Compression versus No Compression after Endovenous Ablation of the Great Saphenous Vein: A Randomized Controlled Trial.

BACKGROUND: The goal of this study is to determine if compression therapy after endovenous ablation (EVA) of the great saphenous vein (GSV) improves efficacy and patient-reported outcomes of pain, ecchymosis, and quality of life. METHODS: This is a prospective randomized controlled trial from 2009 to 2013 comparing the use of thigh-high 30-40 mm Hg compression therapy for 7 days versus no compression therapy following EVA of the GSV. Severity of venous disease was measured by clinical severity, etiology, anatomy, pathophysiology scale and the Venous Clinical Severity Score (VCSS). Quality of life assessments were carried out with a Chronic Venous Insufficiency Questionnaire (CIVIQ-2) at days 1, 7, 14, 30, and 90, and the Visual Analog Pain Scale daily for the first week. Bruising score was assessed at 1 week post procedure. Postablation venous duplex was also performed. RESULTS: Seventy patients and 85 limbs with EVA were randomized. EVA modalities included radiofrequency ablation (91%) and laser ablation (9%). Clinical severity, etiology, anatomy, pathophysiology class and VCSS scores were equivalent between the 2 groups. There was no significant difference in patient-reported outcomes of postprocedural pain scores at day 1 (mean 3.0 vs. 3.12, P = 0.948) and day 7 (mean 2.11 vs. 2.81, P = 0.147), CIVIQ-2 scores at 1 week (mean 36.9 vs. 35.1, P = 0.594) and 90 days (mean 29.1 vs. 22.5, P = 0.367), and bruising score (mean 1.2 vs. 1.4, P = 0.561) in the compression versus no compression groups, respectively. Additionally, there was a 100% rate of GSV closure in both groups and no endothermal heat-induced thrombosis as assessed by postablation duplex. CONCLUSIONS: Compression therapy does not significantly affect both patient-reported and clinical outcomes after GSV ablation in patients with nonulcerated venous insufficiency. It may be an unnecessary adjunct following GSV ablation.

Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.

OBJECTIVE: We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence. METHODS: We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis. RESULTS: We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates. CONCLUSIONS: Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.

Relationship between iliofemoral venous stenting and femoropopliteal deep venous reflux.

OBJECTIVE: Severe presentations of chronic venous insufficiency can result from reflux or obstruction at the deep venous, perforator, or superficial venous levels. Iliofemoral venous stenting can be used to address central venous obstruction; however, its effects on deep venous reflux (DVR) have remained unclear. The purpose of the present study was to evaluate the effects of iliac vein stenting on femoropopliteal DVR with the hypothesis that ultrasound evidence of DVR would remain absent or would have improved after iliac vein stenting. METHODS: The present study was a retrospective review of patients who had undergone iliofemoral venous stenting from 2013 to 2018. The patients were divided into two cohorts according to the preprocedural presence (group A) or absence (group B) of femoropopliteal DVR. Baseline patient variables were collected, including age, gender, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, presence of concomitant superficial or perforator reflux, deep vein thrombosis history, and additional venous interventions. The primary outcome evaluated was the persistent absence or resolution of DVR on the latest venous duplex ultrasound at follow-up. Other outcomes included the follow-up CEAP classification and the need for secondary deep venous interventions. RESULTS: A total of 275 consecutive patients had undergone iliofemoral venous stenting. Of the 275 patients, 58 had presented with DVR (group A). A comparison of groups A and B revealed that group A had had a greater likelihood of prior deep vein thrombosis (P = .0001) and a higher frequency of superficial venous ablation. The remaining demographic variables did not differ significantly between the two groups. Of the 58 patients in group A, DVR had resolved at follow-up in 17 (P = .0001). When stratified by level, 7 of these 17 patients had had isolated popliteal reflux. In group B, DVR had developed at follow-up in 6 of the 217 patients. The CEAP class had improved from before intervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; C6, 24.5%) to the latest follow up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; C6, 13.3%). Significant improvement had occurred in C6 disease within both groups (group A, 16 of 58 [27.6%; P = .0078]; group B, 19 of 217 [8.8%; P = .0203]). CONCLUSIONS: For patients who undergo iliofemoral venous stenting, DVR could improve if present initially and is unlikely to develop if not present before stenting. A cohort of patients had experienced persistent DVR and warranted further evaluation. Prospective studies are required to corroborate the safety, efficacy, and durability of iliofemoral venous stenting for patients with DVR.

