Review
Anesthesiology
W. Scott Beattie, Manoj Lalu, Matthew Bocock, Simon Feng, Duminda N. Wijeysundera, Peter Nagele, Lee A. Fleisher, Andrea Kurz, Bruce Biccard, Kate Leslie, Simon Howell, Giovani Landoni, Hilary Grocott, Andre Lamy, Toby Richards, Paul Myles
Summary: Through a Delphi consensus process, this study identified nine standardized and valid cardiovascular outcomes for perioperative clinical trials, including myocardial infarction, cardiovascular death, and atrial fibrillation, which were rated by experts as valid, reliable, feasible, and clearly defined.
BRITISH JOURNAL OF ANAESTHESIA
(2021)
Article
Cardiac & Cardiovascular Systems
Rebecca T. Hahn, Matthew K. Lawlor, Charles J. Davidson, Vinay Badhwar, Anna Sannino, Ernest Spitzer, Philipp Lurz, Brian R. Lindman, Yan Topilsky, Suzanne J. Baron, Scott Chadderdon, Omar K. Khalique, Gilbert H. L. Tang, Maurizio Taramasso, Paul A. Grayburn, Luigi Badano, Jonathon Leipsic, Joann Lindenfeld, Stephan Windecker, Sreekanth Vemulapalli, Bjorn Redfors, Maria C. Alu, David J. Cohen, Josep Rodes-Cabau, Gorav Ailawadi, Michael Mack, Ori Ben-Yehuda, Martin B. Leon, Joerg Hausleiter
Summary: Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown. The aim of this document is to standardize definitions of disease etiology and severity, as well as endpoints for trials, to address the gaps in our knowledge related to identification and management of patients with TR.
EUROPEAN HEART JOURNAL
(2023)
Article
Cardiac & Cardiovascular Systems
Rebecca T. Hahn, Matthew K. Lawlor, Charles J. Davidson, Vinay Badhwar, Anna Sannino, Ernest Spitzer, Philipp Lurz, Brian R. Lindman, Yan Topilsky, Suzanne J. Baron, Scott Chadderdon, Omar K. Khalique, Gilbert H. L. Tang, Maurizio Taramasso, Paul A. Grayburn, Luigi Badano, Jonathon Leipsic, Joann Lindenfeld, Stephan Windecker, Sreekanth Vemulapalli, Bjorn Redfors, Maria C. Alu, David J. Cohen, Josep Rodes-Cabau, Gorav Ailawadi, Michael Mack, Ori Ben-Yehuda, Martin B. Leon, Joerg Hausleiter
Summary: Interest in TR has grown due to progressively worse outcomes associated with increasing TR severity. The aim of the Tricuspid Valve Academic Research Consortium document is to standardize definitions and endpoints for trials addressing knowledge gaps in TR management. Another document will focus on defining trial endpoints and discussing trial design options.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2023)
Review
Cardiac & Cardiovascular Systems
Rebecca T. Hahn, Matthew K. Lawlor, Charles J. Davidson, Vinay Badhwar, Anna Sannino, Ernest Spitzer, Philipp Lurz, Brian R. Lindman, Yan Topilsky, Suzanne J. Baron, Scott Chadderdon, Omar K. Khalique, Gilbert H. L. Tang, Maurizio Taramasso, Paul A. Grayburn, Luigi Badano, Jonathon Leipsic, JoAnn Lindenfeld, Stephan Windecker, Sreekanth Vemulapalli, Bjorn Redfors, Maria C. Alu, David J. Cohen, Josep Rodes-Cabau, Gorav Ailawadi, Michael Mack, Ori Ben-Yehuda, Martin B. Leon, TVARC Steering Comm
Summary: Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has increased due to studies showing worse outcomes with increasing TR severity. Historical high mortality rates associated with isolated tricuspid valve surgery led to the development of transcatheter treatment options. This document aims to standardize definitions of TR etiology and severity, and provides endpoints for trials to address gaps in knowledge related to TR patients.
ANNALS OF THORACIC SURGERY
(2023)
Review
Cardiac & Cardiovascular Systems
Muhammad Shahzeb Khan, George L. Bakris, Milton Packer, Izza Shahid, Stefan D. Anker, Gregg C. Fonarow, Christoph Wanner, Matthew R. Weir, Faiez Zannad, Javed Butler
Summary: Heterogeneity in the reporting of kidney function and kidney outcomes in clinical trials poses challenges in comparing results and evaluating the benefits of interventions. Future stakeholders need to develop a consensus solution to improve the consistency of reporting in this area.
