American Society of Echocardiography Recommendations for ...

1 American Society OF Echocardiography REPORT. American Society of Echocardiography Recommendations for Use of Echocardiography in Clinical Trials A Report from the American Society of Echocardiography 's Guidelines and Standards Committee and The Task Force on Echocardiography in Clinical Trials Writing Committee: John S. Gottdiener, MD (Chair), James Bednarz, BS, RDCS, Richard Devereux, MD, Julius Gardin, MD, Allan Klein, MD, Warren J. Manning, MD, Annitta Morehead, BA, RDCS, Dalane Kitzman, MD, Jae Oh, MD, Miguel Quinones, MD, Nelson B. Schiller, MD, James H. Stein, MD, and Neil J. Weissman, MD. QUANTITATION OF CARDIAC. TABLE OF CONTENTS. LV Linear Dimension and Wall I. INTRODUCTION ..1088 Thickness ..1090. II. TECHNIQUES IN CARDIOVASCULAR.

2 LV Volumes and EF ..1090. ULTRASOUND ..1088. Two-Dimensional Echocardiography ..1088. Area-Length and Truncated Ellipsoid ..1090. M-Mode Doppler Echocardiography and Color Flow Method of Imaging ..1089 Method of Multiple Diameters ..1091. Stress Echocardiography ..1089 LV Transesophageal Reproducibility ..1091. Three-Dimensional Echocardiography ..1090 LV Systolic Contrast Echocardiography ..1090 Ejection Digital Acquisition and Storage ..1090 Reproducibility ..1092. III. ANATOMIC AND FUNCTIONAL Segmental LV Tissue Doppler Mitral Annular Systolic Velocity ..1092. Midwall Fractional Shortening/LV Systolic From the University of Maryland Hospital, Baltimore, Md Stress Relationship ..1092. ( ); University of Chicago Hospitals, Chicago, Ill ( ).

3 Cornell University-Columbia Presbyterian Medical Center, New Pitfalls in LV Quantitation and Strategies for York, NY ( ); St. John Hospital and Medical Center, Detroit, Obtaining Quantifiable Mich ( ); Cleveland Clinic, Cleveland, Ohio ( , ); Beth Recommendations for Measurement of LV. Israel-Deaconess Medical Center, Boston, Mass ( ); Wake Volumes, EF, Segmental Wall Motion, Forest University Health Sciences, Winston-Salem, NC ( );. Mayo Clinic, Rochester, Minn ( ); Baylor College of Medicine, and LV Mass ..1093. Houston, Tex ( ); University of California-San Francisco, San LV Volumes and Francisco, Calif ( ); University of Wisconsin Medical School, Segmental LV Function ..1093. Madison, Wis ( ); Washington Hospital Center, Washington, LV Mass.

4 1093. DC ( ). Diastolic LV Function ..1093. These Recommendations are endorsed by the American College of Cardiology Foundation. Mitral Inflow Velocities ..1093. Reprint of this document, beyond single use, is prohibited without Pulmonary Venous the prior written authorization of the ASE. Address reprint re- Tissue Doppler Measurement of Mitral quests to the American Society of Echocardiography , 1500 Sunday Annular Velocity ..1093. Dr, Suite 102, Raleigh, NC 27607. Color M-Mode Flow Propagation J Am Soc Echocardiogr 2004;17:1086-1119. Velocity ..1094. 0894-7317/$ Reproducibility ..1094. Copyright 2004 by the American Society of Echocardiography . Recommendations for Assessment of Diastolic Function ..1094. 1086. Journal of the American Society of Echocardiography Volume 17 Number 10 Gottdiener et al 1087.

5 Right Ventricular Mass, Function, and PFO Closure Devices ..1105. Recommendations for TEE-Guided Clinical Left Atrial Size, Volume, and Function ..1095 Prosthetic Valves ..1106. Evaluating Prosthetic Aortic and Pulmonic Recommendations for Measurement of Valves ..1106. LA Size ..1095 Evaluating Prosthetic Mitral and Tricuspid IV. VALVULAR STRUCTURE AND Valves ..1107. Recommendations for Echocardiography in Reproducibility ..1095 Assessment of Prosthetic Recommendations for Assessment of Valvular Echocardiographic Assessments of Cardiac Structure and Toxicity: Opportunity and Challenge ..1108. V. RELATED TECHNIQUES IN Recommendations ..1108. CARDIOVASCULAR Commercial vs Noncommercial Studies: Intravascular and Intracoronary Influence on Trial Design, Data Interpretation, and Publication.