Arteriovenous fistula after endovenous ablation for varicose veins.

Endovenous ablation, using radiofrequency or laser, is becoming the mainstay of treatment for symptomatic varicose veins in the setting of saphenous vein incompetency. Both procedures have been shown to produce high rates of truncal vein occlusion with few complications. This article presents three patients who developed arteriovenous fistula (AVF) following great saphenous vein treatment: two following radiofrequency ablation (RFA) and one following laser ablation. This is the first published report of AVF following RFA for which operative details are known. We review the literature and discuss possible causes and management of this rare complication.

A pre-clinical animal study of a novel mechanical-only ablation device treatment for superficial venous disease.

OBJECTIVE: Current minimally invasive techniques for ablation in superficial venous reflux are limited to thermal based systems requiring tumescent anesthesia, non-thermal chemical sclerosants and permanent glue implantation. The aim of this feasibility study was to determine the safety and efficacy of a novel mechanical-only ablation (MOA) device called EnVena, in a recognised large animal model with chronic follow up. METHODS: Venous ablation of six lateral saphenous veins in three sheep was performed using the EnVena device. Luminal patency and vein wall fibrosis were evaluated by histologic analysis at 51 and 89 days. RESULTS: All treated veins demonstrated fibrotic occlusion in contiguous segments at 51 and 89 days on histological analysis. From 45 consecutive segments spanning the treatment length across the six treated veins, 26 (57%) were fully occluded, 7 (16%) were impinged or partially occluded and 12 (27%) were open. There were no device related complications during the follow up period. CONCLUSIONS: A purely mechanical approach to superficial venous ablation demonstrated safety and efficacy in a recognized large animal model based on histological findings.

The presence of a pathologic perforator may be predictive of central venous pathology and multilevel disease in severe chronic venous insufficiency.

OBJECTIVES: The treatment of a refluxing perforator is indicated in the setting of severe chronic venous insufficiency, but there are limited data on the presence of multilevel disease in these patients. This study sought to evaluate whether the presence of a pathologic perforator is predictive of the presence of central venous pathology. METHODS: This study was a retrospective review of the institutional Vascular Quality Initiative database. Consecutive patient limbs were identified that underwent intervention of refluxing perforators. The patients who underwent imaging, including magnetic resonance imaging or computed tomography (group A), were compared with those who did not undergo imaging (group B). The treated limbs in group A were also compared with the contralateral limbs as an internal control. Anatomical findings on imaging were analyzed by two independent investigators. The primary outcome was the presence and degree of central venous stenosis as measured by an orthogonal diameter reduction of >50% by axial imaging. Secondary outcomes included demographic and clinical differences between the two groups, frequency of central venous intervention, and duration of ulcer healing. Standard statistical analysis was performed. RESULTS: Ninety-three patient limbs underwent treatment of a pathologic perforator, with 30 in group A and 63 in group B. The following demographic and clinical variables were higher in group A compared with group B: male sex, body mass index, deep venous thrombosis history, recent or active anticoagulation use, perforator diameter, Clinical Etiology Anatomy Pathophysiology class 4, 5, or 6, and Venous Clinical Severity Score. Radiographic analysis of group A revealed concordance of a treated pathologic perforator with an ipsilateral central venous stenosis in 53.3% of patients, and a higher frequency of common iliac vein stenosis (50% vs 21.4%, P = .024) and external iliac vein stenosis (20% vs 0%, P = .012) compared with the contralateral limbs. When separated by the left or right limb, the left limbs exhibited a greater degree of common iliac vein stenosis as compared with the contralateral limbs (50.7% ± 20.9% vs 16.3% ± 16.5%, P < .001) as well as a greater frequency of >50% common iliac vein stenosis (46.7% vs 13.3%, P = .046). The right limbs exhibited a greater frequency of >50% external iliac vein stenosis as compared with the contralateral limbs (33.3% vs 0%, P = .022). CONCLUSIONS: This study suggests that patients with severe chronic venous insufficiency who undergo treatment for a pathologic perforator may have additional ipsilateral central venous pathology, supporting the presence of multilevel disease. Additional axial imaging might unmask central venous pathology and provide another option for treatment.

