4/14/2016 Suman Rathbun MD, MS No relevant disclosures Professor of Medicine Director, Vascular Medicine University of Oklahoma Health Sciences Center Epidemiology More common than DVT 1:1000 Clinical Presentation Estimated 3 to 8% of the general population Diagnosis Risk factors: varicose veins, immobilization, trauma, surgery, Treatment pregnancy and post-partum, hormonal contraception or -Medical replacement therapy, increasing age, obesity, history of VTE, -Surgical malignancy, autoimmune disease, thrombophilia, IV catheter -Topical Females>Males -Clinical trials Varicose vein SVT • Most common risk factor for SVT • Lower risk of progression to DVT Varicose veins • May be precipitated by trauma • Tender nodules Traumatic • Localized induration Septic and Suppurative • More common after foam sclera vs. thermal ablation Migratory Mondor’s Disease Small saphenous Upper extremity Post endovascular vein treatment 1 4/14/2016 Septic thrombophlebitis • Infusion therapy • IV lines with septicemia • Direct endothelial injury of irritating solutions • Leukocytosis • Pain, tenderness and erythema at catheter insertion • Intense pain • Vein may contract rather than recanalize • Staph aureus, Pseudomonas, Klebsiella, Candida • Removal of catheter; IV antibiotics • Excision of vein in rare cases Great/Small Saphenous Vein SVT Mondor’s disease • Can progress to common femoral or popliteal DVT • Similar morbidity with GSV or SSV SVT • Thoracoepigastric vein of the breast/chest wall • Breast carcinoma or hypercoagulable states • Benign and self limited • NSAIDs At presentation 3 month follow-up Upper extremity IV line related SVT • Caustic substance with direct injury to endothelium • Basilic or cephalic veins Compression ultrasound • Rare progression to DVT • Catheter removal; occasional anticoagulation 2 4/14/2016 Reduce or ameliorate symptoms Prevent progression to DVT Prevent PE Prevent recurrence/QOL Treatment Options: Topical Pharmacological systemic: Anticoagulation, NSAID Surgical SVT TREATMENT — Treatment differs depending upon whether the thrombosis affects the tributaries (superficial thrombophlebitis) or axial veins (ie, great or small saphenous veins) indicative of superficial vein thrombosis (SVT), and whether or not there are complications. Approach to treatment — Treatment of superficial phlebitis is primarily aimed at alleviating symptoms and preventing propagation of thrombus into the deep venous system. LMWH Uncomplicated — Initial management of uncomplicated thrombophlebitis and less extensive SVT (ie, affected vein segment <5 cm, remote from saphenofemoral/saphenopopliteal junction, no medical risk factors) is supportive and -Titon consists of extremity elevation (ie, waist level), warm or cool compresses, nonsteroidal anti-inflammatory drugs (NSAIDs), and possibly compression therapy [46]. The patient should be encouraged to remain ambulatory if possible. Antibiotic treatment is not indicated -VESALIO in the absence of signs of infection (eg, high fever, purulent drainage) [47]. (See 'Symptomatic care' below.) -CALISTO Anticoagulation is suggested for patients with more extensive superficial thrombophlebitis, particularly those with SVT approaching the deep venous system via the saphenofemoral junction, because of a higher risk for developing a deep vein thrombosis (DVT) [21,37,41,48-50]. A decision to anticoagulate the -STEFLUX patient when thrombus approaches the deep venous system at other sites (ie, saphenopopliteal junction, perforator veins) should be individualized; either anticoagulation or serial duplex ultrasound may be appropriate. Anticoagulation is also appropriate for those patients who demonstrate propagation. (See 'Anticoagulation' below.) An exception to the need for anticoagulation is the patient with superficial vein thrombosis following endovenous ablation therapy. The natural history of endovenous LMWH vs. NSAID heat-induced thrombus (EHIT) appears to be more benign than spontaneous thrombus with less of a propensity for embolization [7]. EHIT is generally managed conservatively. (See "Radiofrequency ablation for the treatment of lower extremity chronic venous disease", section on 'Deep venous thrombosis' and 'Anticoagulation' below.) -STENOX -Rathbun Up to Date Sept 29,2015 LMWH vs. NSAID for Prevention of VTE Study Patients Intervention Outcome Titon 117 RCT Nadro 6150 IU 2.6% STP 1994 + compress Nadro 31.5 IU/kg 5% STP 6 days Naprox 500 mg 2.6% STP No DVT,PE, bleed STENOX 436 RCT Enox 40 qd 0.9/8.3% DVT/STP, 0 PE 2003 STP > 5 cm Enox 1.5mg/kg 0.9/5.7 % DVT/STP, 0 PE + compress Tenoxicam 20 2.0/13.1% DVT/STP, 1 PE 8-12 days Placebo 3.6/29.5% DVT/STP, 0 PE Vesalio 164 RCT Nadroparin 2850 2005 STP >3cm Nadro from jx Di Nisio M, Wichers IM, Middeldorp S. Treatment for superficial thrombophlebitis of the leg. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004982. DOI: 10.1002/14651858.CD004982.pub5. Titon J. Annales de cardiologie et d’angeiologie 1994;43:160-6 STENOX study group. Arch Intern Med 2003;163:157-63 3 4/14/2016 LMWH and NSAIDs reduced the incidence of extension or recurrence of SVT but no effect on VTE Topical treatments relieved local symptoms but trials did not report progression to VTE Surgical treatments and wearing elastic stockings were associated with lower VTE and VTE compared to stockings alone Methodological quality of the 30 studies assessed was poor overall. No differences in major bleeding but NSAID with increased gastrointestinal side effects Di Nisio M, Wichers IM, Middeldorp S. Treatment for superficial thrombophlebitis of the leg. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004982. DOI: 10.1002/14651858.CD004982.pub5. Double-blind RCT 3002 received either fondaparinux (2.5mg/day) or placebo X 45 days Primary efficacy outcome: composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep- vein thrombosis, or symptomatic, extension to the saphenofemoral junction or symptomatic recurrence of STP at day 47 Main safety outcome - major bleeding Follow up to day 77 Major bleeding occurred in one patient in each group Incidence of serious adverse events was 0.7% with fondaparinux and 1.1% with placebo A=parnaparin 8500 IU qd X 10 days + placebo 20 days B=parnaparin 8500 IU qd X 10 days + 6400 IU 20 days C=parnaparin 4250 qd for 30 days 4 4/14/2016 Low-Molecular-Weight Heparin Versus Saphenofemoral Disconnection for the Treatment of Above-Knee Greater Saphenous Thrombophlebitis: A Prospective Study Francisco S. Lozano, MD, PhD and Arturo Almazan, MD, PhD, Salamanca, Sp The objective of this study was to assess the efficacy, safety, and cost of low-molecularweight heparin compared to saphenofemoral disconnection for the treatment of internal saphenous proximal thrombophlebitis (SPT). Eighty-four consecutive patients diagnosed as presenting SPT alone (symptoms/echo-Doppler) were divided into 2 comparable groups treated with (1) saphenofemoral disconnection under local anesthesia with a short hospital stay (n=45) or (2) prospective enoxaparin on an outpatient basis for 4 weeks (n=39). Informed consent was obtained and inclusion, exclusion, and withdrawal criteria were established. Patients were followed up at 1, 3, and 6 months. Thirty patients per group completed the study requirements. In the disconnection group, 2 patients (6.7%) presented complications of the surgical wound, 1 (3.3%) had SPT recurrence (however, there was no deep venous thrombosis), and 2 (6.7%) had nonfatal pulmonary embolism confirmed by radionuclide scan. In the enoxaparin group, there were 2 cases (6.7%) of minor bleeding (epistaxis and rectal bleeding) and 3 (10%) recurrences of SPT. In the enoxaparin group there was no case of progression of the thrombosis to the deep venous system or pulmonary embolism. The study found no statistically significant differences between saphenofemoral disconnection and enoxaparin in the treatment of SPT, but the low-molecular-weight heparin group had socioeconomic advantages. Vascular and Endovascular Surgery Volume 37, Number 6, 2003 DVT Thrombus at 21 days DOI: 10.1002/14651858.CD004982.pub5 Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Rivaroxaban Anticoagulation for Superficial Vein Versus Fondaparinux Thrombosis (RASET) This study is currently recruiting participants. (see Contacts and Locations) This study is currently recruiting participants. (see Contacts and Locations) Verified December 2015 by GWT-TUD GmbH Verified January 2016 by McMaster University Sponsor: Sponsor: GWT-TUD GmbH McMaster University Collaborator: Collaborator: Bayer Bayer Information provided by (Responsible Party): Information provided by (Responsible Party): GWT-TUD GmbH McMaster University ClinicalTrials.gov Identifier: ClinicalTrials.gov Identifier: NCT01499953 NCT02123524 First received: December 19, 2011 First received: April 23, 2014 Last updated: December 3, 2015 Last updated: January 19, 2016 Last verified: December 2015 Last verified: January 2016 History of Changes History of Changes 5 4/14/2016 Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis This study is currently recruiting participants. (see Contacts and Locations) Verified September 2015 by Medinova AG Sponsor: Medinova AG Information provided by (Responsible Party): Medinova AG ClinicalTrials.gov Identifier: NCT01943006 First received: September 6, 2013 Last updated: September 23, 2015 Last verified: September 2015 History of Changes LMWH or NSAID effective for reducing pain and extension/VTE but risk stratification model not available Compression alone not effective for preventing extension Surgery provides symptom relief but may not reduce extension ACCP 2012 recommendation (no change 2016): Superficial thrombosis ≥ 5 cm in length should receive prophylactic dose fondaparinux or LMWH for 45 days (2B). Fondaparinux 2.5 mg is preferred over LMWH (2C). Goals of treatment met by LMWH but dose and duration of LMWH not clear 6 .