Great Saphenous Vein Incompetence Research Articles

Development and External Validation of a Prediction Model for Patients with Varicose Veins Suitable for Isolated Ambulatory Phlebectomy.

Isolated ambulatory phlebectomy is a potential treatment option for patients with an incompetent great saphenous vein (GSV) or anterior accessory saphenous vein and one or more incompetent tributaries. Being able to determine which patients will most likely benefit from isolated phlebectomy is important. This study aimed to identify predictors for avoidance of secondary axial ablation after isolated phlebectomy and to develop and externally validate a multivariable model for predicting this outcome. For model development, data for patients included in the SAPTAP trial were used. The investigated outcome was avoidance of ablation of the saphenous trunk one year after isolated ambulatory phlebectomy. Pre-defined candidate predictors were analysed with multivariable logistic regression. Predictors were selected using Akaike information criterion backward selection. Discriminative ability was assessed by the concordance index. Bootstrapping was used to correct regression coefficients, and the c-index for overfitting. The model was externally validated using a population of 94 patients with an incompetent GSV and one or more incompetent tributaries who underwent isolated phlebectomy. For model development, 225 patients were used, of which 167 (74.2%) did not undergo additional ablation of the saphenous trunk one year after isolated phlebectomy. The final model consists of three predictors for avoidance of axial ablation: tributary length (< 15 cm vs. > 30 cm: odds ratio [OR] 0.09, 95% confidence interval [CI] 0.02 - 0.40; 15 - 30 cm vs. > 30 cm: OR 0.18, 95% CI 0.09 - 0.38); saphenofemoral junction (SFJ) reflux (absent vs. present: OR 2.53, 95% CI 0.81 - 7.87); and diameter of the saphenous trunk (per millimetre change: OR 0.63, 95% CI 0.41 - 0.96). The discriminative ability of the model was moderate (0.72 at internal validation; 0.73 at external validation). A model was developed for predicting avoidance of secondary ablation of the saphenous trunk one year after isolated ambulatory phlebectomy, which can be helpful in daily practice to determine the suitable treatment strategy in patients with an incompetent saphenous trunk and one or more incompetent tributaries. Patients having a longer tributary, smaller diameter of the saphenous trunk, and absence of terminal valve reflux in the SFJ are more likely to benefit from isolated phlebectomy.

Three-year follow-up analysis of automated microfoam preparation system for great saphenous vein incompetence and varicose veins sclerotherapy treatment.

To describe the treatment of patients with great saphenous vein (GSV) incompetence and varicose veins (VVs), utilizing an Automated Microfoam Preparation System (AMPS, Varixio®, VB Devices, Barcelona, Spain). Adults between January and June 2021 were included. The AMPS system was used for foam preparation. Sclerotherapy treatment followed international recommendations. The primary endpoint was GSV closure rate after 36 months. 164 patients were enrolled. During the 7-day follow-up period, all GSVs showed complete closure, which was maintained at the 1-year mark. No major complications were reported. A cumulative complete GSV recanalization rate of 6.1% and a partial recanalization rate of 26.8% after 36 months were noted. Some patients (9.7%) required additional treatment. A higher BMI was associated with complete recanalization. The AMPS offers an easy-to-use and standardized procedure, potentially enhancing treatment outcomes if compared with manual preparation. Caution is advised when treating obese patients.

Radiofrequency ablation for the treatment of great saphenous venous insufficiency using a newly developed VENISTAR catheter: A preliminary study.

This study was aimed to assess the preliminary outcomes of radiofrequency ablation (RFA) using a newly developed catheter (VENISTAR) for the treatment of incompetent great saphenous veins (GSVs). In this prospective observational study, endovenous RFA using a VENISTAR catheter was performed on 16 saphenous veins in 12 patients between August and November 2019. Patients' pre- and post-procedural data were recorded. Doppler ultrasound imaging and clinical evaluation were performed at 1week and 1, 3, and 6months to determine the efficacy and safety of the treatment. Technical success and complete closure of the targeted GSVs immediately after the procedure were observed in all 16 limbs (100%). However, one patient (one limb) was found to have partial occlusion without significant reflux after 1week of follow-up. Kaplan-Meier analysis yielded a complete occlusion rate of 93% at 6months of follow-up. The Venous Clinical Severity Scores at the time of all follow-up were significantly lower than those at baseline (3.3 ± 1.1 at baseline to 0.6 ± 0.6, 0.3 ± 0.6, 0.1 ± 0.4, and 0.2 ± 0.4 at 1week and 1, 3, and 6months, respectively) (p < .001). Mild post-procedural pain was noted in 7 and 4 limbs at 1week and 1month, respectively. Grade 1 ecchymosis over the ablated segment was noted in 5 (35.7%) of 14 limbs at 1-week follow-up. Endovenous treatment of GSV insufficiency using a new VENISTAR radiofrequency catheter has been shown to be feasible, effective, and safe throughout the 6-month follow-up.

High intensity focused ultrasound in treating great saphenous vein incompetence: Perioperative and 1-year outcomes.

To investigate the use of high intensity focused ultrasound (HIFU) for great saphenous vein (GSV) incompetence. Patients with GSV incompetence underwent HIFU. The primary endpoint was the rate of GSV target segment shrinkage or closure after 1year. Out of 188 limbs treated, the GSV treated segment shrinkage/closure rate at 1 week, 3 months, 6 months, and 12 months was 93.3%, 98.2%, 97.6%, and 98.3%, respectively. These preliminary results suggest that HIFU holds promise for the treatment of GSV incompetence. Further trials are needed to compare it with other techniques and assess long-term outcomes.

Editor's Choice – Short Term Cost Effectiveness of Radiofrequency Ablation and High Ligation and Stripping for Great Saphenous Vein Incompetence

Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation/stripping (HL/S), and no treatment/conservative treatment with one year follow up. Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (C in CEAP 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). In total, 78 limbs were treated with RFA and HL/S respectively. No treatment/conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In RFA, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as €1 292 for RFA and €2 303 for HL/S. The cost per QALY (compared with no treatment/conservative treatment) was €6 155 for RFA and €13 549 for HL/S. With added cost for days absent from work the cost per QALY was €7 358 for RFA and €24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. RFA is more cost effective than HL/S and no treatment/conservative treatment at one year follow up.

Factors associated with ablation-related thrombus extension following microfoam versus radiofrequency saphenous vein closure

ObjectivePolidocanol endovenous microfoam ablation (MFA) is approved by the US Food and Drug Administration for great saphenous vein (GSV) closure, yet there are few published data on the subsequent risk of ablation-related thrombus extension (ARTE). Recent societal practice guidelines recommend against routine postprocedure duplex ultrasound (DU) examination after thermal ablation of the GSV in asymptomatic patients. At present, limited data do not allow this recommendation to extend to MFA. Our aim is to identify characteristics and outcomes associated with ARTE following MFA vs radiofrequency ablation (RFA). MethodsA retrospective review of a prospectively maintained database was conducted of patients who underwent MFA and RFA closure of incompetent above-knee GSVs. Patients treated for isolated tributary vein treatment or did not have a postprocedure DU examination within 48 to 72 hours were not included. Patients were classified into two groups: ARTE and no ARTE. Demographic data, Clinical, Etiologic, Anatomic and Pathophysiologic class, Venous Clinical Severity Score, operative details, postprocedure (48-72 hours) DU findings, and adverse events were analyzed. Variables that were significant on univariate analysis were evaluated using multivariate logistic regression with the primary outcome being development of ARTE. ResultsBetween June 2018 and February 2023, 800 limbs were treated with either MFA (n = 224) or RFA (n = 576). Ninety-six GSVs treated with MFA met the study criteria. One hundred fifty successive GSVs treated with RFA during the same period were included as a comparison group. There was no statistically significant difference in baseline demographics between the two groups. Six patients (2.4%) demonstrated ARTE on postoperative DU examination at 48 to 72 hours (MFA, n = 5 [5.2%]; RFA, n = 1 [0.7%]; P = .02). Saphenous vein ablation with MFA (P = .045) and a vein diameter of >10 mm (P = .017) were associated with ARTE on both univariable and multivariable analysis. All patients who developed ARTE were treated with oral anticoagulants (mean, 15.6 days). Body mass index, Clinical, Etiologic, Anatomic and Pathophysiologic class, Venous Clinical Severity Score, microfoam volume, operative time, and prior deep venous thrombosis were not predictive of ARTE. ConclusionsARTE after above-knee GSV closure occurred more frequently after MFA. Our results suggest that a saphenous vein diameter of >10 mm may be associated with ARTE. Despite this finding, all patients with ARTE were treated with short-term anticoagulation with no related complications. Until larger studies with high-risk subgroups have been studied after MFA, DU examination should be performed routinely after this procedure and patients with ARTE anticoagulated until the thrombus retracts caudal to the saphenofemoral junction or is no longer present on DU examination. Current societal guidelines recommending against routine post-thermal ablation DU examination should not be applied to similar patients after saphenous nonthermal MFA ablation.

Mechanochemical ablation: disappointing long-term anatomic results and worsening symptoms.

An updated report on the five-year results in the treatment of great saphenous vein incompetence with mechanochemical ablation (MOCA) provides additional evidence for higher rates of anatomic recanalization compared to other treatment modalities and progressive worsening of symptoms with time.

The Novel Surgical Technique in the Cyanoacrylate Closure for Incompetent Great Saphenous Veins.

The current Instructions for Use (IFU) of cyanoacrylate closure (CAC) is to start initial injection with the catheter tip positioned 5cm distal to the sapheno-femoral junction (SFJ) to prevent endovenous glue-induced thrombosis (EGIT). However, this defensive design is responsible for the relatively long stump length. Although clinical studies on the long-term recurrence rate are still lacking, the long stump length can predict a higher long-term recurrence rate compared to other surgical methods. The author developed a novel surgical technique that can overcome the weakness of CAC, and the initial outcomes of this technique are described in this article. This study retrospectively reviewed 25 great saphenous vein (GSV) in 20 patients who underwent CAC for incompetent GSV at our hospital. The procedure from puncturing the GSV to insertion of the catheter is the same as the conventional method. Place the catheter tip 2-3cm below the SFJ before cyanoacrylate injection. After confirming the position of the SFJ with the longitudinal view of the ultrasound, press the GSV directly above the SFJ transversely with the second to fifth fingertips of the left hand. Then, the ultrasound probe is placed against the distal part of the fingertips, and CA injection is performed while GSV is monitored in real time. The mean stump length immediately after surgery was 19.3 (± 7.8) mm, with a range of .0-38.4mm. The mean stump length after 1week was 12.3 (± 7.4) mm and the range was .1-35.4mm. The mean stump length after 1month was 15.4 (± 10.1) mm, and the range was .0-35.4mm. There was no case with EGIT or recanalization. The author confirmed the possibility of safely reducing stump length with this novel surgical technique, and expect that this method can help overcome the weakness of CAC.

Clinical Efficacy of a Modified Surgical Procedure in the Treatment of Incompetent Great Saphenous Veins.

The aim of this study was to evaluate the clinical efficacy of a modified surgical procedure for the treatment of varicose veins. This retrospective analysis was conducted on lower extremities with symptomatic great saphenous vein (GSV) incompetence that underwent stripping from the groin to the knee, with preservation of the superficial epigastric vein (SEV), between January 2015 and April 2022. Follow-up assessments were performed using Doppler ultrasound, Venous Clinical Severity Score (VCSS), and the Aberdeen Varicose Vein Questionnaire (AVVQ) at 6 and 12 months after surgery. The study included 179 limbs from 120 patients (47 men and 73 women). The mean patient age was 56.5 years (range, 20-78 years), and the distribution of preoperative Clinical-Etiology-Anatomy-Pathophysiology clinical classes was 8% C0-C1, 88% C2, and 4% C3-C6. The preoperative diameter of the saphenofemoral confluence averaged 6.9 mm (range, 2.7-15.8 mm). After a mean postoperative follow-up period of 24 months, evidence of neovascularization around the stump of the saphenofemoral junction (SFJ) was observed in 2 limbs (1.1%). Additionally, varicose vein recurrence was found in 1 limb (0.6%) and was associated with an incompetent thigh perforator. At postoperative follow- up, both VCSS and AVVQ scores were significantly lower than the preoperative scores. Modified surgical treatment of GSV incompetence, involving preservation of the SEV and stripping of a short segment up to the knee, demonstrated favorable clinical results in terms of postoperative complication rate, neovascularization rate around the SFJ stump, varicose vein recurrence rate, and improvement in lower extremity symptoms.

