Anwendbare CPT / HCPCS / ICD-10 Codes
Scope of Policy
This Clinical Policy Bulletin addresses the treatment of varicose veins.
- Aetna considers the following procedures to be medically necessary to treat varicose veins when the following criteria are met:
- V. saphena magna or V. saphena parva Ligatur/Teilung/Stripping,
- high-frequency intravenous occlusion (VNUS procedure) and
- endovenous saphenous vein laser ablation (ELAS) (also known as endovenous laser resurfacing (EVLT)).
Insufficiency at the saphenofemoral or saphenopopliteal junction is documented by recent Doppler or duplex ultrasound (performed within the last 6 months)allthe following criteria are met:
- Ultrasound documented junctional reflux durations of 500 milliseconds (ms) or longer in the saphenofemoral or saphenopopliteal vein being treated;e
- Vein size is 4.5 mm or more in diameter measured by ultrasound below the saphenofemoral or saphenopopliteal junction (not valve diameter at junction);e
- These are saphenous varicose veins.anyof the following:
- Intractable ulceration due to venous stasis;or
- More than 1 episode of light bleeding from a ruptured superficial varicose vein or a single significant bleed from a ruptured superficial varicose vein, particularly when a blood transfusion is required;or
- These are saphenous varicose veins.anyof the following and symptoms persist despite a 3-month study with conservative treatmentfootnote1*(including pain relievers and prescription compression stockings with gradient support):
- recurrent superficial thrombophlebitis;or
- Severe, persistent pain and swelling that interferes with activities of daily living and requires chronic pain relief medication.
footnote1*Use: No attempt at conservative treatment is necessary in individuals with persistent or recurrent varicose veins who have already undergone IV catheter ablation or removal/separation/ligation in the same leg, as conservative treatment is unlikely to be successful in this situation.
Surgical ligations (including endoscopic subfascial perforating vein surgery (SEPS)) or endovenous ablation procedures are considered medically necessary for the treatment of incompetent perforating veins whenallof the following are catered for:
- diameter of the perforating vein, measured by recent ultrasound, equal to or greater than 3.5 mm;e
- external stream duration of 500 ms or more;e
- The perforating vein is located under an active or healed venous stasis ulcer (also known as CEAP C5 or C6). To seeaccessory.
Endovenous ablation procedures are considered clinically necessary adjunctive treatment of symptomatic accessory saphenous veins for individuals who meet the above medical need criteria for endovenous ablation;e
- who are being treated or have been previously treated for insufficiency (ie, reflux) at the saphenofemoral or saphenopopliteal junction;e
- persistent anatomic junctional reflux is demonstrated after removal or ablation of the greater or lesser saphenous veins.
Use:Initially, if criteria are met, endovenous ablation therapy of the first and second and subsequent veins in each affected extremity is considered clinically necessary.Use: Therefore, a primary code and a secondary code for each affected leg are considered clinically necessary for initial IV ablation treatment.
Use: Additional endovenous ablation therapy is considered clinically necessary in individuals with persistent or recurrent junctional reflux of the great saphenous vein, small saphenous vein after initial endovenous ablation therapy. To authorize further IV ablation, the limb must be documented as having ongoing symptoms and the ultrasound showing persistent junctional reflux. Additional endovenous ablation therapy may also be required for the treatment of accessory saphenous veins, as noted above. These procedures are considered experimental and proven procedures for the treatment of varicose veins and accessory veins other than the accessory saphenous vein. These procedures are considered cosmetic for all other indications.
Use: Doppler or duplex ultrasonography is considered necessary before treatment of varicose veins to assess the anatomy and determine if there is significant reflux at the saphenofemoral or saphenopopliteal junction that requires surgical repair and after completion of treatment to assess the success of the procedure to determine and prove thrombosis . Ultrasound guidance includes VNUS or ELAS procedures.
Use: The term endovenous catheter ablation (EVCA) is a nonspecific term that refers to a number of minimally invasive catheter-based alternatives to surgical removal, such as: When assessing the medical need for EVCA, reference should be made to the specific technique used.
Aetna considers liquid or foam sclerotherapy (intravenous chemical ablation) (eg, Varithena) as a clinically necessary adjunctive treatment of symptomatic truncal, varicose, accessory, and perforating veins for individuals who meet medical need criteria for treatment of varicose veins in the Section A above andBoththe following criteria are met:
- Vein size is 2.5 mm or more in diameter as measured by recent ultrasound;e
- The limb is being treated or has been previously treated for insufficiency (ie, reflux) at the saphenofemoral or saphenopopliteal junction with one or more of the procedures listed in Section A above.Observation:Varithena has not proven to be more effective than other methods of foam sclerotherapy.
Use: As ultrasound-guided or duplex sclerotherapy techniques have not been shown to definitively increase the efficacy or safety of this procedure, these tests are considered clinically necessary only when initially performed to determine the extent and configuration of varicose veins.
Observation:Ultrasound or radiologically guided or monitoring techniques have no proven value when used only to guide the needle or introduce the sclerosant into varicose veins.
Use: The number of medically necessary sclerotherapy injections varies according to the number of anatomical areas to be injected and the response to each injection. Typically, 1 to 3 injections are required to sclerolate a vessel, and 10 to 40 vessels or a series of up to 20 injections into each leg can be treated during one treatment session. Initially, up to two sets of injections of the sclerosing solution into multiple veins in each affected leg (i.e. a total of four sets of injections if both legs are affected) are considered medically necessary if the criteria are met.Use: An injection series is defined as multiple sclerotherapy injections during a treatment session. In individuals with persistent or recurrent symptoms, additional sets of sclerosing solution injections are considered medically necessary.
Aetna considers ambulatory phlebectomy or transilluminated powered phlebectomy (TriVexSystem) as a clinically necessary adjunctive treatment of symptomatic saphenous, varicose, accessory, and perforating veins for individuals who meet the medical necessity criteria for treatment of varicose veins in Section A above andBoththe following criteria are met:
- Vein size is 2.5 mm or more in diameter;e
- The limb is being treated or has been previously treated for incompetence (ie, reflux) at the saphenofemoral or saphenopopliteal junction with one or more of the procedures listed in Section A above.
Use:Initially, up to two multiple phlebectomy incisions in each affected limb (ie, a total of four multiple incisions if both legs are affected) are considered medically necessary if the criteria are met. Multiple additional phlebectomy incisions are considered medically necessary in individuals with persistent or recurrent symptoms.Use: A series of puncture phlebectomy incisions is defined as multiple puncture phlebectomy incisions during one treatment session.
Aetna considers valve reconstruction clinically necessary in chronic venous insufficiency.
- Aetna considers the following procedures to be medically necessary to treat varicose veins when the following criteria are met:
experimental and investigative
The following procedures are considered experimental and investigational as they have not been shown to be as effective as established alternatives in comparative studies or have not been demonstrated for the listed indications:
- Ambulatory phlebectomy or electrical X-ray phlebectomy to treat junctional reflux;
- endomechanical or mechanochemical ablation (MOCA) (eg, ClariVein);
- Micronized purified flavonoid fraction;
- sclerotherapy for treatment of iliac vein reflux, saphenofemoral junction or saphenopopliteal junction; Sclerotherapy alone has not been shown to be effective in individuals with saphenofemoral or saphenopopliteal junction reflux; According to established guidelines, individuals with reflux should also be treated with intravenous ablation, ligation, or ligation transection to reduce the risk of variceal recurrence.Use: Gel sclerotherapy of the ovarian veins with the internal iliac veins is considered medically necessary for the treatment of pelvic congestion syndromeCPB 0441 - Pelvic Congestion Syndrome: Treatments;
- Transdermal laser treatment of large varicose veins;Use: Although the transdermal Nd:YAG laser has been shown to be effective in the treatment of telangiectasias and reticular veins, the treatment of these small veins is considered cosmetic;
- VeinGogh ohmic thermolysis system;
- Use of medical grade adhesive (also known as cyanoacrylate superglue, n-butyl cyanoacrylate) (eg, VariClose Vein Sealing System, VenaSeal Closure System) to treat varicose veins;
- Polymorphism genotyping of matrix metalloproteinase genes (eg, MMP1, MMP2, MMP3, and MMP7) as markers of predisposition to varicose veins;
- Synthetic matrix metalloproteinase inhibitors;
- Measurements of plasma growth factors (eg, angiopoietin-1 (ANG1), angiopoietin-2 (ANG2), epidermal growth factor (EGF), platelet-derived growth factor (PDGF), and vascular endothelial growth factor (VEGF) ) to predict treatment suitability and possibility of recurrence of varicose veins before and after treatment with endovenous laser ablation;
- Endovenous ablation (laser or radiofrequency) to treat common femoral vein reflux;
- VeinOPlus vascular device for the treatment of muscle atrophy due to varicose veins;
- Outpatient selective varicose vein ablation under local anesthesia (ASVAL procedure) for the treatment of symptomatic great saphenous vein;
- External valvuloplasty for the treatment of symptomatic great saphenous vein.
Endovenous ablation procedures are considered experimental and investigational for the treatment of varicose veins and accessory veins other than the accessory saphenous vein.
The following procedures are considered cosmetic because they are used to treat small veins that don't cause painful bleeding, ulcers, or other medical problems:
- Photothermal sclerosis (also called intense pulsed light source, eg PhotoDerm VascuLight, VeinLase), used to treat small veins such as small varicose veins and spider veins;
- Sclerotherapy for the treatment of veins less than 2.5 mm in diameter and for all other indications;
- Ambulatory phlebectomy and the TriVex system for veins less than 2.5 mm in diameter and all other indications;Use: Transilluminated motor phlebectomy has not been shown to be superior to other methods of removing varicose veins; therefore, the TriVex procedure should be considered like any other varicose vein removal procedure;
- Asclera-Polydocanol-Injection;Use: Although Asclera has been approved by the Food and Drug Administration (FDA) for the treatment of telangiectasia and reticular veins less than 3 mm in diameter, the treatment of these small veins is considered cosmetic.
Endovenous ablation procedures are considered cosmetic for all indications other than those listed in Section I of the Guideline.
- CPB 0100 - Cryoablation
- CPB 0441 - Pelvic Congestion Syndrome: Treatments
Varicose veins are a common condition. In the adult Western population, visible varicose veins are present in 20 to 25% of women and 10 to 15% of men. For most people, varicose veins don't cause any symptoms other than looking bad. Varicose vein surgery is one of the most commonly performed cosmetic procedures in the United States.
Most varicose veins do not require medical treatment (Tapley et al, 2003). However, in some cases, blood flow may be so restricted that you experience swelling in your feet and ankles, discomfort, tingling, or a feeling of heaviness. For most people with varicose veins, wearing specially fitted elastic stockings is sufficient. Socks should be carefully fitted to the person and put the most pressure on the lower leg. Socks should be put on as soon as you get up in the morning, preferably before you get up. Exercises such as walking or cycling also contribute to better blood flow to the lower body. Lying down with your legs raised promotes blood circulation; On the other hand, sitting cross-legged can make the condition worse. Authorities have recommended 6 months or longer as a reasonable time to try conservative treatment (NHS, 2005).
A significant proportion of varicose vein symptoms respond to conservative treatment. A randomized controlled clinical trial compared surgery (n=124) with conservative treatment (n=122) of varicose veins (Michaels et al., 2006). Conservative treatment consisted of lifestyle counseling regarding exercise, leg elevation, weight and diet management, and use of compression stockings. In the surgical arm of the study, patients received the same lifestyle advice but underwent additional surgical treatment consisting of irrigation ligation of reflux sites, removal of the long saphenous vein, and multiple phlebectomies as needed. Although a greater proportion of patients were referred for surgery plus lifestyle counseling for symptom relief at 1 year, approximately one-third of patients referred for conservative treatment reported some relief from conservative treatment with compression stockings. At 2 years, there was no significant difference in symptom improvement between groups assigned to conservative treatment versus surgery. The authors postulated that the lack of significant difference in symptomatology between the groups at 2 years may be due to crossovers, with 7 patients in the conservative treatment group opting for surgery in year 1 and 37 patients opting for surgery in year 1 2 The study also found that individuals assigned to surgery plus lifestyle counseling had greater cosmetic and quality of life improvements than individuals assigned to lifestyle counseling alone, although it is not known whether improvements in quality of life were primarily associated with cosmetic improvements versus a reduction in symptomatology related to quality of life. Study weaknesses included a significant loss to follow-up in all groups. Fifteen of the 124 patients who were referred for surgery either declined surgery in favor of conservative treatment or declined surgery because of physical condition. Of the 109 remaining operated patients, 43 could not be followed up until the first year. Of the patients referred for conservative treatment, 21 were not followed up in the first year. The authors observed that, although surgery was more effective in improving symptoms at 1 year, a significant proportion of patients undergoing conservative treatment reported resolution or improvement in pain (26%), heaviness (46%), pruritus ( 56%) and pruritus reported swelling (68%). Furthermore, a significant proportion of those allocated to conservative treatment reported improvements in cosmetics. “In fact, 22% of the latter said they no longer had aesthetic concerns. These observations suggest a significant benefit from surgery, but may support careful assessment of patients' symptoms and concerns when considering surgical treatment."
One editorialist noted that the short follow-up of patients referred for surgery can lead to an underestimation of the costs and an exaggeration of the benefits of surgery (van Rij, 2006). By the third year, only 40% of subjects assigned to surgery in the study by Michaels et al. examined. However, the editor noted that most recurrences are diagnosed after 3 years. Focusing on the short term can lead to an underestimation of costs and an overestimation of benefits. The editor noted that prospective comparisons of durability of up to 5 years or longer are rare, and yet the recurrence rate at that point can be as high as 50%.
In patients with varicose veins, leg pain may be associated with superficial thrombophlebitis or venous leg ulcers. When evaluating the role of varicose vein surgery in the treatment of these conditions, the effectiveness of varicose vein surgery versus conservative treatment should be compared.
If the patient has superficial thrombophlebitis, conservative treatment is indicated. According to existing guidelines, uncomplicated superficial thrombophlebitis is usually treated symptomatically with heat, simple analgesia, nonsteroidal anti-inflammatory drugs (NSAIDs), and compression stockings. Treatment should be continued until symptoms have completely disappeared (usually 2 to 6 weeks for resolution, but the thrombosed vein may be palpable and tender for months). More severe thrombophlebitis should be treated with bed rest with elevation of the limb and application of warm, moist compresses, as indicated by the degree of pain and redness and extent of the abnormality.
Leg ulcers that result from problems with the veins are called venous ulcers (varicose veins or stasis). The main conservative treatment was to put a firm compression garment (bandage or stocking) on the lower leg to help blood flow back into the leg. Culum et al. (2002) performed a meta-analysis of the literature on the effectiveness of bandages and compression stockings in the treatment of varicose leg ulcers. The authors concluded that compression increases ulcer healing rates compared with no compression. The authors also found that multi-layer systems are more effective than single-layer systems. High compression is more effective than low compression, but there are no clear differences in the effectiveness of different types of high compression. In a meta-analysis, Nelson et al. (2002) Circumstantial Evidence of Benefit of Compression in Reducing Varicose Recurrence. The authors also noted that recurrence rates may be lower with high compression stockings than with medium compression stockings, and therefore, patients should be offered the highest level of compression they can maintain.
In a study conducted at 20 centers in the United Kingdom and funded by the Health Technology Assessment Program of the National Institute for Health Research, Gohel et al. (2019) randomized 450 patients with venous leg ulcers to receive compression therapy and early intravenous ablation of superficial venous reflux within 2 weeks of randomization (early intervention group) or compression therapy alone, with intravenous ablation delayed until after ulcer healing or up to 6 months after randomization if the ulcer had not healed (delayed intervention group). The primary outcome measure was ulcer healing time. Secondary outcomes were ulcer healing rate at 24 weeks, ulcer recurrence rate, duration of ulcer-free time (ulcer-free time) in the first year after randomization, and patient-reported health-related quality of life. Patient and baseline clinical characteristics were similar in the two treatment groups. Ulcer healing time was shorter in the early intervention group than in the late intervention group; more patients healed ulcers with early intervention (hazard ratio for ulcer healing 1.38; 95% confidence interval [CI] 1.13 to 1.68; p = 0.001). Median ulcer healing time was 56 days (95% CI, 49 to 66) in the early intervention group and 82 days (95% CI, 69 to 92) in the late intervention group. The ulcer healing rate at 24 weeks was 85.6% in the early intervention group and 76.3% in the late intervention group. The median ulcer-free time during the first year after enrollment was 306 days (interquartile range 240 to 328) in the early intervention group and 278 days (interquartile range 175 to 324) in the late intervention group (P = 0.002). The most common procedural complications of endovenous ablation were pain and deep vein thrombosis. Early intravenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and a longer ulcer-free time than late intravenous ablation.
A review (Weiß, et al., 2019) found that the weaknesses of Gohel, et al. it is
- the relatively small (2-3 cm2) Ulcers not representative of common ulcers in inpatient/outpatient wound care facilities,
- the duration of the ulcer is very short (~3 months) compared to real-life situations where patients have long-lasting ulcers,
- the study population is almost exclusively white, and
- venous ulcers are included exclusively, while many ulcers result from a combination of venous and arterial problems.
The reviewers concluded: "Randomized controlled trials of sufficient power and high quality comparing the three available treatment options - compression, conventional venous surgery and intravenous treatment - are still needed. They should measure and report outcomes that include time to ulcer healing, ulcer recurrence, side effects, quality of life and cost-effectiveness”.
Powerful, high-quality randomized controlled trials comparing the three available treatment options - compression, conventional venous surgery and intravenous treatment - are still needed. These should measure and report outcomes that include time to ulcer healing, ulcer recurrence, adverse events, quality of life, and cost-effectiveness.
According to a systematic review of the evidence, pentoxifylline has also been shown to be effective in the treatment of venous leg ulcers (Nelson et al., 2002). According to systematic review of evidence, compression has been shown to prevent venous leg ulcers. The effectiveness of venous surgery to prevent or treat venous ulcers is "unknown" (Nelson et al, 2002).
In addition to conservative therapy, treatment for varicose veins in the lower legs includes injection/compression sclerotherapy and surgical removal or ligation, or a combination of these approaches, depending on the severity of the condition. Despite many years of experience, there is still a disappointingly high rate of varicose vein recurrence, as many patients are inadequately evaluated prior to treatment. As physical examination alone is unreliable, prior to treatment, Doppler or duplex ultrasonography should be performed to locate sites of insufficiency to allow for individual treatment strategy for each patient. Photographs or office charts can be helpful in assessing the size and extent of varicose veins.
According to established guidelines, the key to successful treatment is to eliminate both primary and secondary sources of reflux. These sources are usually a nearby perforator or, more commonly, a large junction causing shunted venous return through veins with intact valves.
Sclerotherapy has been found to be most effective in patients with enlarged superficial or residual varices, recurrent varices, or incompetent perforating veins of small to moderate size (less than 6 mm) without venous reflux. Rosenberg, 2006; MSAC, 2011; MA, 2011). Accidental intra-arterial injection was an unfavorable consequence of sclerotherapy. Almost all cases of painful varicose veins are associated with junctional reflux. When reflux is present at the saphenofemoral and/or saphenopopliteal junctions, accepted guidelines state that sclerotherapy should not be performed until the junction has been surgically ligated and transected. The junctions themselves cannot be adequately treated with sclerotherapy because junctional reflux must be treated by methods of intravenous ablation or surgical ligation or removal (Jakobsen, 1979; MSAC, 2008; MSAC, 2011). Although varices may occasionally be present in absence or reflux, there is no reliable clinical trial evidence of the effectiveness of sclerotherapy in relieving symptomatic varices not associated with junctional reflux. The only randomized controlled clinical trial (n=25) that investigated the effectiveness of sclerotherapy in varicose veins not associated with junctional reflux (Kalheand Leng, 2004) evaluated the effectiveness of sclerotherapy in variceal sclerotherapy, but did not review its efficacy in pain relief. Although sclerotherapy can be used to treat visible subcuticular veins (i.e. spider veins and telangiectasias) less than 2.5 mm in size, these small veins do not cause symptoms and their treatment is purely cosmetic (MSAC, 2011).
Doppler ultrasonography is often used in conjunction with other non-invasive physiologic tests to characterize the anatomy and physiology of the varicose vein network prior to an injection or surgical procedure. However, sometimes duplex scans are also used during the sclerotherapy procedure itself. Its purported usefulness in this regard includes locating deep or otherwise inaccessible injection sites, e.g. B. in extensive networks of large deep varices, areas with significant reflux between superficial and deep systems, or risks to arterial structures. Ultrasound was also used to monitor the effectiveness of compression sclerotherapy in obliterating the lumen of the target vein and reducing reflux/retrograde flow. However, these indications are not scientifically validated. There is little evidence, in the form of prospective randomized clinical trials, that ultrasound makes a significant difference in optimizing outcome or reducing complications in varicose vein sclerotherapy compared to non-ultrasound-guided techniques. A structured review of the evidence conducted by the Alberta Heritage Foundation for Medical Research (AHFMR) (2003) concluded that “the reviewed evidence does not adequately answer the questions; which sclerosant is superior and which technique is most effective with or without ultrasound guidance.”
Venous reflux can be induced manually by compressing and releasing the calf muscle, by the Valsalva maneuver or by releasing the pneumatic tourniquet (Markovic & Shortell, 2014). If there is saphenofemoral reflux lasting longer than 500 ms, the diameter of the great saphenous vein (GSV) is recorded 2.5 cm distal to the saphenofemoral junction. Vein size was correlated with the presence of significant saphenous reflux. The compliant GSV adjusts its lumen size to the level of transmural pressure, and measurement of its diameter has been shown to reflect the severity of hemodynamic compromise in limbs with GSV reflux. In a cohort study, Navarro et al. (2002) evaluated the relationship between femoral and calf GSV diameter and severity of clinical reflux in 112 legs of 85 consecutive patients with saphenofemoral junction insufficiency and trunk GSV. The authors state that they found that GSV diameter proved to be a relatively accurate measure of hemodynamic compromise and clinical severity in a model of saphenofemoral junction and GSV incompetence, not only the absence of abnormal reflux, but also the presence of venous blood. critical predicted incompetence. A GSV diameter of 5.5 mm or less predicted the absence of abnormal reflux with a sensitivity of 78%, specificity of 87%, positive and negative predictive values of 78%, and accuracy of 82%.
Ligation and transection of the saphenofemoral and/or saphenopopliteal junction are indicated in patients with symptomatic varicose veins who have failed conservative treatment when reflux for more than 0.5 seconds is demonstrated by Doppler examination or duplex scan. The literature states that surgical excision of varicose veins in the legs should be reserved for those that are very large (greater than 6 mm), widely distributed or present in large clusters. Ligation alone usually results in a high rate of varicose vein recurrence, which may then require sclerotherapy (MSAC, 2008). Extirpation of the great and/or small saphenous veins together with the ligation and division of their respective junctions is indicated when the saphenous veins themselves show varicose changes (generally greater than 1 cm in diameter). Surgery for varicose veins and/or sclerotherapy during pregnancy is not appropriate because dilation of the leg veins is physiological and will return to normal after delivery, at which time a more accurate assessment can be made. Visible subcutaneous veins (ie spider angiomas and telangiectasias) less than 2.5 mm in size do not cause symptoms and their treatment is purely cosmetic.
Ambulatory (AP) phlebectomy (also known as microphlebectomy) is a minimally invasive procedure performed under local anesthesia and is an accepted outpatient therapy for the removal of varicose veins. This treatment allows excision of almost all major varices, except for the proximal long saphenous vein, which is more manageable with stripping. Varicose veins without reflux on the surface of the legs, with the exception of trunk veins, can be treated on an outpatient basis under local anesthesia using outpatient phlebectomy (MSAC, 2011). However, recurrence rates can be high if the source of reflux is not treated (MSAC, 2011). The junctions themselves cannot be treated with a simple phlebectomy, as junctional reflux must be treated by methods of intravenous ablation or, rarely, surgical ligation and removal (MSAC, 2011; Weiss, 2007). Patients can go to AP immediately. Complications associated with PA include blistering, localized thrombophlebitis, skin necrosis, bleeding, and persistent edema. Use of wide compression pads after AP reduces bleeding and improves absorption.
