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Inferior vena cava filters in the United States: Less is more
International Journal of Cardiology 177 (2014) 742–743
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Editorial
Inferior vena cava filters in the United States: Less is more☆ Mohamad Alkhouli ⁎, Riyaz Bashir Division of Cardiovascular Medicine, Temple University School of Medicine, Philadelphia, PA, United States
a r t i c l e
i n f o
Article history: Received 25 May 2014 Accepted 2 August 2014 Available online 8 August 2014 Keywords: Inferior vena cava filter Deep venous thrombosis Practice disparity Filter retrieval
a b s t r a c t Despite the widespread use of Inferior vena cava (IVC) filters, there is no quality evidence to demonstrate their efficacy for routine use, nor there is a consensus on their appropriate indications among major medical societies. The introduction of retrievable filters led to further increase in the utilization of these devices. However, several studies have shown that retrievable filters are rarely retrieved. The implant rates of IVC filters are many folds higher in the United States than in Europe, yet the retrieval rates are much lower. The U.S. Food and Drug Administration has recently issued a safety alert advocating for consideration of filter retrieval when the protection offered by the filter is no longer needed. The controversies surrounding IVC filter placement and retrieval, however, will likely to continue in the absence of good evidence on their efficacy and side effects. Time has come for initiatives to conduct well designed trials based on agreed-upon criteria to settle this debate. © 2014 Elsevier Ireland Ltd. All rights reserved.
Letter: The U.S. Food and Drug Administration (FDA) recently issued a safety communication regarding the management of retrievable Inferior vena cava (IVC) filters [1]. The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed. This communication updated a prior medical device alert in (August, 2010) that acknowledged the rapid increasing use of IVC filters and the growing number of reported adverse events. The purpose of IVC filters is to decrease recurrent pulmonary embolism (PE) or PE-related mortality. However, only one randomizedcontrolled trial evaluated the efficacy of IVC filters in achieving this goal [2]. In this trial, IVC filters decreased the rates of recurrent PE with no effect on short- or long-term mortality, but were associated with significantly higher rates of recurrent deep venous thrombosis (DVT). Observational studies on IVC filter efficacy yielded mixed results [3]. Despite the limited data supporting the use of IVC filters, the utilization rates of these devices in the United States are increasing [4]. In recent years, the implant rates of IVC filters ranged from 12% to 17% in all patients with venous thromboembolism (VTE) but exceeded 40% in patients who are at a high risk of bleeding [4–6]. Interestingly, these rates
☆ Disclosures: None. ⁎ Corresponding author at: 3041 N. Broad Street, Suite 945, Parkinson Pavilion, Philadelphia, PA 19140, United States. Tel.: +1 215 630 3137; fax: +1 215 707 3946. E-mail address: [email protected] (M. Alkhouli).
http://dx.doi.org/10.1016/j.ijcard.2014.08.010 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
are 25 times higher than implant rates in Europe [3,7], raising concerns about the potential overutilization of IVC filters in the U.S. There are conflicting recommendations with regard to the appropriate indications of IVC filter placement [3,4]. In general, the accepted indications for IVC filter placement are the ‘therapeutic’ indications. These include: proximal DVT or PE and contraindication to anticoagulation, failure of anticoagulation, massive PE, and severe cardiopulmonary disease with DVT. ‘Prophylactic’ indications for IVC filter placement such as prevention of PE in patients undergoing high-risk (spine or bariatric) surgery and trauma victims without established VTE remain controversial. However, in contemporary practice, more than half of IVC filters are placed for ‘prophylactic’ indications [8]. In a population-based study, a panel of experts in thrombosis evaluated 203 IVC filter placement for VTE in Worcester and agreed on an appropriate indication for the filter use only in 51% of cases [6]. Additionally, there is no agreed upon definition of what is considered a ‘contraindication’ to anticoagulation, and many patients who receive IVC filter because of ‘contraindication’ to anticoagulation are indeed anticoagulated. In the RIETE registry, the majority (60%) of patients who received IVC filter because of relative or absolute contraindication to anticoagulation were in fact treated with anticoagulation, posing a question about their true contraindications to anticoagulation [7]. Placement of IVC filters is associated with significant short and longterm complications. These include: device migration or embolization, filter penetration, filter fracture, IVC perforation, and IVC thrombosis [3,9]. Many of these complications are related to filter remaining in the body beyond the time when the risk of pulmonary embolism (PE) has subsided [1,9]. For example, the rates of ‘late’ filter-related thrombosis range between 8 and 30% [3,9]. In 2001, retrievable filters became
Editorial
available in the U.S., and were thought to be the awaited solution that will eliminate long-term complications associated with permanent filters. Unfortunately, many studies have shown that these ‘retrievable’ filters are rarely retrieved [10,11]. Again, significant disparity in practice between US and Europe is noted. The highest reported IVC filter retrieval rate in the US is 34%, compared with 81% in the United Kingdom [11,12]. Although some filters are not retrieved due to technical issues (trapped thrombus, tilting), the most common reason for not retrieving a retrievable filter is the loss to follow up [11]. Initiatives to improve retrieval rates in the US, by implementing filter clinics and tracking systems were promising, but have not gained popularity due to their cost and tedious nature [11]. In summary: The widespread use and the low retrieval rates of IVC filters in the United States are concerning. Physicians taking care of patients with established VTE or at higher risk for VTE are faced with weak evidence, lack of consensus recommendations, two FDA safety warnings and a notable increase of IVC filter use in their communities. The stage appears to be set for well-designed randomized clinical trials to settle the controversies surrounding the use and misuse of IVC filters. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References [1] U.S. Food and Drug Administration. Inferior vena cava (IVC) filters: initial communication: risk of adverse events with long-term use. http://www.fda.gov/Safety/ MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707. htm.
