Cedars-Sinai has received a $26 million award to investigate which treatment method—open-heart surgery or a minimally invasive procedure—yields better outcomes for people born with bicuspid aortic valve, a common congenital heart condition.
The six-and-a-half-year grant from the Patient-Centered Outcomes Research Institute (PCORI) will support a multi-center clinical trial led by Raj Makkar, MD, an interventional cardiologist at Cedars-Sinai. The study will focus on patients aged 50 and older who were born with two flaps in their aortic heart valve instead of the usual three. This condition often leads to a narrowing of the valve, called aortic stenosis, which can restrict blood flow from the heart.
Bicuspid aortic valve affects about 2% of the population. Despite its prevalence, there is limited data comparing open-heart surgery and transcatheter procedures for treating this group. Transcatheter procedures involve inserting a catheter through blood vessels to replace the damaged valve and are considered less invasive than traditional surgery. These are often recommended for patients at higher surgical risk.
“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, principal investigator 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.”
Participants in the study will be randomly assigned to receive either open-heart surgery or transcatheter replacement of their diseased valves. Researchers will compare health outcomes between these groups.
Makkar serves as inaugural director of the Karsh Division of Interventional Cardiology and is recognized as an authority on minimally invasive treatments for 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 Institute at Cedars-Sinai and 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 PCORI award is pending final business review before being formally issued. PCORI funds research that aims to provide evidence-based information so that patients, caregivers, and clinicians can make informed healthcare decisions.
Cedars-Sinai Medical Center was founded in 1902 in Los Angeles, California. Thomas M. Priselac currently serves as its president. The hospital operates as both an acute care facility—with over 50,000 admissions reported in 2022—and as an academic training center.
https://www.cedars-sinai.org/about-us/history.html
