1 Content 2 Introduction Definition Causes Risk Factors Symptoms Importance Treatments Aims Methods Collecting Articles Research Question Query Inclusion / Exclusion criteria Data to extract from the articles Variables for data extraction Results Study type Follow-up Participants Treatments applied Conclusions Introduction Aims Methods Results Definition 3 • Superficial venous thrombosis consists in the formation of a blood clot in a superficial vein. Most commonly, it affects the lower limbs. • Under normal physiological conditions, there is a continuous formation of clots in the veins, but they disintegrate rapidly, not causing any harm. Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Risk Factors 4 Varicose veins; Cigarette smoking; Hormone therapy; Obesity; Family history; Diabetes… History of malignancy; Uncu H., 2009 Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Causes 5 Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Symptoms 6 • Pain • Redness of the skin with increase of temperature • Induration • Edema (swelling) • Fever Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Importance 7 The thrombus can reach the deep venous system through: SVT • Saphenofemoral junction • Perforator veins • Saphenopopliteal junction DVT (deep venous thrombosis) • The thrombus can detach and clot the pulmonary artery Pulmonary Embolism Introduction Aims Results Methods Conclusions Importance - statistics 8 Superficial venous complications, thrombosis rarely causes serious BUT In some cases, SVT can evolve (Litzendorf and Satiani, 2011): • 6-40% - Deep Venous Thrombosis (DVT); • 2-13% - Pulmonary embolism. Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Treatment temporal evolution 9 Elastic compression bandages and anti-inflammatory creams Surgery (patients with serious pain) Medical therapy – Drugs* (Decousus H, Epinat M, Guillot K, 2003) * There is still no consensus about using surgery as a possible treatment. Therefore, in some cases, it is still used. Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Treatments Possible Treatments 10 Symptomatic control Surgery (cut of the saphenofemoral junction) Drugs: - Warfarin; - Low Molecular Weight Heparin; - Nonsteroidal Anti-inflammatory Agent; - Xabans (Direct Xa factor inhibitor); - Fondaparinux (indirect Xa factor inhibitor) If SVT has a history longer than one week, medical therapy is considered to be more effective than surgical therapy (Bergqvist D, Brunkwell J, Jensen N, Persson NH 1990) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Costs 11 Medical costs • Compressions alone had the lowest costs • Treatments including LMWH had the highest costs Medical costs • Lost of working days and/or inactivity was higher in the subjects treated only with stockings Social costs (Belcaro G. et al, 1999) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Aims 12 Discovering the possible treatments Evaluate their results and complications Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Collecting Articles 13 Databases used: Pubmed Scopus ISI Web of Knowledge Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Research Question: 14 Which are the results and complications of Superficial Venous Thrombosis’ treatments? Superficial Superficial Venous Venous Thrombosis Thrombosis of of thethe Lower Lower Limbs Limbs Introduction Aims Results Methods Aim to achieve with the queries 15 SVT of the Lower Limbs Our aim Treatment Results/ complications Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Query - Pubmed 16 Venous Thrombosis – Entry Terms Thrombosis, Venous; Thromboses, Venous; Venous Thromboses; Phlebothrombosis; Phlebothromboses; Deep Vein Thrombosis; Deep Vein Thromboses; Thromboses, Deep Vein; Vein Thromboses, Deep Venous Thrombosis, Deep; Deep-Vein Thrombosis; Deep-Vein Thromboses; Thromboses, Deep-Vein; Thrombosis, Deep-Vein; Vein Thrombosis, Deep; Thrombosis, Deep Vein; Deep-Venous Thrombosis Deep-Venous Thromboses; Thromboses, Deep-Venous; Thrombosis, Deep-Venous; Deep Venous Thrombosis; Deep Venous Thromboses; Thromboses, Deep Venous; Thrombosis, Deep Venous; Venous