July 14, 2015
COLUMBUS, Ohio – In an effort to improve quality and outcomes worldwide, an international academic research consortium of cardiovascular and imaging experts created a set of guidelines for clinical trial design and endpoint definitions to guide evaluation of transcatheter and surgical therapies for mitral valve repair. Dr. William Abraham, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, was among the physician authors.
The guidelines are published online in both the Journal of the American College of Cardiology and the European Heart Journal.
Mitral regurgitation (MR) occurs when blood leaks back through the valve as the heart’s left ventricle contracts. It’s the most common heart valve disorder, can develop for many reasons and prevalence increases with age. Optimal management of MR is complex and involves numerous specialists working together: valve disease and heart failure experts, interventional cardiologists with valve expertise, cardiac surgeons and imaging experts.
“The great news is each specialty area is working hard to develop new approaches and new therapies. However, until now, we didn’t have consistency in how we tested these new treatments and measured success,” Abraham said.
The Mitral Valve Academic Research Consortium (MVARC) consists of 44 cardiologists, surgeons, imaging experts, clinical trial specialists and statisticians from the United States and Europe as well as representatives from the U.S. Food and Drug Administration (FDA). The group met to consider all aspects of mitral valve pathophysiology, prognosis and therapies. The result was a two-part document of recommendations for establishing clinical trials and standardizing endpoints and definitions to allow for more consistent interpretation of trial results.
“The principles adopted by MVARC will help researchers control for the complex nature of mitral valve disease, and will ensure we have strong study results to analyze,” Abraham said.
The consortium addressed guidelines such as classifying and quantifying MR and the implications that has for therapies, the role of non-invasive imaging as well as novel imaging technologies, assessing the consequences of MR on cardiovascular function, eligibility for surgical or transcatheter valve repair or replacement, control group therapies and inclusion and exclusion criteria.
The MVARC also made recommendations for ten clinical endpoints to be collected in all trials of mitral valve therapies including mortality, hospitalization or re-hospitalization, neurologic events, heart attack, access and vascular complications, bleeding, acute kidney injury, arrhythmias and conduction system disturbances, device and procedural success and device-related technical issues or complications.
“Ultimately these recommendations will bring consensus definitions that will promote better understanding of the disorder across various medical specialties; that will lead to scientific progress and better patient care,” Abraham said.
Media Contact: Marti Leitch
Wexner Medical Center Media Relations