Cedars-Sinai Awarded $26M to Study Heart Valve Disease Treatments

Cedars-Sinai has been awarded $26 million to study whether open-heart surgery or a minimally invasive procedure has better outcomes in people born with a common heart condition.

Led by interventional cardiologist Raj Makkar, MD, the six-and-a-half-year award from the Patient-Centered Outcomes Research Institute(PCORI) will fund a multi-center 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. People with this condition typically develop aortic stenosis, when the aortic valve becomes so narrow that it impedes blood flow out of the heart.

Bicuspid aortic valve is the most common congenital heart condition, affecting approximately 2% of people, but little data exists comparing current treatments.

Heart valve disease can cause subtle symptoms at first but progress to heart failure if not diagnosed and treated early. Both surgery and transcatheter procedures are currently used to treat aortic stenosis. Transcatheter procedures use a thin, flexible tube called a catheter to reach the damaged valve. They are considered minimally invasive and are often recommended for patients who are at high risk for complications during surgery.

"Transcatheter aortic valve replacement has changed the paradigm for nonsurgical 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 randomized 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 inaugural director of the Karsh Division of Interventional Cardiology, Makkar is an authority in minimally invasive approaches to treating heart valve disease.

"The Smidt Heart Institute at Cedars-Sinai is a leader in both heart surgery and minimally invasive heart procedures," said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Instituteat 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, MB, ChB, 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 organization 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.