Recalcitrant Venous Leg Ulcers May Heal by Outpatient Treatment of Venous Disease Even in the Presence of Concomitant Arterial Occlusive Disease.

OBJECTIVE/BACKGROUND: Peripheral arterial occlusive disease (PAOD) is reported in about 15-20% of patients with venous leg ulcers (VLU). In such cases arterial recanalization is often recommended, and compression therapy is considered a contraindication when the ankle brachial pressure index (ABPI) is < 0.8. The aim of this study was to compare the outcome of patients with recalcitrant VLU, both without any arterial impairment ("pure venous recalcitrant leg ulcer" [pvRLU]) and with associated PAOD ("mixed arterial and venous recalcitrant leg ulcer" [mavRLU]), by treating only the venous disease. METHODS: The records of 180 outpatients with recalcitrant ulcers treated between January 2011 and July 2014 were reviewed retrospectively. In total, 109 were affected by pvRLU and 71 by mavRLU, with moderate PAOD defined by an ABPI between 0.5 and 0.8. In addition to the same local wound dressing, the patients received ultrasound guided foam sclerotherapy of the refluxing superficial veins and a modified inelastic compression with a pressure ≤ 40 mmHg. No patient was referred for arterial revascularization. The patients were followed until ulcer healing. RESULTS: Patients with pvRLU and mavRLU showed comparable demographic characteristics. Twenty-five patients were lost to follow up and the outcomes were analyzed in 93 patients with pVLU (85.4%) and in 62 patients with mavRLU (87.4%). The maximum time to complete healing was 48 weeks in the pvRLU group and 52 weeks in the mavRLU group (p = .009), The median healing time was 23 (pvRLU) versus 25.5 weeks (mavRLU) (p = .030). Deep venous incompetence (p < .001), ulcer surface area (p < .001), arterial disease (p = .002), and ulcer duration (p < .010) were risk factors for prolonged healing. CONCLUSION: Treatment of recalcitrant leg ulcers by treating venous incompetence by foam sclerotherapy and modified compression is successful, even if underlying moderate PAOD is not actively treated.

Adjustable Velcro Compression Devices are More Effective than Inelastic Bandages in Reducing Venous Edema in the Initial Treatment Phase: A Randomized Controlled Trial.

OBJECTIVE/BACKGROUND: The objective of this study was to compare the efficacy and comfort of inelastic bandages (IBs) and adjustable Velcro compression devices (AVCDs) in reducing venous leg edema in the initial treatment phase. METHODS: Forty legs from 36 patients with untreated venous edema (C3EpsAsdPr) were randomized to two groups. Patients in the first group received IBs (n = 20) and those in the second AVCDs (n = 20). Both compression devices were left on the leg day and night, and were renewed after 1 day. Patients in the AVCD group were asked to re-adjust the device as needed when it felt loose. Leg volume was calculated using the truncated cone formula at baseline (T0), after 1 day (T1) and after 7 days (T7). The interface pressure of the two compression devices was measured by an air filled probe, and the static stiffness index calculated after applying compression at T0 and T1, and just before removal of compression on T1 and T7. Patient comfort with regard to the two compression systems was assessed by grading signs and symptoms using a visual analog scale. RESULTS: At T1, the median percent volume reduction was 13% for the IB group versus 19% for the AVCD group; at T7 it was 19% versus 26%, respectively (p < .001). The pressure of the IBs was significantly higher compared with the AVCDs at T0 (63 vs. 43 mmHg) but dropped by > 50% over time, while it remained unchanged with AVCDs owing to the periodic readjustment by the patient. Comfort was reported to be similar with the two compression devices. CONCLUSION: Re-adjustable AVCDs with a resting pressure of around 40 mmHg are more effective in reducing chronic venous edema than IBs with a resting pressure of around 60 mmHg. AVCDs are effective and well tolerated, not only during maintenance therapy, but also in the initial decongestive treatment phase of patients with venous leg edema.

European guidelines for sclerotherapy in chronic venous disorders.