A single-center experience of anterior accessory saphenous vein endothermal ablation demonstrates safety and efficacy.

OBJECTIVE: Endothermal ablation is well-established for the treatment of the great and small saphenous veins. Data are lacking for treatment of the anterior accessory saphenous vein (AASV). The purpose of this study was to evaluate the safety and efficacy of AASV treatment using endothermal ablation. METHODS: This retrospective review included 314 limbs at a single academic institution from 2016 to 2018 using the institutional Vascular Quality Initiative database. All limbs had documented AASV reflux. Baseline characteristics were evaluated including age; sex; ethnicity; clinical, etiology, anatomy, pathophysiology classification; Venous Clinical Severity Score (VCSS); and vein diameter. Outcomes relating to procedure safety and efficacy included treatment modality and length, successful ablation on postoperative imaging, postprocedural clinical outcomes, incidence of endothermal heat-induced thrombosis (EHIT), and any postprocedural complication. RESULTS: A total of 314 consecutive limbs were identified from 2016 to 2018. The preprocedure VCSS scores were available for 312 limbs and averaged 6.13 ± 3.33. A history of varicose veins were reported in all limbs with 49.4% (n = 155) having previously undergone a procedure. The most common presenting symptom was mild edema in 52.5% (n = 165). Vein diameter and assessment of reflux were obtained by venous duplex ultrasound (DUS) examination. The largest AASV diameter was available for 304 limbs, averaging 7.93 ± 2.69 mm. Treatment modalities included radiofrequency ablation (RFA) in 59.2% (n = 186), endovenous laser ablation (EVLA) in 37.9% (n = 119), and isolated microphlebectomy in 2.9% (n = 9). In all, 38.5% (n = 121) of limbs underwent concomitant microphlebectomy at the time of EVLA. The total treatment length was obtained in 297 limbs, averaging 23.0 cm ± 12.0. Postoperatively, 94.6% of limbs (n = 297) were prescribed compression stockings. Postoperative DUS examination was performed in 312 limbs, revealing successful ablation in 96.5% (n = 303) with 2 limbs (0.6%) developing an EHIT, both treated with therapeutic enoxaparin for 1 week. Repeat DUS examination revealed thrombus resolution in one limb; the other patient was lost to follow-up. VCSS scores after the procedure were available for 145 limbs and averaged 4.45 ± 2.31. This was a statistically significant decrease from preprocedure VCSS scores (P < .01). Average duration of follow-up was 2.2 years, with two limbs lost to follow-up. Of the nine limbs (3.5%) whose initial procedure failed, five (56%) were treated using RFA and four (44%) were treated using EVLA. There were no other postoperative complications. CONCLUSIONS: Our experience over a 3-year period for treating the AASV shows it to be safe and effective in a broad range of disease severity with an improvement in VCSS and a low incidence of EHIT. Additionally, RFA and EVLA exhibit similar treatment efficacy. Long-term follow-up data are needed.

Laser saphenous ablations in more than 1,000 limbs with long-term duplex examination follow-up.

BACKGROUND: The goal of this study was to evaluate the duplex results of endovenous laser ablation in the treatment of incompetent great saphenous veins (GSV) and small saphenous veins (SSV) with at least 1-year follow-up. METHODS: A retrospective registry was entered by 11 centers from Europe and America, organized by the International Endovenous Laser Working Group. Data concerning 1,020 limbs in patients with incompetence of the GSV and/or SSV, treated with the Endovenous Laser Ablation (EVLA) procedure, were collected. EVLA failures were defined on duplex imaging as reflux confined to the saphenofemoral or saphenopopliteal junction, reflux confined to the main saphenous trunk, or reflux of both junction and main trunk (totally patent saphenous vein) were analyzed at one or more years postoperatively. RESULTS: The mean age of patients was 54 ± 5 years (range: 18-91 years). The average body mass index was 25. There was a paucity of severe complications: One case of third-degree skin burn, six patients with postsurgical deep vein thrombosis (0.6%), and 27 cases of sensory nerve damage (2.7%). At 1-year, the rate of complete occlusion of the saphenous trunk was 93.1%. There were 79 cases of treatment failures as evidenced by duplex: 22 isolated junction failures (2.2%), 44 isolated trunk failures (4.4%), and 13 totally patent veins (1.3%). Two-year duplex results were reported for 329 limbs with the identification of 19 new cases of failure. No new cases of failure were reported at 3-year follow-up of 130 limbs. Cumulative failure rates estimated by Kaplan-Meier analysis were 7.7% at 1-year and 13.1% at 2- and 3-year follow-up. CONCLUSIONS: On the basis of a duplex scan performed at least 1-year post-treatment, this multicenter registry confirms the safety and efficacy of the EVLA procedure in the treatment of GSV and SSV reflux. Considering the continued failure rate documented in the present study, an annual follow-up by duplex is recommended to 2 years after EVLA.

