Ziegler J Werner, Dietrich Gary J, Cohen Sidney A, Sterling Keith, Duncan James, Samotowka Michael
Department of Radiology, Sunrise Medical Center, 3186 S Maryland Pkwy, Las Vegas, NV 89109, USA.
J Vasc Interv Radiol. 2008 Aug;19(8):1165-70. doi: 10.1016/j.jvir.2008.04.020. Epub 2008 Jun 27.
A postmarketing surveillance registry was conducted to monitor the safety and effectiveness of the OptEase vena cava filter when used as a permanent filter.
This study was a nonrandomized, multicenter prospective trial with all patients receiving the OptEase vena cava filter for the prevention of pulmonary embolism (PE). A total of 11 clinical sites in the United States enrolled patients. A 1-month postimplantation follow-up examination was performed to determine potential filter migration and the presence of symptomatic thrombosis of the inferior vena cava (IVC) or lower extremities. At 6-month postimplantation follow-up, patients were again assessed for the safety and stability of the filter and any clinical evidence of symptomatic thrombosis.
One hundred fifty patients were enrolled in this study. Fifty-five patients (36.6%) were unable to complete all of the necessary follow-up at 6 months. At 1 month, filter migration and filter-related symptomatic deep vein thrombosis was observed in one patient each (0.9% and 0.8%, respectively). At 6 months, no new cases of filter migration or filter-related symptomatic thrombosis were observed. Filter tilting (> or = 15 degrees off the IVC axis) was observed in one patient at baseline (0.7%), four patients at 1-month follow-up (3.6%), and three patients (11.4%) at 6-month follow-up. Incidental findings on follow-up radiographs included filter fracture in two patients (1.8%) at 1 month and in one additional patient (4.3%) at 6 months. There were no clinical sequelae associated with the filter fracture.
The co-primary endpoints of filter migration and symptomatic thrombus formation at 1 month had an observed frequency of 0.9% and 0.8%, respectively. These co-primary endpoints were stable and unchanged at 6 months.
开展一项上市后监测登记研究，以监测OptEase腔静脉滤器作为永久性滤器使用时的安全性和有效性。
本研究为一项非随机、多中心前瞻性试验，所有患者均接受OptEase腔静脉滤器以预防肺栓塞（PE）。美国共有11个临床站点纳入了患者。植入后1个月进行随访检查，以确定滤器是否可能移位以及下腔静脉（IVC）或下肢是否存在有症状的血栓形成。植入后6个月进行随访时，再次评估滤器的安全性和稳定性以及任何有症状血栓形成的临床证据。
本研究共纳入150例患者。55例患者（36.6%）无法在6个月时完成所有必要的随访。1个月时，各有1例患者（分别为0.9%和0.8%）出现滤器移位和与滤器相关的有症状深静脉血栓形成。6个月时，未观察到新的滤器移位或与滤器相关的有症状血栓形成病例。基线时有1例患者（0.7%）出现滤器倾斜（与IVC轴偏离≥15度），1个月随访时有4例患者（3.6%）出现，6个月随访时有3例患者（11.4%）出现。随访X线片的偶然发现包括1个月时2例患者（1.8%）出现滤器断裂，6个月时又有1例患者（4.3%）出现。滤器断裂未出现临床后遗症。
1个月时滤器移位和有症状血栓形成这两个共同主要终点的观察频率分别为0.9%和0.8%。这些共同主要终点在6个月时稳定且无变化。