EUROPEAN HEART JOURNAL
(2022)
Article
Cardiac & Cardiovascular Systems
Philippe Genereux, Nicolo Piazza, Maria C. Alu, Tamim Nazif, Rebecca T. Hahn, Philippe Pibarot, Jeroen J. Bax, Jonathon A. Leipsic, Philipp Blanke, Eugene H. Blackstone, Matthew T. Finn, Samir Kapadia, Axel Linke, Michael J. Mack, Raj Makkar, Roxana Mehran, Jeffrey J. Popma, Michael Reardon, Josep Rodes-Cabau, Nicolas M. Van Mieghem, John G. Webb, David J. Cohen, Martin B. Leon
Summary: VARC aims to identify appropriate clinical endpoints and standardize their definitions for aortic valve clinical trials, with ongoing refinements and expansions to ensure clinical relevance.
EUROPEAN HEART JOURNAL
(2021)
Article
Clinical Neurology
Mohammad Anadani, Tanya N. Turan, Shadi Yaghi, Alejandro M. Spiotta, Benjamin Gory, Richa Sharma, Kevin N. Sheth, Adam de Havenon
Summary: This study found that persistent smoking after acute ischemic stroke is associated with an increased risk of cardiovascular events and death.
Article
Cardiac & Cardiovascular Systems
Philippe Genereux, Nicolo Piazza, Maria C. Alu, Tamim Nazif, Rebecca T. Hahn, Philippe Pibarot, Jeroen J. Bax, Jonathon A. Leipsic, Philipp Blanke, Eugene H. Blackstone, Matthew T. Finn, Samir Kapadia, Axel Linke, Michael J. Mack, Raj Makkar, Roxana Mehran, Jeffrey J. Popma, Michael Reardon, Josep Rodes-Cabau, Nicolas M. Van Mieghem, John G. Webb, David J. Cohen, Martin B. Leon
Summary: The Valve Academic Research Consortium (VARC) was established in 2010 to standardize clinical endpoint definitions for aortic valve clinical trials. After several years, a meeting was held involving experts to evaluate and revise specific clinical endpoint definitions, leading to the proposal of new classifications and modifications. These updates will ensure accurate reporting and comparisons in clinical research studies involving aortic valve therapies.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2021)
Article
Cardiac & Cardiovascular Systems
Philippe Genereux, Nicolo Piazza, Maria C. Alu, Tamim Nazif, Rebecca T. Hahn, Philippe Pibarot, Jeroen J. Bax, Jonathon A. Leipsic, Philipp Blanke, Eugene H. Blackstone, Matthew T. Finn, Samir Kapadia, Axel Linke, Michael J. Mack, Raj Makkar, Roxana Mehran, Jeffrey J. Popma, Michael Reardon, Josep Rodes-Cabau, Nicolas M. Van Mieghem, John G. Webb, David J. Cohen, Martin B. Leon
Summary: This document provides an update of appropriate clinical endpoint definitions for transcatheter and surgical aortic valve clinical research, aiming to ensure clinical relevance and accurate adjudication in the rapidly evolving field of less-invasive aortic valve therapies.
EUROPEAN HEART JOURNAL
(2021)
Article
Surgery
Candice Roufosse, Jan Ulrich Becker, Marion Rabant, Daniel Seron, Maria Irene Bellini, Georg A. Boehmig, Klemens Budde, Fritz Diekmann, Denis Glotz, Luuk Hilbrands, Alexandre Loupy, Rainer Oberbauer, Liset Pengel, Stefan Schneeberger, Maarten Naesens
Summary: Antibody-mediated rejection (AMR) is caused by antibodies that recognize donor human leukocyte antigen (HLA) or other targets. The European Society for Organ Transplantation (ESOT) considers that an AMR diagnosis should be based on a combination of histopathological factors and the presence of donor-specific HLA antibodies in the recipient. Evidence shows that microvascular inflammation scores ≥ 2 and glomerular basement membrane splitting of > 10% of the entire tuft in the most severely affected glomerulus are associated with impaired graft outcomes in AMR. The European Medicines Agency (EMA) has provided recommendations based on a Broad Scientific Advice request, but further discussion and consensus on the restricted definition of the AMR endpoint are needed.