743
[2] PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation 2005; 112(3):416. [3] Wang SL, Lloyd AJ. Clinical review: inferior vena cava filters in the age of patientcentered outcomes. Ann Med 2013;45(7):474–81. [4] Stein PD, Matta F, Hull RD. Increasing use of vena cava filters for prevention of pulmonary embolism. Am J Med 2011;124(7):655–61. [5] Lashner MA, Zack CJ, Zhao H, Choi E, Wheatley G, Bashir R. Contemporary national trends and outcomes of inferior vena cava filter placement in high bleeding risk patients with proximal deep vein thrombosis. J Am Coll Cardiol 2014;63(12_S). [6] Spencer FA, Bates SM, Goldberg RJ, et al. A population-based study of inferior vena cava filters in patients with acute venous thromboembolism. Arch Intern Med 2010;170(16):1456–62 [13]. [7] Muriel A, Jiménez D, Aujesky D, et al. Survival effects of inferior vena cava filter in patients with acute symptomatic venous thromboembolism and a significant bleeding risk. J Am Coll Cardiol 2014;63(16):1675–83. [8] Kaufman JA, Rundback JH, Kee ST, et al. Development of a research agenda for inferior vena cava filters: proceedings from a multidisciplinary research consensus panel. J Vasc Interv Radiol 2009;20(6):697–707. [9] Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: a prospective, observational cohort study. Chest 2010;137(4):877–82. [10] Dabbagh O, Nagam N, Chitima-Matsiga R, et al. Retrievable inferior vena cava filters are not getting retrieved: where is the gap? Thromb Res 2010;126:493–7. [11] Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol 2011;22(no. 11) 1522.e3–1530.e3. [12] Uberoi R, Tapping CR, Chalmers N, Allgar V. British Society of Interventional Radiology (BSIR) Inferior Vena Cava (IVC) filter registry. Cardiovasc Intervent Radiol 2013; 36(6):1548–61.
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Editorial
Inferior vena cava filters in the United States: Less is more☆ Mohamad Alkhouli ⁎, Riyaz Bashir Division of Cardiovascular Medicine, Temple University School of Medicine, Philadelphia, PA, United States
a r t i c l e
i n f o
Article history: Received 25 May 2014 Accepted 2 August 2014 Available online 8 August 2014 Keywords: Inferior vena cava filter Deep venous thrombosis Practice disparity Filter retrieval
a b s t r a c t Despite the widespread use of Inferior vena cava (IVC) filters, there is no quality evidence to demonstrate their efficacy for routine use, nor there is a consensus on their appropriate indications among major medical societies. The introduction of retrievable filters led to further increase in the utilization of these devices. However, several studies have shown that retrievable filters are rarely retrieved. The implant rates of IVC filters are many folds higher in the United States than in Europe, yet the retrieval rates are much lower. The U.S. Food and Drug Administration has recently issued a safety alert advocating for consideration of filter retrieval when the protection offered by the filter is no longer needed. The controversies surrounding IVC filter placement and retrieval, however, will likely to continue in the absence of good evidence on their efficacy and side effects. Time has come for initiatives to conduct well designed trials based on agreed-upon criteria to settle this debate. © 2014 Elsevier Ireland Ltd. All rights reserved.
Letter: The U.S. Food and Drug Administration (FDA) recently issued a safety communication regarding the management of retrievable Inferior vena cava (IVC) filters [1]. The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed. This communication updated a prior medical device alert in (August, 2010) that acknowledged the rapid increasing use of IVC filters and the growing number of reported adverse events. The purpose of IVC filters is to decrease recurrent pulmonary embolism (PE) or PE-related mortality. However, only one randomizedcontrolled trial evaluated the efficacy of IVC filters in achieving this goal [2]. In this trial, IVC filters decreased the rates of recurrent PE with no effect on short- or long-term mortality, but were associated with significantly higher rates of recurrent deep venous thrombosis (DVT). Observational studies on IVC filter efficacy yielded mixed results [3]. Despite the limited data supporting the use of IVC filters, the utilization rates of these devices in the United States are increasing [4]. In recent years, the implant rates of IVC filters ranged from 12% to 17% in all patients with venous thromboembolism (VTE) but exceeded 40% in patients who are at a high risk of bleeding [4–6]. Interestingly, these rates
☆ Disclosures: None. ⁎ Corresponding author at: 3041 N. Broad Street, Suite 945, Parkinson Pavilion, Philadelphia, PA 19140, United States. Tel.: +1 215 630 3137; fax: +1 215 707 3946. E-mail address: [email protected] (M. Alkhouli).
