Temporary Inferior Vena Cava Filters

Abstract

Despite their widespread use, the indications for the selective use of temporary inferior vena cava (IVC) filters remains uncertain with few trials supporting their use. Additionally, the risks of long-term temporary IVC filter insertion are being increasingly discussed amongst the mainstream media and through multiple class action lawsuits. Retrievable IVC filters were specifically designed to have a less secure implantation in order to facilitate retrieval. However, multiple reports have demonstrated significant filter-related complications, most commonly related to duration of implantation. Furthermore, the risk is not isolated to one manufacturer alone. The incidence of filter-related complications is linearly related to its duration of time on the market. Currently, the FDA recommends that IVC filters be removed within 25-54 days of their implantation. Unfortunately, little evidence exists to show that this recommendation is followed routinely. Recently, the PRESERVE Trial (NCT02381509) was initiated as a multicenter non-randomized open label study to determine the safety and effectiveness of commercially available IVC filters (both temporary and permanent) in individuals who require mechanical prophylaxis against pulmonary embolism. Until such evidence is developed, temporary IVC filters should be implanted based on best available evidence and routinely removed within the guidelines of the FDA of 25-54 days. A fair question at this point is whether the design features themselves that are required to manufacture a low profile removable IVC filter can achieve effective prophylaxis against pulmonary embolism at a low rate of short and long-term complications.

Prevention of venous thromboembolism in gynecologic oncology surgery

“…Later complications include IVC thrombosis that can occur in 3–30% of patients as well as filter migration and perforation of the filter through the wall of the IVC. For these reasons, the Food and Drug Administration recommends that low profile temporary removable filters be placed and removed within 25–54 days [69]. …”

Interventional radiology treatment for pulmonary embolism

“…The FDA in 2010 issued a recommendation advising the recovery of every IVCf as soon as possible, once they had fulfilled their clinical mission[27]. Only temporary IVCf should be implanted based on the available evidence and routinely removed within 25-54 d according to the guidelines of the USFDA[28]. …”

COUNTERPOINT: Do the Benefits Outweigh the Risks for Most Patients Under Consideration for Inferior Vena Cava Filters? No

“…IVC filter manufacturers submit only a premarket notification, known as a 510(k), that, once approved, allows marketing of retrievable filters as "permanent filters with an option for retrieval," inaccurately reflecting the significant discrepancy in designs between permanent filters and those that are specifically designed to have "a less secure implantation to facilitate retrieval." 1,3,10,15 In fact, the availability of optional IVC filters has led to their skyrocketing use based on the fallacy that these devices offer the best of both filter worlds: short-term protection from PE while obviating long-term retention of a foreign body. This has resulted in a plummeting threshold for filter placement despite consistent demonstration that optional filters are infrequently removed and may be less safe than permanent filters.…”

“…Aside from the potential physical harm incurred by IVC filters, which includes filter fracture, perforation, migration, and IVC thrombosis (much of which is based on self-reported adverse events, and almost certainly underreported), the cost of IVC implantation was estimated at $300 million in 2012 (not inclusive of costs from complications, malpractice claims, surveillance, and retrieval-or failed retrieval). 1,3,[5][6][7]11,12,15,17 So, why are so many filters placed in the United States? There are interesting correlative data to consider: the journal.publications.chestnet.org use of IVC filters is geographically disparate, being greatest in Northeastern United States and lowest in the west; filter implantation is directly related to the number of paid malpractice claims and annual liability premiums and is lowest where the population is least insured.…”