Faculty Collaboration Database

Multicenter Trial of the VenaTech Convertible Vena Cava Filter. J Vasc Interv Radiol 2017 Oct;28(10):1353-1362

Date

08/20/2017

Pubmed ID

28821379

DOI

10.1016/j.jvir.2017.06.032

Scopus ID

2-s2.0-85027397474 (requires institutional sign-in at Scopus site)   18 Citations

Abstract

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.

Author List

Hohenwalter EJ, Stone JR, O'Moore PV, Smith SJ, Selby JB, Lewandowski RJ, Samuels S, Kiproff PM, Trost DW, Madoff DC, Handel J, Gandras EJ, Vlahos A, Rilling WS

Authors

Eric J. Hohenwalter MD, FSIR Chief, Professor in the Radiology department at Medical College of Wisconsin
William S. Rilling MD, FSIR Vice Chair, Professor in the Radiology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Female
Humans
Male
Middle Aged
Prospective Studies
Prosthesis Design
Pulmonary Embolism
Treatment Outcome
Vena Cava Filters
Venous Thromboembolism