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1. Correlation between non-invasive myocardial work indices and main parameters of systolic and diastolic function

Author

Arnaud Ancion, Ciro Santoro, Roberto M. Lang, Krasimira Hristova, Dragos Vinereanu, Patrizio Lancellotti, Marie Moonen, Maurizio Galderisi, George Kacharava, José Luis Zamorano, Daniele Barone, Andreas Hagendorff, Julien Magne, Christophe Martinez, Bernard Cosyns, Nico Van de Veire, Monica Baroni, Tolga Ozyigit, Toshimitsu Tsugu, Nuno Cardim, Raluca Elena Dulgheru, Ralph Stephan von Bardeleben, Gonzalo de la Morena, Concetta Zito, Scipione Carerj, Luigi P. Badano, Elena Galli, Martin Penicka, George Athanassopoulos, Bogdan A. Popescu, Erwan Donal, Jose David Rodrigo Carbonero, Adriana Postolache, Federica Ilardi, Monica Rosca, Teresa López, Andreea Calin, Marianna Cicenia, Tadafumi Sugimoto, Roberta Manganaro, Stella Marchetta, Clinical sciences, Cardio-vascular diseases, Cardiology, Manganaro, Roberta, Marchetta, Stella, Dulgheru, Raluca, Sugimoto, Tadafumi, Tsugu, Toshimitsu, Ilardi, Federica, Cicenia, Marianna, Ancion, Arnaud, Postolache, Adriana, Martinez, Christophe, Kacharava, George, Athanassopoulos, George D, Barone, Daniele, Baroni, Monica, Cardim, Nuno, Hagendorff, Andrea, Hristova, Krasimira, Lopez, Teresa, de la Morena, Gonzalo, Popescu, Bogdan A, Penicka, Martin, Ozyigit, Tolga, Rodrigo Carbonero, Jose David, van de Veire, Nico, Von Bardeleben, Ralph Stephan, Vinereanu, Drago, Zamorano, Jose Lui, Rosca, Monica, Calin, Andreea, Moonen, Marie, Magne, Julien, Cosyns, Bernard, Galli, Elena, Donal, Erwan, Carerj, Scipione, Zito, Concetta, Santoro, Ciro, Galderisi, Maurizio, Badano, Luigi P, Lang, Roberto M, Lancellotti, Patrizio, Centre Hospitalier Universitaire de Liège (CHU-Liège), Service de cardiologie [Liège], CHU de Liège-Domaine Universitaire du Sart Tilman, Universität Leipzig [Leipzig], Hospital Univeristario Virgen de la Arrixaca, Johannes Gutenberg - Universität Mainz (JGU), University and Emergency Hospital, Universidad de Alcalá - University of Alcalá (UAH), Service de cardiologie [CHU Limoges], CHU Limoges, Neuroépidémiologie Tropicale (NET), Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM)-CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM), Academisch Ziekenhuis Vrije Universiteit Brussel, Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Messina, Università degli studi di Napoli Federico II, GE Healthcare and Philips Healthcare, Service de cardiologie et maladies vasculaires, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de cardiologie et maladies vasculaires [CHU de Rennes], Manganaro, R, Marchetta, S, Dulgheru, R, Sugimoto, T, Tsugu, T, Ilardi, F, Cicenia, M, Ancion, A, Postolache, A, Martinez, C, Kacharava, G, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, de la Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Rodrigo Carbonero, J, van de Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Rosca, M, Calin, A, Moonen, M, Magne, J, Cosyns, B, Galli, E, Donal, E, Carerj, S, Zito, C, Santoro, C, Galderisi, M, Badano, L, Lang, R, and Lancellotti, P