The TriVex (ray phlebectomy) system is an alternative method to outpatient phlebectomy. This involves endoscopic resection and ablation of the superficial veins using a motorized vein illuminator and rejector, a small motorized surgical device. In this procedure, veins are marked with a magic marker. To make the veins more visible, a bright light is inserted into the leg through a small incision. The motorized vein deflector, which has a motorized swinging end, is then inserted to cut and remove the veins. Pieces of veins are carefully retrieved by suction through a tube. Transilluminated motor phlebectomy is usually performed in the hospital on an outpatient basis and under general or local anesthesia with sedation.
The manufacturer of the TriVex system claims that the unique lighting feature allows the surgeon to quickly and accurately target and remove the vein, then visually confirm its complete extraction. The manufacturer claims that this new procedure makes the removal of varicose veins more effective, more complete and less traumatic for patients, reducing the number of incisions needed to perform the procedure and the duration of surgery. The manufacturer also claims that this method not only reduces the pain associated with removing varicose veins, but also reduces the potential for post-operative infections. However, there is not enough evidence in published and peer-reviewed medical literature to support these claims. The potential benefits of the TriVex System over standard outpatient phlebectomy have not been established. Therefore, the TriVex procedure should be billed like any other varicose vein removal procedure.
The term intravenous catheter ablation (EVCA) has been used to refer to several new minimally invasive catheter-based alternatives to surgical removal, including laser ablation and radiofrequency ablation. Endovenous catheter ablation and surgical ligation/peeling are indicated for the treatment of the same general population: patients who have reflux or insufficiency of the small and/or small saphenous veins for 0.5 seconds or more, as detected on the duplex scan, and symptoms of varicose veins significantly affect quality of life (MSAC, 2011). In these patients, conservative treatment options have been exhausted and sclerotherapy is considered unsuccessful. Endovenous laser ablation and radiofrequency ablation are essentially the same, except for the use of different specialized equipment and catheters, with thermal energy being delivered through a radiofrequency catheter or laser fiber. The objectives of both treatments are the same, that is, to destroy or ablate a vein or vein segment with reflux through the application of thermal energy. The procedure for placing the catheter in the vein is the same for radiofrequency ablation and endovenous laser ablation, and both procedures are performed under duplex ultrasound guidance. The physiological mechanism of venous ablation is also the same, with thermal energy producing endothelial and venous wall damage, denaturing and occluding the vein to close the vein, eliminating venous reflux and visible varicose veins.
ECVA is performed with tumescent anesthesia (Markovic & Shortell, 2014). Tumescent anesthesia allows clinicians to use large volumes (500 mL) of diluted (0.1%) lidocaine in a single session while achieving levels of anesthesia equivalent to those achieved with 1% lidocaine. This allows the entire thigh portion of the GSV to be safely anesthetized (and consequently obliterated) at one time. Epinephrine can be added to the solution to improve postoperative hemostasis, increase venous contraction around the heat-generating catheter, and prolong the duration of postoperative analgesia. A common formula for the tumescent anesthetic solution is 450 mL of saline mixed with 50 mL of 1% lidocaine with epinephrine (1:100,000 dilution) and 10 mL of sodium bicarbonate to buffer the acidity of the lidocaine.
Endovenous saphenous vein laser ablation (ELAS) is a treatment alternative to surgical ligation and stripping of the saphenous vein. Endovenous laser therapy of varicose veins is indicated in patients with clinically documented primary venous reflux, confirmed by duplex ultrasound, of the great or small saphenous veins (MSAC, 2008). Endovenous laser ablation is only suitable for patients with large saphenous veins, as the catheter requires saphenous veins with a diameter of at least 4.5 mm. These patients have exhausted other conservative treatment options and sclerotherapy is considered unlikely to be successful (MSAC, 2008). After ultrasonography to confirm the location and extent of the saphenous reflux, a catheter along a guide wire is inserted into the injured vein via percutaneous puncture at the distal end of the diseased saphenous vein (MSAC, 2008). A perivascular infiltration of diluted local anesthetic along the length of the vein is then performed under ultrasound guidance to collapse the lumen and compress the vein into the catheter to dissipate heat generated during the procedure to prevent tissue damage and close the vein blockage ( MSAC). 🇧🇷 The guidewire is replaced by a laser probe that is inserted through the catheter just below the saphenofemoral or saphenopopliteal junction, with placement confirmed by ultrasound. Laser energy is then delivered as the fiber and catheter are slowly withdrawn to close off the vein and eliminate venous backflow. Pulses of laser light are emitted into the vein, and the vein collapses and seals. This procedure can be performed in the office under local anesthesia. After treatment, a bandage or compression tube is applied to the treated leg. The operation is performed on an outpatient basis.
Endovenous laser treatment can only be used for large veins because a catheter must be inserted into the lumen of the vein to be treated (MSAC, 2008). Treatment of small veins or telangiectasia. Smaller veins can be treated with sclerotherapy or outpatient phlebectomy.
A range of laser wavelengths can be used to achieve an occlusion; There is no clear evidence that one wavelength is superior to another (MSAC, 2008). A systematic review of the evidence reported that reported short-term (within 6 months) GSV and small saphenous vein (SVS) occlusion rates found in studies of endovenous laser therapy were all greater than 90%.
Absolute contraindications to ELAS treatment are occlusive deep vein thrombosis and pregnancy. Relative contraindications include arterial disease, hyperwalkability, tortuous veins, and inability to walk (MSAC, 2008).
Endoluminal radiofrequency thermal warming (USV closure procedure) has been used with or without ligation and division to treat saphenofemoral and saphenopopliteal junction insufficiency. To perform the radiofrequency ablation (RFA) procedure, the affected leg is prepped and draped, and a topical local anesthetic is used to numb the cannulation site. A high-frequency catheter is inserted into the lumen of the great saphenous vein, starting at its confluence with the femoral vein. In some protocols, catheter placement is guided by duplex ultrasound. The radiofrequency catheter heats the internal lumen of the vein to 85°C, with subsequent healing and occlusion of the treated vein. The procedure is performed in the office without general anesthesia; Treatment time is 20 minutes on average. Adverse consequences include purpura, erythema, and pain, which usually resolve days or weeks after treatment, and hardened fibrous cords, which may persist for several months.
Upon completion of the RFA procedure, the venipuncture site is bandaged and compression stockings and/or bandages are applied as needed to reduce the risk of venous thromboembolism and reduce postoperative bruising and tenderness (MSAC, 2011). Nonsteroidal anti-inflammatory drugs are widely used for postoperative pain relief. Most patients require additional procedures, such as sclerotherapy or phlebectomy, to treat superficial veins below the knee, any varicose veins, and telangiectasia. These procedures can be performed during the RFA or endovenous laser treatment procedure, or in one or two follow-up visits.
Radiofrequency ablation is conceived as a single-use therapeutic intervention, performed as a single treatment cycle per affected leg, to obliterate large or small trunk veins through the application of thermal energy (MSAC, 2011). Although generally indicated for primary varices, some patients who have undergone neovascularization or revascularization may be eligible for retreatment of varices with RFA. However, short-term revascularizations after treatment are uncommon. Studies reporting radiofrequency ablation with the most efficient second-generation catheters report ablation rates of nearly 100% at 6-month follow-up without major adverse events (MAS, 2011).
24-month prospective case series have demonstrated success rates with RFA similar to those reported for ligation and removal of veins. Weiss and Weiss (2002) reported complete disappearance of the treated saphenous vein in 90% of 21 patients followed up for 24 months. Endothermic radiofrequency thermal warming can be performed with or without high ligation of the great saphenous vein. Chandler and others. (2000) found no statistically significant difference in the 1-year success rates of radiofrequency endovenous catheter ablation in 120 limbs treated without saphenofemoral ligation and 60 limbs treated with saphenofemoral ligation. The authors concluded that "these initial results suggest that elongated saphenofemoral junction (SFJ) ligation may do little to effectively obliterate the GSV [greater saphenous vein], but our results are not robust enough to justify abandoning SFJ as currently practiced in the US, treatment of primary varicose veins associated with GSV reflux."
Key studies of endovenous catheter ablation (endovenous laser ablation and endovenous radiofrequency ablation) have focused on connection failure. There is a lack of evidence for the effectiveness of IV catheter ablation procedures for the treatment of varicose veins and perforating veins. In addition, there are no studies comparing intravenous catheter ablation procedures with standard procedures for treating tributary varicose veins and perforating veins with sclerotherapy and outpatient phlebectomy.
The Society for Interventional Radiologists (2003) published a position statement on VNUS stating: "(Duplex ultrasound is required to map the anatomy of the venous system before the procedure and during the procedure for proper placement of the catheter and for proper administration of Essential tumescent anesthesia to minimize potential complications. Duplex ultrasound is also required for follow-up after IV ablation."
Sadick (2000) observed that the new less invasive technologies for the treatment of varicose veins need to be evaluated with caution. “Long-term studies using other technologies need to be compared to surgical ligation of the incompetent JSF (saphenofemoral junction). Six-month and five-year follow-ups are two different outcomes. The latter is a more accurate time frame of therapeutic efficacy."
Endoscopic Subfascial Perforating Vein Surgery (SEPS) is a minimally invasive endoscopic procedure that eliminates the need for a large incision in the leg. It has been explored as an alternative to the traditional open surgical treatment of chronic venous insufficiency. The aim of the procedure is to sever the incompetent medial perforating veins of the calf to reduce venous return and ambulatory venous hypertension in critical areas above the ankle where venous ulcers most commonly develop. Kalra and Gloviczki (2002) stated that available evidence supported the superiority of SEPS over open perforator ligation, but did not address its role in the surgical management of advanced chronic venous insufficiency (CVI) and venous ulceration. In most patients undergoing SEPS, ablation of superficial reflux by high ligation and emptying of the great saphenous vein with avulsion of branch varices are performed simultaneously. Clinical and hemodynamic improvements due to SEPS are therefore difficult to determine. As with open perforator ligation, clinical and hemodynamic outcomes are better in patients with primary valve regurgitation (PVI) than in patients with post-thrombotic syndrome (PT). Until prospective, randomized, multicenter clinical trials are performed to answer open questions about the effectiveness of SEPS, the procedure is recommended in patients with advanced CVI after PVI of superficial and perforating veins with or without deep venous insufficiency. The performance of SEPS in patients with PT syndrome remains controversial.
Contraindications for SEPS include associated arterial disease, infected ulcer, non-outpatient patient, and patient at medical risk. Relative contraindications are diabetes, renal failure, hepatic failure, morbid obesity, ulcers in patients with rheumatoid arthritis or scleroderma, and the presence of deep venous obstruction at the level of the popliteal vein or higher on preoperative imaging. Patients with extensive skin lesions, large circumferential ulcers, recent deep vein thrombosis, severe lymphedema, or large legs may not be suitable candidates (Kalra and Gloviczki, 2002).
McDonagh et al. (2002, 2003) reported the efficacy of ultrasound-guided foam sclerotherapy (comprehensive objective mapping, precise image-guided injection, anti-reflux positioning, and sequential sclerotherapy technique (COMPASS)) in treating subjects with varicose veins of the great saphenous vein with reflux in the saphenous vein. Published studies on the COMPASS technique require relatively short follow-up. Study participants were followed for 3 years and only 2 years after completion of a series of repeat sclerotherapy injections given over 1 year. Furthermore, these studies did not include a comparable group of subjects treated with surgery, which was the main method of treating incompetent long saphenous veins. Therefore, it is not possible to make definitive statements about the durability of the results of the COMPASS technique or its effectiveness compared to surgery for the treatment of the great saphenous vein and saphenofemoral insufficiency. Furthermore, the published studies on the COMPASS technique are from a single group of researchers. Reviewing McDonagh's (2002) study, Allegra (2003) commented: "Surgical treatments have a long history with 5- to 20-year follow-up being routine. The 3-year follow-up in the present study is certainly not comparable…. This study is not comparable. responds to the concerns raised against ultrasound-guided sclerotherapy. It would be important to duplicate, reproduce and verify relevant aspects of this study.”
Published long-term randomized controlled clinical trials have shown that surgery associated with sclerotherapy is more effective than surgery alone in treating varicose veins associated with saphenofemoral junction insufficiency. Belcaro et al. (2003) reported the results of the Venous Disease International Control (VEDICO) study, the first long-term randomized controlled clinical trial of foam sclerotherapy. The VEDICO study enrolled 749 patients with varicose veins and saphenous vein insufficiency who were randomized to be treated with six different approaches: standard sclerotherapy, high-dose sclerotherapy, surgical ligation, stab avulsion, foam sclerotherapy, and combined surgery (ligation or avulsion). by stabbing). and high-dose sclerotherapy. At 10 years, the incidence of new veins was 56% with standard sclerotherapy, 51% with foam sclerotherapy, 49% with high-dose sclerotherapy, 41% with puncture avulsion, 38% with ligation, and 27% with combined surgery and sclerotherapy.
Belcaro et al. (2000) reported the results of a randomized controlled clinical trial comparing ultrasound-guided sclerotherapy with surgery alone or surgery in combination with sclerotherapy in 96 patients with varicose veins and superficial venous insufficiency. Although all approaches have been reported to be effective in controlling the progression of venous insufficiency, surgery appears to be the most effective long-term method, and surgery combined with sclerotherapy may be more effective than surgery alone. After 10 years of follow-up, no saphenofemoral junction insufficiency was observed in any of the operated groups, compared to 18.8% of the limbs of patients assigned to ultrasound-guided sclerotherapy. Of limbs treated with ultrasound-guided sclerotherapy, 43.8% of the distal venous systems were incompetent compared with 36% of limbs in patients treated with surgery alone and 16.1% of limbs in patients treated with surgery plus sclerotherapy.
L'Agence Nationale d'Accreditation et d'Evaluation en Sante (l'ANAES) (Grange et al., 1998) carried out a systematic literature search on indications for surgery for varicose veins of the legs. Given the lack of good scientific evidence on the different treatments for primary varicose veins, the working group made recommendations based on professional consensus. They concluded that surgery is the treatment of choice for saphenous veins with reflux. A review of evidence on surgical treatments for deep venous insufficiency by the Alberta Heritage Foundation for Medical Research (Scottand Corabain, 2003) noted that "Sclerotherapy for superficial venous insufficiency is particularly effective when a large vein is close to the ulcer. However, surgery is indicated when there is significant proximal insufficiency in a saphenous vein.”
A comprehensive review of the evidence on sclerotherapy for varicose veins conducted by the Alberta Heritage Foundation for Medical Research (2003) concluded that "the reviewed evidence does not adequately answer the questions: which sclerosant is superior and which technique with or without ultrasound guidance is most effective ." … In recent years, new methods such as ES (endovascular sclerotherapy) and foam sclerotherapy (using ultrasound guidance) have been developed and proposed to improve the safety and effectiveness of sclerotherapy for different types of varicose veins. Evidence on these new techniques for treating patients with long saphenous vein insufficiency is limited." The review concluded that, although "(S)sclerotherapy appears to be the treatment of choice for reticular varicose veins, telangiectasia, and other unsightly small blood vessels. ..(t)sclerotherapy as the first treatment for the greater ern varicose vein (saphenous or non-saphenous) remains controversial."
There is a lack of reliable evidence that one type of sclerosant is significantly better than any other (Tisi 2007; Jia et al., 2006). Jia and colleagues (2007) evaluated the safety and efficacy of foam sclerotherapy for varicose veins. The authors concluded that serious adverse events associated with foam sclerotherapy are rare. However, there is not enough evidence to allow a meaningful comparison of the effectiveness of this treatment with other minimally invasive therapies or surgeries.
Kendler et al (2007) stated that “(r)now the use of foam sclerotherapy has experienced a renaissance. Several studies have documented the effectiveness of foam sclerotherapy in selected patients. The ability to treat patients on an outpatient basis, cheaply and quickly, makes foam sclerotherapy very attractive compared to invasive and minimally invasive methods. However, long-term follow-up in adequately controlled randomized trials is needed before foam sclerotherapy can be recommended as a routine procedure."
The FDA has approved Asclera (polidocanol) injection (BioForm Medical Inc., Franksville, WI) to close authorized vasinhos (small varicose veins less than 1 millimeter in diameter) and reticular veins (those 1 to 3 millimeters in diameter). As these small veins do not cause any symptoms, the treatment of these small veins is considered cosmetic.
There is new evidence for the outpatient conservative hemodynamic treatment of varicose veins (CHIVA) method. In an open-label, randomized, controlled trial, Pares and colleagues (2010) compared the effectiveness of the Ambulatory Conservative Hemodynamic Management of Varicose Veins (CHIVA) method for treating varicose veins with the standard treatment of stripping. According to the authors, CHIVA consists of minimally invasive surgical procedures under local anesthesia based on hemodynamic analysis of the legs with pulsed Doppler ultrasound. A total of 501 adult patients with primary varicose veins were treated at a single center. They were divided into an experimental group, CHIVA method (n = 167) and 2 control groups: clinically labeled stripping (n = 167) and duplex labeled stripping (n = 167). The outcome was clinical recurrence at 5 years, clinically assessed by previously trained independent observers. Duplex ultrasonography has also been used to assess recurrence and causes. In an intention-to-treat analysis, clinical outcomes were better in the CHIVA group (44.3% cure, 24.6% improvement, 31.1% failure) than in the clinically marked removal group (21.0 % cure, 26.3% improvement, 52.7% failure) and duplex marking pickling (29.3% cure, 22.8% improvement, 47.9% failure). The ordinal odds ratio between the clinically marked stripping group and the CHIVA group for recurrence at 5 years of follow-up was 2.64 (95% confidence interval (CI): 1.76 to 3.97, p<0.001 ). The ordinal odds ratio of recurrence at 5 years of follow-up between the duplex-marked stripping group and the CHIVA group was 2.01 (95% CI: 1.34 to 3.00, p<0.001). The authors concluded that these results suggest that the CHIVA method is more effective than clinically marked stripping or marked duplex stripping for the treatment of varicose veins. Furthermore, duplex marking when performing an excision procedure does not improve the clinical results of this ablative technique.
In a randomized study, Rasmussen et al. (2011) Four treatments for varicose GSVs. A total of 500 consecutive patients (580 legs) with VSM reflux were randomized to undergo endovenous laser ablation (EVLT, 980 and 1470 nm, bare fiber), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (USGFS ) or surgical removal under local tumescent anesthesia with light sedation. Mini-phlebectomies were also performed. Patients were examined with duplex imaging before the operation and after 3 days, 1 month and 1 year. In 1 year, 7 (5.8%), 6 (4.8%), 20 (16.3%) and 4 (4.8%) of the VSM were on laser, radiofrequency, foam and stripping, respectively -Group open and with reflux (p < 0.001). One patient developed pulmonary embolism after foam sclerotherapy and 1 deep vein thrombosis after surgical removal. No other major complications were recorded. The mean (SD) post-intervention pain scores (scale from 0 to 10) were 2.58 (2.41), 1.21 (1.72), 1.60 (2.04) and 2.25 ( 2, 23) (p<0.001). The mean time (interval) to return to normal function was 2 (0 to 25), 1 (0 to 30), 1 (0 to 30) and 4 (0 to 30) days, respectively (p<0.001). The corrected days off for weekends were 3.6 (0 to 46), 2.9 (0 to 14), 2.9 (0 to 33) and 4.3 (0 to 42) days, respectively (p< 0.001). Disease-specific quality of life and Short Form 36 (SF-36) scores improved in all groups at 1-year follow-up. In the physical pain and physical function domains of the SF-36, the high-frequency and foam groups performed better than the others in the short term. The authors concluded that all treatments were effective. The technical failure rate was higher after foam sclerotherapy, but both RFA and foam were associated with faster recovery and less postoperative pain than EVLT and stripping.
In a Cochrane review, Nesbitt et al. (2011) reviewed available data from randomized controlled trials (RCT) and compared USGFS, RFA, and EVLT with conventional surgery (high ligation and removal (HL/S)) for the treatment of varicose veins of the great saphenous vein. The Cochrane Peripheral Vascular Diseases (PVD) Group searched its Specialist Registry (July 2010) and CENTRAL (Cochrane Library 2010, Issue 3). In addition, the authors performed an EMBASE search (July 2010). Manufacturers of EVLT, RFA, and sclerotherapy devices were contacted for trial data. All EVLT, RFA, USGFS, and HL/S RCTs were considered for inclusion. Primary outcomes were recurrent varicose veins, recanalization, neovascularization, technical failure or need for reintervention, patient quality of life (QoL) scores, and associated complications. Secondary outcomes were type of anesthesia, duration of procedure, hospital stay and cost. A total of 13 reports from 5 studies with a total of 450 patients were included. Recanalization rates were higher after EVLT than after HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% CI: 0.45 to 32 ,64) and late. Drainage (at 4 months) (9/118 versus 1/80; OR 2.97 95% CI: 0.52 to 16.98), although these results were not statistically significant. Technical error rates favored EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI: 0.02 to 0.75). Recurrences after RFA showed no difference compared to surgery. Recanalization at 4 months was seen more frequently after RFA than after HL/S, although without statistical significance (4/105 versus 0/88; OR 7.86, 95% CI: 0.41 to 151.28); after 4 months no difference was observed. Neovascularization was seen more often after HL/S than after RFA, but again it was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI: 0.09 to 1.63). Technical failure was seen less frequently after RFA than after HL/S, although it was not statistically significant (2/106 versus 7/96; OR 0.48, 95% CI: 0.01 to 34.25). No RCT comparing HL/S with USGFS met the study inclusion criteria. Quality of life scores and operative complications were not amenable to meta-analysis. The authors concluded that currently available clinical trial results indicate that RFA and EVLT are at least as effective as surgery in treating the great saphenous veins. There is not enough data to comment on the USGFS. They stated that more randomized studies were needed; and should aim to report and analyze results in a congruent manner to facilitate future meta-analyses.
Mueller and Raines (2013) stated that the ClariVein system is the first venous ablation technique to use a hybrid technique (two lesions) integrated with a catheter-based delivery system. Endomechanical abrasion is generated by the tip of the rotating catheter wire (mechanical component); and EVCA occurs by simultaneous injection of a sclerosing agent via a rotating wire (chemical component). The author was an early adopter of this technique and has developed a detailed step-by-step protocol from experience. To date, 2 major clinical studies have been published with the ClariVein system. These data were compared with the results of other intravenous ablation methods. The authors concluded that the ClariVein system has the potential to become a first-line treatment.
Lawson and others. (2013) found that less invasive intravenous techniques proved to be as effective as open surgery in the treatment of varicose veins. In addition, they cause less bruising and postoperative pain and allow an early return to normal activities and work. Tumescent anesthesia is safe and avoids the complications of general or spinal anesthesia. Disadvantages are a steep learning curve and painful administration during treatment. Non-tumescence techniques such as ClariVein or the VenaSeal Sapheon Closure System are currently under investigation. The short-term results of VenaSeal are comparable to thermal ablation. The procedure is safe with no serious side effects. Perioperative pain and patient discomfort with this non-tumescent approach are minimal, but postoperative recovery is temporarily impaired by thrombophlebitis in 14-15% of patients. The one-year results of a small feasibility study demonstrated durable closure at this endpoint. There are no long term results. A randomized control trial between VenaSeal and Covidien ClosureFast is in the pipeline.
