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Ee tiene 2nd Mexican Consensus of Endovenous Chemical Ablation (Scleorotherapy) 2018* Zweiter mexikanischer Konsensus zur endovenésen chemischen Ablation (Sklerotherapie) 2018 Authors F. Vega Rasgado, | Angel Lopez Paredes A. Seralde Gallegos, D. Bolas Celaya, . Ramirez Cadena, [M. Alberto Cavazos Ortega, 0 Lira Rodriguez F.Rendén Elia, F. Contreras Cisneros, A. Lugo Ramirez, €, Jiménez Garena Affiliations ‘Academia Mexicana de FlebologhayLinfologia, Mexica City, 2018 Key words Scerotherapy, consensus, endovenous chemical ablation (ea Schlusselworter ‘Sklerotherapie, Konsensus,endovenése chemische Ablation (CA) received 03.08.2018 accepted 26.06.2018, Bibliography DOI Attps:/éo.org/¥0.1055/3-0804-9896 Phlebologie 2019 {© Georg Thieme Verlag KG Stuttgart - New York 15s 0939-978 Correspondence Dr. Fernando Vega Rasgado Xocoyahualeo #78 CColania Nueva tatacala Tlalnepantla Estado de México c.54160 Mexico all: inf ferohotmail.com ABSTRACT Background Sclerotherapy has been carried out since 1516 and is accepted and performed worldwide according ‘10 many references from books and journals. Mexican doc- ‘tors participated in other consensuses in order to obtain vatious agreements references, methods and procedures that ae universally accepted to establish this document, in- cluding the Furopean consensus of sclerotherapy 2003 and ‘ts ast revision in 2006, the Clinical practice guidelines for * Colaborator: De Mago Czaresdaruch De. Gllermo Ure. Dr. lanes Viana Pastrana xcdero, De Ramin lores, Dr Fe nando Torres. Antonio Ramirez Caens feng ea. nde sensi eb 019 prevention, dlagnasis and treatment of chronic venous insuf- ficiency in 2009in México, the Argentine and Latin American «consensus fr sclerotherapy in 2012, European sclerotherapy guidelines in chronic venous diseases of 2013,and various t= erature sources as well. The frst Mexican consensus onsclero- therapy published in January 2014 which was reviewed and pdatedin this document. ‘Objective Review and update the general bases of Endave- ‘nous Chemical Ablation (ECA) also known a Scerotherapy. according to evidence-based medicine updating the previously published consensus ‘Method General questions about Endovenaus Chemical Ab- lation (ECA) wee established concerning: indications, contra- Indications, types of sclerosing agents andthe concentrations used, patient position, methods of application, way to prepare and preserve the sclerosants, necessary equipment, injection volumes, differents administration ways, compressive therapy and special comments. To answer these questions the eusting Iterature andthe topicsin which the ports showed uniform: ‘ty were consulted. Apanel of experts was constituted who pro- vided thel personal experience, the answers were formulated inthe form of clinical guidelines or general recommendations to provide concrete answers tothe specific questions, nsome Issues we include possible accepted variations. ZUSAMMENFASSUNG Hintergrund Die Sklerotherapic wird seit 1516 angewendet undist au Veréffentlchungen in Lehrbichern und Zetschif ten ein weltweit akzeptiertes und durchgefihrtes Verfahren zur Therapie von Varizen. Die verschiedenen Meinungen 2u den allgemein akzeptierten lund etabllerten Methoden und Abaufen konnten mesikanische Arzte auf KonsensusKonferenzen, wiedem -European consen- sus of sclerotherapy *2003 und 2006, der Clinical practice guidelines for prevention, diagnosis and treatment of chronic ‘venous insufficiency" 2008, der Argentine and Latin American consensus for sclerotherapy" 2012, de European sclerothe- ‘apy guidlines in chronic venous diseases, 2013" und durch publizerter Literatur sammeln und in den 2. mexikanischen KonsensuseinfeBen lassen. “This document was downloaded for personal use only Unauthorzed dsribution