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Clinical Studies Reference Guide CLINICAL STUDIES REFERENCE GUIDE July 2016 Sales offices: North America: All other Countries: NeuMeDx Inc. Manatec Biomedical 2014 Ford Road, Unit G 44, rue de Laborde Bristol, PA 19007 75008 PARIS USA FRANCE [email protected] [email protected] tel: (215) 826 9998 tel: +33 (3) 72 82 50 00 fax:(215) 826 8102 fax:+33 (1) 43 87 70 83 Manatec and PhysioFlow are registered trademarks TABLE OF CONTENTS INTRODUCTION ............................................................................................................. 7 1 VALIDATIONS .......................................................................................................... 8 1.1 FICK PRINCIPLE/EXERCISE ............................................................................................................... 9 A New Impedance Cardiograph Device for the Non-invasive Evaluation of Cardiac Output at Rest and During Exercise: Comparison with the "Direct" Fick Method ................................................. 9 Non-invasive Cardiac Output Evaluation during a Maximal Progressive Exercise Test, Using a New Impedance Cardiograph Device ..................................................................................................... 10 Measurements of Cardiac Output during Constant Exercises: Comparison of Two Non- Invasive Techniques ...................................................................................................................................................... 11 Does Thoracic Bioimpedance Accurately Determine Cardiac Output in COPD patients during Maximal or Intermittent Exercise? ........................................................................................................... 12 Reliability of Peak VO(2) and Maximal Cardiac Output Assessed using Thoracic Bioimpedance in Children ........................................................................................................................................... 13 Does Advanced Cardiac Impedance Technology Accurately Measure Cardiac Output During Submaximal Steady State Exercise? ........................................................................................................................ 14 The Ergogenic Effect of Recombinant Human Erythropoietin on VO2max Depends on the Severity of Arterial Hypoxemia ................................................................................................................................. 15 Poor accuracy of noninvasive cardiac output monitoring using bioimpedance cardiography [PhysioFlow(R)] compared to magnetic resonance imaging in pediatric patients ............................. 16 Evaluation of two methods for continuous cardiac output assessment during exercise in chronic heart failure patients .................................................................................................................................... 17 Cardiac output during exercise: A comparison of four methods .......................................................... 18 Comparison of Thoracic Bioimpedance with Acetylene Uptake for Measuring Cardiac Output. ................................................................................................................................................................................. 19 1.2 THERMODILUTION/ECHO-DOPPLER/REST ............................................................................. 20 Cardiac Output Measurements: Comparison between a New Transthoracic Electrical Bioimpedance Method (Physioflow™) and the Swan-Ganz Method (Continuous Cardiac Output or Bolus Technique) ....................................................................................................................................... 20 Conclusion of the report on PhysioFlow Studies performed at MUSC Charleston, SC and UPMC Pittsburgh, PA, 2007 ........................................................................................................................................ 21 Value of Impedance Cardiography in Pulmonary Hypertension .......................................................... 22 Value of Impedance Cardiography in Patients Studied for Pulmonary Hypertension ................ 23 The PhysioFlow Thoracic Impedancemeter Is Not Valid for the Measurements of Cardiac Hemodynamic Parameters in Chronic Anemic Patients ................................................................................. 24 Stroke Volume Variation Measured by Impedance Cardiography During Passive Leg Raising to Assess Fluid Responsiveness After Cardiac Surgery .................................................................. 25 1.3 REPRODUCIBILITY/ELECTRODE PLACEMENT ........................................................................ 26 Measurement of Cardiac Output Using PhysioFlow® with Different Positions of Electrode Placement ........................................................................................................................................................................... 26 2 APPLICATION STUDIES ...................................................................................... 27 Manatec and PhysioFlow are registered trademarks 2.1 CARDIOLOGY ....................................................................................................................................... 28 Best Detection of Coronary Artery Disease using a New Generation Impedance Cardiography: Comparison to Exercise Thallium 201 Scintigraphy ......................................................... 28 Detection of Coronary Artery Disease (CAD) during Bicycle Exercise, using New Generation Impedance Cardiography .................................................................................................................... 29 Changes in Transthoracic Impedance Signal Predict Outcome of 70º Head-up Tilt Test .......... 30 Head-upright Tilt Test with Sublingual Nitroglycerin Predicts Hemodynamic Abnormalities in 70° Head upright Tilt ................................................................................................................. 31 Impedance Cardiography and Quantitative Tissue Doppler Echocardiography for Evaluating the Effect of Cardiac Resynchronization Therapy ...................................................................... 32 Impedance Cardiography a Rapid and Cost effective Screening Tool for Cardiac Disease ........ 33 Isolated Left Ventricular Diastolic Dysfunction: Implications for Exercise Left ventricular Performance in Patients without Congestive Heart Failure ......................................................................... 34 Thoracic Bioimpedance for Optimizing Atrioventricular and Intraventricular Delays after Cardiac Resynchronization Therapy....................................................................................................................... 35 Evaluation of a New Noninvasive, Thoracic Bioimpedance Monitor for Hemodynamic Monitoring in Pediatric Patients .............................................................................................................................. 36 New Non Invasive Marker of Heart Failure with Pulmonary Congestion: Thoracic Electrical Bioimpedance ................................................................................................................................................................... 37 Patients with Systolic Heart Failure Show Improvement with Long-Acting, Cardioselective Beta-Blocker Nebivolol when Others Fail ............................................................................................................. 38 Central hemodynamic responses during high-intensity interval exercise and moderate continuous exercise in patients with chronic heart failure ........................................................................... 39 Microvascular oxygen delivery-to-utilization mismatch at the onset of heavy-intensity exercise in optimally treated patients with CHF. ............................................................................................... 40 Cardiopulmonary and Noninvasive Hemodynamic Responses to Exercise Predict Outcomes in Heart Failure .......................................................................................................................................... 41 Cardiopulmonary Responses and Prognosis in Hypertrophic Cardiomyopathy: A Potential Role for Comprehensive Noninvasive Hemodynamic Assessment. ........................................................... 42 Exercise Cardiac Output Limitation in Pectus Excavatum....................................................................... 43 2.2 LUNG DISEASE AND INTERNAL MEDICINE ................................................................................ 44 Haemodynamics during Exercise are a Better Measure of Vasodilator Response in Human Subjects with Pulmonary Hypertension ............................................................................................................... 44 Dynamic Monitoring during Exercise in Familial Amyloid Polyneuropathy (FAP) Type I ........ 45 Unique cardiac response during apneas in obstructive sleep apnea (OSA) patients ................... 46 CHRONIC OBSTRUCTIVE PULMONARY DISEASE Respiratory muscle unloading improves leg muscle oxygenation during exercise in patients with COPD ................................................................. 47 Skeletal muscle reoxygenation after high-intensity exercise in mitochondrial myopathy. ...... 48 Haemodynamic effects of proportional assist
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