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The latest generation Sapien 3 device for transcatheter aortic valve replacement (TAVR) had good safety and outcomes in high-risk and inoperable patients, a PARTNER II substudy found.

One-year mortality rates were 14.4% overall with the device across the two groups (12.7% for high-risk patients and 17.7% for the inoperable group, P=0.14) and 8.1% for cardiovascular mortality (7.4% and 9.6% for the two risk groups, respectively, P=0.38).

The subset of high-risk patients getting TAVR with a transfemoral strategy had the best odds of survival: an overall rate of 87.7%, or 93.3% for cardiovascular mortality-free survival, , of the Hospital of the University of Pennsylvania in Philadelphia, and colleagues reported online in Circulation.

There were no cases of severe paravalvular leak with the Sapien 3 (2.9% of patients had a moderate case within 30 days, and 2.7% at 1 year). Patients showed no signs of structural valve deterioration or clinical valve thrombosis, either.

The "extremely low" rates of paravalvular leak are crucial for the high-risk patients, according to , of Hôpital du Sacré-Coeur de Montréal, who was not part of Herrmann's investigation.

"It's extremely assuring to finally have a great solution for high-risk patients and inoperable patients," he told MedPage Today in a telephone interview. "Mortality for patients with the transfemoral procedure is the lowest ever seen among those high-risk patients."

Overall in the PARTNER II trial, which pooled data from the newer and older devices, the 1 year mortality rate was and .

Herrmann's group wrote that the data "likely reflect device iteration and procedural evolution, support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis."

"Right now Sapien 3 has set the bar very high for any other device -- it probably should be the default treatment for this treatment," agreed Généreux.

But although , of Erasmus Medical Center in the Netherlands, also called Sapien 3's adverse event rates "remarkable," he told MedPage Today that the new pacemaker implantation rate "seems to be higher compared to former studies with the previous generation of Sapien." Kappetein was also not involved in the present analysis.

The registry study -- the preliminary results of which were presented at the Transcatheter Cardiovascular Therapeutics meeting in 2015 -- included 583 high-risk (65%) or inoperable patients (35%) who got TAVR with the Sapien 3 device between 2013 and 2014. Procedures were performed via the transfemoral (84%) or transapical/transaortic routes (16%).

On multivariable adjustment, the predictors of 1-year mortality were alternative access (hazard ratio [HR] 2.06, 95% CI 1.26-3.36), moderate paravalvular leak (HR 3.75, 95% CI 1.57-8.96), and disabling stroke (HR 10.33, 95% CI 4.62-233.09).

"Even with the low rate of moderate paravalvular leak rate, they found an association with 1 year mortality," commented Kappetein. "Moderate paravalvular leak is bad for a patient!"

Within 30 days, overall stroke and disabling stroke occurred at frequencies of 1.4% and 0.9%, respectively. Between 1 month and 1 year, these rates were 4.3% and 2.4%.

Généreux appeared to be at ease with the 1-year stroke rate, adding that "this reflects it being a high-risk population."

In order to bring mortality and stroke rates even lower, he suggested that clinicians "focus on other strategies such as anticoagulation and other medical or device therapies like left atrial appendage closure."

Nearly all patients improved enough to move out of New York Heart Association class three and four after the procedure (90.1% at baseline versus 7.7% at 1 year, P<0.0001). Self-reported quality of life similarly improved on the Kansas City Cardiomyopathy Questionnaire, with average scores rising from 46.9 to 72.4 at 1 year (P<0.0001).

"A high-risk population is difficult because patients may have mortality related to a comorbidity such as infection and heart failure. That being said, there is still room for improvement in the care of patients beyond the device choice," Généreux said, suggesting that appropriate anticoagulation is key.

For now, "the combination of new design features of Sapien 3, procedural improvements, operator experience and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in high-risk and inoperable patients with severe aortic stenosis," Herrmann and colleagues concluded.

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