Heart Failure Guidelines Forum Better Understand the Heart Failure

FACULTY BIOGRAPHIES

15h & 16th October 2018 6th edition Nice France

Heart Failure Guidelines Forum Better understand the Heart failure

guidelinesGUIDELINES developmentGUIDELINES process FORUM by FORUM by HEART FAILURE and its implicationsHEART FAILURE GUIDELINES GUIDELINES FORUM by FORUM by PRIMARY HYPERTENSION PRIMARY HYPERTENSION

GUIDELINES GUIDELINES FORUM by FORUM by COPD 1 HFGFCOPD GUIDELINES GUIDELINES CONTENTS FORUM by FORUM by LIPIDS LIPIDS Clinical practice guidelines and arise as a result of a rapidly changing associated implementation strategies clinical landscape and attempts at are essential to promote optimal, addressing unmet clinical needs. evidence-based practices in heart failure prevention and management. The Guidelines Forum on While current practice guidelines Heart Failure aims to gather a are generally in agreement, specific multidisciplinary panel of leading recommendations may differ, academic international experts and reflecting diverging interpretations industry representatives involved in of the available evidence or the basic and clinical research to discuss lack of sufficient data to make the latest evidence, ongoing research evidence-based recommendations. and controversial issues that have In addition, a number of questions implications for clinical practice. Heart Failure

Guidelines Forum Chairs ...... 3

Better understand the Heart failure Faculty Members ...... 7 guidelines development process EMA representatives ...... 25 and its implications

2 CONTENTS Guidelines Forum CHAIRS

3 Stefan D. Anker

MD, PhD, FESC Contact: Charité Campus CVK, Division of Cardiology & Metabolism, Dept of Cardiology & BCRT, Augustenburger Platz 1, D-13353 Berlin, Germany.

Stefan D. Anker is Professor of (Tissue)Homeos- Dr. Anker was Vice President of the European tasis in Cardiology & Metabolism (W3) at Cha- Society of Cardiology (ESC, 2016-18), serving rité Berlin (from June 2017). Dr. Anker studied on the ESC board 2012-2018. Dr. Anker serves medicine at Charité Berlin and completed his in the board of the Heart Failure Association clinical training in Germany and the UK. He (HFA) of the ESC since 2006; he was HFA Pre- obtained his M.D. from Charité Medical School, sident (2012-14). He is founding Editor-in-Chief Berlin, Germany (1993), and his Ph.D. (1998) at of the open access journal ESC Heart Failure. National Heart & Lung Institute of Imperial Dr. Anker worked in several ESC Guideline task College London. He was Professor of Cardiolo- forces (e.g. the ESC HF guidelines 2012 & 2016). gy & Cachexia Research (W2) at Charité (2002- Dr. Anker is the founding president of the In- 14), and Professor of Innovative Clinical Trials ternational Society on Sarcopenia, Cachexia (W3) in Göttingen (2014-17). and Wasting Disorders (SCWD – see www. cachexia.org). Dr. Anker is founding Editor- Dr. Anker has authored more than 800 origi- in-Chief of the Journal of Cachexia, Sarcopenia nal papers, reviews, and editorials that are well and Muscle (JCSM, 2016-IF: 12.51, see www. cited. For his work Dr. Anker has won several jcsm.info). Dr. Anker was and is member of >30 prizes, including the 2018 Copernicus Prize international clinical trial steering committees, of German DFG & Polish FNP. He obtained a chairing or co-chairing several currently (FAIR- number of fellowships & grants, incl. 2 from HF2, EMPEROR-HFpEF, Fair-HFpEF, EMPE- NIH (WARCEF EU), 2 EU-FP7 & 2 IMI/Ho- RIAL-HFpEF, RELIEVE-HF) as well as in the rizon2020 grants. He was co-ordinator for “SI- past (incl. FAIR-HF, TIM-HF, AUGMENT-HF, CA-HF” (EU-FP7). He received grants for three IMPULSE-HF & BACH). He served in a num- IITs that are currently running for >13 Mill EUR ber of DMC’s (chairing 4) and end-point com- (from DZHK Germany & several industries). mittees (chairing 4).

