Mechanochemical Ablation Research Articles

Combined Endovenous Laser and Mechanochemical Ablation to Reduce Sclerosant for Three or Four Veins with Chronic Venous Insufficiency

Background: A large amount of sclerosant is needed for the treatment of saphenous vein insufficiency with mechanochemical ablation (MOCA) for three or four veins with chronic venous insufficiency. In addition, what constitutes a safe amount is not clearly defined. In this study, we evaluate the feasibility of the combined endovenous laser and mechanochemical ablation to reduce the amount of sclerosant as compared with mechanochemical ablation monotherapy. Methods: A total of 327 patients diagnosed with superficial vein insufficiency between June 2018 and May 2020 and treated in a single center by one surgeon were evaluated retrospectively. There were 130 patients included who were treated with mechanochemical ablation (MOCA, Group I) and 197 patients who were treated with combined endovenous laser ablation and mechanochemical ablation (EVLA and MOCA, Group II). Results: The amount of sodium tetradecyl sulfate (STD) used per number of limbs was 5.5 ± 2.05 mL in Group I and 4.51 ± 1.2 mL in Group II (p < 0.001). The amount of STD used per number of veins was 4.77 ± 1.91 mL versus 3.12 ± 1.02 mL in Groups I and II, respectively, (p < 0.001). Recanalization rates within 52 weeks were 0% (0/130) in Group I and 5.58% (11/197) in Group II, while after 52 weeks they were 2.31% (3/130) in Group I and 6.60% (13/197) Group II and were not statistically significant. Complications within 4 weeks were 3.84% and 7.11% in Groups I and II, respectively. Conclusions: The results of this study show that combined EVLA and MOCA reduces the amount of sclerosant per the number of veins and legs treated as compared with MOCA monotherapy for three or four veins with chronic venous insufficiency. The combined EVLA and MOCA treatment in patients with three or four varicose veins has few side effects, reduces the amount of sclerotic agent, and can be considered to be an effective treatment method for inducing venous occlusion.

Randomized controlled trial comparing immediate and delayed treatment of varicose veins following mechanochemical ablation

ObjectiveThe standard treatment of superficial venous insufficiency consists of endovenous thermal ablation of the refluxing main trunk, combined with side branch treatment, if needed. Side branches are often treated with phlebectomy concurrently or as a staged procedure. Whether the delayed treatment is justifiable, taking into consideration the long-term outcomes of the treatment and the need for later interventions, remains an open question. The objective of this study is to evaluate the necessity of immediate treatment of varicosities and to compare it with delayed treatment after mechanochemical ablation of the main trunk of the great saphenous vein (GSV). MethodsVenous outpatient clinic patients with varicosities (clinical classification C2-C4) resulting from GSV insufficiency were randomized to receive mechanochemical ablation only or mechanochemical ablation with concurrent phlebectomies at a ratio of 1:1. After eligibility assessment of 1149 patients, 85 met the inclusion criteria, which were age 20 to 70 years, ultrasound-verified GSV insufficiency, mean GSV diameter of 5 to 10 mm in the thigh, and provision of written informed consent. The exclusion criteria were deep venous reflux, peripheral arterial disease, pregnancy, lymphedema, body mass index of >40 kg/m2, an allergy to the sclerosant, a history of deep vein thrombosis, and/or any form of coagulopathy. The primary outcome was the need for sclerotherapy at 3 months after treatment. The secondary outcome measures, which were assessed at 3 months and 1 year, were complications, duration of sick leave, overall patient satisfaction, and GSV occlusion rate. ResultsAt 3 months, 13.2% of the patients randomized to delayed treatment needed sclerotherapy. No statistically significant difference was found in the occlusion rate of the GSV at either 3 months (mechanochemical ablation only group, 94.7%; mechanochemical ablation with phlebectomy group, 100%; P = 1.000) or 1 year (mechanochemical ablation only group, 89.7%; mechanochemical ablation with phlebectomy group, 94.4%; P = 1.000). The groups were also similar in terms of disease-specific quality of life (P = .964), health-related quality of life (P = .337), and the other outcome measures within the study period. ConclusionsThe need for reintervention did not increase and the patients' quality of life and satisfaction with the procedure were similar at 1 year when mechanochemical ablation only was compared with mechanochemical ablation plus phlebectomy.

