Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023.

BACKGROUND: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events. OBJECTIVES: To categorise contraindications to sclerotherapy based on the available scientific evidence. METHODS: An international, multi-disciplinary panel of phlebologists reviewed the available scientific evidence and developed consensus where evidence was lacking or limited. RESULTS: Absolute Contraindications to sclerotherapy where the risk of harm would outweigh any benefits include known hypersensitivity to sclerosing agents; acute venous thromboembolism (VTE); severe neurological or cardiac adverse events complicating a previous sclerotherapy treatment; severe acute systemic illness or infection; and critical limb ischaemia. Relative Contraindications to sclerotherapy where the potential benefits of the proposed treatment would outweigh the risk of harm or the risks may be mitigated by other measures include pregnancy, postpartum and breastfeeding; hypercoagulable states with risk of VTE; risk of neurological adverse events; risk of cardiac adverse events and poorly controlled chronic systemic illness. Conditions and circumstances where Warnings and Precautions should be considered before proceeding with sclerotherapy include risk of cutaneous necrosis or cosmetic complications such as pigmentation and telangiectatic matting; intake of medications such as the oral contraceptive and other exogenous oestrogens, disulfiram and minocycline; and psychosocial factors and psychiatric comorbidities that may increase the risk of adverse events or compromise optimal treatment outcomes. CONCLUSIONS: Sclerotherapy can achieve safe clinical outcomes provided that (1) patient-related risk factors and in particular all material risks are (1a) adequately identified and the risk benefit ratio is clearly and openly discussed with treatment candidates within a reasonable timeframe prior to the actual procedure; (1b) when an individual is not a suitable candidate for the proposed intervention, conservative treatment options including the option of 'no intervention as a treatment option' are discussed; (1c) complex cases are referred for treatment in controlled and standardised settings and by practitioners with more expertise in the field; (1d) only suitable individuals with no absolute contraindications or those with relative contraindications where the benefits outweigh the risks are offered intervention; (1e) if proceeding with intervention, appropriate prophylactic measures and other risk-mitigating strategies are adopted and appropriate follow-up is organised; and (2) procedure-related risk factors are minimised by ensuring the treating physicians (2a) have adequate training in general phlebology with additional training in duplex ultrasound, procedural phlebology and in particular sclerotherapy; (2b) maintain their knowledge and competency over time and (2c) review and optimise their treatment strategies and techniques on a regular basis to keep up with the ongoing progress in medical technology and contemporary scientific evidence.

Rationale and current evidence of aquatic exercise therapy in venous disease: A narrative review.

Chronic venous disorders (CVD) of the lower limbs can be treated with different strategies. Typically, conservative management is based on compression therapy, anticoagulants and venoactive drugs. Endovenous treatments remain the gold standard to treat saphenous insufficiency, with sclerotherapy and surgery maintaining a role in selected cases. In addition, several 'unconventional' approaches have been proposed to prevent CVD progression and complications, minimize symptoms and improve the quality of life and postoperative outcomes. Among these, balneotherapy and aquatic exercises are proving as valid and effective supporting treatments, as mentioned in a growing number of scientific publications. Moreover, aquatic protocols have been studied for both venous and lymphatic insufficiency. For these reasons, they were mentioned in the last CVD guidelines provided by the European Society for Vascular Surgery. The aim of this narrative review is to overview and summarize current literature evidences on the role and effectiveness of aquatic rehabilitative protocols in CVD, reviewing old and current literature. Furthermore, the physical basis of the effects of water immersion on lower limb venous and tissues modifications are also described.