4 Gerasimos Filippatos

Dean, School of Medicine University of Cyprus Professor of Cardiology, University of Cyprus & National and Kapodistrian University of Athens

Gerasimos Filippatos studied Medicine at has published over 450 articles in peer-re- the University of Patras, GR, and earned viewed journals and authored more than his doctorate Cum Laude from the Univer- 30 book chapters including the “Acute sity of Athens. He subsequently completed Heart Failure” chapter in Braunwald’s and his clinical training in Chicago, USA; and Oxford Desc Reference: Cardiology. Moreo- Cambridge, UK. ver, he has (co) edited 5 books including the ESC Textbook of Acute and Intensive Prof Filippatos is past President of the Cardiac Care, Highly Commended in the Heart Failure Association (HFA) of the 2011 British Medical Association Medical European Society of Cardiology (ESC). He Book Awards; in 2014 presented the book has served as Chair of the Clinical Section Heart Failure: The Expert’s Approach and and the Committee on Acute Heart Fai- in 2016 the pocket book: Treatment Algo- lure of the HFA, and as Chair of the ESC’s rithms in Heart Failure. Working Group on Acute Cardiac Care. He was also Coordinator of the ESC Congress Prof. Filippatos is in the Thomson Reuters Programme Committee for Heart Failure list of Highly Cited Researchers. and Acute Cardiac Care, member of the ESC Practice Guidelines Committee and Honorary Member of many Cardiac Socie- American College of Cardiology/American ties: ie French Cardiac Society, Romanian Heart Association HF Guidelines Writing Cardiac Society, Hungarian Cardiac So- Committee, and International Governor of ciety. the American College of Chest Physicians.

Dr. Filippatos is Associate Editor of the Euro- pean Heart Journal (impact factor>20), the International Journal of Cardiology and of the Journal of Cardiovascular Medicine. He

5 Petar M. Seferovic

President, Heart failure Association of the ESC Corresponding member of Serbian Academy of Sciences and Arts Professor, University of Belgrade Faculty of Medicine and Heart Failure Center, University Medical Center, Belgrade President, Heart Failure Society of Serbia Petar Seferovic is President of the Heart His research interests mainly include heart Failure Association of the European So- failure, acute and chronic, cardiomyop ciety of Cardiology. thies, myocarditis, pericardial disease as well as cardiovascular disease and dia- He has a long standing experience in the betes. He has been involved in numerous activities of ESC, and later was involved heart failure clinical trials as a National in Heart Failure Association projects for coordinator and Principal investigator, almost a decade. member of international steering committees, endpoint committees, and advi- He is a Chair of Internal medicine, Bel- sory boards. grade University School of Medicine and Professor, Heart failure Department, Prof. Seferovic has coauthored a total of University Medical Center Belgrade, 570 publications, with cumulative im- Belgrade, Serbia. After completing his pact factor of 730 (h-index 31), including training and fellowship at Belgrade multiple papers in peer-reviewed inter- University School of Medicine and Kings national journals. He has a total citation College Hospital in London, UK, he spent of 15560 (Google Scholar) / 14758 (Sco- two years as a Visiting Assistant pro- pus). He presented more than 221 lec- fessor in Methodist Hospital and Bay- tures at International conferences. lor College of Medicine, Houston, USA. Prof. Seferovic was leading the intro- He acted as a Task Force member on se- duction of several methods of interven- veral ESC guidelines, including ESC gui- tional cardiology and myocardial and delines on the diagnosis and treatment pericardial disease in Serbia, including of acute and chronic heart failure, the percutaneous transluminal angioplasty, ESC guidelines for the management of endomyocardial biopsy, percutaneous pericardial disease, and the guidelines pericardioscopy and pericardial biopsy. on cardiovascular diseases in diabetes. In Starting mid-90’s, he dedicated his clini- addition, Petar Seferovic serves as a re- cal and research activity to chronic and viewer for several journals. acute heart failure. He is Corresponding member of Serbian Academy of Scien- cies and Arts and President, Heart Fai- lure Society of Serbia

6 Guidelines Forum FACULTY

7 William T. Abraham

M.D., F.A.C.P., F.A.C.C., F.A.H.A., F.E.S.C., F.R.C.P. Professor of Internal Medicine, Physiology and Cell Biology Chair of Excellence in Cardiovascular Medicine Associate Dean for Clinical Research Chief, Division of Cardiovascular Medicine Medical Director, Clinical Trials Management Office Deputy Director, Dorothy M. Davis Heart and Lung Research Institute The Ohio State University, Columbus, Ohio

