- Email: [email protected]
Vena Cava Filter Practices of a Regional Vascular Surgery Society
Vena Cava Filter Practices of a Regional Vascular Surgery Society Mark L. Friedell,1 Peter R. Nelson,2 and Michael L. Cheatham,1 Orlando and Gainesville, Florida
Background: Vena cava filter (VCF) use in the United States has increased dramatically with prophylactic indications for placement and the availability of low-profile retrievable devices, which are overtaking the filter market. We surveyed the practice patterns of a large group of vascular surgeons from a regional vascular surgery society to see whether they mirrored current national trends. Methods: A 17-question online VCF survey was offered to all members of the Southern Association of Vascular Surgery. The responses were analyzed using the c2 goodness of fit tests. Results: Of the 276 members surveyed, 126 (46%) responded, with 118 (93%) indicating that they placed filters during their practice. Highly significant differences were identified with each question (at least P < 0.002). Regarding the inferior vena cava, the preferred permanent filters were the Greenfield (31%), the TrapEase (15%), the Vena Tech (5%), and a variety of retrievable devices (49%). Fifty percent of the respondents placed retrievable filters selectively; 26% always placed them; and 24% never did. Filters were placed for prophylactic indications <50% of the time by 63% of the respondents. Overall, retrievable filters (when not used as permanent filters) were removed <25% of the time by 64% of the respondents and <50% of the time by 78% of the respondents. The femoral vein was the preferred access site for 84% of the respondents. Major complications were few but included filter migration to the atrium (one), atrial perforation (one), abdominal pain requiring surgical filter removal (two), inferior vena cava thrombosis (12 vena cava thrombosis - 4 due to TrapEase filters), strut fracture with embolization to heart or lungs (three Bard retrievable filters), and severe tilting precluding percutaneous retrieval and protection from pulmonary emboli (8 filters with severe tilt - 7 of which were Bard). Of the respondents, 59% had never placed a superior vena cava filter, and 28% had placed five or fewer. Conclusions: Although VCF insertion overall appears safe, some complications are specific to biconical and certain retrievable filters. Given the low removal rate and lack of long-term experience with retrievable filters, routine use of these devices as permanent filters should be questioned. If used on a temporary basis, there should be a plan for filter removal at the time of implantation.
INTRODUCTION Over the past 3 decades, the use of vena cava filters (VCFs) in the inferior vena cava (IVC) has increased Presented in Part at the American Venous Forum, San Diego, CA, February 24, 2011. 1
Department of Surgical Education, Orlando Health, Orlando, FL.
2
Division of Vascular Surgery, University of Florida, Gainesville, FL. Correspondence to: Mark L. Friedell, MD, FACS, Department of Surgery, University of Missouri Kansas City, 2301 Holmes Street, Kansas City, MO 64108, USA; E-mail: [email protected] Ann Vasc Surg 2012; 26: 630–635 DOI: 10.1016/j.avsg.2011.11.033 Ó Annals of Vascular Surgery Inc.
630
dramatically in the United States.1e6 This is due primarily to expanded indications for filter placement, ease of percutaneous insertion with lowerprofile devices, and the advent of retrievable filters. VCFs have also been placed in the superior vena cava (SVC) but to a far lesser extent. Historically, vascular surgeons have had the most experience with filter use and the management of venous thromboembolic disease. We surveyed the practice patterns of a large group of vascular surgeons from a regional vascular surgery society as a comparison with current national trends. To our knowledge, this is only the second survey evaluating the use of VCFs, and the first since the advent of the retrievable filter.
Vol. 26, No. 5, July 2012
Fig. 1. Years in practice.
Vena cava filter practices 631
Fig. 3. Bar graph showing how often the respondents place retrievable filters selectively.
Fig. 2. SAVS preferred permanent IVC filters.
METHODS In August 2009, a VCF survey was sent to 276 members of the Southern Association of Vascular Surgery (SAVS) by e-mail and fax. This organization comprises board-certified vascular surgeons in the southern United States. Seventeen questions pertained to the use of filters in the IVC and the SVC. The permanent filter choices offered were the Greenfield (Boston-Scientific, Natick, MA), Vena Tech (B. Braun Medical Inc., Bethlehem, PA), TrapEase (Cordis Corp., New Brunswick, NJ), Simonnitinol (Bard Peripheral Vascular Inc., Tempe, AZ), Bird’s Nest (Cook Medical Inc., Bloomington, IN), OptEase (Cordis), Bard retrievable (Recovery, G2, G2X), and Cook retrievable filters (G€ unther Tulip and Celect). The retrievable filter choices were those listed above as permanent options. The responses were analyzed using c2 goodness of fit tests.