is strictly prohibited. Ee Thieme Der erste mexikansche Stlerotheraple-Konsensus wurde im Januar 2014 publiziert und wurde nun Uberarbeitet und ak- taller. Zielsetzung Oderarbeitung und Aktualisierung des 1. mexi= kanischen Konsensus zur endovendsen chemischen Ablation (CA), auch bekanntalsSkerotherapie, gem der Regeln der Evidena-baserten Medan Methode Allgemeine Fragen und Themen zur endavendsen chemischen Ablation (ECA) wurden bearbeltet. im Finzelnen: Indikationen, Kontraincikationen, Sklerosierungsmittel und ~zuverwendete Konzentrationen, Position des Patienten, AP- plikationsmethoden, Art und Weise der Zubereitung und that des Sklerosierungsmittels, notwendiges Equipment, n= jektionsvolumen, unteschiediche Zugangswege, Komnpressi- ‘onstherapie undspeziellen Anmerkungen. Um dese Fragen zu beantworten, wurden die existerende Literatur und Berichee rmiteiheiticher Meinung einem Thema rerangerogen. Fine CGrupze von Experten beantwortete Fragen auf Grundlagehver ersblichenErfahrung Die Antworten wurden n Form vonk- rischen Leitinien oder allgemeinen Empfehlungen formulert, s0 dass konkrete Antworten aut spezifsche Fragen gegeben werden konnten,Inmanchen Fillen wurden mehvere mégliche Vanationenakzeptiert CONSENSUS ToPICS 1.Overview 1.1 Prerequisites 1.2 Definition ofEndovenaus Chemical Ablation (Sclerother= apy) 1.3 Physical forms of sclerosing application 1ainications 1.5 Contraindications 15:1 Absolute 15.2 Relatives 16 Sderosing agents 1.7 Concentrations and dose of Sclerosing agents 1.8 Volumes of Sdlerosants (liquid and foam) 2. Material and Equipment 2.1 General material 2.2 Syringes and Catheters 2.3 Needles 2.4 Medical Devices 25 Compression devices 3. About the Patients 3.1 Position ofthe Patient during the ECA 3.1 Post ECA Compression 4. Aditional Comments CONCEPTUAL FRAMEWORK "Many worldwide attempts have been made to have stan- Tab.2, Gases: Usually room airis used but pure Oxygen, COs, and O7- CO; mintures are also avalable, as described in different Works. Diluents: The most used ar: Distilled Water, idestlated Water, 0.9% Saline Solution, Lactate Ringer's Solution and 5% Glucose. De- pending on the availabilty ofthe diluent and personal experience, 1.6 Concentrations and Maximum Dose of Sclerosing Agents The folowing doses ae recommended in relation to the type of veintobe treated, which willbe directly related to their diameters (Tab. 1 and» Tab.2) Polidocanol(Lauromacrogol 400):Itcan be supplied in concen- trations ranging from 0.25 % to 3%. Currently in our country itis avalable in ampules of t00.5%, 1%, 2%and 3% Maximum dose of Polidocanol: 2mgikq of bodyweight. protibited. “This document was downloaded for personal use ony, Unauthorized stitution is sic Tetradecyl Sodium Sulfate: The literature suggests the use of concentrations ranging from 0.1 to 1.5%. Maximum Tetradecyl Sodium Sulfate Dose: 4ml3%, (aot avaliable in México) 1.7 Volumes of Sclerasants (Liquld and Foam) There ae several works onthe volumes of foam that should be ad- ‘ministered to each patient, itis important to note thatthe global Varlation is very wide, ranging from 1 to 6Oml; whichis duerothe concentration, gas used for foam, time of administration, num- ber and type of veins to he treated and the personal experience ofthe physician, itis recommended to use # maximum volume each session of 10 ccof the sclerosing agent, the average volumien suggested by the panels Sein bath liquid a foam form (> Tab. 1 and »Tab.2) Remarks: This consensus DOES NOT limit the use of different concentrations or volumes, since, in diferents part of the country, institution or personal experience, they can be varied according to ‘optimizing the results forthe patient Recommendations ater ndovenous Chemical Ablation (Sclero- therapy) 2 Elevation ofthe treated limb of 10-15" by to 10min. with