Triage of patients with venous and lymphatic diseases during the COVID-19 pandemic - The Venous and Lymphatic Triage and Acuity Scale (VELTAS) : A consensus document of the International Union of Phlebology (UIP), Australasian College of Phlebology (ACP), American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), European College of Phlebology (ECoP), European Venous Forum (EVF), Interventional Radiology Society of Australasia (IRSA), Latin American Venous Forum, Pan-American Society of Phlebology and Lymphology and the Venous Association of India (VAI) This consensus document has been co-published in Phlebology [DOI: 10.1177/0268355520930884] and Journal of Vascular Surgery: Venous and Lymphatic Disorders [DOI: 10.1016/j.jvsv.2020.05.002]. 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 coronavirus disease 2019 (COVID-19) global pandemic has resulted in diversion of healthcare resources to the management of patients infected with SARS-CoV-2 virus. Elective interventions and surgical procedures in most countries have been postponed and operating room resources have been diverted to manage the pandemic. The Venous and Lymphatic Triage and Acuity Scale was developed to provide an international standard to rationalise and harmonise the management of patients with venous and lymphatic disorders or vascular anomalies. Triage urgency was determined based on clinical assessment of urgency with which a patient would require medical treatment or surgical intervention. Clinical conditions were classified into six categories of: (1) venous thromboembolism (VTE), (2) chronic venous disease, (3) vascular anomalies, (4) venous trauma, (5) venous compression and (6) lymphatic disease. Triage urgency was categorised into four groups and individual conditions were allocated to each class of triage. These included (1) medical emergencies (requiring immediate attendance), example massive pulmonary embolism; (2) urgent (to be seen as soon as possible), example deep vein thrombosis; (3) semi-urgent (to be attended to within 30-90 days), example highly symptomatic chronic venous disease, and (4) discretionary/non-urgent- (to be seen within 6-12 months), example chronic lymphoedema. Venous and Lymphatic Triage and Acuity Scale aims to standardise the triage of patients with venous and lymphatic disease or vascular anomalies by providing an international consensus-based classification of clinical categories and triage urgency. The scale may be used during pandemics such as the current COVID-19 crisis but may also be used as a general framework to classify urgency of the listed conditions.

Triage of patients with venous and lymphatic diseases during the COVID-19 pandemic - The Venous and Lymphatic Triage and Acuity Scale (VELTAS):: A consensus document of the International Union of Phlebology (UIP), Australasian College of Phlebology (ACP), American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), European College of Phlebology (ECoP), European Venous Forum (EVF), Interventional Radiology Society of Australasia (IRSA), Latin American Venous Forum, Pan-American Society of Phlebology and Lymphology and the Venous Association of India (VAI).

The coronavirus disease 2019 (COVID-19) global pandemic has resulted in diversion of healthcare resources to the management of patients infected with SARS-CoV-2 virus. Elective interventions and surgical procedures in most countries have been postponed and operating room resources have been diverted to manage the pandemic. The Venous and Lymphatic Triage and Acuity Scale was developed to provide an international standard to rationalise and harmonise the management of patients with venous and lymphatic disorders or vascular anomalies. Triage urgency was determined based on clinical assessment of urgency with which a patient would require medical treatment or surgical intervention. Clinical conditions were classified into six categories of: (1) venous thromboembolism (VTE), (2) chronic venous disease, (3) vascular anomalies, (4) venous trauma, (5) venous compression and (6) lymphatic disease. Triage urgency was categorised into four groups and individual conditions were allocated to each class of triage. These included (1) medical emergencies (requiring immediate attendance), example massive pulmonary embolism; (2) urgent (to be seen as soon as possible), example deep vein thrombosis; (3) semiurgent (to be attended to within 30-90 days), example highly symptomatic chronic venous disease, and (4) discretionary/nonurgent- (to be seen within 6-12 months), example chronic lymphoedema. Venous and Lymphatic Triage and Acuity Scale aims to standardise the triage of patients with venous and lymphatic disease or vascular anomalies by providing an international consensus-based classification of clinical categories and triage urgency. The scale may be used during pandemics such as the current COVID-19 crisis but may also be used as a general framework to classify urgency of the listed conditions.

Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.