A randomized controlled trial comparing foam sclerotherapy to laser ablation and surgery found that laser ablation and surgery produced better results and that laser had fewer procedural complications. Brittenden et al. (2014) noted that ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery to treat varicose veins, but their relative efficacy and safety remain uncertain. In a randomized study of 798 participants with primary varicose veins at 11 centers in the United Kingdom, these investigators compared the results of foam, laser (laser ablation of truncal veins, optionally followed by foam sclerotherapy), and surgical treatments (proximal ligation and removal of the great truncal vein with concomitant phlebectomy). Study participants had varicose veins greater than 3 mm in diameter and truncal venous reflux greater than 1 second on duplex ultrasound. The mean age of participants was 49 years, 57% were female, and approximately 30% had bilateral varicose veins. Those with recurrent varicose veins after previous treatment were excluded. The primary endpoints at 6 months were disease-specific quality of life and overall quality of life measured on multiple scales. Secondary endpoints included complications and measures of clinical success. After adjusting for baseline and other covariates, mean disease-specific quality of life was worse after foam treatment than after surgery (p = 0.006), but was similar in the laser and surgery groups. There were no significant differences between the surgical group and the foam or laser groups on measures of overall quality of life. At 6 months, approximately 80% of patients in the laser and surgery groups had complete great saphenous vein ablation on duplex ultrasound, compared with only 43% in the foam group (p < 0.001). The frequency of procedural complications was similar in the foam group (6%) and the surgical group (7%); but it was lower (1%) in the laser group than in the surgical group (p<0.001); the incidence of serious adverse events (approximately 3%) was similar between groups. At 6 months, clumping and skin discoloration were slightly more common in the foam group.
On November 26, 2013, the FDA approved Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicose veins of the great saphenous vein system (GSV) for the treatment of saphenous vein insufficiency, vein accessories saphenous vein and visible varicose veins of the saphenous vein system (SSV) above and below the knee. Varithena improves symptoms of superficial venous insufficiency and the appearance of visible varicose veins." Although FDA approval does not preclude the use of Varithena foam sclerotherapy for the treatment of SF or SP junctional reflux (SPJ), there is a dearth of studies evaluating Varithena compared to intravenous ablation procedures for SF or SPJ reflux.In addition, there is little evidence to investigate the long-term durability of results from treatment of junctional reflux with varithena.
Todd and others. (2014) reported an RCT to determine the efficacy and safety of polidocanol endovenous microfoam in the management of symptoms and manifestations in patients with saphenofemoral junction insufficiency due to reflux from the great saphenous vein or accessory large veins. Patients were equally randomized to receive polidocanol 0.5% intravenous microfoam, polidocanol 1.0% intravenous microfoam, or placebo. The primary efficacy endpoint was patient-reported improvement in symptoms, as measured by mean 7-day electronic diary VVSymQ™ score change from baseline to week 8. Co-secondary endpoints were improvement in the incidence of visible varices from baseline to week 8. beginning through week 8 as measured by patients and an independent medical assessment panel. In 232 treated patients, polidocanol 0.5% intravenous microfoam and polidocanol 1.0% intravenous microfoam were superior to placebo, with greater improvement in symptoms (VVSymQ (-6.01 and -5.06 versus -2. 00, respectively; p < 0.0001) and greater improvements in physician and patient appearance ratings (p < 0.0001). These results were supported by duplex ultrasound results and other clinical measurements. Of 230 patients treated with polidocanol with intravenous microfoam (including open-label patients), 60% had an adverse event compared to 39% with placebo; 95% were mild or moderate No pulmonary embolisms were observed and no clinically significant neurological or visual adverse events were reported. ; most were related treatment and resolved without sequelae.
Brittenden and colleagues (2015) stated that foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins (VV), but there is uncertainty regarding their mid- and long-term effectiveness . These investigators evaluated the clinical efficacy and cost-effectiveness of foam, EVLA, and surgery to treat VV. A total of 798 patients with primary VV (foam, n = 292; surgery, n = 294; EVLA, n = 212) were included in this study. Patients were randomized between all 3 treatment options (8 centers) or between foam and surgery (3 centers). Primary outcome measures included disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic quality [European Quality of Life-5 Dimensions (EQ-5D), Short Form Questionnaire-36 Items (SF-36) Physical and Mental Component Scores] of Life (QL) after 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures included QoL at 6 weeks; residual VV; Clinical Venous Gravity (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. The results appeared generalizable, as baseline participant characteristics (apart from a lower than expected proportion of women) and improvement in outcomes after treatment were comparable to other RCTs. The health gain achieved in AVVQ with foam was significantly less after 6 months than with surgery [effect size -1.74, 95% CI: -2.97 to -0.50; p = 0.006], but it was similar to EVLA. Health gain on the SF-36 mental component score for foam was worse than for EVLA (effect size 1.54, 95% CI: 0.01 to 3.06; p = 0.048), but similar to surgery . There were no differences in EQ-5D or SF-36 component scores in the surgery vs. foam or surgery vs. EVLA at 6 months. Trial-based cost-effectiveness analysis showed that the foam was most likely to be considered cost-effective at 6 months, with a maximum willingness to pay £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained compared to foam, was less expensive and generated slightly more QALYs than surgery. Markov modeling using study costs and the limited recurrence data available suggested that at 5 years, EVLA was most likely (approximately 79%) to be cost-effective at conventional thresholds, followed by foam (approximately 17%) and surgery (approximately 5%). With regard to secondary endpoints, health gains at 6 weeks (p < 0.005) were greater for EVLA than foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) (p < 0.001). Participants returned to a wide range of behaviors more quickly after foam or EVLA than after surgery (p < 0.05). There were no differences in VCSS between the 3 treatments. Rod ablation rates were higher for surgery (p<0.001) and EVLA (p<0.001) than for foam and were similar for surgery and EVLA. The authors concluded that both the clinical results at 6 months and the estimated cost-effectiveness at 5 years indicate that EVLA should be considered the treatment of choice for eligible patients.
Marsden et al. (2015) reviewed the cost-effectiveness of interventional VV treatment in the UK National Health Service (UK NHS) and reported national clinical guidance on VV published by the National Institute of Health and Care Excellence (NICE). 🇧🇷 An economic analysis was performed to compare the cost-effectiveness of surgery, endothermic ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS) and compression stockings (CS). The analysis was based on a Markov decision model developed in consultation with members of the NICE Guideline Development Group (GDG). The model had a time horizon of 5 years and adopted the perspective of the UK NHS. Clinical entries were based on a network meta-analysis (NMA) based on a systematic review of the clinical literature. Results were expressed in cost-quality-adjusted life years (QALYs). All interventional treatments were shown to be cost-effective compared to CS at a cost-effectiveness threshold of £20,000 per QALY gained; ETA proved to be the most cost-effective strategy overall, with an additional cost-effectiveness of £3,161 per QALY gained compared to UGFS. Surgery and CS were dominated by ETA. The authors concluded that interventional treatment of VV in the UK NHS is cost-effective. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is appropriate. The results of this survey were used to inform recommendations within the NICE guidance on VV.
Compression after varicose veins treatment
El-Sheikha et al. (2015) stated that there is still no consensus regarding compression after VV treatment. This systematic review aimed to establish the ideal compression regime after venous treatment. A systematic review of MEDLINE, Embase, and CENTRAL was performed to identify RCTs investigating different compression strategies after treatment of superficial venous insufficiency. A total of 7 RCTs comparing different durations and compression methods met the inclusion criteria. The treatment modality was open surgery in 3 studies, foam sclerotherapy in 2 studies, and EVLA in 2 studies. Study quality varied and there were significant sources of potential bias. Both the studies and the compression schemes used were heterogeneous; 10 products were used in 6 general regimens for periods ranging from 0 to 42 days. One study suggested that 7 days instead of 2 stockings after EVLA was associated with better quality of life and less pain at 1 week. Another study reported that, after surgery, putting on a compression stocking after 3 days of dressing was associated with a slightly longer recovery than no compression after 3 days. One study showed clear adherence of only 40%. The quality and heterogeneity of the studies precluded a meta-analysis. The authors concluded that there is currently little qualitative evidence on which to base recommendations for compression after VV treatment.
Micronized Purified Flavonoid Fraction Therapy
Pietrzycka and colleagues (2015) noted that the etiology of VV includes several pathogenic factors and mechanisms, including activation or dysfunction of endothelial cells, venous hypertension, hypoxia of the venous wall, shear stress disorders, activation of inflammatory responses, or production of free radicals . To improve understanding of the mechanisms of potential pharmacological interventions in chronic venous disease, these researchers evaluated the influence of the micronized purified flavonoid fraction (MPFF) on the relationship between the balance of antioxidant enzymes, endothelin-1 (ET-1) and tumor necrosis factor . alpha (TNF-α). Blood samples were obtained from 89 women with primary VV; 34 were treated with MPFF and 55 were not treated with phlebotropic drugs. To assess the balance of antioxidant enzymes in the blood, catalase (CAT) and superoxide dismutase (SOD) activity was determined and the CAT/SOD ratio was calculated. Patients taking MPFF had significantly lower ET-1 levels than those not taking MPFF [median (25th to 75th quartile): 24.2 (22.30 to 27.87) versus 37.62 (24th 0, 9 to 44.58) pg/ml; p<0.05]. In those taking MPFF, a higher CAT/SOD ratio [39.8 (24.7 to 72.6) versus 28.8 (16.3 to 57.7); p<0.05] and lower concentration of TNF-α [6.82 (4.42 to 13.39) versus 12.94 (6.01 to 27.33) pg/ml; p<0.05] was also observed. In women not taking MPFF, ET-1 levels increased with the CAT/SOD ratio. In those taking MPFF, ET-1 levels were stable around 25.0 pg/mL; up to a CAT/SOD ratio of 100. TNF-α levels increased continuously with increasing CAT/SOD ratio; however, the highest levels of TNF-α were seen in women not taking MPFF. The authors concluded that they demonstrated the ability of MPFF to effectively reduce ET-1 and TNF-α levels in patients with chronic venous disease. They stated that further research is needed to define the therapeutic potential of MPFF, including the potential effect on subclinical chronic inflammation, antioxidant imbalance, and vascular dysfunction during the development of chronic venous disease.
Cyanoacrylate tissue glue (for example, the VariClose vein sealing system and the VenaSeal closure system)
The VenaSeal closure system:
The VenaSeal Closure System (Sapheon Inc., Morrisville, NC) is a minimally invasive, non-tumescent, non-thermal, non-sclerosing procedure that uses a medical grade adhesive to close off the diseased vein in patients with symptomatic venous reflux. Unlike other treatments, the VenaSeal Closure System does not require tumescent anesthesia, allowing patients to return to their normal activities after the procedure; It also eliminates the risk of nerve injuries or other heat-related injuries associated with thermal procedures and may therefore reduce the need for post-procedure compression stockings.
Toonder et al. (2014) noted that percutaneous thermal ablation techniques are still used today and appear to be more effective than non-thermal techniques. However, thermal techniques require anesthesia and can cause unintended damage to surrounding tissues, such as nerves. Cyanoacrylate glue has proven its worth, but not for the treatment of chronic leg vein diseases. Innovations led to the development of the VenaSeal Sapheon Closure System, designed to use a modified cyanoacrylate adhesive as a new therapy for saphenous vein insufficiency. These investigators investigated the feasibility of ultrasound-guided perforating cyanoacrylate adhesive (CAPE) embolization. The authors stated that the results of this feasibility study showed a 76% occlusion rate of incompetent perforating veins without serious complications; further studies with a dedicated delivery device in a larger patient population are needed.
McHugh and Leahy (2014) observed that endothermic treatment of the great saphenous vein has become the first line of treatment for superficial venous reflux. Newer treatments, particularly non-thermal ablation, have potential benefits in both patient acceptance and reduced risk of nerve damage. These researchers described the currently available non-thermal options, including advantages and disadvantages. Ultrasound-guided foam sclerotherapy avoids the risk of nerve damage but is not as effective as endothermic ablation. Mechanical-chemical endovenous ablation combines mechanical endothelial damage with a rotating wire and infusion of a liquid sclerosant (the ClariVein system). Reports have indicated that this system is safe, effective and avoids the need for tumescent anesthesia with no reported cases of nerve injury. Finally, the VenaSeal closure system involves the intravenous delivery of cyanoacrylate tissue glue into the vein causing fibrosis. Perioperative discomfort appears to be minimal, but the complication of thrombophlebitis has been reported in up to 15% of patients. The authors concluded that non-thermal options promise comparable treatment efficacy without the additional morbidity associated with high thermal energies. They said the potential to treat venous reflux without the risk of nerve damage could change the way surgeons approach venous disease.
On February 20, 2015, the FDA granted premarketing authorization for the VenaSeal Closure System to treat superficial varicose veins of the leg by endovascular embolization for adults with clinically symptomatic venous reflux diagnosed by duplex ultrasound. FDA approval was based on a multicenter RCT by Morrison et al. (2015)
Morrison and colleagues (2015) noted that preliminary evidence suggests that CAPE may be effective in treating incompetent GSVs. These investigators reported the first results of an RCT of CAPE versus RFA for the treatment of symptomatically incompetent GSVs. A total of 222 subjects with symptomatic GSV incompetence were randomized to receive CAPE (n=108) with the VenaSeal closure system or RFA (n=114) with the ClosureFast system. After discharge, subjects returned to the clinic on Day 3 and again at Months 1 and 3. The primary endpoint of the study was target vein occlusion at Month 3, as assessed by duplex ultrasound and as assessed by an independent vascular ultrasound laboratory. Statistical test focused on demonstrating non-inferiority with a 10% delta conditionally followed by a superiority test. No further procedures were allowed until after the Month 3 visit, and missing data for Month 3 were imputed by various methods. Secondary outcomes included patient-reported pain during intravenous treatment and extent of ecchymosis on day 3. Additional assessments included general and disease-specific quality of life surveys and rates of adverse events. All subjects received the designated intervention. Using the predictive method to impute missing data, the 3-month closure rates were 99% for cyanoacrylate embolization (CAE) and 96% for RFA. All primary outcome analyzes using different methods to explain the missing data rate (14%) showed evidence supporting the study's non-inferiority hypothesis (all p<0.01); Some of these analyzes supported a trend towards superiority (p=0.07 in the prediction model). Pain experienced during the procedure was mild and similar between treatment groups (2.2 and 2.4 for CAPE and RFA, respectively, on a 10-point scale; p=0.11). On day 3, there was less bruising in the treated region after CAPE compared to RFA (p<0.01). Other adverse events occurred with similar frequency between groups and were generally mild and well tolerated. The authors concluded that 3 months after the procedure, CAPE was shown to be non-inferior to RFA in the treatment of incompetent GSVs. Both treatment modalities had good safety profiles; CAPE does not require tumescent anesthesia and is associated with less post-procedural ecchymosis. Although these results support noninferiority, the reliability of this approach is unclear. These first results need to be validated by well-designed studies with lower rates of data loss and longer follow-up.
Furthermore, VenaSeal/non-thermal ablation is not mentioned as a therapeutic option in an UpToDate review on "Overview and Management of Chronic Lower Limb Venous Disease" (Alguire and Scovell, 2015).
Proebstle et al. (2015) noted that cyanoacrylate (CA) embolization of refluxing GSVs has been previously described. The results of a multicenter study are still pending. A prospective multicenter study was performed at 7 centers in 4 European countries to eliminate GSV reflux by intravenous AC embolization. No tumescent anesthesia (Ta) or post-intervention compression stockings were used. The varicose veins remained untreated for at least 3 months after the initial treatment. Clinical examination, quality of life assessment, and duplex ultrasound assessment were performed at 2 days and at 1, 3, 6, and 12 months. 70 GSV were treated in 70 patients, of which 68 (97.1%) were available for 12-month follow-up. The two-day follow-up showed 1 proximal and 1 distal partial recanalization; 3 additional proximal recanalizations were observed at 3 months (n=2) and 6 months (n=1). Cumulative 12-month survival without recanalization was 92.9% (95% CI: 87.0% to 99.1%). The mean (standard deviation) venous clinical severity score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. The Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (p<0.0001). Side effects were generally mild; a phlebic reaction occurred in 8 cases (11.4%) with a median duration of 6.5 days (range 2 to 12 days). Phlebic unresponsive pain was observed in 5 patients (8.6%) for a median duration of 1 day (range 0 to 12 days). There were no serious adverse events (AEs); and paresthesias were not observed. The authors concluded that endovenous embolization of AC from refluxed GSVs without the use of AT or compression stockings was safe and effective. Furthermore, they indicated that more work is needed to compare CA in RCTs with endothermic ablation.
Lam et al. (2017) stated that the treatment of incompetent saphenous veins innovated with the advent of non-tumescent non-thermal minimally invasive techniques (NTNT). One is the use of cyanoacrylate glue to seal the vein lumen with the VenaSeal device. These investigators evaluated NTNT ablation of insufficient saphenous trunks using the VenaSeal device. They concluded that cyanoacrylate glue embolization of incompetent truncal veins using the VenaSeal device is a safe and effective innovative technique. In addition, they indicated that further studies are needed to assess long-term anatomical and clinical outcomes.
Morrison and others. (2017) stated that endovenous CA occlusion (CAC) is a new FDA-approved therapy for the treatment of clinically symptomatic venous reflux in truncal veins. The device is intended for permanent occlusion of superficial truncal veins in lower extremities, e.g. B. the GSV, indicated. The first results of a randomized CAC trial have already been reported. These investigators reported 1-year results. There were 222 patients with symptomatic GSV incompetence who were randomized to receive CAC (n=108) or RFA (n=114). After the 3rd month visit, subjects could receive complementary therapies aimed at treating visible varicose veins and insufficient tributaries. Venous occlusion was assessed on day 3 and at months 1, 3, 6 and 12 using duplex US. Additional study visit assessments included Venous Clinical Severity Score; Clinical, etiological, anatomical and pathophysiological classification; EuroQol 5 dimension; and Aberdeen Varicose Vein Questionnaire. Both the time to occlusion and the time to the first reopening of the target vein were evaluated by analyzing the survival curve; AEs were evaluated at each visit. Of 222 randomized, enrolled subjects, 192 (95 CAC and 97 RFA; overall follow-up rate 192/222 [86.5%]) underwent 12-month follow-up. At Month 1, 100% of patients with CAC and 87% of patients with RFA demonstrated complete occlusion of the target vein. At month 12, the complete occlusion rate was nearly identical in both groups (97.2% in the CAC group and 97.0% in the RFA group); The 12-month freedom from recanalization was similar in the CAC and RFA groups, although there was a trend toward greater freedom from recanalization in the CAC group (p = 0.08). Symptoms and quality of life improved equally in both groups. Most AEs were mild to moderate and unrelated to the device or procedure. The authors concluded that in patients with incompetent GSVs, treatment with CAC and RFA resulted in high rates of occlusion. Time to full closure was faster with CAC and freedom to reopen was greater after CAC; Quality of life scores improved equally with both therapies.
This study had several drawbacks:
- This study included a modest dropout rate, with 13 of 108 (12.0%) subjects in the CAC group (9 withdrawn and 4 visits missed) and 19 of 114 (16.6%) subjects in the CAC group RFA group no data was available for month 12 (8 withdrawals and 11 missed visits),
- Blinding, although potentially beneficial, was not feasible because RFA requires the administration of TA and CAC has characteristic ultrasound findings. However, the primary study outcome (anatomical occlusion) was easily assessed with ultrasound and is objective.
- ultrasound interpretations performed by investigators may have introduced bias; however, the lead lab was not aware of the site results at the time of the measurements and its results agreed with those of the investigators (there was 100% agreement between the investigator readings and the lead lab readings; the k statistic was 1.0 ) , and
- To minimize confounding due to non-device post-intervention factors, subjects in both groups were required to wear compression stockings for 7 days after the index procedure.
This was done for the study only, but not for 2 previous CAC studies. Whether compression stockings improve the rate of complete occlusion may be the subject of further study.
In a prospective, single-arm, single-center feasibility study, Almeida et al. (2017) The long-term safety and efficacy of cyanoacrylate (CA)-based intravenous closure of failed GSV. This study was carried out at Clínica Canela (La Romana, Dominican Republic) to evaluate the efficacy and safety of a CA-based adhesive for GSV closure 36 months after treatment. A total of 38 subjects were treated with small bolus injections of AC under US guidance and without the use of perivenous AT or graduated compression stockings. Scheduled periodic follow-ups were performed over 36 months. At month 36, 29 subjects were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex US in all subjects except 2 subjects who had recanalization at Month 1 and Month 3. Kaplan-Meier analysis revealed an occlusion rate at Month 36 of 94.7% ( 95% CI: 87.9% to 100%). The mean venous clinical severity score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 (p<0.0001). Pain, edema, and varicose veins (VCSS subdomains) improved at Month 36 in 75.9%, 62.1%, and 41.4% of subjects, respectively. Overall, AEs were mild or moderate and self-limiting. The authors concluded that CA glue appears to be an effective and safe treatment for saphenous vein closure, with long-term closure rates comparable to other thermal and non-thermal methods, and no serious side effects reported. It was a small study (n=38) with a very high dropout rate (23.7%; 9 of 38).
Gibson and Ferris (2017) noted that GSV CA closure using the VenaSeal closure system is a relatively new modality. Studies were limited to moderately sized GSV and some prescribed postoperative compression stockings. These investigators report the results of a prospective study of CA occlusion for the treatment of accessory saphenous veins, accessory saphenous veins (ASV) up to 20 mm in diameter. A total of 50 subjects with symptomatic GSV, SSV and/or ASV incompetence were treated in a single session. Compression stockings were not used after the procedure. Subjects returned to the clinic at week 1 and again at 1 month. Post-procedure assessments were performed at 7 days and 1 month and included numeric pain assessment score, revised venous clinical severity score, Aberdeen varicose veins questionnaire score, and time to return to work and normal activities. Duplex US was performed at each visit. Procedural pain was low (numerical pain scale 2.2 ± 1.8). All treated veins (48 GSV, 14 ASV and 8 SSV veins) had complete occlusion by duplex US at 7 days and 1 month. The mean time to return to work and normal activities was 0.2 ± 1.1 and 2.4 ± 4.1 days, respectively. Revised venous clinical severity improved to 1.8 ± 1.4 (p < 0.001) and the Aberdeen Varicose Vein Questionnaire Score to 8.9 ± 6.6 (p < 0.001) after 1 month. Phlebitis developed in the treatment area or lateral branches in 10 subjects (20%) and completely resolved in all but 1 subject (2%) within 1 month; After 1 month, 98% of subjects were “completely” or “somewhat” satisfied and 2% “dissatisfied” with the procedure, even though the protocol prohibited simultaneous treatment of the side branch. The authors concluded that AC closure is safe and effective for the treatment of one or more incompetent saphenous or accessory saphenous veins. Closure rates were high even without the use of compression stockings or side branch treatments. Time to return to work or normal activities was short, and improvements in venous gravity and quality of life scores were significant, comparing favorably with alternative treatments.
Disadvantages of this study included:
- its one arm design,
- relatively small sample size (n = 50) at a single center,
- Some outcomes may be positively or negatively impacted by the lack of a concurrent comparison group, and both patients and clinicians were aware that AC closure is a relatively new procedure and
- short-term follow-up (1 month).
Zierau (2018) reported 6-year results of a retrospective comparative study of the VenaSeal Closure system in the treatment of 1950 truncal veins (1349 GSV, 517 SSV, VSAL in 53 cases, VSAM in 30 and Giacomini vein in 2 cases); Treatment also included 11 cases of leg ulcers. The present research highlights the advantages and disadvantages and presents the 72-month results of a single-center outpatient clinical study with a retrospective design. The author states that, based on his 17 years of experience, he recommends that each venous center that uses intravenous treatment have at least 2 alternative treatment modalities available. For her, this meant that in practical work with VenaSeal, if possible, all insufficient saphenous veins should be treated in 1 session. Regardless, these Saphenion researchers now see the VenaSeal Closure System as the first choice in the field of catheter-based therapy methods for GSV and SSV or VSAA varicose veins.
