BACKGROUND: The possibility of nickel toxicity has been raised with interatrial shunt closure devices constructed of nitinol. This study is aimed to assess the potential adverse symptoms in terms of incidence, duration, and significance, in patients with interatrial shunt and nickel allergy who underwent nitinol device-based closure. METHODS: We prospectively enrolled 46 consecutive patients (mean age 35 +/- 28.8 years, 30 female) over a 12-month period referred to our center for catheter-based closure of interatrial shunts. Patients were investigated for previous hypersensivity to nickel and were required to test potential nickel allergy with cutaneous patch test (TRUE test) before device implantation. Routinely, clinical visit with laboratory examinations, and TTE were scheduled at 1, 6, and 12 months. RESULTS: Nine patients (19.5%, mean age 31.3 +/- 13.2 years) had proved symptomatic and instrumental nickel allergy as showed by cutaneous patch skin test but preferred to be implanted. All patients underwent successful transcatheter closure with an immediate occlusion rate of 100% without intraoperative complications. Between the 2nd and 3rd postoperative day, 8 out of 9 patients developed a sort of 'device syndrome' that included concurrent chest discomfort, exertional dyspnea and asthenia, and mild leukocytosis. The syndrome was treated with Prednison and Clopidogrel and in all was resolved after 1-week therapy. Interestingly, none of the patients without nickel allergy developed postclosure symptoms (P < .001). CONCLUSIONS: In conclusion, nickel allergy is still a problematic issue in patients scheduled for transcatheter closure of intracardiac shunts; however, our brief study suggests that nickel allergy is not per se a contraindication to nitinol device closure.
BACKGROUND: The possibility of nickeltoxicity has been raised with interatrial shunt closure devices constructed of nitinol. This study is aimed to assess the potential adverse symptoms in terms of incidence, duration, and significance, in patients with interatrial shunt and nickelallergy who underwent nitinol device-based closure. METHODS: We prospectively enrolled 46 consecutive patients (mean age 35 +/- 28.8 years, 30 female) over a 12-month period referred to our center for catheter-based closure of interatrial shunts. Patients were investigated for previous hypersensivity to nickel and were required to test potential nickelallergy with cutaneous patch test (TRUE test) before device implantation. Routinely, clinical visit with laboratory examinations, and TTE were scheduled at 1, 6, and 12 months. RESULTS: Nine patients (19.5%, mean age 31.3 +/- 13.2 years) had proved symptomatic and instrumental nickelallergy as showed by cutaneous patch skin test but preferred to be implanted. All patients underwent successful transcatheter closure with an immediate occlusion rate of 100% without intraoperative complications. Between the 2nd and 3rd postoperative day, 8 out of 9 patients developed a sort of 'device syndrome' that included concurrent chest discomfort, exertional dyspnea and asthenia, and mild leukocytosis. The syndrome was treated with Prednison and Clopidogrel and in all was resolved after 1-week therapy. Interestingly, none of the patients without nickelallergy developed postclosure symptoms (P < .001). CONCLUSIONS: In conclusion, nickelallergy is still a problematic issue in patients scheduled for transcatheter closure of intracardiac shunts; however, our brief study suggests that nickelallergy is not per se a contraindication to nitinol device closure.