Interatrial shunt closure devices in patients with nickel allergy.

We assessed outcomes in nickel allergic patients treated with percutaneous interatrial shunt device closure with the Helex device. Nickel toxicity has been well described in patients undergoing interatrial shunt closure with the Amplatzer device, which has a nitinol design. There have been no reports using Helex in nickel allergic patients. Ninety-five consecutive patients underwent percutaneous interatrial shunt closure at a single US center by one operator. In those with possible nickel allergy, patch testing with the North American Contact Dermatitis Group standard series and a metal series was performed. The mean age was 48 +/- 16 years (range 18-81), 48% were male, 21 (22%) had atrial septal defect, and 74 (78%) had patent foramen ovale. Six patients had a positive skin test to nickel and underwent successful closure with Helex. Of the remaining 89 patients, 88 were closed with Amplatzer and one with Helex. All procedures were successful with no deaths, myocardial infarctions, strokes, or systemic emboli at six-month followup. None of the Helex patients developed an allergic reaction, significant chest pain, or arrhythmia. Of those without pre-procedural known nickel allergy, 12% had palpitations, 5% had atrial fibrillation, and 13% had chest pain. When compared with a published report that 89% of nickel-allergic patients developing an allergic reaction to the Amplatzer or Premere device, Helex appeared far safer in nickel allergic patients (P < 0.001). In patients with nickel allergy, percutaneous interatrial shunt device closure with Helex device is safe, and is not associated with allergy to nickel.