RESULTS One hundred twenty-six of the 276 members (46%) responded, with 117 (93%) indicating VCF placement as part of their practice. Highly significant differences were identified with each question (at least P < 0.002). All respondents were in practice for at least 5 years, with 88% of them in practice
Fig. 4. SAVS preferred retrievable IVC filters.
for >10 years (Fig. 1). Regarding the IVC, the preferred permanent filters were the Greenfield (31%), the TrapEase (15%), the Vena Tech (5%), and a variety of retrievable devices (49%) (Fig. 2). Fifty percent of the respondents placed retrievable filters selectively; 26% always placed them; and 24% never did. Of those who placed them selectively, 51% did so <25% of the time, and 23.5% placed them >75% of the time (Fig. 3). The preferred retrievable filters were the Bard (45%), the Cook Celect (23%), the OptEase (17%), and the Cook G€ unther Tulip (15%) (Fig. 4). Despite the fact that 52% and 46% of the respondents placed VCF in trauma and bariatric patients, respectively, filters were placed for prophylactic indications <50% of the time by 63% of the respondents (Fig. 5). Retrievable filters were chosen 76% and 69% of the time in trauma and bariatric patients, respectively. However, retrievable filters (when not used as permanent filters) were removed <25% of the time by 64% and <50% of time by 78% of the respondents (Fig. 6). Regarding the access site, the femoral vein was preferred by 88 (84%) and the jugular vein by 17 (16%) respondents. IVC filters were either placed
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Fig. 5. Bar graph showing the percentage of filters placed for prophylactic indications.
Fig. 6. Bar graph showing how often the respondents remove retrievable filters.
in the operating room or the angiography suite and rarely at the bedside. Only 17 of the 107 respondents (16%) reported major complications over the years from placement of IVC filters. These included caval thrombosis (12), extreme tilt or angulation making it impossible for the filter to have protective function or be retrieved (9), strut embolization (3), surgical removal because of abdominal pain (2), migration to the atrium (1), and atrial perforation (1) (Table I). There was limited experience with SVC filters. Fifty-nine percent of the respondents had never placed one; 28% had placed 5; and 8% had placed >15 filters. No complications were reported, and only 9% of the respondents had ever retrieved a filter. The preferred filter in this location was the Greenfield (42%), followed by the G€ unther Tulip (14%).
Table I. Major filter complications in SAVS survey
DISCUSSION The intraluminal interruption of the IVC was first described in the late 1960s with the use of the Mobin-Uddin umbrella inserted via a cutdown through the right internal jugular vein.7 Its Achilles heel was a high rate of vena cava thrombosis. In 1973, the Greenfield filter became available for clinical use. A conical shape allowed blood to pass freely through its struts, minimizing the likelihood of caval occlusion.7 Percutaneous insertion began in 1984, but the 24-F sheath required prolonged venous compression for hemostasis after the procedure, leading to a high incidence of insertion site thrombosis.8 A titanium model allowed the carrier system to shrink to 12F in 1989, making percutaneous insertion in the jugular and common femoral veins much simpler and less morbid.7,9,10 Eventually, even smaller delivery systems were developed for
Complication
n
Inferior vena cava thrombosis Variety of filters TrapEase Severe tilt Bard filters TrapEase Strut embolization Bard filters Surgical removal from inferior vena cava Filter migration to heart Atrial perforation
12 8 4 9 8 1 3 2 1 1
the Bird’s Nest, the Simon nitinol, and the Vena Tech filters, but their caval occlusion rates were higher than those for the Greenfield filter.11 Percutaneous insertion with 12-F devices and the excellent long-term track record of the Greenfield filter, with a 5% rate of IVC occlusion and a 5% rate of recurrent pulmonary emboli (PEs), led to the use of VCF for ‘‘prophylactic’’ as well as absolute or relative indications.12e15 Subsequently, retrievable filtersdthe OptEase, the Cook G€ unther Tulip, and the Bard Recoverydwith 6-F delivery systems came on the US market in 2003, leading to an even greater use of VCFs. At present, many filters are placed prophylactically, such as in trauma patients and patients undergoing bariatric surgery.12e17 In fact, the Eastern Association for the Surgery of Trauma has published evidence-based guidelines for the prevention of venous thromboembolism (VTE), including the use of VCF in spinal cord injury, severe head trauma, complex pelvic fractures, and multiple long-bone fractures.18
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Fig. 8. 2010 US IVC filter market.
