Comparative effectiveness of surgical interventions aimed at treating underlying venous pathology in patients with chronic venous ulcer
This review was contracted by the US Agency for Health Care Research and Quality (AHRQ) for the Johns Hopkins Evidence-based Practice Center. Two key questions were developed:
1. For patients with a chronic venous ulcer (CVU), what are the benefits and harms of surgical procedures?
2. For patients with a CVU, what are the comparative benefits and harms of different surgical procedures for a given type of venous reflux and obstruction?
A systematic review was conducted and 10 646 citations were identified, of which, 22 studies were included. Six randomized controlled trials (RCTs) compared a surgical procedure with compression. Adding superficial vein ligation and stripping to compression did not improve wound healing rate. However, the recurrence rate was reduced by 50% when surgery corrected the underlying superficial venous pathology (ie, a moderate-to-high strength of evidence according to the AHRQ criteria). Adding subfascial endoscopic perforator surgery (SEPS) and superficial vein surgery to compression did not improve the healing rate of CVU or reduce the recurrence rate, except for medial and large ulcers. There was insufficient evidence on the surgical treatment of CVUs secondary to deep venous reflux and venous obstruction. Their ability to draw conclusions on the best surgical techniques was limited due to poorly designed and executed studies, with no uniformity of treatment methods, follow-up, or reporting, and a lack of randomization. The authors concluded that RCTs for the endovenous procedures currently used for treating CVUs are needed.
The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) published their clinical practice guidelines for the management of CVUs in the Journal of Vascular Surgery as a supplement to the August 2014 issue.1 This is a 59-page document with 547 references that is based on two systematic reviews and meta-analyses from the Knowledge and Evaluation Research Unit at the Mayo Clinic under the leadership of Mohammad Hassan Murad.2,3 It contains 5 guidelines on compression and 17 guidelines on operative/endovascular management.
Guideline 6.1: superficial venous reflux and active venous ulcer–ulcer healing
In a patient with a venous leg ulcer (C6) and incompetent superficial veins with axial reflux directed to the bed of the ulcer, we suggest ablation of the incompetent veins in addition to standard compression therapy to improve ulcer healing (Grade, 2; level of evidence, C). In guideline 6.2, on prevention of recurrence in the same clinical situation, the same management is recommended (Grade, 1; level of evidence, B). For ulcer healing, ablation is suggested due to weak evidence (C); while for the prevention of recurrence, ablation is recommended due to stronger evidence (B). In the SVS/AVF guidelines, there is a stronger opinion for active treatment than in this reviewed paper. The ESCHAR trial (Effect of Surgery and Compression on Healing And Recurrence) has led to a very nihilistic attitude toward an aggressive management of CVUs: “Patients with open venous ulcers do not benefit from treatment of superficial reflux.” At the recent VEITHsymposium in New York in November 2014, Manjit Gohel from Cambridge, UK, one of the main investigators of the ESCHAR trial, stated that there is unequivocal evidence that treating superficial reflux is beneficial in patients with venous ulceration, and he pointed out several weaknesses of the trial:
• One-quarter of procedures were saphenofemoral junction or saphenopopliteal junction ligation alone.
• A total of 20% of patients randomized to surgery refused an operation.
• The study was not powered to assess ulcer healing.
He reported that a new study is ongoing in the UK: EVRA study (Early Venous Reflux Ablation). This is a randomized clinical trial to compare early vs delayed endovenous treatment of superficial venous reflux in patients with CVU and 500 patients will be included. In the surgical arm, ablation will be performed within 2 weeks after diagnosis; in the compression arm, surgery will be performed after healing of the ulcer.
I hope that the outcome of this RCT will provide the evidence for an aggressive early management of patients with chronic venous ulcers.
1. O’Donnell TF, Passman MA, Marston WA, et al; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2014;60:3s-59s.
2. Mauck KF, Asi N, Undavalli C, et al. Systematic review and meta-analyses of surgical interventions versus conservative therapy for venous ulcers. J Vasc Surg. 2014;60:60s-70s.
3. Mauck KF, Asi N, Undavalli C, et al. Comparative systematic review and meta-analysis of compression modalities for the promotion of venous ulcer healing and reducing ulcer recurrence. J Vasc Surg. 2014;60:71s-90s.