Healing of Venous ulcers and cost of therapy
The treatment of venous leg ulcers (VLU) represents 23% of new patient visits and 36% of all patient visits in vascular surgery practice. Depending on the age of the patient cohort, VLU affects between 0.2% and 1% of the population.1 In first world countries, the treatment of VLU may represent a maximum of 3% of health care expenditures.2 Presently, the standard of care for VLU remains compression therapy, in many cases Unna’s boot, but ideally multilayer wraps.3 With this current treatment, healing rates in patients with normal arterial perfusion is reported to be between 63% at 10 weeks retrospectively and 33% at 12 weeks prospectively.[4] and [5] Overall, annual direct costs for the treatment of VLU are in the range of $30,000 per patient per annum, with only 60-80% of them healing at 6 months. Dr O’Donnell has accurately pointed out that “any treatment modality improving VLU healing time or proportion healed would reduce the burden of VLU care.”6
Others have noted that a maximum of 15% of the limbs affected by VLU observed in large volume vascular practices have an ankle–brachial index (ABI) of <0.8.4 Patients with an ABI of <0.8 were noted to take 19 weeks to heal 50% of their ulcers as compared with 9 weeks taken by the normally perfused group. In another study, which evaluated the closure rate of mixed arterial venous ulcers, the closure rate for the standard of care arm at 16 weeks was 46.2% as compared with the 82.6% in the cohort treated with porcine-derived intestinal submucosa (SIS) (Cook Medical Inc., Bloomington IN).7 A 2004 study conducted in the United Kingdom reported that 13.6% of patients presenting with VLU had an ABI of 0.5-0.85 and 2.2% had an ABI of <0.5.8 M.L. Humphreys, A.H. Stewart and M.S. Gohel et al., Management of mixed arterial and venous leg ulcer, Br J Surg 94 (2007), pp. 1104–1107. View Record in Scopus Cited By in Scopus (9)8 Therefore, to assess the effect of intervening percutaneously on the arterial circulation of patients with mixed arterial venous disease who were dependent on compression therapy. This therefore excluded the few patients who had mixed arterial venous disease with easily correctable, superficial-only venous reflux. The hypothesis was that improving or “normalizing” the lower extremity perfusion, as assessed by ABI and pulse volume recordings (PVRs), would normalize the healing trajectory of this hard-to-close patient subset. Few others have applied this protocol selectively but with a large proportion of patients who underwent arguably more morbid open procedures.8
References:
1 S.R. Baker, M.C. Stacey and A.G. Jopp-McKay et al., Epidemiology of chronic venous stasis ulcers, Br J Surg 78 (1991), pp. 864–867. View Record in Scopus Cited By in Scopus (166)
2 Scottish Intercollegiate Guidelines Network (SIGN), The Care of Patients with Chronic Leg Ulcers. A National Clinical Guideline, SIGN, Edinburgh, United Kingdom (1998) SIGN publication no. 26.
3 E.A. Nelson, C.P. Iglesias and N. Cullum et al., Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers [VenUS 1], Br J Surg 91 (2004), pp. 1292–1299.
4 W.A. Marston, R.E. Carlin and M. Passman et al., Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency, J Vasc Surg 30 (1999), pp. 491–498.
5 F. Vin, L. Teof and S. Meaume, The healing properties of Promogran in venous leg ulcers, J Wound Care 11 (2002), pp. 335–341.
6 T.F. O’Donnell Jr. and J. Lau, A systematic review of randomized controlled trials of wound dressings for chronic leg ulcers, J Vasc Surg 44 (2006), pp. 1118–1125.
7 M. Romanelli, V. Dini and M. Bertone et al., OASIS wound matrix vs Hyaloskin in treatment of difficult-to-heal wounds of mixed arterial/venous aetiology, Int Wound J 4 (2007), pp. 3–7.
8 M.L. Humphreys, A.H. Stewart and M.S. Gohel et al., Management of mixed arterial and venous leg ulcer, Br J Surg 94 (2007), pp. 1104–1107.
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