Retrievable IVC Filters Can Be Removed With Few Complications, Regardless of Dwell Time: Study

Amid continuing concerns about the risk of complications from retrievable IVC filters that are left in place after the risk of pulmonary embolism passes, new research suggests that the length of time the filter remains in the body does not appear to impact a surgeon’s ability to successfully remove the device.

Inferior vena cava (IVC) filters are small, spider-like devices that are implanted to “catch” blood clots that may break free from deep veins, preventing the clot from traveling to the lungs and causing a pulmonary embolism.

Retrievable IVC filters have been introduced in recent years, which allow the surgeon to remove the device once the risk of a clot has passed. However, the filters are often left in place for long periods of time.

Following reports of IVC filters failing, with the struts or legs fracturing or puncturing the vena cava, the FDA issued a warning in May 2014, urging doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed.

In a letter published last month in the medical journal JAMA Internal Medicine, researchers indicate that virtually all retrievable IVC filters can be removed using advanced retrieval techniques. The length of time the IVC filters have been in a patient’s body do not appear to affect success rates for removal, according to the findings.

Researchers from Northwestern University’s Feinberg School of Medicine, looked at 648 IVC retrieval procedures conducted between January 1, 2009, and December 1, 2014.

In nearly 83% of cases, standard retrieval techniques were able to remove the filters. However, in 95 procedures (14.7%), researchers had to use advanced, adjunctive techniques when standard procedures failed. These included the use of directional sheaths, loop wires, balloon disruption, the use of endobronchial forceps, or laser sheath-assisted photothermal ablation.

The need for such techniques were often related to longer dwell times. However, the researchers said they were generally done successfully without an increased risk of complications.

IVC Filter Complications

In recent years, concerns over the safety and effectiveness of removable IVC filters have emerged within the medical community, with several different types of filters associated with high rates of catastrophic failure, often resulting in the need for emergency medical treatment or even fatal complications.

In August 2010, the FDA issued an alert about the risk of problems with removable IVC filters, indicating that the agency had received more than 900 adverse event reports at that time. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved  components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.

In April 2012, a study published in the medical journal Cardiovascular Interventional Radiology indicated that nearly 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.

A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

A growing number of Bard G2 IVC filter lawsuits, Bard Recovery IVC filter lawsuits and Cook Celect and Gunther Tulip filter lawsuits have been filed in recent months, alleging that design defects make these models more prone to experience problems.

A motion is currently pending before the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to centralize all Bard IVC filter lawsuits before one judge in the federal court system to prevent duplicate discovery, avoid conflicting rulings and serve the convenience of the court, witnesses and both parties.

In October 2014, the U.S. JPML granted a similar request to centralize all Cook IVC filter lawsuits, which raised nearly identical allegations over other brands. The Cook litigation is currently centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.