Current status of endothermal heat induced thrombosis.

There remain many questions regarding the pathophysiology and risk factors for endothermal heat induced thrombosis formation. Moreover, there are a paucity of data on the timing of its occurrence, and there has been no consensus regarding for its treatment. The purpose of this review was to summarize the current knowledge on the pathophysiology, risk factors and treatment strategies for endothermal heat induced thrombosis. The PubMed database was searched from 2001 to present for endothermal heat induced thrombosis, EHIT, deep vein thrombosis, chronic venous insufficiency, varicose veins, endovenous laser and radiofrequency ablation (treatment). All relevant articles identified by the authors mentioning endothermal heat induced thrombosis were included in this review. A multitude of risk factors, several pathophysiological hypotheses and different treatment strategies are described in the literature. Endothermal heat induced thrombosis is marginally understood. There remains a theoretical risk for significant venous thromboembolic complications. With the new uniform classification of EHIT (American Venous Forum), healthcare providers should continue to investigate the nature of this event.

An algorithm combining VVSYmQ® and VCSS scores may help to predict disease severity in C2 patients.

OBJECTIVES: The purpose was to assess whether combining patient reported scores (VVSymQ®) and physician reported scores (VCSS) stratifies disease severity in C2 patients. METHODS: Consecutive patients were pooled from the VANISH-1 and VANISH-2 cohorts. VCSS and VVSymQ® were calculated for each patient. The relationship between scoring systems was evaluated using Pearson's correlation and frequency distribution analysis. RESULTS: Two-hundred and ten C2 limbs were included. Scoring systems demonstrated: VVSymQ®: mean = 8.72; VCSS: mean = 6.32; correlation (r = 0.22, p = 0.05). Frequency distribution analysis demonstrated 61.4% of patients had low VVSymQ® and low VCSS; 31.3% had elevated VVSymQ® and increased VCSS; 7.3% were inconsistent with C2 disease. Strict concordance analysis revealed 40.5% had VVSymQ® (< 9)/VCSS (0-6), 18.6% had VVSymQ® (≥ 9)/VCSS (7-9), and 2.9% had VVSymQ® (≥9)/VCSS (≥10). CONCLUSIONS: For combined elevated VVSymQ® and VCSS, moderate/severe disease is corroborated, and intervention may be indicated. For combined lower scores, the disease severity is mild and conservative therapy is more appropriate.

Outcomes after truncal ablation with or without concomitant phlebectomy for isolated symptomatic varicose veins (C2 disease).

OBJECTIVE: Many insurance payers are hesitating to cover interventional treatments in patients with isolated symptomatic varicose veins. In this study, we sought to determine the outcomes of patients with varicose veins who were treated with venous ablation alone or ablation plus phlebectomy using the Vascular Quality Initiative Varicose Vein Registry. METHODS: Using data from the Varicose Vein Registry between January 2015 and March 2019, we investigated immediate postoperative as well as long-term clinical and patient-reported outcomes among patients with documented symptomatic C2 disease undergoing truncal endovenous ablations alone and combined ablation and phlebectomy. Preprocedural and postprocedural comparisons were performed using t-test, χ2 test, or nonparametric tests when appropriate. Multivariable ordinal logistic regression was performed on ordinal outcome variables. RESULTS: Among 3375 patients with symptomatic C2 disease, 40.1% of patients (1376) underwent isolated truncal ablation and 59.9% (1999) underwent ablation and phlebectomy. Complications overall were low (8.6%) and varied between 8.4% and 8.7% in patients undergoing ablation alone and ablation plus phlebectomy, respectively (P = .820). The most common complication noted was paresthesia, 3.4% overall, which occurred more commonly after ablation and phlebectomy (4.5%) than after ablation alone (1.3%; P < .001). An improvement in Venous Clinical Severity Score (VCSS) was experienced by 87.4% of patients; median change in VCSS was 4 points (interquartile range [IQR], 2-5 points), with an improvement of 3 points among patients undergoing ablation alone (IQR, 1-5 points) and 5 points among patients undergoing ablation and phlebectomy (IQR, 3-5 points; P < .001). An improvement in overall symptoms was experienced by 94.4% of patients (median improvement, 11 points; (maximum, 30 points), with more significant decreases among patients undergoing ablation and phlebectomy (median, 12 points; IQR, 8-17 points) compared with ablation alone (median, 9 points; IQR, 5-13 points; P < .001). CONCLUSIONS: Among patients with isolated symptomatic varicose veins (C2 disease), ablation and ablation with phlebectomy are safe and effective in improving both patient-reported outcomes and clinical severity (VCSS). Given these data, payers should continue to cover these treatments.

