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TASC, AHA, SVS:What’s Happening with the

Guidelines?How Are They Relevant?

Michael S. Conte MD, FACSDivision of Vascular and Endovascular Surgery

Co-Director, Heart and Vascular CenterUCSF 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

Vascular SpecialistsIndustryProfessional

Societies

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

– Ancillary benefit may be improved resource utilization and cost efficiency

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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

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Summary of Key ACC/AHA Guidelines Related to PAD

Diagnosis and Screening

– Resting ABI for patients with exertionalsymptoms, 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 1.0-1.4; borderline 0.91-0.99, abnormal ≤ 0.90, incompressible > 1.40

Summary of Key ACC/AHA Guidelines Related to PAD

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

Summary of Key ACC/AHA Guidelines Related to PAD

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

Summary of Key ACC/AHA Guidelines Related to PAD

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

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• 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 Guidelines Related to PAD

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

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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 endvascularfailure 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