Subjects
Adult, Male, medicine.medical_specialty, Systole, adult echocardiography, Diastole, Speckle tracking echocardiography, 030204 cardiovascular system & hematology, myocardial strain, myocardial work, speckle tracking echocardiography, Ventricular Function, Left, Correlation, Ventricular Dysfunction, Left, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Ejection fraction, business.industry, Work (physics), Stroke Volume, MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, General Medicine, Middle Aged, medicine.anatomical_structure, Blood pressure, Echocardiography, Ventricle, Cardiology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Cardiology and Cardiovascular Medicine, business
Abstract

Aims The present study sought to evaluate the correlation between indices of non-invasive myocardial work (MW) and left ventricle (LV) size, traditional and advanced parameters of LV systolic and diastolic function by 2D echocardiography (2DE). Methods and results A total of 226 (85 men, mean age: 45 ± 13 years) healthy subjects were enrolled at 22 collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. Global work index (GWI), global constructive work (GCW), global work waste (GWW), and global work efficiency (GWE) were estimated from LV pressure-strain loops using custom software. Peak LV pressure was estimated non-invasively from brachial artery cuff pressure. LV size, parameters of systolic and diastolic function and ventricular-arterial coupling were measured by echocardiography. As advanced indices of myocardial performance, global longitudinal strain (GLS), global circumferential strain (GCS), and global radial strain (GRS) were obtained. On multivariable analysis, GWI was significantly correlated with GLS (standardized beta-coefficient = −0.23, P Conclusion The non-invasive MW indices show a good correlation with traditional 2DE parameters of myocardial systolic function and myocardial strain.

Published
2020

2. Echocardiographic reference ranges for normal non-invasive myocardial work indices: results from the EACVI NORRE study

Author

Stella Marchetta, Anne Bernard, Ralph Stephan von Bardeleben, Elena Galli, Tadafumi Sugimoto, Concetta Zito, Maurizio Galderisi, Sébastien Robinet, Daniele Barone, Sara Cimino, Monica Baroni, Tolga Ozyigit, Yun Yun Go, Bernard Cosyns, Roberta Manganaro, Marie Moonen, Ciro Santoro, George Athanassopoulos, Gonzalo de la Morena, Scipione Carerj, Andreas Hagendorff, Erwan Donal, José Luis Zamorano, Nico Van de Veire, Federica Ilardi, Patrizio Lancellotti, Dragos Vinereanu, Bogdan A. Popescu, Monica Rosca, Raluca Elena Dulgheru, Krasimira Hristova, Nuno Cardim, Jose David Rodrigo Carbonero, Roberto M. Lang, Teresa López-Fernández, Luigi P. Badano, Andreea Calin, Cécile Oury, Julien Magne, Martin Penicka, George Kacharava, Clinical sciences, Cardio-vascular diseases, Cardiology, Manganaro, R, Marchetta, S, Dulgheru, R, Ilardi, F, Sugimoto, T, Robinet, S, Cimino, S, Go, Y, Bernard, A, Kacharava, G, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, López-Fernández, T, de la Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Rodrigo Carbonero, J, van de Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Rosca, M, Calin, A, Moonen, M, Magne, J, Cosyns, B, Galli, E, Donal, E, Carerj, S, Zito, C, Santoro, C, Galderisi, M, Badano, L, Lang, R, Oury, C, Lancellotti, P, Centre Hospitalier Universitaire de Liège (CHU-Liège), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Universität Leipzig [Leipzig], Universidad de Alcalá - University of Alcalá (UAH), Neuroépidémiologie Tropicale (NET), CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), In vivo Cellular and Molecular Imaging Laboratory, Vrije Universiteit Brussel (VUB), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Messina, GE Healthcare, EACVI Research and Innovation Committee, Heart House, NORRE, Philips Healthcare, Manganaro, R., Marchetta, S., Dulgheru, R., Ilardi, F., Sugimoto, T., Robinet, S., Cimino, S., Go, Y. Y., Bernard, A., Kacharava, G., Athanassopoulos, G. D., Barone, D., Baroni, M., Cardim, N., Hagendorff, A., Hristova, K., Lopez-Fernandez, T., De La Morena, G., Popescu, B. A., Penicka, M., Ozyigit, T., Rodrigo Carbonero, J. D., Van De Veire, N., Von Bardeleben, R. S., Vinereanu, D., Zamorano, J. L., Rosca, M., Calin, A., Moonen, M., Magne, J., Cosyns, B., Galli, E., Donal, E., Carerj, S., Zito, C., Santoro, C., Galderisi, M., Badano, L. P., Lang, R. M., Oury, C., Lancellotti, P., Universität Leipzig, and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, medicine.medical_specialty, adult echocardiography, Work efficiency, 030204 cardiovascular system & hematology, 2D echocardiography, 03 medical and health sciences, 0302 clinical medicine, Reference Values, Internal medicine, medicine.artery, Healthy volunteers, Medicine, Humans, Radiology, Nuclear Medicine and imaging, myocardial work, reference values, Prospective Studies, Brachial artery, adult echocardiography • 2D echocardiography • myocardial work • reference values, business.industry, Non invasive, Healthy subjects, reference value, Mean age, General Medicine, MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Middle Aged, Europe, Blood pressure, Echocardiography, Heart Function Tests, Cardiology, Female, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Cardiology and Cardiovascular Medicine, business, Large group, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing
Abstract