In a single-centre retrospective comparative study, Zierau (2019) reported the 5-year results with the VenaSea-Closure System in 2085 veins (1515 GSV, 570 SSV) compared with RF-induced thermal therapy ablation (RFITT) in 282 veins (181 GSV, 101 SSV). This study compared the advantages and disadvantages of both methods and presented the 5-year results of the author's monocentric study. The author recommended venous occlusion in the case of truncal varicose veins typical of GSV, SSV or SAAV (saphenous vena accessoria anteriore). This was a single-centre retrospective study; and it should be noted that the author is the founder and CEO of Saphenion.
Almeida and others. (2020) stated that VenaSeal is a cyanoacrylate polymer adhesive used to treat patients with CVI. As an implanted device, questions remain about how long cyanoacrylate will persist after occlusion. In this report, a 65-year-old man was examined 5.5 years after CAC and a segment of the GSV was excised for histopathological analysis. The finding was typical of a foreign body reaction. The vessel was occluded with collagenized mature fibrous tissue and polymer residues encapsulated by multinucleated giant cells. Foci of granulomatous inflammation were present in the vein wall extending to the adventitia.
Kolluri and colleagues (2020) noted that several RCTs compared different interventions for managing CVI, but a mixed comparison of these interventions is lacking. In a meta-analysis, these investigators compared the VenaSeal occlusion system with EVLA, RFA, MOCA, sclerotherapy, and surgery to treat CVI for anatomical success (complete occlusion of the treated vein within 6 months of the procedure) as a primary outcome and QoL. health-related (HRQoL; EuroQol-5 Dimension, Aberdeen Varicose Vein Questionnaire), VCSS, pain scores, and AE as secondary outcomes. They performed a systematic review of journal databases and RCTs between January 1996 and September 2018, comparing different therapeutic options. Risk of bias and quality of publications were assessed using the Cochrane bias tool; PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines were used for selection and reporting of studies. A total of 20 RCTs involving 4570 patients were analyzed. Data for anatomical success, VCSS, HRQoL, pain score, and AE were extracted and analyzed using a mixed-treatment comparison in a network meta-analysis. A Bayesian model with fixed or random effects was chosen for the analysis. Rank probability plots were generated for different treatments and corresponding ranks obtained to estimate their probability of being the best. Relative treatment effects were calculated in terms of log ORs for anatomical success and AEs; mean difference (MD) was calculated for VCSS, HRQoL and pain score. For the primary outcome measure (anatomical success), the VenaSeal closure system was most likely to be ranked #1 (p=0.980); RFA ranked 2nd (p=0.365), EVLA ranked 3rd (p=0.397), surgery ranked 4th (p=0.290), MOCA ranked 5th (p=0.695) and sclerotherapy ranked 6th (p=0.982). For secondary outcome measures, the VenaSeal closure system ranked 3rd for VCSS (p = 0.332), 5th for the EuroQol-5 dimension (p = 0.420), and 3rd for the Aberdeen Varicose Vein Questionnaire (p = 0.300). Although the VenaSeal closure system was somewhat inferior to some other interventions for HRQoL, the log OR 95% CI indicated insufficient evidence to draw firm conclusions. The VenaSeal closure system ranked first in reducing postoperative pain score from baseline (p=0.690) and lowest in the occurrence of AEs (p=0.650). The odds of occurrence of AEs were 3.3 times in the sclerotherapy arm, 2.7 times in the EVLA arm, 1.6 times in surgery and 1.1 times in RFA compared to the VenaSeal Closure System arm. The authors concluded that the VenaSeal Closure System is a promising therapeutic option for anatomical success at 6 months, with fewer occurrences of AEs (groin wound and infection, pulmonary embolism) in patients with CVI compared to other interventions in this study. Furthermore, these researchers indicated that additional economic analyses, including a cost-effectiveness analysis, would provide interesting perspectives on real-world insights for patients, payers and providers.
The authors stated that the disadvantages of this analysis were the limited availability of data in terms of time points and data clustering. Therefore, the analysis could only be performed at the available time points. Another disadvantage of this analysis was that the methods were compared in the first 6 months after treatment, which was a relatively short period. Results were reported differently in the included studies; therefore, fewer data points could not be pooled and used in this analysis. None of the 2 included MOCA RCTs (as allowed by the methodology of this study) reported all the results analyzed in this network meta-analysis.
Morrison and others. (2020) noted that the proprietary CAC versus RFA study (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) showed that CAC was effective in venous occlusion with good 36-month outcomes and was not inferior to RFA. The purpose of this extended follow-up, conducted under a separate protocol, was to evaluate the long-term safety and efficacy of CAC and RFA for the treatment of incompetent GSV at 5 years (60 months) of follow-up. This 60-month extension study was conducted for all patients who completed the randomized VeClose study and were willing to participate. The pivotal VeClose study enrolled patients with moderate to severe symptomatic varices (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] Class C2 to C4b) and symptomatic GSV incompetence who were randomized (1:1) to CAC or RFA. The primary endpoint of this 60-month extension study was complete occlusion of the target vein with non-inferiority exploratory analysis planned. Secondary outcomes included CEAP class; Completion of the Venous Clinical Severity Score, EuroQoL Five Dimension Survey and Aberdeen Varicose Vein Questionnaire; patient satisfaction with treatment; AE related to target GSV; and details of further procedures. A total of 89 patients completed the 60-month visit, including 47 from the CAC group, 33 from the RFA group, and 9 roll-in CAC patients. No new recanalization events were observed in the groups between 36 and 60 months of follow-up. At 60 months, the Kaplan-Meier estimates for no recanalization in the randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating the non-inferiority of CAC compared to RFA. Both groups showed sustained improvements in the five EuroQoL dimensions and QoL measures over 60 months. Although patients classified as clinical class C0 or C1 were excluded from the original study, more than 50% of all recurrent patients (64% [57/89]) were classified as clinical class C0 or C1, indicating an improvement in clinical class relative to the baseline. Furthermore, 41.1% of patients with recurrent CAC and 39.4% of patients with recurrent RFA were currently at least 2 clinical CEAP classes below baseline. No serious adverse events related to the long-term device or procedure occurred in either group between 36 and 60 months of follow-up. The authors concluded that CAC and RFA were effective in achieving complete occlusion of the target GSV vein at long-term follow-up, with CAC demonstrating sustained non-inferiority to RFA. These investigators stated that the CAC system was also associated with sustained improvements in symptoms and QoL, a lower CEAP class, and high levels of patient satisfaction without severe AEs between 36 and 60 months.
The authors stated that this study had several drawbacks. A drawback of the original Investigational Device Exemption (IDE) study was that blinding of clinicians, patients, and outcome assessors was not possible due to the nature of the interventions, since RFA requires tumescent anesthesia (TA) and CAC has characteristic US findings. The extension study was conducted under a separate protocol and included only patients from the IDE study who could be contacted and consented to participate. Initial consent for the IDE study did not include this 60-month visit, so patients did not expect a longer follow-up and may have less motivation to participate (especially if they were well). Furthermore, there was a 2-year gap between the 3- and 5-year follow-up, making it much more difficult to find patients. Furthermore, it is well recognized that recruiting patients for follow-up, especially after 5 years, is a challenge. There could be several reasons why patients do not participate in data collection - lack of patient interest, patients' expectations regarding the outcome of interest have been met, or patients have satisfactory results and therefore lose interest in the study. Follow-up may also be lost if participants change their names, addresses and phone numbers, or due to unforeseen personal circumstances that may prevent them from completing the study. Previous research has shown that losses to follow-up were greater when no treatment is needed after surgery, especially with a longer follow-up period when no specific treatment is needed. For patients lost to follow-up, identifying next of kin or other important contacts was a challenge. Despite the challenges that contributed to a smaller sample size, the non-inferiority of the CAC compared to the RFA was still demonstrated (non-inferiority established by the one-tailed CI of 97.5% with a lower limit of -3.5%). Patient satisfaction reported in this study was subjective. Even though there are many standardized and validated patient satisfaction instruments to assess specific aspects of care, they do not apply across the spectrum of care because they have only limited meaning and potential reliability. As a result, the method used to measure patient satisfaction was not validated in this study.
Chan et al. (2020) found that patients with venous leg ulcer (VU) have the worst spectrum of CVI. The landmark Early Venous Reflux Ablation (EVRA) study, published in 2018, showed that early intravenous intervention resulted in faster healing of VUs. These investigators described their post-EVRA experience with the use of intravenous cyanoacrylate patch ablation (ECGA) for the early treatment of superficial venous reflux and evaluated its safety and efficacy in VUs. There were 37 patients (39 legs, 43 truncal veins) with 43 discrete venous ulcers who underwent ECGA for symptoms of CVI and VUs. They received regular compression therapy and dressings for postoperative VUs and were reviewed at 1 week, 3 months, 6 months, and 12 months after the procedure. Post-operative healing time for VUs and complications were recorded along with patient satisfaction and post-procedure pain scores. All venous ulcers were smaller than 30 cm2 before ECGA. The mean VU healing time after surgery was 73.6 ± 21.9 days and the CVI primary closure rate was 100% at 1 week and 3 months. With the exception of 1 case of DVT, no serious AEs were observed. There was a significant improvement in the revised VCSS postoperatively from 11 ± 1.63 (baseline) to 5.6 ± 1.37 (p < 0.001) at the 3-month follow-up (on a scale of 0 to 27, with severity of symptoms in a maximum of 27). VAS pain scores were low postoperatively, decreasing from a preoperative score of 6.84 ± 1.42 to 2.72 ± 1.59 (p < 0.001) at the 3-month follow-up (on a scale of 1 to 10, where 10 is the strongest pain). The mean time to return to normal activities was 7 days (IQR, 5 to 7 days). The authors concluded that ECGA plus compression therapy for VUs was safe and effective in this Asian patient population. ECGA for patients with VUs had excellent patient compliance, minimal morbidity, and low 12-month recanalization rates. Furthermore, these researchers stated that larger studies with longer follow-up periods are needed to validate the preliminary findings of this study, and if it is shown to significantly improve ulcer healing rates, it will change the way clinicians use ulcer treatment. chronic venous ulceration.
In a multiethnic prospective cohort study from Singapore and Asia, Tang et al. (2020) the role of CAC in varicose veins. These investigators reported early clinical outcomes and patient satisfaction 3 months after the intervention. 100 patients (151 legs; 156 truncal veins) underwent CAC between April and December 2018. Of the 151 legs, 49 (32.5%) were treated for GSV insufficiency, 96 (63.6%) for bilateral VSM, 1 (0.7%) for SSV incompetence and 5 (3.3%) for combined unilateral reflux of SSV and SSV. At baseline, 68 legs (45.0%) had disease from C4 to C6 and 67 legs (44.4%) had multiple concurrent point avulsions. Patients were reviewed by duplex US at 2 and 12 weeks for venous recanalization (defined as length greater than or equal to 5 cm), pain score, revised VCSS, EuroQoL-5 questionnaire score, Aberdeen Varicose Vein Questionnaire score , 14- chronic venous insufficiency Score Questionnaire (CIVIQ-14) for Measures of QoL and Patient Satisfaction. Time to return to work and normal activities was also recorded. There were 59 women and the mean age was 60.1 ± 12.7 years. Technical success was 100%. Patients tolerated the procedure well and reported little pain during the procedure (mean pain score 2.9 [range 0-9]). Patient surveys every 3 months showed high satisfaction rates, with 72 of 91 (79.1%) being extremely or very satisfied. By day 10, out of 100 patients, 93 (93%) had resumed their daily activities, while 36 (36%) had returned to work. Within 2 weeks, GSV and SSV were completely occluded in 150/150 (100%) and 6/6 (100%) veins, respectively. At 3 months, the GSV and SSV occlusion rates were 140/141 (99.3%) and 6/6 (100%), respectively. A transient superficial phlebitis was reported in 27 of 151 (18%) legs that was self-limited. At 3 months, the revised VCSS improved from 5.00 (range 1.00 to 18.00) to 1.00 (0.00 to 10.00; p<0.001); EuroQoL-5 Dimension Score, from 0.686 (-0.382 to 1.00) to 1.00 (0.12 to 1.00; p<0.001); Aberdeen Varicose Vein Questionnaire score, from 17.14 (1.29 to 61.15) to 4.83 (0.00 to 57.12; p<0.001); and chronic venous insufficiency questionnaire with 14 items, from 19.64 (1.79 to 73.21) to 7.14 (0.00 to 51.79; p<0.001). The authors concluded that the CAC has a high safety profile and is an effective tool for blocking refluxing trunk veins in Asian patients at initial follow-up. Patients were very satisfied and reported little postoperative pain. There was a significant continuous improvement in quality of life at 3 months. Furthermore, these investigators stated that the initial results are encouraging, but look forward to a longer-term prospective follow-up of the study.
Cho and others. (2020) noted that several modalities are used to treat varicose veins. Open surgical treatment with ligation and removal of the truncal vein has been the standard of care for many years. Endovenous thermal ablation has proven to be a safe and effective alternative with high target rates of long-term venous occlusion. However, there is a possibility of thermal damage to surrounding structures. The newly introduced CAC is also considered a good alternative and the risk of injury to surrounding structures is minimal. In a prospective, multicenter, open-label RCT, these investigators attempt to demonstrate the non-inferiority of CAC with the VenaSeal Closure System compared to surgical removal in terms of clinical outcomes for the treatment of incompetent GSV. After baseline measurements, subjects will be randomly assigned to either the CAC group or the surgical removal group. The primary endpoint of the study is the rate of complete occlusion of the target vein in the CAC group and the absence of venous reflux or residual venous tissue after surgical removal in the surgical removal group. These endpoints will be measured 3 months after treatment by qualified vascular technologists or investigators using Doppler US. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical evaluation (including global and disease-specific quality of life assessments), complete occlusion rate, and absence of venous reflux or residual venous tissue at 12 and 24 months. ups and all EA fees during the 24-month follow-up period. The authors concluded that this multicenter RCT is designed to demonstrate non-inferiority in terms of the rate of complete cyanoacrylate occlusion compared with surgical removal for the treatment of incompetent saphenous veins. The approximate recruitment completion date would be February 29, 2020.
Dimech and Cassar (2020) found that 1/3 of adults in the US and UK suffer from varicose veins; NBCA glue is a new endovascular, non-tumescent, non-thermal ablation technique to treat this condition. In a systematic review, these investigators evaluated the effectiveness of NBCA in ablation of primary saphenous varices and elimination of reflux compared with existing endovascular techniques. Secondary endpoints are complications and quality of life. PRISMA was used as a guide and studies were selected for risk of bias and methodological quality. Subjects should be at least 18 years of age and should undergo subsequent posttreatment with color duplex US (DUS). Eligibility criteria included SFJ or SPJ ineligibility with saphenous vein reflux lasting more than 0.5 seconds at DUS interrogation and a clinical, etiological, anatomical, and pathophysiological classification of venous disease ranging from C1 to C6. Of 2910 patients (3220 veins) in 17 studies, 1981 received NBCA, 445 RFA, and 484 EVLA with mean procedure times of 25.7, 23.2, and 28.7 minutes, respectively. The mean time to recruitment was 9 months (range 1 to 36 months) and the follow-up time was a mean of 12.3 months (range 1 to 36 months). Most were C2 to C3; The 2-year occlusion rates were 93.7, 90.9, and 91.5% for NBCA, RFA, and EVLA, respectively. Patients treated with NBCA had fewer complications, with hematoma, phlebitis and pain being the most common; QoL improved equally in all 3 modalities. The authors concluded that NBCA is easy to administer, safe and effective even without compression stockings. Furthermore, these investigators indicated that further studies are needed to investigate the long-term benefits and effect of anticoagulation on venous obliteration.
The authors stated that this systematic review had several drawbacks. Comprehensive literature search and data extraction were performed by 1 author. He ruled out MOCA and the follow-up time was short. A meta-analysis would have been ideal, but as highlighted in a recent paper, the scarcity and heterogeneity of RCTs made this difficult. As most patients were not sedated, double-blinding was not possible. Outcome evaluators were often the same people who recruited patients, administered treatments, and/or followed up with patients. This was partially explained by the modification of the Cochrane Risk of Bias tool. Some methods have opted for an introductory phase to accommodate the 'learning curve', but others have not. A major disagreement was the duration of the procedure. There were no set standards as to when timing should start and end. The lack of reproducibility made these measurements unreliable. Regarding patient characteristics, one study included more smokers in the NBCA group and another deviated from its protocol to include a patient with a higher BMI. No distinction was made between unilateral or bilateral treatment of varicose veins. "Return to normal activities" needs to be better defined because these activities were different in an elderly or morbidly obese patient than in a healthy individual. Reflux was best assessed standing on DUS, as recommended by the European Society for Vascular Surgery, but some have measured it in the supine position. Finally, it would be interesting to carry out a clinical study on the use of NBCA in varicose veins in anticoagulated patients.
In addition, the National Institute for Health and Care Excellence Guide to Interventional Procedures on “Cyanoacrylate Glue Occlusion in Varicose Veins” (NICE, 2020) includes the following recommendations:
- Evidence of the safety and efficacy of cyanoacrylate adhesive occlusion for varicose veins is sufficient to support the use of this procedure, provided standard precautions for clinical direction, consent, and review are in place.
- The procedure should only be performed by physicians with adequate training in this procedure and experience in the use of venous ultrasound.
The VariClose Vein Closure System:
Bozkurt and Yılmaz (2016) stated that cyanoacrylate ablation is the newest non-thermal venous ablation technique. In a prospective comparative study, these investigators presented the 1-year results of a new cyanoacrylate glue versus endovenous laser ablation for the treatment of venous insufficiency. A total of 310 adult subjects were treated with either cyanoacrylate ablation or endovenous laser ablation. The primary outcome of this study was complete occlusion of the great saphenous vein; Secondary endpoints were procedure time, procedure pain, day 3 ecchymosis, AEs, changes from baseline in VCSS and AVVQ. Operative time was shorter (15 ± 2.5 vs 33.2 ± 5.7, p < 0.001) and periprocedural pain was lower (3.1 ± 1.6 vs 6.5 ± 2.3, p < 0.001 ) in the cyanoacrylate ablation group compared with the endovenous laser ablation group. Ecchymosis on day 3 was also significantly less in the cyanoacrylate ablation group (p<0.001). Temporary or permanent paresthesia developed in 7 patients in the endovenous laser ablation group and none in the cyanoacrylate ablation group (p=0.015). Closure rates at 1, 3, and 12 months were 87.1, 91.7, and 92.2% for the endovenous laser ablation and 96.7, 96.6, and 95.8% for the cyanoacrylate ablation groups , respectively. The 1-month closure rate was significantly better in the cyanoacrylate ablation group (p<0.001). Although there was a trend towards better closure rates in patients with cyanoacrylate ablation, this difference did not reach the statistical difference at months 6 and 12 (p = 0.127 and 0.138, respectively). Both groups had a significant improvement in VCSS and AVVQ postoperatively (p < 0.001), but there was no significant difference in VCSS and AVVQ scores between groups at 1st, 6th and 12th months. Only a slightly better trend towards well-being was seen in the cyanoacrylate ablation group in terms of AVVQ scores (p = 0.062). The authors concluded that the analysis of safety and efficacy demonstrated that cyanoacrylate ablation is a safe and simple method that can be recommended as an effective technique of endovenous ablation. Furthermore, they stated that more than one year of follow-up data will clarify the future role of cyanoacrylate ablation for the treatment of incompetent truncal veins.
Tekin and colleagues (2016) noted that endothermic treatment of the great saphenous vein has become the first line of treatment for superficial venous reflux. A newer technique for venous insufficiency is non-thermal ablation with a venous seal system that involves intravenous delivery of cyanoacrylate tissue glue into the vein causing fibrosis. In a single-center prospective study, these investigators examined the effectiveness of great saphenous vein treatment in 62 patients with the venous sealing system (VariClose). All cases were performed under local anesthesia. Tumescent anesthesia was not required. No NSAIDs were administered to patients postoperatively; recommended to use elastic bandages for 1 day; and compression stockings were not offered. Treatment success was defined as complete occlusion of the treated vein or recanalized segment smaller than 5 cm. Subtotal recanalization was defined as a large flow in the saphenous vein containing a 5 to 10 cm segment of the treated vein. A recanalized great saphenous vein or treatment failure was defined as a patent portion of the treated vein segment greater than 10 cm in length. At 1 week and 1 month follow-up, duplex scan showed complete occlusion in all patients (100%), complete occlusion in 58 patients (93.5%) and subtotal occlusion in the 3rd leg in 4 patients (6.5%). . 🇧🇷 At the end of 6 months, total occlusion in 56 patients (90.3%) and subtotal occlusion in 2 patients (3.2%). No occlusion was observed in 4 (6.5%) patients and the diameter was greater than 11 mm. Since the beginning of this decade, the saphenous vein has been embolized with cyanoacrylate. The combined chemical and physical mechanism of action resulted in permanent venous occlusion. A 24-month occlusion rate of 92% was demonstrated in a recently published study. The most commonly reported complications of using cyanoacrylate to treat varicose veins include ecchymosis and phlebitis. Almeida and others. reported that phlebitis was the most common side effect in 16%. In this study, the rate of phlebitis was not as high as reported. This may be due to a shorter follow-up time in the hospital. The authors concluded that endovenous ablation of the great saphenous vein is insufficiently feasible with cyanoacrylate-based glue. The operating time is short and tumescent anesthesia is not required as compression stockings are required after the procedure. the absence of significant side effects and a 100% annual success rate are advantages of the system. These results need to be validated by well-designed studies with larger samples and longer follow-up.
In a retrospective study, Yasim et al. (2017) presented the first results of the use of non-tumescent intravenous ablation based on N-butyl cyanoacrylate (VariClose) to treat patients with varicose veins. Between May 2014 and November 2014, a total of 180 patients with varicose veins due to insufficient trunk veins were treated with the VariClose endovenous ablation method. Participants were 86 men and 94 women with a mean age of 47.7 ± 11.7 years; they had a large saphenous vein diameter of more than 5.5 mm and a small saphenous vein diameter of more than 4 mm associated with reflux lasting longer than 0.5 s. Patients with varicose veins were treated with a venous duplex -Investigation, CEAP, examined and their VCSS was recorded. The patients' median CEAP score was 3, and the diameters of the trunk veins ranged from 5.5 to 14 mm (mean 7.7 ± 2.1 mm). 169 patients underwent percutaneous access under local anesthesia in the great saphenous vein and 11 patients in the small saphenous vein. Duplex examination immediately after the procedure showed occlusion of the treated vein in 100% of the treated segment. No complications were observed. The mean follow-up time was 5.5 months (ranging from 3 to 7). No recanalization was observed in any of the patients during follow-up. The mean VCSS was 10.2 before the intervention and decreased to 3.9 after 3 months (p < 0.001). The authors concluded that the application of N-butyl cyanoacrylate (VariClose) is an effective method in the treatment of varicose veins; resulted in a high rate of intravenous occlusion without the need for tumescent anesthesia. However, the long-term results are currently unknown.
Furthermore, Bootun and colleagues (2016b) indicated that the initial results of 2 recently introduced non-thermal and non-tumescent methods, intravenous mechanochemical ablation (MOCA) and cyanoacrylate glue, are promising.
