In a groundbreaking international multicenter study, patients with a dysfunctional aortic heart valve who received a prosthetic valve through a minimally invasive procedure experienced similar outcomes at the five-year mark to those who underwent traditional open-heart surgery. The study, with significant contributions from the Cedars-Sinai heart team and recently published in The New England Journal of Medicine, sheds fresh light on the ongoing debate surrounding the efficacy of transcatheter aortic valve replacement (TAVR) as compared to open-heart surgery.
Dr. Raj Makkar, the senior author of the study and Cedars-Sinai’s Vice President of Cardiovascular Innovation and Intervention, as well as the Associate Director of the Smidt Heart Institute, emphasized the significance of the findings. “Our data at five years validate that TAVR is a good alternative to open-heart surgery in younger patients with aortic stenosis,” he stated. “They support routinely offering TAVR, even to patients for whom open-heart surgery wouldn’t pose a high risk.”
What is Aortic Stenosis?
Aortic stenosis is a condition characterized by the narrowing of the aortic artery, impeding the aortic valve’s ability to function properly. This constriction disrupts the flow of blood through the heart and, subsequently, to the rest of the body.
TAVR was granted approval by the U.S. Food and Drug Administration in 2011 for individuals with severe aortic stenosis who were considered high-risk candidates for surgical procedures. Today, minimally invasive options like TAVR are increasingly offered to patients as a viable alternative to conventional surgery.
Eduardo Marbán, MD, Ph.D., the Executive Director of the Smidt Heart Institute, expressed how these findings align with their approach. “These findings support the approach of the Smidt Heart Institute: We individualize therapy to best address the patient’s needs,” he said. “We offer each patient a comprehensive evaluation of their treatment options, which include surgery and transcatheter procedures like TAVR.”
Recruitment around Various Countries
The PARTNER 3 clinical trial was responsible for recruiting patients from various healthcare institutions in the U.S., Australia, Canada, Japan, and New Zealand. The trial randomized 1,000 individuals with severe symptomatic aortic stenosis to either undergo TAVR or traditional surgery. In the end, 496 patients opted for TAVR, while 454 chose surgery.
These patients, all considered to be at low risk for surgical complications, underwent comprehensive assessments at various intervals before and after the procedure. The study assessed their health and well-being in the days following the treatment, at the time of hospital discharge, 30 days later, at the six-month mark, and annually for five years.
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