10/12/2015 1 Top Four Most Important Recent Developments in Venous Disease Gregory L. Moneta, M.D. Professor and Chief, Vascular Surgery Oregon Health & Science University Knight Cardiovascular Institute Portland. Oregon, USA Considered But Rejected • Venous etiology of multiple sclerosis • Endovenous saphenous ablation • Retrievable venous filters • Foam sclerotherapy • American Board of Phlebology • Accreditation process for outpatient venous centers
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10/12/2015
1
Top Four Most Important Recent Developments in Venous Disease
Gregory L. Moneta, M.D.Professor and Chief, Vascular Surgery
Oregon Health & Science UniversityKnight Cardiovascular Institute
Portland. Oregon, USA
Considered But Rejected
• Venous etiology of multiple sclerosis
• Endovenous saphenous ablation
• Retrievable venous filters
• Foam sclerotherapy
• American Board of Phlebology
• Accreditation process for outpatient venous
centers
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Randomized Trials
Tight Glucose Control in Type II Diabetes
No Benefit!
NEJM 2009; 360: 129-139
Good Idea / No Benefit
Aspirin for Primary Prevention of Vascular
Disease
No Benefit!
Lancet 2009; 373:1849-1850
Good Idea / No Benefit
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#4 Efficacy of Thrombolytic Therapy
for Acute Iliofemoral DVT
Possible Correlates With PTS Post DVT
•Thrombus Location, Propagation,
Recurrence, and Resolution
•Reflux: Development, Location,
Severity
•Residual Obstruction
Post Thrombotic Syndrome
• Open-label, randomized, controlled trial of catheter
directed thrombolytic therapy (alteplase) in addition to
standard treatment vs. standard treatment alone in
patients 18-75 years old with first time iliofemoral DVT
• 21 days within symptom onset
• Objective confirmation of DVT
• Primary outcomes:
-PTS at 24 months assessed by Villalta score
-Iliofemoral patency at 6 months
CaVenT Study*
*Lancet 2012; 379:7-13
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CaVenT Study*
(Short and Long-Term Results)
Standard Treatment
and Catheter Directed
Thrombolysis
(n= 90)
Standard Treatment
Only
(n=99)
P value
n %
(95% CI)n %
(95%CI)
PTS @ 6
months27 30%
(22 - 41)
32 32%
(24 - 42)
0.77
Iliofemoral
patency @ 6
months
58 66%
(56 - 75)
45 47%
(38 - 57)
0.012
PTS @ 24
months37 41%
(32 - 51)
55 56%
(46- 65)
0.047
CaVenT Study*
CaVenT Study*
•No improvement in PTS at 6 months.
•Improved iliofemoral patency at 6 months.
•14% improvement in PTS at 24 months.
•Number needed to treat is 7.
•Per-protocol: 17% improvement; NNT: 6
*Lancet 2012; 379:7-13
(Short and Long-Term Results)
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(Stroke and Death at 5-years)
ICA Stenosis Medical Group Surgical Group NNT
NASCET (Symptomatic ICA stenosis)
70% - 99% 26.1% 12.9% 8
50% - 69% 22.2% 15.7% 15
60% - 99% 11% 5% 19
ACAS (Asymptomatic ICA stenosis)
Carotid Endarterectomy Trials
ATTRACT Trial
•Open-label, controlled, multicenter trial
•NIH sponsored
•692 patients with proximal DVT
•Anticipated completion 2015
•NCT00790335
Thrombolytic Therapy for Iliofemoral DVT
The Claim: Thrombolytic therapy decreases
rates of PTS following iliofemoral DVT
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#3 Proliferation of Venous Stents
More venous stents than
the entire planet!
“Venous stents can be
safely placed in the
venous system across
the inguinal crease with
no risk of stent
fractures, narrowing
due to external
compression, focal
development of severe
in-stent re-stenosis and
no effect on long term
patency.”
JVS 2008; 48:1255-1261
What we are Asked to Believe
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• “Iliac venous stenting alone is sufficient to control
symptoms in the majority of patients with combined
outflow obstruction and deep reflux” (JVS 2009)
• Venous stenting results in “major symptom relief in
patients with chronic venous disease not
consistently reflected in any substantial
hemodynamic improvement by conventional
measurement. Benefit is regardless of presence of
remaining reflux, adjunct saphenous procedures or
etiology of obstruction.”
What We Are Asked to Believe
(JVS 2007; 46:979-990)
Stenting and Healed Ulcers
70% at 2 years
Neglen et al JVS 2007; 46:979-90
Non-Operative Treatment of Venous Ulcer
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Non-Operative Treatment of Venous Ulcer
M Marsten W, et al. JVS 1999; 30:491-498
Marsten W, et al. JVS 1999; 30:491-498M
*Marsten W, et al. JVS 1999; 30:491-498
Non-Operative Treatment of Venous Ulcer
Non-Operative Treatment of Venous Ulcer
*Guest, et al. Brit J Surg 1999; 86:1437-1440
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Stenting and Healed Ulcers
70% at 2 years
Neglen et al JVS 2007; 46:979-90
Venous Stents for Treatment of Venous Ulcer
The Claim: Venous stents are all that are
needed to heal venous ulcers
#2 FDA Warning: IVC Filters
• Since 2005 there were 921 adverse event
reports:
-328 migrations
-146 embolizations of device components
-70 IVC perforations
-56 filter fractures
( Posted August 9, 2010)
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IVC Filters
• 1979: 2000 filters
• By 1990: >120,000
Greenfield filters had
been placed
• 2000: 50,000/yr
• 2009:>130,000/yr
(Increasing Utilization)
IVC Filters
• First IVC filter
• Developed in late 1960s
• Initial favorable reports
• Late reports:
-50% IVC occlusion rate
-High rate of PE
-Migration
(Mobin Uddin Filter)
IVC Filters
• 469 patients
• 146 long-term follow-up (mean 43 months)
• 190 lost to follow-up
• 133 died (33%)
• 4% PE rate (17 fatal, 9 nonfatal)
• 4% IVC occlusion
• 44% with post thrombotic syndrome
(Kimray-Greenfield Filter: 1988 report*)
*Surgery 1988; 104: 706-712
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IVC Filters
• Served as evidence for efficacy of IVC filters
• Likely would not be sufficient evidence by
modern standards:
-Half the patients lost by either death or LTFU
-No control group
-No follow-up imaging
(Kimray-Greenfield Filter: 1988 report*)
*Surgery 1988; 104: 706-712
IVC Filters
• U.S. Food and Drug Administration (FDA) approval
process for vena cava filters:
- all filters approved through the 510 (k) process for