International audience; Aims - To obtain the normal ranges for 2D echocardiographic (2DE) indices of myocardial work (MW) from a large group of healthy volunteers over a wide range of ages and gender. Methods and results - A total of 226 (85 men, mean age: 45 ± 13 years) healthy subjects were enrolled at 22 collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. Global work index (GWI), global constructive work (GCW), global work waste (GWW), and global work efficiency (GWE) were estimated from left ventricle (LV) pressure-strain loops. Peak LV systolic pressure was non-invasively derived from brachial artery cuff pressure. The lowest values of MW indices in men and women were 1270 mmHg% and 1310 mmHg% for GWI, 1650 mmHg% and 1544 mmHg% for GCW, and 90% and 91% for GWE, respectively. The highest value for GWW was 238 mmHg% in men and 239 mmHg% in women. Men had significant lower values of GWE and higher values of GWW. GWI and GCW significantly increased with age in women. Conclusion - The NORRE study provides useful 2DE reference ranges for novel indices of non-invasive MW.

Published
2019

3. Echocardiographic reference ranges for normal left ventricular 2D strain: results from the EACVI NORRE study

Author

Ralph Stephan von Bardeleben, José Luis Zamorano, Jose David Rodrigo Carbonero, Maurizio Galderisi, Daniele Barone, Monica Baroni, Erwan Donal, Gonzalo de la Morena, Krasimira Hristova, Federica Ilardi, Tolga Ozyigit, Laura Contu, Anne Bernard, Natela Akhaladze, Martin Penicka, Yun Yun Go, Nico Van de Veire, Karima Addetia, Stella Marchetta, Bernard Cosyns, Nuno Cardim, Luis Caballero, Julien Magne, Roberto M. Lang, Dragos Vinereanu, Raluca Elena Dulgheru, Luigi P. Badano, Patrizio Lancellotti, Andreas Hagendorff, Andrea Calin, Tadafumi Sugimoto, Monica Rosca, Gilbert Habib, George Athanassopoulos, Bogdan A. Popescu, Marie Moonen, Teresa López, Cardio-vascular diseases, Clinical sciences, Faculty of Medicine and Pharmacy, Centre Hospitalier Universitaire de Liège (CHU-Liège), Universität Leipzig [Leipzig], Johannes Gutenberg - Universität Mainz (JGU), Universidad de Alcalá - University of Alcalá (UAH), CHU Dupuytren, Academisch Ziekenhuis Vrije Universiteit Brussel, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Universita degli Studi di Padova, University of Chicago, GE Healthcare, Philips Healthcare, Universität Leipzig, Johannes Gutenberg - Universität Mainz = Johannes Gutenberg University (JGU), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Università degli Studi di Padova = University of Padua (Unipd), Sugimoto, T, Dulgheru, R, Bernard, A, Ilardi, F, Contu, L, Addetia, K, Caballero, L, Akhaladze, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Moonen, M, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Go, Y, Rosca, M, Calin, A, Magne, J, Cosyns, B, Marchetta, S, Donal, E, Habib, G, Galderisi, M, Badano, L, Lang, R, Lancellotti, P, Sugimoto, Tadafumi, Dulgheru, Raluca, Bernard, Anne, Ilardi, Federica, Contu, Laura, Addetia, Karima, Caballero, Lui, Akhaladze, Natela, Athanassopoulos, George D., Barone, Daniele, Baroni, Monica, Cardim, Nuno, Hagendorff, Andrea, Hristova, Krasimira, Lopez, Teresa, De La Morena, Gonzalo, Popescu, Bogdan A., Moonen, Marie, Penicka, Martin, Ozyigit, Tolga, Carbonero, Jose David Rodrigo, Van De Veire, Nico, Von Bardeleben, Ralph Stephan, Vinereanu, Drago, Zamorano, Jose Lui, Go, Yun Yun, Rosca, Monica, Calin, Andrea, Magne, Julien, Cosyns, Bernard, Marchetta, Stella, Donal, Erwan, Habib, Gilbert, Galderisi, Maurizio, Badano, Luigi P., Lang, Roberto M., and Lancellotti, Patrizio

