4/3/2014 Disclosure Vena Cava Filters: Research support: Bayer - PowerPoint PPT Presentation

4/3/2014 Disclosure Vena Cava Filters: • Research support: – Bayer Pharmaceuticals Does “Temporary” Lead to Overuse? – WL Gore – I have nothing relevant to disclose with regard to IVC Robert K. Kerlan Jr., M.D. Professor of Clinical Radiology and Surgery filters University of California, San Francisco Presentation Title: Vena Cava Filters:Does “Temporary” Lead to Overuse? UCSF Vascular Symposium 2014 Presenter: Robert K. Kerlan Jr., MD Hotel Nikko Presenter’s Title: Professor of Clinical Radiology and Surgery Questions Number of Filters Inserted is Increasing 1. Has the utilization of IVC filters increased since the advent of the retrievable device? 2. Do filters prevent pulmonary emboli? 3. Do filters improve patient outcomes? 4. Do filters cause adverse outcomes? Hammond CJ, BakshinDR, Currie RJ, et al. Clinical Radiol 2009;64:502, 1

4/3/2014 Number of Filters Inserted is Increasing Number of Filters Inserted is Increasing Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541 Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541 Number of Filters Inserted is Increasing Number of Filters Inserted is Increasing • Summary Medicare Claims Date 1999 to 2008 1999 2008 % Increase IR 16,531 36,829 +122.8% Surgery 11,295 22,606 +100.1% Cardiology 2,286 7,524 +313.3% TOTAL 30,756 65,041 +111.5% • In 2008, with 65,041 IVC filters placed, only and estimated 801 to 3,339 (1.2 % to 5.1%) were removed Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541 Duszak R, Parker L, Levin DC, Rao VM: JACR 2011;8:483-489, 2

4/3/2014 Number of Filters Inserted is Increasing Number of Filters Inserted is Increasing • Filter placement has increased linearly with PE detection by CT • Population • Filter placement has increased 7-fold from 2003 to 2006 United States 309,000,000 compared to 1985-2003 (p<0.0001) in patients without DVT or Europe’s “Big 5” 313,000,000 PE (the so-called prophylactic indication) • Estimate for 2012 IVC filter placements: • Approximately 224,700 IVC filters were projected to be deployed in 2012, with over half the indications being United States 224,700 “prophylactic” Europe Big 5 combined 9,070 DusStein PD, Mata F, Hull RD Am J Med 2011;124:655 Wang SL, Lloyd AJ Annals of Med 2013;45:474-481 Kaufman JA et al. JVIR 2009;20:697 Questions Questions 1. Has the utilization of IVC filters increased since 1. Has the utilization of IVC filters increased since the advent of the retrievable device? the advent of the retrievable device? YES 2. Do filters prevent pulmonary emboli? 2. Do filters prevent pulmonary emboli? 3. Do filters improve patient outcomes? 3. Do filters improve patient outcomes? 4. Do filters cause adverse outcomes? 4. Do filters cause adverse outcomes? 3

4/3/2014 Questions Do Filters Prevent Pulmonary Emboli? 1. Has the utilization of IVC filters increased since Level 1 Evidence the advent of the retrievable device? YES • Fullen WD, Miller EH, Steele WF, McDonough 2. Do filters prevent pulmonary emboli? JJ: Prophylactic vena caval interruption in hip fractures. Journal of Trauma 1973;13:403-410 3. Do filters improve patient outcomes? • Decousus H, Leizzorovicz A, Parent F, et al.: A clinical trial of vena caval filters in the prevention 4. Do filters cause adverse outcomes? of pulmonary embolism in patients with proximal deep vein thrombosis. NEJM 1998;338:409-415 First Randomized Controlled Trial Second Randomized Controlled Trial: PREPIC • 100 patients with hip or proximal femoral fractures • 400 anti-coagulated patients with proximal DVT • Randomization to filter or no filter – 200 received a filter • No anticoagulation in either arm – 200 did not receive a filter • Mobin-Udin Filter • Diagnosis of PE by VQ scan, pulmonary angio, or plain CXR Filter No Filter Follow-up Filter No filter p PE 4/41 (10%) 19/59 (32%) PE @12 days 2 (1.1%) 9 (4.5%) 0.03 Death from PE 0/41 (0%) 8/59 (7%) PE @ 2 years 6 (3.4%) 12 (6.3%) 0.16 PE @ 8 years 9 (6.2%) 24 (15.1%) 0.008 Fullen WD et al. J Trauma 1973;13:403 Decousus H et al. NEJM 1998;338:409 4

4/3/2014 Questions Questions 1. Has the utilization of IVC filters increased since 1. Has the utilization of IVC filters increased since the advent of the retrievable device? YES the advent of the retrievable device? YES 2. Do filters prevent pulmonary emboli? YES 2. Do filters prevent pulmonary emboli? YES 3. Do filters improve patient outcomes? 3. Do filters improve patient outcomes? 4. Do filters cause adverse outcomes? 1. Do filters cause adverse outcomes? Patient Outcomes: Mortality in DVT Patient Outcomes: Mortality in Patients with Massive PE • Mortality • Mortality at 90 days Follow-up Filter No filter p – Registry data from 108 patients with massive PE 2 years 43 (21.6%) 40 (20.1%) 0.65 – 11 filter patients / 97 non-filter patients 8 years 98 (48.1%) 103 (51.0%) 0.83 – P=0.006 Kucher N et al. Circulation 2006;113:577-582 – PREPIC study group: Circulation 2005;112:416-422 • Decousas H et al.: N Engl J Med 1998;338:409-415 • 5

