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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