AIM: Sclerotherapy is the targeted chemical ablation of varicose veins by intravenous injection of a liquid or foamed sclerosing drug. The treated veins may be intradermal, subcutaneous, and/or transfascial as well as superficial and deep in venous malformations. The aim of this guideline is to give evidence-based recommendations for liquid and foam sclerotherapy. METHODS: This guideline was drafted on behalf of 23 European Phlebological Societies during a Guideline Conference on 7-10 May 2012 in Mainz. The conference was organized by the German Society of Phlebology. These guidelines review the present state of knowledge as reflected in published medical literature. The regulatory situation of sclerosant drugs differs from country to country but this has not been considered in this document. The recommendations of this guideline 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: This guideline focuses on the two sclerosing drugs which are licensed in the majority of the European countries, polidocanol and sodium tetradecyl sulphate. Other sclerosants are not discussed in detail. The guideline gives recommendations concerning indications, contraindications, side-effects, concentrations, volumes, technique and efficacy of liquid and foam sclerotherapy of varicose veins and venous malformations.

Application of microcurrents of bioresonance and transdermal delivery of active principles in lymphedema and lipedema of the lower limbs: a pilot study.

AIM: Application of microcurrents of bioresonance may allow protein aggregates lysis and a related enhancement of lymphatic drainage. Combining bioresonance with transcutaneous passage of active principles, by means of skin electroporation, microcirculation and clearance of connective tissues may be theoretically activated. A pilot study on an electro-medical device which includes these two technologies (Transponder(®)), has been performed on patients affected by lymphedema (LYM) and/or lipedema (LIP) of the lower limbs. METHODS: Eight patients affected by primary or secondary unilateral LYM or LIP were submitted to six consecutive daily sessions with the medical device; the first two sessions were performed by a trained physiotherapist, whilst the following four sessions were self-administered by the patients themselves at home (who were educated about the technique). Magnesium silicate was delivered transcutaneously by means of the device at each session. Pre-post-treatment assessment included: 1) limb volumetry by means of tape measurement; 2) segmental multifrequency bioimpedance spectroscopy for fluid changes, with L-DEX measurement; 3) visual analogue scale (VAS) (0-10 score) questionnaire for related symptoms. RESULTS: All the patients completed the scheduled treatment. After the treatment the mean volume of the whole limb decreased from 9462.85 (±3407.02) to 9297.37 cc (±3393.20), which accounts for a 165.48 cc (2%) reduction after six days of treatment. The pre/post-treatment VAS mean score changes were: heaviness from 4.57±3.46 to 2.43±2.57 (-47%), dysesthesias from 1.71±2.63 to 0.71±1.50 (-58%), pain from 1.57±2.57 to 0.57±0.79 (-64%). Diuresis VAS measurement passed from 7.43±1.81 to 8.57±0.98 (15% increase). The average L-DEX percentage reduction was 21%. No side effects were reported and a good patients' compliance was recorded. CONCLUSIONS: The preliminary data of this pilot study show that the combination of microcurrents of bioresonance with transdermal delivery of active principles indicate that it could result in edema decrease and symptom improvement in patients affected by LYM and/or LIP of the lower limbs. Self-administered modality of the electrical device is possible and effective; no side effects have been reported.

Lymphedema treatment by means of an electro-medical device based on bioresonance and vacuum technology: clinical and lymphoscintigraphic assessment.

AIM: The aim of the study was to assess efficacy and safety of a new medical device, based on electric microcurrents and vacuum mechanism, on lymphedema of the lower limbs. METHODS: This was an observational clinical and instrumental study was performed on eight patients (2 males and 6 females, mean age 40.5 years), affected by secondary (3) or primary (5) lymphedema of the lower limbs. Ten daily sessions with an electro-sound wave and vacuum medical device were performed. Patients did not discontinue antecedently worn compression stockings. Lymphoscintigraphy of the lower limbs was performed before and after the treatment and an independent observer scored the images. Circumference tape measurement and relative volumetry were calculated before and after the treatment. RESULT: Total limb mean volumetry decreased from 9145 cc (±3439 SD) to 8714 (±3307) after 10 sessions (5% improvement); reduction in the lower leg volumetry was 8%. Ankle and mid calf mean circumference (in cm) decreased from 27.7 to 27.2 and from 36.2 to 35.2. Popliteal and inguinal lymph node visualisation at lymphoscintigraphy improved of 72%, 41%, 95% and 192% and of 0%, 33%, 110% and 245% respectively, 5', 45',120' and 180' after the injection. Radiotracer ascension along the leg and the thigh increased respectively of 48% and 33%, 39% and 64%, 50% and 62% and finally of 55% and 78% at the same intervals. Dermal back flow did not significantly vary till 45', whereas it improved of 25% both 120' and 180' after injection. No side effects were highlighted during the treatment. CONCLUSION: In this observational study the application of a medical device, based on bioresonance and vacuum mechanisms, on limbs with lymphedema proved to be both safe and effective in terms of limb volume reduction and of lymphoscintigraphy parameters.

