ACC: Edwards' TAVR safety study holds equal to open surgery after 2 years in low-risk patients

Sapien 3 TAVR device on white background
Last year, the FDA opened up the use of TAVR systems—such as Edwards’ Sapien valve—for use in younger, lower-risk patients with narrowing aortic valves. (Edwards)

In 2019, Edwards Lifesciences presented data showing that patients undergoing less invasive transcatheter aortic valve replacement (TAVR) procedures performed better after one year compared to those who had open heart surgery.

That study continues, and now—at the two-year mark—the data indicate that both sets of patients fare equally well when it comes to risks of stroke, hospitalization and death.

Presented virtually at the annual meeting of the American College of Cardiology (ACC), together with the World Congress of Cardiology, Edwards’ PARTNER 3 trial focused on patients considered low-risk for open heart surgery; in the past, less invasive TAVR therapies been reserved for those with higher chances of not surviving such a serious procedure.

But that has been evolving. In August, the FDA opened up the use of TAVR systems—including Edwards’ Sapien replacement valve—for use in younger, lower-risk patients with narrowing heart valves. The new data presented at ACC appear to support that decision.

“The one-year outcomes were only the first look at how these patients do, and this is the second look,” said the study’s lead presenter, Michael Mack, a cardiothoracic surgeon at Baylor Scott & White Health and former president of the Society of Thoracic Surgeons. 

“On the basis of one-year data, many physicians were counseling patients that TAVR outcomes were better than surgery,” Mack added. “Now, we see that the outcomes are roughly the same at two years.”

RELATED: Edwards study shows TAVR outcomes similar to surgery after 5 years, but with more patient management

In 1,000 low-risk patients with severe aortic stenosis, randomized equally to receive TAVR or open surgery, the combined rate of deaths, strokes or rehospitalizations after two years was 11.5% for the less invasive procedure and 17.4% for surgery—researchers described neither treatment as being superior to the other.

The study’s secondary analyses showed that rates of death and stroke were not significantly different between the two groups. Still, TAVR—where a folded valve is threaded through a person’s arteries from the thigh to inside the heart—offers a faster recovery time compared to a procedure that goes through the chest. 

TAVR did lead to fewer rehospitalizations for cardiovascular issues, with a rate of 8.5% compared to 12.5% for open surgery. However, TAVR patients had higher rates of blood clots forming on the implanted valve, at 2.7% versus 0.7%, though there was no significant deterioration in function, according to researchers. This study plans to run for up to 10 years, while older studies have focused on patient groups at higher risk levels.

“Longer-term outcomes are particularly important for this patient population because younger, low-risk patients have longer to live with this valve than patients that have been previously studied,” said Mack. “Therefore, the durability of the valve is of utmost importance.”