Thromboses, Deep Introduction Aims Methods Results Query - Pubmed 17 Lower Extremity – Entry Terms Extremities, Lower; Lower Extremities; Lower Limb Limb, Lower; Limbs, Lower; Lower Limbs Membrum inferius; Extremity, Lower Therapeutics – Entry Terms Therapeutic Treatment Treatments Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Query - Pubmed 18 Pubmed Query - Main Topics Condition definition: (superficial venous thrombosis OR SVT) AND (lower extremity OR leg OR lower limb) Intervention: (Treatments OR therapeutics OR therapy) Analysis of: (results OR complications) Query applied on Pubmed (superficial venous thrombosis OR SVT) AND (lower extremity OR leg OR lower limb) AND (Treatments OR therapeutics OR therapy) AND (results OR complications) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Query - Scopus 19 Scopus Query - Main Topics Condition definition: (svt OR superficial venous thrombosis) AND (lower limbs OR lower extremity OR legs) Intervention: (Treatments or therapy or therapeutics) Analysis of: (results OR complications) Query applied on Scopus TITLE-ABS-KEY (svt OR superficial venous thrombosis) AND (lower limbs OR lower extremity OR legs)) AND (Treatments or therapy or therapeutics) AND (results OR complications) AND DOCTYPE(ar) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Query - ISI Web of Knowledge 20 Definition of the topic TOPICS (superficial venous thrombosis OR svt) (treatment OR therapy OR therapeutics ) (lower limb) NOT (varicose) NOT (artery) NOT (ulcers) Definition of the target group and thematic scope REFINED BY Languages=(ENGLISH) Document Type=(ARTICLE) Conclusions Introduction Aims Methods Results Query - ISI Web of Knowledge 21 Query obtained and applied on ISI Web of Knowledge Topic=(superficial venous thrombosis OR svt) AND Topic=(treatment OR therapy OR therapeutics) AND Topic=(lower limb) NOT Topic=(varicose) NOT Topic=(artery) NOT Topic=(ulcers) Refined by: Languages=(ENGLISH) AND Document Type=(ARTICLE) Timespan=1980-2011 Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Outcome 22 Articles obtained: Deadline for the research of the articles: March 22, 2012 Superficial Venous Thrombosis of the Lower Limbs Introduction Flowchart 23 Aims Methods Results Conclusions Introduction Aims Methods First selection phase 24 Results Conclusions Introduction Aims Methods Results Conclusions Inclusion and exclusion criteria 25 Inclusion Criteria Studies that fully describe the treatment applied in SVT; Studies describing the evolution of SVT according to the treatment applied. Exclusion Criteria Articles without original data (ex: systematic review); Articles not written in English, Portuguese or Spanish; Articles whose full-text was not available. Articles describing only one clinical case. Introduction Aims Methods Results Conclusions First selection phase 26 - Language - Study Type - Not relevant By reading the abstracts a first selection of the articles was made. Introduction Flowchart 27 Aims Methods Results Conclusions Introduction Aims Methods Second selection phase 28 Results Conclusions Introduction Aims Methods Results Conclusions Second selection phase 29 - Not available - Not relevant1 - Repeated 1 – Articles in doubt, during the first selection phase, due to their ambiguous abstracts. Introduction Aims Methods Results Conclusions Order of exclusion - summary 30 Language 13% of the articles excluded Type of Study 5% of the articles excluded Relevance 73% of the articles excluded For a total of 361 articles obtained Superficial Venous Thrombosis of the Lower Limbs Availability 6% of the articles excluded Introduction Aims Methods Results Conclusions List of the articles 31 1 – High vs. low doses of low-molecular-weight heparin for the treatment of superficial vein thrombosis of the legs: a double-blind, randomized trial 2 – Superficial Thrombophlebitis ofthe Legs: A Randomized, Controlled, Follow-up Study 3 – Simultaneous occurrence of superficial and deep thrombophlebitis in the lower extremity 4 – High versus low doses of unfractionated heparin for the treatment of superficial thrombophlebitis of