Body dysmorphic disorder in patients with telangiectasias.

BACKGROUND: Chronic venous disease (CVD) patients can present with a spectrum of clinical manifestations ranging from severe ulcerations, thrombosis, and varicose vein hemorrhage to milder ones such as telangiectasias. Some CVD patients have a minimal degree of telangiectasias that are almost invisible to the physician. In spite of successful treatment of these telangiectasias, there are patients that might insist on continuing treatment, focusing excessive attention on what they perceive to be persistent telangiectasias that, in their opinion, must be removed. In these cases, one might be facing a possible body dysmorphic disorder (BDD) diagnosis. METHODS: This is a multicentric study performed in 223 patients with telangiectasias (C1s) seeking treatment; the Body Dysmorphic Disorder Questionnaire (BDDQ) was answered in private by all the patients. Furthermore, each questionnaire was evaluated in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for BDD. RESULTS: From a consecutive sample of 223 patients, 38 patients had criteria for BDD according to the DSM-V; indicating that the prevalence of BDD in patients with telangiectasias is 17%. CONCLUSIONS: Telangiectasias can be a stress trigger that changes the way patients perceive their own appearance. BDD patients tend to focus their attention excessively upon these types of veins and demand unnecessary treatment for minimal telangiectasias in order to diminish their discomfort with their physical appearance. Body dysmorphic disorder occurs in patients with limbs with C1s disease in considerable proportion and, upon evaluation, these patients should be referred to a psychiatrist. The initiation of any treatment for telangiectasias prior to the psychiatric assessment should be avoided.

Classification and treatment of endothermal heat-induced thrombosis: Recommendations from the American Venous Forum and the Society for Vascular Surgery.

The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The guidelines serve to compile the body of literature on EHIT and to put forth evidence-based recommendations. The guidelines are divided into the following categories: classification of EHIT, risk factors and prevention, and treatment of EHIT. One major feature is to standardize the reporting under one classification system. The Kabnick and Lawrence classification systems are now combined into the AVF EHIT classification system. The novel classification system affords standardization in reporting but also allows continued combined evaluation with the current body of literature. Recommendations codify the use of duplex ultrasound for the diagnosis of EHIT. Risk factor assessments and methods of prevention including mechanical prophylaxis, chemical prophylaxis, and ablation distance are discussed. Treatment guidelines are tailored to the AVF EHIT class (ie, I, II, III, IV). Reference is made to the use of surveillance, antiplatelet therapy, and anticoagulants as deemed indicated, and the recommendations incorporate the use of the novel direct oral anticoagulants. Last, EHIT management as it relates to the great and small saphenous veins is discussed.

Classification and treatment of endothermal heat-induced thrombosis: Recommendations from the American Venous Forum and the Society for Vascular Surgery This Practice Guidelines document has been co-published in Phlebology [DOI: 10.1177/0268355520953759] and Journal of Vascular Surgery: Venous and Lymphatic Disorders [DOI: 10.1016/j.jvsv.2020.06.008]. The publications are identical except for minor stylistic and spelling differences in keeping with each journal's style. The contribution has been published under a Attribution-Non Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0), (https://creativecommons.org/licenses/by-nc-nd/4.0/).

