Development and External Validation of a Prediction Model for Patients with Varicose Veins Suitable for Isolated Ambulatory Phlebectomy.

OBJECTIVE: Isolated ambulatory phlebectomy is a potential treatment option for patients with an incompetent great saphenous vein (GSV) or anterior accessory saphenous vein and one or more incompetent tributaries. Being able to determine which patients will most likely benefit from isolated phlebectomy is important. This study aimed to identify predictors for avoidance of secondary axial ablation after isolated phlebectomy and to develop and externally validate a multivariable model for predicting this outcome. METHODS: For model development, data for patients included in the SAPTAP trial were used. The investigated outcome was avoidance of ablation of the saphenous trunk one year after isolated ambulatory phlebectomy. Pre-defined candidate predictors were analysed with multivariable logistic regression. Predictors were selected using Akaike information criterion backward selection. Discriminative ability was assessed by the concordance index. Bootstrapping was used to correct regression coefficients, and the c-index for overfitting. The model was externally validated using a population of 94 patients with an incompetent GSV and one or more incompetent tributaries who underwent isolated phlebectomy. RESULTS: For model development, 225 patients were used, of which 167 (74.2%) did not undergo additional ablation of the saphenous trunk one year after isolated phlebectomy. The final model consists of three predictors for avoidance of axial ablation: tributary length (< 15 cm vs. > 30 cm: odds ratio [OR] 0.09, 95% confidence interval [CI] 0.02 - 0.40; 15 - 30 cm vs. > 30 cm: OR 0.18, 95% CI 0.09 - 0.38); saphenofemoral junction (SFJ) reflux (absent vs. present: OR 2.53, 95% CI 0.81 - 7.87); and diameter of the saphenous trunk (per millimetre change: OR 0.63, 95% CI 0.41 - 0.96). The discriminative ability of the model was moderate (0.72 at internal validation; 0.73 at external validation). CONCLUSION: A model was developed for predicting avoidance of secondary ablation of the saphenous trunk one year after isolated ambulatory phlebectomy, which can be helpful in daily practice to determine the suitable treatment strategy in patients with an incompetent saphenous trunk and one or more incompetent tributaries. Patients having a longer tributary, smaller diameter of the saphenous trunk, and absence of terminal valve reflux in the SFJ are more likely to benefit from isolated phlebectomy.

A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial).

BACKGROUND: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. METHODS: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. RESULTS: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. CONCLUSION: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months. REGISTRATION NUMBER: NTR 4821 (www.trialregister.nl).

A prospective, multicentre study to assess frailty in elderly patients with leg ulcers (GERAS study).

BACKGROUND: Although leg ulcers are a burdensome disease most common in those aged 65 years and older, frailty in this population has not yet been well established. OBJECTIVES: The aim of this study was to prospectively explore and compare the presence of frailty in elderly patients with chronic leg or foot ulcers by applying different validated frailty screening methods in three healthcare settings and to assess the feasibility of frailty screening. METHODS: We compared frailty of leg ulcer patients referred to an academic hospital with a non-academic hospital, leg ulcer patients receiving (primary) homecare, and a dermato-oncology patient population (control group). Frailty and quality of life were assessed using four validated questionnaires: the Groninger Frailty Indicator, Geriatric-8, Mini-Cog and Wound Quality of Life. To analyse data multiple (non)-parametric tests were performed. RESULTS: Fifty of 60 included leg ulcer patients (83%) scored "frail" on at least one frailty questionnaire (GFI, G8 or Mini-Cog). The number of patients scoring "frail" on two or three out of three applied frailty questionnaires were significantly higher in the academic and homecare ulcer population compared with the non-academic ulcer population and control group (p = 0.002). In the academic ulcer population mean Wound Quality of Life scores were 30.2 (SD 17.6), compared with 17.7 (SD 13.1) in the non-academic and 15.0 (SD 10.4) in the homecare ulcer population (p = 0.002). CONCLUSION: The majority of patients suffering from leg ulcers in this study was frail. The highest frailty prevalence was observed in the academic and homecare ulcer populations. The largest impaired quality of life was reported in the academic ulcer population. In dermatology practice, implementing frailty screening and initiating appropriate (paramedical) supportive care should be considered to improve patient outcomes.