Significant Decrease in IVC Filter Placement Observed Following FDA Advisory

Following the 2010 release of a safety warning from the U.S. Food and Drug Administration (FDA), prompted by the review of 921 adverse events reported over a five-year period, a 29 percent decrease in the rate of inferior vena cava (IVC) filter placement was recorded between 2010 and 2014, according to a research letter published in JAMA Internal Medicine.

The National Inpatient Sample database shows that an estimated 1,131,274 patients in the U.S. underwent IVC filter implantation over the 10-year study period. Prior to the release of the safety warning, a 22.2 percent increase in the rate of IVC filter placement was recorded between 2005 and 2010; however, authors Satyajit Reddy, MD, et al., note the significant decrease in placement following the advisory.

It has been suggested that the decline in the IVC filter placement rates in the U.S. is the result of decreased reimbursement for the procedure through the bundling of associated Current Procedural Terminology (CPT) codes. However, the observed decline in IVC filter use began in 2010, two years prior to this bundling. Study authors suggest it is likely, however, that the reduction in IVC filter reimbursement will continue to reduce the use of IVC filters across the U.S.

Despite the reduction in IVC filter use following the FDA advisory, and the general uncertainty of the effectiveness of the procedure for the reduction of venous thromboembolism-associated morbidity and mortality, implantation across the U.S. remains high with rates 25-fold higher than in Europe.

"Given the short- and long-term complications associated with IVC filter placement, the use of these devices should be mostly reserved for those patients with an absolute indication like active bleeding," write the study authors. "We believe that the appropriate implantation rate in the U.S. should be similar to or lower than the rate observed in Europe."

In an accompanying editorial opinion, Rita F. Redberg, MD, MSc, FACC, echoes the study authors' concern, writing, "As is true for many treatments that were later shown to be harmful and have been abandoned, such as antiarrhythmic medications for patients following myocardial infarction, or metal-on-metal hips, some argue that it is impossible to do a randomized clinical trial of IVC filters because practice patterns are set. As is true for many invasive treatments, IVC filter use is much higher in the U.S. than any other country. In the absence of evidence of benefit and definite harms, IVC filters get a Less Is More designation. There should be a moratorium on their use unless or until there are data showing efficacy greater than risk."

Keywords: Venous Thromboembolism, Current Procedural Terminology, Vena Cava, Inferior, United States Food and Drug Administration

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