Subjects
Male, Longitudinal strain, deformation imaging, [SDV]Life Sciences [q-bio], Sex Factor, 030204 cardiovascular system & hematology, Standard deviation, Ventricular Function, Left, Heart Ventricle, 2D echocardiography, 0302 clinical medicine, Reference Values, Nuclear Medicine and Imaging, Image Processing, Computer-Assisted, Medicine, Circumferential strain, Age Factor, Reference Value, 030212 general & internal medicine, Multivariate Analysi, Adult echocardiography, Deformation imaging, Reference values, Radiology, Nuclear Medicine and Imaging, Cardiology and Cardiovascular Medicine, Observer Variation, Strain (chemistry), Age Factors, General Medicine, Middle Aged, Healthy Volunteer, Healthy Volunteers, Europe, Homogeneous, Echocardiography, Radiology Nuclear Medicine and imaging, Cardiology, Linear Model, Female, Radiology, Radial stress, Human, Adult, medicine.medical_specialty, adult echocardiography, Heart Ventricles, 03 medical and health sciences, Sex Factors, Internal medicine, Humans, Radiology, Nuclear Medicine and imaging, 2d strain, business.industry, MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Multivariate Analysis, Linear Models, business
Abstract

International audience; Aims - To obtain the normal ranges for 2D echocardiographic (2DE) measurements of left ventricular (LV) strain from a large group of healthy volunteers accounting for age and gender. Methods and results - A total of 549 (mean age: 45.6 ± 13.3 years) healthy subjects were enrolled at 22 collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. 2DE data sets have been analysed with a vendor-independent software package allowing homogeneous measurements irrespective of the echocardiographic equipment used to acquire the data sets. The lowest expected values of LV strains and twist calculated as ± 1.96 standard deviations from the mean were -16.7% in men and -17.8% in women for longitudinal strain, -22.3% and -23.6% for circumferential strain, 20.6% and 21.5% for radial strain, and 2.2 degrees and 1.9 degrees for twist, respectively. In multivariable analysis, longitudinal strain decreased with age whereas the opposite occurred with circumferential and radial strain. Male gender was associated with lower strain for longitudinal, circumferential, and radial strain. Inter-vendor differences were observed for circumferential and radial strain despite the use of vendor-independent software. Importantly, no intervendor differences were noted in longitudinal strain. Conclusion - The NORRE study provides contemporary, applicable 2D echocardiographic reference ranges for LV longitudinal, radial, and circumferential strain. Our data highlight the importance of age- and gender-specific reference values for LV strain.

