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).

Safety and Effectiveness of Endovenous Thermal Ablation for Incompetent Saphenous Veins with an Aneurysm Close to the Junction.

OBJECTIVE: The aim was to evaluate the safety and effectiveness of endovenous thermal ablation (EVTA) with or without adding high ligation (HL) for the treatment of incompetent saphenous veins with an aneurysm (>20 mm for the great saphenous vein, >15 mm for the small saphenous vein) close to the junction. METHODS: This was a prospective observational cohort study in a single centre. All patients presenting with saphenous aneurysms close to the junction were included. Those with a venous aneurysm more distally, at >2 cm from the junction, or with associated deep venous aneurysms were excluded. Patients were treated with EVTA alone or combined with HL in cases of an aneurysm with a diameter >30 mm. Phlebectomies were performed during the same treatment session. Patients were followed up one and six weeks, and one year after treatment. Duplex ultrasound (DUS) was performed to evaluate occlusion of the vein and aneurysm as well as possible complications such as endovenous heat induced thrombosis (EHIT) or deep vein thrombosis (DVT). Venous clinical severity scores (VCSS) were registered before and one year after treatment. RESULTS: Thirteen patients (15 limbs) were included between February 2012 and January 2015. Eleven limbs were treated with EVTA alone, the remaining four limbs with EVTA and HL. No severe adverse events occurred (no EHIT, no DVT). After one year none of the aneurysms was still visible on DUS and the truncal obliteration rate was 80% (two partial, one segmental recanalisation). Both treatment strategies showed significant improvement of the VCSS at the one year follow up, from a median score of 6 (interquartile range [IQR] 5-7) to 2 (IQR 1-3) (p = .001). CONCLUSION: EVTA with or without HL appeared to be a safe and effective treatment for patients presenting with incompetent saphenous veins with an aneurysm close to the junction.