Fig. 7. IVC filter market projected change from 2006 to 2012.23
Rutherford aptly described how the percutaneous placement of lower-profile devices dramatically increased the use of VCFs.19 First, the avoidance of ‘‘open surgery’’ (cutdowns) was empirically attractive to referring physicians; second, other interventionalistsdcardiologists and radiologistsdcould now place VCFs; and third, the referring physicians and the nonvascular surgeons were interested in device placement purely to prevent the perceived threat of PEs, not in the overall management of VTE. One study showed that ‘‘antithrombotic’’ specialists recommended filters less frequently than nonspecialists, inferring that specialists understood and followed the evidencebased guidelines for the management of VTE better than the nonspecialists.20 Multidisciplinary guidelines for the use of retrievable filters, endorsed by the American Venous Forum, were published in 2006.21 There were seven key points of consensus, two of which were as follows: (1) the primary means of therapy and prophylaxis of VTE are pharmacologic, and (2) the quality of literature on optional VCF is not sufficient to support evidence-based recommendations at this time. In August 2010, the Food and Drug Administration released a medical safety device alert because of 921 adverse event reports involving retrievable filters generated since 2005. The Food and Drug Administration recommended that these filters be removed when the risk for PEs had subsided.22 The number of VCFs placed has skyrocketed in the past decade, particularly with prophylactic use and retrievable filters. It is projected that the use of retrievable filters will continue to increase (Fig. 7).23 For 2010, the Millennium Research
Group in Toronto, Ontario, reported approximately 205,000 IVC filters were placed in the United States, 70% of which were retrievable ones. The total 2010 US VCF market value was $225 million, with $170 million from retrievable filters. Total US market shares are shown in Figure 8. Note that the Greenfield filter captured only 4%. It is against this backdrop that we surveyed the membership of the SAVS for VCF practices. This is a large regional society composed solely of vascular surgeons. The majority of those surveyed place VCFs and have >10 years’ experience. Historically, vascular surgeons have had the most experience with intraluminal interruption of the IVC. Surgical residents learn about venous thromboembolic disease and its management throughout their training, and vascular fellows and surgeons deal with it daily. Therefore, it was believed that a survey of vascular surgeons would be most insightful in terms of appropriate VCF use. The only other known VCF survey was sent to US ‘‘trauma surgeons’’ in 1997, before the advent of retrievable filters.24 The most interesting result of that survey was the fact that if, hypothetically, the filter could potentially be removed, the surgeons would have statistically significantly increased the use of filters prophylactically for almost every relative indication for a filterd a harbinger of things to come. The reasons given for the use of the Greenfield filter by the SAVS respondents were that it has an excellent long-term track record of efficacy, with very few complications. Indeed, numerous reports in the literature validate these opinions whether it is used for absolute, relative, or prophylactic indications.7,9e15 It is interesting to see that the use of the Greenfield filter in the SAVS survey is much higher than that reported for the United States in 2010, showing the contrast in permanent filter choices between the SAVS and the United States as a whole. The main reasons given for the use of retrievable filters were the low-profile delivery systems and the removal option. Retrievable filters (when not
634 Friedell et al.
used as permanent filters) and prophylactic filters were uncommonly placed by SAVS members, being used primarily in trauma and bariatric patients. The removal of retrievable filters (when not used as permanent filters) was uncommon (64% were removed <25% of the time and 78.5% were removed <50% of the time). This is in keeping with the low retrieval rates reported in the literature.4,25e29 In fact, with the infrequent removal of retrievable filters, some have called for ‘‘failsafe protocols to ensure retrieval after discharge and transfer of care.’’25,29 The most common reasons mentioned by survey respondents for the use of the jugular vein as the access site were the ease and convenience of the approach and the concern about an insertion site thrombosis in the femoral vein (9 of 17 respondents). Only 11 of the 88 respondents who used the femoral vein for access commented that they had concerns about insertion site thrombosis, and almost all of them noted that the occurrence was <2%. The ease and convenience of the femoral approach was also stressed, particularly in trauma patients with cervical collars and/or tracheostomies. This strong preference for the femoral approach reflects the diminished concern about femoral vein insertion site thrombosis as currently reported in the literature.13e15,30 The preferred hospital location for performing the procedure was evenly distributed between the operating room and the angiography suite. Bedside VCF insertion has not yet become popular with these vascular surgeons. The use of VCFs in the SVC was rare. This is in keeping with the paucity of experience reported in the literature.31 Reported major complications with VCFs (Table I) from the SAVS survey were low, but at least 50% were caused by retrievable filters, which were used as permanent filters by 26% of the respondents in the survey. The 12 reports of caval thrombosis occurred with a variety of permanent and retrievable filters, but four occurred with the biconical TrapEase filter. Indeed, IVC thrombosis rates have been reported to be higher with an opposed biconical filter design.27,32e36 The next most reported major complication was severe filter tilt in nine patients, which precluded appropriate PE protection and filter retrieval. This occurred, in all but one case, with Bard filters, mirroring the recent single-center experience that showed that Bard filters had a statistically significantly higher tilt rate when compared with other filters.36 The three strut fractures with embolization to the heart or lungs occurred exclusively with Bard filters. This has been reported previously.37,38 Perforation
Annals of Vascular Surgery
of the IVC was noted with permanent and retrievable VCFs in this survey, two of which required open surgical removal because of abdominal pain. Symptomatic perforation requiring filter removal has been previously described, and two of the more recent reports involved retrievable filter use exclusively, of which two were Bard filters.39,40 Surprisingly, there was only one reported filter migration to the heartdwith a G€ unther Tulip filterdand only one procedural atrial perforation in this extensive experience. In summary, unlike the long-term excellent safety profile of the Greenfield filter, significant complications specific to biconical and certain retrievable filters have been noted in this survey and in the literature.
CONCLUSION This is the only survey on VCF use since the advent of the retrievable filter in 2003. It reflects the results of experienced vascular surgeons who appear to be more conservative in their use of VCFs than other specialty groups, as demonstrated by the fact that permanent filter use is higher and retrievable and prophylactic filter use is lower than in the country as a whole. The uncommon use of prophylactic and retrievable filters by the SAVS members might suggest that vascular surgeons may place fewer filters altogether. This practice pattern may reflect a better understanding of the management of VTE and VCF use, although a high level of comfort with the Greenfield filter and a lack of familiarity with filter retrieval might also play a role with these more senior surgeons. Overall, VCFs appear to be safe, but certain complications, both from the survey and a review of the literature, appear to be specific to biconical and certain retrievable filters. Given the low removal rate of retrievable filtersdboth in the SAVS experience and in the literaturedand the lack of long-term experience with their use, routine insertion of these devices as permanent filters should be questioned. If used as temporary devices, there should be a clearly defined plan for patient follow-up and filter removal at the time of implantation. REFERENCES 1. Athanasoulis C, Kaufman J, Halpern E, et al. Inferior vena caval filters: review of a 26-year single-center clinical experience. Radiology 2000;216:54e66. 2. Stein P, Kayali F, Olson R. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med 2004;164: 1541e5.