Dr. Abraham earned his medical degree from Harvard and vasopressin receptor antagonists; and acute Medical School in Boston, Massachusetts, following heart failure and renal dysfunction complicating which he completed his residency in Internal heart failure. His work has contributed to the approval Medicine and fellowships in Cardiovascular Disease and adoption of several therapies for heart failure, and Advanced Heart Failure/Transplant Cardiology at including beta-blockers, natriuretic peptides, cardiac the University of Colorado Health Sciences Center. He resynchronization therapy, ultrafiltration devices, previously held leadership positions at the University implantable hemodynamic monitoring devices, and of Colorado, the University of Cincinnati, and the transvenous phrenic nerve stimulation.Dr. Abraham University of Kentucky. At the Ohio State University, Dr. has authored more than 1,000 original papers, Abraham holds several leadership positions including abstracts, book chapters, and review articles. His work an Associate Dean position, managing the College has been published in high impact journals, including of Medicine’s non-cancer clinical and translational The New England Journal of Medicine, The Lancet, research portfolio. As Division Director, Dr. Abraham the Journal of the American Medical Association, has developed one of the largest and most successful Circulation, the European Heart Journal, and the academic programs of Cardiovascular Medicine in the Journal of the American College of Cardiology. Dr. U.S. Abraham has co-authored national heart failure Clinically, Dr. Abraham is board certified in Internal practice guidelines and co-edited a leading textbook Medicine and Advanced Heart Failure and Transplant on heart failure entitled Heart Failure: A Practical Cardiology. He spends the majority of his clinical Approach to Treatment and serves as series editor time managing heart failure patients in the inpatient for the Color Atlas and Synopsis of Cardiovascular and outpatient settings. Dr. Abraham has been Medicine. Dr. Abraham serves on the editorial boards recognized as one of the “Best Doctors in America” of several major journals. From 2014 through 2018, for sixteen consecutive years and has been ranked he was named to the Clarivate Analytics (formerly among the top 10% of physicians nationally in patient Thomson Reuters) Highly Cited Researchers list and as satisfaction. one of The World’s Most Influential Scientific Minds. In 2017, he received the Distinguished Scientist Dr. Abraham’s research program focuses on Award (Clinical Domain) from the American College elucidating basic mechanisms in heart failure and of Cardiology. on clinical drug and device trials in heart failure. Dr. Abraham has received grants from the National Institutes of Health (NIH) including current NIH funding totaling more than $18 million, the American College of Cardiology, and the Aetna Quality Care Foundation. He has made major contributions to advancing clinical science and patient care in heart failure in at least three areas: device development in heart failure; neurohormonal therapies in heart failure including beta-blockers, natriuretic peptides,

8 Javed Butler

MD, MPH, MBA

Javed Butler is the Patrick H. Lehan Chair Dr. Butler is board certified in cardiovascu- in Cardiovascular Research, and Profes- lar medicine and advanced heart failure sor and Chairman of the Department of and transplant medicine. His research inte- Medicine at the University of Mississippi in rests focus on clinical trials in patients with Jackson Mississippi. He is also Professor of heart failure. He serves on several natio- Physiology. Prior to joining the University nal committees for the American College of Mississippi, he was Charles A. Gargano of Cardiology, American Heart Associa- Professor and Director of the Division of tion, National Institutes of Health, and the Cardiovascular Medicine and Co-Director Heart Failure Society of America. He is the of the Heart Institute at Stony Brook Uni- recipient of the Simon Dack Award by the versity, New York. He had served as the American College of Cardiology as well as director for heart failure research at Emo- the Time, Feeling, and Focus Award by the ry University and director of the heart and American Heart Association. heart-lung transplant programs at Van- derbilt University prior to that. Dr. Butler has authored more than 500 peer-reviewed publications. He serves on He received his medical degree from the the editorial board of several peer reviewed Aga Khan University and then completed cardiovascular journals. He has been cited residency training at Yale University, car- numerous times in America’s Best Doctors diology fellowship and advanced heart list. failure and transplant fellowships at Van- derbilt University, and cardiac imaging fellowship at the Massachusetts General Hospital at the Harvard Medical School. He has completed Master of Public Health degree from Harvard University and Mas- ter in Business Administration from Emory University.