Outcomes of Saphenous Vein Intervention in the Management of Superficial Venous Incompetence: A Systematic Review and Network Meta-Analysis

To determine the most effective modality of intervention to treat saphenous vein insufficiency.Endovenous therapies have instigated a paradigm shift in the management of superficial venous incompetence. When compared with open surgery, endovenous interventions (foam sclerotherapy, radiofrequency ablation, endovenous laser ablation (EVLA), mechanochemical ablation, and CAE closure) potentially offer reduced morbidity with similar procedural efficacy.A systematic review and series of network meta-analyses of randomized controlled trials were performed assessing risks of procedural failure (within 6-weeks) and recurrence (6-weeks to 5-years), defined by ultrasound, between the different modalities of intervention for superficial venous incompetence. Treatment comparisons addressing risks of common adverse events, venous clinical severity score, and pain were also performed.A systematic search identified 51 articles, describing 36 randomized controlled trials, incorporating 7576 limbs. Outcome data on 10 modalities of intervention were analyzed up to 5-year follow-up. CAE resulted in the lowest risk of procedural failure within 6-weeks. Foam sclerotherapy had the highest risk of recurrence while high ligation with stripping (HLS) and Conservatrice Hemodynamique de l'Insuffisance Veineuse en Ambulatoire were ranked best to reduce long-term recurrence. No intervention increased risks of venous thromboembolism and there was minimal difference in morbidity between treatments. All interventions improved venous clinical severity score (range -1.02 to -4.95), however, radiofrequency ablation demonstrated the greatest improvement, followed by EVLA and HLS between 2 to 5-years. EVLA was associated with the highest risk of pain, while mechanochemical ablation offered the least.Although CAE offered the lowest risk of initial procedural failure, HLS resulted in lower rates of long-term recurrence without considerably increasing morbidity when compared with other endovenous options.

Endovenous ablation of varicose veins current status and overview of methods.

During the last two decades, superficial venous surgery has experienced an unprecedented boom. Traditional surgical procedures (crossectomy and stripping) are now being replaced to a greater or lesser extent by new less invasive endovenous methods. Our aim is to provide an up-todate review of all available endovenous techniques (laser, radiofrequency, steam, mechanochemical ablation and venous glue) describing the indications, the technique and mechanism of action, and the results. In experienced hands, all endovenous techniques are safe and effective, with long-term results comparable to conventional surgical procedures.

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

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. 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. 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. 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.

Third-generation treatment of varicose veins: cyanoacrylate adhesive closure and mechanochemical ablation

Background: The mainstream of incompetent saphenous veins treatment has dramatically changed from the first-generation conventional high ligation and stripping surgery to the second-generation endovenous thermal ablation as a minimally invasive technique using laser or radiofrequency. The third-generation treatment of nonthermal non-tumescent techniques is already available, including cyanoacrylate adhesive closure (CAC) and mechanochemical ablation (MOCA).Current Concepts: The non-thermal non-tumescent techniques are developed to overcome the complications of thermal ablation, including nerve injury and vein perforation. The technique also reduces the need for painful tumescent anesthesia and postoperative compression. MOCA employs a dual injury using a single-catheter-based delivery system consisting of a mechanical abrasion with a rotating wire and chemical ablation with a sclerosant. CAC is executed by injecting a glue that produces a polymer with the blood and obliterates the lumen. CAC does not need tumescent anesthesia and postoperative compression. Therefore, patient recovery is fast and satisfaction is excellent. However, the new devices are expensive and not included in the medical insurance in Korea, and long-term effects of the new treatments are unproven; therefore, the cost-effectiveness is unconfirmed.Discussion and Conclusion: MOCA and CAC are newly developed minimal invasive treatments for varicose veins. They are reported to be safe and effective techniques. However, further studies are needed to evaluate the long-term outcomes and cost-effectiveness.

Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence

Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE). To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment. The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months. Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE. The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores. Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions). To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score. ClinicalTrials.gov Identifier: NCT03392753.

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

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.

Comparing Mechanochemical Ablation to Cyanoacrylate Adhesive for the Truncal Saphenous Veins (MOCCA study)

This was a prospective, multicenter, randomized clinical trial comparing mechanochemical ablation (MOCA) to cyanoacrylate adhesive injection (CAE) in terms of pain profile in patient with primary truncal saphenous vein incompetence using a 100-mm visual analogue scale (VAS).

