April 30, 2015 — JAMA has published a study by French researchers who found that implanting an inferior vena cava (IVC) filter offered no benefit for patients who could have used a blood-thinner alone.
All of the patients were at high risk of a pulmonary embolism (blood clots in the lungs) because they had lower-limb venous thrombosis. Conclusions of the study were based on data from nearly 400 patients in France who were randomly assigned to receive an IVC filter plus a blood-thinner, or a blood-thinner alone.
Six patients (3%) in the IVC filter group had a pulmonary embolism and all of them died. Pulmonary embolism occurred in three patients (1.5%) who only took a blood-thinner, and two of them died.
Serious adverse events in the IVC filter patients included access-site hematoma (2.6%), filter thrombosis (1.6%), failure to retrieve the filter for mechanical reasons (5.7%), and one patient who had a cardiac arrest while the filter was being inserted.
The authors of the study warned:
“These findings do not support the use of this type of filter in patients who can be treated with anticoagulation.”
The study adds growing evidence that IVC filters pose serious risks and have questionable benefits for patients who are able to take a blood-thinning medication. Two years ago, JAMA published another study in which researchers asked, “How could a medical device be so well accepted without any evidence of efficacy?”
The FDA has received hundreds of adverse event reports associated with retrievable IVC filters. In 2010, the agency issued a Safety Communication to recommend removing the filters as soon as possible in patients who are no longer at risk of pulmonary embolism.
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