Filter - Thrombosis and Hemostasis Societies of North America

Thrombosis & Hemostasis Summit of North America
2016Apr16
IVC Filters
Bill Geerts, MD, FRCPC
Thromboembolism Consultant, Sunnybrook HSC
Professor of Medicine, University of Toronto
National Lead, VTE Prevention, Can. Pat. Safety Institute
Executive, Thrombosis Canada
Disclosures
Financial disclosures
None
Off-label use of drugs
No
Outline
§  Epidemiology of IVCF use
§  Indications
§  Evidence from clinical trials
§  Complications
§  Suggestions and summary
Types of IVC Filters
1. Permanent
VENATECH
2. Temporary
A. Retrievable (optional)
B. Tethered
IVC Filters Approved in USA in 2016
Type
Filter name
Company
Permanent
Bird’s Nest
Cook
Greenfield
Boston Scientific
Simon Nitinol
Bard
TrapEase
Cordis
VenaTech
Braun
Retrievable
(Optional)
IVC Filters Approved in USA in 2016
Type
Filter name
Company
Permanent
Bird’s Nest
Cook
Greenfield
Boston Scientific
Simon Nitinol
Bard
TrapEase
Cordis
VenaTech
Braun
ALN
ALN
Celect
Cook
Crux
Volcano
Denali
Bard
Gunther Tulip
Cook
OptEase
Cordis
OptionElite
Argon
Retrievable
(Optional)
IVC Filter Placement in USA
300,000
259,000
250,000
200,000
167,000
150,000
78,000
100,000
49,000
50,000
0
2,000
1979
1999
2002
2007
2012
Stein – Arch Intern Med 2004;164:1541; Smouse – Endovasc
Today 2010;74; Kuy – J Vasc Surg: Ven Lymph 2014:2:15
IVC Filters in Acute VTE Rx
§ 
§ 
263 California hospitals, 2006-2011
130,643 patients with acute VTE
§ 
IVCF in 15% of VTE patients (0-39%)
White – JAMA Intern Med 2013;173(7):506
Cultural
differences
in IVC Filter
use
IVC Filters Inserted in 2012
Population
in 2012
IVCF
placed
Germany, France, 316,600,000
UK, Italy, Spain
9,070
USA
313,000,000
225,000
25 times more
Lee – Cardiovasc Intervent Radiol 2015;38:1502
Regional Variation in IVCF Use
RatesofIVCFuse/1,000PEpa<ents
1999(92à217)
2010(113à222)
NewEnglandonlyregionwithdecrease
.
Bikdeli – J Am Coll Cardiol 2016;67(9):1027
Dramatic Increase in IVCF Rates
§  Expanded (off-label) indications
§  Ease of insertion
§  More experienced filter inserters
§  Removable filters – “must be safer”
§  Defensive medicine
§  ?Financial incentives
Dramatic Increase in IVCF Rates
§  Expanded (off-label) indications
§  Ease of insertion
§  More experienced filter inserters
§  Removable filters – “must be safer”
§  Defensive medicine
§  ?Financial incentives
NOT:
§  ↑ evidence of benefit
§  ↑ evidence of safety
Outline
§  Epidemiology of IVCF use
§  Indications
§  Evidence from clinical trials
§  Complications
§  Suggestions and summary
What is the purpose of an IVCF?
What is the purpose of an IVCF?
1.  To prevent PE
2.  To prevent fatal PE
3.  To prevent fatal and life-threatening PE
4.  To prevent fatal and life-threatening PE
without causing greater harm than benefit
What is the purpose of an IVCF?
1.  To prevent PE
2.  To prevent fatal PE
3.  To prevent fatal and life-threatening PE
4.  To prevent fatal and life-threatening PE
without causing greater harm than benefit
5.  To prevent fatal and life-threatening PE
without causing greater harm than benefit
and at a cost that is worth it
Patients with VTE:
1. Anticoagulation contraindicated
2. In addition to anticoagulation
IVC
filters
“Therapeutic indications”
Primary prophylaxis (no VTE):
1. Trauma
2. Bariatric surgery, orthopedic surgery
“Prophylactic indications”
FDA Approved Indications for IVCF
1.  Pulmonary thromboembolism when
anticoagulant therapy is contraindicated
2.  Failure of anticoagulant therapy in
thromboembolic diseases
3.  Emergency treatment following massive
PE when anticipated benefits of
conventional therapy are reduced
4.  Chronic recurrent PE when anticoagulant
therapy has failed or is contraindicated
Streiff – Thromb Res 2010;125:S128
Outline
§  Epidemiology of IVCF use
§  Indications
§  Evidence from clinical trials
§  Complications
§  Suggestions and summary
Smoke
Spark
(N=2)
Flame
(?)