Treatment of Recurrent Symptomatic Saphenous Trunk Reflux with Catheter Directed Foam Sclerotherapy and Tumescent Anaesthesia

ObjectiveThe aim was to assess short and midterm efficacy and safety of catheter directed foam sclerotherapy (CDFS) with tumescent anaesthesia in patients with recurrent symptomatic saphenous reflux.MethodsThis was a prospective observational study (February 2018 to February 2019) including 21 consecutive patients referred with recurrent symptomatic varicose veins. Standing duplex ultrasound (DUS) with saphenous vein diameter measurement 3 cm from the terminal valve was performed pre-operatively. All the patients were operated on under local anaesthesia. By ultrasound guided puncture a hydrophilic 0.035″ guidewire and 5F Berenstein catheter were inserted through a 5F introducer sheath. Peri-saphenous tumescent anaesthesia (PSTA) was performed under ultrasound guidance. Sclerosant foam was prepared with sodium tetradecyl sulphate 3% or polidocanol 3% using the Tessari method. Concomitant phlebectomies were performed in 52%. Clinical evaluation and DUS were performed pre- and post-operatively at one week, six months, and 12 months.ResultsThere were 11 men and 10 women (median age 52 years; interquartile range [IQR] 43 – 61). The great saphenous vein was treated in 18 patients. The median vein diameter was 6.8 mm (IQR 4.7 – 8.9). Previous procedures were Cure conservatrice et Hemodynamique de l'Insuffisance Veineuse en Ambulatoire (CHIVA), mechanochemical ablation, thermal ablation, and cyanoacrylate closure. The distribution of the clinical class (Clinical Etiology Anatomy Pathophysiology [CEAP] classification) was 16 C2, three C3, and two C4 limbs. Immediate technical success was 100%. There were no complications in the early post-operative period. The median follow up was eight months (IQR 5 – 10). The occlusion rate demonstrated by DUS was 100% (21/21) at one week, 100% (21/21) at six months, and 86% (18/21) at 12 months. The median post-procedural vein diameter at one week, six months, and 12 months was 4.8 mm (IQR 3.9 – 6), 4.3 mm (IQR 3.5 – 5.5), and 4 mm (IQR 3 – 4.9), respectively.ConclusionCombination CDFS with PSTA achieves good short and medium term venous occlusion rates, associated with few complications in patients with recurrent symptomatic saphenous reflux.

СРАВНИТЕЛЬНЫЙ АНАЛИЗ РЕЗУЛЬТАТОВ ЭНДОВЕНОЗНОЙ МЕХАНОХИМИЧЕСКОЙ ОБЛИТЕРАЦИИ БОЛЬШОЙ ПОДКОЖНОЙ ВЕНЫ С ИСПОЛЬЗОВАНИЕМ ПЕНЫ ПОЛИДОКАНОЛА КОМНАТНОЙ ТЕМПЕРАТУРЫ И ОХЛАЖДЕННОЙ

Objective. To conduct a comparative analysis of long-term (3-yars) results of varicose veins treatment by mechanochemical endovenous ablation (MOCA) with using polidocanol foam of room temperature and a chilled one. Methods. The study is based on the treatment results of 122 patients with great saphenous vein (GSV) incompetence. The patients were randomized into 2 groups. In the main group (n=60), mechano-chemical ablation was performed according to original technique, using a cooled sclerosant, 60ᵒ degrees leg elevation and a shin bandage; in the comparison group (n=62) standard technique was used. The median GSV diameter in the main group was Me (Q25; Q75) = 7.4 (5.8; 8.2) mm, in the comparison group - Me (Q25; Q75) = 7.3 (5.6; 8.3) mm (P=0.794). Results. One month after the surgery, the GSV was totally occluded in 100% cases in the main and in 96.7% cases in the comparison group (P=0.496). One year after the surgery, occlusion rates were 94.6% and 80.4% respectively (P=0.042). 3 years later, GSV occlusion was diagnosed in 92.6% cases and in 76.4% cases, respectively (P=0.0033). Hyperpigmentation was reported in 21.7% legs in the main group and 22.6% legs in the comparison group (P>0,99). Transient superficial phlebitis developed in 6.7% and in 8.1% legs, respectively (P=0.744). Conclusion. Endovenous mechanochemical cryoablation is more effective than the standard MOCA technique and can be considered as the most preferable method for eliminating reflux in the GSV. What this paper adds A comparative safety and efficacy of the endovenous mechanochemical cryoablation in comparison with the standard technique to eliminate GSV reflux has been evaluated for the first time. A small number of complications and significant positive dynamics of clinical symptoms were reported in both groups. After 3 years, GSV recanalization rate was 3.2 times higher using the standard technique.

