International consortium recommends neurological endpoints for cardiovascular trials

The Neurologic Academic Research Consortium (NeuroARC) recently released a consensus paper proposing neurological endpoints that could be used in cardiovascular clinical trials.

The group also encouraged investigators to use standard definitions and consistent clinical, neuroimaging and cognitive assessments.

The paper was published online in the Journal of the American College of Cardiology and the European Heart Journal.

The authors noted that strokes are often under-reported in trials involving transcatheter aortic valve replacement (TAVR) and other cardiac procedures. They mentioned that silent ischemic cerebral infarcts affect an estimated 600,000 patients each year in the U.S., although their clinical significance and association with future cognitive decline and stroke are unknown.

“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,” Michael Mack, MD, co-chair of NeuroARC and the medical director of cardiovascular surgery at Baylor Scott & White Health in Dallas, said in a news release. “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.”

Members of NeuroARC convened for in-person meetings in October 2015 in San Francisco and on January 2016 in New York. The stakeholders included physician and scientific leaders in interventional and structural cardiology, electrophysiology, cardiac surgery, neurology, neuroradiology and neuropsychology as well as clinical trialists from the U.S. and Europe and representatives from the FDA and the medical device industry.

NeuroARC’s goals included establishing consensus on definitions of endpoints for neurological and cognitive outcomes that were relevant for numerous cardiovascular procedures; classification of neurological events and methods for consistent event identification, adjudication and reporting.

NeuroARC recommended classifying neurological injury based on symptoms and evidence of central nervous system injury. The authors defined type 1 injury as overt damage to the central nervous system, type 2 injury as covert injury to the central nervous system and type 3 injury as neurologic dysfunction without detectable injury.

“In order to properly assess the impact of various cardiovascular procedures, we recommend specific standardized and validated methods of evaluation,” Steven Messé, MD, co-chair of NeuroARC and an associate professor of neurology in the Perelman School of Medicine at the University of Pennsylvania, said in a news release. “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.”