Blood clots can cause serious health complications or even death if not treated. Equally important to note is that a large portion of the population is at risk for blood clots. If you are over the age of 60, sit for long periods of time, travel frequently, or take oral contraceptives (to name just a few factors), then you could be vulnerable to having blood clots.
IVC (inferior vena cava) filters were the standard for years to trap blood clots to prevent them from causing blockages in organs. However, usage greatly declined after it was discovered that they could cause more harm than good. Now a new generation of IVC filters are on the market. Are these new versions safer to use?
What is an IVC Filter?
An IVC filter looks like a mini umbrella frame. It’s placed in the IVC which is a large vein in the abdomen that returns blood from the lower half of the body to the heart. If a blood clot forms in the leg or pelvis, the cage-like device prevents the clot from entering the lungs which could cause a pulmonary embolism.
The problem with IVC filters is that the prongs could erode, break off, and migrate to other parts of the body. This could cause puncturing of organs, blood vessels, or lungs creating internal bleeding and there have even been cases of death reported. According to Stanford Medicine, San Francisco Bay Area resident Susan Karnstedt suffered from serious injuries due to her filter. “Over time, a few of the filter legs had eroded through, perforating her IVC, and one of them had impaled her intestines,” explained interventional radiologist William Kuo, MD, at Stanford Hospital & Clinics. “The filter tip had also become tilted and was embedded within the IVC wall. The degree of filter leg penetration through the intestines was shocking and undoubtedly the cause of her chronic and worsening abdominal pain.” Karnstedt described it as a “fork poking” into her intestines.
A New Generation of IVC Filter
“I think it’s fair to characterize the field of IVC filters over the last decade as rife with controversy,” commented investigator Michael Dake, MD. Retrievable filter use rose between 2005 and 2010 but then fell following the 2010 US Food and Drug Administration’s alert concerning the many complications (and recalls) involved with this device.
Currently, a new generation has been introduced to market. On December 3, 2018, Market Watch announced that, “BTG plc (BTG), the global healthcare company, today announced the first patients outside of a clinical trial have been successfully implanted with the BTG Sentry device – the world’s first bioconvertible IVC filter.”
Many of the previous types of filters were only temporary and required a second surgery to retrieve them. With this BTG model, the filter is permanent and reduces the risks presented by a second procedure. This filter is also deemed “bioconvertible” which means that after 60 days, the device “shifts to an open configuration” causing the arms to retract against the IVC creating an open tube-like structure. This allows the device to be permanent and supposedly reduces the dangers associated with the previous models.
While many medical professionals have high hopes for this new device, patients should understand that there still may be complications ahead. “You’re still leaving behind a permanent implant in the IVC,” warns Kush R. Desai, MD of Northwestern University. “People think that that’s not a big deal, and it may very well not be, but we just don’t know. Certainly, I think a lot of people originally thought that it wasn’t a big deal to leave a retrievable filter in place forever and we now know that’s not the case.”
In fact, over 9,000 lawsuits have been filed in the United States due to faulty IVC filters. Hopefully, this new version reduces patient injuries, but we believe that more time and research are needed to fully show the full benefits and risks associated with any new medical device.