Polymer coating embolism from intravascular medical devices — a clinical literature review

摘要

Abstract 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. Highlights ? Recent literature associates polymer coating embolism with a range of adverse clinical sequelae. ? The elusive, microscopic phenomenon has been difficult to detect for almost three decades. ? Major polymer-emboli-related conditions include obstructions of blood flow in small vessels. ? Polymer emboli incidence is dependent on device coating integrity measured by particulate release. ? Regulators may default to controlling particulate release from intravascular devices. ? Research highlights the potential of using low-particulate-release coatings on intravascular devices.