Millions of Americans live with different kinds of heart valve diseases but for those patients suffering from aortic stenosis — one of the most common heart valve disorders — a landmark clinical trial called EARLY TAVR has led to FDA approval for a new therapy for aortic stenosis patients who don’t yet have symptoms.
Philippe Genereux, MD, director of the Structural Heart Program at Atlantic Health Morristown Medical Center, shares more about this groundbreaking trial and what it means for patients experiencing aortic stenosis.
Updating an inadequate treatment protocol
Aortic stenosis is a condition where the aortic valve is narrowed, restricting blood flow to the aorta (the largest artery in the body). Since many people living with aortic stenosis don’t have symptoms, treatment up to this point has mostly been managed through “watchful waiting,” or continuous monitoring of the condition to see if symptoms appear or if the condition gets worse over time.
Unfortunately, symptoms of aortic stenosis, like chest pain, dizziness, shortness of breath and fatigue, can be hard to detect. The condition can also progress rapidly, leading to a risk of cardiac events like stroke and even death. Without treatment, up to 10% of patients who have symptoms of severe aortic stenosis may die within just a few weeks.
“There is an urgent need to change practice and treatment guidelines,” says Dr. Genereux. “As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team.”
A new use for TAVR
Patients with symptomatic aortic stenosis have been treated in the past with transcatheter aortic valve replacement (TAVR). This minimally invasive procedure replaces the damaged aortic valve with a healthy artificial one. While TAVR is a safe and effective surgery, it has not traditionally been used to treat patients who do not have symptoms.
The EARLY TAVR trial, co-led by the nationally recognized structural heart team at Atlantic Health’s Morristown Medical Center, was the first study of its kind to explore whether treating patients early with TAVR is better than waiting for symptoms to appear. The study followed patients for nearly four years and found that those who received TAVR early had better long-term results—including a lower risk of death, stroke, and unexpected hospital visits for heart problems—compared to those who waited for treatment.
The EARLY TAVR trial led to the recent FDA approval of the SAPIEN 3 TAVR therapy for patients with asymptomatic severe aortic stenosis. FDA approval for this treatment means patients with severe aortic stenosis have hope for early, proactive treatment for their condition with a chance for improved long-term outcomes.
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