Transcatheter closure of patent ductus arteriosus with a self-expanding platinum-coated nitinol device.

J Invasive Cardiol 21(6):286-9 (2009) PMID 19494407

BACKGROUND: An occluding device for closure of patent ductus arteriosus (PDA) was developed from meshed nitinol wires coated with platinum for prevention of nickel release after implantation. OBJECTIVES: Our purpose was to assess the immediate and short-term results of transcatheter PDA closure with this device. METHODS: Sixty patients (13 males and 47 females) underwent catheter-based PDA closure. The age ranged from 9 months to 65 years, with a median age of 4 years. The weight ranged from 4.2-65 kg, with a median of 15.2 kg. The mean PDA diameter at the narrowest segment was 4.7 +/- 2.2 mm, with a range of 2.0-15.1 mm. Eighteen cases had serial blood samples for serum nickel analysis taken before and at 1, 3 and 30 days after device implantation. RESULTS: The devices were successfully deployed in all 60 patients. There were no serious procedural complications. Color Doppler demonstrated complete occlusion rate of 78.3%, 90.0% and 100% at 1 day, 1 month and 1 year after implantation, respectively. There was no statistical difference in serum nickel concentrations between pre- and post-implantation. CONCLUSION: Transcatheter PDA closure using a platinum-coated nitinol device can be performed safely and successfully. There was no evidence of nickel release or nickel reaction after device implantation. This device model may be an alternative for PDA closure, especially in patients with potential nickel allergy.