August 28, 2012 — The American Journal of Medicine has published a study that questions the benefits of the IVC filter for most pulmonary embolism patients. The device is commonly implanted in people who are suffering from a pulmonary embolism, when blood clots travel to the lungs.
The study has found that stable patients who are implanted with the IVC filter do not have a lower risk of death, but they are at risk of severe side effects of the IVC filter. The study found the IVC filter only reduced mortality for unstable patients (those in shock or in need of ventilation) — a very small percentage of people hospitalized for a pulmonary embolism.
The IVC filter is a medical device that is implanted in a patients inferior vena cava (a large blood vessel between the heart and the lungs). During a pulmonary embolism, blood clots that form in deep veins can break loose, travel to the heart, and be pumped into the lungs. Blood clots can obstruct major blood vessels, causing severe organ damage and even death.
The author of the study, Dr. Paul Stein, analyzed data from nearly 2 million people who were treated for a pulmonary embolism. He found, “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.”
This finding is concerning because the use of IVC filters has increased in recent years. Dr. Stein found that the IVC filters were beneficial for unstable patients having a pulmonary embolism, but it was absolutely critical that those patients also receive anticoagulant medication. Less than one-third of the patients received anticoagulation medication. Increasing that rate could potentially reduce the mortality.
Dr. Stein also found that the majority of people who were implanted with removable IVC filters never actually had the devices removed. This practice has prompted an FDA warning, and Dr. Stein also warned that it is associated with “unacceptable morbidity and mortality.”
The study also provided data on the rate of common complications associated with the IVC filter:
- Improperly placed filter – 7%
- Migration of the filter – 2-3%
- Angulation of the filter – 2%
- Stenosis (narrowing) of vena cava – 2%
- Occlusion of vena cava – 2-9%
- Air embolism – 1%
- Vena cava perforation – 1%
- Edema (fluid swelling) of lower extremities – 13-26%
- Slow blood flow through filter, causing other complications – 27%
- Blood clots clogging a removable filter that was not removed – 10-22%
Dr. Stein also noted other complications included deformation of the filter, fractured filter, insufficient opening of the filter, and erosion of the filter into the wall of the vena cava.
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