| Abstract: |
Background: Public awareness of inferior vena cava (IVC) filter-related controversies has been elevated by the Food and Drug Administration (FDA) safety communication in 2010. Objectives: To examine population level trends in IVC filter utilization, complications, retrieval rates, and subsequent pulmonary embolism (PE) risk. Design: A retrospective cohort study. Subjects: Patients receiving IVC filters during 2005-2014 in New York State. Measures: IVC filter-specific complications, new PE occurrences and IVC filter retrievals were evaluated as time-to-event data using Kaplan-Meier analysis. Estimated cumulative risks were obtained at various timepoints during follow-up. Results: There were 91,873 patients receiving IVC filters between 2005 and 2014 in New York State included in the study. The average patient age was 67 years and 46.6% were male. Age-adjusted rates of IVC filter placement increased from 48 cases/100,000 in 2005 to 52 cases/100,000 in 2009, and decreased afterwards to 36 cases/100,000 in 2014. The estimated risks of having an IVC filter-related complication and filter retrieval within 1 year was 1.5% [95% confidence interval (CI), 1.4%-1.6%] and 3.5% (95% CI, 3.4%-3.6%). One-year retrieval rate was higher post-2010 when compared with pre-2010 years (hazard ratio, 2.70; 95% CI, 2.50-2.91). Among the 58,176 patients who did not have PE events before or at the time of IVC filter placement, the estimated risk of developing subsequent PE at 1 year was 2.0% (95% CI, 1.9%-2.1%). Conclusions: Our findings suggest that FDA communications may be effective in modifying statewide clinical practices. Given the 2% observed PE rate following prophylactic IVC filter placement, large scale pragmatic studies are needed to determine contemporary safety and effectiveness of IVC filters. © 2018 Wolters Kluwer Health, Inc. All rights reserved. |
