Surgical Explantation of Atrial Septal Closure Devices for Refractory Nickel Allergy Symptoms

Abstract Objectives Systemic allergic reactions to nickel alloys in percutaneous atrial septal defects (ASD) occlusion devices have a poorly defined natural history. We describe our experience of surgical removal of the offending device in a series of patients with nickel allergy and refractory symptoms. Methods Patients with ASD device explants for nickel allergy were reviewed. Administered questionnaires focused on symptoms, quality of life, and satisfaction along with the Short Form (SF)-36 health survey to measure physical and mental health post-surgery. Results ASD devices were removed for nickel allergy in 58 patients over the last 10 years. The median age was 42 (range 24-71) and 95% were females. Explantation occurred at a median of 8 years (range 6 mos-18 yrs) after insertion. Symptoms included fatigue (82%), chest pain (78%), headache (73%), and palpitation (58%). Surveys were available for 45 patients: 58% rated their quality of life as poor and 69% were not at all satisfied with their device. Post explant, all patients reported improvement in their symptoms, with 18 patients (42%) noting complete resolution. In 12 patients prospectively studied, the preoperative scores in physical and mental health domains were lower than the validation group indicating significant disability. Similarly, there was marked improvement in each domain post-removal. Conclusions Patients with nickel allergy and severe refractory symptoms after ASD device implantation experience profound resolution of symptoms and improved quality of life after removal. Nickel allergy should be considered prior to device insertion, and a low threshold should exist for surgical removal for refractory symptoms.