April 30, 2015 — Patients at risk of a blood clots might not benefit if they are implanted with a retrievable inferior vena cava (IVC) filter instead of taking a blood-thinner alone, according to a study published in JAMA.
Pulmonary embolism occurred within three months in six patients (3%) with the filters, all of whom died. In comparison, three patients (1.5%) treated with blood-thinners alone had a pulmonary embolism, two-thirds of whom died.
The combination of a blood-thinner (anticoagulant medication) plus a retrievable IVC filter did not reduce the risk of recurrent pulmonary embolism at three or six months compared to a blood-thinner alone, suggesting that the high-risk devices provided no benefit.
There were also serious adverse events in patients implanted with IVC filters, including access site hematoma (2.6%), filter thrombosis (1.6%), retrieval failure due to mechanical reasons (5.7%), and one case of cardiac arrest during filter insertion.
“These findings do not support the use of this type of filter in patients who can be treated with anticoagulation.”
The conclusions of the study were based on data from 399 patients hospitalized at 17 clinics in France with sudden, severe pulmonary embolisms. All of the patients had lower-limb vein thrombosis (blood clots in the legs), which is a serious risk-factor for recurrent pulmonary embolism.
In 2013, another study published in JAMA was an accompanied by an editorial that asked, “How could a medical device be so well accepted without any evidence of efficacy?”
Implanting an IVC filter is an invasive medical procedure that was widely-accepted for decades, but questions about effectiveness and safety risks have been growing. In 2010, the FDA issued a Safety Communication to recommend removing retrievable filters as soon as the patient was no longer at risk of a pulmonary embolism due to the risk of severe, life-threatening complications.
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