Abstract
Introduction There is a concern about release of nickel and titanium after implantation of nitinol-containing devices. Objective To evaluate serum nickel and titanium release after implantation of Amplatzer occluder. Materials and methods In 38 pediatric patients with no history of nickel sensitivity, blood samples were drawn 24 hours before and 24 hours, 1, 3, 6, and 12 months after implantation. Nickel and titanium concentrations were measured by atomic absorption spectrophotometry. Results The median serum nickel level which was 0.44 ng/mL before the implantation increased to 1.01 ng/mL 24 hours after implantation and 1.72 ng/mL one month after implantation. The maximum level was detected 3 months after implantation, with a median level of 1.96 ng/mL. During follow-up, the nickel levels decreased to those measured before implantation. Serum nickel levels at the 24th hour, 1st month, and 3rd month following implantation were found to have increased significantly. No patients showed a detectable serum titanium level. Discussion This is the first study that evaluated both serum nickel and titanium release after implantation of the Amplatzer occluder. Our study shows that nickel is released from the device in the first few months after implantation. Therefore, in patients with nickel allergy, other devices may be considered.
Highlights
Secundum-type atrial septal defects (ASD) account for about 6%–10% of congenital heart defects in children [1, 2]
Systemic side effects associated with nickel allergy, pericarditis, and increased migraine headaches have been reported in patients with transcatheter closure of interatrial shunts [13,14,15]
The median serum nickel level gradually dropped after the implantation to 1.08 ng/mL in month 6 and 0.52 ng/mL in month 12 (Figure 1)
Summary
Secundum-type atrial septal defects (ASD) account for about 6%–10% of congenital heart defects in children [1, 2]. Results of surgical closure are good, they are associated with morbidity, discomfort, and thoracotomy scar. E Amplatzer septal occluder (AGA Medical Corp, Golden Valley, MN; USA) is a nickel-titanium alloy (nitinol) device which is the commonly implanted device for the transcatheter closure of ASD and produces good early-, middle-, and long-term results in children and adults [6,7,8,9,10]. Nitinol is an alloy composed of nickel and titanium It is used commonly in medical products due to its good radioopacity, superelasticity, corrosion resistance, and shape memory quality [11, 12]. Systemic side effects associated with nickel allergy, pericarditis, and increased migraine headaches have been reported in patients with transcatheter closure of interatrial shunts [13,14,15]. It can cause allergic and toxic effects in blood, fibrotic tissues, and osteogenic cells [20]. ese reasons make it all the more
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