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.
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.
Department of Clinical Pharmacology, University Clinic of Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
M
M
Burian
T
T
Neumann
M
M
Weber
R
R
Brandt
G
G
Geisslinger
V
V
Mitrovic
C
C
Hamm
D000328:Adult; D000368:Aged; D000497:Alloys / Q000009:adverse effects*; D001241:Aspirin / Q000627:therapeutic use*; D000077144:Clopidogrel; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009532:Nickel / Q000009:adverse effects* / Q000097:blood / Q000652:urine; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019736:Prostheses and Implants / Q000009:adverse effects*; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000497:Alloys; D010975:Platelet Aggregation Inhibitors; C013616:nitinol; D009532:Nickel; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin