HOW IMPORTANT ARE THESE ECHO MEASUREMENTS ANYWAY?

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Reynard Leslie Oliver
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1 HOW IMPORTANT ARE THESE ECHO MEASUREMENTS ANYWAY? John D. Carroll, MD Professor, Director of Interventional Cardiology and Co-Medical Director of the Cardiac and Vascular Center, University of Colorado TVT Registry Steering Committee Susan Fitzgerald, RN, MSN Associate Director, Registry Development Disclosures Dr. Carroll has a relationship with: AGA Medical/ST Jude Medical Corporation Evalve/Abbott Structural Heart Disease Phillips HealthCare Steering Committee RESPECT Susan Fitzgerald has no disclosures Why Are Echo Measurements So Important? Registry Disease Diagnostic Tools CathPCI Coronary artery disease Stress test or diagnostic cath ICD Arrhythmias TVT Heart valve disease Electrophysiology studies Echocardiogram 1

2 Assessment and Diagnosis of Heart Valve Disease Gold standard - echocardiography Echo variables are required to assess heart valve function for all transcatheter valve procedures Baseline Post procedure Follow-up (30 day and 1 year) Cardiac catheterization does not capture many variables to assess function of heart valve Diagnosis of Heart Valve Disease Symptoms New York Heart Association (NYHA) classification Valve anatomy Bicuspid vs tricuspid aortic valve Valve area Effective orifice area (EOA) or effective regurgitant orifice area (EROA) in cm2 Diagnosis of Heart Valve Disease Valve hemodynamics Angiographic grade ( ) Gradient Velocity Hemodynamic consequences of valve disease Ejection fraction 2

3 What are the Echo Guidelines/Standards? Not aligned ASSESSMENT OF MITRAL REGURGITATION AHA/ACCF Classification of Mitral Regurgitation (MR) Anatomy (e.g. prolapse) Symptoms Severity (mild-severe) Hemodynamics Angiographic grade (1+ -3+) Effective orifice area (EOA) or effective regurgitantorifice area (EROA) in cm2 Consequences (atrial or ventricular enlargement, ejection fraction) 3

4 Classification of MR What is the Difference? Type ASE Any AHA/ACCF Primary (DMR) and secondary (FMR) classified separately Classification Mild-moderate-severe Grade A - D Symptoms Valve anatomy Valve hemodynamics (e.g. doppler study of jets and quantitative parameters (EROA) Hemodynamic consequences (e.g. LA and LV size) (normal or abnormal) (more descriptive - valve prolapse, flail thickening of leaflets) Classification of MR Different EROA Between Standards ASE AHA/ACCF Grade EROA (cm 2 ) Grade EROA (cm 2 ) Mild < 0.20 A < 0.40 Moderate (mild-mod) B < 0.40 (mod-severe) C >=0.40 Severe >=0.40 D >=0.40 ASSESSMENT OF AORTIC STENOSIS 4

$dysfunction, hypertrophy and reduced ejection fraction) Morphology of Aortic Stenosis Valve Area$

5 AHA/ACCF Staging of Aortic Stenosis (Stage A-D) Symptoms Valve anatomy Bicuspid Calcification Valve area Valve hemodynamics Gradient Velocity Hemodynamic consequences (left ventricular dysfunction, hypertrophy and reduced ejection fraction) Morphology of Aortic Stenosis Valve Area (Mitral or Aortic) VARC endpoint - device success Key measure in regulatory definition of device success 5

6 TAVR - Device Success VARC 1 Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system. Correct position of the device in the proper anatomical location; Only one valve implanted in the proper anatomical location. Intended performance of the prosthetic heart valve (aortic valve area >1.2 cm2 and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR). TVT Registry Registry Report Metric Correct positioning of a single prosthetic heart valve in the proper anatomical location (Device Implanted Successfully) Mean AV gradient <20 (post implant or post-procedure) and post procedure aorticinsufficiency = none; trace/trivial or mild. Conversion to open heart surgery = no 1 Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials (JACC, 2011, vol 57, No 3) Paravalvular Leaks Classifying Regurgitation Coding Challenges No gold standard American Society for Echo (ASE) and AHA/ACCF Guidelines not aligned Echo reports not consistent or missing key variables Current registry specs: Up-code to highest value Includes a category for trace which isn t described in current classifications Not aligned with AHA/ACCF standards 6

7 QUESTIONS? 7

Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data

Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data Echo Florida 2013 Jonathan J. Passeri, M.D. Co-Director, Heart Valve Program Director,