NEW HAVEN, Conn., Feb. 6, 2017 /PRNewswire/ -- In response to a growing body of evidence of the existence of "covert" brain injury to patients undergoing transcatheter aortic valve replacement (TAVR) and other cardiac procedures, The Neurologic Academic Research Consortium (NeuroARC) today announces the simultaneous publication of a consensus paper offering a new classification of neurologic outcomes and testing to better ensure the safety of cardiac procedures. The paper is available online, and will be published in the February 14 issue of Journal of American College of Cardiology and a future issue of the European Heart Journal.
"As even the smallest damage to particular parts of the brain can impact a patient's memory and day-to-day ability to function, my colleagues and I have grown increasingly concerned that safety evaluations of the newer cardiovascular procedures only evaluate the extreme life-threatening forms of brain damage," said Alexandra Lansky, MD, Professor of Medicine, Yale University School of Medicine, lead author and Co-Chair of The Neurologic Academic Research Consortium, which produced this consensus paper. "This paper outlines the need to use and report more modern and sensitive measures to evaluate brain injury related to cardiac procedures."
The consensus paper is the product of collaboration among leading physician/scientist experts from academic research institutions in the United States and Europe as well as regulators from the US Food and Drug Administration, and representatives from the medical device industry.
The paper highlights that strokes are among the most feared and costly complications of cardiovascular interventions and are under-reported in clinical trials. It raises the important point that even minor damage to the brain that has been observed in patients undergoing cardiac procedures can affect the patient's processing speed and executive function as well as fundamental functions such memory, language, and balance.
"Until now, many studies evaluating the safety of TAVR and other cardiovascular procedures only recorded the most devastating strokes, which meant that doctors – and their patients – were unaware of the full risk potential," said Michael Mack, MD, Co-Chair, NeuroARC and Chair, Cardiovascular Governance Council, and Medical Director, Cardiovascular Surgery, Baylor Scott & White Health, Dallas, TX. "We hope this paper will cause researchers to report their findings in a more comprehensive and consistent way so that clinicians can properly interpret the results to provide the best care to patients."
The paper offers a simple classification of the levels of potential damage to the brain in an effort to allow for better consistency and comprehensive reporting of results
- Type 1: Overt damage to the central nervous system represent neurologic damage with symptoms of stroke, such as weakness or paralysis
- Type 2: Covert injury to the central nervous system, represent neurologic damage without apparent symptoms of stroke, but recognized by brain imaging
- Type 3: Neurologic dysfunction without detectable injury, include transient neurological symptoms such as temporary weakness, numbness, slurred speech or delirium without any evidence of damage on brain imaging
"A unique aspect of the consensus is that it identifies three different categories of trials and adapts recommendations for assessments and endpoints as appropriate for the procedure," said Andreas Baumbach, MD, Professor of Medicine, St Bartholomew's Hospital and Queen Mary University of London, United Kingdom; and Co-chair of NeuroARC. "By tailoring neurologic assessments to the goals of the procedure we hope to be able to demonstrate the benefit of protecting the brain during cardiac procedures."
"In order to properly assess the impact of various cardiovascular procedures, we recommend specific standardized and validated methods of evaluation," said Steven Messé, MD, Associate Professor of Neurology, in the Perelman School of Medicine at the University of Pennsylvania and Co-chair of NeuroARC. "We hope the adoption of these recommendations will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies."
The publication is "Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials", by AJ Lansky et al. European Heart Journal, doi: 10.1093/eurheartj/ehx037 and Journal of American College of Cardiology, doi: 10.1016/j.jacc.2016.11.045.
Contributors to the consensus paper consisted of:
- Alexandra J. Lansky, MD, Division of Cardiovascular Medicine, Yale School of Medicine
- Steven R. Messé, MD, Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
- Michael Mack, MD, Department of Cardiovascular Surgery, Baylor Scott & White, Dallas, TX,
- Andreas Baumbach, MD, Professor of Medicine, St Bartholomew's Hospital and Queen Mary University of London, UK
- Adam M. Brickman, PhD, Department of Neurology, Columbia University, New York, NY
- Michael Dwyer, PhD,j x Buffalo Neuroimaging Analysis, University of Buffalo, Buffalo, NY
- Bart van der Worp, MD, PhD, Department of Neurology, University Medical Centre, Utrecht, NL
- Ronald M. Lazar, PhD, Department of Neurology, Columbia University, New York, NY
- Cody G. Pietras, PhD, Yale Cardiovascular Research Group, Yale School of Medicine
- Kevin J. Abrams, MD, Baptist Hospital of Miami, Miami, FL
- Eugene McFadden, MD, Cork University Hospital, Cork, IE
- Nils H. Petersen, MD, PhD, Yale School of Medicine, New Haven, CT
- Jeffrey Browndyke, MD, PhD, Duke Institute for Brain Sciences
- Bernard Prendergast, MD, MD, St. Thomas' Hospital, London, UK
- Vivian G. Ng, MD, Department of Emergency Medicine
- Donald E. Cutlip, MD, Harvard Clinical Research Institute; Beth Israel Deaconess Medical Center, Boston, MA
- Samir Kapadia, MD Cleveland Clinic, Cleveland, OH
- Mitchell W. Krucoff, MD, Duke Clinical Research Institute, Durham, NC
- Axel Linke, MD, University of Leipzig, Leipzig, DE
- Claudia Scala Moy, PhD, National Institute of Neurological Disorders and Stroke, Bethesda, MD
- Joachim Schofer, MD, Albertine Heart Center, Hamburg, DE
- Gerrit-Anne van Es, PhD, Cardialysis, Rotterdam, NL
- Renu Virmani, MD, CVPath Institute, Gaithersburg, MD
- Michael Parides, PhD, Mount Sinai Center for Biostatistics, Icahn School of Medicine at Mount Sinai Group, New York, NY
- Susheel Kodali, MD, Center for Interventional Vascular Therapy, New York, NY
- Michel Bilello, MD, PhD, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
- Joseph Akar MD, Yale University School of Medicine, New Haven, CT
- Karen L. Furie, MD, MPH, Rhode Island Hospital, Providence, RI
- Daryl Gress, MD University of Nebraska Medical Center, Omaha, NE
- Szilard Voros, MD, Global Institute for Research and Global Genomics Group, Richmond, VA
- Jeffrey Moses, MD, Columbia University Medical Center / New York-Presbyterian Hospital, New York, NY
- David Greer, MD Yale School of Medicine, New Haven, CT
- John K. Forrest, MD, Yale School of Medicine, New Haven, CT
- David Holmes, MD,, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN
- Arie P. Kappetein, MD, PhD MD, PhD, Erasmus University Medical Center, Rotterdam, NL
The Neurologic Academic Research Consortium (NeuroARC) is a collaboration among leading physician/scientist experts, trialists representing Academic Research Organizations in the United States and Europe, regulators from the US Food and Drug Administration, and representatives from the medical device industry. Two meetings were convened to establish consensus on the definition, classification, and assessment of neurologic endpoints applicable to a broad range of clinical trials of cardiovascular devices and interventions.