ANNUAL OCT. 31-NOV. 2, 2017 MEETING ARLINGTON, VA Implementing Shared Decision-Making for Patients with Aortic Valve Disease Susan Strong J. Matthew Brennan, MD MPH Patient Representative Interventional Cardiology Denver, CO Duke Triangle Heart Associates Associate Professor of Medicine Duke University School of Medicine #PCORI2017 November 1, 2017
ANNUAL MEETING | #PCORI2017 Overview • Patient’s Perspective: Personalizing the Treatment of Aortic Valve Disease • PCORI ADVICE Study: Developing Decision Aids for Aortic Valve Disease 2
ANNUAL MEETING | #PCORI2017 Aortic Valve Disease: What are the treatment options? Surgical Valve Replacement Transcatheter Valve Replacement (SAVR) (TAVR) 3
ANNUAL MEETING | #PCORI2017 The Counterfactual 4
ANNUAL MEETING | #PCORI2017 PCORI ADVICE Study: Data Sources & Design • Procedural registry data - STS National Database - STS/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry • Follow-up: Medicare claims • Observational Study (non-randomized) • Propensity-matched cohort 5
ANNUAL MEETING | #PCORI2017 Exclusions: Clinical Equipoise No TAVR • Age <65 yrs • Age >90 yrs • Endocarditis • Hostile chest • Emergency/Salvage • Aortic Insufficiency Other without stenosis • Centers with <10 TAVR • Moderate/Severe cases Mitral Stenosis • Low risk for SAVR (STS PROM <3%) No SAVR Spectrum of Patient Risk 6
ANNUAL MEETING | #PCORI2017 Assessing Balance Measured Confounders Unmeasured Confounders Propensity Matching Falsification Outcome (UTI) HR 1.45 (1.04-2.02) p=0.028 SAVR TAVR (Nov 2011 – June 2014) 7
ANNUAL MEETING | #PCORI2017 Assessing Balance Urinary Tract Infection SAVR TAVR (Jan 2014 – Q3 2015) 8
ANNUAL MEETING | #PCORI2017 PCORI ADVICE Study: Risk Models (SAVR vs TAVR) 5 Clinical Outcomes Model Parameters 1. Discharge to home • Demographics 2. Death, 1 year • Medical History 3. Stroke, 1 year • Labs Days alive and out of hospital, 1 st year 4. • Testing 5. Alive and better, 1 year • Clinical Status Stroke – 1 year “Alive and Better” Mortality – 1 year 9
ANNUAL MEETING | #PCORI2017 PCORI ADVICE Study: Decision Assistance Tool 10
ANNUAL MEETING | #PCORI2017 Questions? J. Matthew Brennan, MD MPH Interventional Cardiology Duke Triangle Heart Associates Associate Professor of Medicine Duke University School of Medicine j.matthew.brennan@dm.duke.edu November 1, 2017 11
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