Complications of foam sclerotherapy.

Foam sclerotherapy may result in drug and/or gas-related complications of a generalized or localized nature. Significant complications include anaphylactic/anaphylactoid reactions (very rare), deep vein thrombosis (1-3%), stroke (0.01%), superficial venous thrombosis (4.4%), tissue necrosis (variable frequency), oedema (0.5%) and nerve damage (0.2%). Cosmetic complications include telangiectatic matting (15-24%) and pigmentation (10-30%). Patent foramen ovale and other cardio-pulmonary right-to-left shunts seem to play a role in the systemic gas-related complications. In conclusion, foam sclerotherapy is characterized by an overall high degree of safety, though special attention should be given to the embolic and thrombotic complications. Good technique, adequate imaging, general precautions and compliance with post-treatment instructions may help avoid some of the adverse events and an appropriate early intervention may minimize possible sequelae. Higher volumes of sclerosant foam have been attributed to local and distant thrombotic complications and should be avoided.

Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins - UIP consensus document.

OBJECTIVES: Duplex ultrasound has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this article was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology and terminology to be used for assessment after treatment of incompetent superficial and perforating veins in the lower limb by ultrasound imaging. DESIGN: The study design was consensus meetings leading to a consensus document. METHODS: The UIP invited group submitted relevant literature references and written contributions concerning the methodology, terminology and value of duplex imaging after treatment. The authors prepared a draft document that was circulated to a larger group of experts and revised according to the comments received. Eventually, all participants agreed upon the final version of the article. RESULTS: Formal analysis of the results of interventions for varicose veins relies on adequate preoperative assessment and a careful description of the procedure employed. The timing of investigations of outcome should be classified as immediate (1-4 weeks), short-term (1 year), midterm (2-3 years) and long-term (5 years or more). The examination should employ standard methodology and formally described variables, which can be tailored to the intervention that was undertaken. The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination and reporting after various treatments for varicose veins, including novel treatments under scientific study. CONCLUSIONS: Duplex ultrasonography is a fundamental component of the investigation of the lower limb venous system after treatment for varicose veins.

Limb volume measurement: from the past methods to optoelectronic technologies, bioimpedance analysis and laser based devices.

Accurate measurement of limb volume is considered crucial to lymphedema management. Various non-invasive methods may be used and have been validated in recent years, though suboptimal standardisation has been highlighted in different publications.

Foam sclerotherapy techniques: different gases and methods of preparation, catheter versus direct injection.

INTRODUCTION: Foam sclerotherapy has gained a great popularity among phlebologists worldwide, although a major lack of homogeneity in the material used to produce sclerosant foam (SF) and to inject SF has been reported. AIMS: To highlight the literature data and a few personal clinical and experimental outcomes concerning the main variables in SF production and injection. METHODS: A review of the published literature and of our own 12 year clinical and experimental experience has been undertaken in order to focus on a few variables of the material and methods used to produce SF with Tessari method and to inject SF. RESULTS: In SF production, differences in gas components, liquid to gas ratio, as well in disposable material can variably influence the resulting SF. Similarly SF injection through ultrasound guidance, with needle, or with short/long catheter may exhibit different foam behaviours according to the variable material and techniques which are employed. More recently the introduction of long catheters, possibly together with hook phlebectomy, seems to potentiate the short-mid term outcomes of foam sclerotherapy. CONCLUSION: SF formation is greatly influenced by the choice of the gas component, the liquid-to-gas ratio, the type of syringes; also larger needles are to be preferred for injection of SF, while long catheters seem to represent a valid alternative especially when combined with tumescence to minimise saphenous diameter.

[Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs: UIP consensus document - Parte II: anatomy]. / Investigação eco-doppler das veias dos membros inferiores na doenca venosa cronica: Documento de Consenso da UIP - Parte II: anatomia.

OBJECTIVES: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP), The aim was to obtain a consensus of international experts on the methodology to be used for assessment of anatomy of superficial and perforating veins in the lower limb by ultrasound imaging. DESIGN: Consensus conference leading to a consensus document. METHODS: The authors performed a systematic review of the published literature on duplex anatomy of the superficial and perforating veins of the lower limbs; afterwards they invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the authors and the experts (text and images) were made available to all participants via the UIP website. The authors prepared a draft document for discussion at the UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually all participants agreed the final version of the paper. RESULTS: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document provides a detailed methodology for complete ultrasound assessment of the anatomy of the superficial and perforating veins in the lower limbs. CONCLUSIONS: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography, with specific reference to the anatomy of the main superficial veins and perforators of the lower limbs in healthy and varicose subjects.

[Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs--UIP consensus document part I: basic principles]. / Investigação eco-Dopler das veias dos membros inferiores na doença venosa crónica. Documento de consenso da UIP. Parte I. Principios básicos.

OBJECTIVES: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of veins in the lower limbs by ultrasound imaging. DESIGN: Consensus conference leading to a consensus document. METHODS: The authors invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the experts were made available to all participants via the UIP website. The authors prepared a draft document for discussion at a UIP Chapter meeting held in San Diego, USA in August 2005. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually all participants agreed to the final version of the paper. RESULTS: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document suggests a methodology for complete assessment of the superficial and perforating veins of the lower limbs, including recommendations on reporting results and training of personnel involved in these investigations. CONCLUSIONS: The authors and a large group of experts have agreed to a methodology for the investigation of the lower limbs venous system by duplex ultrasonography.

Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs--UIP consensus document. Part I. Basic principles.

BACKGROUND: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of veins in the lower limb by ultrasound imaging. METHODS: The authors invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the experts were made available to all participants via the UIP website. The authors prepared a draft document for discussion at an UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually all participants agreed the final version of the paper. RESULTS: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document suggests a methodology for complete assessment of the superficial and perforating veins of the lower limbs, including recommendations on reporting results and training of personnel involved in these investigations. CONCLUSIONS: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography.

Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs--UIP consensus document. Part II. Anatomy.

BACKGROUND: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of anatomy of superficial and perforating veins in the lower limb by ultrasound imaging. METHODS: The authors performed a systematic review of the published literature on duplex anatomy of the superficial and perforating veins of the lower limbs; afterwards they invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the authors and the experts (text and images) were made available to all participants via the UIP website. The authors prepared a draft document for discussion at the UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually, all participants agreed the final version of the paper. RESULTS: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document provides a detailed methodology for complete ultrasound assessment of the anatomy of the superficial and perforating veins in the lower limbs. CONCLUSIONS: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography, with specific reference to the anatomy of the main superficial veins and perforators of the lower limbs in healthy and varicose subjects.

Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs--UIP consensus document. Part II. Anatomy.

OBJECTIVES: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP), The aim was to obtain a consensus of international experts on the methodology to be used for assessment of anatomy of superficial and perforating veins in the lower limb by ultrasound imaging. DESIGN: Consensus conference leading to a consensus document. METHODS: The authors performed a systematic review of the published literature on duplex anatomy of the superficial and perforating veins of the lower limbs; afterwards they invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the authors and the experts (text and images) were made available to all participants via the UIP website. The authors prepared a draft document for discussion at the UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually, all participants agreed the final version of the paper. RESULTS: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document provides a detailed methodology for complete ultrasound assessment of the anatomy of the superficial and perforating veins in the lower limbs. CONCLUSIONS: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography, with specific reference to the anatomy of the main superficial veins and perforators of the lower limbs in healthy and varicose subjects.