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

4/3/2014
Disclosure
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
Questions
• 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
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,
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Number of Filters Inserted is Increasing
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
Stein PD, Kayali F, Olson RE: Arch Intern Med 2004;164:1541
1999
2008
IR
16,531
36,829
% Increase
+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
Duszak R, Parker L, Levin DC, Rao VM: JACR 2011;8:483-489,
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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)
Number of Filters Inserted is Increasing
• Population
United States
Europe’s “Big 5”
309,000,000
313,000,000
• Estimate for 2012 IVC filter placements:
• 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
Questions
United States
Europe Big 5 combined
224,700
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?
1. Has the utilization of IVC filters increased since
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?
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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?
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
3. Do filters improve patient outcomes?
4. Do filters cause adverse outcomes?
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
• Decousus H, Leizzorovicz A, Parent F, et al.: A
clinical trial of vena caval filters in the prevention
of pulmonary embolism in patients with proximal
deep vein thrombosis. NEJM 1998;338:409-415
Second Randomized Controlled Trial: PREPIC
• 400 anti-coagulated patients with proximal DVT
– 200 received a filter
– 200 did not receive a filter
Filter
No Filter
Follow-up
PE
4/41 (10%)
19/59 (32%)
PE @12 days
2 (1.1%)
9
(4.5%)
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
Filter
No filter
p
0.03
Decousus H et al. NEJM 1998;338:409
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4/3/2014
Questions
Questions
1. Has the utilization of IVC filters increased since
the advent of the retrievable device? YES
1. Has the utilization of IVC filters increased since
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
• Mortality
Follow-up
Patient Outcomes: Mortality in Patients with Massive PE
• Mortality at 90 days
Filter
No filter
p
2 years
43 (21.6%)
40 (20.1%)
0.65
8 years
98 (48.1%)
103 (51.0%)
0.83
•
•
PREPIC study group: Circulation 2005;112:416-422
Decousas H et al.: N Engl J Med 1998;338:409-415
– 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
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
– 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
Patient Outcomes: Post-Thrombotic Syndrome
•Phlebothrombosis
• Post-thrombotic syndrome
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
–
–
–
–
Edema
Varicose veins
Trophic disorders
Ulcers
Follow-up
PREPIC study group: Circulation 2005;112:416-422
Decousas H et al.: N Engl J Med 1998;338:409-415
Filter
No filter
p
2-years
---
---
---
8-years
109 (70.3%)
107 (69.7%)
0.30
•
•
PREPIC study group: Circulation 2005;112:416-422
Decousas H et al.: N Engl J Med 1998;338:409-415
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Questions
Questions
1. Has the utilization of IVC filters increased since
the advent of the retrievable device? YES
1. Has the utilization of IVC filters increased since
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
• 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
Trapease (Cordis)
22,000
32
Optease (Cordis)
16,000
11
Greenfield (Boston Sci)
18,000
3
Option (Angiotech)
0% (n=100)
0% (n=27)
9% (n=100)
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Migration
Perforation
• Device dependent
• Caudal migration more common & clinically benign
• Cranial migration rare but potentially lethal
• Usually radiographic, but occasionally associated
with poor outcomes
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
104
Trapease (Cordis)
22,000
15
G2 (Bard)
52,000
124
Trapease (Cordis)
22,000
33
Optease (Cordis)
16,000
20
Greenfield (Boston Sci)
18,000
23
Option (Angiotech)
12% (n=100)
0% (n=27)
2% (n=100)
Do you remove this filter?
Optease (Cordis)
16,000
1
Greenfield (Boston Sci)
18,000
3
Option (Angiotech)
26% (n=100)
0% (n=27)
5% (n=100)
Do you remove this filter?
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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
Trapease (Cordis)
22,000
27
Optease (Cordis)
16,000
17
Greenfield (Boston Sci)
18,000
4
Option (Angiotech)
1% (n=100)
0% (n=27)
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
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???
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 longterm complications
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