SAPIEN 3 Improves Outcomes in Intermediate-risk Patients

Compared with earlier generation devices, the SAPIEN 3 heart valve exhibited lower death, stroke, and paravalvular leak rates in high-risk surgery patients and demonstrated encouraging results in intermediate-risk patients.

The report from a US trial of third-generation device in high and intermediate risk patients was presented at the American College of Cardiology meeting in San Diego, CA.

Transcatheter aortic valve replacement (TAVR) is approved for patients with severe aortic stenosis whose health profile makes them high-risk candidates for surgery.

This trial, called PARTNER II S3, evaluated 30-day outcomes with the SAPIEN 3 valve, the latest modification of the balloon-expandable system used in these procedures.

The study’s 583 high-risk or inoperable patients as well as 1,076 intermediate-risk patients were administered the new device. They successfully noted the death rate in the high-risk group was 2.2% (13 patients) and 1.1% (12 deaths) in the intermediate-risk group. Also, high-risk patients had a stroke rate of “1.5 %, 0.9% of them disabling; in the intermediate-risk group, those rates were 2.6%, and 1%, respectively”.

Susheel Kodali, MD, director of the Heart Valve Center, Columbia University Medical Center/New York-Presbyterian Hospital, New York City, and a co-principal investigator of the study, said, “The 30-day mortality rates were extremely low, stroke rates were approximately 1% in both groups and significant paravalvular regurgitation was rare. Death and stroke rates have been decreasing with every modification of the SAPIEN system.”

Paravalvular leak has been associated with poorer outcomes after TAVR. The researchers modified the third-generation model with an outer skirt to reduce leak by sealing gaps around the valve. As a result, 3.7% of patients experienced a moderate leak, while a 0.1% had severe leak. Whereas, currently approved devices have rates of moderate or severe paravalvular leak ranging from 10 to 20%.

Other alterations enabled the valve to be delivered with a smaller catheter, increasing the percentage of procedures that can be performed through the preferred route, the femoral artery, presumably hailing better outcomes.

Though, when transfemoral delivery is not possible, the alternate route taken is through the ribs.

“For the first SAPIEN devices, we were able to use the less invasive transfemoral approach in about 60% of patients. For SAPIEN 3, more than 90% of procedures can be transfemoral,” said Kodali.

One-year data for high-risk patients with the new device will be available later in 2015.

“We needed to see if we’ve solved the valve leakage issue before we move to lower-risk patients,” Kodali said,” said Kodali. Longer-term outcomes for the intermediate-risk patients treated with the new device will be compared with the intermediate-risk surgical patients in the PARTNER IIA trial once the two-year endpoint is reached.

“Although we have to wait for longer-term data, what we’ve seen thus far makes us excited about those data and what they’ll show,” concluded Kodali.