Gunther Tulip IVC Filters Troubling Studies

IVC Filter GraphicIVC blood clot filters have a troubled history when one looks closely at their safety and efficacy studies. The general safety profile of IVC filters makes them difficult to justify using for the general population.

Gunther Tulip IVC Filter Tilt 91%

Several researchers – including Alan Sag, BS; Joseph M. Stavas, MD; Charles T. Burke, MD; and several others – analyzed a retrospective review of 175 patients with the Gunther Tulip IVC filter implanted from 2003-2007. They reviewed each patient’s medical records and cavagrams, and published their conclusions in the Journal of Vascular and Interventional Radiology in 2008. Ninety-one percent (91%), 159/175 patients had tilt in their filters upon the first retrieval attempt. They found that the tilt “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing.”

IVC Filters increase DVTs

An American Heart Association study published in March 2005 by the PREPIC Study Group concluded that, at eight years, vena cava filters reduced the risk of PE, but increased the risk of DVT’s, and had no effect on patient survival. The authors’ conclusion was that although IVC filter use “may be beneficial in patients at high risk for pulmonary embolism, systematic use in the general population with venous thrombotic embolism (DVT and PE) is not recommended.” (emphasis ours)

IVC Filter Role Unproven

A clinical investigation by the International Society of Endovascular Specialists in 2007 looked at the retrievability of Cook’s Gunther Tulip Vena Cava Filter after dwell times longer than 180 days for multiple trauma patients. Thirty three (33) of 115 filters could not be retrieved. The investigation concluded that the role of IVC filters is unproven, and that retrieval should be done as soon as clinically indicated.

IVC Filters Difficult Removal

A Journal of Medical Imaging and Radiation Oncology article published in 2008 looked at the retrievable Gunther Tulip inferior vena cava filter in 317 patients. The authors reported that reported retrieval periods for the Gunther Tulip filter have continued to lengthen despite recommendations to remove them at 14 days, which later became at the doctor’s discretion.

The authors concluded: “Our data suggest (that) the extended filter dwell times may compromise successful retrieval.”

IVC Filters Not Retrieved

A Journal of Vascular and Interventional Radiology article published in 2008 examined 188 patients with attempted filter removal, with a mean dwell time of 63 days. Even at just two months, 12% were retrieval failures. The authors concluded that 90 percent of filters not retrieved perforated the IVC, the connection between perforation and inability to remove. Just as disconcerting, they concluded that increased dwell time was a significant factor in determining retrieval success.

Gunther Tulip worsens over time

Another Journal of Vascular and Interventional Radiology article, this one published in 2013, found the Gunther Tulip Filter troubling when left in a person over time. The authors concluded: “Although the Gunther Tulip and Option filters exhibit caval penetration on CT imaging, only the GTF (Cook) exhibits progressive penetration over time.

Gunther Tulip IVC Filters Troubling Studies

A 2007 study published in The Journal of Trauma and Acute Care Surgery found that despite IVC filters being generally accepted to reduce the risk of fatal PE, “this has not been proven, particularly when used for prophylactic indications.”

Further troubling, the study found that most IVC filters are not retrieved when placed for trauma patients. That information comes in addition to the fact that IVC filters have not been proven to increase trauma patients mortality.

Related

Share