IVC Filter Study Questions Use of Blood Clot Filters in Patients with Traumatic Spine Injuries

Published on August 21, 2017 by Sandy Liebhard

A new study suggests that inferior vena cava (IVC) filters might increase the risk for venous thromboembolism when used in patients with traumatic spine injuries.

The findings, which were recently presented at the 2017 New York Surgical Society Meeting, are just the latest to raise concerns regarding the safety and effectiveness of the controversial blood clot filters.

Hospitals Urged to Rethink IVC Filter Policies

For the study, surgeons from the Jacobi Medical Center, Jacobi Medical Center, and Yeshiva University’s Albert Einstein College of Medicine reviewed more than 3.6 million medical charts by accessing the American College of Surgeons’ National Trauma Data Bank over a four-year period. They identified 69,000 patients with traumatic spinal cord injury and analyzed outcomes among those who had received the blood clot filters.

Just over 10% of those who received an IVC filter experienced a pulmonary embolism – the very complication the devices are intended to prevent. By contrast, only 7.6% of who received chemoprophylaxis only suffered a pulmonary embolism.

According to General Surgery News, one of the study authors suggested hospitals that mandate IVC filter insertion for all traumatic spine injury patients rethink their policy.

“Since a filter predisposes [to] thrombogenesis, we really need to consider the consequences for the patient, such as the likelihood that we’ll be able to retrieve the filter and the age of the patient,” Ravi N. Kapadia, MD, a general surgery chief resident at Jacobi Medical Center and Montefiore Medical Center, Albert Einstein College of Medicine.  Most of our trauma population [is composed of] young adult males. It’s one thing to have a filter as a 70-year-old, but it’s another thing when a 20-year-old is walking around with one.”

IVC Filter Complications

IVC filters are placed in the inferior vena cava in patients at risk for pulmonary embolism who can’t use standard blood-thinning drugs. Retrievable filters are designed to be removed once a patient is out of danger.

In 2010, the U.S. Food & Drug Administration (FDA) warned that its adverse event database had logged more than 900 IVC filter complication reports, including incidents of migration, filter fracture, and embolization, as well as cases where pieces of an IVC filter perforated organs and blood vessels. The FDA reminded healthcare providers to remove the filters as soon as the blood clot risk subsided in order to reduce the potential for patient harm.

In May 2014, the FDA issued a second alert to remind doctors of the importance of IVC filter retrieval.

IVC Filter Lawsuits

Retrievable blood clot filters marketed by C.R. Bard, Inc. and Cook Medical, Inc., are the subject of more than 4,000 product liability lawsuits filed on behalf of those allegedly injured by the devices. Plaintiffs claim that C.R. Bard and Cook Medical failed to provide doctors with appropriate safety warnings, including information regarding the importance of IVC filter retrieval.

Federally-filed IVC filter lawsuits involving Cook Medical products been centralized in the U.S. District Court, Southern District of Indiana, where bellwether trials are scheduled to begin in October.  Cases involving C.R. Bard blood clot filters have been consolidated in the U.S. District Court, District of Arizona.

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