Koramaz et al. (2017) retrospectively compared an ablation method based on n-butyl cyanoacrylate (NBCA) with EVLA for the management of incompetent GSV. Between May 2013 and August 2014, 339 patients with insufficient varices were treated with intravenous application of NBCA (VariClose Vein Sealing System [VVSS]; Biolas, Ankara, Turkey) or EVLA. Pre-procedure, intra-procedure, post-procedure and patient follow-up data were collected and retrospectively compared. Mean age was 45.09 ± 12 years in the VVSS group and 47.08 ± 11 years in the EVLA group (p = 0.113). The mean length of the ablated vein was 31.97 ± 6.83 cm in the VVSS group and 31.65 ± 6.25 cm in the EVLA group (p = 0.97). The mean use of tumescent anesthesia was 300 mL (range 60-600 mL) in the EVLA group. The mean intervention time was 7 minutes (ranging from 4 to 11 minutes) in the VVSS group and 18 minutes (ranging from 14 to 25 minutes) in the EVLA group (p<0.01). Based on the US studies performed at the end of the procedure, all procedures in both groups were successful and the target vein segments were completely occluded. The overall occlusion rates at 12 months in the VVSS and EVLA groups were 98.6% and 97.3%, respectively (p=0.65). In both the VVSS and EVLA groups, the VCSS significantly decreased with no difference between groups. There were fewer AEs after VVSS treatment compared to EVLA treatment (pigmentation, p ≤ 0.002; phlebitis, p ≤ 0.015). No tumescent anesthesia was required in the VVSS group. The authors concluded that the NBCA-based venous sealing system is a quick and effective therapeutic option for the management of incompetent saphenous veins that does not involve tumescent anesthesia, compression stockings, paresthesia, burn marks or pigmentation. Furthermore, they explained that more large-scale studies with long-term outcomes are needed to identify optimal treatment modalities for patients with SVI.
Vos et al. (2017) performed a systematic review and meta-analysis to assess the effectiveness of MOCA and venous cyanoacrylate ablation (CAVA) in GSV incompetence. Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases were searched for articles published between January 1966 and December 2016. Eligible articles were prospective studies that included patients treated for GSV incompetence and that described the primary outcome. Exclusion criteria were unavailable full texts, case reports, retrospective studies, small series (n less than 10), reviews, abstracts, animal studies, SSV incompetence studies, and recurrent GSV incompetence studies. The primary endpoint was anatomical success; secondary endpoints were initial technical success, VCSS, AVVQ score, and complications. A total of 15 articles met the inclusion criteria. The combined anatomical success for MOCA and CAVA was 94.7% and 94.8% at 6 months and 94.1% and 89.0% at 1 year, respectively; VCSS and AVVQ scores significantly improved after treatment with MOCA and CAVA. The authors concluded that these results are promising for these new techniques that can serve as alternatives to thermal ablation techniques. However, they stated that determining their precise role in clinical practice requires high-quality RCTs comparing these new modalities with established techniques.
Eroglu and colleagues (2017) presented interim results of patients with varicose veins treated with N-butyl cyanoacrylate (VariClose), a non-tumescent endovenous ablation technique. Between May and October 2014, intravenous ablation was performed in 180 patients with saphenous vein insufficiency. A total of 168 individuals who could be followed up for 30 months were included. Pre- and postoperative patient data were recorded. Interventions were performed on the GSV in 159 patients and on the SSV in 9 patients. Saphenous vein diameters ranged from 5.5 mm to 14 mm. Complete ablation was achieved in all patients after the procedure. There were no complications. Patients were followed up for 30 months. Ablation rates were 100% at 3 months, 98.3% at 6 months, 96.6% at 1 year, and 94.1% at 30 months. The mean VCSS was 10.2 before surgery and decreased to 3.9 at 3 months, 4.2 at 6 months, 2.9 at 12 months, and 2.7 at 30 months (p = 0.000). The authors concluded that endovenous ablation with N-butyl cyanoacrylate is a good method due to its high success rate, absence of complications, no need for tumescent anesthesia and high patient satisfaction. However, they indicated that long-term follow-up results are needed.
Prasad et al (2018) noted that recurrent lower limb venous insufficiency often presents a challenge in clinical practice and is most commonly caused by insufficient perforators. Many of these patients do not experience adequate relief of compression symptoms and require some form of treatment for incompetent perforator rupture. Various methods with different efficiencies have been tried. These investigators evaluated the feasibility, safety, and efficacy of combined sclerotherapy with cyanoacrylate and sodium tetradecyl sulfate for the treatment of patients with symptoms of persistent or recurrent venous insufficiency in the lower limbs secondary to incompetent perforators. A total of 83 limbs of 69 patients with symptoms of persistent or recurrent lower limb venous insufficiency due to insufficient perforators were treated with cyanoacrylate embolization of insufficient perforators and sclerotherapy of dilated collateral veins (superficial varicose veins). Technical success, procedural pain, perforator occlusion, venous occlusion, clinical improvement, and ulcer healing were evaluated. Follow-up was performed 3 and 6 months after the procedure. The procedure can be performed successfully in all patients; A total of 191 perforators were treated. The closure rate of perforating veins and varicose veins was 100%. Deep venous dilation by cyanoacrylate occurred in 4 (4.8%) patients without adverse clinical sequelae. Venous clinical severity improved from a baseline of 8.18 ± 3.60 to 4.30 ± 2.48 at 3-month follow-up and to 2.42 ± 1.52 at 6-month follow-up (p < 0. 0001). All ulcers healed completely within 3 months. Significantly prolonged thrombophlebitis occurred in 38.5% of the members. The authors concluded that combined sclerotherapy using cyanoacrylate and sodium tetradecyl sulfate adhesion was technically simple, had many advantages, including an outpatient procedure, and was highly effective but with a guarded safety profile. The main disadvantages of this study were the relatively small sample size (n = 69) and the short follow-up time (6 months); and the results were confounded by the combined use of cyanoacrylate adhesion and sodium tetradecyl sulfate sclerotherapy.
Gibson and colleagues (2018) previously reported closure rates at 3 months and 12 months after treatment of clinically symptomatic saphenous vein reflux with cyanoacrylate (CAC) closure using the VenaSeal closure system (Medtronic, Dublin, Ireland) or ablation by radio frequency (RFA) . in a randomized, multicenter clinical trial, the VenaSeal Sapheon Closure System compared with radiofrequency ablation for failing great saphenous veins (VeClose). These investigators reported the 24-month follow-up results of the VeClose study. There were 222 patients with symptomatic great saphenous vein (GSV) insufficiency who were randomized to receive CAC (n=108) or RFA (n=114). Patients were not allowed to receive adjunctive treatment for tributary varicose veins until after the 3-month visit. Duplex ultrasonography (US) of the target vein was performed on Day 3 and Months 1, 3, 6, 12 and 24 after treatment, and the occlusion was assessed by US by the attending physician. Overall, 24-month success rates were compared; in addition, the time until the first reopening of the target vein was evaluated using survival analysis. Endpoints such as Venous Clinical Severity Score, EuroQoL-5 Dimension and Aberdeen Varicose Vein Questionnaire were evaluated. Of the 222 randomized patients, 171 completed the 24-month follow-up, including 87 from the CAC group and 84 from the RFA group. The complete occlusion rate at 24 months was 95.3% in the CAC group and 94.0% in the RFA group, demonstrating the continued non-inferiority of the CAC compared to the RFA (p=0.0034). Symptoms and quality of life (QoL) improved similarly in both groups. There were no clinically significant late adverse events (AEs) related to the device or procedure. The authors concluded that both CAC and RFA were effective in closing the target GSV, resulting in similar and significant improvements in the patient's quality of life over 24 months. They stated that these results indicate that the GSV CAC is safe and stable for up to 2 years. Investigators will continue to monitor patient cohorts and long-term data will be collected at 3 and 5 years.
The authors stated that this study was limited by the moderate abstinence rate at 24 months. 21 of the 108 subjects (19.4%) in the CAC discontinued treatment. Furthermore, it was impossible to blind patients to the requirements of the tumescent application (since RFA requires tumescent anesthesia but CAC does not), as well as blinding physicians (CA is clearly evident on long-term US examination). . As the patient's expectations of the control treatment (RFA) and the new treatment (CAC) were unknown at the time of treatment, it is unclear whether "excitement" towards the latter would affect patient-reported outcomes. Furthermore, the impact of concomitant care on patients' perception of the success or failure of their treatment and on quality of life is unknown.
Radak et al (2019) noted that varicose vein surgery has gone through great turmoil and several innovations in the last 20 years. Several new techniques have been introduced with the aim of increasing the success rate, reducing periprocedural complications and improving the patient's overall quality of life. The most recent of these, namely the CAE technique, threatens to undermine the reputation of established intravenous procedures. These investigators analyzed all previous studies by searching the Medline database using PubMed. Although the idea of using NBCA glue for medical purposes was not new, the first in vivo and animal experiments using NBCA for venous occlusion were performed only at the beginning of this millennium. The results of these studies gave confidence to start with the first interventions in humans. Early studies reported very high success rates of over 90%, with the longest follow-up being 36 months. No serious AEs were reported, while minor ones - mostly phlebic reactions - were defined as mild to moderate. The latest direct comparative studies have shown that CAE is not inferior to other intravenous methods with higher occlusion rates and fewer adverse events. Short procedure times and no need for tumescent anesthesia or compression stockings reduce patient discomfort to a minimum and definitely seem to be a step forward to meet the modern requirements of "walk-in-walk-out" surgery. The authors concluded that CAE has undoubtedly led the way to the forefront of varicose vein surgery as an easy-to-use technique; However, more comparative clinical studies with longer follow-up times are needed to get a clearer picture.
Belramman et al (2018) observed that thermal ablation techniques for the treatment of truncal veins have become the first choice in the treatment of chronic venous disease (CVD). Despite excellent results, these methods are often associated with pain; usually due to the use of heat and the need for fluid to seep around the vein. More recently, new non-thermal techniques such as MOCA and CAE have been developed to overcome these undesirable effects. So far, new techniques have been found to have similar efficacy to thermal methods, however, no direct comparison between non-thermal treatment techniques has been made to motivate this study. This is a prospective, multicenter, randomized clinical trial, recruiting patients with saphenous insufficiency. Patients will be randomized to undergo MOCA or CAE trunk ablation, followed by varicose vein treatment. All patients must wear compression stockings for 4 days after the procedure. The primary end point is pain score immediately after completion of trunk ablation, measured with a 100 mm VAS. Secondary outcomes are total treatment pain scores, clinical scores, quality of life scores, occlusion rates, time to return to usual activities/work at 2 weeks, 3, 6, and 12 months. The reintervention rate is considered from the 3rd month onwards. Cost-effectiveness is assessed for each intervention after 12 months. The study is designed to detect an average difference of 10 mm in maximum pain score. Taking into account loss to follow-up, the total enrollment target is 180 patients. The study will be the first to compare MOCA versus CAE and aims to determine which method causes less pain. This study is expected to be completed by the end of 2019.
In a multicenter prospective RCT, Morrison et al. (2019) The safety and efficacy of 36 months of CAC for the treatment of incompetent GSV compared with RFA. A total of 222 symptomatic subjects with incompetent GSVs were assigned to CAC or RFA. The primary endpoint, complete closure of the target GSV, was determined using duplex US scanning from the 3-month visit. At month 36, GSV completion rates were 94.4% for the CAC group and 91.9% for the RFA group. Stable improvement in symptoms and QoL was observed in both groups; Rates of AEs between the 24- and 36-month visits were similar between groups, as were serious AEs, which occurred infrequently and were considered unrelated to the device or procedure in both groups. The authors concluded that this study continued to demonstrate the safety and efficacy of CAC for the treatment of GSV incompetence with a 36-month GSV closure rate similar to RFA, indicating that CAC versus RFA was non-inferior. The improvement in quality of life scores was also sustained and similar between the two treatment groups. These investigators also noted that follow-up of patient cohorts would continue for up to 60 months after the procedure.
The authors noted that this study had several drawbacks. While blinding may have been beneficial, it was not entirely feasible because RFA requires the administration of tumescent anesthesia. The study was also limited by a relatively high number of patients with missing data from each treatment group (missing data for approximately 1/3 of patients in each group was due to patient discontinuation or data could not be collected in time skillful during the specified period of study). Finally, the potential advantages of CAC over RFA were intentionally not addressed in this study, as the present report was only intended to show the 36-month parity of CAC with RFA. CAC and RFA cost analysis comparisons were not included in the study design, but may appear in future studies in addition to the analyzes of potential benefits of CAC described above.
Additionally, an UpToDate review of “Fluid, Foam, and Glue Sclerotherapy Techniques for Treating Lower Limb Veins” (Scovell, 2019) states that “Cyanoacrylate glue—a system that bonds the treated vein with an adhesive ( VenaSeal) removes for use in the United States. The use of glue was first described in 2013 to treat saphenous insufficiency. The procedure is performed like radiofrequency and laser ablation, but without the need for tumescent anesthesia. In a randomized trial comparing this system to radiofrequency ablation, short-term results at 3 months were similar. Long-term follow-up is needed to determine the durability of the results.”
Witte et al. (2015) stated that endovenous mechanochemical occlusion using the ClariVein catheter is a new technique that combines mechanical injury to the venous endothelium with simultaneous catheter-directed infusion of a sclerosing fluid. This leads to irreversible damage to the endothelium, leading to vein fibrosis. The technique is associated with a low rate of complications and a 96% success rate at 2 years and a sustained improvement in quality of life. This occlusion rate is comparable to endothermic techniques, but significantly less postoperative pain and faster return to normal activities and work have been reported with endovenous mechanochemical occlusion. The authors concluded that ClariVein mechanochemical occlusion has been shown to be safe and effective and has several advantages compared to endothermic techniques. The possibility of retrograde ablation of distal SSV insufficiency in C6 ulceration is considered a significant advantage. In addition, they state that randomized comparative studies with long-term follow-up will continue to define the definitive site of mechanochemical occlusion.
Deijen et al. (2016) observed that mechanochemical endovenous ablation is a new technique for the treatment of GSV and SSV insufficiency that combines mechanical injury to the endothelium with simultaneous infusion of liquid sclerosant. The main objective of this study was to evaluate early occlusion. All consecutive patients eligible for treatment with intravenous mechanochemical ablation were included. The enrollment period was from the introduction of the device in hospitals (September 2011 and December 2011) until December 2012. A total of 449 patients were enrolled, representing 570 incompetent veins. Duplex ultrasonography was performed during follow-up in 506 treated veins: 457 veins (90%) were occluded after 6 to 12 weeks of follow-up. In the univariate and multivariate analysis, failure of the treated GSV was associated with saphenofemoral junction incompetence (OR 4; 95% CI: 1.0 to 17.1, p = 0.049). The authors concluded that the ClariVein device appeared to be safe and had high short-term technical efficacy. Long-term clinical results are needed to determine the clinical value of ClariVein.
In an RCT, Lam et al. (2016) the optimal dosage and form of polidocanol for mechanochemical ablation for GSV occlusion. When maintained at safe dosages, higher concentrations of sclerosants can limit the scope of treatment. It has been shown that this problem can be overcome using Polidocanol as a microfoam. This article was prepared based on the results of a preliminary analysis. The original study was a single-blind, multicenter RCT in which patients were allocated to 3 treatment arms. Group 1 consisted of mechanochemical ablation + 2% liquid polidocanol, Group 2: mechanochemical ablation + 3% liquid polidocanol and Group 3: mechanochemical ablation + 1% polidocanol foam. A total of 87 (34 men and 53 women (60.9%)), mean age 55 years; SD 16.0 (range 24 to 84) were included in the study. Treatment duration was 30 cm (range 10 to 30) in 95.2% of patients. Mean operating time was 16 minutes (range 5 to 70). The mean diameter of the saphenofemoral junction (7.7 mm) was similar in the 3 groups. 6 weeks after treatment, duplex ultrasound showed that 25 of 25 (100%), 27 of 28 (96.4%) and 13 of 23 (56.5%) were occluded in mechanochemical ablation + 2% Polidocanol liquid, mechanized chemical removal + liquid polidocanol 3% or mechanochemical removal + polidocanol 1% microfoam (p < 0.001). However, more rigorous tests showed that the anatomical success rate, defined as occlusion of at least 85% of the treated length, was 88.0%, 85.7% and 30.4%, respectively (p<0.001). The authors concluded that mechanochemical ablation with ClariVein in combination with 1% polidocanol microfoam is significantly less effective and should not be considered a treatment option for incompetent truncal veins. They indicated that further research to determine the optimal dosage of liquid Polidocanol using mechanochemical ablation is recommended and will be conducted accordingly.
Vun and colleagues (2015) evaluated the effectiveness of the MOCA ClariVein system in superficial venous insufficiency. The ClariVein treatment uses a micropuncture technique and a 4 Fr sheath to allow a catheter to be placed 1.5 cm from the SFJ. Unlike EVLT or RFA, no tumescence is required. The technique is based on a wire rotating at 3,500 rpm, causing endothelial damage while a liquid sclerosing agent (1.5% sodium tetradecyl sulfate) is infused. The wire is withdrawn while the sclerosant is infused continuously along the length of the target vessel. Initially, 8 mL of diluted sclerosant was used, but later it was increased to 12 mL. No routine postoperative analgesia was prescribed and, in particular, no NSAIDs. Procedure times and pain scores (visual analogue scale [VAS]) were recorded and compared with EVLT and RFA. All patients were invited for duplex follow-up. In the 10 months from July 2011, a total of 51 GSV and 6 SSV were duplexed and followed up. No major complications or deep vein thrombosis were reported. Duplex demonstrated patency of 3 treated veins, with 2 other veins having only a short occlusal length, giving a technical success rate of 91%. A comparison of 50 RFA and 40 EVLT showed that procedure times with ClariVein (23.0 ± 8.3 minutes) were significantly shorter than with RFA (37.9 ± 8.3 minutes) or EVLT (44.1 minutes). ± 11.4 minutes). Median pain scores were significantly lower with ClariVein than with RFA and EVLT (1 versus 5 versus 6, p<0.01). The authors concluded that MOCA is safe and effective with the ClariVein System. After some initial failures, the use of 12 mL of diluted sclerosant resulted in a very high technical success rate, greater than 90%, consistent with the limited published literature; and procedure times and pain scores were significantly better than RFA and EVLT. These researchers said they look forward to long-term clinical results.
Bootun et al (2016a) observed that endovenous techniques are currently the recommended choice for the treatment of truncal veins. However, thermal techniques require tumescent anesthesia, which can be uncomfortable during administration. Non-tumescent and non-thermal techniques would therefore have potential advantages. In an RCT, these researchers compared the level of pain that patients experience during treatment with MOCA or RFA. The first results of this RCT are reported here. Patients presenting for treatment of primary varicose veins were randomized to receive MOCA (ClariVein) or RFA (Covidien Venefit). The most symptomatic member was randomized. The primary endpoint was pain during the procedure using a validated VAS. Secondary outcomes were change in quality of life and clinical scores, time to return to normal activities and work, and rate of occlusion. A total of 119 patients were randomized (60 in the MOCA group). The initial characteristics were similar. Maximum pain score was significantly lower in the MOCA group (19.3 mm, SD ± 19 mm) than in the RFA group (34.5 mm ± 23 mm; p < 0.001). The mean VAS was also significantly lower in the MOCA group (13.4 mm ± 16 mm) compared to the RFA group (24.4 mm ± 18 mm; p = 0.001); 66% attended a 1-month follow-up and the complete or proximal occlusion rate was 92% for both groups. At 1 month, clinical and quality of life scores showed similar improvements for both groups. The authors concluded that early results showed that MOCA is less painful than the RFA procedure and that clinical and quality of life scores similarly improved at 1 month. Long-term data, including 6-month occlusion rates and quality of life scores, will be collected. Furthermore, Bootun and colleagues (2016b) stated that the first results of 2 recently introduced non-thermal and non-tumescent methods, MOCA and cyanoacrylate glue, are promising.
Lam and colleagues (2016) stated that the ClariVein system is an intravenous technique that uses MOCA to treat incompetent truncal veins. This study was conducted to identify the optimal dosage and form of polidocanol for MOCA to occlude the GSV. When maintained at safe dosages, higher concentrations of sclerosants can limit the scope of treatment. It has been shown that this problem can be overcome using Polidocanol as a microfoam. This article was prepared based on the results of a preliminary analysis. The original study was a single-blind, multicenter RCT in which patients were allocated into 3 treatment arms:
- Group 1 consisted of MOCA + 2% liquid polidocanol,
- Group 2: composed of MOCA + 3% liquid polidocanol, and
- Group 3: consisted of MOCA + 1% Polidocanol foam.
A total of 87 patients (34 men and 53 women, mean age 55 years [SD 16.0 and range 24 to 84]) were enrolled in the study. Treatment duration was 30 cm (range 10 to 30) in 95.2% of patients. Mean operating time was 16 minutes (range 5 to 70). Mean SFJ diameter (7.7 mm) was similar in all 3 groups. 6 weeks after treatment, duplex ultrasound showed that 25 of 25 (100%), 27 of 28 (96.4%) and 13 of 23 (56.5%) on MOCA + 2% liquid polidocanol, MOCA + 3% Liquid polidocanol or MOCA + 1% polidocanol microfoam were occluded (p < 0.001). However, more rigorous tests showed that the anatomical success rate, defined as occlusion of at least 85% of the treated length, was 88.0%, 85.7% and 30.4%, respectively (p<0.001). The authors concluded that MOCA with ClariVein in combination with 1% polidocanol microfoam was significantly less effective and should not be considered a therapeutic option for incompetent truncal veins. They indicated that further research to determine the optimal dosage of liquid polidocanol with MOCA is recommended and will be conducted accordingly.
Leung and colleagues (2016) stated that intravenous thermal techniques such as EVLA are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that they require the administration of tumescent anesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques such as MOCA have potential advantages; MOCA combines physical damage to the endothelium with a rotating wire and infusion of a liquid sclerosant. Preliminary experience with MOCA has shown good results and less pain after the procedure. The Laser Ablation versus Mechanochemical Ablation (LAMA) study is a single-center RCT in which 140 patients will be randomly assigned to EVLA or MOCA. All patients with primary superficial venous insufficiency (IVS) who meet the eligibility criteria will be invited to participate in this study. Primary endpoints are intraprocedural pain and technical efficacy at 1 year, defined as complete occlusion of the target vein segment and assessed with duplex ultrasound. Secondary outcomes are post-procedure pain, analgesic use, procedure time, clinical severity, general and disease-specific quality of life, bruising, complications, satisfaction, cosmetics, time required to return to daily activities and/or work, and cost. -effectiveness Analysis according to EVLA or MOCA. Both groups are evaluated on an intention-to-treat basis. The purpose of the LAMA study is to determine whether MOCA is superior to current first-line EVLA therapy. The 2 main hypotheses are:
- MOCA may cause less initial pain and disability, allowing for more acceptable treatment with improved recovery and
- this can come at the expense of reduced efficacy, which can lead to increased recurrence and compromise long-term quality of life, thus increasing the need for secondary interventions.
In a large, single-center study, Tang et al. (2017) evaluated the efficacy and patient experience of the ClariVein® endovenous occlusion catheter for varicose veins. A total of 300 patients (371 legs) were treated with ClariVein for varicose veins; 184 for GSV incompetence, 62 bilateral GSV, 23 SSV, 6 bilateral SSV, and 25 combined unilateral GSV and SSV. Patients were reviewed at an interval of 2 months after the procedure and underwent duplex ultrasonography. Postoperative complications were recorded along with patient satisfaction. All 393 procedures were successfully completed under local anesthesia. Complete occlusion of the treated vein was initially achieved in all patients, but at 8 weeks of follow-up there was only partial occlusion in 13/393 (3.3%) veins. All were successfully treated with ultrasound-guided foam sclerotherapy. The procedures were well tolerated with a mean pain score of 0.8 (0 to 10) and no significant complications were reported. The authors concluded that ClariVein can be used for ablation of long and short saphenous varices on a walk-in, walk-out basis. Bilateral procedures can be performed successfully and have been well tolerated, as have multiple veins in the same leg. They indicated that initial results are promising, but further evaluation and longer-term follow-up are needed.