OBJECTIVE: The proprietary cyanoacrylate closure (CAC) system vs radiofrequency ablation (RFA) trial (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) showed that CAC, a nontumescent, nonthermal, nonsclerosant ablation technique, was effective and noninferior to RFA in vein closure with good 36-month outcomes. Conducted under a separate protocol, the aim of this extended follow-up was to assess the long-term safety and effectiveness of CAC and RFA for the treatment of incompetent great saphenous veins (GSV) at 5 years (60 months) of follow-up. METHODS: This 60-month extension study was conducted for all patients who completed the randomized VeClose study and who were willing to participate. The pivotal VeClose study included patients with symptomatic moderate to severe varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] class C2-C4b) and symptomatic GSV incompetence who were randomly assigned (1:1) to either CAC or RFA. The primary outcome measure of this 60-month extension study was complete closure of the target vein, with planned exploratory analysis of noninferiority. 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; adverse events (AEs) related to target GSV; and details of adjunctive procedures. RESULTS: A total of 89 patients completed the 60-month visit, which included 47 from the CAC group, 33 from the RFA group, and 9 CAC roll-in patients. No new recanalization events have been observed in the groups between 36 and 60 months of follow-up. At 60 months, Kaplan-Meier estimates for freedom from recanalization in the randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating noninferiority of CAC compared with RFA. Both groups demonstrated sustained improvements in EuroQol-Five Dimension and quality of life measures through 60 months. Whereas patients assigned to C0 or C1 clinical class were excluded from the original study, more than half of all returning patients (64% [57/89]) were now assigned to C0 or C1, suggesting an improved clinical class from baseline. Furthermore, 41.1% of returning CAC patients and 39.4% of returning RFA patients are presently at least two CEAP clinical classes lower than at baseline. No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up. CONCLUSIONS: CAC and RFA were effective in achieving complete target vein closure of the GSV at long-term follow-up, with CAC demonstrating continued noninferiority to RFA. CAC was also associated with sustained improvements in symptoms and quality of life, lower CEAP class, and high level of patient satisfaction without serious AEs between 36 and 60 months.

Risks and contraindications of medical compression treatment - A critical reappraisal. An international consensus statement.

OBJECTIVES: Medical compression therapy is used for non-invasive treatment of venous and lymphatic diseases. Medical compression therapy-associated adverse events and contraindications have been reported, although some contraindications are theoretically based. This consensus statement provides recommendations on medical compression therapy risks and contraindications. METHODS: A systematic literature search of medical compression therapy publications reporting adverse events up until November 2017 was performed. A consensus panel comprising 15 international experts critically reviewed the publications and formulated the recommendations. RESULTS: Sixty-two publications reporting medical compression therapy adverse events were identified. The consensus panel issued 21 recommendations on medical compression therapy contraindications and adverse event risk mitigation, in addition to reviewing medical compression therapy use in borderline indications. The most frequently reported non-severe medical compression therapy-associated adverse events included skin irritation, discomfort and pain. Very rare but severe adverse events, including soft tissue and nerve injury, were also identified. CONCLUSION: This consensus statement summarises published medical compression therapy-associated adverse events and contraindications, and provides guidance on medical compression therapy. Severe medical compression therapy-associated adverse events are very rarely encountered if compression is used correctly and contraindications are considered.

Improper Potency and Impurities in Compounded Polidocanol

Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against compounding drugs that are essentially copies of FDA-approved or commercially available products, polidocanol is also available from compounding pharmacies and outsourcing facilites. Compounded drug products are not FDA-approved and have not undergone premarket FDA review for safety, effectiveness, and quality. Seven samples of polidocanol were obtained from three compounding pharmacies and analyzed using high pressure liquid chromatography. None of the samples contained the labeled concentration of polidocanol and five contained excessive levels of impurities. Since the potency and purity of compounded polidocanol injection cannot be assured, physicians who use these products should consider FDA-approved products to ensure optimal safety and efficacy. J Drugs Dermatol. 2019;18(11):1124-1127.

Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.

OBJECTIVE: We previously reported 3-month and 12-month occlusion rates after treatment of clinically symptomatic saphenous vein reflux with either cyanoacrylate closure (CAC) using the VenaSeal Closure System (Medtronic, Dublin, Ireland) or radiofrequency ablation (RFA) in a randomized, multicenter, clinical trial, VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). Herein we report the 24-month follow-up results of the VeClose trial. METHODS: There were 222 patients with symptomatic great saphenous vein (GSV) incompetence who were randomly assigned to receive either CAC (n = 108) or RFA (n = 114). Patients were not allowed to receive adjunctive treatment of tributary varicosities until after the 3-month visit. Duplex ultrasound of the target vein was performed at day 3 and months 1, 3, 6, 12, and 24 after treatment, and closure was assessed by ultrasound by the treating physician. Overall 24-month success rates were compared; in addition, time to first reopening of the target vein was evaluated using survival analysis. End points such as Venous Clinical Severity Score, EuroQoL-5 Dimension, and Aberdeen Varicose Vein Questionnaire were evaluated. RESULTS: Of 222 randomized patients, 171 completed the 24-month follow-up, which included 87 from the CAC group and 84 from the RFA group. The 24-month complete closure rate was 95.3% in the CAC group and 94.0% in the RFA group, demonstrating continued noninferiority of CAC compared with RFA (P = .0034). Symptoms and quality of life improved similarly in both groups. No clinically significant device- or procedure-related late adverse events occurred. CONCLUSIONS: Both CAC and RFA were effective in closure of the target GSV, resulting in similar and significant improvements in the patient's quality of life through 24 months. These results suggest that CAC of the GSV is safe and durable out to 2 years.

