Self-expanding platinum-coated nitinol devices for transcatheter closure of atrial septal defect: prevention of nickel release.
BACKGROUND
A variety of nitinol-containing devices for transcatheter closure of atrial septal defects (ASD) has been widely used. However, there is concern about the release of nickel after nitinol device implantation. In this study, a platinum-coated nitinol device was braided from nanoplatinum-coated nitinol wires in order to prevent nickel release. The serum nickel levels before and after device implantation and the 1-year results were evaluated.


METHODS
Thirty-one patients, aged 4-59 years, and weighing 13.7-90.0 kg, underwent transcatheter closure. Blood samples for serum nickel levels were taken before, 1 day, 1 week, 1 month and 3 months after implantation.


RESULTS
Twenty-nine (93.6%) patients had a successful implantation. The mean ASD diameter was 19.7 +/- 4.8 mm (range 10-30 mm). Procedure-related complications included transient brachial plexus injury in 1 patient and transient dysrhythmia in 4 patients. All 29 patients had complete closure within 1 month after implantation. The mean serum nickel levels at baseline and at 1 day, 1 week, 1 month and 3 months after implantation were 0.65 +/- 0.28, 0.63 +/- 0.18, 0.67 +/- 0.34, 0.55 +/- 0.16, 0.52 +/- 0.14 ng/ml, respectively. There was no significant difference in serum nickel levels before and after implantation. There were no device-related complications at 1-year follow up.


CONCLUSIONS
Transcatheter ASD closure using a platinum-coated nitinol device can be performed safely and successfully with good outcomes. Nano-coating of platinum on nitinol wires can prevent nickel release following device implantation.
Division of Pediatric Cardiology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. lpornthep@yahoo.com
Pornthep
P
Lertsapcharoen
Apichai
A
Khongphatthanayothin
Suphot
S
Srimahachota
Ruenreong
R
Leelanukrom
D000293:Adolescent; D000328:Adult; D000497:Alloys / Q000009:adverse effects*; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation; D002648:Child; D002675:Child, Preschool; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000628:therapy*; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009532:Nickel / Q000009:adverse effects*; D017671:Platinum Compounds / Q000009:adverse effects*; D011446:Prospective Studies; D012307:Risk Factors
D000497:Alloys; D017671:Platinum Compounds; C013616:nitinol; D009532:Nickel