Over the past seven years, the popularity of inferior vena cava (IVC) filters has consistently declined in the United States. After hitting an all-time high in 2010, IVC filter use began to drop when federal regulatory agencies issued a serious safety warning about the risk of complications.
Safety Issues with IVC Filter Use
IVC filters work by catching blood clots before they reach the lungs and heart. The implantation takes place in the inferior vena cava, the body’s largest blood vessel.
A study published in Nov. 2017 in JAMA Internal Medicine tracked IVC filter trends from 2005 to 2014. The researchers observed a significant downward shift following a 36-year rise in the implantation of blood clot filters.
Researchers collected data from the Nationwide Inpatient Sample, the National Inpatient Sample, the Healthcare Cost and Utilization Project, and the Agency for Healthcare Research and Quality.
In 2010, JAMA Internal Medicine published a study indicating high rates of life-threatening complications are associated with IVC filters. On that same day, the U.S. Food and Drug Administration (FDA) issued its initial safety communication.
The agency warned blood clot filter patients and physicians of 921 adverse events with IVC filters, including:
- Device migration (328 reports)
- Device detachment (146 reports)
- Vein perforation (70 reports)
- Filter fracture (56 reports)
About IVC Filter Use and Regulation
Originally designed as permanent implants, other IVC filter designs have allowed the option for removal. However, many of these removable filters are never retrieved, leading to a much higher risk of filter fracture with wear and tear.
This was the focus of the FDA’s second safety alert in 2014. It states: “For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided.”
According to TCTMD, the FDA recommends filter removal between 29 and 54 days after implantation. Risk of filter fracture begins 7 months or longer following implantation. The time that passes before device removal, or “dwell time,” occurs for reasons as simple as poor patient follow-up by a physician.
In March of last year, JACC: Cardiovascular Interventions suggested the increase in IVC thrombosis may be linked to unretrieved IVC filters. This thrombosis may manifest as severe lower back and abdominal pain.
While IVC filters are still the best treatment for those with an actively bleeding clot, Dr. Rita Redberg, MD, from the University of California at San Francisco, argues that “there should be a moratorium on [IVC filter] use unless or until there are data showing efficacy greater than risk.”