October 11, 2012—Matthew Johnson, MD, outlined plans for the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas.
Dr. Johnson discussed how, in response to a perceived increase in complications with inferior vena cava filters (IVCFs) paralleling the increased utilization of retrievable IVCFs, the US Food and Drug Administration (FDA) issued a letter in August 2010 suggesting that retrievable IVCFs should be removed when they are no longer needed. Subsequent discussions between members of the Society of Interventional Radiology, the Society for Vascular Surgery, the FDA, and IVCF manufacturers have led to the development of a soon-to-be-initiated national study directed toward the evaluation of safety and efficacy of retrievable and permanent IVCFs.
As summarized by Dr. Johnson, the PRESERVE study will be composed of approximately 2,500 patients who will undergo IVCF placement in up to 50 centers in the United States. Demographic, clinical, and procedural data will be obtained. Patients will undergo mandatory postprocedural imaging, including abdominal radiography at 3 months after IVCF placement and abdominal computed tomography scans at 1 and 2 years after IVCF placement. Mandatory follow-up will include clinic visits at those times, as well as at 6 and 18 months after IVCF placement. Data regarding IVCF removal will be recorded at the time of that procedure. Data from studies evaluating recurrent or new pulmonary embolism will be recorded as well.
Dr. Johnson stated that as a multidisciplinary initiative conceived and created by the Society of Interventional Radiology and the Society for Vascular Surgery in association with the FDA and industry, PRESERVE represents a paradigmatic shift in which each of those bodies accepts the need to address an important question relevant to the care of patients in the United States, and they have agreed to work together to answer that question. This study also represents a shift toward recognition that registries—not just randomized controlled trials—can be used to test safety and effectiveness of such devices. The PRESERVE leaders hope that physicians implanting IVCFs will support this effort, concluded Dr. Johnson.
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