By: Mark H. Meissner, MD Visit VeinGlobal at http://www.veinglobal.com/ for more presentations and videos on this topic, or for more information on venous disease news, education and research.

1. Disclosure
Mark Meissner, M.D.
I have no financial relationship(s) to disclose.

2. Mark H. Meissner, MD
Professor of Surgery
University of Washington School of Medicine
Seattle, WA
Outcomes of Venous
Interventions in C5-6 Disease

3. Chronic Venous Insufficiency
 5% prevalence (US) of CEAP class 4 - 6
 6 - 7 million people with skin changes
 400,000 - 500,000 people with ulcers
 90% require medical treatment
 Direct medical costs of $600 - $2000
 > $10,000 if not healed within 12 weeks
 Treatment options
 Medical
Compression
Pharmacologic adjuncts
Wound care adjuncts
 Surgical
Superficial venous surgery
Perforator interruption
Valvular reconstruction
Iliac stenting
C5
C6

4. Compression for Ulceration (C6)
Cullum et al; Cochrane Reviews 2001
Compression
(# healed)
No Compression
(# healed)
Relative Risk
(95% CI)
Charles 19/27 6/23 2.70 (1.30 - 5.60)
Eriksson 9/17 7/17 1.29 (0.62 - 2.65)
Kitka 21/30 15/39 1.82 (1.15 - 2.89)
Rubin 18/19 7/17 2.30 (1.29 - 4.10)
Sikes 17/21 15/21 1.13 (0.81 - 1.59)
Taylor 12/18 4/18 3.00 (1.19 - 7.56)
0.1 0.2 0.5 1 2 5 10

5.  Observational study of 119 patients
 34% bed rest followed by ECS
 66% ambulatory treatment with ECS
 Complete Healing
 Compliant 97%
 Noncompliant 55%
 Recurrence (5 yr life table)
 Compliant - 29%
 Noncompliant - 100%
Compression for Venous Leg Ulcers
Mayberry, Surgery 1991

6. Pentoxifylline: A Meta-Analysis
Jull et al, Lancet 2002
Author
Trental
n/N
Control
n/N
Relative Risk RR
Barbarino 4 / 6 1 / 6 4.00
Colgan 23 / 38 12 / 42 2.12
Dale 65 / 101 52 / 99 1.23
Falanga 61 / 86 28 / 45 1.14
Schurmann 2 / 12 3 / 12 0.67
Total 155 / 243 96 / 204 1.30Favors
Control
Favors
Trental
1.0

7. Surgery for C5-6 Disease
The ESCHAR Trial - Barwell JR, Lancet 2004
 Prospective randomized trial
 High ligation, stripping, phlebectomy
 Multilayer compression bandaging
 500 patients with CEAP 5 and 6 disease
 Endpoints
 24 week ulcer healing (NS)
Compression - 65%
Surgery + Compression - 65%
 12 month ulcer recurrence (p < .0001)
Compression - 28%
Surgery + Compression - 12%
Ulcer healing
Freedom from recurrence

8. IPV Interruption & Ulcer Recurrence
O’Donnell TO, J Vasc Surg 2008
 Systematic review of RCTs for venous ulceration (C6)
 Compression vs perforator surgery (2 trials)
 Compression vs superficial surgery (2 trials)
Author N
Trial
Intervention
Zamboni 47
Superficial
Surgery
ESCHAR 428
Superficial
Surgery
Van Gent 196
Perforator
Surgery
Stacey 41
Perforator
Surgery
Risk Ratio (95% CI)
0.50.20.10.050.02 1 2 5 10 20 50
Favors Surgery Favors Compression

9. The Problem of Perforator “Incompetence”
 Perforator reflux often resolves with correction of superficial
reflux
 Perforator incompetence unlikely to be the primary cause of
recurrent / residual varicosities
 Perforator interruption does not reduce recurrent ulceration
 Current studies have often taken non-specific approach
 Ability to distinguish important perforators is limited
 Unknown role for identification and interruption of critical
perforators in future
Available Evidence Suggests…
But…

10. Defining Important Perforators
Gloviczki et al, J Vasc Surg 2011
 > 3.5 mm diameter
 Outward flow > 0.5 sec
 Localized in the area of a healed or
active ulcer
Think “Pathologic”
NOT
“Incompetent”
Perforators

11. Deep Venous Valvular Reconstruction
 Populations not strictly comparable

12. Iliac Stenting for C5-6 Disease
Raju s, J Vasc Surg 2002
 304 limbs with iliac obstruction
 Etiology
 Primary (nonthrombotic) – 142 (47%)
 Postthrombotic – 162 (53%)
Outcome Pre-Stent Post-Stent
Class 5 & 6
Active Ulcer - 49
Healed Ulcer - 13
68% Healing
Recurrence - 2 (3%)
Swelling
(Grade 1 - 3)
2 (0 - 3) 1 (0 - 3)
Pain
(VAS, 0 - 10)
4 (0 - 9) 0 (0 - 9)

13. GRADE Recommendations
Guyatt et al, Chest 2006
GRADE
Benefit vs
Risk
Methodology Implication
1A Clear High quality
Strong recommendation; Precise estimate of
effect unlikely to change; Generalizeable
1B Clear Moderate
Strong recommendation; May change with
further research; Applies to most patients
1C Clear Low
Strong recommendation; Likely to change
change with better evidence
2A Balanced High quality
Weak recommendation, Action differs with
patient/societal values
2B Balanced Moderate
Weak recommendation, Action differs with
patient/societal values
2C Uncertain Low
Very weak recommendation, Alternatives
equally reasonable

14. Interventions For C5-6 Disease
Treatment Outcome Methodology Grade
Compression Ulcer healing RCT 1B
Debridement Accelerated healing Observational 1C
Pentoxyfylline Ulcer healing RCT 2B
Wound care adjuncts Ulcer healing RTC 2A/B/C
Superficial surgery Ulcer healing RTC 1A Against
Systemic antibiotics Ulcer healing RTC 1B Against
Compression Ulcer recurrence Observational 1A
Superficial surgery Ulcer recurrence RTC 1A
Venous ablation Ulcer recurrence Indirect 1B
Deep reconstruction Ulcer recurrence Case series 2C
Perforator interruption Ulcer recurrence RTC 2C
Treatment Outcome Methodology Grade
Compression Ulcer healing RCT 1B
Debridement Accelerated healing Observational 1C
Pentoxyfylline Ulcer healing RCT 2B
Wound care adjuncts Ulcer healing RTC 2A/B/C
Superficial surgery Ulcer healing RTC 1A Against
Systemic antibiotics Ulcer healing RTC 1B Against