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Evidence-based guidelines
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Evidence-based medicine is the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients.1 Listing the evidence-
based guidelines of the American Venous Forum has been a hallmark of this handbook, and the fourth edition is no exception. At the end of each chapter, a table summarizes the relevant guidelines. e grade of recommendation of a guide­line can be St rong (1) or We ak (2), depending on the risk and burden of a particular diagnostic test or a therapeutic pro­cedure to the patient versus the expected benet. e words “we recommend” are used for Grade 1, strong recommenda­tions, if the benets clearly outweigh risk and burdens, or vice versa, and the words “we suggest” are used for Grade 2, weak recommendations, when the benets are closely balanced with risks and burden. Letters A, B, and C mark the level of evidence (A: high quality; B: moderate quality; C: low or very low quality).
2
ese guidelines of the American Venous Forum are based on the GRADE system, as was reported previously by Guyatt et al. (Table 0.1).2 When there are no comparable alternatives to a recommendation or evidence is lacking, the authors and editors have relied on case series supplemented by the best opinion of a panel of experts, and the recommendation was labeled Best Practice. Chapter 68 gives a summary of all 300 guidelines presented in this book.
e American Venous Forum, the rst academic organi-
zation in the United States dedicated exclusively to venous
and lymphatic disorders, is committed to promoting research, education, awareness, prevention, and delivery of care. e American Venous Forum, jointly with the Society for Vascular Surgery and other organizations, has long rec­ognized the need to formulate clinical practice guidelines based on scientic evidence in order to aid physicians and patients to receive the best and latest information regard­ing venous and lymphatic disorders.
4–6
Clinical guide­lines, as published in the fourth edition of this handbook, however, should not be used as dogma when a diagnostic test is selected or a therapeutic procedure is performed. Scientic evidence should always be combined with the clinical experience of the physician and the patient’s pref­erence (Figure0.1).
7,8
e correct decision on care requires patient-centered communication skills from the physician, who is well aware of the informed preferences of his or her patient. Optimal patient care requires both evidence-based medicine and shared decision making.9 e intentions of the authors and editors of this volume were to help with the evaluation and treatment of patients, with the ideals in mind, which were suggested by Dr. William J. Mayo already in 1910, that “e best interest of the patient is the only interest to be considered.”
Peter Gloviczki
Figure 0.1 A shared clinical decision to select optimal patient care is based on scientific evidence, the clinician’s experi-
ence and communication skills, and the patient’s values and informed preferences.
Clinician’s
experience and
communication
skills
Scientic evidence
Optimal
patient care
Patient’s
values and
informed
preferences
xxi
xxii Evidence-based guidelines
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Table 0.1 Grading recommendations according to evidence
Grade of recommendation/ description
1A/strong recommendation,
high-quality evidence
1B/strong recommendation,
moderate-quality evidence
1C/strong recommendation,
low-quality or very-low­quality evidence
2A/weak recommendation,
high-quality evidence
2B/weak recommendation,
moderate-quality evidence
2C/weak recommendation,
low-quality or very-low­quality evidence
Source: From Guyatt G, Gutterman D, Baumann MH etal. Chest 2006;29:174–81. With permission. Note: RCT, randomized clinical trials.
Benefit vs. risk and
burdens
Benefits clearly outweigh
risk and burdens, or vice versa
Benefits clearly outweigh
risk and burdens, or vice versa
Benefits clearly outweigh
risk and burdens, or vice versa
Benefits closely balanced
with risks and burden
Benefits closely balanced
with risks and burden
Uncertainty in the estimates
of benefits, risks, and burden; benefits, risk, and burden may be closely balanced
Methodological quality of
supporting evidence Implications
RCTs without important
limitations or overwhelming evidence from observational studies
RCTs with important
limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies
Observational studies or
case series
RCTs without important
limitations or overwhelming evidence from observational studies
RCTs with important
limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies
Observational studies or
case series
Strong recommendation,
canapply to most patients in most circumstances without reservation
Strong recommendation,
canapply to most patients in most circumstances without reservation
Strong recommendation,
butmay change when higher-quality evidence becomes available
Weak recommendation,
bestaction may differ depending on circumstances or patients’ or societal values
Weak recommendation,
bestaction may differ depending on circumstances or patients’ or societal values
Very weak recommendations;
other alternatives may be equally reasonable
REFERENCES
1. Sackett DL. Evidence-based medicine. Spine 1998;23:1085–6.
2. Guyatt G, Gutterman D, Baumann MH etal. Grading strength of recommendations and quality of evi­dence in clinical practice guidelines: Report from an American College of Chest Physicians task force. Chest 2 0 06;129:174 – 81.
