Serum Nickel Level after Implantation of Amplatzer(R) Occluder

ABSTRACT

PURPOSE: Transcatheter closure of patent foramen ovale (PFO), atrial septal defect (ASD) and patent ductus arteriosus (PDA) is a new and less traumatic technique than open heart surgery. One of the more popular occluding devices is the Amplatzer(R) septal occluder which is made of nitinol. The present study was undertaken to evaluate the safety and release of nickel after implantation of Amplatzer(R) occluder in patients with PFO, ASD and PDA. METHODS: Random blood samples were obtained from 25 patients with Amplatzer(R) PFO, ASD, PDA occluder during 4-year and 7-month post closure period. The nickel content in the specimens was determined using atomic absorption spectrometer. RESULTS: All patients showed satisfactory clinical improvements and there was no echocardiographic evidence of complications. During the post closure, concentrations of nickel in serum were within normal range with values 0.2 ug/dL. CONCLUSION: Nickel seems to be released from Amplatzer(R) occluder. The dissolusion of nickel from Amplatzer(R) occluder is minimal and systemic rise in serum levels of nickel are within normal range. However, further studies are needed to evaluate biological effects in patients with nickel hypersensitivity.