TRANSPLANT INTERNATIONAL
(2022)
Article
Surgery
Daniel Seron, Marion Rabant, Jan Ulrich Becker, Candice Roufosse, Maria Irene Bellini, Georg A. Boehmig, Klemens Budde, Fritz Diekmann, Denis Glotz, Luuk Hilbrands, Alexandre Loupy, Rainer Oberbauer, Liset Pengel, Stefan Schneeberger, Maarten Naesens
Summary: The diagnosis of acute T cell-mediated rejection (aTCMR) is important for research and clinical treatment purposes. This paper reviews the history and classifications of TCMR and discusses its potential role in clinical trials. There is variability and ambiguity in the clinical monitoring and management of aTCMR, and further research is needed to improve treatment outcomes.
TRANSPLANT INTERNATIONAL
(2022)
Review
Cardiac & Cardiovascular Systems
Mattia Lunardi, Yves Louvard, Thierry Lefevre, Goran Stankovic, Francesco Burzotta, Ghassan S. Kassab, Jens F. Lassen, Olivier Darremont, Scot Garg, Bon-Kwon Koo, Niels R. Holm, Thomas W. Johnson, Manuel Pan, Yiannis S. Chatzizisis, Adrian Banning, Alaide Chieffo, Dariusz Dudek, David Hildick-Smith, Jerome Garot, Timothy D. Henry, George Dangas, Gregg W. Stone, Mitchell W. Krucoff, Donald Cutlip, Roxana Mehran, William Wijns, Faisal Sharif, Patrick W. Serruys, Yoshinobu Onuma
Summary: The Bifurcation Academic Research Consortium (Bif-ARC) project aims to address the lack of standardization and comparability in studies on bifurcation coronary lesions. This document, the result of collaboration between academic research organizations and interventional cardiology societies, provides standardized definitions, criteria for side branch relevance, and procedural, mechanistic, and clinical endpoints for different types of bifurcation studies. It also includes instructions for site and core laboratory analysis of bifurcation lesions.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2022)
Article
Surgery
Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helantera, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche, Roslyn B. Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O'Doherty, Ahmed Osama Gaber, William E. Fitzsimmons
Summary: New immunosuppressive therapies are needed for kidney transplant to improve long-term graft survival. The iBOX Scoring System has received qualification as a novel endpoint for kidney transplant clinical trials, allowing it to be used to demonstrate the superiority of new immunosuppressive therapies compared to standard care.
AMERICAN JOURNAL OF TRANSPLANTATION
(2023)
Review
Oncology
Saskia Litiere, Jan Bogaerts
Summary: The translation article introduces the importance and challenges of the Response Evaluation Criteria in Solid Tumors (RECIST) in clinical trials, as well as attempts to update and replace the criteria. The article emphasizes the value and goals of RECIST as a standardized tool, mentions issues in immunotherapy and PET imaging, and states that efforts are being made to address these issues.
JOURNAL FOR IMMUNOTHERAPY OF CANCER
(2022)
Review
Immunology
Jie Wang, Sinan Lin, Jonathan Mark Brown, David van Wagoner, Claudio Fiocchi, Florian Rieder
Summary: The incidence of inflammatory bowel diseases poses a global public health challenge, with intestinal fibrosis being a common complication in Crohn's disease. Recent progress has implicated mesenchymal cells, cytokines, microbial products, and mesenteric adipocytes in the pathogenesis of intestinal fibrosis. This information suggests that innovative therapies validated by reliable clinical trial endpoints may prevent or reverse intestinal strictures.
IMMUNOLOGICAL REVIEWS
(2021)
Article
Cardiac & Cardiovascular Systems
Mark C. Petrie, Pardeep S. Jhund, Eugene Connolly, Patrick B. Mark, Michael R. MacDonald, Michele Robertson, Stefan D. Anker, Sunil Bhandari, Kenneth Farrington, Philip A. Kalra, David C. Wheeler, Charles R. Tomson, Ian Ford, John J. McMurray, Iain C. Macdougall
Summary: This study aimed to investigate the effect of high-dose vs. low-dose intravenous iron on myocardial infarction in patients on maintenance haemodialysis. The results showed that high-dose IV iron reduced myocardial infraction in patients receiving haemodialysis.
