Comparison of Outcomes in Patients With Venous Leg Ulcers Treated With Compression Therapy Alone Versus Combination of Surgery and Compression Therapy

Transcription

1 J Wound Ostomy Continence Nurs. 2015;42(1): Published by Lippincott Williams & Wilkins WOUND CARE Comparison of Outcomes in Patients With Venous Leg Ulcers Treated With Compression Therapy Alone Versus Combination of Surgery and Compression Therapy A Systematic Review Magali Rezende de Carvalho ABSTRACT BACKGROUND: Venous leg ulcers (VLUs) are the most prevalent type of lower extremity ulcers and can be difficult to manage. Clinicians are challenged to provide care and recommendations that promote timely healing, minimize the risk of recurrence, and are cost-effective. Compression therapy is generally considered the primary intervention for both ulcer management and prevention of recurrence. However, recent studies suggest that surgical correction of venous insufficiency may enhance healing of venous ulcers or help prevent recurrence. PURPOSE: The objective of this systematic review was to compare wound healing and recurrence rates in patients managed with compression therapy alone versus compression therapy plus surgery. SEARCH STRATEGY: The author conducted a literature review selecting primary studies published between 2002 and 2012, using the electronic databases MEDLINE/PubMed and CINAHL/EBSCOhost. The following key words were applied: leg ulcer; varicose ulcer; bandage; stockings, compression, venous ulceration; venous ulcer; compressive therapy; compression therapy; stocking; venous surgery. Inclusion criteria included randomized controlled trials that compared VLU healing rates and recurrence rates among patients receiving compression therapy alone, and patients receiving both compression therapy and surgical intervention to correct venous incompetence. Studies published in English, Spanish, or Portuguese were included. RESULTS: Sixty-seven studies were retrieved and 4 were identified that met inclusion criteria. In 3 of the studies, researchers reported no differences in healing rates for patients managed with compression plus surgery when compared to patients managed with compression alone. One study reported higher healing rates in the surgical group. Most studies revealed lower recurrence rates in patients who were managed with surgery plus compression, but these differences were not statistically significant. CONCLUSIONS: Existing evidence supports compression therapy as the most critical element in the management of venous leg ulcers. However, evidence also suggests that surgical obliteration of incompetent perforator veins may promote longer ulcerfree periods and lower rates of recurrence. KEY WORDS: compression therapy, compressive therapy, systematic literature review, surgical obliteration incompetent perforator veins, vascular surgical procedures, venous insufficiency, venous leg ulcer, venous valvular incompetence, venous surgery Introduction Chronic wounds represent a significant problem for the health system; in the United States, they affect 6.5 million patients, and estimates of treatment costs are as high as $25 billion per year. 1 Leg ulcers are a common type of chronic wounds, and venous leg ulcers (VLUs) represent about 70% to 90% of these lower extremity wounds. The cost of VLUs is significant, reaching $3.5 billion annually for the US health system. 2 In addition, many venous ulcers Magali Rezende de Carvalho, RN, BSN, WOC nurse, School of Nursing Aurora de Afonso Costa, Universidade Federal Fluminense, Niterói, RJ, Brazil. Conflict of interest: none declared. Disclosure of funding received for this work: none declared. Correspondence: Magali Rezende de Carvalho, RN, BSN, Rua Clarice Indio do Brasil, 34 apto 301, Botafogo, Rio de Janeiro, RJ, Brazil ( magalirecar@gmail.com ). DOI: /WON J WOCN January/February 2015 Copyright 2015 by the Wound, Ostomy and Continence Nurses Society

2 J WOCN Volume 42/Number 1 de Carvalho 43 fail to heal normally and thus become chronic. A leg ulcer is considered chronic when there is no healing of the wound within 6 weeks or when there is a recurrence. 3 Besides treatment costs, many patients with VLUs are unable to reconcile wound care therapy with the requirements of their jobs. These challenges may lead to lost wages or early retirement. 1 Furthermore, patients with VLU experience changes in their health-related quality of life, including pain with dressing changes, daily discomfort related to edema, odor, impaired mobility, and social and family isolation. 4, 5 Multiple studies have been conducted to determine the best management approach to VLU, specifically therapies that promote healing, reduce the cost and duration of treatment, reduce or prevent recurrence, and improve patients health-related quality of life. Pathophysiology of Venous Leg Ulcers Venous insufficiency develops when the valves in the superficial and/or deep venous system are damaged, leading to increased hydrostatic pressure and venous hypertension. 