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. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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镍超敏反应和血管内装置：系统评价和荟萃分析

客观镍过敏很常见；血管内专家经常在植入血管内装置之前遇到镍过敏患者，其中许多是含镍的。我们的目的是阐明镍超敏反应是否与放置含镍血管内装置后更差或不良结果显着相关。方法 纳入标准是：涉及镍过敏患者的冠状动脉、结构性心脏、神经血管和外周血管病变的血管内和经导管手术。所有不良结局均按照纳入研究的定义纳入。使用随机效应模型进行了系统评价和荟萃分析。对 1947-2019 年发表的文章进行了 MEDLINE 和 EMBASE 的搜索。结果 190 条记录被识别，78篇文章被纳入定性综合，15篇符合荟萃分析标准。斑贴试验证实，镍过敏与植入含镍血管内装置后不良结局风险增加相关（n=14 篇文章，1740 名患者；OR 2.61，95% CI 1.41 至 4.85）。这一发现在冠状动脉（n=12 篇文章，1624 名患者；OR 1.94，95% CI 1.16 至 3.23）和结构性心脏亚组（n=2 篇文章，83 名患者；OR 52.28，95% CI 1.31 至 2079.14）中进一步观察到，但不在神经血管亚组中（n=1 篇文章，33 名患者；OR 3.04，95% CI 0.59 至 15.72）或患者报告的镍过敏史（n=2 篇文章，207 名患者；OR 2.14，95% CI 0.23 至 19.70）。结论 经斑贴测试的镍过敏与血管内装置植入后不良后果的风险增加相关，应考虑替代治疗方案。面对患者自我报告的镍过敏的专家应考虑进行诊断性贴片测试。所有与研究相关的数据都包含在文章中或作为补充信息上传。