Mechanochemical Endovenous Ablation of the Saphenous Vein: A Look at Contemporary Outcomes

Endovenous ablation techniques have replaced greater saphenous vein (GSV) ligation and stripping for treatment of venous insufficiency. Our objective was to investigate our initial procedural experience and clinical presentation of patients undergoing mechanochemical ablation (MOCA) at a single institution. We hypothesized that closure level and success rate improved over time and were comparable to other endovenous ablation techniques. We retrospectively reviewed all MOCA procedures performed at the Greater Los Angeles Veterans Affairs Hospital from 2015 - 2020. Variables included CEAP and VCSS scores, patient symptoms, post procedure duplex ultrasound, closure level, and need for anticoagulation. Success was defined as GSV thrombosis on initial post procedure duplex ultrasound. Procedure associated extension of thrombus into the deep veins was defined using the American Venous Forum (AVF) endothermal heat induced thrombosis (EHIT) classification. 104 venous ablation procedures were performed on 86 patients. Eleven (12.8%) patients received bilateral interventions, and six (7%) patients had asynchronous interventions on the same leg. The average age was 58.4 years (SD 12) and 93% were male. Pre-procedural symptoms included pain (102, 98.1%), varicose veins (87, 83.7%), edema (58, 55.8%), and active ulcers (19, 18.3%). A CEAP category of C2 was the most common indication (34.6%), followed by C3 (22.1%) and C6 (21.2%). Forty-five (43.2%) patients had deep system reflux, and 53% had concomitant phlebectomies. Average VCSS score was 7.5 (SD 3.5).We observed a GSV ablation rate of 92.7% (n=89) in the 96 procedures which had post-procedure follow up, with no temporal evidence of a learning curve. On post procedure duplex of the 89 technically successful ablations, 77 (86.5%) patients had AVF EHIT level 1 closure, three (3.4%) had level 2 closure, eight (8.9%) had level 3 closure, and one had a level 4 closure. Fourteen (15.7%) patients were newly started on anticoagulation for an average of 33.2 days (SD 34.1). Of the 19 legs treated for active venous ulcers, 13 (68.4%) had improvement or resolution of their venous ulcers. No pulmonary embolic complications were reported. We observed a successful GSV thrombosis rate of 92.7% using MOCA without evidence of a learning curve and comparable to that reported in the literature. The rate of thrombus extension into the deep veins was 14.6%, with no adverse effects associated with anticoagulation or clinically significant sequelae of AVF EHIT level 2 or greater. Comparisons with MOCA associated thrombus extension into deep veins in the literature are limited as post procedure screening duplex are not standard of care. However, we demonstrated that MOCA ablation of the GSV is a safe procedure that may be performed with good technical success.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

BackgroundThe purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). MethodsWe performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. ResultsFrom 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). ConclusionsThe results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

THERMAL AND NON-THERMAL METHODS OF TREATMENT OF PATIENTS WITH PRIMARY VARICOSЕ DISEASES OF THE LOWER LIMBS OF STAGE C2

Abstract. Treatment results of primary varicose disorders has been shown. The experience of using of thermal (endovenous laser ablation) and non-thermal methods (endovenous mechanochemical ablation, echo-controlled introduction of bioglue) in treatment of stage C2 chronic venous is shown. The purpose of this work is to evaluate the efficiency of endovenous ablation techniques. The treatment of 58 patients was analyzed. In the group of patients who underwent endovenous laser obliteration, reflux was not detected. In the group of patients with mechanochemical obliteration, reflux was determined in 3 patients (27.2%) at follow-up after 3 months required supplementation with foam sclerobliteration. In the group of patients with the introduction of bio glue, reflux was determined in 1 patient (20%) at the examination after 3 months. The received results lead to conclusion, that endovenous laser coagulation of affected veins is a reliable method of threatment, the gold standard. The advantage of non-thermal methods is the absence of thermal effects on the paravenous structures, respectively, patients have no pain during the procedure, increases comfort, and there is no risk of damage to the paravenous nerves. Another advantage of non-thermal techniques is no need to use of tumescent anesthesia, since only one puncture is required for the operation, which is comfortable for patients. The use of adhesive vein obliteration is justified in patients with signs of a short reflux duration and has an advantage for the patient due to the absence of the need for compression in the postoperative period. Non-thermal methods require further research and widespread implementation in practice.

