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Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins.

ABSTRACT: This was a prospective study of radiofrequency segmental thermal ablation (RFA) for the treatment of incompetent varicose great saphenous veins (GSVs). The present report describes long-term follow-up at 5 years.The 5-year follow-up of this multicentre European study included assessment of the Venous Clinical Severity Score (VCSS), and GSV occlusion and reflux on duplex imaging.A total of 225 patients had 295 GSVs treated by RFA, achieving an initial vein occlusion rate of 100 per cent. With 80·0 per cent compliance, Kaplan-Meier analyses showed a GSV occlusion rate of 91·9 per cent and a reflux-free rate of 94·9 per cent at 5 years. Among the 15 GSVs noted with reflux during follow-up, only three showed full recanalization of the GSV at 1 week, 6 months and 3 years. Of the 12 legs with partial recanalization, reflux originated at the saphenofemoral junction in ten, with a mean length of the patent segment of 5·8 (range 3·2-10) cm; only six patients were symptomatic. Mean(s.d.) VCSS scores improved from 3·9(2·1) at baseline to 0·6(1·2), 0·9(1·3) and 1·3(1·7) at 1, 3 and 5 years.At 5 years RFA proved to be an efficient endovenous treatment for incompetent GSVs in terms of sustained clinical and anatomical success for the vast majority of treated patients.

SUBMITTER: Proebstle TM

PROVIDER: S-EPMC4328454 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins.

Proebstle T M TM Alm B J BJ Göckeritz O O Wenzel C C Noppeney T T Lebard C C Sessa C C Creton D D Pichot O O

The British journal of surgery 20150201 3

<h4>Background</h4>This was a prospective study of radiofrequency segmental thermal ablation (RFA) for the treatment of incompetent varicose great saphenous veins (GSVs). The present report describes long-term follow-up at 5 years.<h4>Methods</h4>The 5-year follow-up of this multicentre European study included assessment of the Venous Clinical Severity Score (VCSS), and GSV occlusion and reflux on duplex imaging.<h4>Results</h4>A total of 225 patients had 295 GSVs treated by RFA, achieving an in ...[more]

PMID: 25627262

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Project description:BackgroundThe objective of this study is to examine factors associated with thrombus extension after early experience with mechanochemical ablation, which combines mechanical damage to the venous endothelium with infusion of a sclerosant.MethodsA retrospective review was performed of patients who underwent mechanochemical ablation to treat saphenous vein insufficiency in the thigh including the saphenofemoral junction. Data abstracted included patient demographics, procedural details, and postprocedural outcomes. Thrombus extension was determined by postprocedural duplex ultrasound and classified as flush closure with the femoral vein and any extension of thrombus into the femoral vein.ResultsSeventy-three patients met inclusion criteria. The mean age of the population was 60, 17.8% were female, and the mean body mass index (BMI) was 30.7. Seven (9.6%) patients who underwent mechanochemical ablation experienced saphenous vein closure flush with the femoral vein. Eleven (15%) patients experience extension of thrombus to less than 50% of the diameter of the femoral vein and one patient experienced complete thrombosis of the femoral vein. There was no significant difference in age, sex, or comprehensive classification system for chronic venous disorders between the group with thrombus extension and the group without, with the exception of BMI. The mean BMI in the group with thrombus extension was 26.8 vs. 32 in the group without (P = 0.02). There was no significant difference between the 2 groups in sclerosant volume used, distance between catheter tip and SFJ, and mean diameter of GSV in the thigh.ConclusionsIn this cohort, the incidence of thrombus extension into the femoral vein with mechanochemical ablation was high relative to rates of thrombus extension associated with reported rates of thermal ablation. Further investigation with larger cohorts, and standardized reporting is required to characterize the true rate of thrombus extension after mechanochemical ablation and identify maneuvers which may prevent thrombus extension.

Project description:ImportanceLong-term patency of human saphenous veins (HSVs) used as autologous conduits for coronary artery bypass grafting (CABG) procedures remains limited because of vein graft failure (VGF). Vein graft failure has been reported to be as high as 45% at 12 to 18 months after surgery and leads to additional surgery, myocardial infarction, recurrent angina, and death. Preparation of HSVs before implantation leads to conduit injury, which may promote VGF.ObjectivesTo investigate whether pressure distension during vein graft preparation leads to endothelial injury and intimal thickening and whether limiting intraluminal pressure during pressure distension by using a pressure release valve (PRV) preserves endothelial function and prevents neointima thickening.Design, setting, and participantsSegments of HSVs were collected in a university hospital from 13 patients undergoing CABG procedures immediately after harvest (unmanipulated [UM]), after pressure distension (after distension [AD]), and after typical intraoperative surgical graft preparation (after manipulation [AM]). Porcine saphenous veins (PSVs) from 7 healthy research animals were subjected to manual pressure distension with or without an in-line PRV that prevents pressures of 140 mm Hg or greater. Endothelial function of the HSVs and PSVs was determined in a muscle bath, endothelial integrity was assessed, and intimal thickening in PSVs was evaluated after 14 days in organ culture.Main outcomes and measuresEndothelial function was measured in force, converted to stress, and defined as the percentage relaxation of maximal phenylephrine-induced contraction. Endothelial integrity was assessed by immunohistologic examination. Neointimal thickness was measured by histomorphometric analysis.ResultsPressure distension of HSVs led to decreased mean (SEM) endothelial-dependent relaxation (5.3% [2.3%] for AD patients vs 13.7% [2.5%] for UM patients; P < .05) and denudation. In the AM group, the function of the conduits was further decreased (-3.2% [3.2%]; P < .05). Distension of the PSVs led to reduced endothelial-dependent relaxation (7.6% [4.4%] vs 61.9% [10.2%] in the control group; P < .05), denudation, and enhanced intimal thickening (15.0 [1.4] µm vs 2.2 [0.8] µm in the control group; P < .05). Distension with the PRV preserved endothelial-dependent relaxation (50.3% [9.6%]; P = .32 vs control), prevented denudation, and reduced intimal thickening (3.4 [0.8] µm; P = .56 vs controls) in PSVs.Conclusions and relevanceUse of a PRV during graft preparation limits intraluminal pressure generated by manual distension, preserves endothelial integrity, and reduces intimal hyperplasia. Integration of this simple device may contribute to improved long-term vein graft patency.

Dataset Information

Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins.

Publications

Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins.

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