3. Murad MH, Montori VM, Sidawy AN, Ascher E, Meissner MH, Chaikof EL, and Gloviczki P. Guideline methodology of the Society for Vascular Surgery including the experience with the GRADE frame­work. J Vasc Surg 2011;53(5):1375–80.
4. Gloviczki P, Comerota AJ, Dalsing MC etal. The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the AmericanVenous Forum. J Vasc Surg 2011;53(5Suppl.):2S–48S.
5. Meissner MH, Gloviczki P, Comerota AJ etal. Early thrombus removal strate­gies for acute deep venous thrombo­sis: Clinical practice guidelines of the Society for Vascular Surgery and the AmericanVenous Forum. J Vasc Surg 2012;55(5):1449–62.
Evidence-based guidelines xxiii
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6. O’Donnell TF Jr., Passman MA, Marston WA etal. Management of venous leg ulcers: Clinical prac­tice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2014;60(2Suppl.):3S–59S.
7. Haynes RB, Devereaux PJ, and Guyatt GH. Physicians’ and patients’ choices in evidence based practice. BMJ 2002;324:1350.
8. Montori VM, Brito JP, and Murad MH. The optimal practice of evidence-based medicine: Incorporating patient preferences in practice guidelines. JAMA 2013;310(23):2503–4.
9. Hoffmann TC, Montori VM, and Del Mar C. The connection between evidence-based medicine and shared decision making. JAMA. 2014;312(13):1295–6.
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Abbreviations
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25(OH)D 25-hydroxyvitamin D AAGSV anterior accessory great saphenous vein AASV anterior accessory saphenous vein ACA anticardiolipin antibodies ACCP American College of Chest Physicians ACH acetylcholine ACP activated protein C ACT activated clotting time ACVRL1 activin receptor-like kinase-1 ADP adenosine diphosphate AF atrial brillation AHA American Heart Association AK above the knee AM arterial malformation AMP adenosine monophosphate AP anterior–posterior aPE antiphosphatidylethanolamine APG air plethysmography APS antiphospholipid antibody syndrome aPTT activated partial thromboplastin time ASA aspirin ASD atrial septal defect ASVAL Ablation Selective des Varices sous
Anesthesie Locale
ATTRACT Acute Venous rombosis: rombosis
Removal with Adjunctive Catheter-
Directed rombolysis trial AV axillary vein AVF American Venous Forum AVF arteriovenous stula AVL anterior vein of the leg AVM arteriovenous malformation AVVS/AVVQ Aberdeen Varicose Vein Scores or
Questionnaire b.i.d. bis in die = twice daily / before the current (common) era bFGF basic broblast growth factor BK below the knee BMI body mass index BNP brain natriuretic peptide BV brachial vein C4b-BP C4b-binding protein CA cyanoacrylate CAE cyanoacrylate embolization
cAMP cyclic adenosine monophosphate CAPS catastrophic antiphospholipid antibody
syndrome
CaVenT Catheter-Directed rombolysis in
Acute Iliofemoral Vein rombosis trial
CBS cystathione β synthase CBT catheter-based treatment CCJ costoclavicular junction CD-31 cluster of dierentiation-31 CDT catheter-directed thrombolysis CDT complex decongestive therapy CE common era CE contrast-enhanced CEAP C, clinical; E, etiology; A, anatomy;
P,pathophysiology CFD color-ow duplex ultrasonography cFN bronectin CFV common femoral vein CHIVA conservative hemodynamic ambulatory
treatment of venous insuciency CHIVA Cure Conservatrice et Hemodynamique
de l’Insusance Veineuse en
Ambulatoire CI condence interval CIV common iliac vein CIVIQ Chronic Venous Insuciency
Questionnaire CLF ClosureFast CM capillary malformations cm centimeter CMS Centers for Medicare & Medicaid
Services CNS central nervous system CO
carbon dioxide
2
COPD chronic obstructive pulmonary disease CP ClosurePlus CPT current procedural terminology code