flesion-extension exercise ofthe ankle. Put ona Flastocompression system Immediate mobilization after 5-10 minutes (see above) Consider that adverse elects may occur Keep in touch withthe patient. Percutaneous thrombectomy by puncture or aspiration inthe next 10 days. 2. Material and Equipement 2.1 Material + Cotton + Alcohol + Disposable gloves, + Adhesive Tapes + Gauzes + Antiseptic solutions + Physiological Solution 100ml and 250ml + Pads with Alcohol (Wipes) + Work table Scissors + Measuring tape + Marker (Surgical and Indelible) + Bway keys + Hypodermic needles + Blood pressure cut + Stethoscope + Lamps + Elevators for the fim 2.2 Syringes and Catheters Disposable syringes of: 0.5, 1,3, Sand 10cc. Catheters (short or long) with different needle gauges. Other devices of similar calibers (punzocats, butterflies, etc) 10 and 20 cc syringes are recommended only for dilutions (tab), fgado FV eal, 2d Mescn Cnn. eblagle 2019 2.3 Needles ‘Thefollowing needle size and syringes are recommended to punc- ture the veins according their diameter. (Tab. 3). When injecting Foam through needles with gauge greater than 27, the bubbles ‘are destroyed and liquid is mostly injected, therefore no needles larger than 27.G are recommended for foam injection into large siameter veins. 2.4 Medical Devices + Venous Transiluminator: The panel agreed that transilumina- ‘on equipments mandatory in the ECA procedure. + Polarized Light and Magnifying Glases: Polarized light em inates reflections due ta the refraction of light inthe dermis, which allows usto observe with greater precision Telangiecta- sias and smal caliber vessel, the magnifying glases allow to ‘observe not perceptible ven under conventional conditions. + Vein Visualizerin Real Time: System that emits 2 near infrared light which when absorbed by the blood, produce the reflec ‘on oft and project adit image ofthe veins on the skin. + Linear Doppler or Hand Doppler: tis essential to have Linear ‘orhand Doppler equipment for diagnosis and verification of, the arterial and venous points and verify the ankle-brachial index (AB) + Ultrasound Doppler Colo: The Color Doppler equipmentis ac- cepted worldwide asthe ideal device forthe diagnosis of ve ous disease, being also very useful to perform punctures of the vascular system and essential to ultrasound quided abla- tion and sclerosis treatments. + Onygen Tank: Medical Oxygen canbe used through nasaltips corto prepare foam + 02 (Carbon Dione) Tank: Medical use gas whichis used in ‘non-routine way to prepare the foam af the sclerosing agent. + Oximeter: Useful for testing arterial saturation ofthe 02 after bandages. + Photographic camera: For medical records and as clinical evi= ences. + Computer Variant of quipmentand Additional Devices: + Glucometer Needle Extenders + Podium for Exploration + Pletismograph 2.5 Material for Compression ‘The lastocompression system is considered asindispensablestrat- cay after the treatment of ECA, which an be done with the follow- ing material: "dost bandges of 10and 15cm. (High, meduman low compression) + Compression socks higher than 25 mmHa, For compression stockings, it can be used below the knee, thigh ‘or pantyhose, depending on the preference and sclerosed ea. “This document was downioaded fr personal use only. Unauthorized distbuton is stich prohisited Cs Thieme 3. About the Patients 3.1 Position of the Patient during the ECA leis prefesred to perform the ECA with the patient in lying posi- tion, which will avoid the presence of accidents caused by lipathy- mia or adverse reaction tothe sclerosing agent, in addition to of fering greater comfort In sometimes the evident varicosities in standing positon ds- appear wit the lying poston, then by this: 2. Proofif the veins can be located with Transilumination device. Mark the insufficient veins with the patient standing before chemical ablation in decubitus «_Sitthe patient onthe examination table with the leg hanging and treat the insuficient veins inthis position, immediately af- terwards place the patientin lying postion. 