Lin Lawrence, Hom Katherine Cavallo, Hohenwalter Eric J, White Sarah B, Schmid Ryan K, Rilling William S
Department of Radiology, Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital, 9200 West Wisconsin Avenue, Milwaukee, WI 53226.
Department of Radiology, Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital, 9200 West Wisconsin Avenue, Milwaukee, WI 53226.
J Vasc Interv Radiol. 2020 Sep;31(9):1419-1425. doi: 10.1016/j.jvir.2020.05.023. Epub 2020 Aug 11.
To report device-related adverse events 6 months after placement or conversion of the VenaTech convertible vena cava filter (VTCF).
A review of 6-month follow-up data of an investigational device exemption multicenter, prospective, single-arm study was performed. The VTCF was implanted in 149 patients. Conversion was attempted in 64.4% of those patients (n = 96) and successfully in 96.9% of the patients (n = 93). A total of 76 patients completed imaging evaluation at 6 months after filter conversion. Patients who required continued venous thromboembolism prophylaxis at 6 months did not undergo a conversion attempt and were designated as nonconverted filter subjects. A total of 28 nonconverted filter subjects completed imaging evaluation at 6 months after implantation.
Evaluation of patients at 6 months after conversion demonstrated 1 of 76 (1.3%) inferior vena cava (IVC) perforations with a filter strut greater than 3 mm outside of the caval lumen. No cases of recurrent PE, clinically significant filter migration, filter fracture, or IVC thrombosis were reported in the converted subjects. In the nonconverted filter subjects, there was a 14.3% (4 of 28) complete or nearly complete rate of IVC thromboses. There were no cases of recurrent pulmonary embolism, penetration, fracture, or spontaneous conversion in the nonconverted filter subjects. There was a significant reduction in the rate of IVC thrombosis and migration in the converted cohort compared to that in the nonconverted cohort.
At 6 months, the VTCF demonstrated low adverse event rates in the converted configuration, whereas a minority of patients with the nonconverted configuration demonstrated a high risk of IVC thrombosis.
报告VenaTech可转换腔静脉滤器（VTCF）植入或转换6个月后与装置相关的不良事件。
对一项研究性器械豁免多中心、前瞻性、单臂研究的6个月随访数据进行回顾。149例患者植入了VTCF。其中64.4%（n = 96）的患者尝试进行转换，96.9%（n = 93）的患者转换成功。共有76例患者在滤器转换后6个月完成影像学评估。在6个月时仍需要持续进行静脉血栓栓塞预防的患者未尝试进行转换，被指定为未转换滤器的受试者。共有28例未转换滤器的受试者在植入后6个月完成影像学评估。
对转换后6个月的患者进行评估发现，76例中有1例（1.3%）下腔静脉（IVC）穿孔，滤器支柱在腔静脉腔外大于3 mm。转换后的受试者中未报告复发性肺栓塞、具有临床意义的滤器移位、滤器断裂或IVC血栓形成的病例。在未转换滤器的受试者中，IVC血栓形成的完全或几乎完全发生率为14.3%（28例中有4例）。未转换滤器的受试者中没有复发性肺栓塞、穿透、断裂或自发转换的病例。与未转换队列相比，转换队列中的IVC血栓形成和移位发生率显著降低。
在6个月时，VTCF在转换配置下显示出较低的不良事件发生率，而少数未转换配置的患者显示出IVC血栓形成的高风险。
