March 21, 2013 — The Journal of the American Medical Association (JAMA) has published an editorial and two studies that call into question the effectiveness and safety of IVC filters.
These small, cage-like devices are implanted in a patient’s inferior vena cava (the blood vessel between the heart and lungs) to catch blood clots before they are pumped into the lungs and cause a pulmonary embolism. Unfortunately, the risks of an IVC filter may outweigh the benefit of preventing a pulmonary embolism.
The editorial, titled “How could a medical device be so well accepted without any evidence of efficacy? warned about “shortcomings of medical device approval in the United States” and the lack of scientific evidence regarding assumptions about IVC filter effectiveness.
According to the editorial, modern IVC filers (such as the Bard G2 and Recovery IVC filter) have been “grandfathered” into approval based on their similarity to filters developed in the 1960s that were “plagued by high rates of IVC occlusion (in over half of patients), pulmonary embolism (PE), and migration.” These early filters were replaced in the 1980s by the Greenfield design, but the Greenfield safety studies are “uninterpretable” due to a lack of a control group and other study design problem. Despite the lack of safety studies, by the year 2000, four major professional groups recommended IVC filters, and nearly 50,000 IVC filters were placed every year.
JAMA published one study that found wide variation in how frequently IVC filters were used among California hospitals from January 2006 until December 2010. The variation persisted even after adjusting for clinical and socioeconomic factors. It is unknown why some hospitals were more likely to use IVC filters than others.
JAMA also published a study of retrievable IVC filters, with startling results:
- Of 679 retrievable IVC filters that were placed, only 58 (8.5%) were successfully removed. This is very concerning because the risk of life-threatening complications increases with time, and the FDA has warned that retrievable IVC filters should be removed as soon as the patient is no longer at risk of a pulmonary embolism.
- Unsuccessful retrieval attempts were made in 13 patients.
- 7.8% of 952 patients in the study developed a blood clot
- 2.6% of 952 patients had a pulmonary embolism with the IVC filter in place
- 48% of patients who developed a blood clot had no blood clots before receiving the IVC filter
- Many people were implanted with an IVC filter when a blood-thinning medication may have been more appropriate. Nearly 25% of patients were discharged with a prescription for blood-thinning medications.
The researchers concluded that IVC filters should not be used due to the high risk of blood clots:
“Our research suggests that the use of IVC filters for prophylaxis and treatment of venous thrombotic events, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes due to high rates of venous thromboembolism.”
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