1st RCT of IVC Filter Use = PREPIC
IVC Filter* for Treated Proximal DVT
§  Patients at “high risk” for PE; anticoagulated >3 mos
Outcomes Day 12
PE
Death
*4 different permanent filters
No filter
(n=200)
Filter
(n=200)
P
9 (4.8%)
5 (2.5%)
2 (1.0%)
5 (2.5%)
0.03
1.0
Decousus – NEJM 1998;338:409
IVC Filter for Treated Proximal DVT
Outcomes at
Day 12
No filter
(n=200)
Filter
(n=200)
P
All PE
9 (4.8%)
2 (1.0%)
0.03
Asympt PE
4
0
Sympt PE
5
2
“Fatal PE”*
4
0
0.25
*autopsy in only 1
Decousus – NEJM 1998;338:409
IVC Filter for Proximal DVT
§  Patients at “high risk” for PE; anticoagulated >3 mos
Outcomes
Day 12
All PE
Symptomatic PE
Death
2 years
Symptomatic PE
Recurrent DVT
Death
No filter
(n=200)
Filter
(n=200)
P
9 (4.8%)
5 (2.5%)
5 (2.5%)
2 (1.0%)
2 (1.0%)
5 (2.5%)
0.03
0.25
1.0
12 (6.3%)
21 (12%)
40 (20%)
6 (3.4%)
37 (21%)
43 (22%)
0.16
0.02
0.65
Decousus – NEJM 1998;338:409
JAMA 2015;313(16):1627
2nd RCT of IVC Filter Use = PREPIC-2
Retrievable IVCF in PE (PREPIC-2)
§  RCT at 18 centers in France; N=399
Patients with unprovoked
PE + DVT/SVT +
•  Age >75
•  RV dysfunction
•  Active cancer
•  Bilateral or iliocaval DVT
•  Cardiorespiratory failure
Anticoagulation
3 mos
Anticoagulation + ALN IVCF
Mismetti – JAMA 2015:313(16):1627
Retrievable IVCF in PE (PREPIC-2)
§  RCT at 18 centers in France; N=399
Patients with unprovoked
PE + DVT/SVT + >1
additional risk factor(s)
Outcomes @ 3
mos
Anticoagulation
3 mos
Anticoagulation + ALN IVCF
Anticoagulation
(n=199)
Anticoagulation
+ IVCF (n=200)*
P
3 (1.5%)
6 (3%)
0.5
Fatal PE
2
6
DVT
1
1
1.04
6.0%
7.5%
0.55
Recurrent PE
Death
*21% of filters not removed
Mismetti – JAMA 2015:313(16):1627
2016;4(1):127
2016;4:127
§  No Class I evidence to support prophylactic
IVCF placement in any patient group
SIR/SVS/Industry/FDA IVC Filter
Study (PRESERVE)
Objectives:
1.  Document current IVCF practice
2.  Evaluate safety and effectiveness
Design: prospective, national cohort study
with long-term follow-up in ~60 sites
Study population: ~2,100 patients (7 filters x
>300 patients each), all indications
SIR/SVS/Industry/FDA IVC Filter
Study (PRESERVE)
venogram or
IVUS
abd film
venogram
IVCF
insertion discharge retrieval 1 mo
IVCF not removed
venogram or 3 mos 6 mos
(phone)
IVUS
abd film
1 year
CT scan
18 mos
(phone)
2 years
CT scan
FDA Approved Indications for IVCF
evidence
1.  Pulmonary thromboembolism when
no
anticoagulant therapy is contraindicated
2.  Failure of anticoagulant therapy in
no
thromboembolic diseases
3.  Emergency treatment following massive
PE when anticipated benefits of
no
conventional therapy are reduced
4.  Chronic recurrent PE when anticoagulant
therapy has failed or is contraindicated no
What is the purpose of an IVCF?