Witte and colleagues (2016) reported the interim results of mechanochemical ablation (MOCA) for the treatment of GSV insufficiency. Over a 1-year period, 85 consecutive patients (mean age 51.4 years; 71 women) undergoing MOCA with polidocanol in 104 limbs were enrolled in a prospective registry. Patients were assessed at baseline and during follow-up (4 weeks and 1, 2, and 3 years) using duplex ultrasonography, CEAP classification (clinical, etiological, anatomical, and pathophysiological classification), Venous Clinical Severity Score (VCSS), and the A RAND reviews the Short Form 36-Item Health Survey (RAND-SF36) and the Aberdeen Varicose Vein Questionnaire (AVVQ). Primary endpoints were clinical and anatomic success; secondary outcomes included global and disease-specific quality of life and repeated interventions. Technical success (99%) was achieved in all but 1 patient, in whom technical problems with the device led to a switch to another method to treat 2 limbs. After a median follow-up of 36 months (interquartile range [IQR] 12.5, 46.3), recanalization occurred in 15 (15%) of 102 successfully treated vein segments. Anatomical success was 92%, 90%, and 87% at 1, 2, and 3 years, respectively. VCSS improved at all time points compared to the pre-procedure median. Clinical success after 3 years was 83%. AVVQ and RAND-SF36 scores showed improvement from baseline at all time intervals. However, a significant deterioration in the VCSS was observed between 12 and 36 months, which was accompanied by a deterioration in disease-specific and overall quality of life. The authors concluded that, in the longest MOCA follow-up to date, this study has demonstrated that MOCA is an effective treatment modality for GSV failure at mid-term follow-up; however, clinical outcomes appeared to decline over time. The main disadvantages of this study were:
- the results were influenced by the chosen definition of success. Although the definition used is consistent with previous reference studies, heterogeneity in definition across studies has been a major problem when comparing outcomes and has emphasized the need for standardization of outcome measures and
- Follow-up was not completed for all patients and questionnaires were not always completed.
Lane et al (2017) found that intravenous thermoablation has revolutionized the treatment of varicose veins. New non-thermal techniques such as MOCA allow entire strains to be treated with single injections of anesthetic. Previous non-randomized work has reduced postoperative pain with MOCA. This study presented a multicenter RCT evaluating the difference in pain during trunk ablation with MOCA and intravenous radiofrequency ablation (RFA) with 6 months of follow-up. Patients undergoing intravenous local anesthetic ablation for primary varicose veins were randomized to MOCA or RFA. Pain scores using VAS and a numerical scale (0 to 10) during nail ablation were recorded. Additional procedures were then completed. Pain after phlebectomy was not recorded. Patients were evaluated at 1 and 6 months with clinical scores, quality of life scores, and a duplex ultrasound assessment of the treated leg. A total of 170 patients were recruited over a period of 21 months from 240 selected patients. Patients in the MOCA group experienced significantly less maximal pain during the procedure by VAS (median MOCA 15 mm (IQR 7 to 36 mm) versus RFA 34 mm (IQR 16 to 53 mm), p = 0.003) and numerical scale (median MOCA of 3 (IQR 1 to 5) versus RFA 4 mm (IQR 3 to 6.5), p=0.002). “Average” pain scores were also significantly lower in the MOCA group; 74% underwent simultaneous phlebectomy. Closure rates, clinical severity, disease-specific and generic quality of life scores were similar between groups at 1 and 6 months. There were 2 deep vein thrombosis, 1 in each group. The authors concluded that pain after nail ablation in MOCA was less painful than in RFA with similar technical, quality of life and safety results in the short term. They indicated that more work is needed with larger studies and longer follow-up to assess long-term outcomes and recurrence rates.
The authors noted that “this study was limited by the lack of treatment blinding to patients and interventional clinicians. This was due to the technical differences between the devices, i.e. H. Tumescent injections in the RFA group and device vibration in the MOCA group. Follow-up appointments and ultrasound examinations were blinded to treatment. Another limitation of this study is the lack of long-term follow-up - only short-term occlusion rates are evaluated in this study, with the primary end point being obtained at the time of the procedure. Activity time was not recorded in this study; However, all cases were performed in standardized single-interval surgical sessions, with one surgeon performing all tasks, and 74% of patients underwent concomitant phlebectomy. A major limitation of all nontumescent techniques is the treatment of varicose veins remaining after stem ablation, with first-level evidence now supporting combined treatment with phlebectomies. This study was planned and started before the completion of the last study, but took into account the fact that phlebectomies cause pain and therefore pain scores were collected after trunk ablation but before phlebectomies were completed. This constitutes, therefore, a significant limitation of the results of this study, as the pain scores presented above do not evaluate the complete treatment, with the exception of those patients who did not undergo phlebectomy.” evaluated during the periprocedural phase.
The National Institute for Health and Care Excellence guideline on “Endovenous mechanochemical ablation for varicose veins” (2016) states: “Current evidence regarding the safety and efficacy of endovenous mechanochemical ablation for varicose veins appears adequate to support the use of this supportive procedure where standard agreements are in place for consent, audit, and clinical governance. Clinicians are encouraged to collect long-term follow-up data.”
Elias and Raines (2012) evaluated the safety and efficacy of the ClariVein system using mechanochemical ablation (MOCA) of the great saphenous vein (GSV). Patients eligible for GSV ablation received micropuncture access under local anesthesia just to introduce a 4 or 5 Fr sheath. The ClariVein catheter was placed through the sheath, the wire extruded and the distal end of the wire positioned 2 cm from the saphenofemoral junction under ultrasound (US) guidance. Catheter wire rotation was then activated for 2 to 3 seconds at approximately 3500 rpm. While the wire rotated, the sclerosant infusion was started simultaneously with the removal of the catheter. 1.5% liquid sodium tetradecyl sulfate was used as a sclerosant. A total of 30 GSVs were treated in 29 patients. All patients reached the 6-month follow-up; the median number of postoperative days was 260. No adverse events (AERs) were reported; the primary occlusion rate was 96.7%. The authors concluded that MOCA appears to be safe and effective. The ClariVein technique eliminated the need for tumescent anesthesia. The vast majority of incompetent VGS can be treated with this technique. (This was a small study (n=29) with short-term follow-up (6 months))
In a prospective cohort study, Boersma et al (2013) evaluated the feasibility, safety, and 1-year outcomes of MOCA in small saphenous vein insufficiency (SSV). A total of 50 consecutive patients were treated with MOCA using the ClariVein device and polidocanol for primary VSS failure. Initial technical success, complications, patient satisfaction and visual analogue scale (VAS) pain were evaluated. Anatomical and clinical success was evaluated after 6 weeks and after 1 year. The initial technical success of MOCA was 100%. At the 6-week evaluation, all treated veins were occluded. The 1-year follow-up duplex showed anatomical success in 94% (95% confidence interval [CI]: 0.87 to 1). The Venous Clinical Severity Score (VCSS) decreased significantly from 3.0 (interquartile range (IQR) 2 to 5) before treatment to 1.0 (IQR 1 to 3, p<0.001) at 6 weeks and to 1.0 ( IQR 1 to 2, p<0.001 ). ) in 1 year. The median procedural VAS score for pain was 2 (IQR 2 to 4). No major complications were observed, notably no nerve damage. The authors concluded that MOCA is a safe, feasible and effective technique for the treatment of SSV insufficiency. One-year follow-up showed a 94% anatomical success rate and no major complications.
One of the disadvantages of this study was that the maximum diameter of the treated SSV was 11 mm. The technical and clinical success of MOCA in larger diameter varicose veins was still unknown. Pain scores during MOCA were very low. Post-procedure pain scores were not measured. The authors state that more controlled studies are needed to compare pain with other VSS ablation techniques. Patients on oral anticoagulation were excluded; therefore, these investigators were unable to provide data on the effect of anticoagulant therapy on MOCA. In contrast to endothermic therapy, anticoagulants can affect clot formation and lead to increased recanalization.
In a prospective, multicenter observational report, Bishawi and colleagues (2014) evaluated the efficacy of a tumescence-free technique using MOCA in selected patients with chronic venous disease of the lower limbs. Demographic information, clinical and procedural data were collected in a customized database. The distribution and extent of venous reflux and the occlusion rate of treated veins were evaluated by duplex US. Pain was assessed during the procedure and postoperatively using an analogue scale. The presence and severity of complications were recorded. Patient improvement was assessed using the grade of clinical etiology-anatomy-pathophysiology (CEAP) and the Venous Clinical Severity Score (VCSS). At the beginning of the study, 126 patients were included, 81% of them women, with a mean age of 65.5 ± 14 years. The mean BMI was 30.5 ± 6, the mean diameter of the great saphenous vein in the thigh was 7.3 mm, and the mean treatment length was 38 cm. In 11% of patients, concomitant treatment of varicose veins was performed during the procedure. Completion rates were 100% at 1 week, 98% at 3 months, and 94% at 6 months. Postoperative complications included hematoma 1%, ecchymosis 9% and thrombophlebitis 10%. There were no cases of venous thromboembolism. There was a significant improvement in VCSS (p < 0.001) for all time intervals. The authors concluded that the saphenous vein MOCA has the advantage of endovenous ablation without tumescent anesthesia, making it an almost painless procedure. With this method, high occlusion rates with significant clinical improvement can be achieved in the short term.
Ozen et al. (2014) evaluated the reliability and 2-year outcomes of the ClariVein device used in the GSV MOCA. In the authors' clinic, a total of 63 patients with GSV failure were treated with the ClariVein device and polidocanol for two years. In 10 of these patients, both legs were treated. Anatomical and clinical success was evaluated 6 months, 1 year and 2 years later using Doppler US. The success rate of implementing the technique was 98%. Anatomical success was 94% at 6 months, 95% at 1 year, and 95% at 2 years. Venous clinical severity was 3.2 (IQR: 2 to 6) after 6 months, 1.2 (IQR: 1 to 3, p<0.001) after 1 year and 1.1 (IQR: 1 to 2, p< 0.001) determined) after 2 years. No complications developed in any of the patients. The authors concluded that ClariVein is a simple, reliable and effective treatment for GSV failure. At the 2-year follow-up, the anatomical success rate was 95% and no major complications were observed.
Stanisic et al. (2016) found that MOCA of GSV and SSV is an alternative to thermal ablation for the treatment of superficial venous reflux. These investigators evaluated the effectiveness of MOCA in the treatment of incompetent GSV and SSV. They included 50 patients (60 legs) with incompetent GSV or SSV. The age of the patients ranged from 22 to 71 years, with a mean of 41 years. The diameters of the treated saphenous veins ranged from 4 to 16 mm, with a mean diameter of 9 mm. The length of the incompetent segments of the VGS ranged from 20 to 45 cm, with a mean of 36 cm. The length of the incompetent segments of the SSV ranged from 12 to 25 cm, with a mean of 17 cm. These investigators performed venous ablation using the ClariVein device while simultaneously injecting 2% polidocanol at a dose of 0.2 mL/cm into the treated vein. All patients completed the 12-month follow-up. In all patients, the procedure resulted in complete occlusion of the incompetent segment of the saphenous vein. Additional foam sclerotherapy was required in 41 legs (68.3%). After 12 months, 1 GSV and 3 SSVs had partial or complete recanalization. The other veins (93.3%) were completely occluded. During the procedure, these investigators observed transient signs of polidocanol toxicity in 2 patients. The authors concluded that MOCA with the ClariVein device is a safe method for ablation of incompetent saphenous veins in patients who prefer a quick, painless treatment with satisfactory results within one year.
In a 2-year follow-up on the effectiveness of MOCA in patients with symptomatic C2 or more advanced chronic venous disease, Kim et al (2017) reported whether early efficacy was maintained at 24 months. Patients with reflux in the great saphenous vein involving the saphenofemoral junction and without previous venous interventions were included. Demographic, clinical, and procedural data were collected. The occlusion rate of treated veins was evaluated by duplex US. The patient's clinical improvement was assessed by CEAP class and venous clinical severity. Of the initial 126 patients, there were 65 patients with a 24-month follow-up. Of these 65 patients, 70% were women with a mean age of 70 ± 14 years and a mean BMI of 30.5 ± 6. The mean diameter of the great saphenous vein of the thigh was 7.6 mm and the mean treatment length was 39 cm . In 14% of patients, concomitant treatment of varicose veins was performed during the procedure. Completion rates were 100% at 1 week, 98% at 3 months, 95% at 12 months, and 92% at 24 months. There was 1 patient with complete recanalization and 4 with partial recanalization ranging from 7 to 12 cm (mean length 9 cm). There was a significant improvement in CEAP and clinical venous severity (p < 0.001) at all time intervals. The authors concluded that a high rate of early occlusion with MOCA was associated with a significant clinical improvement that was maintained at 24 months, making it a very good option for the treatment of great saphenous vein insufficiency.
Whiteley et al. (2017) examined the effects of MOCA with ClariVein on GSV ex vivo using histology and immunofluorescence staining. Extrafascial GSVs were harvested during varicose vein surgery and treated ex vivo for 10 to 11 minutes with liquid sclerotherapy or the use of ClariVein with and without 3% sodium tetradecyl sulfate. Veins were sectioned and subjected to hematoxylin and eosin staining and immunofluorescence staining for endothelial and smooth muscle cell markers (CD31 and α-actin) to assess overall damage and cell death in the vein wall compared to control. Histological observations confirmed intimal damage by ClariVein as previously demonstrated; however, medial damage was also evident, which was not observed in the control or liquid sclerotherapy sections. Immunofluorescence staining on the 3 sections examined showed a 42% reduction in CD31 staining and a mean 27% reduction in α-actin staining at a depth of 300 µm with liquid sclerotherapy. This cytotoxic effect was significantly enhanced by MOCA with a reduction in CD31 staining of just over 60% and a mean reduction in α-actin staining of 46% detected at a depth of 300 µm. Significantly greater reductions in staining compared to sclerotherapy were observed up to a depth of 600 µm. The authors concluded that MOCA using 3% sodium tetradecyl sulfate increased sclerosant penetration and its effect on the vein wall and demonstrated superior rates of tissue destruction compared to liquid sclerotherapy alone. In this model, it appears not only to damage the endothelium, but also to disrupt the media layer, creating small lesions into which the sclerosant can flow and exert its cytotoxic effects. These researchers stated that short-term follow-up studies of MOCA showed results comparable to those of RFA or EVLA. Initial investigations into the short to mid-term success rates of ClariVein for the treatment of reflux in GSV revealed excellent closure rates, exceeding 95% up to 1 year after the procedure, with the longer follow-up of 2 years showing 92% closure. Separate analyzes also showed significantly less postoperative pain and faster patient recovery with MOCA compared with RFA. This showed a significant advantage over US-guided foam sclerotherapy, which was associated with a high risk of recanalization and reflux as early as 1 year after the procedure. These investigators noted that, over time, the mid- and long-term success rates of MOCA need to be evaluated and compared to existing treatment modalities.
This study had several drawbacks. First, these investigations were performed ex vivo and involved only 3 extrafascial veins in contrast to the true GSV. Furthermore, as an ex vivo model, there was no blood flow during our 10-minute test sessions, and although the freshly harvested veins exhibited some spasm during treatment, these researchers could not be certain that this was as intense as it would have been in - live can be reached. However, they do not believe that these factors invalidate the basic results of this model. The presence of blood would inactivate only part of the sclerosant and the fact that MOCA acted in vivo indicated that this was not clinically significant. Furthermore, any additional spasm would tend to increase the shear effect observed in this study. The study did not look at other concentrations of sodium tetradecyl sulfate (STS) or other active ingredients such as polidocanol, as the study focused on the mechanism of MOCA and not the effectiveness of MOCA. These researchers used 3% STS as a cell death marker, which they had already detected and reported to show the increased penetration of the cytotoxic effect in the medium by adding the mechanical effect of the MOCA system. Likewise, as foam was not used with MOCA as a sclerotherapy product, foam sclerotherapy was not studied, and this study examined the mechanism of action of MOCA rather than presenting a comparison between different methods of ablation of veins using different methods. sclerotherapy techniques.
Witte et al. (2017) reported the interim results of MOCA for the treatment of GSV insufficiency. Over a 1-year period, 85 consecutive patients (mean age 51.4 years; 71 women) undergoing MOCA with polidocanol in 104 limbs were enrolled in a prospective registry. Patients were assessed at baseline and during follow-up (4 weeks and 1, 2, and 3 years) by duplex US, CEAP classification (clinical, etiologic, anatomical, and pathophysiologic) and Venous Clinical Severity Score (VCSS). 36-item Health Survey Form (RAND-SF36) and Aberdeen Varicose Vein Questionnaire (AVVQ). The primary endpoints were clinical and anatomic success. Secondary endpoints included reinterventions and overall and disease-specific quality of life. Technical success (99%) was achieved in all but 1 patient, in whom technical problems with the device led to a switch to another method to treat 2 limbs. After a median follow-up of 36 months (IQR 12.5 to 46.3), recanalization occurred in 15 (15%) of 102 successfully treated vein segments. Anatomical success was 92%, 90%, and 87% at 1, 2, and 3 years, respectively. VCSS improved at all time points compared to the pre-procedure median. Clinical success after 3 years was 83%. AVVQ and RAND-SF36 scores showed improvement from baseline at all time intervals. However, a significant deterioration in the VCSS was observed between 12 and 36 months, which was accompanied by a deterioration in disease-specific and overall quality of life. The authors concluded that, in the longest MOCA follow-up to date, this study has demonstrated that MOCA is an effective treatment modality for GSV failure at mid-term follow-up; however, clinical outcomes appeared to decline over time. The authors claim that the results of the present study were influenced by the chosen definition of success. Although the definition used was consistent with previous reference studies, heterogeneity in definition across studies was a major problem when comparing results and emphasized the need for standardization of outcome measures. In addition, follow-up was not completed for each patient and questionnaires were not always completed.
While a Cochrane review on "Endovenous ablation therapy (laser or radiofrequency) or foam sclerotherapy versus conventional surgical repair for short saphenous varices" (Paravastu et al., 2016) did not address the use of MOCA, it is interesting to note that the authors state that “further RCTs are needed for all comparisons with longer follow-up (at least 5 years). In addition, the measurement of outcomes such as recurrence of reflux, time to return to work, procedure duration, pain, etc. and the choice of times during follow-up should be standardized so that future studies evaluating new technologies can be efficiently compared”.
Kugler and Brown (2017) conducted a systematic search of the literature on non-thermal ablative techniques using a Medline (Ovid) search from January 2000 to August 2016. Only prospective studies and literature review articles in English were included for the analysis. Final. A total of 358 unique articles were identified, with a total of 60 articles that met the specified inclusion and exclusion criteria. In the past, non-thermal ablative techniques have not shown clinical results equivalent to thermal ablative procedures. However, in the United States, 3 new non-thermal ablative techniques are available for use. The literature review showed significant improvements in non-thermal ablative results, with intermediate data indicating greater durability. The authors concluded that advances in non-thermal ablative techniques have led to an evolving role and acceptance in the primary treatment of varicose veins and venous insufficiency, even in difficult cases. Furthermore, they noted that due to advances in technology, non-thermal ablative techniques for the primary treatment of superficial venous insufficiency have acceptable success rates compared to thermal techniques and may be preferred in certain cases where the techniques thermal veins may have disadvantages, such as: Patellar vein or tortuous and superficial trunk veins. However, data on long-term results and direct comparisons of techniques are scarce in the literature. Although the clinical, etiologic, anatomical, and pathophysiologic (CEAP) classifications help provide a basis for comparing disease severity, each study has additional exclusion and inclusion criteria that limit the comparison. Finally, there are not good data, including randomized trials, to allow comparison between non-thermal techniques.
Witte and colleagues (2017) systematically reviewed all available English literature on mechanochemical intravenous ablation and reported anatomical, technical, and clinical success. A systematic literature search was performed in PubMed, Embase and the Cochrane Library on mechanochemical endovenous ablation for the treatment of incompetent saphenous vein and/or saphenous vein. The methodological quality of the included studies was assessed using the MINORS score. The primary outcome was anatomical success, defined as occlusion of the treated vein in duplex ultrasound follow-up. Secondary outcomes were technical and clinical success and severe complications defined as deep vein thrombosis, pulmonary embolism or paresthesia. The literature search identified 759 records, of which 13 were included and 10 describe unique cohorts. A total of 1521 veins (1267 great saphenous vein and 254 small saphenous vein) were included with cohort sizes ranging from 30 to 570 veins. The combined anatomical success rate after short-term follow-up was 92% (95% CI: 90 to 94%) (n = 1314 veins). At 6 and 12 months, these values were 92% (95% CI: 88 to 95%) (n = 284) and 91% (95% CI: 86 to 94%) (n = 228), respectively. Long-term anatomical success rates at 2 and 3 years were 91% (95% CI: 85 to 95%) (n = 136) and 87% (95% CI: 75 to 94%) (n = 48) , respectively . 🇧🇷 Serious complications and particularly nerve damage were very rare (less than or equal to 0.2%). All studies were of moderate or good quality according to the juvenile rating scale. The authors concluded that endovenous mechanochemical ablation with ClariVein in combination with a liquid sclerosant is associated with an anatomical success rate of 87% to 92% and good clinical success. To date, there are no randomized controlled trials (RCTs) examining anatomical success after mechanochemical ablation compared with endothermic ablation. The risk of serious complications after the procedure is very low.
The authors stated that this study had several drawbacks. To date, long-term data are limited and approximately 50% of initially enrolled patients are lost to follow-up 2 to 3 years after treatment. Although it is widely accepted that anatomical success should be assessed by follow-up duplex ultrasound, there is still heterogeneity regarding the precise definition of occlusion; in 5 cohorts a description of the exact definition used was missing. Furthermore, the definition of anatomic success ranged from an occlusion greater than 85% of the total treated length to less than 10 cm of recanalization. Furthermore, it should be noted that all published data are from cohort studies or RCTs that are not powerful enough for anatomical success. A protocol for the LAMA study, an RCT comparing anatomical success and pain after MOCA versus EVLA, has recently been published. This study is currently recruiting participants. Unfortunately, enrollment in the randomized controlled trials comparing MOCA and RFA in GSV and SSV ended early due to reimbursement issues in the Netherlands.
Khor and colleagues (2018) evaluated the efficacy and patient experience of ClariVein for varicose veins and CVI in a multiethnic Asian population from Singapore. A total of 121 patients underwent mechanochemical ablation. Patients were reviewed at intervals of 1 week, 3, 6 and 12 months postoperatively and underwent duplex US with patient satisfaction assessments. At 3-month follow-up, the GSV and SSV occlusion rates were 90.8% and 96.0%, respectively. At 6-month follow-up, the GSV and SSV occlusion rates were 86.9% and 90.9%, respectively. At 1 year, the closure rates of GSV and SSV were 84.8% and 94.3%, respectively. The authors concluded that the first results are similar to those previously reported in the mechanochemical ablation literature; but recurrences were more than expected at 1 year. These researchers stated that these results were disappointing but were mitigated by the fact that most patients were asymptomatic and did not require repeated intervention.
In a single-center cohort study, Mohamed et al. (2019) evaluated the clinical efficacy of mechanochemical ablation for the treatment of SVI at 1 year. Mechanochemical ablation treatment using ClariVein with 1.5% sodium tetradecyl sulfate was offered to patients with primary unilateral symptomatic axial insufficiency. Assessments, including clinical examination, duplex ultrasound, and patient-reported health-related quality of life, were performed at baseline and at weeks 1, 6, 26, and 52. A total of 32 patients were enrolled in the study. Complete occlusion of the target vein at 1 year was found in 21 (75%) patients; 6 patients (21.4%) required secondary interventions, 3 of them with axial endovenous thermoablation and 3 with outpatient phlebectomy with perforator ligation. There was a significant improvement in the median (interquartile range) of the Clinical Venous Severity Score from baseline 6 (5 to 8) to a score of 1 (0 to 2) at 1 year (p<0.001). There was also a significant improvement in health-related quality of life, both generic (p = 0.001) and disease-specific (p < 0.001); 1 patient (3.1%) had non-fatal postoperative pulmonary embolism. The authors concluded that mechanochemical ablation is a viable and effective treatment for superficial venous insufficiency. Using consensus definitions for anatomical closure, the results of mechanochemical ablation may be less favorable than previously reported. These investigators indicated that further studies are needed to compare the clinical and technical results after mechanochemical ablation with other methods of intravenous ablation.
