Objective Nickel allergy is common; endovascular specialists are often confronted with nickel allergic patients ahead of the implantation of endovascular devices, many of which are nickel-containing. Our aim was to elucidate whether nickel hypersensitivity is significantly associated with worse or adverse outcomes after placement of a nickel-containing endovascular device.
Methods Inclusion criteria were: endovascular and transcatheter procedures for coronary, structural heart, neurovascular and peripheral vascular pathology involving nickel-allergic patients. All adverse outcomes were included as defined by included studies. A systematic review and meta-analysis were undertaken using a random-effects model. Searches of MEDLINE and EMBASE were conducted for articles published 1947–2019.
Results 190 records were identified, 78 articles were included for qualitative synthesis and 15 met criteria for meta-analysis. Patch-test confirmed nickel allergy was associated with an increased risk of adverse outcomes following implantation of a nickel-containing endovascular device (n=14 articles, 1740 patients; OR 2.61, 95% CI 1.41 to 4.85). This finding further was observed in coronary (n=12 articles, 1624 patients; OR 1.94, 95% CI 1.16 to 3.23) and structural heart subgroups (n=2 articles, 83 patients; OR 52.28, 95% CI 1.31 to 2079.14), but not in the neurovascular subgroup (n=1 article, 33 patients; OR 3.04, 95% CI 0.59 to 15.72) or with a patient-reported history of nickel allergy (n=2 articles, 207 patients; OR 2.14, 95% CI 0.23 to 19.70).
Conclusions Patch-tested nickel allergy is associated with an increased risk of adverse outcomes following endovascular device implantation and alternative treatment options should be considered. Specialists faced with patients’ self-reporting nickel allergy should consider proceeding to diagnostic patch-testing.
- aortic diseases
- cardiac surgical procedures
- coronary artery disease
- endovascular procedures
- heart defects
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
Statistics from Altmetric.com
Contributors AMG, JS and AHD designed the study. AMG and AA-B selected and reviewed the articles. AMG did the statistical analysis. AMG wrote the first draft with input from JS and AHD. JS and AHD are the guarantors of this work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests Grants received from UK National Institute for Health Research not related to this submitted work.
Provenance and peer review Not commissioned; internally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.