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

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

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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

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Vena Cava Filters: Does “Temporary” Lead to Overuse?

Robert K. Kerlan Jr., M.D. Professor of Clinical Radiology and Surgery University of California, San Francisco UCSF Vascular Symposium 2014 Hotel Nikko

Disclosure

  • Research support:

– Bayer Pharmaceuticals – WL Gore – I have nothing relevant to disclose with regard to IVC filters

Presentation Title: Vena Cava Filters:Does “Temporary” Lead to Overuse? Presenter: Robert K. Kerlan Jr., MD Presenter’s Title: Professor of Clinical Radiology and Surgery

Questions

  • 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?

Number of Filters Inserted is Increasing

Hammond CJ, BakshinDR, Currie RJ, et al. Clinical Radiol 2009;64:502,

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Number of Filters Inserted is Increasing

Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541

Number of Filters Inserted is Increasing

Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541

Number of Filters Inserted is Increasing

Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541

Number of Filters Inserted is Increasing

  • Summary Medicare Claims Date 1999 to 2008
  • In 2008, with 65,041 IVC filters placed, only and

estimated 801 to 3,339 (1.2 % to 5.1%) were removed

Duszak R, Parker L, Levin DC, Rao VM: JACR 2011;8:483-489,

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%

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Number of Filters Inserted is Increasing

  • Filter placement has increased linearly with PE detection by CT
  • Filter placement has increased 7-fold from 2003 to 2006

compared to 1985-2003 (p<0.0001) in patients without DVT or PE (the so-called prophylactic indication)

  • Approximately 224,700 IVC filters were projected to be

deployed in 2012, with over half the indications being “prophylactic”

DusStein PD, Mata F, Hull RD Am J Med 2011;124:655 Kaufman JA et al. JVIR 2009;20:697

Number of Filters Inserted is Increasing

  • Population

United States 309,000,000 Europe’s “Big 5” 313,000,000

  • Estimate for 2012 IVC filter placements:

United States 224,700 Europe Big 5 combined 9,070

Wang SL, Lloyd AJ Annals of Med 2013;45:474-481

Questions

  • 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?

Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli?
  • 3. Do filters improve patient outcomes?
  • 4. Do filters cause adverse outcomes?
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Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli?
  • 3. Do filters improve patient outcomes?
  • 4. Do filters cause adverse outcomes?

Do Filters Prevent Pulmonary Emboli? Level 1 Evidence

  • Fullen WD, Miller EH, Steele WF, McDonough

JJ: Prophylactic vena caval interruption in hip

  • fractures. Journal of Trauma 1973;13:403-410
  • Decousus H, Leizzorovicz A, Parent F, et al.: A

clinical trial of vena caval filters in the prevention

  • f pulmonary embolism in patients with proximal

deep vein thrombosis. NEJM 1998;338:409-415 First Randomized Controlled Trial

  • 100 patients with hip or proximal femoral fractures
  • Randomization to filter or no filter
  • No anticoagulation in either arm
  • Mobin-Udin Filter
  • Diagnosis of PE by VQ scan, pulmonary angio, or

plain CXR

Fullen WD et al. J Trauma 1973;13:403

Filter No Filter PE 4/41 (10%) 19/59 (32%) Death from PE 0/41 (0%) 8/59 (7%)

Second Randomized Controlled Trial: PREPIC

  • 400 anti-coagulated patients with proximal DVT

– 200 received a filter – 200 did not receive a filter

Decousus H et al. NEJM 1998;338:409

Follow-up Filter No filter p PE @12 days 2 (1.1%) 9 (4.5%) 0.03 PE @ 2 years 6 (3.4%) 12 (6.3%) 0.16 PE @ 8 years 9 (6.2%) 24 (15.1%) 0.008

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Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli? YES
  • 3. Do filters improve patient outcomes?
  • 4. Do filters cause adverse outcomes?

Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli? YES
  • 3. Do filters improve patient outcomes?
  • 1. Do filters cause adverse outcomes?