CARDIOVASCULAR RESEARCH
(2023)
Article
Cardiac & Cardiovascular Systems
Kieran F. Docherty, John J. V. McMurray, Brian L. Claggett, Zi Michael Miao, Kirkwood F. Adams, Alexandra Arias-Mendoza, John G. F. Cleland, Rafael Diaz, Luis E. Echeverria Correa, G. Michael Felker, Candida Fonseca, Jing Li, Marco Metra, Karen Sliwa-Hahnle, Scott D. Solomon, Hans J. Vandekerckhove, Dragos Vinereanu, Adriaan A. Voors, Stephen B. Heitner, Stuart Kupfer, Fady I. Malik, Lisa Meng, John R. Teerlink
Summary: This study aimed to examine the effect of omecamtiv mecarbil in heart failure patients according to the NT-proBNP levels. The results showed that omecamtiv mecarbil had a greater benefit in patients with higher baseline NT-proBNP levels, especially those without atrial fibrillation/flutter.
EUROPEAN JOURNAL OF HEART FAILURE
(2023)
Article
Cardiac & Cardiovascular Systems
Robert J. H. Miller, Derek S. Chew, Lei Qin, Nowell M. Fine, Jieling Chen, John J. V. McMurray, Jonathan G. Howlett, Phil McEwan
Summary: This study compares the cost-effectiveness of immediate and 12-month delayed initiation of dapagliflozin treatment in patients with a history of hospitalization for heart failure from different healthcare perspectives. Using a decision-analytic Markov model, the study found that immediate initiation of dapagliflozin reduces heart failure events and cardiovascular mortality. Immediate initiation of dapagliflozin provides greater clinical benefits and should be considered standard of care.
EUROPEAN JOURNAL OF HEART FAILURE
(2023)
Review
Cardiac & Cardiovascular Systems
James P. Curtain, Matthew M. Y. Lee, John J. McMurray, Roy S. Gardner, Mark C. Petrie, Pardeep S. Jhund
Summary: In this meta-analysis, we examined the efficacy of implantable haemodynamic monitoring (IHM)-guided care in patients with heart failure (HF). The results showed that IHM-guided care reduced HF hospitalisations and worsening HF events across all ejection fraction (EF) ranges. However, the effect of IHM-guided care on worsening HF events in patients with HFpEF (EF >= 50%) was uncertain and further studies are needed.
Letter
Cardiac & Cardiovascular Systems
Jawad H. Butt, Scott D. Solomon, John J. V. McMurray
Article
Cardiac & Cardiovascular Systems
Leanne Mooney, Colette E. Jackson, Carly Adamson, Alex McConnachie, Paul Welsh, Rachel C. Myles, John J. V. McMurray, Pardeep S. Jhund, Mark C. Petrie, Ninian N. Lang
Summary: Circulating levels of interleukin-6 may identify patients at greater risk of adverse outcomes following hospitalization with heart failure with preserved ejection fraction.
CIRCULATION-HEART FAILURE
(2023)
Article
Cardiac & Cardiovascular Systems
Karola S. Jering, Brian L. Claggett, Marc A. Pfeffer, Christopher B. Granger, Lars Kober, Eldrin F. Lewis, Aldo P. Maggioni, Douglas L. Mann, John J. V. McMurray, Margaret F. Prescott, Jean L. Rouleau, Scott D. Solomon, Phillippe Gabriel Steg, Dirk von Lewinski, Eugene Braunwald
Summary: NT-proBNP is an important prognostic factor in patients with acute myocardial infarction and certain risk factors. It is associated with heart failure, death, and atherosclerotic events, and this predictive information is independent of hs-cTnT.
CIRCULATION-HEART FAILURE
(2023)
Review
Cardiac & Cardiovascular Systems
Ewa A. Jankowska, Tomas Andersson, Claudia Kaiser-Albers, Biykem Bozkurt, Ovidiu Chioncel, Andrew J. S. Coats, Loreena Hill, Friedrich Koehler, Lars H. Lund, Theresa McDonagh, Marco Metra, Clemens Mittmann, Wilfried Mullens, Uwe Siebert, Scott D. Solomon, Maurizio Volterrani, John J. V. McMurray
Summary: Despite the rapid development of therapies and tools for heart failure (HF), everyday management in clinical practice remains suboptimal. A workshop convened by the European Society of Cardiology (ESC) identified barriers, such as the complexity of HF and its treatment, financial constraints, failure to meet patient needs, suboptimal outpatient management, and fragmented healthcare systems. Ongoing initiatives and proposed actions aim to address these barriers and improve patient outcomes.