the leg. A prospective, controlled, randomized study 5 – A comparison of low-molecular-weight heparin and combined therapy of low-molecular-weight heparin with an anti-inflammatory agent in the treatment of superficial vein thrombosis Introduction Aims Methods Results Conclusions List of the articles 32 6 – The use of liposomal heparin spray-gel in the treatment of superficial thrombophlebitis: a multicenter clinical investigation analysis; 7 – A Pilot Randomized Double-blind Comparison of a Low-Molecular-Weight Heparin, a Nonsteroidal Anti-inflammatory Agent, and Placebo in the Treatment of Superficial Vein Thrombosis; 8 – Prospective five-year study of ultrasound-guided foam sclerotherapy in the treatment of great saphenous vein reflux; 9 – Fondaparinux for the Treatment of Superficial-Vein Thrombosis in the Legs; 10 – A retrospective analysis of patients treated for superficial vein thrombosis; 11 – Fondaparinux for Isolated Superficial Vein Thrombosis of the Legs : A Cost-Effectiveness Analysis; Introduction Aims Results Methods Conclusions 33 Distribution of the articles through time 4 2008 Number of Articles 3 2 1990 1999 2002 2003 2005 2009 2010 2011 1 0 1988 1993 1998 2003 2008 2013 Introduction Aims Methods Results Conclusions General table of the articles’ data 34 Article nº Follow-up (in days) Nº of participants Treatments 1 90 164 LMWH* 2 6 562 Surgery, LMWH*, elastic compression 3 1825 42 Heparin; Warfarin; surgery 4 183 60 LMWH* 5 10 50 LMWH* 6 14 88 Lipossomal gel-spray heparin 7 97 427 Heparin; placebo; tenoxicam 8 1825 146 Ultra-sound guided foam sclerotherapy 9 77 3002 Fondaparinux; Placebo 10 1825 73 LMWH*; vitamin k antagonists; nasodroparin 11 45 10000 Fondaprinux; Placebo * LMWH: Low Molecular Weight Heparin Introduction Aims Methods Results Conclusions Variables for data extraction 35 Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Results Methods Conclusions Variables 36 Relative to the article extraction: Database Article number Year Study Type Relative to article’s content: Nº of participants Nº of groups Follow-up Drop out Age Gender Treatments Efficacy Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Data extraction to SPSS 37 Superficial Venous Thrombosis of the Lower Limbs Conclusions Introduction Aims Methods Results Conclusions Study Type 38 1 Double-blind, randomized trial (including clinical trials) Restrospective study 2 Cohort 8 Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Results Methods Conclusions Follow-up (in days) 39 2000 1800 1600 Follow-up (days) 1400 1200 1000 800 600 400 200 Article nº0 Series1 1 90 2 6 3 1825 4 183 5 10 6 14 7 97 8 1825 Superficial Venous Thrombosis of the Lower Limbs 9 77 10 1825 11 45 Introduction Aims Results Methods Conclusions Participants 40 60 164 42 50 88 562 427 Article nº 146 1 2 3 3002 4 5 6 7 73 10000 8 9 10 11 Total of participants: 14 488 Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Results Methods Conclusions Different treatments applied 41 Eleven articles analyzed: a total of 14 488 patients received treatment, 1502 with placebo and 11500 with Fondaparinux. The remaining treatments used are in the chart below. Treatments applied 350 300 309 301 298 250 200 150 100 50 0 146 112 102 78 71 40 20 6 3 Introduction Aims Results Methods Conclusions Heparin Data 42 Use of different kinds of heparin 15 25 LMWH Low dose LMWH 113 111 High dose LMWH Nasodoparin Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Results Methods Conclusions Antithrombotic therapy vs placebo (1/2) 43 Incidence of DVT by day 12 Placebo 4/111 - (3.6%) 40-mg enoxaparin* 1/109 - (0.9%) 1.5 mg/kg enoxaparin* 1/102 - (1.0%) Data obtained from article 7 Incidence of DVT and SVT by day 12 Placebo 34/111 - (30.6%) 40-mg enoxaparin* 9/109 - (8.3%) 1.5 mg/kg enoxaparin* 7/102 - (6.9%) * enoxaparin: a kind of heparin (in this case, different doses were used) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Antithrombotic therapy vs placebo (2/2) 44 Incidence of pulmonary embolism or DVT Placebo 20/1500 - (1.3%) Fondaparinux 3/1502 - (0.2%) Incidence of delayed surgery by day 77 Placebo 