A new study suggests older patients with pulmonary embolism are more likely to die if they receive an inferior vena cava (IVC) filter.
IVC filters treat patients at risk for pulmonary embolism when standard blood-thinning medications are not an option. Once inserted in the inferior vena cava – the body’s largest blood vessel – the devices catch blood clots before they can travel to heart and lungs.
In 2010, the U.S. Food & Drug Administration (FDA) warned the filters been linked to more than 900 adverse reports, involving migration, fracture, embolization, and more. Among other things, the FDA suggested the failure to remove retrievable devices caused many of the reported injuries.
Just four years later, the agency issued a new alert to reiterate its warning.
This latest study was published on December 10th as a research letter in JAMA: Internal Medicine.
The authors identified 14,579 older fee-for-service Medicare beneficiaries (57.4% women; 84.9% white; mean age, 77.8 years) hospitalized for acute pulmonary embolism between 2011 and 2014. Of these, 13% were treated with an IVC filter.
From that pool, they created a cohort consisting of 76,198 patients matched for various factors, including demographics and co-morbidities. Just over 18% of the matched-cohort patients received a filter.
According to the study authors, IVC filters were associated with a higher rate of 30-day all-cause mortality (11.6% vs 9.3%). Although the difference was not significant when a mixed effects regression adjustment was performed, it became so with inverse probability weighting or individual matching analyses.
1-year all-cause mortality was also higher among filter patients, 20.5% vs 13.4%. However, the difference was significant for all three analyses.
“These findings stand in contrast with prior reports from administrative databases that suggested efficacy of IVC filters but did limited adjustment for potential confounders. Instead, our study showed hypothesis-generating findings for increased risk,” the authors wrote.
C.R. Bard, Inc. and Cook Medical, Inc. collectively face more than 9,900 product liability claims over injuries and complications allegedly caused by defective IVC filters.
Federal cases filed against C.R. Bard are centralized in the U.S. District Court, District of Arizona. The litigation’s first bellwether trial concluded last March, after a jury awarded $3.6 million to a recipient of Bard’s G2 filter. However, two subsequent trials resulted in defense verdicts.
Federally-filed IVC filter lawsuits involving Cook Medical’s devices are centralized in the U.S. District Court, Southern District of Indiana. The company won the litigation’s first bellwether trial in November 2017.
In May, however, a Texas state court jury awarded $1.2 million in case involving Cook’s Celect blood clot filter.