Document Detail

Nickel release, a possible indicator for the duration of antiplatelet treatment, from a nickel cardiac device in vivo: a study in patients with atrial septal defects implanted with an Amplatzer occluder.
MedLine Citation:
PMID:  16550732     Owner:  NLM     Status:  MEDLINE    
The present study was undertaken to evaluate the safety and release of nickel after implantation of a nickel device (Amplatzer occluder) in patients with an atrial septal defect (ASD) receiving antiplatelet therapy. METHODS: Blood and urine samples were obtained from 24 patients with ASD before occluder implantation (baseline) and during a 12-month post closure period. Antiplatelet drugs were administered for the initial 6-month period post implantation. The nickel content in the specimens was determined using electrothermal atomic absorption spectroscopy. The clinical, sonographic and magnetic resonance imaging follow-ups were carried out 1 week, 1 month, 6 months and 12 months post implantation. RESULTS: Mean baseline concentrations of nickel in serum and urine were within normal range with values of 0.6 +/- 0.2 microg/l and 3.1 +/- 1.2 microg/l, respectively. During the 6-week post closure period, the time needed for the formation of neointima on the surface of the graft, nickel levels in serum increased up to 5-fold (p < 0.01 versus baseline). Mean concentrations in serum and urine returned to baseline levels within 4-6 months post implantation. All patients showed satisfactory clinical improvements and there was no sonographic evidence of complications. CONCLUSIONS: The initial dissolution of nickel from the Amplatzer occluder is not a specific cardiovascular risk and is temporarily linked to the formation of the non-thrombogenic neointima on the surface of the graft. The antiplatelet drug regimen used (300 mg aspirin + 75 mg clopidogrel daily for 3 months in the initial phase and 100 mg aspirin daily for a further 3 months) appears to cover the period of neointima formation on the nickel device when nickel levels are significantly elevated. However, further studies in a larger number of patients and over a period greater than 12 months are needed to confirm the validity of these conclusions and to formulate definitive recommendations on the duration of the antiplatelet treatment.
M Burian; T Neumann; M Weber; R Brandt; G Geisslinger; V Mitrovic; C Hamm
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  44     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-03-22     Completed Date:  2006-07-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  107-12     Citation Subset:  IM    
Department of Clinical Pharmacology, University Clinic of Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
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MeSH Terms
Alloys / adverse effects*
Aspirin / therapeutic use*
Heart Septal Defects, Atrial / surgery*
Middle Aged
Nickel / adverse effects*,  blood,  urine
Platelet Aggregation Inhibitors / therapeutic use*
Prostheses and Implants / adverse effects*
Ticlopidine / analogs & derivatives*,  therapeutic use
Reg. No./Substance:
0/Alloys; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 52013-44-2/nitinol; 55142-85-3/Ticlopidine; 7440-02-0/Nickel; 90055-48-4/clopidogrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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