outcomes of venous interventions in c5-6 disease
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Disclosure Mark Meissner, M.D.
I have no financial relationship(s) to disclose.
Mark H. Meissner, MD Professor of Surgery
University of Washington School of Medicine
Seattle, WA
Outcomes of Venous Interventions in C5-6 Disease
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
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
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
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 1.30 Favors
Control
Favors
Trental 1.0
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
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)
0.5 0.2 0.1 0.05 0.02 1 2 5 10 20 50
Favors Surgery Favors Compression
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…
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
Deep Venous Valvular Reconstruction
Populations not strictly comparable
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)
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
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
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