Multicenter Trial of the VenaTech Convertible Vena Cava Filter
| Autor: | Paul V. O’Moore, Eric J. Gandras, Paul M. Kiproff, Athanasios Vlahos, Jeremy Handel, David W. Trost, Steven J. Smith, David C. Madoff, William S. Rilling, J. Bayne Selby, Shaun Samuels, Eric J. Hohenwalter, James R. Stone, Robert J. Lewandowski |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Vena Cava Filters Investigational device exemption 030204 cardiovascular system & hematology Prosthesis Design Inferior vena cava 030218 nuclear medicine & medical imaging 03 medical and health sciences Surgical prophylaxis 0302 clinical medicine Multicenter trial medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Prospective cohort study Contraindication Aged business.industry Venous Thromboembolism Middle Aged medicine.disease Pulmonary embolism Surgery Treatment Outcome medicine.vein Female Implant Pulmonary Embolism Cardiology and Cardiovascular Medicine business |
| Zdroj: | Journal of Vascular and Interventional Radiology. 28:1353-1362 |
| ISSN: | 1051-0443 |
| DOI: | 10.1016/j.jvir.2017.06.032 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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