The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The guidelines serve to compile the body of literature on EHIT and to put forth evidence-based recommendations. The guidelines are divided into the following categories: classification of EHIT, risk factors and prevention, and treatment of EHIT.One major feature is to standardize the reporting under one classification system. The Kabnick and Lawrence classification systems are now combined into the AVF EHIT classification system. The novel classification system affords standardization in reporting but also allows continued combined evaluation with the current body of literature. Recommendations codify the use of duplex ultrasound for the diagnosis of EHIT. Risk factor assessments and methods of prevention including mechanical prophylaxis, chemical prophylaxis, and ablation distance are discussed.Treatment guidelines are tailored to the AVF EHIT class (ie, I, II, III, IV). Reference is made to the use of surveillance, antiplatelet therapy, and anticoagulants as deemed indicated, and the recommendations incorporate the use of the novel direct oral anticoagulants. Last, EHIT management as it relates to the great and small saphenous veins is discussed.

Endovenous laser ablation: A comprehensive review.

OBJECTIVE: To provide an evidence-based overview of endovenous laser ablation and describe its role as an effective and durable technique for the management of superficial venous insufficiency. METHODS: The published literature on the treatment of varicose veins using endovenous laser ablation was reviewed. The literature search focused on the history of endovenous laser ablation, its safety and durability, known complications, and differences in outcomes based on the iterations of fiber type and laser wavelength. RESULTS: Treatment safety and efficacy of endovenous laser ablation appear to be based on the amount of energy administered over a defined distance, or the linear endovenous energy density. The ideal linear endovenous energy density varies with the laser wavelength and fiber-type. Post-operative pain and bruising may be reduced by the use of higher wavelength fibers or the use of radial or jacket-tip fibers as compared to bare-tip fibers. The incidence of endothermal heat-induced thrombosis remains low and has declined with increasing experience. Reports have demonstrated a greater than 90% technical success rate with saphenous endovenous laser ablation, long-term durability of ablation, and commensurate improvement in quality of life. CONCLUSIONS: Endovenous laser ablation is a safe and durable treatment option for the management of incompetent superficial and perforator veins of the lower extremities. As an endothermal technology, it remains a key component of the standard of care for the treatment of chronic venous insufficiency.

A prospective safety and effectiveness study using endovenous laser ablation with a 400-µm optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial).

BACKGROUND: Treatment of pathologic perforator veins (PPVs) can shorten time to healing and reduce recurrence of ulcers in patients with advanced venous disease. Because of limited clinical evidence and device options, widespread adoption of PPV treatment is controversial. The objective of this study was to evaluate the safety and efficacy of endovenous laser therapy using a 400-µm optical fiber to treat PPVs. METHODS: This study was a single-arm, prospective, seven-center, nonblinded clinical study examining patients with advanced skin changes or healed or active ulceration (Clinical, Etiology, Anatomy, and Pathophysiology clinical class C4b, C5, and C6). Patients received treatment with a 1470-nm laser. Procedural technical success and 10-day primary closure were evaluated. All device-related adverse events were reported. Follow-up of patients was continued for 12 months after initial ablation. RESULTS: The primary PPV closure (at 10-day visit) rate was 76.9% (95% confidence interval, 70.3%-82.4%). Successful primary closure rates of 75.7%, 70.3%, 62.1%, 68.8%, and 71.3% of PPVs were achieved at 1 month, 3 months, 6 months, 9 months, and 12 months, respectively. Statistically significant improvements (P < .05) were seen in patients' quality of life at 1 month, 3 months, 6 months, 9 months, and 12 months compared with screening. The percentage of patients with ulcers (22.9% at screening, 14.1% at 1 month, 13.7% at 3 months, 10.1% at 6 months, 12.3% at 9 months, and 11.1% at 12 months) displayed improvement during the course of the study. Tibial deep venous thrombosis and procedural pain were the only device-related adverse events observed. CONCLUSIONS: Endovenous laser therapy for PPV using the 400-µm optical fiber with the 1470-nm laser yielded safe and effective outcomes with no major adverse sequelae.

Clinical response to combination therapy in the treatment of varicose veins.