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3. Shackford S, Cook A, Rogers F, et al. The increasing use of vena cava filters in adult trauma victims: data from the American College of Surgeons national trauma data bank. J Trauma 2007;63:764e9. 4. Yunus T, Tariq N, Callahan R, et al. Changes in inferior vena cava filter placement over the past decade at a large community-based academic health center. J Vasc Surg 2008;47:157e65. 5. Hammond C, Bakshi D, Currie R, et al. Audit of the use of IVC filters in the UK: experience from three centres over 12 years. Clin Radiol 2009;64:502e10. 6. Moore P, Andrews J, Craven T, et al. Trends in vena caval interruption. J Vasc Surg 2010;52:118e26. 7. Greenfield L. Evolution of venous interruption for pulmonary thromboembolism. Arch Surg 1992;127:622e6. 8. Kantor A, Glanz S, Gordon D, Sclafani S. Percutaneous insertion of the Kimray-Greenfield filter: incidence of femoral vein thrombosis. Am J Roentgenol 1987;149:1065e6. 9. Greenfield L, Proctor M, Cho K, et al. Extended evaluation of the titanium Greenfield vena caval filter. J Vasc Surg 1994;20:458e65. 10. Greenfield L, Proctor M. Twenty-year clinical experience with the Greenfield filter. Cardiovasc Surg 1995;3:199e205. 11. Ferris E, McCowan T, Carver D, McFarland D. Percutaneous inferior vena caval filters: follow-up of seven designs in 320 patients. Radiology 1993;188:851e6. 12. Patton J, Fabian T, Croce M, et al. Prophylactic Greenfield filters: acute complications and long-term follow-up. J Trauma 1996;41:231e7. 13. Rogers F, Strindberg G, Shackford S, et al. Five-year followup of prophylactic vena cava filters in high-risk trauma patients. Arch Surg 1998;133:406e11. 14. Langan E, Miller R, Casey W, et al. Prophylactic inferior vena cava filters in trauma patients at high risk: follow-up examination and risk/benefit assessment. J Vasc Surg 1999;30: 484e90. 15. Phelan H, Gonzalez R, Scott W, et al. Long-term follow-up of trauma patients with permanent prophylactic vena cava filters. J Trauma 2009;67:485e9. 16. Piano G, Ketteler E, Prachand V, et al. Safety, feasibility, and outcome of retrievable vena cava filters in high-risk surgical patients. J Vasc Surg 2007;45:784e8. 17. Trigilio-Black C, Ringley C, McBride C, et al. Inferior vena cava filter placement for pulmonary embolism risk reduction in super morbidly obese undergoing bariatric surgery. Surg Obes Relat Dis 2007;3:461e4. 18. Rogers F, Cipolle M, Velmahos G, et al. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma 2002;53:142e64. 19. Rutherford R. Prophylactic indications for vena cava filters: critical appraisal. Semin Vasc Surg 2005;18:158e65. 20. Marmor D, Merli G, Whellan D, et al. Relationship of inferior vena cava filter usage in post-surgical patients by various surgical and medical subspecialists. Am J Cardiol 2008;102:226e30. 21. Kaufman J, Kinney T, Streiff M, et al. Guidelines for the use of retrievable and convertible vena cava filters: report from
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22. 23. 24.
25.
26. 27.
28.
29.
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31.
32. 33.
34.
35.
36.
37.
38.
39.
40.
