Serum Nickel and Titanium Levels after Transcatheter Closure of Atrial Septal Defects with Amplatzer Septal Occluder

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.

Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial

“…[ 22 ] The present results showed no increased serum levels of nickel after parylene-coated device implantation in the trial group, while implantation of the traditional device in the control group resulted in significantly increased serum levels of nickel at 2 weeks and a peak value at 1 month after implantation before gradually decreasing to baseline levels during follow-up, which was consistent with previous studies. [ 12 – 14 ] These results suggest that the parylene-coated ASD occluder has the potential to prevent nickel release after device implantation, and may be a viable alternative for patients with ASD, especially those with nickel allergy.…”

“…Previous studies have demonstrated evidence of nickel release after nitinol-containing occluder implantation [12–14] . Ries et al [12] reported a significant rise in serum nickel levels after the Amplatzer device implantation; the mean serum levels of nickel were significantly increased at 24 h and reached the peak value at 1 month after implantation, before gradually decreasing to the baseline level.…”

“…Previous studies have demonstrated evidence of nickel release after nitinol-containing occluder implantation. [ 12 – 14 ] Ries et al [ 12 ] reported a significant rise in serum nickel levels after the Amplatzer device implantation; the mean serum levels of nickel were significantly increased at 24 h and reached the peak value at 1 month after implantation, before gradually decreasing to the baseline level. Burian et al [ 13 ] also reported a significant rise in both serum and urine nickel levels after implantation of a nickel device in patients with ASD; the serum nickel levels significantly increased by up to five-fold ( P < 0.01 vs. baseline) during the 6-week post-closure period, and the mean nickel concentrations in serum and urine returned to baseline levels within 4 to 6 months post-implantation.…”

“…A recent study also demonstrated a significant rise in serum nickel levels after implantation of the Amplatzer occluder; the maximum serum level of nickel was detected at 3 months after implantation and gradually returned to the baseline level during follow-up. [ 14 ] The nickel release after implantation of nitinol-containing devices may trigger allergic reactions. Systemic adverse effects associated with nickel allergy, such as pericarditis and increased frequency of migraine headaches, have been reported in patients with transcatheter closure of interatrial shunts.…”

Local release of metal ions from endovascular metallic implants in the human biological specimens: An overview of in vivo clinical implications

“…Percutaneous ASD closure using Nitinol devices can be carried out safely without any significant ill effects related to nickel release. In another study by Elkiran et al [78] it was examining the serum nickel and titanium release after transcatheter implantation of Amplatzer device used. 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 of Amplatzer occluder.…”