6 The increased hydrostatic pressures in the capillary beds force fluid, red and white blood cells, and plasma proteins out of the vessels into the surrounding tissues; triggering an inflammatory response that, over time, produces tissue fibrosis and renders the tissues vulnerable to breakdown. Minor trauma may lead to ulceration that is frequently nonhealing or recurring. 7 A systematic review published in 2007 pointed out that the most efficient way of treating venous ulcers is to address the underlying venous insufficiency and recommended the use of compression therapy as the gold standard treatment for VLUs. 8 Compression therapy can minimize or reverse the effects of venous insufficiency by forcing fluid out of the interstitial space and back into the vascular system. However, this is a temporary solution and works only while the patient is wearing the compression device; this means that the patient must wear compression stockings even after the ulcer has healed. 8 Compression therapy is recommended by the Scottish Intercollegiate Guidelines Network, Royal College of Nursing, and the Wound, Ostomy and Continence Nurses Society for edema control and venous ulcer healing However, there is no consensus regarding the most effective compression therapy device, the best approaches for topical therapy, or the role of adjunct therapies, such as surgical correction of incompetent perforator veins. 12 The Scottish Intercollegiate Guidelines Network recommends high compression multilayer wraps as the best approach to compression therapy. 9 This guideline also addresses the importance of individualizing therapy based on the size and shape of the limb, the patient s tolerance or preference, and the practitioner s level of expertise. 13 Another way to correct venous insufficiency is surgical correction of the underlying anatomic defect; surgery may promote wound healing and prevent recurrence of VLUs in selected patients. 8, 14 The most commonly performed surgical procedures for correction of venous insufficiency include surgical ablation of incompetent superficial veins and perforator veins and subfascial endoscopic perforator surgery (SEPS). 15, 16 The SEPS procedure involves ligation of the incompetent perforator veins, which prevents backflow of blood and transmission of high pressures from the deep venous system to the superficial venous system. The aim of this systematic review was to review studies that compared healing rates and recurrence rates among VLU patients managed with compression therapy alone and those managed with compression therapy plus surgery. Methodology This systematic literature review targeted randomized controlled trials (RCTs) that compared compression therapy with and without surgery for the treatment of VLUs, published between 2002 and The search was performed using the following key words: leg ulcer; varicose ulcer; bandage; stockings, compression, venous ulceration; venous ulcer; compressive therapy; compression therapy; stocking; venous surgery. The search was conducted in December 2012, using the electronic databases MEDLINE/ PubMed and Cumulative Index to Nursing and Allied Health Literature (CINAHL)/EBSCOhost. Inclusion criteria were RCTs that compared healing rates for VLU patients treated with both compression therapy and any kind of surgical intervention versus RCT that evaluated VLU using conservative treatment with compressive bandages/stockings alone. Studies published in 3 languages (English, Spanish, and Portuguese) were included in this review; studies published in all other languages were excluded. Sixty-seven studies were identified, and abstracts for all of these studies were reviewed; 60 were rejected. Most of the rejected studies addressed only 1 treatment modality and did not provide comparative data. Seven of the studies appeared to meet the inclusion criteria based on abstract review, and I reviewed the full text for these 7 RCTs. Three studies did not meet inclusion criteria and were excluded (1 was written in Russian and 2 focused on different outcomes). Finally, 4 RCTs were selected for discussion in this article ( Table 1 ). Results Four articles were selected for analysis; 2 were related to the same study (Effect of Surgery and Compression on Healing and Recurrence [ESCHAR] study). Both articles derived from the ESCHAR study reported the same outcomes but at different points following the intervention. The first paper was published in 2004 and reported outcomes at 24 weeks and 12 months postintervention, 17 and the second paper, published in 2007, evaluated outcomes at 3 and 4 years postintervention. 18 The outcomes evaluated by the authors were healing rates and ulcer recurrence rates. The ESCHAR study screened 1418 patients with open VLUs or recently healed ulcers ( < 6 months); 500 met study criteria

