IVC filtration for prevention of pulmonary embolism has been around for decades, and yet this important area of vascular medicine remains in a state of flux. The situation has been made all the more complex and unclear by the emergence of multiple new filter technologies and devices over the last several years as well as the marked uptick in rates of filter placement. The latter was driven primarily by an expansion in clinical indications with the advent of retrievable devices that, paradoxically, only rarely are actually removed after implantation!
In August 2010, the U.S. Food and Drug Administration issued a warning letter advising the medical community (and society at large) of a perceived increase in complications related to IVC filter placement, and conveying the unmistakable impression that retrievable filters may be dangerous. This became the main driver of an important and still-evolving process that followed, with the ultimate formation of a combined task force by the SIR and SVS societies. These leaders, working in close communication with the FDA, have established the foundations for the design a of large prospective registry-style clinical study: PRESERVE – PREdicting the Safety and Effectiveness of InferioR Vena Cava Filters. The study will be funded by industry, and it is anticipated to commence in the near future.
PRESERVE will be timely, and it will hopefully address and resolve some of the most critical aspects surrounding this important area of interventional medicine. First and foremost, we need definitive answers on the issues of safety and efficacy as well as on-label and off-label usage. With any luck, we may get them within the next 2 to 3 years. I will keep my fingers crossed.