ABSTRACT
Under the direction of the German Society of Phlebology (Deutsche Gesellschaft für Phlebologie) and in cooperation with other specialist associations, the S1 guideline on intermittent pneumatic compression (IPC) was adopted in January 2018. It replaces the previous guideline from March 2005. The aim of the guideline is to optimize the indication and therapeutic use of IPC in vascular diseases and edema. An extensive literature search of MEDLINE, existing guidelines, and work relevant to the topic was performed. In view of the often methodologically weak study quality with often small numbers of cases and heterogeneous treatment protocols, recommendations can often only be derived from the available data using good clinical practice/expert consensus. Intermittent pneumatic compression is used for thromboembolism prophylaxis, decongestive therapy for edema, and to positively influence arterial and venous circulation to improve clinical symptoms and accelerate ulcer healing in both the outpatient and inpatient care setting. The therapy regimens and devices used depend on the indication and target location. They can be used as outpatient and inpatient devices as well as at home for long-term indications. A target indication is thrombosis prophylaxis. IPC should be used in severe chronic venous insufficiency (stages C4b to C6), in extremity lymphedema as an add-on therapy and in peripheral arterial occlusive disease (PAOD) with stable intermittent claudication or critical ischemia. IPC can be used in post-traumatic edema, therapy-resistant venous edema, lipedema and hemiplegia with sensory deficits and edema. Absolute and relative contraindications to IPC must be taken into account and risks considered and avoided as far as possible. Adverse events are extremely rare if IPC is used correctly. If the indication and application are correct-also as an add-on therapy-it is a safe and effective treatment method, especially for the treatment of the described vascular diseases and edema as well as thrombosis prophylaxis.
Subject(s)
Intermittent Pneumatic Compression Devices , Thromboembolism , Venous Insufficiency , Anticoagulants , Edema , Humans , Thromboembolism/prevention & control , Treatment OutcomeABSTRACT
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.
Subject(s)
Polyethylene Glycols/therapeutic use , Sclerosing Solutions/therapeutic use , Sclerotherapy/standards , Sodium Tetradecyl Sulfate/therapeutic use , Varicose Veins/therapy , Chronic Disease , Europe , Female , Humans , Male , Polidocanol , Polyethylene Glycols/adverse effects , Sclerosing Solutions/adverse effects , Sclerotherapy/methods , Societies, MedicalABSTRACT
Foam sclerotherapy is a minimally invasive, effective technique for the treatment of varicoses up though venous malformations. This efficient therapy can be easily integrated in daily clinical practice and shows only minor side effects. It provides an alternative to invasive therapies like vein stripping, endovenous laser therapy or endovenous radiofrequency ablation, but without the need for anesthesia. The treatment can be performed in an outpatient setting and the patient is able to return quickly to everyday life.
Subject(s)
Sclerosing Solutions/therapeutic use , Sclerotherapy/methods , Varicose Veins/therapy , Dermatology , Germany , HumansABSTRACT
OBJECTIVES: To assess the efficacy and safety of polidocanol (POL) in comparison to sodium tetradecyl sulphate (STS) and isotonic saline (placebo) for sclerotherapy of telangiectases or reticular veins by means of standardized digital imaging system, independent medical observers and detailed monitoring. METHODS: Of 316 randomized patients, 160 with telangiectases were randomly assigned to 0.5% POL, 1% STS or placebo, and 156 with reticular veins received 1% POL, 1% STS or placebo. Veins selected for injection were clearly visible telangiectases or reticular veins in a predefined treatment area (10x10 cm). Exact retrieval of the location was guaranteed by a newly established digital imaging system. Images were taken before first injection and 12 and 26 weeks after the last of three possible injection visits, and evaluated by the investigator and two blinded independent observers. The detailed safety monitoring included ultrasound screening for 'silent' deep vein thrombosis, electrocardiograms and clinical laboratory tests. RESULTS: POL demonstrated a statistically significant superiority versus placebo (P < 0.0001) for the primary criterion 'improvement of veins'. Significantly more patients were satisfied with POL at 12 or 26 weeks (84%, 88%) compared to STS (64%, 63%; P < 0.0001) and placebo (14%, 11%; P < 0.0001). POL was safe and well tolerated apart from expected local symptoms at the injection site. CONCLUSION: Sclerotherapy of telangiectases and reticular veins with detergent-like sclerosants such as polidocanol (POL) or sodium tetradecyl sulphate (STS) is a well-established technique. However, evidence from clinical trials comparing these substances with a non-active solution is sparse and does not live up to expectations of modern clinical trial concepts necessary for authorisation purposes. The presented multicentre EASI study fulfils these requirements and clearly demonstrates that Sclerotherapy of C1 veins with POL is highly effective and deserves the adjunct 'gold standard'.