1.  To prevent PE
Probably vs nothing
2.  To prevent fatal PE
No evidence
3.  To prevent fatal and life-threatening
PE
No evidence
No evidence;
4.  To prevent fatal and life-threatening
PE without causing greater harm than estimates show
complic>benefit
benefit
5.  To prevent fatal and life-threatening
PE without causing greater harm than
benefit and at a cost that is worth it
No evidence
(There never
will be)
Outline
§  Epidemiology of IVCF use
§  Indications
§  Evidence from clinical trials
§  Complications
§  Suggestions and summary
IVC-Related Complications
§  Procedure-related
Access site bleeding 2-4%
Contrast nephropathy 1%
Access site thrombosis
Misplacement 1-5%
Acute embolization
§  Short-term
Delayed anticoagulation
Filter migration
Filter thrombosis 5-40%
PE 0-1%
§  Long-term
Inability to remove (5-20%)
↑ DVT
Fracture & embolization
Perforation (aorta, RPH, etc)
IVC thrombosis
IVC stenosis
Related to long-term anticoagulation
Major complications: 3-5% (minimum)
Complications of Retrievable IVCFs
§  Systematic review of 37 studies; N=6,834
§  Mean follow-up only 9.9 mos
Complication
Filters
Frequency
DVT
1,277
5.4%
Filter migration
2,716
1.3%
IVC thrombosis or
stenosis
Unable to remove
4,078
2.8%
1,815
5.5%
Not removed
5,043
66%
Angel – JVIR 2011;1522
JVIR 2014;25(8):1181
§  FDA MAUDE (Manufacturer and User Device Experience)
§  2009-13: 1,606 reported AEs
Complications of IVC Filters
§  FDA MAUDE (Manufacturer and User Device Experience)
Complications
All
No. of AEs Perm IVCFs Retrievable IVCFs
1,606
13%
Fracture
350
5%
Placement issue
318
31%
IVC penetration
228
6%
Migration >2 cm
215
21%
Tilt
197
2%
Limb embolization
154
3%
IVC thrombosis
41
20%
VTE/PE
30
27%
<
<
<
<
<
<
<
<
<
p
87%
<0.0001
95%
<0.0001
69%
<0.0001
94%
<0.0001
79%
<0.0001
98%
<0.0001
97%
<0.0001
80%
<0.001
73%
<0.007
Andreoli – JVIR 2014;25:1181
Complications of Retrievable Filters
Complications
All
1,394
Fracture
334 (24%)
Placement issue
219 (16%)
IVC penetration >3 cm
214 (15%)
Tilt
194 (14%)
Migration >2 cm
169 (12%)
Limb embolization
150 (11%)
IVC thrombosis
33 (2%)
VTE/PE
22 (2%)
Duodenum28
Aorta14
Vertebra12
RPH9
Andreoli – JVIR 2014;25:1181
Strut Penetration with Celect Filters
595CelectIVCFatU.Chicago
2007-2013
Follow-upabdominalCTin193(mean
176daysaVerinser<on)
Strutpenetra<on>3mm
(range:4-9mm)
55(29%)*
*rate increased with dwell time
Bos – JVIR 2015;26(1):101
Risk of Recovery IVCF Fracture
§  Cleveland Clinic, 2003-06
§  363 Recovery filters; 73% not retrieved
Dwell time
2 yrs
4 yrs
5.5 yrs
Fracture rate
10%
20%
40%
Tam – JVIR 2012;23:199
Tricuspid valve
Caval + Aortic
thrombosis
Spinal canal
Right atrium
Aorta
Duodenum
Filter thrombosis à amputation
Filter thrombosis
Right atrium
Pericardial
tamponade
Caval
stenosis
What does the IVC
look like after a filter
is removed?
§ Major head injury
§ Prophylactic IVCF
inserted
§ Filter removed at 14
days
§ Died following day
(unrelated to filter)
Ashley – J Trauma 2005;59:847
Additional Adverse
Consequences of IVCF Placement
§  Unjustified delays in initiating
anticoagulant prophylaxis or therapy
§  Risks of long-term anticoagulation
related to presence of the filter alone
§  Potential risks during pregnancy, exercise
(or hockeyJ)
§  Huge costs
Long-Term Safety?