Polymorphism genotyping of matrix metalloproteinase genes (eg, MMP1, MMP2, MMP3, and MMP7) as predisposition markers for varicose veins
Kurzawski et al. (2009) observed that several risk factors for varicose veins were identified: female sex combined with obesity and pregnancy, occupations that require long stay, sedentary lifestyle, history of deep vein thrombosis (DVT) and family history. However, specific genetic variants associated with a broad prevalence of varicose veins in the general population have not been identified. The composition of the extracellular matrix, which is primarily maintained by matrix metalloproteinases (MMPs), can affect the structure of the vein wall, which can lead to vasodilation and varicose veins. The expression of MMP-1 (tissue collagenase I) and MMP-3 (stromelysin I) was found to be increased in varicose veins compared to normal vessels. Therefore, these investigators conducted a study to evaluate a possible association between MMP1 and MMP3 promoter polymorphisms and the risk of varicose veins. Genotyping for the presence of polymorphisms -1607dupG (rs1799750) in MMP1 and -1171dupA (rs3025058) in the MMP3 promoter region was performed using polymerase chain reaction (PCR) and restriction fragment length polymorphism assays in a group of 109 patients, those diagnosed with varicose veins and 112 healthy controls. MMP1 and MMP3 allele frequencies (minor allele frequencies 0.440 in patients versus 0.451 in controls for MMP1-1607*G and 0.514 versus 0.469 for MMP3-1171*dupA, respectively) and genotypes did not differ significantly between patients and controls. The authors concluded that MMP1-1607dupG and MMP3-1171dupA promoter polymorphisms are not valuable susceptibility markers for varicose veins.
Shadrina and colleagues (2017) examined the effects of single nucleotide polymorphisms (SNPs) on the promoter regions of the MMP genes rs1799750 (-1607dupG) MMP1, rs243865 (C-1306T) MMP2, rs3025058 (-1171dupA) MMP3 and rs11568818 (A-MP181G ) MMP3 on the risk of varicose veins in the lower extremities in ethnic Russians residing in the Russian Federation. These researchers genotyped 536 patients with this pathology and 273 healthy participants with no history of chronic venous disease. The association was examined by logistic regression analysis. None of the polymorphisms examined showed a statistically significant association with the risk of varicose veins in the lower extremities. The authors concluded that these findings provide evidence that these polymorphisms are not involved in the pathogenesis of varicose veins and cannot serve as markers of predisposition to this pathology.
Matrix metalloproteinase inhibitors for the treatment of varicose veins
Chen and colleagues (2017) found that lower limb veins are equipped with an efficient wall, contractile vascular smooth muscle (VSM) and competent valves to withstand the high venous hydrostatic pressure in the lower limb and allow unidirectional movement from lack of oxygen, allowing blood to reach the heart. The structure and function of the vein wall are regulated in part by MMPs, which are zinc-dependent endopeptidases secreted as inactive pro-MMPs by various cells in the vein wall, including fibroblasts, VSM, and leukocytes. Pro-MMPs are activated by other MMPs, proteinases and other endogenous and exogenous activators. Matrix metalloproteinases degrade various extracellular matrix (ECM) proteins, including collagen and elastin, and can affect other cellular processes, including endothelium-mediated dilation, VSM cell migration and proliferation, and modulation of calcium ion (Ca2+) signaling and contraction ) in VSM. Increased venous hydrostatic pressure in the lower extremities is thought to increase hypoxia-induced factors and other MMP inducers such as extracellular MMP inducers, resulting in increased MMP expression/activity, ECM protein degradation, wall relaxation venous and venous dilation. Inflammation of the vein wall and infiltration of leukocytes cause a further increase in MMPs and further dilation of the venous wall and valvular degeneration, which can lead to chronic venous disease and VVs, which often manifest as dilation and tortuosity of the venous wall , incompetent venous valves and reflux. Different regions of VVs show different levels of MMP and ECM proteins, with atrophic regions showing high levels/activity of MMP and little ECM compared to hypertrophic regions with few or inactive MMPs and abundant ECM. Treatment for VVs includes compression stockings, venotonics, sclerotherapy, or surgical removal. However, these approaches do not address the root cause of VVs, and other lines of treatment may be needed. The authors noted that modulation of endogenous tissue inhibitors of metalloproteinases (TIMPs) and exogenous synthetic MMP inhibitors could offer new approaches in the treatment of VVs.
Measurements of plasma growth factors in patients with varicose veins treated with endovenous laser ablation to predict adequacy of treatment and possibility of recurrence
Al-Zoubi and colleagues (2018) measured pre- and postoperative plasma concentrations of growth factors (angiopoietin-1 [ANG1], angiopoietin-2 [ANG2], epidermal growth factor [EGF], platelet-derived growth factor [PDGF] and vascular endothelial growth factor [VEGF]) in patients with primary VVs of the lower limbs treated with EVLA. Blood samples were obtained from 30 patients with primary VVs treated before and 1 week after EVLA treatment. As a control, similar samples were obtained from 20 matched healthy adults. Plasma concentrations of growth factor derivatives (ANG1, ANG2, EGF, PDGF and VEGF) were measured by a commercially available enzyme-linked immunosorbent assay (ELISA). There was a statistically significant reduction in mean levels of plasma growth factors (ANG1, EGF, PDGF and VEGF) in the preoperative group (p=0.001) compared to the control group, with the exception of ANG2, which increased plasma levels (p= 0.001). However, plasma concentration values of these growth factors after treatment with EVLA were almost equal to those of the control group, mainly for EGF and VEGF (p = 0.564 and 0.515, respectively). The authors concluded that altered plasma concentrations of growth factors ANG1, ANG2, EGF, PDGF, and VEGF normalized in patients with VVs 1 week after EVLA treatment compared to controls. This may support the role of these factors in disease pathogenesis. In addition, they indicated that future studies could assess whether these changes may have prognostic and/or predictive value in terms of adequacy of treatment and possibility of recurrence.
VeinOPlus vascular device for the treatment of muscle atrophy due to varicose veins
LeTohic et al. (2009) investigated whether electrical stimulation of the lower limbs (VeinOPlus) relieves symptoms of lower limb venous insufficiency during pregnancy. A study was carried out in 2 stages. First, a prospective single-center preliminary study was performed in 30 pregnant women to investigate the effects of electrical stimulation on fetal monitoring and uterine contractions. Subsequently, a prospective, multicenter, non-randomized study was carried out in 58 pregnant women with amenorrhea between 23 and 33 weeks of gestational age to evaluate treatment with electrostimulation. This assessment was based on a pre- and post-treatment clinical examination, a pre- and post-treatment CIVIQ questionnaire, and a patient diary completed during the treatment period. Treatment duration was 21 days, including 2 daily 20-minute treatment sequences; 3 groups of patients were identified based on the initial intensity of symptoms related to venous insufficiency (Group 1 mild symptoms, Group 2 moderate symptoms, Group 3 severe symptoms). The preliminary study did not show interference between electrical stimulation and fetal heart rate, uterine contractions and maternal uterine and fetal umbilical artery Doppler. To evaluate electrostimulation: In group 1, electrostimulation significantly reduced the feeling of heavy legs (p<0.001) and calf pain (p=0.02) between the beginning and the end of treatment. The 4 scores calculated with the CIVIQ questionnaire decreased after treatment and significant reductions in general pain (p=0.04) and psychological effects (p=0.03) were observed. In group 2, a significant decrease in fatigue (p<0.001), feeling of heavy legs (p<0.001), calf pain (p<0.001) and edema (p=0.02) was observed between the beginning and the end of the treatment. The 4 values calculated with the CIVIQ questionnaire significantly decrease after 21 days of treatment. In Group 3, there was a significant decrease in leg heavyness (p=0.03) and calf and ankle circumference (p<0.05). After 21 days of treatment, the four values calculated with the CIVIQ questionnaire significantly decreased (p<0.05). Comparing the 3 groups, the beneficial effects of treatment were more pronounced in group 2 in terms of subjective symptoms, CIVIQ questionnaire scores, and leg pain. According to the patients in the 3 groups, the efficacy and tolerability of the treatment ranged from good to excellent. The authors concluded that electrical stimulation is an effective and well-tolerated treatment of symptoms of venous insufficiency of the lower limbs in pregnant women. Its use during pregnancy had no effects on the fetus and pregnancy.
Bogachev et al. (2011) noted that electromuscular stimulation (EMS) with VEINOPLUS has recently emerged as a new technique to activate the calf muscle pump that improves symptoms of venous disease. These investigators examined the effectiveness of EMS and its impact on nocturnal edema, venous pain, venous drainage, and quality of life (QOL) of patients. A total of 30 patients (32 legs) aged between 19 and 50 years (mean 45.2 ± 1.3) with CEAP-C3 classification and chronic nocturnal venous edema (22 limbs: C3, S, Ep, Asp, Pr and 10 members: C3, S , Es, Aspd, Pr). All patients were treated with the EC-registered VEINOPLUS neuromuscular stimulator for 30 days; 3 sessions per day (each session lasted 20 minutes) for the first 10 days, for the next 10 days 2 sessions per day and 1 session per day for the last 10 days. The most important evaluation criterion for venous edema was the circumference of the supramalleoal tibial segment, measured twice with a measuring tape; at night the day before and 5 days after treatment. All measurements were performed between 6 pm and 8 pm. All patients were asked to rate venous pain using the visual analogue scale (VAS) and to complete a CIVIQ questionnaire (validated for Russian patients) for measuring quality of life. Venous filling time (RT) was also measured by digital PPG. This was also done twice - before treatment and 35 days after treatment. No other treatments were used. The EMS treatment was well tolerated by the patients. There were no dropouts and patients did not have to change their lifestyle. After treatment, 93.8% of the limbs showed a complete or partial reduction of nocturnal edema, the leg circumference decreased by 20.3 mm (p<0.001), the number of painful legs decreased from 28 to 12, and the venous pain severity was reduced from 8.3 ± 1.1 to 3.8 ± 0.9 points (p < 0.001), quality of life improved significantly as the score increased from 34.5 ± 7.8 to 17, 2 points ± 4.6 (p < 0.001) dropped and RT increased from 17.3 ± 0.9 to 21.5 seconds ± 1.1 ( p < 0.001). Three months after treatment with VEINOPLUS, complete remission of symptoms was observed in 50% of the legs, although no further treatment was performed. The authors concluded that VEINOPLUS stimulation is an effective and well-tolerated therapy method for the treatment of chronic venous diseases. The presented scheme of EMS application proved to be useful for treating chronic edema, reducing pain and improving quality of life. It can be used as an adjunct in the treatment and prevention of CVI symptoms. This study also showed that calf muscle stimulation with VEINOPLUS can improve venous drainage and CVI symptoms; this finding should be investigated and confirmed in further studies.
Abraham et al. (2013) investigated the effect of electrical stimulation of calf muscles on arterial inflow and tissue oxygen content in peripheral artery disease (PAD) in the area of stimulation. A total of 15 adult patients [mean (SD) age 62 (12) years; height 165 (8) cm; weight 76 (13) kg; lower ankle-brachial index 0.66 (0.19)] with stable arterial claudication were recruited. All patients performed a treadmill test (3.2 km/h, 10% incline) in conjunction with a transcutaneous oximetry test, expressed as a decrease in residual oxygen pressure index (DROP) values (calf changes less chest changes at rest) with a maximum walking distance (median [25th./75th percentile]) of 295 [133 to 881] m. The DROP index on the symptomatic side was -25 [-18/-34] mm Hg more symptomatic on the treadmill was electrically stimulated in a sitting position. After resting values were recorded, the gastrocnemius was stimulated for 20 minutes with increasing contraction rates in 5-minute increments of 60, 75, 86, and 100 bpm on the most symptomatic side. Arterial blood flow with duplex Doppler ultrasound (US) of the femoral artery, transcutaneous DROP oxygen pressure value and oxygen concentration (O2Hb) of the calf near-infrared spectroscopy signal were recorded on both sides. Patients were instructed to report any contraction-induced pain in the stimulated calf. Depending on distribution, results are presented as mean (standard deviation) or median [25./75. percentile] and the level of statistical significance was set at p < 0.05 in two-tailed tests. Lower extremity inflow (mL/min) was 64 [48/86] versus 63 [57/81] (p > 0.05) before stimulation, 123 [75/156] versus 57 [44/92] ( p<0.01) at 60 bpm, 127 [91/207] versus 49 [43/68] (p<0.01) at 75 bpm, 140 [84/200] versus 57 [45/71] (p< 0.01) at 86 bpm and 154 [86/185] versus 55 [46/94] (p<0.01) at 100 bpm in the stimulated and unstimulated limb, respectively. No apparent decrease or significant difference in the legs was observed in the DROP index or O2Hb values. None of the patients reported contraction-induced leg pain. The authors concluded that electrical stimulation of the calf muscle with the Veinoplus device resulted in a significant increase in arterial flow without pain or measurable muscle ischemia. These researchers stated that the potential use of this device as an adjunctive treatment to improve ambulation in patients with PAD has yet to be evaluated.
In a prospective, non-randomized, controlled study, Lobastov et al. (2014) reviewed the potential effect of electrical calf muscle stimulation (EMS) in preventing postoperative deep vein thrombosis (DVT) in high-risk patients and evaluated the safety and efficacy of EMS in patients with calf DVT. This study included 80 patients over 40 years of age undergoing major surgery (44 abdominal surgeries and 36 cranial or spine surgeries; duration greater than 60 minutes under general anesthesia). Patients were divided into 2 comparable groups: main group (n=40) and control group (n=40). In both groups, on the 1st or 2nd to 5th postoperative day, a graduated compression bandage with a compression force of 20 to 40 mmHg and injections of low-dose unfractionated heparin (LDUH) (5,000 U s.c. 3 t.i.d) were initiated and continued until discharge. The time to onset of LDUH was comparable in both groups. Furthermore, in the core group, EMS was performed with the Veinoplus device for no less than 5 periods of 20 minutes/day (over 100 minutes in total). Control of venous patency was performed with duplex US, which was mandatory at the beginning (first 24 hours after surgery) and then every 3 days until discharge. The incidence of DVT was 2.5% in the main group and 25% in the control group (p=0.007). In patients without DVT at baseline, it was 3% versus 21% (p=0.025). Patients with baseline thrombosis undergoing EMS did not have new cases of DVT and PE, while in patients without EMS, thrombotic progression was observed in 43% of cases, even without pulmonary embolism (not significant). The authors concluded that EMS with the Veinoplus device in more than 100 minutes/day (more than 5 sessions) can reduce the rate of postoperative DVT in high-risk patients. The use of EMS in patients with calf DVT did not increase the rate of PE. These researchers stated that these results need to be confirmed in a randomized controlled trial (RCT).
Bogachev et al. (2015) analyzed the results of using EMS in patients with venous ulcers co-developed with post-thrombotic syndrome (PTS). A total of 60 patients (60 legs) with active venous ulcers (C6EsAsdpPr according to CEAP classification) were divided into 2 groups. In addition to background therapy, consisting of standardized compression with ULCER X and ingestion of a micronized purified flavonoid fraction (MPFF 1000 mg daily), EMS with Veinoplus V.I. for at least 3 times a day. Follow-up visits were performed on days 30, 60, and 90. These included assessing pain severity using 100 mm VAS, measuring disease severity using VCSS (Venous Clinical Severity Score) and ankle circumference above the ankle, and recording the number of healed venous ulcers. By day 90, pain intensity was reduced in both the main and control groups. However, according to VAS, pain reduction rates were significantly higher in patients in the main group (from 8.7 ± 0.6 to 1.9 ± 0.3 in the main group and 8.4 ± 0, 6 to 3.9 ± 0.5 in the control group). At the end of the study, ankle circumference increased from 270.9 ± 4.6 mm to 257.1 ± 4.2 mm in the main group and from 269.7 ± 5.3 mm to 263.4 ± 5.2 mm in the remote control group. VCSS before treatment was 7.3 ± 0.6 in the main group and 6.8 ± 0.5 in the control group. At day 90, VCSS significantly decreased to 2.3 ± 0.4 and 4.6 ± 0.5 in the main and control groups, respectively. Cure rates were significantly higher in the main group. At day 90, the number of open venous ulcers in the main group was three times less than in the control group (4 versus 12). The authors concluded that EMS showed high efficacy and good tolerability and produced a significant reduction in pain intensity, VCSS score and ankle edema and a 3-fold increase in the number of healed venous ulcers.
Mechanochemical ablation with Flebogrif for the treatment of great saphenous vein insufficiency
Ammollo and colleagues (2020) noted that Flebogrif (Balton, Poland) is a new MOCA device for saphenous vein insufficiency. It combines endothelial damage performed by radially retractable cutting hooks with chemical ablation by sclerosing injection of 3% polidocanol foam according to its instructions for use (IFU). These investigators examined the effectiveness of Flebogrif on the rate of recanalization and recurrence by varying concentrations of polidocanol foam. They performed 24 MOCAs on 23 patients with Flebogrif between January and May 2019. In 12 cases, polidocanol foam was produced with a concentration of 3%, in another 12 cases with a concentration of 1.5%; GSV recanalization and truncal recurrence were evaluated at 1 and 3 months with a DUS scan. At the 1- and 3-month follow-up visits, no GSV recanalization or truncal recurrence was observed in any of the 14 patients treated with 3% Polidocanol foam. Only 2 of the 14 (14.3%) cases treated with 1.5% Polidocanol foam showed evidence of recanalization in the first centimeters of the saphenofemoral junction (p > 0.05). All patients showed clinical benefit without recurrence of symptoms. The authors concluded that MOCA with Flebogrif is a safe, relatively inexpensive and effective alternative to standard methods in the management of saphenous insufficiency, with encouraging short-term results. Despite the relatively small sample of patients, statistical significance in terms of recurrence was not observed in the 3% foam-treated and 1.5% foam-treated group. Furthermore, these investigators indicated that a long-term analysis of GSV patency and recurrence is needed to better assess the effect of Flebogrif and actual indications in the treatment of chronic venous disease. Further investigations are also needed to expand the number of cases treated and include a comparison with surgical or thermal ablation techniques.
The authors pointed out the small number of cases (n = 23 patients) and the short follow-up period (3 months) as disadvantages of this study. Furthermore, the Flebogrif procedures were performed on patients with relatively small incompetent GSV and no comparison with other techniques was made.
Mechanochemical Ablation (MOCA) / Cyanoacrylate Adhesive Closure (CAC).
Ontario Health (2021) conducted a health technology assessment of non-thermal intravenous procedures (CAC and MOCA) for people with symptomatic varicose veins that included an assessment of the efficacy, safety, cost-effectiveness, and budgetary impact of publicly funded MOCA and CAC and patient preferences and values. The authors concluded that CAC and MOCA produced similar patient-relevant outcomes and a slightly shorter recovery compared to thermal ablation. Furthermore, CAC gave anatomical results similar to endovenous thermal ablation, but the technical results of MOCA were slightly inferior. Compared with surgical removal of the vein, all intravenous treatments were more effective and less expensive.
The technology assessment reached the following conclusions:
Evidence indicated that in GSV failure, MOCA:
- Leads to venous occlusion slightly worse than RFA (grade: moderate) or EVLA (grade: moderate)
- Slightly increased recanalization compared to RFA (grade: moderate) or EVLA (grade: moderate)
- Results in little or no difference in the magnitude of improvement in clinical symptoms (Grade: Moderate), QoL (Grade: Low), or patient satisfaction (Grade: Moderate) compared with RFA.
- Results in little or no difference in the magnitude of improvement in clinical symptoms (Grade: High), QOL (Grade: High), or patient satisfaction (Grade: High) compared to EVLA.
- It can reduce recovery time compared to RFA (grade: low) or EVLA (grade: moderate).
- May provide faster healing of venous ulcers and similar healing time and ulcer recurrence compared to thermal ablation (Grade: Low).
Evidence indicated that CAC for GSV failure:
- Results in little or no difference in venous occlusion (level: medium), recanalization (level: medium), extent of improvement in clinical symptoms (level: medium), quality of life (level: medium), or patient satisfaction (level: low ). ), compared to RFA
- Results in little or no difference in venous occlusion (grade: medium), recanalization (grade: medium), extent of improvement in clinical symptoms (grade: medium), quality of life (grade: low), or patient satisfaction (grade: low ). ), compared to EVLA
- Will likely reduce recovery time compared to RFA (Level: Low) or EVLA (Level: Low)
- May result in slightly worse improvements in clinical signs or quality of life compared to surgical removal of the vein; however, the evidence is very uncertain (grade: very low)
- In subjects with a GSV diameter of 10 mm or more, this may result in slightly worse venous occlusion, slightly greater recanalization, and comparable improvement in clinical symptoms compared with RFA, EVLA, and surgical removal of veins, but the evidence is very uncertain (classification : very low).
Evidence indicated that CAC for SSV failure:
- May result in slightly less recanalization compared to 980 nm EVLA and surgical removal of veins and recanalization similar to RFA and 1470 nm EVLA (Level: Low)
- Results in greater improvement in clinical symptoms compared to surgical removal of the vein and similar improvement to EVLA and RFA (Grade: Low).
These researchers stated that this review had several drawbacks. Although almost all studies involved individuals with GSV failure and treatment, the heterogeneity of studies in terms of design, time of measurement of results and inclusion criteria prevented the quantitative synthesis of most results. Had these investigators chosen to perform a network meta-analysis, the evidence would have been extremely limited and restricted to RCTs, and the clinical diversity and heterogeneity of the data would likely have challenged the main assumptions of the network meta-analysis. Key findings from RCTs and non-randomized trials were generally similar in direction and magnitude, despite differences in study methods, patient characteristics (eg, range of disease severity), and treatment protocols. Procedural factors that may influence the success of venous occlusion in MOCA include, for example, the withdrawal rate (speed at which the catheter is gradually withdrawn) and the concentrations, volumes, and type of sclerosant used. These investigators did not predefine interprocedural or postprocedural pain as a discrete outcome; However, they did assess clinical symptoms, quality of life, and adverse events (including pain, if reported), which may capture part of the patient's experience of pain and discomfort during and after treatment. No difference was found. This review summarizes comparative evidence for treatment options covering most clinical practices in Ontario. These investigators did not identify any published studies comparing MOCA to CAC or comparing any nonthermal intravenous procedure to less common vein-sparing procedures (eg, conservatrice et hémodynamique de l'insuffisance veineuse en ambulatoire]). There are several subpopulations and potential effect modifiers for which it would have been valuable to better understand the safety and efficacy of non-thermal intravenous interventions. For example, although these investigators did not specify them explicitly, it would have been interesting to compare patients with and without prior DVT, with and without significant deep venous reflux, and mild disease (eg, C1 to C4) to C5 to C6. The limiting factor in carrying out the subgroup analyzes planned by these researchers was the lack of reporting of these key characteristics in the studies. This review examined outcomes over a longer period of time after treatment (greater than 12 months in many studies), providing information on short-, mid-, and long-term effects (e.g., persistence of venocclusion and impact on important patient outcomes) . They did not include compression stockings or garments as a comparison, recognizing that while they may be effective in controlling the symptoms of chronic venous insufficiency (eg, swelling, pain) or preventing the recurrence of venous ulcers, they fail to correct incompetent veins. underlying. In some jurisdictions, including Ontario, compression stockings may be tried or required as a first-line treatment. Invasive treatment may be sought because compression stockings are impractical (e.g., putting on and taking off may be difficult for an elderly person), affordable, or sufficiently effective.
