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IVC filter implantation rates

No known significant benefit found for IVC filter usage rates in US

IVC filter implantation rates are 25-fold higher than in Europe

A research team that examined nationwide utilisation rates of IVC filter placement in the US and assessed what impact the 2010 FDA advisory had on these rates, has reported that the appropriate implantation rate in the US should be similar to, or lower than, the rate observed in Europe, because there is no known significant benefit of current usage rates.

"The findings of this study are noteworthy as they reflect the critical need for publications reflecting safety issues related to medical therapies even after they have been approved by FDA,” said lead author of the study, Dr Bashir, Professor of Medicine at the Lewis Katz School of Medicine at Temple University (LKSOM), and Director of Vascular and Endovascular Medicine at Temple University Hospital (TUH). “The significant decrease in IVC filter implantations after the FDA communication reflects that such communications are a very powerful means of affecting contemporary practice patterns around the country.”

While IVC filter usage has increased rapidly over the years, its safety has been questioned. In 2010, the FDA issued a device safety communication after reviewing more than 900 adverse events related to the filters over a five-year period. Those adverse events included device migration, embolizations, perforation of the IVC, and filter fractures. Some of these events led to adverse clinical outcomes in patients, often with the filter remaining in the body long after the risk of PE had subsided. Out of concern that these IVC filters were not always removed once a patient's risk for PE subsided, the FDA safety communication recommended removal of the filter as soon as protection from PE is no longer needed.

"Since venous thromboembolism (VTE) is a diagnosis that includes both DVT and PE, in this study we also evaluated VTE-related hospitalization rates during the same period in order to determine whether any change in IVC filter implantation could be accounted for by changes in VTE-related hospitalizations,” added Bashir.

The research team used the National Inpatient Sample (NIS) database to identify all patients in the US that underwent IVC filter implantation from January 2005 to December 2014. The researchers also identified all patients diagnosed with DVT or PE during the study period, as well as the rates of IVC filter implantation, and VTE-related hospitalizations per 100,000 in the U.S. population.

The team report that:

  • An estimated 1,131,274 patients underwent IVC filter placement over the 10-year study period
  • There was a 22.2% increase in the rate of IVC filter placement from 45.2/100,000 in 2005 to 55.1/100,000 in 2010.
  • Following the FDA safety communication, there was a 29% decrease in the rate of IVC filter placement from 55.1/100,000 in 2010 to 39.1/100,000 in 2014.
  • The rate of VTE-related hospitalizations remained steady between 2010 and 2014.
  • Despite the significant reduction in IVC filter use following the FDA advisory, implantation rates across the US remain high compared to the IVC filter implantation rate in five large European countries each of which was less than 3/100,000 population.

"In the United States, the IVC filter implantation rates are 25-fold higher than in Europe. The hospitals across this country collectively are spending close to a billion dollars on these devices every year without a known significant benefit," concluded Dr Bashir. “With current level of evidence we believe that the appropriate implantation rate in the US should be similar to, or lower than, the rate observed in Europe.”