9 John G. F. Cleland

MD, PhD, FRCP, FACC, FESC. [email protected] / [email protected]

implementation of guidelines. Particular Professor Cleland was appointed the Di- current interests include the influence of rector of the Robertson Centre for Bios- myocardial substrate on therapeutic res- tatistics and Clinical Trials in 2016, an ponse, congestion and inflammation as internationally accredited Clinical Trials novel therapeutic targets, telemonito- Unit offering a complete service both ring and theranostics. to academic clinicians and industry. The special area of expertise is cardiovascular He is a Past Chairman of the ESC Wor- disease but includes all branches of me- king Group on Heart Failure and of the dicine and social sciences. British Society for Heart Failure, founded the European Journal of Heart Failure He qualified from the University of Glas- and chairs the Academic Committee of gow and completed his training at St. the National Heart Failure Audit and Mary’s, Paddington and Hammersmith the National Clinical Specialties Research Hospitals, London in 1989. In 1994, he was group on Heart Failure. He has published awarded a Senior Fellowship by the Bri- more than 800 papers in peer reviewed tish Heart Foundation, moving back to journals and is a Thomson Reuters Highly Glasgow. He was appointed Professor Cited Researcher. of Cardiology at the University of Hull in 1999 and subsequently, in 2013, at the National Heart & Lung Institute, Royal Brompton and Harefield Hospitals, Im- perial College London, where he retains a part-time contract.

His main area of interest is in heart failure, extending from its epidemiology and prevention, to Phase II-IV randomized trials through to the development and

10 Andrew Coats

Andrew was born in Melbourne, Australia Andrew has been Chairman or Committee and studied Medicine at Oxford and Cam- member of the following major Cardio- bridge. He has published over 20 patents vascular and Cancer Cachexia Clinical and more than over 600 peer-reviewed Trials: CHRISTMAS, CHARM, COPERNI- research papers. He has more than 75,000 CUS, OXAM, OPTIMAAL, OVERTURE, career citations, and a personal H-index of REPLACE, SENIORS, AUGMENT-HF and 121. He served as Editor-in-Chief of the Inter- ACT-ONE. He has served Head of Car- national Journal of Cardiology from1999 to diology at Imperial College and Director 2016 and has served on more than 10 major of Cardiology at Royal Brompton Hospi- journal editorial boards. Andrew is an ex- tal, London then as Dean of Medicine and pert on heart failure. He first described the Deputy Vice-President at the University of Muscle Hypothesis of Chronic Heart Failure Sydney, and as Joint Academic Vice-Pre- that explained dyspnoea and exaggerated sident of Monash University, Australia and ventilatory responses in CHF patients. He the University of Warwick, UK. He is pre- first described chemoreflex overactivity in sently President Elect of the Heart Failure CHF and periodic breathing and published Association of the ESC. the first ever randomised trial of exercise training for CHF.

11 Kenneth Dickstein

MD, PhD FESC University of Bergen, Stavanger University Hospital, Stavanger, Norway.

Kenneth Dickstein was born in Phila- Professor Dickstein is a Past-President delphia and completed undergraduate of the Heart Failure Association of the education at the Univ. of Pennsylvania. European Society of Cardiology and has He has medical degrees from the Univ. been a councillor on the ESC Board. He of London and the Royal College of Sur- was Chairman of the Task Forces for two geons in Dublin. He was a research fellow of the ESC Guidelines on Heart Failure. at Harvard Medical School (1988-90) and In 2016, he received the National Re- completed his PhD in exercise physiology search Prize from the Norwegian Natio- at the Univ. of Bergen in 1992. Professor nal Society and the Falch Research Prize Dickstein was in charge of the coronary from the University of Bergen in 2017. care unit at Stavanger University Hospi- Prof. Dickstein has been an author on tal, full professor of medicine at the Univ. over 370 scientific papers and held over of Bergen and was coordinator for the 400 invited lectures at international ve- medical student teaching program at nues. He is the founder of the ESC pa- the hospital. His primary focus is clinical tient website heartfailurematters.org, is research in heart failure with an interest a member of numerous editorial boards in both pharmacologic therapy and the and steering committees and is an active use of cardiac devices in patients with associate editor of the European Journal heart failure. of Heart Failure. He resides with his wife and 2 sons on the west coast of Norway and spends his summers fly fishing.

12 Gerd Hasenfuß

Gerd Hasenfuß is Professor of Internal Me- In 2013, he joined the Board of Directors dicine and Cardiology and is Chair of the of DGIM (Deutsche Gesellschaft für Innere Clinic of Cardiology and Pneumology at Medizin e.V.). Dr. Hasenfuß has authored University Medical Center Göttingen (from 495 original papers, reviews, and editorials April 1998) and Chair of Heart Center Göt- (h-index: 72). Dr. Hasenfuß has won seve- tingen, and of HRCG. ral prizes and obtained a number of fellowships, awards and honours. He has been Dr. Hasenfuß received his training in me- a Principal Investigator of several clinical dicine at University of Freiburg from 1982 trials. to 1988. From 1988 to 1990 he was Visiting Assistant Professor at Department Molecu- His main research interests are heart failure lar Physiology and Biophysics, University of pathophysiology and clinical treatment, Burlington, Vermont, USA. 1993 to 1998 he calcium cycling, electrophysiology, and was an Assistant Professor in Internal Medi- stem cell biology. cine and Cardiology, University of Freiburg. He is also Chief of Clinics and Rehabilita- tion Center Lippoldsberg since 2005. Since 2011 he is member of the Board of Direc- tors of the DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.), and since 2012 Speaker of the SFB 1002, CRC (Col- laborative Research Center) «Modulatory Units in Heart Failure».

13 Friedrich Koehler © Peitz/Charité Universitätsmedizin Berlin. Universitätsmedizin © Peitz/Charité

MD, FESC is Senior Physician in Cardiolo- of heart failure patients. From 2013-2018 gy at the Medical Department, Division he was Principial Investigator of the pu- of Cardiology and Angiology, Charité - blic funded randomized controlled trial Universitätsmedizin Berlin and Professor «Telemedical Interventional Manage- for Cardiovascular Telemedicine. ment in Heart Failure II» (TIM-HF2, NCT01878630) with 1,538 heart failure He is Head of the Centre for Cardio- patients. Also, he is working in task forces vascular Telemedicine which is the spe- for Digital Medicine in the European So- cialized in research and development ciety of Cardiology and German Society projects of remote patient management for Internal Medicine (DGIM).

14 Mitja Lainscak

Dr. Mitja Lainscak is Professor at Faculty of Medicine, University of Ljubljana and does clinical practice & research at Division of Cardiology, General Hospital Murska Sobota, Slovenia. His clinical and research interest is cardiovascular medicine with particular emphasis on heart failure, pharmacotherapy, and metabolism with body composition. Currently he holds an Execu- tive Committee member position at the Heart Failure Association of the ESC, and is a Fellow of the HFA and of the ESC. In 2018, he was the Scientific Chairperson of the Heart Failure Association annual congress. Professor Lainscak has published more than 200 papers and contributed to several book chapters. He is Associate Edi- tor at Journal of Cachexia, Sarcopenia, and Muscle and ESC Heart Failure.

15 Theresa A. McDonagh

MD, FRCP, FESC. Consultant Cardiologist, and Clinical Lead for Cardiology and Heart Failure King’s College Hospital Denmark Hill London, SE5 9RS Tel:020 3299 3259 Email: [email protected]

Professor McDonagh qualified from the Her main research interests are in novel University of Edinburgh and completed biomarkers for heart failure and the de- her internal medicine training there. She livery of heart failure services. trained in Cardiology at the Western In- firmary in Glasgow. Her main research She is a past Chair of the British Society was on the epidemiology of Left Ventri- for Heart Failure a Past Chair of the cular Dysfunction and Natriuretic Pep- Clinical Section of the Heart Failure As- tides hormones. sociation of the European Society of Car- diology. She is the Clinical Lead for the Subsequently she was appointed as National Heart Failure Audit. a Senior Lecturer at the University of Glasgow and Glasgow Royal Infirmary where she ran the Heart Failure Service and was the Cardiologist involved in the Heart Transplant Programme (1999- 2004). Following this she was a Consul- tant Cardiologist at the Royal Brompton Hospital, London (2004-2011) where led the Heart Failure Service, before moving to King’s College Hospital to head up the Heart Failure Programme.

16 Marco Metra

University of Brescia, Italy

Marco Metra is Professor of Cardiology and research activity is focused on treatment of Director of the Institute of Cardiology of heart failure and its comorbidities. He has the Department of Medical and Surgical had a leading role in multiple trials of new Specialties, Radiological Sciences and Pu- therapies in patients with heart failure. blic Health of the University and Civil Hos- pitals of Brescia, Italy. He is the ex-officio member of the board of HFA, a fellow of HFA, ESC, the Heart He is Editor-in-Chief of the European Jour- Failure Society of America, a member of nal of Heart Failure, the official journal the Italian Society of Cardiology (SIC) and of the Heart Failure Association (HFA) of many other scientific societies. the European Society of Cardiology (ESC), Senior Consulting Editor of the European He is author of more than 500 articles in Heart Journal and member of the Editorial peer-reviewed journals with a current goo- board of many other scientific journals. His gle scholar H index of 86.

17 Martin Möckel

Prof. Dr. Martin Möckel, FESC, FAHA Charité-Universitätsmedizin Berlin, Germany

Martin Möckel is a Senior Physician, Professor Möckel has delivered more Professor of Cardiology and Head of than 200 oral and poster presentations Emergency Medicine and Acute Cardio- at leading national and international vascular Care at Charité-Universitäts- conferences and has published exten- medizin Berlin, Germany. His research sively in the fields of emergency medi- focuses on biomarkers, health care re- cine, acute cardiac care and health care search in Emergency and Acute Medi- research. He is part of the biomarker core cine, the application of interventional groups of the Acute Cardiovascular Care therapy in acute coronary care and he Association and the upcoming congress has led a number of multicentre trials. president 2019 of the German Society for He is an Adjunct Professor at the James Internal Intensive Care and Emergency Cook University, School of Public Health Medicine. and Epidemiology, Townsville, Australia. Professor Möckel is joint Head of the Me- dical Apps Group for the German Car- diac Society. He is also a Fellow of the European Society of Cardiology, and an International Fellow of the American Heart Association.

18 Georg Nickenig

MD Germany Professor of Internal Medicine/Cardiology Direktor of the Medical Clinic II, - Internal medicine, Cardiology, Angiology, Pneumology and Intensive Care University Clinic Bonn

Prof. Georg Nickenig has studied me- The focus of the work of Georg Nickenig dicine at Rheinischen Friedrich-Wil- are coronary heart disease, heart failure helms-University in Bonn. After residency and atrial fibrillation. Research focuses at the Medical University Polyclinic in on molecular and cellular mechanisms Bonn, he spent two years with research of atherosclerosis and aortic disease and grant in Emory University Medical clinical research on coronary structural School, Department of cardiology/Phar- heart disease. macology in Atlanta, USA. From 2000 to 2005, after working at the Cardiology He has authored or co-authored more Department of the University Hospital than 500 articles in international peer-re- in Cologne, he was working as Profes- viewed journals. sor of Cardiology in the Department of Internal Medicine III (Cardiology) at the University Hospital of the Saarland in Homburg.

In 2005 he was appointed to the Chair of Internal Medicine, Division of Cardiology and Pneumology at the University of Bonn and as Director of Medical Hospital II at the University Hospital Bonn.

19 Jean-François Obadia

Professor Jean-François Obadia is ac- strong input in the developpement of the tually the chief of a department of Adult per-cutaneous approaches for the aortic Cardiac surgery in Lyon – France. As a valves (TAVI) and Mitral vales (Mitraclip, member of EACTS, ISHLT, AATS, he is Valve in Valve, Valve in MAC, Neochord, mainly involved in valvular Surgery and Tendyne…). He was the PI of the Mitra.fr Cardiac assistance and transplantation. study recently published in the NEJM.

The valvular program includes all as- The transplantation program includes pects of valvular surgery from the most 45 hearts transplantations, 15 Mono Left complex repairs for endocarditis (Ho- assistance, 15 bi-VAD and around 100 mograft of monobloc aorto-mitral) to ECMO. the minimally invasive approaches for mitral. The surgeons are involved with a

20 Ileana L. Piña

MD, MPH Professor of Medicine Professor of Epidemiology & Population Health Albert Einstein College of Medicine Associate Chief for Academic Affairs Montefiore Medical Center Heart and Vascular Bronx, New York

Ileana L. Piña, MD, MPH, is a Professor health from Case Western Reserve Univer- of Medicine, Epidemiology & Population sity School of Medicine in Cleveland, Ohio Health at the Albert Einstein College of while pursuing a VA Quality Fellowship. Medicine and Associate Chief for Acade- mic Affairs at Montefiore Medical Center in Dr. Piña’s research interests include transi- the Bronx, New York. Dr. Piña also serves tion of care in heart failure patients, and the as advisor/consultant to the Food and Drug role of natriuretic peptide–guided mana- Administrations’ Center for Devices and Ra- gement for patients hospitalized for heart diological Health and their section of Epi- failure, biomarkers of myocardial stress and demiology. fibrosis in chronic heart failure, and heart failure differences by sex. She is the author/ Dr. Piña earned her undergraduate degree co-author of more than 100 publications. in chemistry from the University of Miami in Florida. She completed her medical degree and cardiology fellowship at the University of Miami School of Medicine; an internal medicine residency at the University of Sou- th Florida Tampa, where she was Chief Re- sident; and fulfilled a surgery internship at the University of Miami Hospitals and Cli- nics. She earned a master’s degree in public

