August 28, 2012 — A study published in the American Journal of Medicine has found that IVC filters do not reduce the mortality rate for stable patients suffering from a pulmonary embolism.
Although the IVC filter does reduce mortality for unstable patients, these patients are a small minority. The study raises concerns about the risk-benefit of using IVC filters, especially since the use of these devices has increased dramatically in recent years.
An IVC filter is a medical device that is implanted in a person’s inferior vena cava (IVC), a large blood vessel that carries blood into the lungs. The IVC filter is supposed to catch blood clots before they reach the lungs and cause a pulmonary embolism, which is a life-threatening condition that occurs when blood clots form in deep veins, travel to the lungs, and block major blood vessels in the lungs.
According to Dr. Paul Stein, the lead researcher who conducted the study, “It appears the vast majority of filters that are placed in patients with a pulmonary embolism may not reduce mortality.” Furthermore, he said, “Only a small percentage of patients suffering from a pulmonary embolism are in shock or in need of ventilation support, and therefore only a small proportion need a filter.”
Dr. Stein also found that anticoagulant medications were not used routinely. He recommends that for unstable patients with a pulmonary embolism, it is critical they they receive anticoagulant medications in addition to an IVC filter. This treatment has lower risks than surgical removal of a blood clot (called an embolectomy). Dr. Stein found that embolectomies were associated with a very high risk of mortality, unless the clinician was highly specialized and experienced.
Dr. Stein based his recommendations on a study of more than 2 million patients suffering from pulmonary embolisms. Many of them were treated with an IVC filter; in fact, the use of IVC filters has increased substantially in recent years.
As the use of IVC filters has increased, so has concern about the risk of severe, life-threatening side effects. Dr. Stein found that many patients were implanted with removable IVC filters, but very few patients had the device removed — a problem that is associated with “unacceptable morbidity and mortality.”
Dr. Stein also found the following rates of complications:
- Improper placement of the IVC filter (7%)
- Migration (2-3%)
- Filter changes position (2%)
- Narrowing of the vena cava (2%)
- Obstruction of the vena cava (2-9%)
- Air embolism (1%)
- Perforation of the vena cava (1%)
- Lower-extremity edema, swelling with fluid (13-26%)
- Other injuries caused by slow blood flow through the filter (27%)
- For retrievable IVC filters that were not removed, blood clots clogging the filter caused complications in 10-22% of cases
- Other complications included filter deformation, filter fracture, insufficient opening of the filter, and erosion of the device into the vena cava wall
Do I have an IVC Filter Lawsuit?
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