http://dx.doi.org/10.1016/j.ijcard.2014.08.010 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
are 25 times higher than implant rates in Europe [3,7], raising concerns about the potential overutilization of IVC filters in the U.S. There are conflicting recommendations with regard to the appropriate indications of IVC filter placement [3,4]. In general, the accepted indications for IVC filter placement are the ‘therapeutic’ indications. These include: proximal DVT or PE and contraindication to anticoagulation, failure of anticoagulation, massive PE, and severe cardiopulmonary disease with DVT. ‘Prophylactic’ indications for IVC filter placement such as prevention of PE in patients undergoing high-risk (spine or bariatric) surgery and trauma victims without established VTE remain controversial. However, in contemporary practice, more than half of IVC filters are placed for ‘prophylactic’ indications [8]. In a population-based study, a panel of experts in thrombosis evaluated 203 IVC filter placement for VTE in Worcester and agreed on an appropriate indication for the filter use only in 51% of cases [6]. Additionally, there is no agreed upon definition of what is considered a ‘contraindication’ to anticoagulation, and many patients who receive IVC filter because of ‘contraindication’ to anticoagulation are indeed anticoagulated. In the RIETE registry, the majority (60%) of patients who received IVC filter because of relative or absolute contraindication to anticoagulation were in fact treated with anticoagulation, posing a question about their true contraindications to anticoagulation [7]. Placement of IVC filters is associated with significant short and longterm complications. These include: device migration or embolization, filter penetration, filter fracture, IVC perforation, and IVC thrombosis [3,9]. Many of these complications are related to filter remaining in the body beyond the time when the risk of pulmonary embolism (PE) has subsided [1,9]. For example, the rates of ‘late’ filter-related thrombosis range between 8 and 30% [3,9]. In 2001, retrievable filters became
Editorial
available in the U.S., and were thought to be the awaited solution that will eliminate long-term complications associated with permanent filters. Unfortunately, many studies have shown that these ‘retrievable’ filters are rarely retrieved [10,11]. Again, significant disparity in practice between US and Europe is noted. The highest reported IVC filter retrieval rate in the US is 34%, compared with 81% in the United Kingdom [11,12]. Although some filters are not retrieved due to technical issues (trapped thrombus, tilting), the most common reason for not retrieving a retrievable filter is the loss to follow up [11]. Initiatives to improve retrieval rates in the US, by implementing filter clinics and tracking systems were promising, but have not gained popularity due to their cost and tedious nature [11]. In summary: The widespread use and the low retrieval rates of IVC filters in the United States are concerning. Physicians taking care of patients with established VTE or at higher risk for VTE are faced with weak evidence, lack of consensus recommendations, two FDA safety warnings and a notable increase of IVC filter use in their communities. The stage appears to be set for well-designed randomized clinical trials to settle the controversies surrounding the use and misuse of IVC filters. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References [1] U.S. Food and Drug Administration. Inferior vena cava (IVC) filters: initial communication: risk of adverse events with long-term use. http://www.fda.gov/Safety/ MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707. htm.
743
[2] PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation 2005; 112(3):416. [3] Wang SL, Lloyd AJ. Clinical review: inferior vena cava filters in the age of patientcentered outcomes. Ann Med 2013;45(7):474–81. [4] Stein PD, Matta F, Hull RD. Increasing use of vena cava filters for prevention of pulmonary embolism. Am J Med 2011;124(7):655–61. [5] Lashner MA, Zack CJ, Zhao H, Choi E, Wheatley G, Bashir R. Contemporary national trends and outcomes of inferior vena cava filter placement in high bleeding risk patients with proximal deep vein thrombosis. J Am Coll Cardiol 2014;63(12_S). [6] Spencer FA, Bates SM, Goldberg RJ, et al. A population-based study of inferior vena cava filters in patients with acute venous thromboembolism. Arch Intern Med 2010;170(16):1456–62 [13]. [7] Muriel A, Jiménez D, Aujesky D, et al. Survival effects of inferior vena cava filter in patients with acute symptomatic venous thromboembolism and a significant bleeding risk. J Am Coll Cardiol 2014;63(16):1675–83. [8] Kaufman JA, Rundback JH, Kee ST, et al. Development of a research agenda for inferior vena cava filters: proceedings from a multidisciplinary research consensus panel. J Vasc Interv Radiol 2009;20(6):697–707. [9] Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: a prospective, observational cohort study. Chest 2010;137(4):877–82. [10] Dabbagh O, Nagam N, Chitima-Matsiga R, et al. Retrievable inferior vena cava filters are not getting retrieved: where is the gap? Thromb Res 2010;126:493–7. [11] Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol 2011;22(no. 11) 1522.e3–1530.e3. [12] Uberoi R, Tapping CR, Chalmers N, Allgar V. British Society of Interventional Radiology (BSIR) Inferior Vena Cava (IVC) filter registry. Cardiovasc Intervent Radiol 2013; 36(6):1548–61.