Cedars-Sinai (Los Angeles, USA) has been awarded US$26 million by the Patient-Centered Outcomes Research Institute (PCORI) to study outcomes of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with bicuspid aortic stenosis.
Led by interventional cardiologist Raj Makkar, the six-and-a-half-year award from PCORI will fund a multicentre clinical trial of patients 50 and older who were born with a bicuspid aortic valve, a condition in which the aortic heart valve has two flaps regulating the flow of blood rather than the normal three.
Bicuspid aortic valve is the most common congenital heart condition, affecting approximately 2% of people, but little data exists comparing current treatments.
“Transcatheter aortic valve replacement has changed the paradigm for non-surgical treatment of aortic stenosis, but it needs to be studied more rigorously in patients with bicuspid aortic valves,” said Makkar, a principal investigator of the study and vice president of Cardiovascular Innovation and Intervention at Cedars-Sinai. “We look forward to addressing this important evidence gap with this PCORI-funded randomised controlled trial in collaboration with our esteemed co-investigators.”
Patients with bicuspid aortic valve stenosis enrolled in the clinical trial will be randomly assigned to have their aortic valve replaced via open-heart surgery or by a transcatheter procedure. Investigators will review results from both groups to understand which option results in better health outcomes.
“The Smidt Heart Institute at Cedars-Sinai is a leader in both heart surgery and minimally invasive heart procedures,” said Eduardo Marbán, executive director of the Smidt Heart Institute at Cedars-Sinai and the Mark S. Siegel Family Foundation Distinguished Professor. “This study reflects our commitment to advancing heart research and care.”
“This research is a prime example of how Cedars-Sinai fosters innovation and brings leading-edge and clinically effective research directly to patient care,” said Shlomo Melmed, Cedars-Sinai’s executive vice president of Medicine and Health Sciences and dean of the Medical Faculty. “The findings from this clinical trial will help doctors globally advise their patients born with a bicuspid aortic valve on the best and safest approach for treating their cardiac condition.”
The award has been approved pending completion of a business and programmatic review by PCORI and issuance of a formal award contract. PCORI is a non-profit organisation with a mission to fund research designed to provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
