TAVR Device: from Non-Inferior to Superior in One Day

A newer version of a valve system used in transcatheter aortic valve replacement has proved superior to surgery in elderly patients. The study was released a day after a report on the older device showed it was as good as surgery.

Just a day after researchers announced that using the Sapien 2 device for transcatheter aortic valve replacement was as good as surgery in preventing deaths from cardiovascular events, a newer device has proved even better.

Yesterday's news was about a study called PARTNER 2 using a device called Sapien 2.

Both studies were presented at the American College of Cardiology’s 65th Scientific Session & Expo in Chicago, IL.

Reporting today on a trial of an improved device called Sapien 3, Vinod Thourani, MD of Emory University School of Medicine in Atlanta, GA and colleagues said that when used on patients of similar risk as in the PARTNERS 2 study, patients were less likely to die or experience serious adverse events.

In both studies, patients were of intermediate risk, and had severe aortic stenosis and were average 82 years old.

“TAVR is clearly here to stay,” Thourani said discussing his study, “We’ve got lower mortality and lower stroke incidence.”

The next task is seeing if younger patients at lower risk will also do better with TAVR than with surgery.

In this SAPIEN 3 study, 1,077 patients at 51 sites in the US and Canada got TAVR with the device. Most of those patients got the device through a transfemoral access procedure—a sign that they were healthier in general than those who could not undergo transfemoral access.

The team assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation a year after implantation.

They then compared the outcomes to those who were treated with surgical valve replacements in the PARTNER 2A trial.

At 30 days, 10 patients died of cardiac events in the SAPIEN 3 group, compared to 29 in the surgery group.

At one year, there were 47 SAPIEN deaths vs. 74 in the surgery group.

Stroke deaths were also lower.

Describing their findings in The Lancet, the team said there had been an early concern about TAVR causing periprocedural embolic strokes.

But as physicians gained experience in the procedure, their track record has gotten better.

For instance, he said, they now place the device differently to get a better fit and less chance of leakage.

“There’s been a lot of progress for operators and in imaging,” Thourani said.