Positive Reactions to Nickel on a Patch Test Do Not Predict Clinical Outcome of Nickel Alloy-Based Atrial Septal Defect Occluder Implantation

Abstract

Background: Patch testing is thought to be necessary prior to metal device implantation to rule out metal allergy-related complications; however, there are controversies over the effects of nickel allergy on the outcome of nickel alloy-based device implantation. Objective: This study aimed to evaluate the adverse events in a Korean population of nickel allergy patients who underwent atrial septal defect (ASD) closure with a nickel-titanium alloy-based device. Methods: We retrospectively reviewed the medical records of patients who underwent ASD closure with a nitinol device. Results: Among 38 patients who had ASD closure, 4 of 5 nickel-allergic patients and 10 of the 33 non-nickel-allergic patients had post-closure complications. All patients fared well, without device failure culminating in device removal. Conclusion: In this study, positive reactions to nickel in a patch test were not associated with adverse early or late outcomes following ASD closure with a nickel alloy-based device.

Evaluation of Nickel Release from Endobronchial Valves as a Possible Cause of Hypersensitivity Pneumonitis in a Patient Treated with Bronchoscopic Lung Volume Reduction

“…In addition, for patients with a positive history to nickel allergy, patch testing is thought to be necessary prior to nitinol device implantation to rule out nickel contact allergy-related complications. However, in the study of Kim et al [8] , positive reactions to nickel in a patch test were not associated with adverse outcomes following closure of atrial septal defects with a nickel alloy-based device.…”

“…Conclusions: To the best of our knowledge, Formally, EBVs are contraindicated in patients with known allergies to nitinol or silicone [6] . In addition, there is controversy regarding the effects of nickel alloybased device implantation in patients with nickel contact allergy, since there is concern about the release of nickel after nitinol device implantation [7,8] .…”

Transcatheter Closure Of Atrial Septal Defect With Atrial Septal Occluder In Patients With Nickel Allergy

“…[4,6] However, according to another study, allergic symptoms after device implantation were similar between nickel-allergic and non-nickel-allergic groups. [7] But negative trial was a retrospective analysis and number of patients was inadequate.…”

Left Atrial Thrombus Associated With Interatrial Septal Occluder 5 Years After Implantation

“…Atrial thrombus was not reported in any patients, including 33 nonallergic patients. 4 However, this study has limited generalizability, particularly to other types of devices with different structures, nickel content, and nickel exposure. In this patient, the surgical specimen was noted to have significant inflammation and hypertrophied scar on visual inspection raising concern that a chronic inflammatory process may have played a role.…”