the Society of Interventional Radiology Multidisciplinary Consensus Conference. J Vasc Interv Radiol 2006;17:449e59. Removing retrievable inferior vena cava filters: initial communication, 2010. Available at: www.fda.gov. Smouse B, Johar A. Is market growth of vena cava filters justified? Endovasc Today 2010;9:74e7. Quirke T, Ritota P, Swan K. Inferior vena caval filter use in U.S. trauma centers: a practitioner survey. J Trauma 1997;43:333e7. Antevil J, Sise M, Sack D, et al. Retrievable vena cava filters for preventing pulmonary embolism in trauma patients: a cautionary tale. J Trauma 2006;60:35e40. Gaspard S, Gaspard D. Retrievable inferior vena cava filters are rarely removed. Am Surg 2009;75:426e8. Helling T, Kaswan S, Miller S, Tretter J. Practice patterns in the use of retrievable inferior vena cava filters in a trauma population: a single-center experience. J Trauma 2009;67: 1293e6. Johnson O, Gillespie D, Aidinian G, et al. The use of retrievable inferior vena cava filters in severely injured military trauma patients. J Vasc Surg 2009;49:410e6. Karmy-Jones R, Jurkovich G, et al. Practice patterns and outcomes of retrievable vena cava filters in trauma patients: an AAST multicenter study. J Trauma 2007;62:17e25. Rosenthal D, Wellons E, Lai K, et al. Retrievable inferior vena cava filters: initial clinical results. Ann Vasc Surg 2006;20:157e65. Usoh F, Hingorani A, Ascher E, et al. Long-term follow-up for superior vena cava filter placement. Ann Vasc Surg 2008;23:350e4. Corriere M, Suave K, Ayerdi J, et al. Vena cava filters and inferior vena cava thrombosis. J Vasc Surg 2007;45:789e94. Harlal A, Ojha M, Johnston K. Vena cava filter performance based on hemodynamics and reported thrombosis and pulmonary embolism patterns. J Vasc Interv Radiol 2007;18:103e15. Proctor M, Greenfield L. Form and function of vena cava filters: how do optional filters measure up? Vascular 2008;16:10e6. Usoh F, Hingorani A, Ascher E, et al. Prospective randomized study comparing the clinical outcomes between inferior vena cava Greenfield and TrapEase filters. J Vasc Surg 2010;52:394e9. Nazzal M, Chan E, Nazzal M, et al. Complications related to inferior vena cava filters: a single-center experience. Ann Vasc Surg 2010;24:480e6. Hull J, Han J, Giessel G. Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle. J Vasc Interv Radiol 2008;19:1107e11. Nazzal M, Abbas J, Shattu J, Nazzal M. Complications secondary to the Bard retrievable filter: a case report. Ann Vasc Surg 2008;22:684e7. Parkin E, Serracino-Inglott F, Chalmers N, Smyth V. Symptomatic perforation of a retrievable inferior vena cava after a dwell time of 5 years. J Vasc Surg 2009;50:417e9. Arabi M, Willatt J, Shields J, et al. Retrievability of optional inferior vena cava filters with caudal migration and caval penetration: report of three cases. J Vasc Interv Radiol 2010;21:923e6.
Background: Vena cava filter (VCF) use in the United States has increased dramatically with prophylactic indications for placement and the availability of low-profile retrievable devices, which are overtaking the filter market. We surveyed the practice patterns of a large group of vascular surgeons from a regional vascular surgery society to see whether they mirrored current national trends. Methods: A 17-question online VCF survey was offered to all members of the Southern Association of Vascular Surgery. The responses were analyzed using the c2 goodness of fit tests. Results: Of the 276 members surveyed, 126 (46%) responded, with 118 (93%) indicating that they placed filters during their practice. Highly significant differences were identified with each question (at least P < 0.002). Regarding the inferior vena cava, the preferred permanent filters were the Greenfield (31%), the TrapEase (15%), the Vena Tech (5%), and a variety of retrievable devices (49%). Fifty percent of the respondents placed retrievable filters selectively; 26% always placed them; and 24% never did. Filters were placed for prophylactic indications <50% of the time by 63% of the respondents. Overall, retrievable filters (when not used as permanent filters) were removed <25% of the time by 64% of the respondents and <50% of the time by 78% of the respondents. The femoral vein was the preferred access site for 84% of the respondents. Major complications were few but included filter migration to the atrium (one), atrial perforation (one), abdominal pain requiring surgical filter removal (two), inferior vena cava thrombosis (12 vena cava thrombosis - 4 due to TrapEase filters), strut fracture with embolization to heart or lungs (three Bard retrievable filters), and severe tilting precluding percutaneous retrieval and protection from pulmonary emboli (8 filters with severe tilt - 7 of which were Bard). Of the respondents, 59% had never placed a superior vena cava filter, and 28% had placed five or fewer. Conclusions: Although VCF insertion overall appears safe, some complications are specific to biconical and certain retrievable filters. Given the low removal rate and lack of long-term experience with retrievable filters, routine use of these devices as permanent filters should be questioned. If used on a temporary basis, there should be a plan for filter removal at the time of implantation.
INTRODUCTION Over the past 3 decades, the use of vena cava filters (VCFs) in the inferior vena cava (IVC) has increased Presented in Part at the American Venous Forum, San Diego, CA, February 24, 2011. 1
Department of Surgical Education, Orlando Health, Orlando, FL.
2
Division of Vascular Surgery, University of Florida, Gainesville, FL. Correspondence to: Mark L. Friedell, MD, FACS, Department of Surgery, University of Missouri Kansas City, 2301 Holmes Street, Kansas City, MO 64108, USA; E-mail: [email protected] Ann Vasc Surg 2012; 26: 630–635 DOI: 10.1016/j.avsg.2011.11.033 Ó Annals of Vascular Surgery Inc.
630
dramatically in the United States.1e6 This is due primarily to expanded indications for filter placement, ease of percutaneous insertion with lowerprofile devices, and the advent of retrievable filters. VCFs have also been placed in the superior vena cava (SVC) but to a far lesser extent. Historically, vascular surgeons have had the most experience with filter use and the management of venous thromboembolic disease. We surveyed the practice patterns of a large group of vascular surgeons from a regional vascular surgery society as a comparison with current national trends. To our knowledge, this is only the second survey evaluating the use of VCFs, and the first since the advent of the retrievable filter.
Vol. 26, No. 5, July 2012
Fig. 1. Years in practice.
Vena cava filter practices 631
Fig. 3. Bar graph showing how often the respondents place retrievable filters selectively.
Fig. 2. SAVS preferred permanent IVC filters.