Rehabilitation of patients with venous diseases of the lower limbs: State of the art.

BACKGROUND: To date, no document comprehensively focused on the complex issue of the rehabilitation of chronic venous diseases of the lower limbs. METHOD: This article overviews and summarizes current strategies concerning venous rehabilitation of lower limbs. RESULTS: Venous rehabilitation is based on four main strategies: (1) lifestyle adaptations and occupational therapies; (2) physical therapies; (3) adapted physical activities; (4) psychological and social support. Rehabilitative protocols must be tailored to the specific needs of each patient, depending on the severity of chronic venous disease and on the location and pattern of venous lesion(s), but also on age, motor deficits, co-morbidities and psychosocial conditions. CONCLUSIONS: Venous rehabilitation consists of non-pharmacologic and non-surgical interventions aiming at prevention of venous disease progression and complications, reduction of symptoms and improvement of quality of life. Well-designed clinical trials are required to evaluate the efficacy of the described rehabilitative protocols in influencing the evolution of venous disorders.

VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins.

OBJECTIVE: Endovenous cyanoacrylate closure (CAC) is a new U.S. Food and Drug Administration-approved therapy for treatment of clinically symptomatic venous reflux in saphenous veins. The device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV). Early results from a randomized trial of CAC have been reported previously. Herein we report 1-year outcomes. METHODS: There were 222 subjects with symptomatic GSV incompetence randomly assigned to receive either CAC (n = 108) or radiofrequency ablation (RFA; n = 114). After the month 3 visit, subjects could receive adjunctive therapies aimed at treating visible varicosities and incompetent tributaries. Vein closure was assessed at day 3 and months 1, 3, 6, and 12 using duplex ultrasound. Additional study visit assessments included the Venous Clinical Severity Score; Clinical, Etiology, Anatomy, and Pathophysiology classification; EuroQol-5 Dimension; and Aberdeen Varicose Vein Questionnaire. Both time to closure and time to first reopening of the target vein were evaluated using survival curve analysis. Adverse events were evaluated at each visit. RESULTS: Of 222 enrolled and randomized subjects, a 12-month follow-up was obtained for 192 (95 CAC and 97 RFA; total follow-up rate, 192/222 [86.5%]). By month 1, 100% of CAC subjects and 87% of RFA subjects demonstrated complete occlusion of the target vein. By 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). Twelve-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 = .08). Symptoms and quality of life improved equally in both groups. Most adverse events were mild to moderate and not related to the device or procedure. CONCLUSIONS: In patients with incompetent GSVs, treatment with both CAC and RFA results in high occlusion rates. Time to complete occlusion was faster with CAC, and freedom from reopening was higher after CAC. Quality of life scores improved equally with both therapies.

Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins.

OBJECTIVE: Cyanoacrylate closure (CAC) was shown in the recently published VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) randomized clinical study to be an effective and noninferior option (in terms of both safety and effectiveness) to radiofrequency ablation (RFA) in the treatment of incompetent great saphenous veins. The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups. METHODS: The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician's familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study's primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events. RESULTS: Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P < .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%. Reported intraprocedural pain ratings were similar between the roll-in and randomized groups. Other clinical assessments, including quality of life improvement and adverse events, were similar between the roll-in and randomized groups. Increasing procedure number did not affect clinical outcomes. CONCLUSIONS: The results from the VeClose study roll-in group demonstrate that despite the physician's lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period.

Venous hemodynamic changes in lower limb venous disease: the UIP consensus according to scientific evidence.