book CrCl creatinine clearance CRP C-reactive protein CS conventional surgery CT computed tomography CTV computed tomography venography CUS compression ultrasound
xxv
xxvi Abbreviations
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CV contrast venography CVA cerebrovascular accident CVC central venous catheter CVD chronic venous disease CVI chronic venous insuciency CVM congenital vascular malformation CVT central venous thrombosis Cx43 Connexin43 CXVUQ Charing Cross Venous Ulceration
Questionnaire
dceMRI dynamic contrast-enhanced magnetic
resonance imaging DIC disseminated intravascular coagulation DMSO dimethyl sulfoxide DNA deoxyribonucleic acid DP dynamic pressure DTI direct thrombin inhibitor DUS duplex ultrasound DVT deep vein thrombosis DWI diusion-weighted imaging ECG electrocardiogram ECM extracellular matrix ECMO extracorporeal membrane oxygenation ECOG Eastern Cooperative Oncology Group ECTR endothelial cell turnover rate EGF epidermal growth factor EHIT endovenous heat-induced thrombosis or
thrombi EIV external iliac vein EKG electrocardiography ELISA enzyme-linked immunosorbent assay ELS elastic compressive stockings EMMPRIN extracellular matrix metalloproteinase
inducer EN enteral nutrition ENG endoglin EPCR endothelial cell protein C receptor EPC endothelial progenitor cell ePTFE expanded polytetrauoroethylene gra EQ-5D EuroQol questionnaire ERK extracellular signal-regulated kinase ETA endothermal ablation EVF European Venous Forum EVL endovenous laser ablation EVOH ethylene copolymer and vinyl alcohol EVRF endovenous radiofrequency FDA Food and Drug Administration FGFR-2 broblast growth factor receptor-2 FPDL ashlamp pumped dye laser FPNI ferroportin gene FS foam sclerotherapy FSE free precession sequence FV femoral vein FVIII factor VIII FVL factor V Leiden mutation FXIII factor XIII gal3 galectin 3
gal3bp galectin 3 binding protein GFR glomerular ltration rate GI gastrointestinal GM-CSF granulocyte-macrophage colony
stimulating factor
GPIbα glycoprotein Ibα GRE standard gradient recalled echo GSV great saphenous vein GVM glomuvenous malformation GWOT global war on terrorism HFE hemochromatosis C282Y HFVM high-ow vascular malformation HGF hepatocyte growth factor HHC hyperhomocysteinemia HHT hereditary hemorrhagic telangiectasia HIF-1 hypoxia inducible factor-1 HIT heparin-induced thrombocytopenia HITT heparin-induced thrombocytopenia and
thrombosis HL/S high ligation and stripping HLM hemolymphatic malformation HOPE Heart Outcomes Prevention Evaluation
trial HP hydrostatic pressure HR hazard ratio HRQL health-related quality of life HRT hormone-replacement therapy Ht height IAC Intersocietal Accreditation Commission IBD inammatory bowel disease ICAM-1 intercellular adhesion molecule-1 ICG indocyanine green ICU intensive care unit IED improvised explosive device IF iliofemoral IFN-γ interferon-γ Ig immunoglobulin IJV internal jugular vein IL-12p40 interleukin-12p40 IL-1α interleukin-1α IL-1β interleukin-1β INR international normalized ratio of
prothrombin time of blood coagulation IPC intermittent pneumatic compression IPG impedance plethysmography IPL intense pulsed light IRR incidence rate ratio ISCVS International Society for Cardiovascular
Surgery ISS Injury Severity Score ISSVA International Society for the Study of
Vascular Anomalies ISTH International Society of rombosis and
Hemostasis ITGA9 integrin α9 IUA International Union of Angiology IUP International Union of Phlebology
Abbreviations xxvii
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IV iliac vein IV intravenous injection IVC inferior vena cava IVUS intravenous or intravascular ultrasound JNK c-Jun N-terminal kinases JUPITER Justication for the Use of Statins in
Prevention: an Intervention Trial
Evaluating Rosuvastatin kDa kilo-Dalton kg kilogram KO knockout KTP potassium titanyl phosphate L liter LA lupus anticoagulant LA-ICGFA laser-assisted indocyanine green
