Objective: To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency (SVI) have greater benefits from treatment than those with only symptomatic varicose veins.
Background: A commonly held view is that SVI is only a minor ailment, yet randomized clinical trials (RCTs) show that treatment improves quality of life (QoL) and is cost-effective. In an effort to curb the treatment costs of this common disorder, rationing is applied in many health care systems, often limiting the reimbursement of treatment to those with soft tissue changes.
Methods: This cohort study draws its data from an interventional RCT. After informed consent, consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation. This analysis differentially studies the outcomes of patients with simple varicose veins (C2: n = 191) and soft tissue complications (C3–4: n = 76). Effectiveness outcomes measured up to 1 year included the following: Qol [short form 36 (SF36), EuroQol, and the Aberdeen Varicose Veins Questionnaire], clinical recurrence, and the need for secondary procedures. Multivariable regression analysis was used to control for potential confounding factors.
Results: Both groups saw significant improvements in QoL. All improvements were equal between groups apart from the SF36 domain of Bodily Pain, where C2 saw an improvement of 12.8 [95% confidence interval (CI): 4.8–20.8] points over C3–4 participants (P = 0.002), who also suffered more recurrence [odds ratio (OR) = 2.7, 95% CI: 1.2–6.1, P = 0.022] and required more secondary procedures (OR = 4.4, 95% CI: 1.2–16.3, P = 0.028).
Conclusions: This study suggests that rationing by clinical severity contradicts the evidence. Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence.
Trial registration: NCT00759434 Clinicaltrials.gov
A total of 267 patients were treated with surgery or endovenous ablation for superficial venous insufficiency of the leg. Patients with varicose veins saw greater improvement in quality of life than those with soft tissue changes, and lower recurrence and need for re-treatment. Evidence does not support rationing of treatment to those with complications.
From the Academic Vascular Surgical Unit, Hull York Medical School, UK.
Reprints: Daniel Carradice, MD (Hons), MBChB, MRCS, Academic Vascular Surgical Unit, Vascular laboratory, Hull Royal Infirmary, Anlaby Road, Hull HU3 2JZ, United Kingdom. E-mail: firstname.lastname@example.org.
Disclosure: The primary funding source for the original randomized clinical trial was internal University funding. Diomed/Angiodynamics (Cambridge, UK) also provided 50% of a research nurse's salary over a 12-month period to facilitate that study but had no involvement or influence in the design, data collection/analysis, and writing of the report or in the decision to submit for publication. No commercial companies have access to any unpublished data. I.C. is a paid consultant for Diomed/Angiodynamics and is a member of the Medical Advisory Board of Angiodynamics. D.C. is a paid consultant for Angiodynamics who has developed educational presentations on endothermal ablation. T.W. and R.G. have no conflicts of interest to report.