3 44 de Carvalho J WOCN January/February 2015 TABLE 1. Trial Name, Authors, and Journal of the Analyzed Studies Trial Name Authors Journal Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomized controlled trial Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial Early and long-term results of physical methods in the treatment of venous leg ulcers: a randomised controlled trial Barwell, J. R., Davies, C. E., Deacon, J., et al. van Gent, W. B., Hop, W. C., van Praag, M. C., et al Gohel, M.S., Barwell, J. R., Taylor, M., et al Taradaj, J., Franek, A., Cierpka, L., et al. Lancet 2004 Journal of Vascular Surgery 2006 BMJ 2007 Phlebology 2011 including ankle-brachial index test 0.85 and agreed to participate in the study. All patients were randomized to 1 of 2 groups; 258 patients received treatment with compression therapy alone and 242 received both compression therapy and surgery. At baseline (prior to intervention), 341 patients had open VLU (156 in the compression therapy plus surgery group and 185 in the compression therapy alone group) and 159 patients had recently healed wounds (86 were treated with surgery and compression and 73 with compression alone). The compression system used for patients in both groups was a 4-layer system, which provides 40 mmhg of pressure at the ankle and 17 to 20 mmhg in the upper calf. Elastic stockings class II, which provide 18 to 24 mmhg of pressure at the ankle, were used once the ulcer healed. Surgeries performed were saphenofemoral junction disconnection, stripping of the long saphenous vein to the knee, calf varicosity avulsions, and saphenopopliteal junction disconnection. Researchers used color duplex imaging to determine the best surgical approach for each patient. Patients in both groups were similar in regard to clinical and demographic characteristics commonly associated with delayed VLU healing. Both groups showed similar healing rates after 24 weeks of follow-up (82% healing in the group treated with compression plus surgery, and 76% in the group treated with compression alone, P =.85). Four hundred twenty-eight patients with healed legs (159 with healed legs at baseline plus 269 whose ulcers healed during the first 24 weeks of the study) were analyzed for ulcer recurrence at 12 months (214 patients in each group). The recurrence rate was significantly lower in the compression plus surgery group when compared to subjects managed by compression alone (12% vs 28%; P <.0001). 17 However, when groups were compared at 3 years postintervention, 93% of patients were healed in the compression plus surgery group versus 89% in the compression group. This difference was not statistically significant ( P =.73). Recurrence rates were also analyzed 4 years postintervention; this analysis included patients who had healed ulcers at baseline plus patients whose ulcers healed during the study ( = 226 patients in the compression group and = 216 in the compression plus surgery group). This comparison revealed significantly lower recurrence rates in the compression plus surgery group (31% vs 56%; P <.001). 18 van Gent and colleagues 19 conducted a similar study in the enrolled subjects from 12 centers in the Netherlands. The researchers randomly allocated 103 VLU patients to the group treated with compression therapy alone, and 97 patients to treatment with surgery (SEPS) plus compression therapy. Subjects in the SEPS group underwent surgery of the superficial venous system (saphenopopliteal ligation and/or saphenofemoral ligation and limited stripping of the long saphenous vein). All patients were randomized by a computer program at an independent randomization center; in patients with bilateral leg ulcers, each ulcer was randomized separately. Patient characteristics were similar in both groups at baseline, with the exception of a higher proportion of diabetes mellitus in the group managed with compression alone. The compression system used was the 2-layer short-stretch bandaging system, which was used until the ulcer healed. The short-stretch system provides lower resting pressures (30-40 mmhg) and higher working pressures (40-50 mmhg at the ankle). After the ulcer healed, patients were asked to wear compression hosiery class II (18-24 mmhg) or III (25-35 mmhg), depending on concomitant incompetence of the deep venous system, and immediately report any recurrence. The outcomes evaluated were healing rates and ulcerfree time. Ulcerfree time was defined as the total percentage of days during follow-up a patient had no open wound. The follow-up period from 0 to 36 months was divided into intervals of 3 months each in order to better observe the ulcerfree period. This outcome was considered for analysis only when the number of ulcerfree days was more than 45 days. For example, if the patient was ulcerfree for 50 days during an interval of 90 days, the percentage of ulcerfree time during that interval would be /90 = 55.5%. Therefore, each patient had 12 partial results at the end of the study, and the author averaged the percentage of ulcerfree time for each group (compression group vs surgical group).

