Cardiologist behind EARLY TAVR explains how proactive treatment improves patient outcomes

Genereux said the study found a clear benefit to early intervention in terms of reducing the composite outcome of death, stroke and unplanned cardiovascular hospitalizations. Early TAVR patients also showed improved quality of life, reduced cardiac damage, and better overall left ventricular and atrial function compared to those in the surveillance group. He added the study indicated no penalty for early intervention in terms of procedural risks.

Waiting for TAVR increases complications

The differences between the two groups were not extremely wide, which led some experts at TCT to say the study also reinforced the ability for cardiologists and patients take a "wait-and-see" approach without a major difference in outcomes. However, Genereux said the data clearly favored an early intervention approach because it saves the patient from an elevated risk of complications that come with a more emergent procedure when their health status has declined. He said they also found a rapid decline in quality of life when patients do become symptomatic, and then they need to still wait before TAVR can be performed.

"The concept here is the wait is not that long, 50% will convert within a year and 70% plus within two years. So it's not like the wait is five years. The vast majority of the patients within one or two years, they're going to become symptomatic and sometimes very symptomatic. So I give the analogy, if you need a hip replacement, it is better to do it electively and not wait until you fall and you have a fracture. And we know that when you fall you have a fracture, you have a longer length of stay, you take longer to recover, etc. This is what we saw in EARLY TAVR," Genereux explained.

AS is a progressive disease; it is not a disease that stops in time. Genereux said you can wait, but the symptoms and decline in quality of life are still coming and there is no way to stop that unless the source of the disease is treated. He said it is going to happen to these patients anyway, and often at a rate much faster than they may realize.

"It's just more practical to treat. Even if there was a great result in both groups, there's all those signals that add either increased hospitalization, stroke or complications for surgical valve replacement ... there's not a lot of benefit in waiting," Genereux added.

Waiting under surveillance for AS to progress

For patients who remained under surveillance, the study revealed that the progression to symptomatic status was rapid: 26% developed symptoms within six months, and half of the participants did so within a year. Notably, 40% of these patients experienced severe symptoms upon conversion, with syncope, pulmonary edema and severe heart failure. These findings indicate that many patients transition quickly to severe and potentially life-threatening conditions if left untreated.

The practical implications of the EARLY TAVR study are profound. Genereux stressed that referring asymptomatic patients early could streamline care and avoid the "crash and burn" scenarios often seen when symptoms develop suddenly. He noted that the trial’s structured approach minimized delays between symptom onset and treatment, with TAVR performed within 30 days of symptom development for most surveillance patients. This was mostly due to the fact that the patient already had a baseline CT scan when they entered the trial that could be used for TAVR planning. The patient's history and condition was already known because they were being closely monitored.

Adding knowledge on the natural history of asymptomatic AS

"This has been a burning question: What to do with those 80 year-old patients that come to the clinic with severe aortic stenosis and no symptoms. It is a very common problem," Genereux explained.

He said the trial offers data to learn about the national history of the disease, because there have not been any large-scale studies to study this. Patients were converted from asymptomatic to symptomatic status very quickly. Also, symptoms did not come on gradually for all patients; Genereux noted that 40% of patients experienced severe symptoms right away when they did convert to being symptomatic.

"I think the description of the national history will be very, very meaningful and useful to the clinician," he said.

Genereux said EARLY TAVR redefines the understanding of asymptomatic AS and shows a more proactive intervention approach is warranted. He recommended clinicians consider early referrals and evaluations for patients with severe asymptomatic aortic stenosis, as waiting often leads to rapid health deterioration and increased procedural risks.

Watch the video for more insights from Genereux about the trial.