Nickel hypersensitivity and endovascular devices: a systematic review and meta-analysis

Abstract

ObjectiveNickel 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.MethodsInclusion 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.Results190 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).ConclusionsPatch-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.

Hypersensitivity Reactions to Components of Cardiac Implantable Electronic Devices and Their Treatment: A Systematic Review

“…60 In neuroendovascular intervention or intracardiac devices, allergic reaction may cause embolic events as it forms a nidus for thrombus. 61 In patients with a CIED, the reported symptoms of HSRs are varied and non-specific, and they are difficult to differentiate from CIED infection. The latter is a frequent and severe complication of CIED implantation with a reported average incidence of 1-2%, depending of CIED type.…”

“…3 The materials used to make each of these components varies slightly depending on the manufacturer and type of device.Hypersensitivity reactions (HSR) to metals and epoxies have been reported in orthopaedic, vascular neurosurgical and interventional cardiology in the form of coronary and vascular stents and endovascular occluder devices. [4][5][6][7] HSRs to components of CIEDs are thought to be a rare complication. However, while the true incidence is not known, it may be as high as 1/500 cases.…”

Metal Allergy: State-of-the-Art Mechanisms, Biomarkers, Hypersensitivity to Implants

“…The ACD can conduct in-stent restenosis or prominent eczematous reaction overlying the implant and the need for removal. Ni allergy is linked with a raised risk of adverse outcomes following endovascular device implantation, which was a systematic review of a group of 1740 patients in 78 different studies [ 102 ].…”

“… Metal that Caused Hypersensitivity/Implant Type Symptoms Ref. Multiple metals/orthopedic implants: hip, knee shoulder joint Different; the most common—delayed wound healing and/or recurrent wound issues after the implantation, joint failure or loosening [ 86 , 92 , 93 , 98 , 106 ] Ni/endovascular implants (stents) In-stent restenosis or prominent eczematous reaction overlying the endovascular implant, eosinophilia [ 102 , 107 ] Co, Ni/drug-eluting stents Pruritic rash with hypereosinophilia [ 108 ] Au and Pd/dental implant Oral lichenoid contact lesion (OLCLs) [ 103 ] Ti/dental implants Rash, urticaria, pruritus, redness, dermatitis and facial eczema, pain, hyperaemia of soft tissues, swelling in submental and labial sulcus, gingival hyperplasia acne-like facial inflammation [ 105 ] Ni/metal anchors Erythematous and vesicular lesions around the grafted tattoo skin, but the tattoo was not affected (placed with clips or anchors) [ 59 ] Ni/stainless-steel skull pins Erythema on sites of the head where the skull pins inserted [ 109 ] Ti/cervical implant Persistent refractory neck pain; subsequently, after eight years, a planter rush …”

Correspondence on “Nickels and tines: the myth of nickel allergy in intracranial stents” by Vanentet al

“…A wide variety of clinical signs and symptoms have been described, depending on the area of device implantation 1 2. A recent meta-analysis supported that adverse events were increased in nickel-allergic patients after endovascular interventions 3. Against this context, we read with great interest the article by Vanent et al on nickel allergy in intracranial stents 4.…”