4 J WOCN Volume 42/Number 1 de Carvalho 45 Analysis of study findings revealed an 83% VLU healing rate in patients treated with surgery plus compression therapy versus 73% in patients treated with compression therapy alone. Ulcer-free time averaged 72% in the surgery plus compression group versus 53% in the compressiononly group; this difference was not statistically significant ( P =.11). However, patients in the surgical group had significantly longer ulcerfree periods during follow-up (62% vs 33% in the conservative group; P =.02). In contrast, there was no statistical significance in the overall recurrence rates for the group managed with surgery plus compression compared to subjects managed with compression alone (22% vs 23%; P = ns). 19 Taradaj and colleagues 12 evaluated 305 patients with VLU and ankle-brachial index test > 1.0. Participants had similar characteristics at baseline but were managed with a variety of therapies for 7 weeks. After the presenting VLU healed, the patient was scheduled for follow-up after 1 and 2 years. One hundred seventy-five patients agreed to undergo surgery to correct the venous insufficiency; the remaining 130 subjects were assigned to a variety of treatment groups. All patients were randomly allocated to the groups using computer-generated random numbers sealed in sequentially numbered envelopes. The surgical procedures performed were crossectomy (also known as saphenopopliteal ligation), partial (short) stripping of the greater or short saphenous vein, local phlebectomy, and ligation of insufficient perforators. Patients were assigned to 10 groups; interventions included surgery, compression therapy, drug therapy, ultrasound, high-voltage stimulation, and low-level stimulation. Analysis revealed that surgery plus compression therapy achieved superior healing rates after 7 weeks to compression plus drug therapy or alternative treatments. In addition, patients who underwent surgery plus compression therapy and drug therapy (group D) had significantly lower recurrence rates after 2 years than did subjects randomized to other treatment combinations ( Table 2 ). 12 Discussion Results of the ESCHAR study and the Van Gent studies revealed no statistically significant difference in healing rates for patients managed with compression plus surgery and those managed with compression alone In contrast, Taradaj s group 12 reported a statistically significant difference favoring surgery plus compression. Nevertheless, findings from this study must be interpreted with care because the investigation involved multiple treatment arms, with small numbers of patients in each arm, and because several of the treatment groups received drug therapy, which also may have affected outcomes. When considering recurrence rates, both the ESCHAR study group and Taradaj found lower incidence of recurrence among patients who underwent surgery in addition to compression as compared to patients who were managed with compression alone. 12, 17 In the ESCHAR TABLE 2. Study Outcomes a Group (Group Size) Group A (n = 40) Group B (n = 33) Group C (n = 30) Group D (n = 35) Group E (n = 37) Group F (n = 32) Group G (n = 20) Group H (n = 21) Group I (n = 31) Group J (n = 27) Group Comparisons Groups Intervention Surgery + HVS + drug therapy (900 mg of diosmin mg of hesperidim once a day) Surgery + ultrasound + drug therapy Surgery + LLLT + drug therapy Surgery + compression stockings (25-31 mmhg) + drug therapy Surgery + drug therapy HVS + drug therapy Ultrasound + drug therapy LLLT + drug therapy compression + drug therapy Drug therapy only Outcome (Superior Healing Rates) Group D vs Group I 53.1% vs 30.8%, P =.03 Group A vs Group D 37.3% vs 53.1%, P =.03 Group B vs Group D 30.1% vs 53.1%, P =.03 Group C vs Group D 32.3% vs 53.1%, P =.03 Group D vs Group E 53.1% vs 32.2%, P =.03 Group D vs Group F 53.1% vs 30.2%, P =.03 Group D vs Group G 53.1% vs 30.1%, P =.03 Group D vs Group H 53.1% vs 13.5%, P =.002 Group D vs Group I 53.1% vs 30.8%, P =.03 Group D vs Group J 53.1% vs 11.4%, P =.002 Abbreviations: HVS, high-voltage stimulation; LLLT, low-level stimulation. a From Taradaj and colleagues. 12 Reprinted by Permission of SAGE, Copyright study, there was a 12% recurrence rate at 1 year for patients managed with compression plus surgery, as compared to 28% in the group managed with compression alone ( P <.0001). 17 Recurrence rates at 4 years continued to favor surgery plus compression versus compression alone (31% vs 56%; P <.001). 18 Taradaj and colleagues 12 also reported lower recurrence rates at 2 years postintervention in patients who received surgery, compression, and drug therapy compared to the group that received compression stockings and drug therapy ( P <.001). In contrast, van Gent did not find any statistical difference in recurrence rates for patients treated with compression alone and those treated with compression plus surgery (23% and 22%, respectively). 19 Taradaj and colleagues suggest that a possible cause for the high recurrence rates