Furthermore, the authors are aware of several ongoing comparative studies that have potential relevance to the research question, including an RCT of MOCA versus CAC for the treatment of varicose veins (NCT03392753; expected completion of data collection: December 2019); and 2 on VenaSeal - "Randomized controlled trial comparing clinical outcomes after cyanoacrylate closure with the VenaSeal closure system and surgical removal in incompetent saphenous veins" (KCT0003203; expected completion of data collection: February 2021) and "Global, post- Commercialization, Prospective, Multicenter Randomized Controlled Trial of VenaSeal™ Closure System Compared to Surgical Removal or Endothermic Ablation (ETA) for the Treatment of Early and Advanced Superficial Venous Disease” (NCT03820947; expected completion of data collection: September 2023) .
Whing and colleagues (2021) found that GSV insufficiency, which causes varicose veins and venous insufficiency, is responsible for most superficial venous diseases of the lower extremities. Therapeutic options for GSV incompetence include surgery (aka HL/S), laser, and RFA and UGFS. Newer treatments include cyanoacrylate glue, MOCA, and endovenous steam ablation (EVSA). These techniques avoid the need for general anesthesia; and may result in fewer complications and better quality of life. These treatments should be compared in order to make decisions about the treatment of varicose veins in GSV. This is an update of a Cochrane Review first published in 2011; these investigators examined the effects of EVLA, RFA, EVSA, UGFS, cyanoacrylate glue, MOCA, and HL/S for the treatment of GSV varicose veins. The authors concluded that their results were limited due to the relatively small number of studies for each comparison and differences in outcome definitions and reported time points. Technical success was comparable across most modalities. EVLA can provide improved technical success compared to UGFS or HL/S. HL/S may have improved technical success compared to UGFS. No evidence of a difference in recurrence was found, except for a possible long-term benefit of RFA compared with EVLA or HL/S. These investigators indicated that studies are needed that provide more evidence of the breadth of treatments; Future studies should attempt to standardize the clinical terminology of outcome measurements and the time points at which they are measured.
Polidocanol for the treatment of varicose veins of the lower extremities
Li and colleagues (2021) observed that varicose veins of the lower limbs had worm-like dilation and venous protrusion of the lower limbs. Sclerotherapy with polidocanol foam has achieved good results as a minimally invasive treatment with rapid recovery, less trauma and not easy recurrence; however, evidence-based support is lacking. In a meta-analysis, these investigators will examine the safety and efficacy of polidocanol in the treatment of lower extremity varicose veins. China National Knowledge Infrastructure, Wanfang Database, China Scientific Journal Database, China Biology Medicine Disc, PubMed, Embase Database, Web of Science and Cochrane Library are used as data sources to search RCTs of polidocanol in the treatment of varicose veins in the lower part jaw uses ends. The search time is defined in this study from the constitution of the database in December 2020. Two researchers will extract files independently, delete, extract data and assess the quality. Revman software version 5.3 is used for statistical analysis of the data. This study evaluates the safety and efficacy of polidocanol in the treatment of lower extremity varicose veins in terms of overall efficacy rate, complication rate, and recurrence rate. The authors concluded that the results of this study will provide reliable evidence-based support for the clinical use of polidocanol in the treatment of varicose veins of the lower limbs.
Outpatient selective varicose vein ablation under local anesthesia (ASVAL procedure) for the treatment of symptomatic great saphenous vein
In a prospective study, Zolotukhin et al. (2017) examined the effect of phlebectomy alone in patients with incompetent Ambulatory Varicose Vein Ablation under Local Anesthesia (ASVAL) on reflux and trunk diameter, and assessed the rate of variceal recurrence at 1 Year . This study included 67 patients (51 women and 16 men; 75 limbs) with primary varicose veins and with classes C2 or C2.3 or C2.3.4 or C2.4 of chronic venous disease and GSV insufficiency; age range from 17 to 71 years; mean age of 46.8 years (SD 13.9). These investigators recorded the presence or absence of reflux on GSV with duplex US before and after surgery. Recurrence of varicose veins was examined after 12 months. All subjects underwent the ASVAL procedure. 1 year after withdrawing the incompetent tribe's tributaries, 66% of them were operational. Reflux was present in 17% of GSVs with reflux above mid-thigh and in 61% of trunks with reflux below mid-thigh (p=0.0004). The diameter of all veins significantly decreased whether the reflux disappeared or not. Varicose veins recurred in 13.5% of cases. 6.5% of extremities with reflux above mid-thigh had recurrence after 1 year, while in extremities with reflux below mid-thigh the recurrence rate was 25% (p = 0.036). The authors concluded that isolated phlebectomy with preservation of the incompetent GSV resulted in reflux resolution in most cases and a significant decrease in vein diameter in all cases. These investigators indicated that the ASVAL procedure could be considered a less aggressive and less expensive approach in selected cases; however, clear indications for phlebectomy alone must be made.
Richards and colleagues (2021) stated that the ASVAL technique follows the "bottom-up" theory of varicose vein etiology, which recommends primary outpatient phlebectomy as a treatment for tributary varices and saphenous vein insufficiency. In a systematic review, these investigators examined the safety and efficacy of the ASVAL technique for treating symptomatic varicose veins. They performed a comprehensive search of Medline and Embase databases and the Cochrane Register of Controlled Trials in May 2019 and found 11 original articles that were qualitatively reviewed. The primary endpoint was the absence of recurrent varices at 1-year follow-up. Secondary outcomes were resolution of GSV reflux on duplex ultrasound, change in GSV diameter, objective and subjective clinical improvement in chronic venous disease, and patient-reported outcome measures (PROMs). A total of 2106 limbs were treated in 1734 patients reported in 2 RCTs, 1 case-control study, 3 cohort studies and 5 case series studies. Varicose recurrence at 1 year ranged from 0.5% to 13.5% in patients. Of 1622 limbs diagnosed with GSV incompetence before surgery, 1114 were functional at 1 year (mean 68.2% [± 12.62%]). All studies that measured GSV diameter reported statistically significant reductions in vein size. The authors concluded that ASVAL can be considered a minimally invasive treatment for the early stages of chronic venous disease in the presence of truncal reflux. The evidence base should be strengthened by prospective RCTs that follow standardized procedures and report according to accepted QoL standards along with clinical and hemodynamic data.
External valvuloplasty for the treatment of symptomatic great saphenous vein
Muhlberger and colleagues (2021) stated that external valvuloplasty (eVP) is a reconstructive surgical approach to restore function of terminal and preterminal valves. In an observational study, these investigators examined the 6-month results of eVP in relation to GSV diameter. This study included patients from 5 venous centers; Follow-up included GSV duplex US. Both VCSS and CEAP classifications were recorded. These investigators enrolled 210 patients with a follow-up rate of 58%; eVP was sufficient in 95.24% of patients. GSV diameters significantly decreased from 4.4 mm (standard deviation (SD): 1.39) to 3.9 (SD: 1.12) 4 cm distal to the saphenofemoral junction (SFJ); from 3.7 mm (SD: 1.10) to 3.5 mm (SD: 1.02) at mid-thigh; from 3.6 mm (SD: 1.14) to 3.3 mm (SD: 0.94) in the knee; and from 3.1 mm (SD: 0.99) to 2.9 mm (SD: 0.78) at mid-calf. The VCSS significantly decreased from 4.76 (SD: 2.13) preoperatively to 1.77 (SD: 1.57) 6 months after surgery. The authors concluded that GSV function can be restored by eVP; The diameter along the entire length of the GSV has significantly decreased. The results of this observational study need to be validated by well-designed studies.
The authors stated that this study had several drawbacks. First, this study had a high rate of loss to follow-up, and these investigators reexamined only 210 of 359 patients, resulting in a follow-up rate of only 58.5%. They tried to motivate patients to participate in the follow-up examination through several phone calls. However, as follow-up examinations mostly took place in the afternoon, most patients did not attend for work-related reasons. However, data from the general population were similar to preoperative and 6-week data, indicating a comparable study population. Second, eVP was limited to approximately 15% of all patients, and patients with SFJ reflux and persistent ASV reflux benefited the most from eVP; therefore, these findings represented a highly selective patient group. Third, this study had a large number of missing data for the reflux measurements.
glossary of terms
|sclerotherapy||Intravenous chemical ablation|
|flebectomia||Procedure in which varicose veins are removed using a small scalpel or needle|
List: Clinical, Etiological, Anatomical and Pathophysiological Classification (CEAP)
- C0: No visible or tactile signs of venous disease
- C1: telangiectasias, reticular veins, ankle rashes
- C2: Varicose Veins
- C3: edema without skin changes
- C4: Skin changes attributed to venous disease (eg, pigmentation, venous eczema, lipodermatosclerosis)
- C4a: pigmentation or eczema
- C4b: Lipodermatosclerosis or white atrophy
- C5: Skin lesions defined above with healed ulceration
- C6: Skin lesions defined above with active ulceration
What: Gloviczki et al.
The above policy is based on the following references:
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- Adi Y, Bayliss S, Taylor R. Systematic review of the clinical efficacy and cost-effectiveness of radiofrequency ablation for the treatment of varicose veins. DPHE Report n. 49. Birmingham, United Kingdom: West Midlands Health Technology Assessment Collaboration (WMHTAC), Department of Public Health and Epidemiology, University of Birmingham; 2004
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- Alberta Heritage Foundation for Medical Research (AHFMR). Sclerotherapy for varicose veins of the legs. technote. TN 40. AHFMR; October 2003. Available at: www.ahfmr.ab.ca/hta/hta-publications/technotes/tn40.pdf. Accessed February 6, 2004.
- Alberta Heritage Foundation for Medical Research (AHFMR). Surgical treatment of chronic venous insufficiency. Edmonton, Canada: AHFMR; 2002
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- Allegra C. Abstract and Comment: Effectiveness of comprehensive objective mapping, precise image-guided injection, antireflux positioning, and sequential sclerotherapy (COMPASS) technique in the treatment of greater saphenous varices with saphenofemoral incompetence. American College of Phlebology Venous Digest. 2003;10(3):3-4. Available at: http://www.phlebology.org/venousdigest/vd-mar03.pdf. Accessed December 10, 2003.
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What is the Aetna criteria for varicose veins? ›
Vein size is 2.5 mm or greater in diameter, measured by recent ultrasound; and. Member is being treated or has previously been treated by one or more of the procedures noted in section A above for incompetence (i.e., reflux) at the saphenofemoral junction or saphenopopliteal junction.Can varicose veins be covered by insurance? ›
Most insurance types (including Medicare and Molina) will cover varicose vein treatments that are considered “medically necessary care” but not for “cosmetic care”. Varicose veins (bulging leg veins) have to cause symptoms such as leg pain to be covered by insurance.What is the newest treatment for varicose veins? ›
Endovenous ablation therapy isn't completely non-invasive, but it can be done in a physician's office with local anesthesia. During the procedure, a catheter is inserted into the vein via a small incision before laser or radio wave heat causes the vein to close off.What is the gold standard in varicose vein treatment? ›
EVLT is an effective procedure for varicose veins because it actually treats the affected vein from the inside out. The vein is completely eliminated by natural body processes and blood is rerouted to healthier vessels.Are varicose veins cosmetic or medical? ›
Varicose veins are a very prevalent condition that no one really talks about as an illness. People who have not experienced them may think they are purely a cosmetic eyesore, but they are in fact a component of a condition called venous disease.Can you get disability for varicose veins? ›
Yes. Varicose veins can result in the inability to work and result in award of benefits from the SSA. However, the SSA looks at the severity of your varicose veins to determine disability status. They look to see if you have superficial phlebitis (spider veins) or deep vein thrombosis.When is varicose vein treatment medically necessary? ›
The need for medical attention paves in when symptoms such as leg ulcers, swelling, or ulcers turn stubborn and do not go away with time. Aside from this, some people are affected by the physical appearance of varicose veins, consider them 'embarrassing', and therefore seek treatment.How many treatments does it take to get rid of varicose veins? ›
Varicose veins take 3 to 4 months. To get the best results, you may need 2 or 3 treatments. A dermatologist can perform these treatments during an office visit.How much does it cost to elevate your legs for varicose veins? ›
You may be instructed to elevate your feet above the level of your heart three or four times a day for about 15 minutes at a time. If you need to sit or stand for a long period of time, flexing (bending) your legs occasionally can help keep blood circulating.What is the least invasive varicose vein treatment? ›
Microphlebectomy. Unlike the previous treatments, microphlebectomy requires tiny incisions. The vein doctor makes small incisions in the skin through which the varicose vein is removed. The incisions are so small that they do not require stitches and heal with minimal to no scarring.
What is the best non surgical treatment for varicose veins? ›
- Sclerotherapy works best for spider veins. These are small varicose veins.
- Laser treatment can be used on the surface of the skin. Small bursts of light make small varicose veins disappear.
- Phlebectomy treats surface varicose veins. ...
- Ablation uses intense heat to treat the vein.
Sclerotherapy involves using a tiny needle to inject a solution directly into the faulty veins and causes them to contract and collapse. All of these are outpatient treatments, and people can expect to resume normal activities within a day.What is the best treatment for varicose veins 2022? ›
Laser treatment sends strong bursts of light onto the vein, which makes the vein slowly fade and disappear. No cuts or needles are used. Catheter-based procedures using radiofrequency or laser energy. This procedure is the preferred treatment for larger varicose veins.Does vitamin K shrink varicose veins? ›
But while vitamin K plays an essential role in your vascular health and overall well-being, it cannot eliminate bulging varicose veins or clusters of spider veins. There is no quick cure, at-home or herbal, for vein disease.Does vitamin K work for varicose veins? ›
Also, vitamin K can help strengthen the wall of blood vessels, preventing them from bulging and breaking. Studies indicate that inadequate levels of Vitamin K can increase one's chances of developing varicose veins. This vitamin comes in 2 forms: K1 and K2.Are varicose veins a health threat? ›
"Varicose veins typically aren't life-threatening or limb-threatening, and they generally don't increase your chance of deep vein thrombosis (DVT) or developing blood clots, which is what a lot of people worry about," says Dr. Lu.Are varicose veins a serious medical condition? ›
Varicose veins are not considered a serious medical condition. But, they can be uncomfortable and can lead to more serious problems. And, because they may be very noticeable, they may cause people to feel uncomfortable or embarrassed.Is varicose veins a disease or disorder? ›
Varicose veins are a common condition caused by weak or damaged vein walls and valves. Veins have one-way valves inside them that open and close to keep blood flowing toward the heart. Weak or damaged valves or walls in the veins can cause blood to pool and even flow backwards.Can stress make varicose veins worse? ›
Although stress does not cause the development of varicose veins, stress can exacerbate an underlying problem and amplify the symptoms of varicose veins. When we become stressed, our blood pressure rises. When blood pressure remains elevated, either consistently or chronically, our blood vessels weaken.Who do you inherit varicose veins from? ›
If you have one parent with varicose veins, you have about a 40 percent chance of inheriting them. If both your parents have them, your risk drastically increases to 90 percent. Having too few valves or valves that do not function properly is also a common problem that can be inherited.
What are 3 risk factors of getting varicose veins? ›
- Age. Aging causes wear and tear on the valves in the veins that help control blood flow. ...
- Sex. Women are more likely to develop the condition. ...
- Pregnancy. During pregnancy, the blood volume in the body increases. ...
- Family history. ...
- Obesity. ...
- Standing or sitting for long periods of time.
Increased pain and swelling – When varicose veins go untreated, the veins continue to get more damaged, which ends up making the pain worse and the legs swollen.
Can I use my insurance to cover Sclerotherapy cost? Sclerotherapy treatment for spider veins and varicose veins is generally not covered by insurance.Should you walk a lot if you have varicose veins? ›
Walking is especially good for people who suffer from varicose veins, due to the fact that walking is a very low-impact workout. There is no jarring or pounding of your legs — just a simple movement that helps strengthen your calf muscles without straining your body.What happens if I don t wear compression stockings after sclerotherapy? ›
If the patient does not wear compression stockings following sclerotherapy, there is a chance that the treated veins will fill back up with blood after the treatment. The results of sclerotherapy will be undermined in such a situation.Which doctor is best for varicose veins? ›
If you plan to treat your varicose veins or spider veins, you'll want a highly qualified doctor to perform the procedure. Vascular surgeons, phlebologists, and plastic surgeons commonly perform vein treatments. Dermatologists perform some types of vein treatments.How painful is varicose vein treatment? ›
Each of these treatments is virtually painless. This is because veins have no nerve endings. The only sensation a patient typically feels is the poke of the tiny needle used to administer local anesthetic.Does sitting worsen varicose veins? ›
Regularly sitting for long periods leads to poor circulation in your legs. When you sit your veins must work harder to move blood to your heart. This can lead to swelling in your ankles, varicose veins, and even blood clots, also known as deep vein thrombosis (DVT). Sitting with your legs crossed or bent can be worse.What is the best sleeping position for varicose veins? ›
Something as simple as changing your sleeping position could help reduce varicose veins symptoms. Instead of reclining on your back or stomach, switch to sleeping on your left side. That's helpful because the body's largest vein, the vena cava, is on the right side.Does sitting with your legs up help varicose veins? ›
When you elevate your legs, ideally at or above heart level, it helps keep the blood from pooling in your lower legs and improves blood flow to the rest of your body. There are simple ways to improve the blood flow in your legs and prevent or improve varicose veins: Prop up your legs when you are sitting.
How do I get rid of varicose veins on my legs permanently? ›
- Endothermal ablation. This is a procedure where heat is used to seal the affected veins.
- Ambulatory phlebectomy. ...
- Sclerotherapy. ...
- Ligation and stripping. ...
- Laser surgeries. ...
- Endoscopic vein surgery.
Sclerotherapy is better for treating larger varicose veins, especially those on the legs, while laser therapy suits thinner veins on other parts of the body. Sometimes it may need a combination approach to get the best results.What is the most common varicose vein treatment? ›
Larger varicose veins are generally treated with ligation and stripping, laser treatment, or radiofrequency treatment. In some cases, a combination of treatments may work best. Smaller varicose veins and spider veins are usually treated with sclerotherapy or laser therapy on your skin.How can I stop varicose veins getting worse? ›
- Exercise regularly.
- Lose weight if you're overweight.
- Avoid standing or sitting for a long time.
- Don't wear tight-fitting clothes.
- Be sure to put your feet up.
- Wear support pantyhose.
- Invest in a compression hose.
Low-impact exercise that improves blood flow can help reverse the unhealthy qualities of varicose veins. Swimming, walking, cycling, yoga, and stretching are all beneficial as they circulate the blood and exercise the calf muscles without the danger of physical injury.What foods help varicose veins? ›
The foods rich in fiber, such as oats, apples, flaxseed, carrots, berries, and barley, are good for fighting against varicose veins and keeping veins healthy.Can turmeric cure varicose veins? ›
Garlic and turmeric can visibly reduce spider veins as they have anti-inflammatory properties. Add some garlic to your diet regularly. You can also take turmeric capsule pills if you don't want to incorporate more of it into your diet.
Varicose veins are usually caused by weak vein walls and valves. Inside your veins are tiny one-way valves that open to let the blood through, and then close to prevent it flowing backwards. Sometimes the walls of the veins become stretched and lose their elasticity, causing the valves to weaken.Can compression stockings reverse varicose veins? ›
No, compression stockings will not reverse varicose veins. Unfortunately, they don't treat the underlying cause. However, they can help with itchy skin and tired, aching legs if you wear them regularly. Once you stop wearing them, however, your symptoms will return.What vitamins improve varicose veins? ›
For instance, B3 and B12 help with blood circulation and lowering cholesterol. Taken consistently, B vitamins can provide long-term repair to varicose veins. Like vitamin C, vitamin E has strong antioxidant properties. As part of skincare products, vitamin E has been used for years to treat varicose veins.
What is the new technology for varicose veins? ›
Endovenous Laser Ablation
Endovenous Laser Ablation or EVLA is an advanced heat technique that enables the vein specialist to destroy the varicose veins. This treatment is similar to Endovenous radiofrequency ablation, including utilizing the radiofrequency to remove the abnormal vein from your body.
How can apple cider vinegar help veins? Due to its antioxidant properties, apple cider vinegar may possess the ability to improve blood flow and circulation in the body. It is also speculated it may help to cleanse the body of accumulated toxins and free radicals.Can B12 deficiency cause varicose veins? ›
Genetically predicted coffee consumption and circulating vitamin B12 and magnesium levels were suggestively associated with varicose veins.Does Vitamin D Help varicose veins? ›
Vitamin D is another powerful nutrient, which can be beneficial in preventing varicose veins. This vitamin helps to relax blood vessels and aids in flexibility. Vitamin D maintains circulatory health and assists in the prevention of varicose veins.What is the best supplement for circulation in legs? ›
Potassium (Vitamin K)
Potassium is an essential mineral for many important bodily functions, including blood circulation. It keeps the blood vessel walls strong and can even help prevent bulging veins.
Caffeine consumption can impact your vein health, whether you already have varicose veins or are at risk for developing them. But how does this occur? Caffeine can constrict blood vessels and elevate blood pressure. Prolonged, elevated blood pressure can place increased strain on your veins.What is the best vitamin for veins? ›
Some of the most important Supplements for vein health include Vitamin E, Vitamin B, and Vitamin K. These Supplements help to protect your veins from damage, improve circulation, and keep your veins healthy and functioning properly.What is the VA disability rating for varicose veins? ›
Under the varicose veins provisions of Diagnostic Code 7120, a 20 percent rating is warranted where there is persistent edema, incompletely relieved by elevation of extremity, with or without beginning stasis pigmentation or eczema.What test is required for varicose veins? ›
To diagnose varicose veins, a health care provider might recommend a test called a venous Doppler ultrasound of the leg. A Doppler ultrasound is a noninvasive test that uses sound waves to look at blood flow through the valves in the veins. A leg ultrasound can help detect a blood clot.When is sclerotherapy medically necessary? ›
Sclerotherapy usually works best on small varicose veins. Sclerotherapy involves using a needle to put a solution into the vein. The sclerotherapy solution causes the vein to scar. The scarring forces blood through healthier veins.
Do varicose veins affect life expectancy? ›
There's some good news, though. "Varicose veins typically aren't life-threatening or limb-threatening, and they generally don't increase your chance of deep vein thrombosis (DVT) or developing blood clots, which is what a lot of people worry about," says Dr. Lu.What does 40% VA disability mean? ›
Compensation benefits at the 40% level
Veterans with no dependents at the 40% rating level receive $673.28 per month for 2022. If you have dependents, you'll receive additional monthly compensation. Your monthly compensation for 2022 is: Veteran with spouse – $747.28. Veteran with spouse and one parent – $806.28.
A 10 percent rating for hypertension is assigned where the Veteran has diastolic pressure that is predominantly 100 or more; or systolic pressure that is predominantly 160 or more; or where the Veteran has a history of diastolic pressure predominantly 100 or more and requires continuous medication for control.Does varicose veins mean heart problems? ›
The short answer: No, it does not. Varicose veins are formed due to weakened vein valves, which has nothing to do with your current heart health. There is no link between varicose veins and heart disease or arterial disease, or being overweight. What is influenced by heart health, however, is your arteries.Who is not a candidate for sclerotherapy? ›
Who should not get sclerotherapy treatment. Just like any other cosmetic treatment, spider vein removal is not for everyone. It is designed for adult patients who are generally healthy and do not have a history of blood clots. Pregnant or breastfeeding women are also not right for treatment at this time.Who should not get sclerotherapy? ›
Also, sclerotherapy may not be not suitable for people who are pregnant, breastfeeding, or confined to bedrest. After giving birth, people must wait 3 months before having sclerotherapy.What are the cons of sclerotherapy? ›
Those serious side effects include ulceration of skin around the injected area, allergic reaction to the sclerotherapy solution, mild inflammation and discomfort around the injected area, and blood clot formation in the treated veins.