Published
2017

4. Two-dimensional transthoracic echocardiographic normal reference ranges for proximal aorta dimensions: Results from the EACVI NORRE study

Author

Teresa López, Nico Van de Veire, Daniele Barone, Ralph Stephan von Bardeleben, Bogdan A. Popescu, Monica Baroni, Erwan Donal, Jose David Rodrigo Carbonero, Dragos Vinereanu, Roberto M. Lang, Ann-Stephan Gori, Luigi P. Badano, Gonzalo de la Morena, Seisyou Kou, Martin Penicka, Tolga Ozyigit, Gilbert Habib, Natalia Gonjilashvili, Karima Addetia, Krasimira Hristova, Patrizio Lancellotti, George Athanassopoulos, Nuno Cardim, José Luis Zamorano, Anne Bernard, Andreas Hagendorff, Bernard Cosyns, Luis Caballero, Raluca Elena Dulgheru, Daniel Saura, Saura, D, Dulgheru, R, Caballero, L, Bernard, A, Kou, S, Gonjilashvili, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Gori, A, Cosyns, B, Donal, E, Habib, G, Addetia, K, Lang, R, Badano, L, Lancellotti, P, Hospital Clínico Universitario Virgen de la Arrixaca = University Hospital Virgen de la Arrixaca [Murcia], Groupe Interdisciplinaire de Génoprotéomique Appliquée (GIGA-Research), Université de Liège, Service de cardiologie, Cardiology, University and Emergency Hospital, CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), GE Healthcare and Philips Healthcare, Hospital Virgen de la Arrixaca, Murcia, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Cardio-vascular diseases, Clinical sciences, and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)

Subjects
Male, Aorta, Thoracic, Sex Factor, 030204 cardiovascular system & hematology, Reproducibility of result, Cohort Studies, 0302 clinical medicine, Diastole, Medicine, Thoracic aorta, Age Factor, Reference Value, Prospective Studies, 030212 general & internal medicine, Multivariate Analysi, Body surface area, Cardiac cycle, Age Factors, General Medicine, NORRE study, Middle Aged, Healthy Volunteer, Healthy Volunteers, Europe, Echocardiography, echocardiography, reference values, reproducibility of results, sinus of valsalva, thoracic aorta, Cardiology, Linear Model, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Female, Cardiology and Cardiovascular Medicine, Human, Adult, medicine.medical_specialty, Systole, Normal values, Reference values, 03 medical and health sciences, Young Adult, Sex Factors, Internal medicine, medicine.artery, Ascending aorta, Humans, Radiology, Nuclear Medicine and imaging, Measurement method, Aorta, Analysis of Variance, business.industry, Sinus of valsalva, Reproducibility of Results, MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Prospective Studie, Multivariate Analysis, Linear Models, Cohort Studie, business
Abstract

International audience; AIMS: To report normal reference ranges for echocardiographic dimensions of the proximal aorta obtained in a large group of healthy volunteers recruited using state-of-the-art cardiac ultrasound equipment, considering different measurement conventions, and taking into account gender, age, and body size of individuals. METHODS AND RESULTS: A total of 704 (mean age: 46.0 ± 13.5 years) healthy volunteers (310 men and 394 women) were prospectively recruited from the collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. A comprehensive echocardiographic examination was obtained in all subjects following pre-defined protocols. Aortic dimensions were obtained in systole and diastole, following both the leading-edge to leading-edge and the inner-edge to inner-edge conventions. Diameters were measured at four levels: ventricular-arterial junction, sinuses of Valsalva, sino-tubular junction, and proximal tubular ascending aorta. Measures of aortic root in the short-axis view following the orientation of each of the three sinuses were also performed. Men had significantly larger body sizes when compared with women, and showed larger aortic dimensions independently of the measurement method used. Dimensions indexed by height and body surface area are provided, and stratification by age ranges is also displayed. In multivariable analysis, the independent predictors of aortic dimensions were age, gender, and height or body surface area. CONCLUSION: The NORRE study provides normal values of proximal aorta dimensions as assessed by echocardiography. Reference ranges for different anatomical levels using different (i) measurement conventions and (ii) at different times of the cardiac cycle (i.e. mid-systole and end-diastole) are provided. Age, gender, and body size were significant determinants of aortic dimensions