METHODS In August 2009, a VCF survey was sent to 276 members of the Southern Association of Vascular Surgery (SAVS) by e-mail and fax. This organization comprises board-certified vascular surgeons in the southern United States. Seventeen questions pertained to the use of filters in the IVC and the SVC. The permanent filter choices offered were the Greenfield (Boston-Scientific, Natick, MA), Vena Tech (B. Braun Medical Inc., Bethlehem, PA), TrapEase (Cordis Corp., New Brunswick, NJ), Simonnitinol (Bard Peripheral Vascular Inc., Tempe, AZ), Bird’s Nest (Cook Medical Inc., Bloomington, IN), OptEase (Cordis), Bard retrievable (Recovery, G2, G2X), and Cook retrievable filters (G€ unther Tulip and Celect). The retrievable filter choices were those listed above as permanent options. The responses were analyzed using c2 goodness of fit tests.
RESULTS One hundred twenty-six of the 276 members (46%) responded, with 117 (93%) indicating VCF placement as part of their practice. Highly significant differences were identified with each question (at least P < 0.002). All respondents were in practice for at least 5 years, with 88% of them in practice
Fig. 4. SAVS preferred retrievable IVC filters.
for >10 years (Fig. 1). Regarding the IVC, the preferred permanent filters were the Greenfield (31%), the TrapEase (15%), the Vena Tech (5%), and a variety of retrievable devices (49%) (Fig. 2). Fifty percent of the respondents placed retrievable filters selectively; 26% always placed them; and 24% never did. Of those who placed them selectively, 51% did so <25% of the time, and 23.5% placed them >75% of the time (Fig. 3). The preferred retrievable filters were the Bard (45%), the Cook Celect (23%), the OptEase (17%), and the Cook G€ unther Tulip (15%) (Fig. 4). Despite the fact that 52% and 46% of the respondents placed VCF in trauma and bariatric patients, respectively, filters were placed for prophylactic indications <50% of the time by 63% of the respondents (Fig. 5). Retrievable filters were chosen 76% and 69% of the time in trauma and bariatric patients, respectively. However, retrievable filters (when not used as permanent filters) were removed <25% of the time by 64% and <50% of time by 78% of the respondents (Fig. 6). Regarding the access site, the femoral vein was preferred by 88 (84%) and the jugular vein by 17 (16%) respondents. IVC filters were either placed
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Fig. 5. Bar graph showing the percentage of filters placed for prophylactic indications.
Fig. 6. Bar graph showing how often the respondents remove retrievable filters.
in the operating room or the angiography suite and rarely at the bedside. Only 17 of the 107 respondents (16%) reported major complications over the years from placement of IVC filters. These included caval thrombosis (12), extreme tilt or angulation making it impossible for the filter to have protective function or be retrieved (9), strut embolization (3), surgical removal because of abdominal pain (2), migration to the atrium (1), and atrial perforation (1) (Table I). There was limited experience with SVC filters. Fifty-nine percent of the respondents had never placed one; 28% had placed 5; and 8% had placed >15 filters. No complications were reported, and only 9% of the respondents had ever retrieved a filter. The preferred filter in this location was the Greenfield (42%), followed by the G€ unther Tulip (14%).
Table I. Major filter complications in SAVS survey
DISCUSSION The intraluminal interruption of the IVC was first described in the late 1960s with the use of the Mobin-Uddin umbrella inserted via a cutdown through the right internal jugular vein.7 Its Achilles heel was a high rate of vena cava thrombosis. In 1973, the Greenfield filter became available for clinical use. A conical shape allowed blood to pass freely through its struts, minimizing the likelihood of caval occlusion.7 Percutaneous insertion began in 1984, but the 24-F sheath required prolonged venous compression for hemostasis after the procedure, leading to a high incidence of insertion site thrombosis.8 A titanium model allowed the carrier system to shrink to 12F in 1989, making percutaneous insertion in the jugular and common femoral veins much simpler and less morbid.7,9,10 Eventually, even smaller delivery systems were developed for
Complication
n
Inferior vena cava thrombosis Variety of filters TrapEase Severe tilt Bard filters TrapEase Strut embolization Bard filters Surgical removal from inferior vena cava Filter migration to heart Atrial perforation
12 8 4 9 8 1 3 2 1 1
the Bird’s Nest, the Simon nitinol, and the Vena Tech filters, but their caval occlusion rates were higher than those for the Greenfield filter.11 Percutaneous insertion with 12-F devices and the excellent long-term track record of the Greenfield filter, with a 5% rate of IVC occlusion and a 5% rate of recurrent pulmonary emboli (PEs), led to the use of VCF for ‘‘prophylactic’’ as well as absolute or relative indications.12e15 Subsequently, retrievable filtersdthe OptEase, the Cook G€ unther Tulip, and the Bard Recoverydwith 6-F delivery systems came on the US market in 2003, leading to an even greater use of VCFs. At present, many filters are placed prophylactically, such as in trauma patients and patients undergoing bariatric surgery.12e17 In fact, the Eastern Association for the Surgery of Trauma has published evidence-based guidelines for the prevention of venous thromboembolism (VTE), including the use of VCF in spinal cord injury, severe head trauma, complex pelvic fractures, and multiple long-bone fractures.18
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Vena cava filter practices 633
Fig. 8. 2010 US IVC filter market.
