FDA guidelines overlooked for common blood clot device: 5 notes

Designed to temporarily prevent blood clots from traveling to the lungs, approximately 85% of inferior vena cava filters inserted over an eight-year period were not removed, according to a study published Nov. 6 in JAMA.

Researchers from Boston-based Beth Israel Deaconess Medical Center, in collaboration with the FDA, examined CMS data of 270,866 Medicare beneficiaries who had inferior vena cava filters placed between Jan. 1, 2013, and Dec. 31, 2021.

Inferior vena cava filters are routinely used for pulmonary embolism prevention, according to a Nov. 12 news release from Beth Israel Deaconess Medical Center. 

Here are five takeaways from the investigation: 

  1. The number of inferior vena cava filter insertions decreased from 44,680 in 2013 to 19,501 in 2021.

  2. The incidence of device retrieval was 15.3% at a median follow-up of 1.2 years and 16.8% at a maximum follow-up of nine years. The vast majority (93.5%) of retrieval attempts were successful, highlighting the safety of the procedure.

  3. "Safety guidelines released by the FDA in 2010 and again in 2014, strongly advise the prompt removal of IVCFs after their clinical utility has waned," lead author Enrico Ferro, MD, said in the release.

  4. Among patients with nonretrieved devices, 2.2% experienced caval thrombosis and 9.2% experienced deep vein thrombosis.

  5. Device retrieval was less likely to occur if patients were Black, older or had more comorbidities. Device retrieval was more likely if placement had occurred at a larger teaching hospital.

Read the full investigation here

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