Considerable efforts have been placed on the development of degradable microspheres for use in transarterial embolization indications. Using the guidance of the U.S. Food and Drug Administration (FDA) special controls document for the preclinical evaluation of vascular embolization devices, this review consolidates all relevant data pertaining to novel degradable microsphere technologies for bland embolization into a single reference. This review emphasizes intended use, chemical composition, degradative mechanisms, and pre-clinical safety, efficacy, and performance, while summarizing the key advantages and disadvantages for each degradable technology that is currently under development for transarterial embolization. This review is intended to provide an inclusive reference for clinicians that may facilitate an understanding of clinical and technical concepts related to this field of interventional radiology. For materials scientists, this review highlights innovative devices and current evaluation methodologies (i.e., preclinical models), and is designed to be instructive in the development of innovative/new technologies and evaluation methodologies.
Objectives: To evaluate the interobserver agreement between radiologists using the Ultrasound Liver Reporting And Data System (US LI-RADS) visualization score and assess association between visualization score and cause of liver disease, sex, and body mass index (BMI). Methods: This retrospective, single institution, cross-sectional study evaluated 237 consecutive hepatocellular carcinoma surveillance US examinations between March 4, 2017 and September 4, 2017. Five abdominal radiologists independently assigned a US LI-RADS visualization score (A, no or minimal limitations; B, moderate limitations; C, severe limitations). Interobserver agreement was assessed with a weighted Kappa statistic. Association between US visualization score (A vs B or C) and cause of liver disease, sex, and BMI (< or ≥ 25 kg/m2) was evaluated using univariate and multivariate analyses. Results: The average weighted Kappa statistic for all raters was 0.51. A score of either B or C was assigned by the majority of radiologists in 148/237 cases and was significantly associated with cause of liver disease ( P = 0.014) and elevated BMI ( P < 0.001). Subjects with viral liver disease were 3.32 times (95% CI: 1.44-8.38) more likely to have a score of A than those with non-alcoholic steatohepatitis ( P = 0.007). The adjusted odds ratio of visualization score A was 0.249 (95% CI: 0.13-0.48) among those whose BMI was ≥25 kg/m2 vs. BMI < 25 kg/m2. Conclusion: Interobserver agreement between radiologists using US LI-RADS score was moderate. The majority of US examinations were scored as having moderate or severe limitations, and this was significantly associated with non-alcoholic steatohepatitis and increased BMI.
Chemotherapeutic-loaded bone cement may be an effective method of drug delivery for the management of cancer-related vertebral fractures that require cement injection for pain relief. Recent advancements in the development of aluminum-free glass ionomer cements (GICs) have rendered this class of biomaterials clinically viable for such applications. To expand the therapeutic benefits of these materials, this study examined, for the first time, their drug delivery potential. Through incrementally loading the GIC with methotrexate (MTX) by up to 10-wt%, composition-property relationships were established, correlating MTX loading with working time and setting time, as well as compressive strength, drug release, and cytotoxic effect over 31 days. The most significant finding of this study was that MTX was readily released from the GIC, while maintaining cytotoxic activity. Release correlated linearly with initial loading and appeared to be diffusion mediated, delivering a total of 1-2% of the incorporated drug. MTX loading in this range exerted minimal effects to handling and strength, indicating the clinical utility of the material was not compromised by MTX loading. The MTX-GIC systems examined herein are promising materials for combined structural delivery applications.
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