There are excellent guidelines for clinicians to manage venous diseases but few reviews to assess their hemodynamic background. Hemodynamic concepts that evolved in the past have largely remained unchallenged in recent decades, perhaps due to their often complicated nature and in part due to emergence of new diagnostic techniques. Duplex ultrasound scanning and other imaging techniques which evolved in the latter part of the 20th century have dominated investigation. They have greatly improved our understanding of the anatomical patterns of venous reflux and obstruction. However, they do not provide the physiological basis for understanding the hemodynamics of flow, pressure, compliance and resistance. Hemodynamic investigations appear to provide a better correlation with post-treatment clinical outcome and quality of life than ultrasound findings. There is a far better prospect for understanding the complete picture of the patient's disability and response to management by combining ultrasound with hemodynamic studies. Accordingly, at the instigation of Dr Angelo Scuderi, the Union Internationale de Phlebologie (UIP) executive board commissioned a large number of experts to assess all aspects of management for venous disease by evidence-based principles. These included experts from various member societies including the European Venous Forum (EVF), American Venous Forum (AVF), American College of Phlebology (ACP) and Cardiovascular Disease Educational and Research Trust (CDERT). Their aim was to confirm or dispel long-held hemodynamic principles and to provide a comprehensive review of venous hemodynamic concepts underlying the pathophysiology of lower limb venous disorders, their usefulness for investigating patients and the relevant hemodynamic changes associated with various forms of treatment. Chapter 1 is devoted to basic hemodynamic concepts and normal venous physiology. Chapter 2 presents the mechanism and magnitude of hemodynamic changes in acute deep vein thrombosis indicating their pathophysiological and clinical significance. Chapter 3 describes the hemodynamic changes that occur in different classes of chronic venous disease and their relation to the anatomic extent of disease in the macrocirculation and microcirculation. The next four chapters (Chapters 4-7) describe the hemodynamic changes resulting from treatmen by compression using different materials, intermittent compression devices, pharmacological agents and finally surgical or endovenous ablation. Chapter 8 discusses the unique hemodynamic features associated with alternative treatment techniques used by the CHIVA and ASVAL. Chapter 9 describes the hemodynamic effects following treatment to relieve pelvic reflux and obstruction. Finally, Chapter 10 demonstrates that contrary to general belief there is a moderate to good correlation between certain hemodynamic measurements and clinical severity of chronic venous disease. The authors believe that this document will be a timely asset to both clinicians and researchers alike. It is directed towards surgeons and physicians who are anxious to incorporate the conclusions of research into their daily practice. It is also directed to postgraduate trainees, vascular technologists and bioengineers, particularly to help them understand the hemodynamic background to pathophysiology, investigations and treatment of patients with venous disorders. Hopefully it will be a platform for those who would like to embark on new research in the field of venous disease.

Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose).

BACKGROUND: Whereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs. METHODS: Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal Sapheon Closure System (Sapheon, Inc, Morrisville, NC) or RFA (n = 114) with the ClosureFast system (Covidien, Mansfield, Mass). After discharge, subjects returned to the clinic on day 3 and again at months 1 and 3. The study's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Statistical testing focused on showing noninferiority with a 10% delta conditionally followed by superiority testing. No adjunctive procedures were allowed until after the month 3 visit, and missing month 3 data were imputed by various methods. Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality of life surveys and adverse event rates. RESULTS: All subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study's noninferiority hypothesis (all P < .01); some of these analyses supported a trend toward superiority (P = .07 in the predictive model). Pain experienced during the procedure was mild and similar between treatment groups (2.2 and 2.4 for CAE and RFA, respectively, on a 10-point scale; P = .11). At day 3, less ecchymosis in the treated region was present after CAE compared with RFA (P < .01). Other adverse events occurred at a similar rate between groups and were generally mild and well tolerated. CONCLUSIONS: CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month 3 after the procedure. Both treatment methods showed good safety profiles. CAE does not require tumescent anesthesia and is associated with less postprocedure ecchymosis.

Guidelines of the First International Consensus Conference on Endovenous Thermal Ablation for Varicose Vein Disease--ETAV Consensus Meeting 2012.

AIM: Endovenous thermal ablation (ETA) procedures are catheter-directed, ultrasound (US)-guided thermal methods for treatment in varicose veins disease. Radiofrequency, laser or steam energy thermally denatures vein wall collagen, leading first to vein wall inflammation, then fibrosis and finally to occlusion. The aim of this guideline is to give evidence-based recommendations for ETA procedures. METHODS: These guidelines were drafted during a consensus meeting of a group of experts in the field of ETA in June 2012 (Hvar, Croatia) under the auspices of the International Union of Phlebology (IUP). These guidelines review the present state of knowledge as reflected in peer-reviewed published medical literature. The recommendations of these guidelines are graded according to the American College of Chest Physicians Task Force recommendations on Grading Strength of Recommendations and Quality of Evidence in Clinical Guidelines. RESULTS: Recommendations on the use of ETA procedures were made based on the quality of evidence for efficacy, safety, tolerability, cosmetic outcome, patient satisfaction/preference and, where appropriate, on the experts' opinion. Health economics were not considered, since differences in national health systems and pricing make it difficult to form general conclusions that are relevant at an international level.