Subject(s)
Polyethylene Glycols/administration & dosage , Sclerosing Solutions/administration & dosage , Sclerotherapy/methods , Sodium Tetradecyl Sulfate/administration & dosage , Telangiectasis/therapy , Adolescent , Adult , Aged , Double-Blind Method , Female , Humans , Isotonic Solutions/therapeutic use , Male , Middle Aged , Patient Satisfaction , Photography , Placebos , Polidocanol , Polyethylene Glycols/adverse effects , Sclerosing Solutions/adverse effects , Sclerotherapy/adverse effects , Sodium Chloride/therapeutic use , Sodium Tetradecyl Sulfate/adverse effects , Treatment Outcome , Veins/drug effects , Young AdultABSTRACT
RATIONALE: The spread of foam sclerotherapy has resulted in the renaissance of sclerotherapy as a non-invasive treatment method for varicosis. An expanded European expert committee meeting in Tegernsee in April 2006 was prompted by new findings and continuous further development of the method and worked especially on the topics "The role of (duplex) ultrasound in Foam sclerotherapy" and "Evaluation of therapeutic effects of foam Sclerotherapy". It was felt that these criteria are"non-specific" to foam sclerotherapy and would possibly also be suitable for other endovenous ablative procedures. The organisers of the 2nd European Consensus Meeting on foam sclerotherapy (2nd ECMFS) were then asked to publish these recommendations in this separate publication. The entire recommendations of the 2nd ECMFS are published in an extensive overview in this journal (VASA 2008; 37; Supplement 71: 1-32). METHODOLOGY: The 29 participants were sent a comprehensive questionnaire in advance covering all the relevant aspects of foam sclerotherapy. The organisers drew up various preliminary statements on the basis of the results. During the meeting itself the participants revised and/or approved and/or rejected these statements. For the "non-specific" topics, two working groups were given the task of conducting the concluding assessment of these items. Their final results were presented in March and April 2007. RESULTS: For foam sclerotherapy, duplex ultrasound is important in pre-treatment diagnosis, treatment monitoring/guidance, post-treatment efficacy evaluation and surveillance. In the pre-treatment diagnosis of varicose veins, the exact localisation of the insufficient saphenous, communicating and perforating veins is important. Duplex ultrasound is the accepted gold standard for this purpose. The application of ultrasound imaging during foam sclerotherapy increases the safety of accessing the vein in certain indications, and it can help when making a decision concerning the foam volumes to be injected, the patients' position or specific movements the patients should perform. Following treatment, the findings of duplex ultrasound, the clinical findings and the patients' symptoms can be arranged according to the recommended definitions. This allows grading of the therapeutic outcome and enables a better comparability between different treatment protocols or different treatments. Besides the evaluation of treatment success, duplex ultrasound is the method of choice to exclude or confirm complications such as deep venous thrombosis or disease progression.
Subject(s)
Sclerosing Solutions/therapeutic use , Sclerotherapy , Ultrasonography, Doppler, Duplex , Varicose Veins/diagnostic imaging , Varicose Veins/therapy , Europe , Humans , Sclerotherapy/methods , Treatment OutcomeABSTRACT
RATIONALE: The spread of Foam Sclerotherapy has resulted in the renaissance of sclerotherapy as a non-invasive treatment method for varicosis. The use of sclerosant foam for various forms of varicosis has now become established world-wide as safe and effective. An expanded European expert committee meeting in April 2006, in Tegernsee was prompted by new findings and continuous further development of the method, but also because it had not been possible to consider all the relevant aspects of Foam Sclerotherapy in depth at the first meeting. OBJECTIVES: To revise and update the results of the 1st European Consensus Meeting and to include new, important topics in the development of Foam Sclerotherapy. To provide practical information for less experienced colleagues. METHODOLOGY: The 29 participants were sent a comprehensive questionnaire in advance covering all the relevant aspects of Foam Sclerotherapy. The organisers drew up various preliminary statements on the basis of the results. During the meeting itself the participants revised and/or approved and/or rejected these statements. An additional analysis of the questionnaire data also enabled preparation of an illustrative description of the broad spectrum of individual procedures used in this form of treatment. RESULTS: Foam Sclerotherapy has become an established treatment option for varicosis and has undoubtedly improved the management of varicose veins. European experts met Tegernsee for a second time to revise and expand their previous recommendations. In addition, individual working groups focused extensively on important issues. The current consensus, recommendations and descriptions of the individual aspects of the methods concern such issues as the indications for Foam Sclerotherapy, concentration and volume of the liquid sclerosants, relative and absolute contraindications, access and puncture options as well as clinical and ultrasound-guided recording of the treatment results. This final document reflects the experts' opinions on the principles of the effective and, above all, safe use of sclerosant foam for various indications and correct monitoring of the results of Foam Sclerotherapy.
Subject(s)
Sclerotherapy , Varicose Veins/therapy , HumansABSTRACT
BACKGROUND: Sclerotherapy is the targeted elimination of intracutaneous, subcutaneous, and/or transfascial varicose veins (perforating veins) as well as the sclerosation of subfascial varicose vessels in the case of venous malformation by the injection of a sclerosant. With duplex-guide sclerotherapy and foam sclerotherapy, modified methods came into use. OBJECTIVE: The objective was to create a guideline, based on the available publications and on the European Consensus Document on foam sclerotherapy from April 2003. METHODS: This guideline was drafted on behalf of the German Society of Phlebology (Deutsche Gesellschaft für Phlebologie) and adopted by the committee and scientific advisory board of the Deutsche Gesellschaft für Phlebologie on June 15, 2001, and amended on December 5, 2003. The guideline considers the present state of knowledge as reflected in the literature. CONCLUSIONS: This guideline represents the recent state of the art of sclerotherapy of varicose veins in Germany including foam sclerotherapy.