4/3/2014 Patient Outcomes: In Hospital Mortality in Patients with PE Patient Outcomes: In Hospital Mortality in Patients with PE • AHRQ Nationwide Inpatient Sample Healthcare Cost and Utilization Project 1999 to 2008 (ICD-9-CM based) • 2,110,320 discharges • Number of deaths analyzed in patients with discharge diagnosis of PE with and without IVC filter – In all 4 groups, the mortality rate was significantly lower in Stein PD et al. Amer J Med 2012;125:478 patients who had an IVC filter placed (p<.0001) – Stein PD et al. Amer J Med 2012;125:478 Patient Outcomes: Post-Thrombotic Syndrome Patient Outcomes: Phlebothrombosis •Phlebothrombosis • Post-thrombotic syndrome Follow-up Filter No filter p – Edema 2-years 37 (20.8%) 21 (11.6%) 0.02 – Varicose veins 8-years 57 (35.7%) 41 (27.5%) 0.042 – Trophic disorders – Ulcers Follow-up Filter No filter p 2-years --- --- --- 8-years 109 (70.3%) 107 (69.7%) 0.30 PREPIC study group: Circulation 2005;112:416-422 PREPIC study group: Circulation 2005;112:416-422 • Decousas H et al.: N Engl J Med 1998;338:409-415 Decousas H et al.: N Engl J Med 1998;338:409-415 • 6

4/3/2014 Questions Questions 1. Has the utilization of IVC filters increased since 1. Has the utilization of IVC filters increased since the advent of the retrievable device? YES the advent of the retrievable device? YES 2. Do filters prevent pulmonary emboli? YES 2. Do filters prevent pulmonary emboli? YES 3. Do filters improve patient outcomes? YES 3. Do filters improve patient outcomes? YES 1. Do filters cause adverse outcomes? 1. Do filters cause adverse outcomes? Filters: Adverse Outcomes IVC Thrombosis • Confounding variables • Often radiographic, but may be associated with disabling post-phlebitic syndrome – Permanent versus temporary – Different types of devices Filter Sales (2009) Maude Literature • Major events Tulip (Cook) 29,000 3 0% (n=554) Celect (Cook) 31,000 2 0% (n=95) – IVC thrombosis Recovery (Bard) discontinued 2 – Migration G2 (Bard) 52,000 15 0% (n=100) – Perforation Trapease (Cordis) 22,000 32 – Fracture Optease (Cordis) 16,000 11 0% (n=27) Greenfield (Boston Sci) 18,000 3 Option (Angiotech) 9% (n=100) 7

4/3/2014 Migration Perforation • Device dependent • Usually radiographic, but occasionally associated • Caudal migration more common & clinically benign with poor outcomes • Cranial migration rare but potentially lethal Filter Sales (2009) Maude Literature Filter Sales (2009) Maude Literature Tulip (Cook) 29,000 19 No data Tulip (Cook) 29,000 7 0% (n=554) Celect (Cook) 31,000 7 0% (n=100) Celect (Cook) 31,000 32 0% (n=95) Recovery (Bard) discontinued 126 Recovery (Bard) discontinued 27 G2 (Bard) 52,000 124 12% (n=100) G2 (Bard) 52,000 104 26% (n=100) Trapease (Cordis) 22,000 33 Trapease (Cordis) 22,000 15 Optease (Cordis) 16,000 20 0% (n=27) Optease (Cordis) 16,000 1 0% (n=27) Greenfield (Boston Sci) 18,000 23 Greenfield (Boston Sci) 18,000 3 Option (Angiotech) 2% (n=100) Option (Angiotech) 5% (n=100) Do you remove this filter? Do you remove this filter? 8

4/3/2014 Sure! How about this one??? Sure! Fracture • A problem with nitinol • Potentially serious and can lead to embolization Filter Sales (2009) Maude Literature Tulip (Cook) 29,000 3 0% (n=554) Celect (Cook) 31,000 4 0% (n=95) Recovery (Bard) discontinued 103 G2 (Bard) 52,000 58 1% (n=100) Trapease (Cordis) 22,000 27 Optease (Cordis) 16,000 17 0% (n=27) Greenfield (Boston Sci) 18,000 4 Option (Angiotech) 0% (n=100) 9

4/3/2014 Questions IVC Filters: Conclusions 1. Has the utilization of IVC filters increased since • Filters are effective in preventing PE the advent of the retrievable device? YES – Most common indication for placement is contraindication to anti-coagulation – Prophylactic insertion prior to bariatric surgery, 2. Do filters prevent pulmonary emboli? YES neurosurgery, and trauma??? 3. Do filters improve patient outcomes? YES • Complications can be significant 1. Do filters cause adverse outcomes? YES • The main problem with removable filters is that they are not actually removed to diminish long- term complications 10