Fig. 7. IVC filter market projected change from 2006 to 2012.23
Rutherford aptly described how the percutaneous placement of lower-profile devices dramatically increased the use of VCFs.19 First, the avoidance of ‘‘open surgery’’ (cutdowns) was empirically attractive to referring physicians; second, other interventionalistsdcardiologists and radiologistsdcould now place VCFs; and third, the referring physicians and the nonvascular surgeons were interested in device placement purely to prevent the perceived threat of PEs, not in the overall management of VTE. One study showed that ‘‘antithrombotic’’ specialists recommended filters less frequently than nonspecialists, inferring that specialists understood and followed the evidencebased guidelines for the management of VTE better than the nonspecialists.20 Multidisciplinary guidelines for the use of retrievable filters, endorsed by the American Venous Forum, were published in 2006.21 There were seven key points of consensus, two of which were as follows: (1) the primary means of therapy and prophylaxis of VTE are pharmacologic, and (2) the quality of literature on optional VCF is not sufficient to support evidence-based recommendations at this time. In August 2010, the Food and Drug Administration released a medical safety device alert because of 921 adverse event reports involving retrievable filters generated since 2005. The Food and Drug Administration recommended that these filters be removed when the risk for PEs had subsided.22 The number of VCFs placed has skyrocketed in the past decade, particularly with prophylactic use and retrievable filters. It is projected that the use of retrievable filters will continue to increase (Fig. 7).23 For 2010, the Millennium Research
Group in Toronto, Ontario, reported approximately 205,000 IVC filters were placed in the United States, 70% of which were retrievable ones. The total 2010 US VCF market value was $225 million, with $170 million from retrievable filters. Total US market shares are shown in Figure 8. Note that the Greenfield filter captured only 4%. It is against this backdrop that we surveyed the membership of the SAVS for VCF practices. This is a large regional society composed solely of vascular surgeons. The majority of those surveyed place VCFs and have >10 years’ experience. Historically, vascular surgeons have had the most experience with intraluminal interruption of the IVC. Surgical residents learn about venous thromboembolic disease and its management throughout their training, and vascular fellows and surgeons deal with it daily. Therefore, it was believed that a survey of vascular surgeons would be most insightful in terms of appropriate VCF use. The only other known VCF survey was sent to US ‘‘trauma surgeons’’ in 1997, before the advent of retrievable filters.24 The most interesting result of that survey was the fact that if, hypothetically, the filter could potentially be removed, the surgeons would have statistically significantly increased the use of filters prophylactically for almost every relative indication for a filterd a harbinger of things to come. The reasons given for the use of the Greenfield filter by the SAVS respondents were that it has an excellent long-term track record of efficacy, with very few complications. Indeed, numerous reports in the literature validate these opinions whether it is used for absolute, relative, or prophylactic indications.7,9e15 It is interesting to see that the use of the Greenfield filter in the SAVS survey is much higher than that reported for the United States in 2010, showing the contrast in permanent filter choices between the SAVS and the United States as a whole. The main reasons given for the use of retrievable filters were the low-profile delivery systems and the removal option. Retrievable filters (when not
634 Friedell et al.
used as permanent filters) and prophylactic filters were uncommonly placed by SAVS members, being used primarily in trauma and bariatric patients. The removal of retrievable filters (when not used as permanent filters) was uncommon (64% were removed <25% of the time and 78.5% were removed <50% of the time). This is in keeping with the low retrieval rates reported in the literature.4,25e29 In fact, with the infrequent removal of retrievable filters, some have called for ‘‘failsafe protocols to ensure retrieval after discharge and transfer of care.’’25,29 The most common reasons mentioned by survey respondents for the use of the jugular vein as the access site were the ease and convenience of the approach and the concern about an insertion site thrombosis in the femoral vein (9 of 17 respondents). Only 11 of the 88 respondents who used the femoral vein for access commented that they had concerns about insertion site thrombosis, and almost all of them noted that the occurrence was <2%. The ease and convenience of the femoral approach was also stressed, particularly in trauma patients with cervical collars and/or tracheostomies. This strong preference for the femoral approach reflects the diminished concern about femoral vein insertion site thrombosis as currently reported in the literature.13e15,30 The preferred hospital location for performing the procedure was evenly distributed between the operating room and the angiography suite. Bedside VCF insertion has not yet become popular with these vascular surgeons. The use of VCFs in the SVC was rare. This is in keeping with the paucity of experience reported in the literature.31 Reported major complications with VCFs (Table I) from the SAVS survey were low, but at least 50% were caused by retrievable filters, which were used as permanent filters by 26% of the respondents in the survey. The 12 reports of caval thrombosis occurred with a variety of permanent and retrievable filters, but four occurred with the biconical TrapEase filter. Indeed, IVC thrombosis rates have been reported to be higher with an opposed biconical filter design.27,32e36 The next most reported major complication was severe filter tilt in nine patients, which precluded appropriate PE protection and filter retrieval. This occurred, in all but one case, with Bard filters, mirroring the recent single-center experience that showed that Bard filters had a statistically significantly higher tilt rate when compared with other filters.36 The three strut fractures with embolization to the heart or lungs occurred exclusively with Bard filters. This has been reported previously.37,38 Perforation
Annals of Vascular Surgery
of the IVC was noted with permanent and retrievable VCFs in this survey, two of which required open surgical removal because of abdominal pain. Symptomatic perforation requiring filter removal has been previously described, and two of the more recent reports involved retrievable filter use exclusively, of which two were Bard filters.39,40 Surprisingly, there was only one reported filter migration to the heartdwith a G€ unther Tulip filterdand only one procedural atrial perforation in this extensive experience. In summary, unlike the long-term excellent safety profile of the Greenfield filter, significant complications specific to biconical and certain retrievable filters have been noted in this survey and in the literature.