Published
2017

5. Geographic variations in the PARADIGM-HF heart failure trial

Author

Pardeep S. Jhund, Kee-Sik Kim, Juan Luis Arango, Sergey Boytsov, Milton Packer, Jun Huang, Søren Lund Kristensen, Dragos Vinereanu, Raymond Chiew-Chiew Wong, Albert Hagège, Victor Shi, Jan Bĕlohlávek, Felipe Martinez, Karl Swedberg, Martin Lefkowitz, Iain B. Squire, Jianjian Gong, Michael R. Zile, Scott D. Solomon, Songsak Kiatchoosakun, Jean L. Rouleau, Efrain Gomez, Walter Cabrera, Michele Senni, John J.V. McMurray, Adel R. Rizkala, Ivan Mendoza, Kristensen, S, Martiez, F, Jhund, P, Arango, J, Bĕlohlávek, J, Boytsov, S, Cabrera, W, Gomez, E, Hagège, A, Huang, J, Kiatchoosakun, S, Kim, K, Mendoza, I, Senni, M, Squire, I, Vinereanu, D, Wong, R, Gong, J, Lefkowitz, M, Rizkala, A, Rouleau, J, Shi, V, Solomon, S, Swedberg, K, Zile, M, Packer, M, and Mcmurray, J

Subjects
medicine.medical_specialty, Pediatrics, Prognostic variable, Asia, Prognosi, heart failure, 030204 cardiovascular system & hematology, Sacubitril, Paradigm hf, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, In patient, 030212 general & internal medicine, Aged, business.industry, geographical variation, clinical trial, Middle Aged, medicine.disease, Comorbidity, Europe, Hospitalization, Clinical trial, Valsartan, Heart failure, treatment outcome, prognosis, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

Aims The globalization of clinical trials has highlighted geographic variations in patient characteristics, event rates, and treatment effects. We investigated these further in PARADIGM-HF, the largest and most globally representative trial in heart failure (HF) to date. Methods and results We looked at five regions: North America (NA) 622 (8%), Western Europe (WE) 1680 (20%), Central/Eastern Europe/Russia (CEER) 2762 (33%), Latin America (LA) 1413 (17%), and Asia-Pacific (AP) 1487 (18%). Notable differences included: WE patients (mean age 68 years) and NA (65 years) were older than AP (58 years) and LA (63 years) and had more coronary disease; NA and CEER patients had the worst signs, symptoms, and functional status. North American patients were the most likely to have a defibrillating-device (53 vs. 2% AP) and least likely prescribed a mineralocorticoid receptor antagonist (36 vs. 61% LA). Other evidence-based therapies were used most frequently in NA and WE. Rates of the primary composite outcome of cardiovascular (CV) death or HF hospitalization (per 100 patient-years) varied among regions: NA 13.5 (95% CI 11.7–15.6), WE 9.6 (8.6–10.6), CEER 12.3 (11.4–13.2), LA 11.2 (10.0–12.5), and AP 12.5 (11.3–13.8). After adjustment for prognostic variables, relative to NA, the risk of CV death was higher in LA and AP and the risk of HF hospitalization lower in WE. The benefit of sacubitril/valsartan was consistent across regions. Conclusion There were many regional differences in PARADIGM-HF, including in age, symptoms, comorbidity, background therapy, and event-rates, although these did not modify the benefit of sacubitril/valsartan. Clinical trial registration URL . Unique identifier: [NCT01035255][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01035255&atom=%2Fehj%2Fearly%2F2016%2F06%2F27%2Feurheartj.ehw226.atom