Article
Cardiac & Cardiovascular Systems
Toru Kondo, Xiaowen Wang, Mingming Yang, Pardeep S. Jhund, Brian L. Claggett, Muthiah Vaduganathan, Adrian F. Hernandez, Carolyn S. P. Lam, Silvio E. Inzucchi, Felipe A. Martinez, Rudolf A. de Boer, Mikhail N. Kosiborod, Akshay S. Desai, Lars Kober, Piotr Ponikowski, Marc S. Sabatine, Anna Maria Langkilde, Magnus Petersson, Natalia Zaozerska, Erasmus Bachus, Scott D. Solomon, John J. V. Mcmurray
Summary: The efficacy and safety of dapagliflozin were consistent across global regions despite geographic differences in patient characteristics, background treatment, and event rates.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2023)
Article
Cardiac & Cardiovascular Systems
Shingo Matsumoto, Toru Kondo, Pardeep S. Jhund, Ross T. Campbell, Karl Swedberg, Dirk J. van Veldhuisen, Stuart J. Pocock, Bertram Pitt, Faiez Zannad, John J. V. McMurray
Summary: This study evaluated the safety and efficacy of eplerenone according to the duration of heart failure with reduced ejection fraction (HFrEF). The results showed that the benefits of eplerenone were consistent regardless of HFrEF duration, with the longest-duration group experiencing the greatest absolute benefit.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2023)
Article
Urology & Nephrology
Robert A. Fletcher, Niels Jongs, Glenn M. Chertow, John J. V. Mcmurray, Clare Arnott, Meg J. Jardine, Kenneth W. Mahaffey, Vlado Perkovic, Patrick Rockenschaub, Peter Rossing, Ricardo Correa-Rotter, Robert D. Toto, Muthiah Vaduganathan, David C. Wheeler, Hiddo J. L. Heerspink, Brendon L. Neuen
Summary: This study analyzed the effect of SGLT2 inhibitors on the discontinuation of RAS blockade and found that patients receiving SGLT2 inhibitors had a lower risk of discontinuing RAS blockade. This effect was particularly pronounced in patients with a high baseline urinary albumin-to-creatinine ratio.
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
(2023)
Review
Cardiac & Cardiovascular Systems
Matthew M. Y. Lee, Toru Kondo, Ross T. Campbell, Mark C. Petrie, Naveed Sattar, Scott D. Solomon, Muthiah Vaduganathan, Pardeep S. Jhund, John J. Mcmurray
Summary: This meta-analysis evaluates the safety and efficacy of renin-angiotensin system (RAS) blockers in the treatment of COVID-19. The results suggest that ACE inhibitors and ARBs can be continued in non-severe patients, but initiation of RAS blockers may be harmful in critically ill patients.
EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
(2023)
Article
Cardiac & Cardiovascular Systems
Joanna Osmanska, Katriona Brooksbank, Kieran F. Docherty, Stacy Robertson, Kirsty Wetherall, Alex McConnachie, Jerry Hu, Roy S. Gardner, Andrew L. Clark, Iain B. Squire, Paul R. Kalra, Pardeep S. Jhund, Pieter Muntendam, John J. McMurray, Mark C. Petrie, Ross T. Campbell
Summary: This study compared the bioavailability, pharmacokinetic and pharmacodynamic profiles between subcutaneous and intravenous furosemide, and described the use of a mini-pump for subcutaneous administration. The results showed that subcutaneous furosemide had similar bioavailability to intravenous furosemide, and administration via a patch pump was feasible and well tolerated.
EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
(2023)
Meeting Abstract
Cardiac & Cardiovascular Systems
John Ostrominski, B. Claggett, M. Packer, M. Pfeffer, C. Lam, M. Zile, A. Desai, P. Jhund, M. Lefkowitz, J. Mcmurray, S. Solomon, M. Vaduganathan
EUROPEAN JOURNAL OF HEART FAILURE
(2023)
Meeting Abstract
Endocrinology & Metabolism
M. Vaduganathan, S. E. Inzucchi, B. L. Claggett, I. Kulac, R. A. de Boer, A. S. Desai, K. F. Docherty, A. F. Hernandez, M. N. Kosiborod, P. S. Jhund, C. S. P. Lam, F. A. Martinez, S. J. Shah, J. J. V. McMurray, S. D. Solomon