Hohenwalter Eric J, Stone James R, O'Moore Paul V, Smith Steven J, Selby J Bayne, Lewandowski Robert J, Samuels Shaun, Kiproff Paul M, Trost David W, Madoff David C, Handel Jeremy, Gandras Eric J, Vlahos Athanasios, Rilling William S
Division of Vascular and Interventional Radiology, Department of Radiology, Medical College of Wisconsin, 9200 West Wisconsin Avenue, Room 2803, Milwaukee, WI 53226.
Department of Radiology, University of Virginia Health Systems, Charlottesville, Virginia.
J Vasc Interv Radiol. 2017 Oct;28(10):1353-1362. doi: 10.1016/j.jvir.2017.06.032. Epub 2017 Aug 16.
To demonstrate rates of successful filter conversion and 6-month major device-related adverse events in subjects with converted caval filters.
An investigational device exemption multicenter, prospective, single-arm study was performed at 11 sites enrolling 149 patients. The VenaTech Convertible Vena Cava Filter (B. Braun Interventional Systems, Inc, Bethlehem, Pennsylvania) was implanted in 149 patients with venous thromboembolism and contraindication to or failure of anticoagulation (n = 119), with high-risk trauma (n = 14), and for surgical prophylaxis (n = 16). When the patient was no longer at risk for pulmonary embolism as determined by clinical assessment, an attempt at filter conversion was made. Follow-up of converted patients (n = 93) was conducted at 30 days, 3 months, and 6 months after conversion. Patients who did not undergo a conversion attempt (n = 53) had follow-up at 6 months after implant.
All implants were successful. One 7-day migration to the right atrium required surgical removal. Technical success rate for filter conversion was 92.7% (89/96). Mean time from placement to conversion was 130.7 days (range, 15-391 d). No major conversion-related events were reported. The mean conversion procedure time was 30.7 minutes (range, 7-135 min). There were 89 converted and 32 unconverted patients who completed 6-month follow-up with no delayed complications.
The VenaTech Convertible filter has a high conversion rate and low 6-month device-related adverse event rate. Further studies are necessary to determine long-term safety and efficacy in both converted and unconverted patients.
阐述已转换下腔静脉滤器的受试者成功进行滤器转换的比例以及6个月内与器械相关的主要不良事件。
在11个研究点开展了一项器械临床试验豁免多中心、前瞻性、单臂研究，纳入149例患者。将VenaTech可转换下腔静脉滤器（美国宾夕法尼亚州伯利恒市贝朗介入系统公司）植入149例静脉血栓栓塞且有抗凝禁忌或抗凝失败的患者（n = 119）、高风险创伤患者（n = 14）以及用于手术预防的患者（n = 16）。当通过临床评估确定患者不再有肺栓塞风险时，尝试进行滤器转换。对已转换的患者（n = 93）在转换后30天、3个月和6个月进行随访。未尝试转换的患者（n = 53）在植入后6个月进行随访。
所有植入均成功。1例滤器在7天时向右心房移位，需手术取出。滤器转换的技术成功率为92.7%（89/96）。从放置到转换的平均时间为130.7天（范围15 - 391天）。未报告与转换相关的主要事件。平均转换操作时间为30.7分钟（范围7 - 135分钟）。89例已转换和32例未转换的患者完成了6个月随访，无延迟并发症。
VenaTech可转换滤器具有高转换率和低6个月器械相关不良事件发生率。有必要进一步研究以确定已转换和未转换患者的长期安全性和有效性。
