the utilization of the Amplatzer Vascular Plug (AVP) II and IV for various percutaneous occlusions in children under 10 years

Abstract

Even though several devices have been developed to facilitate occlusion of cardio vascular structures in adults, only a few types of plugs have been approved in selected pediatric indications. However, apart from patent ductus arteriosus (PDA) closure, little data has been published in children, particularly with regard to the heterogeneity of the procedures and outcomes. To describe the efficacy, safety, and characteristics of the utilization of the Amplatzer Vascular Plug (AVP) II and IV for cardiovascular percutaneous occlusions in children under 10 years. Retrospective multicenter (2006–2020, 6 academic centers) observational review of pediatric transcatheter occlusions using AVP II or IV. A total of 125 consecutive children (60 < 1 year, 145 lesions) underwent 136 successive procedures using 175 different devices (112 AVP IV, 63 AVP II) with a success rate of 98.5%. The mean device diameter was 7.7 ± 3.2 mm (4–20 mm). The median age and weight at implantation were 1.0 year (0.01–9.98 years) and 9.1 kg (1–69 kg), respectively. Procedures involved 55 PDA, 28 arterial bronchial or aorto-pulmonary collaterals, 18 sequestrations or Scimitar syndrome, 16 arteriovenous or veinovenous fistulae, 6 coronary fistulae, 6 vertical veins, 6 conduits, 5 ventricular septal defect, and 7 miscellaneous occlusions. The occlusion rate at Day1 was 96.3% and 100%, 6 months after, without hemolysis. Major adverse events (MAE) occurred in 5.1% mainly the need for surgery, without any related death. MAE was related to a lower weight ( P = 0.04), a younger age ( P = 0.02) and large PDA closure using AVP II ( P < 0.01). AVP II and IV are safe and effective for the percutaneous treatment of numerous cardiovascular lesions in children under ten. In our multicenter experience, such devices represent a real “off-label” pediatric alternative in well-selected patients.