Disclosures. TASC, AHA, SVS: What s Happening with the Guidelines? How Are They Relevant? Purpose of Practice Guidelines
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1 TASC, AHA, SVS: What s Happening with the Guidelines? How Are They Relevant? Michael S. Conte MD, FACS Division of Vascular and Endovascular Surgery Co-Director, Heart and Vascular Center UCSF Medical Center UCSF 2012 Vascular Symposium Disclosures Consultant Humacyte Aastrom Baxter Cell Therapies Co-Chair, SVS LE Guidelines TASC III Writing Group Member Vice-Chair, PVD Council of AHA Evidence-Based Practice in PAD? Purpose of Practice Guidelines Aid providers in clinical decision-making Bridge the Evidence to Practice gap Support implementation of best practices Streamline care pathways and improve patient outcomes Industry Vascular Specialists Professional Societies Ancillary benefit may be improved resource utilization and cost efficiency 1
2 How Are Guidelines Generated? Panel of experts is selected Literature is searched, evidence is synthesized (e.g. systematic review) Evidence is graded based on quality Recommendations made based on weight of evidence, and consensus of expert opinions Evidence and Recommendation Grading Systems Several systems in use: AHA, GRADE, Oxford, modified versions Grade the levels of evidence Meta-analyses, multiple RCTs Single RCT, nonrandomized studies Case studies, consensus opinion of experts Grades of recommendation based on evidence, with consistent phrasing to reflect the strength of opinion ACC/AHA Grading System 2
3 Diagnosis and Screening Resting ABI for patients with exertional symptoms, nonhealing wounds, age 65 or older, age 50 or older with history of smoking or diabetes (Class I; Level B) Remains controversial and rejected by USPSTF Report normal as ; borderline , abnormal 0.90, incompressible > 1.40 Risk Factor and Medical Therapies Antiplatelet therapy for Symptomatic pts No benefit and potential harm for warfarin Smoking cessation, lipid lowering, diabetes and HTN treatment Statins for all patients with PAD to achieve LDL < 100 mg/dl or <70 for higher risk pts Claudication Supervised exercise recommended as initial treatment (Class I/ Level A) Consider trial of cilostazol (Class I/ Level A) Endovascular treatment preferred for TASC A, focal disease amenable to treatment Surgical therapy for advanced symptoms Infrainguinal bypass should be constructed with vein conduit CLI PTA as initial therapy for pts with estimated life expectancy of 2 years or less (IIA/LevelB) Bypass with vein as initial therapy for pts with estimated life expectancy greater than 2 years (IIA/Level B) Based on the long term F/U data from BASIL 3
4 TASC (I) published January 2000 Co-Chairs Dormandy, Rutherford 14 societies endorsed Supported by grant from Schering AG TASC II published January 2007 Co-Chairs Hiatt, Norgren 15 societies participated Support from Sanofi-Aventis and Bristol-Myers Squibb TASC III underway Summary of Key TASC II Diagnosis and Screening- similar to AHA Risk factors/medical therapy- AHA Claudication Supervised exercise should be offered 3 to 6 month trial of cilostazol Recommendations regarding revascularization are based on anatomy, scheme changed from TASC I 4
5 Key Limitations to TASC II Focus on segmental arterial anatomy Multi-level disease common in CLI Tibial disease scheme inadequate Factors such as lesion characteristics less relevant for bypass than for endo outcomes De-emphasized clinical factors e.g. severity of ischemia, tissue loss Evolving technology- is TASC II outdated? ESVS Guidelines for CLI and Diabetic Foot Published EJVES 2011; 42 (S2) Sections on definitions, diagnostic methods, risk factors, CLI treatment, diabetic foot Bypass with vein recommended for long (>15 cm) SFA lesions if life expectancy >2 yrs PTA reasonable as initial therapy for infrapopliteal disease; surgery for more complex anatomical lesions or in case of endvascular failure and persisting symptoms Autogenous vein should be used for bypass PAD Guidelines: Current Status and Controversies TASC II discordant with current clinical practice patterns Newer technology, increased dissemination Growing volume of endovascular interventions But little new high quality evidence Lack of consensus between VS/IC/IR in many areas Carotid stenting discord between surgical and interventional societies Failed attempt at TASC IIb Increased scrutiny of process and conflicts of interest Limited influence on providers, although recent trends with federal agencies (CMS, AHRQ) are noteworthy SVS Guidelines 5
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