Combination of Minimally Invasive Methods for the Treatment of Varicose Veins.

The aim of the study was to evaluate the efficacy and safety of the combination of minimally invasive methods for the treatment of incompetent great saphenous vein and perforating veins. Between December 2019 and October 2020, F-care radiofrequency ablation combined with ultrasound-guided foam sclerotherapy and residual perforator ligation and concomitant microphlebectomy were adopted for all eligible patients. The clinical symptoms scores, complications, and quality of life were recorded. 49 patients (64 limbs) with a mean age of 63.29 ± 10.14years, and 60.9%4 were male. The 1-year truncal closure rate was 63/64 (98.4%).1 A significant improvement in the Venous Disability Score, the Venous Segmental Disease Score, the Venous Clinical Severity Score and Chronic Venous Disease Quality of Life Questionnaire Score, at 12months after the combination of minimally invasive treatment, were observed in the study. One patient developed intermuscular vein thrombosis that was successfully managed with rivaroxaban. The combination of minimally invasive methods is a safe and effective method for the treatment of lower extremity varicose veins. Further large-scale, prospective, multi-center studies are needed to further verify the findings of this study.

Outcomes of Cyanoacrylate Closure Versus Radiofrequency Ablation for the Treatment of Incompetent Great Saphenous Veins

Evaluation of the efficacy and safety of cyanoacrylate closure (CAC) for treating incompetent great saphenous veins (GSVs) compared to radiofrequency ablation (RFA). In this prospective, randomized controlled study, 248 symptomatic subjects with incompetent GSVs were assigned to either CAC or RFA. The primary end point, complete closure of the target GSV, was determined using a duplex ultrasound examination. In this study, 248 patients (mean age 33.64±8.06years including 71% women) were treated with either CAC (n=128) or RFA (n=120) between August 2018 to May 2022. As a follow-up, after a 1-month duration, the closure rates were 128/128 at the CAC and 154/158 at the RFA. At month 24, closure rates were 122/128 at CAC and 146/158 at RFA. Apart from phlebitis and pigmentation, the incidences of bruising, skin burn, and paresthesia were lower in the CAC group compared to the RFA group. The mean procedural times were shorter for CAC. The satisfaction level with the treatment was moderately higher among CAC patients than RAF patients. This study suggests that Cyanoacrylate glue closure of the GSV and RFA are effective techniques for managing primary varicose veins. Cyanoacrylate glue closure of the GSV appears to have a lower rate of complications and higher satisfaction levels, rapid return to normal activities, and improved procedure time without the need for perivenous tumescent anesthesia and postprocedure compression stockings when compared to RFA.

Early Results of Mechanochemical Ablation by Flebogrif and Radiofrequency Ablation in Treating Primary Varicose Veins of Lower Limb.

Introduction Chronic venous insufficiency is a common condition that leads to the development of incompetent great or short saphenous veins (GSV or SSV) resulting in varicose vein development. Conservative management is initially employed for its treatment; however, the varicosities that do not respond to conservative management may require intervention by surgery or endovenous routes. Radiofrequency ablation (RFA) and mechanochemical ablation (MOCA) are the two most common endovascular techniques available for the management of incompetent GSVor SSV. Clarivein and Flebogrif are two devices to treat incompetent GSV or SSV by MOCA. Mechanical ablation is provided by their flexible cutting elements and chemical ablation is provided by polidocanol or sodium tetradecyl sulfate (STS). RFA uses radiofrequency waves to treat venous insufficiency. Therefore, the aim of this study was to determine the early treatment outcome results for incompetent GSV or SSV treated with RFA or MOCA by Flebogrif. Materials and methods This was a retrospective cross-sectional study undertaken at the Radiology Department of Indus Hospital and Health Network. Electronic Medical Records of all the patients who underwent RFA or MOCA for GSV or SSV for venous insufficiency from January 2021 to December 2021 were included. Both male and female patients aged 18 years and above diagnosed with venous insufficiency having Clinical, Etiologic, Anatomic, and Pathophysiologic (CEAP) scores of >1 were included. Statistical Package for Social Sciences (SPSS) v 22(IBM Corp., Armonk, NY) was used for data entry and analysis. Results 137 patients were included in the present study with a mean age of 53.8 ± 12.1 years. Pre-procedure CEAP score was C3 in 59 (84.4%), C4 in four (5.7%), and C6 in seven (10.0%) patients in patients who underwent RFA, and it was successful in 69 (98.6%) patients. Pre-procedure CEAP score was C3 in 62 (92.5%), C4 in two (3.0%), and C6 in three (4.5%) patients who underwent MOCA, and it was successful in 59 (88.1%) patients. Pain was the most frequent complication observed in both RFA and MOCA. Conclusion RFA has a high success rate as compared to MOCA by Flebogrif in treating incompetent GSV or SSVs.

