12 Jul Use of IVC Filters Drops After FDA Device Warning
MedicalResearch.com Interview with:
Dr. Bashir
Riyaz Bashir MD, FACC, RVT
Professor of Medicine
Director, Vascular and Endovascular Medicine
Department of Medicine
Division of Cardiovascular Diseases
Temple University Hospital
Philadelphia, PA 19140
MedicalResearch.com: What is the background for this study?
Response: The use of inferior vena cava filters (IVCF) has been increasing in the United States (US) despite uncertainty about the effectiveness of IVCFs in reducing venous thromboembolism (VTE)-associated morbidity and mortality. Prompted by the report of high prevalence of fracture and embolization of Bard IVCFs, the US Food and Drug Administration (FDA) issued a device safety warning on August 9th 2010.
In this study, we evaluated national trends of IVCF placement in the US between 2005 and 2014 using the National Inpatient Sample database. The authors found that there was a 29% reduction in filter use following the 2010 FDA advisory, even though the rates of VTE-related hospitalizations remained unchanged.
MedicalResearch.com: What are the main findings?
Response: The authors found that there was a 29% reduction in filter use following the 2010 FDA advisory, even though the rates of VTE-related hospitalizations remained unchanged.
The other findings include the following:
- An estimated 1,131,274 patients underwent IVC filter placement over the 10-year study period
- There was a 22.2% increase in the rate of IVC filter placement from 45.2/100,000 in 2005 to 55.1/100,000 in 2010.
- Following the FDA safety communication, there was a 29% decrease in the rate of IVC filter placement from 55.1/100,000 in 2010 to 39.1/100,000 in 2014.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The findings of this study are noteworthy as they reflect the critical need for publications reflecting safety issues related to medical therapies even after FDA has approved them. The significant decrease in IVC filter implantations after the FDA communication reflects that such communications are a very powerful means of affecting contemporary practice patterns around the country.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We need to invest in a multicenter randomized clinical trial to definitively understand the role of these devices in patients with venous thromboembolism.
MedicalResearch.com: Is there anything else you would like to add?
Response: Despite the significant reduction in IVC filter use following the FDA advisory, implantation rates across the U.S. remain high compared to the IVC filter implantation rate in five large European countries, which is less than 3/100,000 population. In the United States, the IVC filter implantation rates are 25 fold higher than in Europe. The hospitals across this country collectively are spending close to a billion dollars on these devices every year without a known significant benefit. With current level of evidence we believe that the appropriate implantation rate in the U.S. should be similar to or lower than the rate observed in Europe
Dr. Bashir is a co-founder and has equity interest in Thrombolex Inc, a medical device company which is developing the treatment of large vessel thrombosis.
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Last Updated on July 12, 2017 by Marie Benz MD FAAD