VIDEO: TAVR for asymptomatic patients with severe calcific aortic stenosis

According to Genereux, asymptotic severe aortic stenosis (AS) is associated with poor prognosis, especially when a patient has an abnormal stress test. However, better evidence is needed to determine how to best manage these patients. 

"Obviously TAVR has been shown to be equal to surely in some patients, and now what we are doing is investigating the need to intervene earlier in patients, not only when the patient has severe or critical aortic stenosis, but sometimes patients have moderate to severe aortic stenosis and they don't have any symptoms and there are no clear guidelines for these patients," Genereux explained. 

He said the two trials he is involved in hope to answer the question of how to best manage these patients with earlier interventions, or to just monitor them for worsening symptoms. 

Genereux is the principal investigator for the EARLY TAVR trial that is expected to show whether earlier intervention in these patients improves outcomes. The results of the trial are expected by the end of 2022 or in early 2023. He also serves as a co-principal investigator on the PROGRESS trial. Both trials are sponsored by Edwards Lifesciences and will study the safety and effectiveness of the Edwards Sapien 3 or Sapien 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients. The Progress study will look at symptomatic moderate aortic stenosis patients, and Early TAVR is looking at patients with severe, calcific aortic stenosis.

The EARLY TAVR trial finished recruitment by January 2022 and the patients will be followed out to two years. Genereux said the first data from the study should come out in the next 12-18 months. 

He said the PROGRESS trial just started this year and had the first 50 patients enrolled as of June 2022. The study will randomize up to 750 patients at 75 centers. 

"I believe these two trials together will help increase our understanding the disease," Genereux explained. "And it is not just about TAVR or surgical aortic valve replacement (SAVR), but to understand the nature evolution of this disease and if we should treat earlier and how should we follow them."

There have been increasing calls for cardiology to switch to preventive care rather than reactionary care when a patient presents with advanced disease and severe symptoms. Genereux said when open heart surgery was the only option, cardiologists waited for things to get bad before intervening on the valves. But, with the advent of minimally invasive TAV, he said it is much easier to intervene in a patient earlier in the disease process to possibly prevent worsening symptoms before they occur in these patients. 

"In the future, I can totally see these patients being treated earlier before cardiac damage occurs, and before a second or third disease occurs, like left ventricular dysfunction or atrial fibrillation," he said. "This upstream management of aortic stenosis I believe will become a very important concept over the next 10 years."