Comparisons of side effects using air and carbon dioxide foam for endovenous chemical ablation.

OBJECTIVE: This clinical study evaluated prospectively adverse events immediately following ultrasound-guided foam sclerotherapy (UGFS) for the treatment of lower extremity venous valvular insufficiency. Incidence of side effects associated with carbon dioxide (CO(2)) foam was compared with a historical control using air-based foam. The literature on the subject was reviewed. METHODS: Vital signs were monitored during and immediately after UGFS, and adverse events were recorded for 24 hours following the procedure. The air-based foam group had 49 patients: 44 women and 5 men. The CO(2)-based foam group had 128 patients: 115 women and 13 men. CEAP class was C2EpAsPr, describing varicose veins, primary etiology, and saphenous reflux. UGFS followed thermal ablation of the great saphenous vein. Foam was prepared using the three-way tap technique to mix gas with 1% polidocanol in a 4:1 ratio. Segments of the great and small saphenous veins and their tributaries were treated with UGFS. Foam volumes injected were 27 +/- 10 (SD) (6-46 range) and 25 +/- 12 (6-57 range) mL for air- and CO(2)-based foams respectively (P = .39). Incidence of adverse events was compared by chi(2) statistics. Vital signs were compared by paired t test. RESULTS: During the procedure, the average heart rate decreased by less than 5 bpm for both groups (P < .001), and blood pressure decreased by less than 3 mm Hg in the CO(2) group (P < .02). Respiratory rate, electrocardiogram, and pulse oxymetry did not change significantly in both air- and CO(2)-foam series (P > .05). Visual disturbances were experienced by 3.1% (4/128) and 8.2% (4/49) patients in the CO(2) and air groups respectively (P = .15). Respiratory difficulties or circumoral paresthesia each occurred in 0.8% (n = 1) of the CO(2) patients. Incidence of chest tightness (3.1% vs 18%), dry cough (1.6% vs 16%), or dizziness (3.1% vs 12%) were significantly lower in the CO(2) vs air groups (P < .02). Nausea occurred in 2% and 4% of the CO(2) and air-based foam groups (P = .53). Overall, the proportion of patients describing side effects decreased from 39% (19/49) to 11% (14/128) as CO(2) replaced air for foam preparation (P < .001). Similar findings were described in the literature of air-based foam but data on the use of physiological gas were rare. CONCLUSIONS: Side effects decreased significantly if CO(2) rather than air was employed to make the sclerosing foam for chemical ablation of superficial veins of the lower extremity.

Primary chronic venous disorders.

Primary chronic venous disorders, which according to the CEAP classification are those not associated with an identifiable mechanism of venous dysfunction, are among the most common in Western populations. Varicose veins without skin changes are present in about 20% of the population while active ulcers may be present in as many as 0.5%. Primary venous disorders are thought to arise from intrinsic structural and biochemical abnormalities of the vein wall. Advanced cases may be associated with skin changes and ulceration arising from extravasation of macromolecules and red blood cells leading to endothelial cell activation, leukocyte diapedesis, and altered tissue remodeling with intense collagen deposition. Laboratory evaluation of patients with primary venous disorders includes venous duplex ultrasonography performed in the upright position, occasionally supplemented with plethysmography and, when deep venous reconstruction is contemplated, ascending and descending venography. Primary venous disease is most often associated with truncal saphenous insufficiency. Although historically treated with stripping of the saphenous vein and interruption and removal of major tributary and perforating veins, a variety of endovenous techniques are now available to ablate the saphenous veins and have generally been demonstrated to be safe and less morbid than traditional procedures. Sclerotherapy also has an important role in the management of telangiectasias; primary, residual, or recurrent varicosities without connection to incompetent venous trunks; and congenital venous malformations. The introduction of ultrasound guided foam sclerotherapy has broadened potential indications to include treatment of the main saphenous trunks, varicose tributaries, and perforating veins. Surgical repair of incompetent deep venous valves has been reported to be an effective procedure in nonrandomized series, but appropriate case selection is critical to successful outcomes.