Long-term results and predictors of failure after mechanochemical endovenous ablation in the treatment of primary great saphenous vein incompetence.

Mechanochemical endovenous ablation (MOCA) was introduced to treat superficial venous insufficiency of the lower leg with less pain and haematoma. Long-term outcome is still lacking. The purpose was to report long-term outcome and to analyse possible predictors for failure. The study was a retrospective pooled analysis of two prospective cohorts previously reported, but with prolonged long-term outcome up to 5-years follow-up. 163 treated legs were analysed. Mean follow-up was 5.4±0.6years, in which 33 total failures occurred. Four procedures were partially successful. VCSS improved significantly and remained stable after 1 and 2-years, but significantly rose again after 5-years. AVVQ dropped significantly, but increased after 1year to 4.3 and 6.1 at 5-years follow-up. MOCA was effective with minimal pain perioperative. However, anatomical success deteriorated after 1-year and showed even less results after 5-years, mainly due to partly recanalization, while clinical results were less affected. There were no clear clinical predictors for failure.

Factors influencing recurrent varicose vein formation after radiofrequency thermal ablation for truncal reflux performed in two high-volume venous centers

ObjectiveRecanalization of the saphenous vein trunk after endovenous radiofrequency ablation (RFA) is often associated with recurrent varicose veins (RVVs) or recanalization. This study aimed to assess the long-term results of RFA of the great saphenous vein (GSV) and identify the risk factors for GSV recanalization and RVVs during follow-up for patients presenting to dedicated outpatient vein centers. MethodsAll consecutive patients with incompetent GSVs who underwent RFA between 2009 and 2019 were retrospectively analyzed. The primary study end points were freedom from GSV recanalization and the RVV rate during follow-up. The secondary study end points were the postoperative complication rate and the risk factors for GSV recanalization and RVVs. Univariate and multivariate analyses were performed to identify the potential risk factors for GSV recanalization and RVVs. ResultsDuring the study period, 1568 limbs were treated in 1300 consecutive patients (mean age, 53.5 ± 12.9 years; 71.9% women; CEAP [clinical, etiology, anatomy, pathophysiology] C2-C6; venous clinical severity score >5). Technical success was achieved in 99.7% of cases. At a mean follow-up of 57.2 ± 25.4 months, the GSV occlusion and freedom from reintervention rates were 100% and 100% within 1 week, 97% and 95.7% at 1 year, 95.2% and 93.1% at 3 years, and 92.4% and 92.8% at 5 years, respectively. The recurrence rate was 10% (n = 158) during the follow-up period. On multivariate analysis, a direct confluence of the accessory saphenous vein into the saphenofemoral junction (odds ratio [OR], 1.561; 95% confidence interval [CI], 1.0-7.04; P = .032), a history of pregnancy >2 (OR, 3.68; 95% CI, 1.19-11.36; P = .023), C4 (OR, 6.41; 95% CI, 1.36-30.28; P = .019), and preoperative GSV diameter >10 mm (OR, 1.82; 95% CI, 1.65-4.03; P = .043) were risk factors for GSV recanalization. Moreover, age >70 years (OR, 1.04; 95% CI, 1.01-1.06; P = .014) and incompetent perforator veins (OR, 1.17; 95% CI, 0.65-2.03; P = .018) were also risk factors for RVVs. ConclusionsRFA is a safe technique to ablate the GSV with a low complication rate and durability during 5 years of follow-up. However, patients with a high clinical score and those with direct confluence of the accessory saphenous vein into the saphenofemoral junction experienced higher long-term GSV recanalization and RVV rates.