Endovenous Laser Ablation, Radiofrequency Ablation and Flebogrif versus Conventional Surgery in Treatment of Primary Varicose Vein of the Lower Limb: Prospective Randomized Controlled Study

Background: Endovenous laser ablation (EVLA), radiofrequency ablation (RFA) and mechanochemical ablation (MOCA) of primary varicose vein are thought to minimise postoperative morbidity and reduce work loss compared with the conventional surgical procedure. Objective: To determine, whether endovenous ablation methods (radiofrequency, laser and mechanochemical) have any advantages or disadvantages in comparison with conventional surgery, in the treatment of primary varicose vein. Patients and Methods: This was a prospective randomized study,conductedonforty patients presented at Vascular Outpatient Clinic for management of chronic venous insufficiency. All patients underwent clinical examination and duplex ultrasonography. Ten (10) patients were treated with ligation and stripping of the great saphenous vein (GSV). Ten (10) patients were treated with radiofrequency ablation. Ten (10) patients were treated with endovenous laser ablation. Ten (10) patients were treated with Flebogrif. Results: Compared with conventional surgery, endovenous ablation methods reduced postoperative discomfort and pain, with a lower complication rate after treatment for avoidance of a groin incision and dissection at the saphenofemoral confluence. Cosmetic demands were also better satisfied. Non-controlled clinical trials have shown that the ablation rate of GSV after EVLA is over 90%. However, risks of EVLA, RFA and Flebogrif remain in terms of recanalization and neoreflux via junctional tributaries. Conclusion: RFA, EVLA, and Flebogrif are minimally invasive procedures. Their potential early benefits, by avoiding groin dissection and GSV stripping, have been confirmed by the findings from this trial. Current evidence based on randomized trials consistently demonstrates significant early benefits after RFA, EVLA and Flebogrif in suitable patients with varicose veins.

Comparison of mechanochemical ablation versus ligation and stripping for the treatment of incompetent small saphenous vein.

to compare the outcomes of mechanochemical ablation (MOCA) versus saphenopopliteal junction ligation and stripping (OS) for symptomatic small saphenous vein (SSV) insufficiency. This is a retrospective study including symptomatic SSV patients treated with MOCA using the ClariVein catheter (Merit Medical, South Jordan, Utah, USA) or OS from 2015 to 2019. A total of 60 limbs (73.3% women, mean age 54.7 ± 14.4 years) were treated with MOCA and 58 limbs (63.8% women, mean age 54 ± 11.6 years) with OS. At 18 months follow-up, recurrence rates were 7.5% (4/53) for MOCA vs. 5.7% (3/52) for the OS group. MOCA group was associated with less pain at first postoperative day, and an early return to work (MOCA 3.5 ± 2.3 days vs. OS 14.2 ± 3.8 days, p < .0001). No cases of leg paresthesia/dysesthesia were observed in the MOCA group, while two patients (3.4%) presented neurological symptoms after OS treatment. MOCA and OS are both safe and effective techniques for symptomatic SSV insufficiency. MOCA group demonstrated to be associated with less postoperative pain and early return to work compared to OS.

Interventions for great saphenous vein incompetence.

Interventions for great saphenous vein incompetence.

Utility of compression immediately after venous closure: Does it matter?

