Tapson Victor F, Hazelton Joshua P, Myers John, Robertson Claudia, Gilani Ramyar, Dunn Julie A, Bukur Marko, Croce Martin A, Peick Ann, West Sonlee, Lottenberg Lawrence, Doucet Jay, Miller Preston R, Crookes Bruce, Gandhi Rajesh R, Croft Chasen A, Manasia Anthony, Hoey Brian A, Lieberman Howard, Guillamondegui Oscar D, Novack Victor, Piazza Gregory, Goldhaber Samuel Z
Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
Division of Trauma and Surgical Critical Care, Cooper University Hospital, Camden, New Jersey.
J Vasc Interv Radiol. 2017 Sep;28(9):1248-1254. doi: 10.1016/j.jvir.2017.05.001. Epub 2017 Jun 20.
To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients.
In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25% of volume of filter) detected by cavography before retrieval.
The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93%) were critically ill trauma patients, 129 (85%) had head or spine trauma, and 102 (79%) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100%) patients (95% confidence interval [CI], 97.8%-100%, P < .01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7%) occurring during the first 7 days. There were no (0%) catheter-related bloodstream infections. There were 5 (3.1%) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6%) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission.
This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications.
评估一种将下腔静脉（IVC）滤器和中心静脉导管（CVC）相结合的新型装置在预防重症患者肺栓塞（PE）方面的有效性和安全性。
在一项多中心、前瞻性、单臂临床试验中，该装置在无需荧光透视的情况下于床边插入，随后在从重症监护病房（ICU）转出前取出。主要疗效终点是在装置取出或出院后72小时（以先发生者为准）无临床显著PE或致命PE。次要终点包括急性近端深静脉血栓形成（DVT）、导管相关血栓形成、导管相关血流感染、大出血事件的发生率，以及取出前通过腔静脉造影检测到的临床显著血栓（占滤器体积>25%）。
该装置被放置在163例有抗凝禁忌的重症患者中；151例（93%）为重症创伤患者，129例（85%）有头部或脊柱创伤，102例（79%）有颅内出血。所有163例（100%）患者均达到主要疗效终点（95%置信区间[CI]，97.8%-100%，P<.01）。新发或恶化的急性近端DVT的诊断与时间相关，11例（7%）在最初7天内发生。无（0%）导管相关血流感染。有5例（3.1%）大出血事件。14例（8.6%）患者的IVC滤器中出现显著血栓。ICU入院后平均5.5天±4.3天未开始预防性抗凝。
这种新型装置在并发症风险较低的重症创伤患者中预防了临床显著和致命的PE。