BACKGROUND: Varicose vein ablation procedures are being performed with increasing frequency; however, there is a lack of consensus on the relative efficacy of combined treatment of saphenous incompetence and symptomatic varicosities vs a staged approach. In this study, we examined the impact on symptom severity when a procedure to eliminate varicosities was added to standard endovenous saphenous ablation. METHODS: The Varicose Vein Module of the American Venous Registry was established by the American Venous Forum in 2010 and collected data from 48 physicians during a 5-year period. We analyzed patients with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) C2 disease severity and without prior treatment. Combination therapy (CT) was defined as the use of a procedure directly addressing visible varicosities (stab phlebectomy or injection of sclerosant into varicosity) combined with endovenous saphenous vein ablation. Unimodal therapy (UT) was defined as endovenous saphenous vein ablation alone (radiofrequency or laser). Change in symptom severity was assessed by the pretreatment and 1-month follow-up Venous Clinical Severity Score (VCSS). Univariate statistics compared the CT and UT groups, with P values obtained using the Student t-test or Pearson χ2 test as appropriate. A multivariable linear regression model assessed the association of CT with the change in VCSS. RESULTS: There were 526 patients included for analysis (UT, 97; CT, 429). UT patients were more likely to be white (85.6% vs 62.7%; P < .001), had a higher initial VCSS (6.71 vs 5.07; P < .001), and were assessed at an earlier follow-up visit (28.9 days postoperatively vs 33.3 days; P < .001). Compared with UT, CT was associated with an additional half-point reduction in VCSS on univariate analysis (-3.71 points for UT vs -4.20 for CT; P = .13). After treatment, CT was associated with significantly lower scores on the pain and varicose vein components of the VCSS (pain: 0.31 for UT vs 0.07 for CT [P = .0008]; varicose veins: 0.47 for UT vs 0.03 for CT [P < .001]). On the multivariable model, after adjustment for white race, day of follow-up, age group, and initial VCSS, CT was associated with an additional reduction in VCSS of 1.52 points compared with UT (P = .002). CONCLUSIONS: Invasive treatment of C2 chronic venous insufficiency improves symptom severity. Whereas treatment of venous reflux is essential to address venous symptoms, our results suggest that patients further benefit from additional direct treatment of varicosities. For selected patients, CT may present a more effective treatment strategy than saphenous ablation alone.

In Well-Selected Patients With a Femoral Deep Vein Thrombosis Central Venous Imaging May Identify Additional Iliocaval Disease.

OBJECTIVE: Patients who present acutely with a femoral deep vein thrombosis (DVT) diagnosed by ultrasound are often treated with anticoagulation and instructed to follow-up electively. This study sought to assess whether obtaining axial imaging of the central venous system results in the identification of additional iliocaval pathology warranting treatment. METHODS: This study was a retrospective review of a prospectively maintained registry from November 2014 through April 2017 with follow-up through March 2020. Consecutive patients with a diagnosis of femoral DVT diagnosed by ultrasound were evaluated; those who underwent axial imaging of the iliocaval system (Group A) were compared to those who did not undergo imaging of the central veins (Group B). The primary outcome was the performance of any percutaneous central venous intervention. Secondary outcomes included the extent of DVT identified on duplex and after axial imaging, follow-up duplex patency and persistence of severe symptoms. RESULTS: Eighty patients presented with an ultrasound diagnosis of a femoral vein DVT. Mean follow-up was 551 ± 502 days. Group A comprised 24 patients (30%) and Group B comprised 56 patients (70%). Baseline demographics did not differ significantly between the 2 groups. After duplex imaging, Group A exhibited an increased prevalence of DVT in the common femoral vein. After central imaging, Group A exhibited an increased prevalence of DVT in the iliocaval veins. The number of patients who underwent invasive treatment differed significantly between the 2 groups, Group A 16/24 (67%) vs. Group B 9/56 (16%), P < 0.0001. The number of patients that demonstrated duplex patency and had persistent symptoms on follow-up did not differ significantly. CONCLUSIONS: Patients with an ultrasound diagnosis of femoral DVT may have additional iliocaval pathology warranting intervention. Well-selected imaging of the central veins may reveal a more complete picture, potentially altering management.

Radiofrequency and laser vein ablation for patients receiving warfarin anticoagulation is safe, effective, and durable.

