Surgical explantation of atrial septal closure devices for refractory nickel allergy symptoms

J Thorac Cardiovasc Surg. 2020 Aug;160(2):502-509.e1. doi: 10.1016/j.jtcvs.2019.10.177. Epub 2019 Nov 21.

Abstract

Objectives: Systemic allergic reactions to nickel alloys in percutaneous atrial septal defect 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 atrial septal defect device explants for nickel allergy were reviewed. Administered questionnaires focused on symptoms, quality of life, and satisfaction along with the 36-Item Short Form Health Survey to measure physical and mental health postsurgery.

Results: Atrial septal defect devices were removed for nickel allergy in 58 patients during the past 10 years. The median age was 42 years (range, 24-71 years) and 95% were women. Explantation occurred at a median of 8 years (range, 6 months-18 years) 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. Postexplant, 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 postremoval.

Conclusions: Patients with nickel allergy and severe refractory symptoms after atrial septal defect device implantation experience profound resolution of symptoms and improved quality of life after removal. Nickel allergy should be considered before device insertion, and a low threshold should exist for surgical removal for refractory symptoms.

Keywords: atrial septal defect; nickel hypersensitivity; occluding devices; patent foramen ovale.

Publication types

  • Webcast

MeSH terms

  • Adult
  • Aged
  • Cardiac Catheterization / adverse effects*
  • Cardiac Catheterization / instrumentation*
  • Databases, Factual
  • Device Removal* / adverse effects
  • Female
  • Health Status
  • Heart Septal Defects, Atrial / therapy*
  • Humans
  • Hypersensitivity / diagnosis
  • Hypersensitivity / etiology
  • Hypersensitivity / surgery*
  • Male
  • Mental Health
  • Middle Aged
  • Nickel / adverse effects*
  • Patient Satisfaction
  • Prosthesis Design
  • Quality of Life
  • Retrospective Studies
  • Septal Occluder Device / adverse effects*
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Nickel