Patient Outcomes: Mortality in DVT

  • Mortality
  • PREPIC study group: Circulation 2005;112:416-422
  • Decousas H et al.: N Engl J Med 1998;338:409-415

Follow-up Filter No filter p 2 years 43 (21.6%) 40 (20.1%) 0.65 8 years 98 (48.1%) 103 (51.0%) 0.83

Patient Outcomes: Mortality in Patients with Massive PE

  • Mortality at 90 days

– Registry data from 108 patients with massive PE – 11 filter patients / 97 non-filter patients – P=0.006

– Kucher N et al. Circulation 2006;113:577-582

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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

Stein PD et al. Amer J Med 2012;125:478

Patient Outcomes: In Hospital Mortality in Patients with PE

– In all 4 groups, the mortality rate was significantly lower in patients who had an IVC filter placed (p<.0001)

– Stein PD et al. Amer J Med 2012;125:478

Patient Outcomes: Phlebothrombosis

Follow-up Filter No filter p 2-years 37 (20.8%) 21 (11.6%) 0.02 8-years 57 (35.7%) 41 (27.5%) 0.042

  • Phlebothrombosis

PREPIC study group: Circulation 2005;112:416-422 Decousas H et al.: N Engl J Med 1998;338:409-415

Patient Outcomes: Post-Thrombotic Syndrome

  • Post-thrombotic syndrome

– Edema – Varicose veins – Trophic disorders – Ulcers

  • PREPIC study group: Circulation 2005;112:416-422
  • Decousas H et al.: N Engl J Med 1998;338:409-415

Follow-up Filter No filter p 2-years

  • 8-years

109 (70.3%) 107 (69.7%) 0.30

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Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli? YES
  • 3. Do filters improve patient outcomes? YES
  • 1. Do filters cause adverse outcomes?

Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli? YES
  • 3. Do filters improve patient outcomes? YES
  • 1. Do filters cause adverse outcomes?

Filters: Adverse Outcomes

  • Confounding variables

– Permanent versus temporary – Different types of devices

  • Major events

– IVC thrombosis – Migration – Perforation – Fracture

IVC Thrombosis

  • Often radiographic, but may be associated with

disabling post-phlebitic syndrome

Filter Sales (2009) Maude Literature Tulip (Cook) 29,000 3 0% (n=554) Celect (Cook) 31,000 2 0% (n=95) Recovery (Bard) discontinued 2 G2 (Bard) 52,000 15 0% (n=100) Trapease (Cordis) 22,000 32 Optease (Cordis) 16,000 11 0% (n=27) Greenfield (Boston Sci) 18,000 3 Option (Angiotech) 9% (n=100)

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Migration

  • Device dependent
  • Caudal migration more common & clinically benign
  • Cranial migration rare but potentially lethal

Filter Sales (2009) Maude Literature Tulip (Cook) 29,000 19 No data Celect (Cook) 31,000 7 0% (n=100) Recovery (Bard) discontinued 126 G2 (Bard) 52,000 124 12% (n=100) Trapease (Cordis) 22,000 33 Optease (Cordis) 16,000 20 0% (n=27) Greenfield (Boston Sci) 18,000 23 Option (Angiotech) 2% (n=100)

Perforation

  • Usually radiographic, but occasionally associated

with poor outcomes

Filter Sales (2009) Maude Literature Tulip (Cook) 29,000 7 0% (n=554) Celect (Cook) 31,000 32 0% (n=95) Recovery (Bard) discontinued 27 G2 (Bard) 52,000 104 26% (n=100) Trapease (Cordis) 22,000 15 Optease (Cordis) 16,000 1 0% (n=27) Greenfield (Boston Sci) 18,000 3 Option (Angiotech) 5% (n=100)

Do you remove this filter? Do you remove this filter?

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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)

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Questions

  • 1. Has the utilization of IVC filters increased since

the advent of the retrievable device? YES

  • 2. Do filters prevent pulmonary emboli? YES
  • 3. Do filters improve patient outcomes? YES
  • 1. Do filters cause adverse outcomes? YES

IVC Filters: Conclusions

  • Filters are effective in preventing PE

– Most common indication for placement is contraindication to anti-coagulation – Prophylactic insertion prior to bariatric surgery, neurosurgery, and trauma???

  • Complications can be significant
  • The main problem with removable filters is that

they are not actually removed to diminish long- term complications