uorescence angiography LARA Laser and Radiofrequency Ablation
study LDS lipodermatosclerosis LDUH low-dose unfractionated heparin LE lower extremity LEDVT lower extremity deep vein thrombosis LFA-1 lymphocyte function-associated
antigen-1 LFT liver function test LFVM low-ow vascular malformation LGV le gonadal vein LM lymphatic malformation LMWH low-molecular-weight heparin LRV le renal vein LS liquid sclerotherapy LV le ventricle LVA lymphaticovenous anastomosis LVR lymphovenous reconstruction MAP kinase/MAPK mitogen-activated protein kinase MAUDE FDA Manufacturer and User Facility Device
Experience database MCP-1 monocyte chemoattractant protein-1 MCT medium-chain triglyceride MDCT multiple detector computed tomography MHz megahertz, unit of frequency MI P-1β macrophage inammatory protein-1β MKK MAPK kinase mL milliliter MLD manual lymphatic drainage mm millimeter mmHg millimeters of Mercury MMP-1, -2 … matrix metalloproteinase-1,-2… MOCA mechanochemical endovenous ablation
or mechanical occlusion chemically
assisted MRI magnetic resonance imaging MRL magnetic resonance lymphangiography mRNA messenger ribonucleic acid MRV magnetic resonance venogram ms miliseconds MTFR methylenetetrahydrofolate reductase
MTHFR methylenetetrahydrofolate reductase MT-MMP membrane-type matrix
metalloproteinase mTOR mammalian target of rapamycin MTS May–urner syndrome MVT mesenteric venous thrombosis nBCA or NBCA N-butyl cyanoacrylate NCNS non-central nervous system Nd:YAG neodymium-doped yttrium aluminum
garnet lasers NETS neutrophil extracellular traps NGAL neutrophil gelatinase-associated
lipocalin NHS-TAS National Health Services Health
Technology Assessment Survey NIH National Institutes of Health NIVL non-thrombotic iliac vein lesion NLN National Lymphedema Network nm nanometer NOAC novel oral anticoagulant NORVIT Norwegian Vitamin trial NPV negative predictive value NR non-reported NS nutcracker syndrome NSF nephrogenic sclerosing brosis NSQIP National Surgical Quality Improvement
Project database NTNT non-thermal non-tumescent technique OC oral contraceptive OCP oral contraception OR odds ratio OTC over-the-counter drug PA pulmonary artery PAI-1 plasmin activator inhibitor-1 PASTE post-ablation supercial thrombus
extension PAV posterior arch vein PCDT pharmacomechanical catheter-directed
thrombolysis PCP pneumatic compression pump PCP pre-test clinical probability score PCS pelvic congestion syndrome PCV post-capillary venule PD polidocanol PDA patent ductus arteriosus PDGFR-α and -β platelet-derived growth factor receptor-α
and -β PE pulmonary embolism PEM polidocanol endovenous microfoam PERT Pulmonary embolism response team PFO patent foramen ovale PFV profunda femoris vein PIC or PICC peripherally inserted central catheter PIN perforate–invaginate technique of
stripping PIOPED Prospective Investigation of Pulmonary
Embolism Diagnosis study
xxviii Abbreviations
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PISA-PED Prospective Investigative Study of Acute
Pulmonary Embolism Diagnosis PMN polymorphonuclear neutrophil PN parenteral nutrition PP primary patency rate PPG photoplethysmography ppRb phosphorylated protein retinoblastoma PPV positive predictive value pRb protein retinoblastoma PREVAIT PREsence of Varices Aer InTervention
study PRF pulse repetition frequency proBNP prohormone of BNP PROM patient-reported outcome measure PSGL-1 P-selectin glycoprotein ligand-1 PSVs peak systolic velocities PT prothrombin time PTA percutaneous transluminal angioplasty PTFE polytetrauoroethylene PTS post-thrombotic syndrome PTT partial thromboplastin time PV perforating vein PV popliteal vein PVI primary venous insuciency PVL primary venous leiomyosarcoma PVS peritoneovenous shunt PWS Parkes–Weber syndrome q.d. quaque die = every day QoL quality of life qPCR quantitative real-time polymerase chain
