Multicenter Trial of the VenaTech Convertible Vena Cava Filter.

Autor:	Hohenwalter EJ; Division of Vascular and Interventional Radiology, Department of Radiology, Medical College of Wisconsin, 9200 West Wisconsin Avenue, Room 2803, Milwaukee, WI 53226. Electronic address: eho@mcw.edu., Stone JR; Department of Radiology, University of Virginia Health Systems, Charlottesville, Virginia., O'Moore PV; Department of Radiology, Abington Memorial Hospital, Abington, Pennsylvania., Smith SJ; Department of Radiology, Adventist Health System, Hinsdale, Illinois., Selby JB; Department of Radiology, Medical University of South Carolina, Charleston, South Carolina., Lewandowski RJ; Department of Radiology, Northwestern Memorial Hospital, Chicago, Illinois., Samuels S; Department of Radiology, Baptist Hospital of Miami, Miami, Florida., Kiproff PM; Department of Radiology, Allegheny General Hospital, Pittsburgh, Pennsylvania., Trost DW; Department of Radiology, Weill Cornell Medical College, New York, New York., Madoff DC; Department of Radiology, Weill Cornell Medical College, New York, New York., Handel J; Department of Radiology, Beaumont Health System, Royal Oak, Michigan., Gandras EJ; Department of Radiology, North Shore University Hospital, Manhassat, New York., Vlahos A; Department of Radiology, Adventist Health System, Hinsdale, Illinois., Rilling WS; Division of Vascular and Interventional Radiology, Department of Radiology, Medical College of Wisconsin, 9200 West Wisconsin Avenue, Room 2803, Milwaukee, WI 53226.
Jazyk:	angličtina
Zdroj:	Journal of vascular and interventional radiology : JVIR [J Vasc Interv Radiol] 2017 Oct; Vol. 28 (10), pp. 1353-1362. Date of Electronic Publication: 2017 Aug 16.
DOI:	10.1016/j.jvir.2017.06.032
Abstrakt:	Purpose: To demonstrate rates of successful filter conversion and 6-month major device-related adverse events in subjects with converted caval filters. Materials and Methods: 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. Results: 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. Conclusions: 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. (Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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