A systematic review and meta-analysis of mechanochemical endovenous ablation using Flebogrif for varicose veins

Alozai, Tamana; Huizing, Eline; Schreve, Michiel A; Mooij, Michael C.; Vlijmen, Clarissa J. van; Wisselink, Willem; Ünlü, Çağdaş

doi:10.1016/j.jvsv.2021.05.010

Cited by 21 publications

(13 citation statements)

References 68 publications

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“…In two other studies, the Flebogrif system presents similar to the Clarivein 3-year efficacy of 92% and clinical success demonstrated by improvement of VCSS (Venous Clinical Severity Score) [ 11 , 20 ]. Only one study compared Flebogrif with EVLA in a randomized controlled trial, with occlusion rates of 96% vs. 98%, respectively [ 10 ].…”

Section: Resultsmentioning

confidence: 99%

Mechanical Characteristics of the Flebogrif System—The New System of Mechano-Chemical Endovenous Ablation

et al. 2022

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Non-thermal endovenous ablations, due to the lowest probability of complications, are the new method of treating chronic venous insufficiency—one of the most common diseases globally. The Flebogrif system (Balton Sp. z o.o., Warsaw, Poland) is a new mechano-chemical ablation system causing the mechanical damage of endothelium that allows for better sclerosant penetration into its wall. The purpose of the article is to provide mechanical characteristics in the form of force–displacement dependence for a single cutting element, and a bundle of cutting elements of Flebogrif as a whole for different levels of protrusion of the bundle of cutting elements. A TA.HD plus (Stable Micro Systems, Godalming, UK) analyzer equipped with special handles, was used for characteristics testing. The head movement speed used was 5 mm·s−1. The Flebogrif system was tested for three cutting element protrusion levels: L = Lmax, L = 0.9·Lmax, and L = 0.8·Lmax. Before testing, geometric measurement of the spacing of the cutting elements for three proposed protrusions was performed. It was established that decreasing the working length of the cutting elements will increase their rigidity, and, as a result, increase the force exerted on the internal surface of the vein wall. The obtained characteristics will allow for specifying contact force variability ranges and the corresponding diameter ranges of operated veins.

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Section: Resultsmentioning

confidence: 99%

Mechanical Characteristics of the Flebogrif System—The New System of Mechano-Chemical Endovenous Ablation

et al. 2022

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“…Anyway, since our first study, when only a study was available on Flebogrif, 23 evidence about this tool is growing, and it has been collected in a recent systematic review and meta-analysis by Alozai et al 24 In one of the studies, 25 the device has been directly compared to EVLA, with better clinical outcome and lower rate of postoperative phlebitis. Thus, MOCA with Flebogrif is safe and well-tolerated, but further studies are still necessary to establish its peculiarities and its role in the vast panorama of venous treatments.…”

Section: Discussionmentioning

confidence: 99%

Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience

et al. 2022

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Background Selective crossectomy and mechanochemical ablation (MOCA) of great saphenous vein (GSV) have been used, for years, individually in the treatment of chronic venous insufficiency. In this paper, we focus on the advantages of a combination of the two techniques, in order to prevent complications and recurrence. Methods A preoperative clinical and instrumental screening phase was conducted for the purpose of dividing patients into three groups: “Saph+Cross” group (51/139 patients) underwent saphenectomy and crossectomy; “MOCA” group (44/139 patients) underwent MOCA of GSV with Flebogrif® device; “MOCA + Cross” group (44/139 patients) subjected to both MOCA and crossectomy procedures. Recurrence rate, defined as total recanalization of GSV and/or onset of neosaphena and/or new varicose veins, was used as a primary outcome. Secondary outcomes were procedural time and intra- and post-procedural complications. Results We conducted a 1-, 6-, and 12-month follow-up with Duplex scan. The recurrence rates were 3.9%, 21.8%, and 4.5% for “Saph+Cross,” “MOCA,” and “MOCA+Cross,” respectively, with a significant difference for the comparison between “MOCA” and “Saph+Cross” (MOCA vs Saph+Cross: OR 5.35, CI95% [0.98; 54.6], p-value .040). The sub-analysis of primary outcome highlighted a lower recanalization rate of GSV when combining the crossectomy with MOCA procedure (2.2% MOCA+Cross vs 15.9% MOCA; 0.12 OR, [0.002; 1.02] CI95%, p-value .029). Among the secondary outcomes, “MOCA” showed a shorter procedural time than the other groups (Saph+Cross: 51.3 ± 11.4; MOCA: 45.1 ± 7.5; MOCA+Cross: 50.4 ± 10; p-value .027). No significant differences were noted in terms of intra- and post-procedural complications. Conclusions The results showed that patients treated with saphenectomy and crossectomy have a lower recurrence rate compared to MOCA alone and MOCA + crossectomy procedures. The association of crossectomy with MOCA significantly reduces the recanalization rate of GSV, and it is also characterized by a higher free survival from recurrence (SSF) than with MOCA alone.