Leg compression after venous closures for 24-48 hours or longer is commonplace and controversial. The goal of our study was to evaluate compression immediately post-venous closures and its associated costs. Records were retrospectively reviewed after consecutive therapies of sclerotherapy, mechanochemical ablation (MOCA) & radiofrequency ablation (RFA) from 1 clinic with 2 cohorts: 7/2/13-10/15/15 were immediately ACE-wrapped for 3-5 days (AW, N = 52) and 10/20/15-1/5/16 were non ACE-wrapped (NAW, N = 49). All procedures were performed in an outpatient office setting of one surgeon (P.L.). Follow-up was within 1 week and 3 months with ultrasounds. Financial data of ACE wraps and ABD pads were assessed. Closures consisted of consecutive therapies of sclerotherapy (4 patients); MOCA (44 patients) and RFA (53 patients). No statistical difference existed in age (p = 0.61), sex (p = 0.2063); race (0.3689), CAD (p = 0.1442), ESRD (p = 0.2914), diabetes mellitus (p = 0.8943), hypertension (p = 0.681), COPD (p = 0.38), or smoking (p = 0.3628). NAW group had higher rate of hyperlipidemia (p = 0.0225), obesity (p = 0.0283), MOCA and sclerotherapy (p = 0.0005). No difference existed in pain (p = 0.8897); wound complications were too small to perform analysis; and swelling was greater in AW group compared to NAW group (p = 0.0132, OR 3.3951, CI 1.269; 9.0834). Closure rates were 98% and 100% in AW and NAW groups, respectively. NAW were only a total cost savings of $1.58 per leg per procedure. AW for compression after vein closures confers no benefit in postoperative period with no effect on closure rates; may be associated with increased swelling, discomfort, and wound complications while increasing unnecessary and negligible monetary costs. Larger sample size is needed to validate these conclusions.

Choosing the Best Treatment Approach for Axial Vein Reflux: Thermal versus Nonthermal Approaches.

Chronic venous insufficiency is a common and treatable medical condition which has a high morbidity if left untreated, progressing to lower extremity edema, skin changes of lipodermatosclerosis, and venous ulceration. Treatment options have significantly expanded over the last several decades, shifting away from the traditional surgical approach to more minimally invasive procedures such as endoluminal venous laser ablation or radiofrequency ablation. Even more recently, several techniques using nonthermal methods to ablate varicose veins have been developed, which offer the advantage of not requiring labor-intensive and painful tumescent anesthesia to protect the surrounding tissues. These techniques include mechanochemical ablation, cyanoacrylate closure, or polidocanol microfoam injection and can be offered to a wider range of patients without the need for sedation while offering similar closure rates and improved postprocedure symptom profile. Furthermore, certain patient characteristics which might preclude or complicate the use of thermal ablation methods might not pose a problem with nonthermal nontumescent methods.

Efficacy of Micronized Purified Flavonoid Fraction-Based Venoactive Therapy After Endovenous Mechanochemical Obliteration: Prospective Comparative Study

BackgroundEndovenous interventions and minimally invasive open procedures are effective in the management of varicose veins, but can result in post-operative pain/discomfort.ObjectiveThe objective of this study was to evaluate the clinical efficacy of micronized purified flavonoid fraction venoactive therapy for postoperative pain, vein-specific symptoms, and quality of life in patients with varicose veins following an endovenous mechanochemical ablation procedure.MethodsThis prospective, observational, single-center study allocated patients into two groups: Group A, micronized purified flavonoid fraction 1000 mg once daily for 30 days; Group B, no venoactive drug prescribed (control). The Clinical-Etiology-Anatomy-Pathophysiology classification system for chronic venous disorders was used to assess varicose veins; a 10-point Visual Analog Scale assessed pain syndrome intensity; the Venous Clinical Severity Score measured overall varicose vein severity; and the Chronic Venous Insufficiency QoL Questionnaire measured total quality of life.ResultsThe study enrolled 58 patients (mean age 36.9 ± 4.1 years; 24 men) with varicose veins of C2–C4 who underwent truncal mechanochemical ablation plus mini-phlebectomy or foam sclerotherapy. Group A had significantly lower pain syndrome at days 14 and 30 compared with Group B (1.76 vs 2.20, p = 0.039; 1.38 vs 2.07, p = 0.003, respectively), and clinical symptom severity at day 30 (2.67 vs 3.13, p = 0.05). Significant differences in quality-of-life scores existed between groups at days 14 and 30 (15.21 vs 18.75, p = 0.008; 12.98 vs 16.33, p = 0.001). No micronized, purified flavonoid, fraction-related adverse effects were observed.ConclusionsMicronized purified flavonoid fraction-based venoactive adjuvant therapy after mechanochemical ablation alleviated pain, reduced the severity of symptoms, and improved the quality of life in patients with varicose veins.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40801-021-00249-4.