3.2 Compression After- ECA ‘The usefulness of compressive therapy is described in many works ually to prevent reflax, promote the venous upflow, decrease venous stasis, edema and pain in addition to improve the lym- pphatic function, the microcirculation and promote the healing of ‘venous ulcers The placement ofa venous compression system ater perform- Ing ECA sclerotherapy) is unanimous. The use of beatings cotton lor other direct compression system on the sclerosed veins con- venient but not a generalized practice. 4. Additional Observations 1. Priortothe ECA procedure itis suggested: Avoid the tight clothing, danot apply creams, avoid exposure to sunlight and laser hai removal sessions (2 weeks before). 2. Adverse, Collateral, Secondary Effects and Complications of FCA (Sclerotherapy} Injection ofa sclerosant can produce in some cases: cardiac ab- normalities, cough and respiratory disorders, vomiting, visual dis- ‘urbances, metalic taste, fever, back pain or headache, but it can also produce local reactions such as phlebitis or even ulcers by ex- travasation. Like any other substanceit can lead to allergic reactions suchas rash, urticaria or even anaphylaxis reactions ‘The adverse effects of ECA are mainly + cchymmosis + Local pain when applying the sclerosing agent + Intense ané continuous painin the treated site + Superficial Phlebitis and thrombophlebitis + Detmatitis, itching, non-allergic erythema + Local necrosis and ulcers due to extravasation + Cough and dyspnea + Nausea and vorniting + Neurological injuries, Neuromas, Neuropraxia or Neuritis + Deep Venous Thrombosis + Neovascularization post sclerotherapy (Matting) + Lipothymia and Disorders inthe gait ‘+ Headache, Migraine and Dizziness «+ Paresthesias,Aphasia, Ataxia and Hemiparesis «Transient Loss of Consciousness and Confusion “+ Metallic Flavor and Hypoesthesiaandjor Oral Dysesthesia (Crofacial) ‘Scotoma and Transient disturbance ofthe vision + Alteration into the General Condition (Fever, Asthenia, Ady- rama) = Hypertrichosis Complications of ECA (sclerotherapy) descr worldwide: TA Stroke Anaphylactic Shock and Angioedema Tachycardia, Arthythmias and Cardio Respiratory Arrest Tako-Taubo Syndrome and other cardiac complications Venous thromboembolic Disease (Pulmonary Embolism) Instability of blood pressure (Hypotension-Hypertension) Ischemia inthe limbs by intra arterial application ofthe scle- rosant Vasovagal Syncope Angina Pectors Vasculits 4, Evaluation and therapeutic continuity s recommended from Tod weeks 5. Medications and Local Measures after ECA Physicians use drugs after Endovenous Chemical Ablation inthe Fallowing proportions + Anti-phlebitic Medications: 10% + Non-Pharmacological Agents with Ant-phlebiti Effect (na turist): 90% «+ Topical gels: 10% + Analgesics and Oral Anti-nflammatories: 10% + Local Cold: 15% 6. It is notadvised to apply slerosants via the perivascular route, although this described as an option, 7. Post-sclerotherapy thrombectomy is ussually required by Per- ‘cutaneous puncture or Aspiration within the frst 10 days after the treatment and at any time that is necessary. 8B. InMexico, its mandatory to collect the folowing documents, before conducting sessions of ndovenous Chemical Ablation (Sclerotherapy) Complete Medical Record (Printed or Electronic) Medical history according to NON-004SSA3-2012 ofthe Medical Record Phlebological Background Format Informed Consent to treatment Specific Registry of each medical and therapeutic session ‘Authorization to obtain sensitive data and to take photo-

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