OBJECTIVE: The objective of this study was to evaluate the efficacy, durability, and safety of radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) of the great saphenous vein (GSV) and small saphenous vein (SSV) to treat symptomatic venous reflux in patients receiving therapeutic anticoagulation. METHODS: Patients treated at a single institution with RFA or EVLA while receiving warfarin (Coumadin) anticoagulation were identified retrospectively along with a consecutive sample of patients not receiving anticoagulation who were similarly treated. Patients' demographics, comorbidities, procedural details, and follow-up data were obtained from electronic medical records. Outcomes of interest included the rates of persistent vein ablation, bleeding, deep venous thrombosis (DVT), and endothermal heat-induced thrombosis. Groups were compared using χ2 tests, Fisher exact test, Kaplan-Meier curves, and Cox proportional hazard modeling. RESULTS: There were 100 procedures performed in 65 patients receiving anticoagulation and 127 procedures in 89 control patients. Mean follow-up time was 467 days. The most common indications for anticoagulation were atrial fibrillation (52%), remote DVT (29%), and mechanical heart valves (8%). Patients receiving anticoagulation were on average older (67 years vs 52 years), were more likely to be male (51% vs 27%), and had higher rates of coronary disease (9% vs 0%) and hypertension (55% vs 20%), although they were more likely to have never smoked (86% vs 69%). There were 127 RFA procedures (56%) and 100 EVLA procedures (44%); 189 procedures treated the GSV or its tributaries (83%), and 38 treated the SSV (17%). At 1 year, the target vessel remained ablated after 96% of procedures performed with anticoagulation and in 99% of controls; at 18 months, rates were 92% vs 95% (P = .96). Rates of persistent ablation did not differ significantly by vessel treated (P = .28), EVLA vs RFA (P = .36), or use of antiplatelet therapy (P = .92). One patient had bleeding from a phlebectomy site 2 days postprocedurally when supratherapeutic on warfarin; this was controlled with pressure. DVT in the ipsilateral leg occurred within 90 days after 1 of 100 (1%) procedures in patients receiving anticoagulation and 2 of 127 (1.6%) procedures in control patients; endothermal heat-induced thrombosis rates were similarly 1 of 100 (1%) procedures in patients receiving anticoagulation and 1 of 127 (0.8%) in control patients. CONCLUSIONS: This is the largest series to date reporting >30-day follow-up for patients undergoing venous ablation procedures while receiving anticoagulation and the longest follow-up reported of any series. Durability, safety, and efficacy of vein ablation in patients receiving anticoagulation are comparable to those in control patients. Anticoagulation should not be considered a contraindication to endothermal ablation of the GSV or SSV for symptomatic venous reflux.

Treatment of superficial and perforator reflux and deep venous stenosis improves healing of chronic venous leg ulcers.

OBJECTIVE: To evaluate the impact of three treatment modalities, superficial truncal vein ablation, perforator vein ablation, and deep venous stenting on venous leg ulcer (VLU) healing, as well as their cumulative effect on ulcer healing, in an attempt to establish the best algorithm for the treatment of chronic and recalcitrant VLUs. METHODS: Multicenter retrospective cohort study using a standardized database to evaluate patients with chronic venous ulcers treated between January 2013 and December 2017. RESULTS: Eight-hundred thirty-two consecutive patients with VLU were identified at 11 centers in the United States. All patients were initially managed with wound care and compression for at least 2 months. Compression and wound care management alone, used in 187 patients, led to ulcer healing in 75% of patients by 36 months. Ulcer recurrence in patients managed without surgery at 6, 12, and 24 months was 3%, 5% and 15%, respectively. Five hundred twenty-eight patients underwent ablation of incompetent superficial veins, and 344 of those also underwent incompetent perforator ablation. Patients who underwent truncal vein ablation alone had an ulcer healing rate of 51% at 36 months. Patients who received both superficial and perforator ablation were significantly younger, and had a 17% improvement in healing at 36 months (68% vs 51%, respectively), but there was no impact of combined superficial and perforator ablations on ulcer recurrence rates. One hundred thirty-four patients had stenosis of one of more lower extremity deep veins and 95 (71%) underwent endovenous stenting. Ulcer healing and recurrence rates for those who underwent stent placement alone was 77% and 27%, respectively, at 36 months. Patients who underwent deep venous stenting and ablation of both incompetent truncal and perforator veins had an ulcer healing rate of 87% at 36 months and ulcer recurrence of 26% at 24 months. CONCLUSIONS: This study demonstrates that correction of superficial truncal vein reflux, as well as deep vein stenosis, both contribute to healing of VLU. Patients who fail to heal their VLU after superficial and perforator ablation should have the iliocaval system imaged to identify hemodynamically significant stenoses or occlusions amenable to stenting, which facilitates venous ulcer healing even in patients with large ulcers.