Published
2016

6. Echocardiographic reference ranges for normal cardiac Doppler data: results from the NORRE Study

Author

Anne Bernard, Luigi P. Badano, Raluca Elena Dulgheru, Natalia Gonjilashvili, Daniele Barone, Nico Van de Veire, Dragos Vinereanu, Christophe Martinez, Seisyou Kou, Martin Penicka, Luis Caballero, Andreas Hagendorff, Alessandro Salustri, Monica Baroni, Ralph Stephan von Bardeleben, Julien Magne, Bogdan A. Popescu, Teresa López, José Juan Gómez de Diego, Jens-Uwe Voigt, Erwan Donal, Krasimira Hristova, María J. Oliva, Roberto M. Lang, George Athanassopoulos, Gonzalo de la Morena, Nuno Cardim, Jose David Rodrigo Carbonero, Tolga Ozyigit, José Luis Zamorano, Patrizio Lancellotti, Clinical sciences, Cardio-vascular diseases, Cardiology, University and Emergency Hospital, Service de cardiologie, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe Interdisciplinaire de Génoprotéomique Appliquée (GIGA-Research), Université de Liège, Hospital Virgen de la Arrixaca, Murcia, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospital Clínico Universitario Virgen de la Arrixaca = University Hospital Virgen de la Arrixaca [Murcia], Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Caballero, L, Kou, S, Dulgheru, R, Gonjilashvili, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, De Diego, J, Oliva, M, Hagendorff, A, Hristova, K, Lopez, T, Magne, J, Martinez, C, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Carbonero, J, Salustri, A, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Voigt, J, Zamorano, J, Bernard, A, Donal, E, Lang, R, Badano, L, and Lancellotti, P

Subjects
Male, Aging, Left, 030204 cardiovascular system & hematology, Doppler echocardiography, Ventricular Function, Left, NORRE Study, Cohort Studies, 0302 clinical medicine, Diastole, Reference Values, Nuclear Medicine and Imaging, Ventricular Function, 030212 general & internal medicine, reference values, systolic and diastolic function, Adult, Age Factors, Aged, Echocardiography, Doppler, Europe, Female, Healthy Volunteers, Heart Ventricles, Humans, Middle Aged, Sex Factors, Systole, Young Adult, Radiology, Nuclear Medicine and Imaging, Cardiology and Cardiovascular Medicine, medicine.diagnostic_test, Doppler, General Medicine, Cardiovascular physiology, medicine.anatomical_structure, Echocardiography, Cardiology, symbols, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Radiology, Doppler effect, Cohort study, medicine.medical_specialty, 03 medical and health sciences, symbols.namesake, Internal medicine, medicine, Radiology, Nuclear Medicine and imaging, business.industry, reference value, Ventricle, Reference values, business
Abstract

International audience; AIMS: Reference values for Doppler parameters according to age and gender are recommended for the assessment of heart physiology, specifically for left ventricular (LV) diastolic function. In this study, we report normal reference ranges for Doppler parameters obtained in a large group of healthy volunteers. Echocardiographic data were acquired using state-of-the-art cardiac ultrasound equipment following Doppler acquisition and measurement protocols approved by the European Association of Cardiovascular Imaging. METHODS AND RESULTS: A total of 449 (mean age: 45.8 ± 13.7 years) healthy volunteers (198 men and 251 women) were enrolled at the collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. A comprehensive echocardiographic examination was obtained from all subjects following predefined protocols. The majority of the Doppler diastolic parameters (e', E/e') as well as right ventricle systolic s' wave velocity were similar in men and women. Left ventricle s' wave velocity was higher in men than in women. E wave and e' were higher in younger subjects and decreased progressively in the older ones. E/e' ratio increased with ageing. Septal e' \textless8 cm/s was present in 19.7% of the subjects in the 40-60 year group and in 55% of those in the ≥60 year group. However, the cut-off value of average E/e' or lateral E/e' remained \textless15 or 13, respectively, in the majority of patients. CONCLUSION: The NORRE study provides the reference values for the most useful Doppler parameters in the evaluation of heart physiology. These data highlight the need of using age-specific reference values especially for the diagnosis of LV systolic and diastolic dysfunction and for the estimation of LV filling pressures

