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Endovenous laser ablation versus mechanochemical ablation with ClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial.

ABSTRACT: Endovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.The Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1 year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.The aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.ClinicalTrials.gov identifier: NCT02627846 , registered 8 December 2015 EudraCT number: 2015-000730-30 REC ref: 15/YH/0207 R&D ref: R1788.

SUBMITTER: Leung CC

PROVIDER: S-EPMC4995808 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Endovenous laser ablation versus mechanochemical ablation with ClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial.

Leung Clement C M CC Carradice Daniel D Wallace Tom T Chetter Ian C IC

Trials 20160824 1

<h4>Background</h4>Endovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosan ...[more]

PMID: 27552990

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Project description:ImportanceOne-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux.ObjectiveTo evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration.Design, setting, and participantsBetween October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019.InterventionsPatients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team.Main outcomes and measuresThe primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness.ResultsThe early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year.Conclusions and relevanceEarly endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence.Trial registrationClinicalTrials.gov identifier: ISRCTN02335796.

Project description:Background and objectivesEndovenous laser treatment (ELT) has been recently proposed as an alternative in the treatment of reflux of the Great Saphenous Vein (GSV) and Small Saphenous Vein (SSV). Successful ELT depends on the selection of optimal parameters required to achieve an optimal vein damage while avoiding side effects. Mathematical modeling of ELT could provide a better understanding of the ELT process and could determine the optimal dosage as a function of vein diameter.Study design/materials and methodsThe model is based on calculations describing the light distribution using the diffusion approximation of the transport theory, the temperature rise using the bioheat equation and the laser-induced injury using the Arrhenius damage model. The geometry to simulate ELT was based on a 2D model consisting of a cylindrically symmetric blood vessel including a vessel wall and surrounded by an infinite homogenous tissue. The mathematical model was implemented using the Macsyma-Pdease2D software (Macsyma Inc., Arlington, MA, USA). Damage to the vein wall for CW and single shot energy was calculated for 3 and 5 mm vein diameters. In pulsed mode, the pullback distance (3, 5 and 7 mm) was considered. For CW mode simulation, the pullback speed (1, 2, 3 mm/s) was the variable. The total dose was expressed as joules per centimeter in order to perform comparison to results already reported in clinical studies.ResultsIn pulsed mode, for a 3 mm vein diameter, irrespective of the pullback distance (2, 5 or 7 mm), a minimum fluence of 15 J/cm is required to obtain a permanent damage of the intima. For a 5 mm vein diameter, 50 J/cm (15W-2s) is required. In continuous mode, for a 3 mm and 5 mm vein diameter, respectively 65 J/cm and 100 J/cm are required to obtain a permanent damage of the vessel wall. Finally, the use of different wavelengths (810 nm or 980 nm) played only a minor influence on these results.Discussion and conclusionThe parameters determined by mathematical modeling are in agreement with those used in clinical practice. They confirm that thermal damage of the inner vein wall (tunica intima) is required to achieve the tissue alterations necessary in order to lead the vein to permanent occlusion. However, in order to obtain a high rate of success without adverse events, the knowledge of the vein diameter after tumescent anesthesia is recommended in order to use the optimal energy. As clearly demonstrated by our calculations, both pulsed and continuous mode operations of the laser can be efficient. An interesting observation in our model is that less amount of energy is required in pulsed mode than in continuous mode. Damaging the vein sequentially along its entire length may lead to permanent occlusion. However, the pulsed mode requires a very precise positioning of the fiber after each pullback and the duration of the treatment is much longer. For these reasons, continuous irradiation seems to be preferred by most clinicians. This model should serve as a useful tool to simulate and better understand the mechanism of action of the ELT.

Project description:BackgroundRecurrent varicosities after endovascular laser ablation (EVLA) of the great saphenous vein (GSV) are frequently due to varicose transformed, initially unsealed major ascending tributaries of the saphenofemoral junction (SFJ). Preventive ablation of these veins, especially the anterior accessory saphenous vein, is discussed as an option, along with flush occlusion of the GSV. However, few related data exist to date.MethodsA consecutive case series of 278 EVLA procedures of the GSV for primary varicosis in 213 patients between May and December 2019 was retrospectively reviewed. The ablations were performed with a 1470 nm dual-ring radial laser and always included flush occlusion of the GSV, and concomitant ablation of its highest ascending tributaries by additional cannulation and ablation when this seemed anatomically appropriate. The initial technical success, comprising occlusion of the GSV and its major tributaries, was set as the primary endpoint. Possible determinants were explored using downstream multiple logistic regression analysis.ResultsThe early technical success was 92.8%, with the GSV occluded in 99.6% and the highest ascending SFJ tributary, if present, in 92.4%. Additional ablations of ascending tributaries were performed in 171 cases (61.5%), the latter being associated with success (OR 10.39; 95% CI [3.420-36.15]; p < 0.0001). Presence of anterior as opposed to posterior accessory saphenous vein was another positive predictor (OR 3.959; 95% CI [1.142-13,73]; p = 0.027), while a confluence of the tributary in the immediate proximity to the SFJ had a negative impact (OR 0.2253; 95% CI [0.05456-0.7681]; p = 0.0253). An endothermal heat-induced thrombosis (EHIT) ≥ grade 2 was observed in three cases (1.1%).ConclusionsA co-treatment of the tributaries is feasible and could improve the technical success of EVLA if a prophylactic closure of these veins is desired, especially if their distance to the SFJ is short. Its effect on the recurrence rate needs further research.

Dataset Information

Endovenous laser ablation versus mechanochemical ablation with ClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial.

Publications

Endovenous laser ablation versus mechanochemical ablation with ClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial.

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