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:Observationa...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.展开更多
文摘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.