Published
2015

7. Echocardiographic reference ranges for normal cardiac chamber size: Results from the NORRE study

Author

Daniele Barone, Monica Baroni, Nico Van de Veire, Krasimira Hristova, Seisyou Kou, Christine Henri, Damien Voilliot, George Kacharava, Julien Magne, Luigi P. Badano, José Juan Gómez de Diego, Ralph Stephan von Bardeleben, Dragos Vinereanu, Alessandro Salustri, Martin Penicka, Jens-Uwe Voigt, Andreas Hagendorff, Jose David Rodrigo Carbonero, Roberto M. Lang, Carla de Sousa, Bogdan A. Popescu, George Athanassopoulos, Patrizio Lancellotti, Tolga Ozyigit, Teresa López, Erwan Donal, Nuno Cardim, Gonzalo de la Morena, José Luis Zamorano, Raluca Elena Dulgheru, Luis Caballero, Kou, S, Caballero, L, Dulgheru, R, Voilliot, D, De Sousa, C, Kacharava, G, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Gomez De Diego, J, Hagendorff, A, Henri, C, Hristova, K, Lopez, T, Magne, J, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Rodrigo Carbonero, J, Salustri, A, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Voigt, J, Zamorano, J, Donal, E, Lang, R, Badano, L, and Lancellotti, P

Subjects
Male, Lower blood pressure, Sex Factor, Heart Ventricle, Cohort Studies, Chamber size and function, Reference values, Two-dimensional echocardiography, Cardiology and Cardiovascular Medicine, Radiology, Nuclear Medicine and Imaging, Medicine (all), Nuclear Medicine and Imaging, Age Factor, Reference Value, Young adult, Body surface area, Observer Variation, Age Factors, General Medicine, Stroke volume, Middle Aged, Echocardiography, Cardiology, Female, Radiology, Human, Cohort study, Adult, medicine.medical_specialty, Heart Ventricles, Reproducibility of Result, Risk Assessment, Young Adult, Sex Factors, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Heart Atria, Aged, business.industry, Reproducibility of Results, Mean age, Stroke Volume, MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Original Articles, Cardiac chamber, Cohort Studie, business
Abstract

AimsAvailability of normative reference values for cardiac chamber quantitation is a prerequisite for accurate clinical application of echocardiography. In this study, we report normal reference ranges for cardiac chambers size obtained in a large group of healthy volunteers accounting for gender and age. Echocardiographic data were acquired using state-of-the-art cardiac ultrasound equipment following chamber quantitation protocols approved by the European Association of Cardiovascular Imaging.MethodsA total of 734 (mean age: 45.8 ± 13.3 years) healthy volunteers (320 men and 414 women) were enrolled at 22 collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. A comprehensive echocardiographic examination was performed on all subjects following pre-defined protocols. There were no gender differences in age or cholesterol levels. Compared with men, women had significantly smaller body surface areas, and lower blood pressure. Quality of echocardiographic data sets was good to excellent in the majority of patients. Upper and lower reference limits were higher in men than in women. The reference values varied with age. These age-related changes persisted for most parameters after normalization for the body surface area.ConclusionThe NORRE study provides useful two-dimensional echocardiographic reference ranges for cardiac chamber quantification. These data highlight the need for body size normalization that should be performed together with age-and gender-specific assessment for the most echocardiographic parameters. © 2014 The Author.

Published
2014

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