21 Piotr Ponikowski

Piotr Ponikowski is professor of cardio- Professor Ponikowski serves as an advi- logy and Head of the Department of sor and consultant for a range of phar- Heart Diseases at the Wroclaw Medical maceutical companies and has been a University in Poland. He is also Head of member of international steering/exe- the Department of Cardiology at the cutive committees and endpoint com- Centre for Heart Diseases at the 4th Mi- mittees of numerous clinical trials. litary Clinical Hospital, Wroclaw, Poland. At the Wroclaw Medical University, he His research interests focus on the patho- currently serves as the Vice-rector for physiology and management of acute scientific affairs. and chronic heart failure, and recently particularly on the aspects of iron defi- Professor Ponikowski is the President of ciency and reflex control in the cardiores- the Polish Cardiac Society, he served as piratory system. He has co-authored the President of the Heart Failure Asso- over 600 publications and has more ciation of the European Society of Car- than 44000 citations in international li- diology (2010-2012) and was a Councilor terature. of the European Society of Cardiology board (2012-2014). He has been involved in the development of several ESC guidelines as the member of the ESC Com- mittee for Practice Guidelines and was the Chair of the 2016 ESC Heart Failure Guidelines. He is also a guest editor and member of the editorial board for several cardiology-focused journals.

22 Prof. Lynn W. Stevenson

Dr. Stevenson has been Director of Car- diomyopathy and Heart Failure Pro- grams at UCLA, Brigham and Women’s Hospital, and has recently moved to be- come Director of Cardiomyopathy and the Lisa Jacobson Professor of Medicine at Vanderbilt University. She has been an active member of AHA, ACC, ISHLT, and HFSA societies and a major contributing writer to 30 national guidelines relating to heart failure, cardiac transplantation, ventricular assist devices, arrhythmia devices, and decision-making in advanced heart failure.

For the past 30 years she has supervised training of 50 fellows in heart failure and and a systematic approach to collection transplantation, over half of whom over of the contemporary data vital for pa- are women and almost all are currently tient-centered decision-making. She is in academic positions in heart failure and currently serving as co-chair for ACC transplantation. committees on the inpatient HF pathway and incorporation of patient-reported She has served on the FDA cardio-renal outcomes into cardiology practice. panel and the MEDCAC advisory panel and participated over many years Strong commitments for her remain trai- in the national accreditation of heart ning for the next generation to sustain transplant and VAD programs. She has the spirit of challenge, the patient-doc- played leadership roles in NHLBI-spon- tor relationship, and the synthesis of evi- sored studies for strategies of medical dence to guide individualization of care and device therapies in advanced heart for patients into alignment with their failure, was one of the designers of the goals for quality and length of life. INTERMACS and NCDR ICD registries, collaborates with the Cardio-Thoracic Surgery Network and has mentored 2 networks of NHLBI young investigators.

Her academic work reflects multiple aspects of heart failure physiology and clinical assessment focusing on ta- king the congestion out of heart failure,

23 Ralph Stephan von Bardeleben

Heart Center Mainz Cardiology I Universitätsmedizin Mainz Langenbeckstr. 1, 55131 Mainz [email protected] +49-(0)6131-17-2892/-6903 Current position Nucleus Valvular Heart Disease AGIK,  Senior Consulting Cardiologist, Heart Member EAPCI, EACVI Center Cardiology, University Medicine Stipendia/Honors Universitätsmedizin , Mainz, Germany   1995: Zondek-Reward Charité, Berlin Vize Head Structural and Valve Interven-  2003: EAE/ESC-Young Investigator tions, Head Mitral/Tricuspid Inverventions Award Fin., ESC Cardiology Head GUCH Adult Congenital Heart Di-  sease  President German WG Echocardio- 2015: ESC Award Interventional Valve graphy of the German Society of Cardiology Therapy on TRAMI registry Nucleus Valve Therapies AGIK WG Inter- Boards/Trials ventional Cardiology  Member ESC, EAP-  Board Member: Nucleus DGIM, President CI, EACVI, Faculty ACC, EuroPCR, TVT, TCT Echocardiography German Soc. Of Cardio- Scientific background logy 3D Cardiac Imaging incl. Image Fusion  Faculty Mitgliedschaften: TCT, EAPCI, Imaging of Coronary Ischemia TVT, PCR, Akademie der DGK, EAPCI, CEUS Contrast Imaging EACVI, AGIK Interventional Valve Therapy and Imaging  Review: Review Journals wie CAIM, IJC, Professional Career EHFJ, PCR Eurointervention, JACC CVI etc.  1988-1995: Medical Studies at the Johannes  Trials: Bracco, Mailand, SonoVue BRA-013 Gutenberg-Universität Mainz and UCSF Echo Corelab, Bracco Phönix-Trial als PI Medical School San Franscisco (DAAD). In- Bracco Lumason local PI; Abbott Vascular ternal Medicine Ludwigshafen RESHAPE 2 Steering com./ PI / Echo Core-  1995-2003: Internal Medicine, Intensive lab; Valtech Cardioband ce mark trial local Care Medicine, Cardiology PI. IIT RCT RESHAPE-HF PI. EnLigthn-Stu-  2004-2005: Interventional Cardiology die Renal Denervation, MATTERHORN ,  2006-2011: Senior Consultant and Head local PI und Echocorelab. Absorb IV-Stu- of the Cardiovascular Imaging Labs. Certi- die, Sub-investigator; Apposition-V Stu- ficate Grown Up Congenital Heart Disease die; Steering Commitee FDA Pivotal Trial incl. Cardiac Dimension Carillon (USA); Steering  2010: Interventions Faculty EuroPCR,TCT, Committee RESHAPE-2 Trial (IIT Göttin- TVT, EAPCI, EACTS gen – Europa MCT); Steering Committee  2014-2018: President WG Echocardiogra- TRILUMINATE and eligibility commitee phy of the German Soc. Of Cardiology TRI REPAIR ce mark local PI