Outline
§  Epidemiology of IVCF use
§  Indications
§  Evidence from clinical trials
§  Complications
§  Suggestions and summary
10th ACCP Guideline
IVCF Use (Therapeutic)
17. In patients with acute DVT or PE who
are treated with anticoagulants, we
recommend AGAINST the use of an
inferior vena cava (IVC) filter [Grade 1B]
Kearon – Chest 2016;149:315
9th ACCP Conference on Antithrombotic Therapy
IVC Filter Use (Prophylactic):
§  Recommend AGAINST IVCF as
thromboprophylaxis in trauma or
spinal cord injury [Grade 2C]
Gould - Chest 2012;141(Suppl 1):e227S
All IVCFs inserted at Sunnybrook, 2006-2015
No. of IVC Filters
30
25
Notremoved
Removed
21/yr
20
15
10
60%
5
0
200620072008200920102011201220132014201520006-15
§  Mean 21/yr (None prophylactic)
§  60% removed
All IVC Filter Use/Hospital/Year
§  Consecutive patients with filters placed, North America
Author, year
Group
Time
period
Dabbagh, 2010
U. Missouri
2004-08
351
Mission, 2010
UCSF Med Center
2002-07
393
Meisner, 2012
Stony Brook UH
2007-09
244
Eifler, 2013
Northwestern U.
2008-11
399
Desai, 2014
North-Shore U.
2005-10
1,234
Duffett, 2014
U. Ottawa
2007-10
336
Inagaki, 2016
Boston Med Cntr
2003-14
1,275
7 major HSC
2002-14
Sunnybrook HSC
2006-15
Combined
No.
IVCF/
yr
IVCF
retriev
4,232
88
78
122
150
206
84
116
121
13%
12%
6%
40%
5%
42%
10%
14%
207
21
60%
IVCFs in Trauma at Sunnybrook, 2000-2015
No. of IVC Filters
10
Permanent
Op<onal
8
6
4
2
0
2000200120022003200420052006200720082009201020112012201320142015
§  Mean 4.1/yr (None prophylactic)
§  76% removed during trauma admission
IVCF Practice in Trauma, 2009-15
§  Consecutive papers reporting IVCF use in trauma, North America
Author, year
Location
Total
IVCF
IVCF/yr
Helling, 2009
Johnstown, PA
144
36
14
22%
Johnson, 2009
Walter Reed MC
91
23
6
14%
Smoot, 2010
Mayo Clinic
226
45
36
38%
Kalina, 2012
Newark, DE
307
44
NR
24%
Rogers, 2012
Lancaster, PA
NR
NR
105
20%
Sarosiek, 2013
Boston, MA
478
63
49
9%
Charlton-Ouw, 2015
UT, Houston
311
78
~60
34%
Combined
7 centers
1,557
48
45
22%
207
4
0
76%
Sunnybrook, 2000-15 Toronto
Proph
IVCF
IVCF/yr retrieved
*average/center
Single Indication for an IVC Filter
Recent PROXIMAL DVT PLUS an
absolute contraindication to full
anticoagulation
NOT Indicators for IVC Filters
1.  PE with contraindication to therapeutic
anticoagulation (if no DVT)
2.  Primary prophylaxis in trauma / major surgery
3.  Anticoagulant “failure” = a contraindication
4.  Extensive proximal DVT or VTE with poor
cardiopulmonary reserve
5.  During catheter-directed management of DVT
Considering an IVC Filter . . .
The 4 steps (+ 1)
1.  Is the indication appropriate?
2.  Only use a removable filter
3.  Start anticoagulation as soon as it’s safe –
often escalating the dose as bleeding risk ↓
4.  Remove filter after therapeutic anticoagulation
achieved – almost always same admission
+ Mandatory, regular follow-up of all nonretrieved filters
Additional Costs of IVCF in USA
Population in 2012 IVCF placed
Germany, France,
UK, Italy, Spain
USA
316,600,000
~10,000
313,000,000
>250,000
Lee – Cardiovasc Intervent Radiol 2015;38:1502
~240,000 more
filters in USA/yr vs
Europe
Additional cost*
Cost $5,000
Cost $10,000
$1.2 billion
$2.4 billion
*NOT considering costs of retrieval, complications, medical-legal
IVC Filter Use: Summary
1.  Exponential increased use past 15 years
2.  No evidence of benefit for the indications in
which they are used (and there never will be)
3.  Many filters are placed for inappropriate
indications
4.  Most retrievable filters are not removed
5.  Retrievable filters can be dangerous if not
removed promptly
6.  Enormous, unjustified costs