Evidence Supporting IVC Use In Heart Patients Grows Thinner

Inferior vena cava (IVC) filters play a key role in pulmonary embolism treatment, but the benefits may not outweigh the risks.

Atlanta, United States – October 13, 2016 /MarketersMedia/ —

First introduced in the previous decade, inferior vena cava (IVC) filters are designed to break up blood clots inside the inferior vena cava, a large vein that carries blood toward the heart. But medical reports indicate that for some patients, the risks of IVC filters may outweigh the benefits.

The inferior vena cava is a large-diameter vein that carries blood from the lower half of the body back toward the heart. When a blood clot develops in the lower limbs, it may travel back to the heart via the inferior vena cava, where it may cause serious injury.

For patients who are unable to take anticoagulant medications for blood clots, IVC filters appeared to offer a good alternative. The cage-like design of the IVC filter is intended to trap and break up blood clots, while allowing the rest of the blood to flow freely.

Many IVC filters developed in recent years are designed to be retrieved after a few weeks or months, when the danger of a blood clot has subsided. In August 2010, the U.S. Food and Drug Administration (FDA) communicated that certain side effects, including migration of the device or perforation of the vein, “may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism has subsided.” The FDA recommended that IVC filters be removed as soon at the risk passed.

In May 2014, the FDA repeated this recommendation in a second communication. The agency also noted that the retrievable IVC filters could migrate, or move within the body. The FDA also indicated that in some patients, the risk of removal could outweigh the benefits.

Meanwhile, studies of retrievable IVC filter use with patients indicated that removal was not standard procedure. A 2013 study published in JAMA found that fewer than 10 percent of IVC filters were successfully removed, and that 8 percent of patients suffered a pulmonary embolism in spite of an implanted filter. The theory that the IVC filter should prevent pulmonary embolism “has never been validated by empirical studies,” according to a companion piece published in JAMA in the same year.

Studies of IVC filters performed since the FDA’s 2014 communication indicate that the 510(k) clearance process the agency uses may play a role. Under the 510(k) process, medical devices may be sent to market without full FDA approval, as long as they are “substantially similar” to devices that are already on the market.

IVC filters of several types have reached patients under the 510(k) clearance process, which may be linked to the rates of serious side effects, according to the 2013 JAMA companion piece.

For the full study, see: Interior Vena Cava Filters: Evidence Supporting Benefits is Thin, originally posted on RecallGuide.org.

For more information, please visit https://www.recallguide.org

Contact Info:
Name: Chase Billow
Organization: RecallGuide

Source: http://marketersmedia.com/evidence-supporting-ivc-use-in-heart-patients-grows-thinner/134032

Release ID: 134032