During the latest American College of Cardiology (ACC) 68th Annual Scientific Session held in New Orleans, LA, on March 2019, data presented demonstrated strong evidence that Transcatheter Aortic Valve Implantation (TAVI/ TAVR) is non-inferior or even better than open-heart surgery for aortic valve replacement for low-risk patients with aortic stenosis. Two studies, PARTNER 3 and the Evolut TAVR in Low-Risk Patients trial were presented.
The PARTNER 3 trial exceeded noninferiority expectations, with investigators reporting that treatment with the balloon-expandable Sapien 3 transcatheter heart valve (Edwards Lifesciences) was better than surgery for the prevention of death, stroke, and rehospitalization at 1 year, the study’s primary endpoint.
In the Evolut Low-Risk trial, which tested the self-expanding CoreValve, Evolut R, and Evolut PRO (Medtronic) valves in a low-risk patient population, the 24-month estimated incidence of death or disabling stroke was similar in the TAVR and surgical arms, meeting the definition of statistical noninferiority but not superiority.
Michael Reardon, MD (Houston Methodist DeBakey Heart and Vascular Center, TX), the co-principal investigator of the Evolut Low-Risk TAVR trial and cardiac surgeon, said TAVI/ TAVR should be the preferred strategy across the entire risk spectrum of patients. When discussing treatment options in low-risk patients with severe aortic stenosis, unless he mentions the benefits of TAVI/ TAVR, “I have not truly given informed consent,” he added.
The results of the trials were said to change the landscape of treatment for severe aortic stenosis.
From a patient’s perspective, only one-third of the TAVR patients from the trial underwent general anesthesia and very few were taken to the intensive care unit after the procedure. TAVR patients were hospitalized for shorter periods after valve replacement and the vast majority were discharged home or to self-care. “In the first 30 days, they have almost complete recovery to normal functional status,” said Martin Leon, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), one of the lead PARTNER 3 investigators. All of this, said Leon, “is very powerful from the standpoint of a new therapy for low-risk patients.”
“If you had a TAVR, you’re going to be out of the hospital in less than half the time as surgery patients and more likely to go directly home,” said Reardon. “The hemodynamics are what we’ve come to see in all the randomized trials with the supra-annular valve, that is single-digit mean gradients and [effective orifice areas] that are 2 [cm2] or above.”
Both trials are now published in the New England Journal of Medicine following an embargo break ahead of the ACC presentation.
The Heart and Vascular Centre performs TAVI with Edwards Sapien S3 valve, Corevalve Evolut R and Evolut Pro, along with a FDA approved Cerebral Protection Device for stroke prevention during the procedure.