Study of nickel levels in patients with atrial septal defect undergoing amplatzer device closure

Abstract

Transcatheter closure of atrial septal defects (ASDs) using nickel titanium Naval Ordnance Laboratory (Nitinol)-containing devices (Amplatzer, AGA Medical, Golden Valley, Minnetosa) is being widely practiced. Controversies still exist regarding the release of nickel from these devices and the allergy and other ill effects of nickel and also the duration of antiplatelet therapy to aid endothelization of the device. Objective: To study the nickel levels in patients who underwent ASD closure with platinum-coated Nitinol-containing Amplatzer septal occluder. Methodology: A prospective study was conducted on 25 patients, between 6 years and 40 years of age who underwent ASD closure with Amplatzer septal occlude sizes ranging from 12 to 36 mm from January 2009 to January 2010. Blood nickel levels were estimated using atomic absorption photometry before and 24 h after the procedure and later at 1 month, 3 months, and 6 months postprocedure. A value of <2 mcg/dl was considered to be normal. Statistical analysis was performed by the use of the Wilcoxon test. Results: The blood nickel levels at mean baseline, 24 h, 1 month, 3 months, and 6 months postprocedure were 1.05, 1.39, 0.98, 0.79, and 0.74 (mcg/dl), respectively. Conclusions: Percutaneous ASD closure using Nitinol devices can be carried out safely without any significant ill effects related to nickel release.

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

“…Controversies still exist regarding the release of nickel from these devices and the allergy and other ill effects of nickel and also the duration of antiplatelet therapy to aid endothelization of the device [74,75]. Narayana et al [77] followed a total 25 patients in whom the platinum-coated Nitinol-containing Amplatzer septal occluder was used for transcatheter closure of ASD for a period of one year. Blood nickel levels were estimated before and 24 h after the procedure and later at 1 month, 3 months, and 6 months post procedure.…”

Safety Evaluation for Nickel Release of Nickel–Titanium alloys Cardiovascular stents

“…As far as possible, please keep the introduction comprehensible to scientists outside your particular eld of research. References should be numbered in order of appearance and indicated by a numeral or numerals in square brackets-e.g., [1] or [2,3], or [4][5][6]. See the end of the document for further details on references.…”

“…Once sensitization occurs, Ni allergy can persist inde nitely. The Ni released by long-term implantation of NiTi alloy, because of its direct contact with human blood organs and tissues, may bring more serious harm to patients compared to skin and gastrointestinal absorption [3][4][5][6], therefore, more attention should be paid to its safety issues. The international jewelry and textile industry has discovered the allergic reaction of Ni and promulgated relevant regulations to avoid its risk.…”