Six Year Extension Study of Patients From a Randomised Clinical Trial Comparing Venefit, Radiofrequency Induced Thermal Therapy, and Endovenous Radiofrequency Ablation for Treatment of Incompetent Great Saphenous Veins

Six Year Extension Study of Patients From a Randomised Clinical Trial Comparing Venefit, Radiofrequency Induced Thermal Therapy, and Endovenous Radiofrequency Ablation for Treatment of Incompetent Great Saphenous Veins

Quantifiable remaining reflux 1 year after treatment of superficial venous incompetence is associated with impaired clinical outcome

ObjectiveRemaining symptoms after treatment of superficial venous incompetence is a common problem. Duplex ultrasound is often used during follow-up, but does not permit an overall quantification of venous function. We have developed a plethysmographic method using occlusion cuffs for separation of superficial and deep venous reflux. By assessing the superficial component it is possible to quantify a potential suboptimal hemodynamic treatment in patients with superficial venous incompetence. The aim was to examine whether patients with hemodynamically quantifiable remaining reflux after treatment experience impaired clinical outcomes. MethodsThis single-center prospective cohort study evaluated 156 limbs with great saphenous vein incompetence treated with radiofrequency ablation or high ligation and stripping. Duplex ultrasound and strain-gauge plethysmography (SGP) with and without selective superficial occlusion were performed before and one-year after treatment. Time taken (seconds) to reach 50% of the venous volume (T50) was evaluated. A difference in the T50of >5 seconds between postoperative strain-gauge plethysmography with and without superficial occlusion was defined as remaining reflux. The Venous Clinical Severity Score (VCSS) and Aberdeen Varicose Vein Questionnaire (AVVQ) were evaluated and compared between patients with and without remaining reflux. Multivariable logistic regression was used to evaluate risk factors for remaining plethysmographic reflux. ResultsIn all patients, median (25th, 75th percentile) T50 increased preoperatively from 7 seconds (3, 12 seconds) to 17 seconds (11, 28 seconds) (P < .001) 1 year after treatment. The VCSS and AVVQ were reduced (VCSS, 8.0 [6.0, 10.0] vs 3.0 [1.0, 5.0] [P < .001]; AVVQ, 21.8 [15.8, 32.1] vs 6.4 [2.2, 11.0] [P < .001]). Of the 156 limbs, 87 (56%) demonstrated remaining reflux 1 year after treatment. Patients with remaining plethysmographic reflux displayed higher median (25th, 75th percentile) VCSS (3.0 [2.0, 5.0] vs 2.0 [1.0, 4.0]; P = .012) and AVVQ (7.5 [2.7, 14.9] vs 4.7 [1.6, 9.2]; P = .025). Multivariate logistic regression showed that higher preoperative C in the Clinical Etiology Anatomy Pathophysiology classification (CEAP) (odds ratio [OR], 2.9 [95% confidence interval [CI], 1.34-6.46), age (OR, 1.03; 95% CI, 1.001-1.065), small saphenous vein incompetence (OR, 4.2; 95% CI, 1.30-13.73) and postoperative great saphenous vein reflux below the treated area (OR, 2.16; 95% CI, 1.02-4.56) were significant risk factors for remaining plethysmographic reflux. ConclusionsA majority of treated limbs showed quantifiable reflux 1 year after intervention and these patients displayed worse patient related outcomes assessed with the VCSS and AVVQ. Remaining plethysmographic reflux was associated with preoperative small saphenous vein incompetence and reflux below the treated area as well as advanced age and higher C in CEAP.

A comparison of patient-reported outcome measures following technical success and technical failure in the treatment of great saphenous vein incompetence using ClariVein: A subanalysis of a multicenter randomized controlled trial comparing 2% and 3% polidocanol.

