Clinical StudyComparison of Complication Rates Associated with Permanent and Retrievable Inferior Vena Cava Filters: A Review of the MAUDE Database
Section snippets
Materials and Methods
The MAUDE database was reviewed from January 1, 2009 to December 31, 2012. Product class search criteria were “filter, intravascular, cardiovascular.” Type of device used and specific adverse events (AEs) were recorded.
Results
For the period January 2009–December 2012, 1,606 reported AEs involving 1,057 IVC filters were identified in the MAUDE database (Table 1). Of reported AEs, 1,394 (86.8%) involved rIVCFs, and 212 (13.2%) involved pIVCFs (P < .0001). Patient symptoms were not reported in association with 82% of AEs.
Table 2 summarizes the most commonly reported AEs associated with use of pIVCFs and rIVCFs. Each specific AE was reported with significantly higher frequency in rIVCFs compared with pIVCFs.
The most
Discussion
The American College of Chest Physicians (ACCP) and American College of Radiology (ACR)/Society of Interventional Radiology (SIR) have each published evidence-based guidelines for the placement of IVC filters. The ACCP recommends placement of an IVC filter in patients with acute proximal lower extremity deep venous thrombosis or PE in whom anticoagulation is contraindicated or failed. When bleeding risk resolves, a conventional course of anticoagulation therapy should be administered (6). The
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From the SIR 2014 Annual Meeting.
R.J.L. and R.K.R. are consultants for Cook Medical Inc. Neither of the other authors has identified a conflict of interest.