reaction RA right atrium RBC red blood cell RCC renal cell cancer RCT randomized controlled trial REVAS recurrent varices aer surgery RF radiofrequency RFA radiofrequency ablation RFiTT radiofrequency-induced thermotherapy RIETE Computerized Registry of Patients with
Venous romboembolism RIJV right internal jugular vein rPSGL PSGL-1 receptor RR relative risk RV right ventricle rVCSS revised Venous Clinical Severity Score RVF residual volume fraction RVO residual venous obstruction S&L stripping and ligation SA-β-Gal β-galactosidase SALP suction-assisted protein lipectomy SBP systolic blood pressure s-CT spiral computed tomography SDF-1 stromal cell-derived factor-1 SEPS subfascial endoscopic perforator surgery SEV supercial epigastric vein SF-36 Short Form 36-Item health survey
SFJ saphenofemoral junction SGP strain-gauge plethysmography SIR Society of Interventional Radiology SLE systemic lupus erythematosus SMA superior mesenteric artery SMC smooth muscle cell SNP single nucleotide polymorphism SNR signal-to-noise ratio SOB shortness of breath SP secondary patency rate SPE surgical pulmonary embolectomy SPGR spoiled gradient recalled echo SPJ saphenopopliteal junction SQ subcutaneous injection SSFP steady-state free precession SSV small saphenous vein STS sodium tetradecyl sulfate SVC superior vena cava SVI secondary venous insuciency SVS Society for Vascular Surgery SVT supercial vein thrombosis TAFI thrombin activatable brinolysis
inhibitor
Tc- f SC
99m
Tc–sulfur colloid TD thoracic duct TDD mechanical needle disruption technique TDE thoracic duct embolization TED thromboembolic deterrent stocking TEE transesophageal echocardiogram TF tissue factor TGC time gain compensation TGF-β1 transforming growth factor-β1 TIA transient ischemic attacks TIMP-1 tissue inhibitor of metalloproteinases-1 TIPP transilluminated powered phlebectomy TIPS transjugular intrahepatic portosystemic
shunt
TLPS transarterial lung perfusion scintigraphy TNF-α tumor necrosis factor-α TORPEDO rombus Obliteration by Rapid
Percutaneous Endovenous Intervention
in Deep Venous Occlusion trial tPA tissue plasminogen activator TREAT echo-shared angiographic technique TRICKS time-resolved imaging of contrast
kinetics TRISS Trauma Injury Severity Score TRPV transient receptor potential vanilloid
channel TSOAC target-specic oral anticoagulant TT thermal tumescent TVI total vascular isolation UE upper extremity UEDVT upper extremity deep vein thrombosis UFH unfractionated heparin UGFS ultrasound-guided foam sclerotherapy uPA urokinase plasminogen activator
Abbreviations xxix
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uPAR urokinase plasminogen receptor US ultrasound VAS visual analog scale VATS video-assisted thoracoscopy VBAS V block-assisted sclerotherapy VCAM-1 vascular adhesion molecule-1 VCSS Venous Clinical Severity Score VDS Venous Disability Score VEGF vascular endothelial growth factor VEINES-QOL/Sym venous insuciency epidemiologic and
economic study of quality of life
VESPA Venous Enhanced Subtracted Peak
Arterial study
VFI
venous lling index
90
90
VFT venous lling time VISP Vitamin Intervention for Stroke
Prevention trial
VITRO Vitamins and rombosis trial
VKA vitamin K antagonist VLA-4 very late antigen-4 VLNT vascularized lymph node transfers VLU venous leg ulcer VM venous malformation Vn vitronectin VP ventilation–perfusion VQ ventilation and perfusion scintigraphy VSDS Venous Segmental Disease Score VT vein thrombosis VTE venous thromboembolism VTOS venous thoracic outlet syndrome VV varicose vein VVSymQ Varicose Vein Symptom Questionnaire vWF von Willebrand’s factor WBC white blood cell
β2-GPI β2-glycoprotein I μm micrometer