CONCLUSION This is the only survey on VCF use since the advent of the retrievable filter in 2003. It reflects the results of experienced vascular surgeons who appear to be more conservative in their use of VCFs than other specialty groups, as demonstrated by the fact that permanent filter use is higher and retrievable and prophylactic filter use is lower than in the country as a whole. The uncommon use of prophylactic and retrievable filters by the SAVS members might suggest that vascular surgeons may place fewer filters altogether. This practice pattern may reflect a better understanding of the management of VTE and VCF use, although a high level of comfort with the Greenfield filter and a lack of familiarity with filter retrieval might also play a role with these more senior surgeons. Overall, VCFs appear to be safe, but certain complications, both from the survey and a review of the literature, appear to be specific to biconical and certain retrievable filters. Given the low removal rate of retrievable filtersdboth in the SAVS experience and in the literaturedand the lack of long-term experience with their use, routine insertion of these devices as permanent filters should be questioned. If used as temporary devices, there should be a clearly defined plan for patient follow-up and filter removal at the time of implantation. REFERENCES 1. Athanasoulis C, Kaufman J, Halpern E, et al. Inferior vena caval filters: review of a 26-year single-center clinical experience. Radiology 2000;216:54e66. 2. Stein P, Kayali F, Olson R. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med 2004;164: 1541e5.
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3. Shackford S, Cook A, Rogers F, et al. The increasing use of vena cava filters in adult trauma victims: data from the American College of Surgeons national trauma data bank. J Trauma 2007;63:764e9. 4. Yunus T, Tariq N, Callahan R, et al. Changes in inferior vena cava filter placement over the past decade at a large community-based academic health center. J Vasc Surg 2008;47:157e65. 5. Hammond C, Bakshi D, Currie R, et al. Audit of the use of IVC filters in the UK: experience from three centres over 12 years. Clin Radiol 2009;64:502e10. 6. Moore P, Andrews J, Craven T, et al. Trends in vena caval interruption. J Vasc Surg 2010;52:118e26. 7. Greenfield L. Evolution of venous interruption for pulmonary thromboembolism. Arch Surg 1992;127:622e6. 8. Kantor A, Glanz S, Gordon D, Sclafani S. Percutaneous insertion of the Kimray-Greenfield filter: incidence of femoral vein thrombosis. Am J Roentgenol 1987;149:1065e6. 9. Greenfield L, Proctor M, Cho K, et al. Extended evaluation of the titanium Greenfield vena caval filter. J Vasc Surg 1994;20:458e65. 10. Greenfield L, Proctor M. Twenty-year clinical experience with the Greenfield filter. Cardiovasc Surg 1995;3:199e205. 11. Ferris E, McCowan T, Carver D, McFarland D. Percutaneous inferior vena caval filters: follow-up of seven designs in 320 patients. Radiology 1993;188:851e6. 12. Patton J, Fabian T, Croce M, et al. Prophylactic Greenfield filters: acute complications and long-term follow-up. J Trauma 1996;41:231e7. 13. Rogers F, Strindberg G, Shackford S, et al. Five-year followup of prophylactic vena cava filters in high-risk trauma patients. Arch Surg 1998;133:406e11. 14. Langan E, Miller R, Casey W, et al. Prophylactic inferior vena cava filters in trauma patients at high risk: follow-up examination and risk/benefit assessment. J Vasc Surg 1999;30: 484e90. 15. Phelan H, Gonzalez R, Scott W, et al. Long-term follow-up of trauma patients with permanent prophylactic vena cava filters. J Trauma 2009;67:485e9. 16. Piano G, Ketteler E, Prachand V, et al. Safety, feasibility, and outcome of retrievable vena cava filters in high-risk surgical patients. J Vasc Surg 2007;45:784e8. 17. Trigilio-Black C, Ringley C, McBride C, et al. Inferior vena cava filter placement for pulmonary embolism risk reduction in super morbidly obese undergoing bariatric surgery. Surg Obes Relat Dis 2007;3:461e4. 18. Rogers F, Cipolle M, Velmahos G, et al. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma 2002;53:142e64. 19. Rutherford R. Prophylactic indications for vena cava filters: critical appraisal. Semin Vasc Surg 2005;18:158e65. 20. Marmor D, Merli G, Whellan D, et al. Relationship of inferior vena cava filter usage in post-surgical patients by various surgical and medical subspecialists. Am J Cardiol 2008;102:226e30. 21. Kaufman J, Kinney T, Streiff M, et al. Guidelines for the use of retrievable and convertible vena cava filters: report from
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