19214 Village 19, Camarillo, Los Angeles, CA 93012, USA..
Artemis Hospital, Department of Cardiology, Sector 51, Gurgaon, 122001, Haryana, India.
Cardiovasc Pathol. 2017 Sep-Oct;30:45-54. doi: 10.1016/j.carpath.2017.06.004. Epub 2017 Jun 22.
Over the past three decades, lubricious (hydrophobic and/or hydrophilic) polymer-coated devices have been increasingly adopted by interventional physicians and vascular surgeons to access and treat a wider range of clinical presentations. Recent clinical literature highlights the presence of polymer coating emboli within the anatomy - a result of coating separation from an intravascular device - and associates it with a range of adverse clinical sequelae. The 2015 U.S. Food and Drug Administration safety communication titled "Lubricious Coating Separation from Intravascular Medical Devices" acknowledges these concerns and concludes that it will work with stakeholders to develop nonclinical test methodologies, establish performance criteria, and identify gaps in current national and international device standards for coating integrity performance. Despite this communication and multiple case reports from interventional physicians, pathologists, dermatologists and other involved physician specialties, polymer coating embolism remains clinically underrecognized. This article consolidates the available literature on polymer coating embolism (1986-2016) and highlights the following relevant information for the physician: (a) the history and elusive nature of polymer coating embolism; (b) potential incidence rates of this phenomenon; (c) reported histologic findings and clinical effects of polymer emboli in the anatomy; (d) the importance of the collaborative clinician-pathologist partnership to report polymer embolism findings; and (e) the importance to study particulate release from intravascular devices so as to further understand and potentially evolve coated interventional technologies. Preliminary research on coatings highlights the potential of using iterations of coatings on medical devices that attain the desired therapeutic result and mitigate or eliminate particulates altogether.
在过去的三十年中，介入医师和血管外科医生越来越多地采用了具有润滑性（疏水性和/或亲水性）的聚合物涂层设备，以更广泛地治疗各种临床表现。最近的临床文献强调了在解剖结构中存在聚合物涂层栓塞物的现象，这是由于涂层从血管内设备上分离所致，并将其与一系列不良临床后果联系起来。2015 年美国食品和药物管理局发布的题为“血管内医疗设备的润滑涂层分离”的安全通讯，承认了这些担忧，并得出结论，将与利益相关者合作制定非临床测试方法、建立性能标准，并确定当前国家和国际设备标准中涂层完整性性能的差距。尽管发布了这一通讯以及介入医师、病理学家、皮肤科医生和其他相关专业医生的多份病例报告，但聚合物涂层栓塞仍然在临床上被低估。本文整合了 1986 年至 2016 年期间关于聚合物涂层栓塞的现有文献，并为医生重点介绍了以下相关信息：（a）聚合物涂层栓塞的历史和隐匿性质；（b）这种现象的潜在发生率；（c）报告的聚合物栓塞在解剖结构中的组织学发现和临床影响；（d）临床医生-病理学家合作报告聚合物栓塞发现的重要性；以及（e）研究血管内设备中颗粒释放的重要性，以便进一步了解和可能改进涂层介入技术。对涂层的初步研究强调了在医疗设备上使用具有润滑性的涂层迭代的潜力，这些涂层可以达到所需的治疗效果，并减轻或完全消除颗粒。
