Complications of inferior vena cava filters.

Abstract

Inferior vena cava filter (IVCF) complications have been receiving increasing attention recently, as reflected in the United States Food and Drug Administration (FDA) advisory published in 2010 and updated in 2014.1U.S. Food and Drug Administration. Removing retrievable inferior vena cava filters: FDA Safety Communication. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm. Accessed July 1, 2016.Google Scholar Although the FDA advisory was meant to be a safety communication directed at physicians placing retrievable IVCFs, recommending “removing the filter as soon as protection from pulmonary embolism was no longer needed,” these concerns have spilled over into the public domain, bordering on mass hysteria, with major network news pieces highlighting IVCF problems, and law firm late night television commercials and Internet advertisements seeking patients who have been harmed by IVCFs. Many vascular surgeons are experiencing the backlash of this amplified assault on IVCFs as patients with IVCFs in place for many years seek advice about IVCF removal. It has also become more difficult for providers to provide appropriate patient care when an IVCF may be indicated with the extended medical and legal implications of IVCF placement, even when clinical decisions are supported by evidenced-based guidelines.2Kearon C. Aki E.A. Ornelas J. Blaivas A. Jimenez D. Bounameaux H. et al.Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report.Chest. 2016; 149: 315-352Crossref PubMed Scopus (3362) Google Scholar Although there are several reason why we have gotten to this point, including the exponential volume increases of IVCF placement in the 2000s related to ease of deployment, introduction of retrievable IVCF designs, industry promotion, financial incentives, and perceived expansion of indications for venous thromboembolism prophylaxis despite lack of evidence supporting this practice, the most important short sight was the misperception that IVCFs are harmless. Now that the pendulum is swinging in the opposite direction, what remains unclear is just how big the problem is: Lack of a true denominator has been a significant limitation across current published evidence. The current study by Wang et al3Wang S.L. Siddiqui A. Rosenthal E. Long-term complications of inferior vena cava filters.J Vasc Surg Venous Lymphat Disord. 2017; 5: 33-41Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar focuses on a small subset of patients who had computed tomography imaging at a minimum of 4 years after implantation showing that long-term device complications were relatively common; however, this is only a small sample across many different devices at random intervals, lacks clinical significance, and has statistical limitations in the analysis that tempers these findings. That said, this current study does add to the growing body of evidence that some IVCFs will develop problems later after placement and that occasional imaging of patients with IVCF at extended intervals may also be important. However, without a complete understanding of the scope of the problem, more data will be needed to better define this concern. As noted in the recent FDA advisory, the FDA is requiring collection of additional clinical data for currently marketed IVCFs in the United States to assess the use and safety profile of these devices, understand evolving patterns of clinical use of IVCFs, and ultimately, improve patient care. Some manufacturers are participating in the PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study,4PRESERVE. Predicting the safety and effectiveness of inferior vena cava filters. Available at: http://www.preservetrial.com/. Accessed July 1, 2016.Google Scholar a collaborative effort between the Society for Vascular Surgery and Society of Interventional Radiology, whereas other manufacturers are conducting postmarket surveillance (522 Studies). Until more complete data are available better defining IVCF practice patterns and device-related issues, IVCFs as a device class will continue to be under public scrutiny. Within the current climate, as providers we need to consider the appropriate indications for IVCF use based on current evidence-based guidelines; continue to advise our patients that although some IVCFs can develop problems, not all are problematic and may be appropriate in certain situations; better differentiate permanent and retrievable IVCF needs; and when using a retrievable IVCF design, to actively plan removal as soon as possible once therapeutic anticoagulation can be used. Long-term complications of inferior vena cava filtersJournal of Vascular Surgery: Venous and Lymphatic DisordersVol. 5Issue 1PreviewSome inferior vena cava filter (IVCF) complications only manifest after prolonged dwell time (IVCF fracture, inferior vena cava [IVC] occlusion, and IVC perforation). Incidence of these complications is often based on mathematical projections given the lack of long-term imaging follow-up. The aim of this study was to assess the incidence of long-term complications of IVCFs using ideal imaging, contrast-enhanced computed tomography (CT). Full-Text PDF