24 Guidelines Forum EMA REPRESENTATIVES

25 Giuseppe M.C. Rosano

MD, PhD Consultant Cardiologist and Professor of Cardiology St George’s University Medical School, London, UK Director of the Centre for Experimental and Clinical Phar- macology IRCCS San Raffaele Rome, Italy E-mail: [email protected]

MD in Medicine and Surgery at the La area of Cardiovascular Medicine for the Sapienza University of Rome with full European Assessment Office of the Italian honors in 1988, Specialization in Cardio- Drug Agency (AIFA), he is core member logy in 1992 of the Cardiovascular Working Party of PhD in Medical Sciences from the Impe- the European Medicines Agency. rial College in London He is board member of the Heart Failure He has authored over 400 peer-reviewed Association (HFA) and Nucleus member articles, 5 books and 28 book chapters. of the Working Group on Cardiovascular He currently serves as an expert in the Pharmacotherapy of the ESC

26 Krishna Prasad

MB, BS, MD, FRCP, FF-FMLM Group Manager, and Expert Assessor MHRA, DoH, UK and St Thomas Hospital, London Email; [email protected]

Krishna Prasad is a Group Manager at the An active member of two different UK Regulatory Agency with direct mana- EMA/CHMP working groups- cardio- gement responsibility for 3 therapy areas vascular-Diabetes WP (2008) and the (Cardiovascular-Diabetes, Anti-infectives Pharmacogenomics WP (2005), he has and Oncology) and an Honorary Cardio- coordinated several regulatory guidelines logist at St. Thomas’ hospital, London. He in these areas. He is an author and rap- has worked for MHRA, the UK regulatory porteur for several EMA/CHMP guide- agency over 15 years initially as reviewer lines in CV area including the heart failure progressing to lead the cardio-renal-dia- guidelines, lipid lowering agents, and has betes areas and subsequently to the cur- lead the European efforts in harmonising rent post. His areas of special interest the ICH E14 guideline including the Q and in cardiology are heart failure, CV risk As. factors, arrhythmias, cardiomyopathies and sudden death. He is a long-standing Keenly interested in developing propor- member of European Society of Cardiolo- tionate regulation and advances in regu- gy. He has a keen interest in clinical trials, latory science, he is the joint lead on the trial methodology and CV endpoints for agency’s Personalised Medicine strategy. outcome trials and biomarkers. His ex- He is an active participant in the UK and perience includes review of renal toxicity European regulatory initiatives in these biomarkers, applications for renal diseases areas. An active participant and propo- and CV outcomes in renal disease pa- nent of many of the regulatory-scientific tients. Krishna is a regular participant in dialogues across the globe, he has a keen the regulatory roundtable dialogues with interest in harmonisation of approaches European Society of Cardiology and Eu- to both clinical trials and regulatory gui- ropean Heart Failure association. dance development.

27 ORGANISATION

The Heart Failure Guidelines Forum is organized by the Translational Medicine Academy.

TMA Foundation Email: [email protected] Charles Schoen William Melhuish / Yann Colardelle Tel.: + 33 (0) 6 16 54 81 57 E-mail: [email protected] and [email protected]