An 82-year-old woman who'd had a filter placed because she had multiple pulmonary emboli and deep vein thrombosis, and had a "perceived inability to anticoagulate after a recent surgical procedure." The filter was placed in her renal vein, but "despite multiple attempts, it could not be successfully repositioned or removed." Shortly thereafter, her hemoglobin level fell, she refused transfusion "for religious reasons, and died days later."
The two papers will inform many practitioners "how thin the evidence base is for these filters," and prompt a change in "how I will approach the next patient with a deep venous thrombosis and a contraindication to anticoagulation, wrote journal editor Mitchell Katz, MD, in an Editor's Note.
"Rather than 'recommending' an inferior vena cava filter, I intend to discuss with the patient the lack of data on the effectiveness of the filter and the growing evidence of harm," Katz wrote.
"I think (these papers show) we have a failure of a lot of things," says Greg Maynard, MD, a blood clot expert and director of the University of California San Diego Center for Innovation and Improvement Science (CIIS). "A failure of our system to provide better trials, a failure of approval of these devices with the rigor that should be done, and a failure to monitor — we have registries for pacers, but we don't have a registry for IVC filters that goes across these different kinds, and asks why they were put in.
"If we're not going to do the trials, we need to at least do a registry, because this variability is tremendous, which is what you always see in the face of bad evidence: huge variation and differences in costs."