NeuroARC Proposes Classification System for Neurologic Outcomes After Cardiac Procedures

February 6, 2017—The Neurologic Academic Research Consortium (NeuroARC) announced the publication of a consensus paper offering a new classification of neurologic outcomes and testing to better ensure the safety of cardiac procedures.

According to NeuroARC, the document is a 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 paper, "Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials," is available online and will be published in the February 14 issue of Journal of the American College of Cardiology, as well as a future issue of the European Heart Journal. The cochairs of the document's writing committee are Alexandra J. Lansky, MD, Steven R. Messé, MD, Michael Mack, MD, and Andreas Baumbach, MD.

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.

As noted in the paper, strokes are among the most feared and costly complications of cardiovascular interventions and are underreported in clinical trials. Even minor damage to the brain has been observed in patients undergoing cardiac procedures that can affect the patient's processing speed and executive function, as well as fundamental functions such memory, language, and balance.

The paper offers a simple three-type 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, represented by neurologic damage with symptoms of stroke such as weakness or paralysis 
• Type 2: Covert injury to the central nervous system, represented by neurologic damage without apparent symptoms of stroke, but recognized by brain imaging 
• Type 3: Neurologic dysfunction without detectable injury, which includes transient neurologic symptoms such as temporary weakness, numbness, slurred speech, or delirium without any evidence of damage on brain imaging

In the announcement, Dr. Lansky commented, "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. This paper outlines the need to use and report more modern and sensitive measures to evaluate brain injury related to cardiac procedures."

Dr. Messé added, "In order to properly assess the impact of various cardiovascular procedures, we recommend specific standardized and validated methods of evaluation. 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."