This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

Cyanoacrylate adhesive closure in the European and American 2022 clinical practice guidelines

Over the last decade non-thermal non-tumescent (NTNT) methods of truncal reflux elimination in chronic venous disease (CVD) are becoming increasingly popular. The main NTNT modalities are mechanochemical ablation and cyanoacrylate adhesive closure (CAC). The advantages of non-thermal ablation are avoidance of tumescent anesthesia, low periprocedural pain and bruising, high patient comfort and satisfaction rates. CAC method has an additional benefit of avoiding the postprocedural compression. CAC is one of promising non-thermal ablation procedures, that leads to truncal vein occlusion and reflux elimination via endovenous delivery of n-butyl-2-cyanoacrylate. This review is aimed at assessment of the updated European and American clinical practice guidelines on CVD management, particularly the role of CAC. Current evidence shows high efficacy and safety of the CAC, its advantages regarding the periprocedural pain and ecchymoses, risk of adverse events, closure rates in the long-term, procedure and recovery time and patients’ quality of life. Therefore, along the current gold standard of varicose vein treatment – thermal ablation, the updated 2022 European and American clinical practice guidelines have significantly emphasized the role of NTNT modalities in general and CAC in particular. Specifically, the European Society for Vascular Surgeons guidelines recommend CAC for patients with great saphenous vein (GSV) incompetence when the NTNT technique is preferred. American guidelines recommend both thermal and non-thermal ablation for the patients with symptomatic axial reflux of the GSV, depending on the available expertise of the treating physician and the preference of the patient.

Comparison of outcomes following polidocanol microfoam and radiofrequency ablation of incompetent thigh great and accessory saphenous veins

BackgroundMicrofoam ablation (MFA) and radiofrequency ablation (RFA) are both approved by the Food and Drug Administration for treatment of proximal saphenous truncal veins. The objective of our study was to compare early postoperative outcomes between MFA and RFA following treatment of incompetent thigh saphenous veins. MethodsA retrospective review of a prospectively maintained database was conducted of patients who underwent treatment of incompetent great saphenous veins (GSVs) or anterior accessory saphenous veins (AASVs) in the thigh. All the patients underwent duplex ultrasound of the treated leg at 48 to 72 hours postoperatively. Patients were excluded from analysis if concomitant stab phlebectomy was performed. Demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, venous clinical severity score (VCSS), and adverse events were recorded. ResultsBetween June 2018 and September 2022, 784 consecutive limbs (RFA, n = 560; MFA, n = 224) underwent venous closure for symptomatic reflux. A total of 200 consecutive thigh GSVs and ASVs treated within the study period using either MFA (n = 100) or RFA (n = 100) were identified. The patients were predominantly women (69%) with a mean age of 64 years. The preoperative CEAP classification was similar between the MFA and RFA groups. The mean preoperative VCSS was 9.4 ± 2.6 for the RFA patients and 9.9 ± 3.3 for the MFA patients. Among the RFA patients, the GSV was treated in 98% and the AASV in 2% compared with the GSV in 83% and the AASV in 17% in the MFA group (P < .001). The mean operative time was 42.4 ± 15.4 minutes in the RFA group and 33.8 ±16.9 minutes in the MFA group (P < .001). The median follow-up was 64 days for the study cohort. The mean postoperative VCSS declined to 7.3 ± 2.1 in the RFA group and 7.8 ± 2.9 in the MFA group. Complete closure occurred in 100% of the limbs after RFA and 90% after MFA (P = .005). Eight veins were partially closed and two remained patent following MFA. The incidence of superficial phlebitis was 6% and 15% (P = .06) after RFA and MFA, respectively. Overall, symptomatic relief was 90% following RFA and 89.5% following MFA. The complete ulcer healing rate for the entire cohort was 77.8%. Deep venous proximal thrombus extension (RFA, 1%; vs MFA, 4%; P = .37) and remote deep vein thrombosis (RFA, 0%; vs MFA, 2%; P = .5) showed a trend toward being higher following MFA but the difference did not reach statistical significance. All were asymptomatic and resolved with short-term anticoagulation therapy. ConclusionsMFA and RFA are both safe and effective for treating incompetent thigh saphenous veins, with excellent symptomatic relief and a low incidence of postprocedure adverse thrombotic events. RFA resulted in improved complete closure rates following initial treatment compared with MFA. The operative times were shorter with MFA. Both modalities can be used for patients with active venous ulcers with good healing rates. Longer term studies are required to characterize the durability of MFA closure for above knee truncal veins.

VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers

ObjectiveChronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates. MethodsThe VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months. ResultsWe enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points. ConclusionsTreatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.