Venous Interventions
Matt Johnson, MD, FSIR
Professor of Radiology and Surgery, Department of Radiology and Imaging Sciences
Indiana University
Disclosure(s): No relevant disclosure to display
Vena cava filters are commonly implanted in patients with or at risk for pulmonary embolus. Concerns about VCF-related adverse events and whether VCF are effective in preventing clinically significant PE and/or cause deep vein thrombosis led the FDA to mandate prospective study of their use. PRESERVE was performed in response to that mandate. The objective of the PRESERVE Trial was to characterize the current practice of VCF use in the United States, including indications, safety and effectiveness, based on composite measures of outcome. PRESERVE is a multicenter, prospective, open-label, non-randomized longitudinal evaluation of subjects in whom commercially available VCF from seven manufacturers were implanted at 54 sites in the US between October 10, 2015 and March 31, 2019. Composite Primary Safety Endpoint (PSE): freedom from perioperative significant AE and freedom from clinically significant perforation, filter embolization, caval thrombotic occlusion, and/or new DVT within 1 and 2 years months following placement. Composite Primary Effectiveness Endpoint (PEE): procedural success and freedom from new clinically significant PE at 1, 2, or one-month post-retrieval. Subjects were evaluated at procedure, discharge, and three, six, twelve, eighteen-and 24-months post-procedure. Follow-up imaging was performed at three and twelve months. Subjects from whom VCF were removed were followed for one-month post-retrieval. Filters were implanted in 1421subjects. Procedural complications were uncommon and clinically significant VCF-related AEs were rare. Implantation of VCF in patients with VTE and contraindication to or complication or failure of AC is associated with few AE and is effective in preventing clinically significant PE. Prophylactic use is associated with very few AE and is effective in preventing clinically significant PE. The purpose of this SVS Educational Session is to understand the clinical environment regarding the use of IVC filters that lead the FDA to instruct the SVS and to design and implement the PRESERVE Trial, the difficulties and considerations involved in designing a clinical trial describing the real-world use of VCF and their complications, review the 1 year results of the trial, and understand the limitations and implications of the trial results on clinical practice.
Speaker: John Kaufman, MD, FSIR – Dotter Interventional Institute/OHSU
Speaker: James Spies, MD, MPH, FSIR – Georgetown University Medical Center
Speaker: Matt Johnson, MD, FSIR – Indiana University
Speaker: Rodney A. White, MD – UCLA
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