6 1108. Reproducibility ..1096 Recommendations for Echocardiographer- Recommendations for Performance of Investigator Participation in Clinical IVUS and ICUS ..1096 Flow-Mediated Brachial Arterial Dilation VII. HOW TO EVALUATE AND CONTROL ECHO. Assessment of Endothelial Function ..1097 VARIABILITY IN CLINICAL TRIALS: METHODS FOR QUALITY Reproducibility ..1097. Methods to Limit Measurement Recommendations for Assessment of FMD. Variability ..1108. With Brachial Carotid Artery Imaging in Cardiovascular Site Clinical Trials Measurement of Intima- Core Laboratory ..1110. Media Thickness ..1097 Sonographer Training ..1110. Reproducibility ..1099 VIII. SUMMARY AND Recommendations FOR. Recommendations for Measurement of USE OF CARDIOVASCULAR ULTRASOUND.

7 IN CLINICAL TRIALS ..1110. VI. APPLICATIONS OF Echocardiography . IN CLINICAL TRIALS ..1099. Epidemiological and Observational LIST OF TABLES. Hypertension ..1101. Evaluation of Treatment Effects on LV. Table 1. Major Applications of Echocardiography in Clinical Trials Effects of Treatment of Systolic and Table 2. Echocardiographic Measures of Diastolic Diastolic LV Function ..1101 Function Intercenter Differences in Acquisition Table 3. Recommendations for Echocardiography in Quality ..1101 Clinical Trials of Hypertension Recommendations for Echocardiography in Table 4. Summary of Selected Trials With Ultra- Hypertension Clinical Trials ..1101 sound Measurements of Carotid Intima-Media Heart Failure ..1102 Thickness as a Surrogate for Atherosclerosis Resynchronization/Biventricular Pacing Table 5.

8 Echocardiography in Epidemiological Studies in Heart Studies What to Measure With Echocardiography Table 6. Selected Multicenter Treatment Trials in in Heart Failure Trials ..1104 Hypertension With Echocardiography Recommendations for Echocardiography in Table 7. Echocardiography in Clinical Trials of Heart Failure Congestive Heart Failure Myocardial Table 8. Commonly Used Echocardiography Mea- Clinical Trials With TEE: Stroke, Atrial sures in Heart Failure Trials Fibrillation, and Guidance of Interventional Table 9. Echocardiography in Clinical Trials of Procedures ..1105 Stroke Clinical Trials in Atrial Fibrillation: TEE- Table 10. Recommendations for Use of All Cardiac Guided Cardioversion ..1105 Ultrasound Techniques in Multicenter Clinical LA Appendage Closure Devices.

9 1105 Trials Journal of the American Society of Echocardiography 1088 Gottdiener et al October 2004. Table 1 Major applications of Echocardiography in clinical trials 1. Epidemiology and genetics Define cardiac structural and functional phenotype. Identify cardiac parameters of prognostic significance. 2. Hypertension Measure LV mass and assess systolic and diastolic cardiac function. Assess effects of treatment on cardiac structure and function. 3. Prosthetic valves Assess prosthetic valve hemodynamics; required by FDA. 4. Myocardial infarction and coronary artery disease Assess disease impact on LV remodeling and LV function. Use of stress Echocardiography to determine ischemic vulnerability, viability, functional capacity.

10 Assess effects of interventions on cardiac structure and function. 5. Heart failure Assess LV systolic and diastolic function, LV remodeling, comorbidity (eg, mitral regurgitation, pulmonary hypertension). Patient selection for device therapy. Assess treatment effects, including reverse remodeling. 6. Noncardiovascular trials Assess potential cardiac toxicity of treatment of disease, eg, cancer (radiation, chemotherapy), diabetes (glitazones). 7. Miscellaneous Diet-drug valvulopathy, echocardiographic contrast agents, TEE-guided cardioversion, atrial fibrillation, interventional device trials, cardiac surgery trials. FDA, Food and Drug Administration; LV, left ventricular; TEE, transesophageal Echocardiography . Echocardiography , this document is intended for I.