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Venous ulcers: The role of interventions in the venous
system Raghu Kolluri, MS, MD, RVT, FSVM
Director – Syntropic Core Lab
Medical Director – Vascular Medicine and Laboratories
OhioHealth Heart & Vascular
Columbus, OH
@RKolluriMD
Disclosure Statement of Financial Interest
• I, Raghu Kolluri, have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
• Consultant/ Advisor – UNCOMPENSATED• Bard/ BD, Boston Scientific, BTG, Inari, Innovein, Intervene, Janssen,
Medtronic, Philips IGT/ Ultrasound, Vascular Insights, Vesper Medical, Thrombolex
• Board Member – VIVA Physicians Inc, 501c
• Medical Director – Syntropic Core lab, 501c
Superficial Venous Interventions
Ulcer Healing Recurrence
ESCHAR trial
Br Med J 2007; 335: 83-87
J Vasc Surg 2012;55:458-64.
Early Intervention Deferred Intervention HR
Median Time to Heal 56 days (95% CI, 49 to 66) 82 days (95% CI, 69 to 92) 1.42 (95% CI 1.16 – 1.73) p=0.001
Rate of Ulcer Healing at 24 weeks
85% 76.3%
Ulcer Free time in first year 306 278 1.54 (95% CI 1.07 – 2.21) p=0.02
N Engl J Med 2018; 378:2105-2114
VCSS, AVVQ, E5-QD Index, SF-36 body pain
• Improved from baseline to 6 months in both groups
• Early intervention group better than Deferred intervention group
• Before the end of the 1-year follow-up period • Early group 11.4% (24 of 210 patients) • Deferred group 16.5% (32 of 194 patients)
ULCER RECURRENCE
Overall Healing at 1 year ~ 90%
Sclerotherapy
Varithena® VLU Registry: The Effects Of Polidocanol EndovenousMicrofoam On Wound Healing And Recurrence
Kolluri, R VEITH 2019
Tissue Migration: median rate of change in perimeter (mm/week) by week from treatment
• Early boost in healing with a median reduction in perimeter of 12.4mm/wk for first two weeks; overall median reduction of 2.0mm/week over 12 weeks
• On post-hoc analysis, even wounds that didn’t heal had a reduction in size of 1.8mm/wk over 12 weeks
Kolluri, R VEITH 2019
Interim Analysis of 50 patients (target 200)
Wound Closure
• Healed at 12 weeks post-treatment: 46.3%
• Mean time to wound closure : 76.1 days
Wound Recurrence
• At the time of the interim analysis, 5 ulcers had a recurrence
• Wound age in weeks: mean (min, max)• 27.5 (1, 142)
Kolluri, R VEITH 2019
Superficial Interventional Therapies - EVRA
More Foam than
endothermal
Deep venous interventions
EVRA6555 screened
496 - Clinician decision
434 - Patient declined
1772 Excluded because ulcer > 6months old
Etiology
Deep vein obstruction ?
Ulcer healing rates ?
Recurrence rates after one year.
LUPA Results
Treatment N = 110
SVI Treatment 67 61%
Venous Stent 37 33%
Other 7 6%
Slide courtesy Mr. Stephen Black
Outcomes 12 months
Healed 80%
Healing 11%
Not Healed 9%
Baseline Demographics N = 110
Male 75 68%
Female 35 32%
Age 59 years (20 – 91)
Ulcer < 3mo 11 10%Ulcer 4-6 month 31 28%
Ulcer 7-12 months 15 14%Ulcer > 12 months 53 48%
Compression Therapy
Compression Therapy: Mechanism of Benefit
• External pressure
• Reduces edema and Improves oxygen diffusion• Improves the interstitial pressure
• Protein and fluid driven back into capillary space
CMAJ 2014;186(10)E391-E398
SVS/ AVF Guidelines
• Patients with a venous ulcers (C6), recommend compression therapy over no compression therapy to increase venous leg ulcer healing (Grade 1A)
• Patients with a healed venous ulcer, suggest compression therapy to decrease the risk of ulcer recurrence (Grade 2B)
J Vasc Surg 2014;60:3S-59S
Trials of Compression Methods
Primary
author
Journal ref # pts % healed
group A
% healed
group BP val
Nelson J Vasc Surg
2007;45:134
245; 4 layer vs
single layer
67% 4 layer at
24 wks
49% single
layer at 24 wks
.009
Nelson Br J Surg 2004
91:1292
387; 4 layer vs
short str
92 days
median for 4
layer
126 days
median for SS
< .05
Partsch Vasa 2001;30:108 112; 4 layer vs
short str
62% 4 layer at
16 wks
73% SS at 16
wks
NS
Franks Wound Rep
Regen
2004;12:157
156; 4 layer vs
SS
69% 4 layer at
24 wks
73% SS at 24
wks
NS
Polignano J Wd Care
2004;13:21
68; 4 layer vs
Unna
74% 4 layer at
24 wks
66% Unna at
24 wks
NS
Compression Rx
Compression Therapy
Multilayered or short stretch compression used in
>75% of patients in both groups, at baseline
? Possible reason for the high healing rates and low recurrences
Ulcer Healing Recurrence
Eschar Trial
Br Med J 2007; 335: 83-87
Pentoxifylline in Venous ulcers
• Meta analysis - 12 trials/ 864 participants
• Pentoxifylline with placebo or no treatment (with or without compression) - pentoxifylline is more effective for complete ulcer healing/significant improvement
• Pentoxifylline plus compression more effective than placebo plus compression
• Pentoxifylline in the absence of compression appears to be more effective than placebo or no treatment
Cochrane Database Syst Rev.
2002;(1):CD001733.
CVP/ Obesity/ Calf pump dysfunction
1.Vascular and Endovascular Surgery 2005; 39(6): 505–09. 2.Journal of Internal Medicine 1997; 241(1): 71–79. 3.Journal of Vascular Surgery 2003; 37(1): 79–85.
Reflux therapies + Sub ulcer Foam
Compression Garments
Deep Vein Revascularization
pentoxifylline
CVI/ Obesity/
Calf pump
VLU CARE 2020
Venous ulcers: The role of interventions in the venous
system Raghu Kolluri, MS, MD, RVT, FSVM
Director – Syntropic Core Lab
Medical Director – Vascular Medicine and Laboratories
OhioHealth Heart & Vascular
Columbus, OH
@RKolluriMD