Deso Steven E, Idakoji Ibrahim A, Kuo William T
Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, California.
Semin Intervent Radiol. 2016 Jun;33(2):93-100. doi: 10.1055/s-0036-1583208.
Many inferior vena cava (IVC) filter types, along with their specific risks and complications, are not recognized. The purpose of this study was to evaluate the various FDA-approved IVC filter types to determine device-specific risks, as a way to help identify patients who may benefit from ongoing follow-up versus prompt filter retrieval. An evidence-based electronic search (FDA Premarket Notification, MEDLINE, FDA MAUDE) was performed to identify all IVC filter types and device-specific complications from 1980 to 2014. Twenty-three IVC filter types (14 retrievable, 9 permanent) were identified. The devices were categorized as follows: conical (n = 14), conical with umbrella (n = 1), conical with cylindrical element (n = 2), biconical with cylindrical element (n = 2), helical (n = 1), spiral (n = 1), and complex (n = 1). Purely conical filters were associated with the highest reported risks of penetration (90-100%). Filters with cylindrical or umbrella elements were associated with the highest reported risk of IVC thrombosis (30-50%). Conical Bard filters were associated with the highest reported risks of fracture (40%). The various FDA-approved IVC filter types were evaluated for device-specific complications based on best current evidence. This information can be used to guide and optimize clinical management in patients with indwelling IVC filters.
许多下腔静脉(IVC)滤器类型及其特定风险和并发症尚未得到确认。本研究的目的是评估美国食品药品监督管理局(FDA)批准的各种IVC滤器类型,以确定特定器械的风险,从而帮助识别哪些患者可能从持续随访中受益,哪些患者需要及时取出滤器。我们进行了基于证据的电子检索(FDA上市前通知、MEDLINE、FDA不良事件报告系统),以确定1980年至2014年间所有IVC滤器类型及特定器械并发症。共识别出23种下腔静脉滤器类型(14种可取出型,9种永久型)。这些器械分类如下:锥形(n = 14)、带伞锥形(n = 1)、带圆柱形元件的锥形(n = 2)、带圆柱形元件的双锥形(n = 2)、螺旋形(n = 1)、螺旋状(n = 1)和复合型(n = 1)。据报道,单纯锥形滤器穿透风险最高(90 - 100%)。带有圆柱形或伞形元件的滤器,据报道下腔静脉血栓形成风险最高(30 - 50%)。Bard锥形滤器据报道骨折风险最高(40%)。基于当前最佳证据,对FDA批准的各种IVC滤器类型进行了特定器械并发症评估。这些信息可用于指导和优化留置IVC滤器患者的临床管理。