52/1500 - (3.5%) Fondaparinux 8/1502 - (0.5%) Data obtained from article 9 Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Elastic compression vs anti-coagulants and surgery (1/2) 45 Elastic compression only Thrombus extension at 3 months 32/78 - (41.0%) DVT at 3 months 6/78 - (7.7%) Thrombus extension at 6 months 13/78 - (16.7%) Total for complications 51/78 - (65.4%) Data obtained from article 2 Elastic compression + LMWH + Delayed surgery Thrombus extension at 3 months 4/76 - (5.3%) DVT at 3 months 0/76 - (0.0%) Thrombus extension at 6 months 1/76 - (1.3%) Total for complications 5/76 - (6.6%) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Elastic compression vs anti-coagulants and surgery (2/2) 46 Elastic compression + oral anti-coagulant Thrombus extension at 3 months 5/71 - (7.0%) DVT at 3 months 0/71 - (0.0%) Thrombus extension at 6 months 5/71 - (7.0%) Total for complications 10/71 - (14.0%) Data obtained from article 2 Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions High vs low doses of LMWH 47 Incidence of thromboembolic complications During treatment period After drug discontinuation High doses Low doses 0/30 - (0%) 4/30 - (13.3%) 1/30 - (3.3%) 2/30 - (6.7%) Data obtained from article 4 Incidence of thrombus extension During treatment period After drug discontinuation High doses Low doses 3/30 - (10.0%) 7/30 - (23.3%) 0/30 - (0%) 0/30 - (0%) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Prophylactic vs therapeutic doses of LMWH 48 Prophylatic doses Nº of patients with complications During treatment period 5/81 - (6.2%) After drug discontinuation 2/81 - (2.5%) Data obtained from article 1 Therapeutic doses Nº of patients with complications During treatment period 2/83 - (2.4%) After drug discontinuation 4/83 - (4.8%) Superficial Venous Thrombosis of the Lower Limbs Introduction Aims Methods Results Conclusions Lipossomal gel-spray heparin vs heparin injections 49 Data obtained from article 6 N – Lipohep: 43 N – injections: 45 Lipohep spray-gel is an heparin gel that has recently appeared on the market. Its effect has been compared with subcutaneous injections of heparin (as showed above) . Introduction Aims Methods Results Conclusions Conclusions (1/3) 50 Antithrombotic therapy is more effective than placebo and may avoid surgery; Elastic compression by itself seems not to be a good option of treatment. Although the group involving delayed surgery as treatment had better outcomes, anti-coagulants seem to be a good alternative to it; High doses of LMWH have better results than low doses. Introduction Aims Methods Results Conclusions Conclusions (2/3) 51 There are no statistically significant differences between prophylactic and therapeutic doses of LMWH, after drug discontinuation. There are no statistically significant differences between the spray-gel and the injections, so as it represents an easier way of treatment Lipohep spray gel seems to be an alternative to be considered. Introduction Aims Methods Results Conclusions Conclusions (3/3) 52 It also important to mention ultrasound-guided foam sclerotherapy (UGFS), a recent treatment in which study (article 8) no serious adverse outcomes were observed and it had 100% patient acceptance of success. However, as it is a recent finding, more studies need to be done in order to evaluate its effect in treating SVT. Unfortunately, we did not found any articles comparing fondaparinux and heparin, therefore we were not able to conclude which one was the best. Even so, there seems to exist a preference regarding heparin. Introduction Aims Methods Results Conclusions Study Limitations 53 Heterogeneity of the articles included: each article presented unique points of view and different methodology; Unavailability of articles in the UP database (23 articles): we can't assure the inexistence of important information among those whose full-text wasn’t available; Articles describing very specific populations: clinical cases or articles describing SVT within very specific populations (cancer patients, etc.) were excluded. Superficial Venous Thrombosis of the Lower Limbs