5 46 de Carvalho J WOCN January/February 2015 could be the quality of the SEPS procedure and recommend further evaluation. 19 Considered collectively, evidence from these studies indicates that complementing compression with surgical procedures in select patients to correct venous insufficiency does not reduce VLU healing time. Nevertheless, existing evidence suggests that surgical intervention may promote healing of ulcers in some patients, reduce the risk of recurrence, and prolong ulcer free periods. 20, 21 Conclusion The results of the 4 studies reviewed in this article support compression therapy as the main pillar of VLU care. Evidence also supports that surgical correction of venous insufficiency may be a viable treatment option for some patients, prolonging ulcerfree periods and reducing the rate of recurrence. KEY POINTS Compression therapy is the primary option for effective treatment for VLU. Surgical procedures that correct venous insufficiency may reduce VLU recurrence. References 1. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen ; 17 ( 6 ): Hankin CS, Knispel J, Lopes M, et al. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. Manag Care Pharm ; 18 ( 5 ): Markova A, Mostow EN. United States skin disease needs assessment US skin disease assessment: ulcer and wound care. Dermatol Clin ; 30 ( 1 ): Fonseca C, Franco T, Ramos A, et al. The individual with leg ulcer and structured nursing care intervention: a systematic literature review. Rev esc enferm USP ; 46 ( 2 ): O Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev : 11. doi: / cd pub3. 6. Oliveira BGRB, Nogueira GA, Carvalho MR, et al. The characterization of patients with venous ulcer followed at the outpatient wound repair clinic. Rev Eletr Enf ; 14 ( 1 ): Casey G. Chronic wound healing: leg ulcers. Nurs N Z ; 17 ( 11 ): Borges EL, Caliri MHL, Haas VJ. Systematic review of topic treatment for venous ulcers. Rev Latino-Am Enfermagem ; 15 ( 6 ): Management of chronic venous leg ulcers. Guideline no 120. Scottish Intercollegiate Guidelines Network (SIGN), Healthcare Improvement Scotland. Edinburgh : Gyle Square ; The nursing management of patients with venous leg ulcer. Clinical Practice Guidelines. London, UK : Royal College of Nursing; Quick assessment of leg ulcers. Guidance on OASIS Skin and Wound. Mt Laurel, NJ : Wound, Ostomy and Continence Nurses Society ; Taradaj J, Franek A, Cierpka L, et al. Early and long-term results of physical methods in the treatment of venous leg ulcers: randomized controlled trial. Phlebology ; 26 ( 6 ): Milic DJ, Jankovic RJ, Zivic SS, et al. The influence of different sub-bandage pressure values on venous leg ulcers healing when treated with compression therapy. J Vasc Surg ; 51 ( 3 ): Alden PB, Lips EM, Zimmerman KP, et al. Chronic venous ulcer: minimally invasive treatment of superficial axial and perforator vein reflux speeds healing and reduces recurrence. Ann Vasc Surg ; 27 ( 1 ): Bryant RA, Nix DP. Acute & Chronic Wounds: Current Management Concepts. 4th ed. St Louis, MO : Elsevier Mosby ; 2012 : O Donnell TF Jr. The present status of surgery of the superficial venous system in the management of venous ulcer and the evidence for the role of perforator interruption. J Vasc Surg ; 48 : Barwell JR, Davies CE, Deacon J, et al. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet ; 363 ( 9424 ): Gohel MS, Barwell JR, Taylor M, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ ; 335 ( 7610 ): van Gent WB, Hop WC, van Praag MC, et al. Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial. J Vasc Surg ; 44 ( 3 ): Mosti G. Compression and venous surgery for venous leg ulcers. Clin Plast Surg ; 39 ( 3 ): Fradique C, Pupo A, Quaresma L, et al. Úlcera flebostática estudo prospectivo de 202 doentes. Acta Med Port ; 24 ( 1 ): For more than 20 additional continuing education articles related to wound, ostomy and continence, go to NursingCenter.com\CE. Notice: Online CE Testing Only Coming in 2015! Starting with the first issue of 2015, the tests for CE articles will appear only in the online version of the issue, and all tests must be completed online at Simply select the CE article you are interested in. Both the article and the test are available there. You will no longer have the option to mail or fax in the test. If you haven t done so already, you will want to create a user account for yourself in NursingCenter s CEConnection it s free to do so! Look for the Login link in the upper right hand corner of the screen.