New Sapien 3 Transcatheter Valve Impresses with Low 30-Day Stroke and Mortality Rates: PARTNER II

March 15, 2015

SAN DIEGO, CA — New data with the latest iteration of the Sapien (Edwards Lifesciences) balloon-expandable transcatheter valve impressed today at the American College of Cardiology (ACC) 2015 Scientific Sessions, with investigators reporting historically low rates of death and disabling stroke at 30 days among patients of varying degrees of surgical risk.

Among patients considered high-risk/inoperable for aortic-valve-replacement surgery, 2.2% of those who underwent transcatheter aortic-valve replacement (TAVR) with the Sapien 3 device died at 30 days and 1.5% had a stroke. At 30 days, cardiovascular mortality was 1.4% and 0.9% of patients had a disabling stroke.

"I was surprised by the low stroke rates," lead investigator Dr Susheel Kodali (Columbia University Medical Center/New York Presbyterian Hospital, New York) told heartwire from Medscape."If we had 100 patients, I'd say it was an artifact, but we had over 1600 patients. The numbers really speak for themselves."

Dr Ian Meredith (Monash University, Melbourne, Australia), one of the moderators during the late-breaking clinical-trials session, said he was "stunned" and left "speechless" by the results. Dr Jeffrey Popma (Brigham and Women's Hospital, Boston, MA), another moderator who commented on the trial for the media, said he attributes the low 30-day stroke rate to better patient selection, more emphasis on imaging to assist in properly sizing the valve, and improved implantation techniques.

"By the time you're 4 or 5 years into a therapy, you really know how to get in and get out of the lab without much of a problem," said Popma. "I think all of those things put us in a place right now where the bar is very, very high for surgery. You have to ask, 'How does surgery ever compete with this?' "

The PARTNER II S3 trial

Presenting the results at the late-breaking clinical-trials session, the PARTNER II S3 trial included 1076 patients considered intermediate risk for valve-replacement surgery and 583 patients at high risk for surgery or who were inoperable. In the high-risk cohort, the average STS score was 8.6% and the average patient age was 83 years. In the intermediate-risk cohort, the average STS score was 5.3% and the average patient age was 82 years.

Historically, in the PARTNER cohort A study of high-risk surgical patients, the mortality rate at 30 days was 5.2% and the stroke rate was 5.6%. "Even in the high-risk cohort, the mortality rate is much lower than what we observed in previous studies," said Kodali.

For the intermediate-risk patients, all-cause and cardiovascular mortality at 30 days was 1.1% and 0.9%, respectively. Overall, 2.6% of the intermediate-risk patients had a stroke at 30 days and 1.0% had a disabling stroke. The rate of severe and moderate paravalvular regurgitation in the entire cohort of patients treated with the newest Sapien device was 0.1% and 3.7%, respectively.

Dr Susheel Kodali

To heartwire , Kodali said changes to the Sapien valve were likely the reason for the lower stroke and mortality rates. "It has a lot to do with the device," he said. "Strokes with TAVR are related to the debris, at least we think, breaking off the valve. It's not debris from crossing the arch so much, but when you look at the Doppler studies, it is debris that's liberated when people are either crossing the valve or deploying the valve."

The Sapien 3 valve has a low frame height and improved frame geometry with a low delivery profile. "There are several key features with this device," said Kodali. "In turns of crossing, it has a lower profile, so there's less of a footprint. The balloon on the end also shields the frame, making it less traumatic when crossing the valve. The fine positioning of the device also allows you to dial in and out, so you're not really manipulating the valve as much during positioning."

The Sapien 3 will be available in 20-mm, 23-mm, 26-mm, and 29-mm sizes. The Sapien 3 is not yet available in the US, but Edwards has submitted data to the US Food and Drug Administration (FDA) as part of the premarket approval (PMA) for use in high-risk/inoperable patients.

Kodali reports grant/research support from Edwards, Medtronic, Boston Scientific, and Claret Medical; equity in Thubrikar Aortic Valve; and honoraria from St Jude Medical and Claret Medical.


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