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“…Currently, the major non-thermal catheter-based techniques that are widely used are the mechanochemical ablation devices (MOCA) 121 , 122 and cyanoacrylate glue (CAG). 123 , 124 In most specialised vein clinics, patients are treated by an ambulatory approach, only using local or tumescent anaesthesia and without any sedation, regional blocks nor general anaesthesia.…”

Section: Treatmentsmentioning

confidence: 99%

“…There are two main devices currently available for MOCA. 121 , 122 Both of these work on the principle of mechanical damage to the vein wall to enhance the effect of sclerotherapy. 127–129 In other words, trying to ensure that the chemical ablation from the sclerosant becomes transmural.…”

Section: Treatmentsmentioning

confidence: 99%

Current Best Practice in the Management of Varicose Veins

Whiteley¹

2022

CCID

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This article outlines the current best practice in the management of varicose veins. “Varicose veins” traditionally means bulging veins, usually seen on the legs, when standing. It is now a general term used to describe these bulging veins, and also underlying incompetent veins that reflux and cause the surface varicose veins. Importantly, “varicose veins” is often used for superficial venous reflux even in the absence of visible bulging veins. These can be simply called “hidden varicose veins”. Varicose veins usually deteriorate, progressing to discomfort, swollen ankles, skin damage, leg ulcers, superficial venous thrombosis and venous bleeds. Patients with varicose veins and symptoms or signs have a significant advantage in having treatment over conservative treatment with compression stockings or venotropic drugs. Small varicose veins or telangiectasia without symptoms or signs can be treated for cosmetic reasons. However, most have underlying venous reflux from saphenous, perforator or local “feeding veins” and so investigation with venous duplex should be mandatory before treatment. Best practice for investigating leg varicose veins is venous duplex ultrasound in the erect position, performed by a specialist trained in ultrasonography optimally not the doctor who performs the treatment. Pelvic vein reflux is best investigated with transvaginal duplex ultrasound (TVS), performed using the Holdstock-Harrison protocol. In men or women unable to have TVS, venography or cross-sectional imaging is needed. Best practice for treating truncal vein incompetence is endovenous thermal ablation. Increasing evidence suggests that significant incompetent perforating veins should be found and treated by thermal ablation using the transluminal occlusion of perforator (TRLOP) approach, and that incompetent pelvic veins refluxing into symptomatic varicose veins in the genital region or leg should be treated by coil embolisation. Bulging varicosities should be treated by phlebectomy at the time of truncal vein ablation. Monitoring and reporting outcomes is essential for doctors and patients; hence, participation in a venous registry should probably be mandatory.

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A systematic review and meta-analysis of mechanochemical endovenous ablation using Flebogrif for varicose veins

Cited by 21 publications

References 68 publications

Mechanical Characteristics of the Flebogrif System—The New System of Mechano-Chemical Endovenous Ablation

Mechanical Characteristics of the Flebogrif System—The New System of Mechano-Chemical Endovenous Ablation

Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience

Current Best Practice in the Management of Varicose Veins

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