SAPIEN 3: 1-Year TAVR Outcomes in High-Risk, Inoperable Aortic Stenosis Patients

The SAPIEN 3 transcatheter aortic valve replacement (TAVR) system improved one-year survival outcomes in high-risk and inoperable patients with aortic stenosis, according to the results of the SAPIEN 3 trial, presented Oct. 15 at TCT 2015.

Following the positive 30-day outcome results of the PARTNER II trial, Howard C. Herrmann, MD, FACC, et al., sought to evaluate the one-year outcomes with the SAPIEN 3 TAVR system. The 583 patients included in this study had an STS score of greater than eight, were assessed as inoperable (risk of death or serious morbidity greater than 50 percent) and had severe aortic stenosis, as determined by echocardiography.

The SAPIEN 3 TAVR system features a low frame height, enhanced frame geometry for low delivery profile, bovine pericardial tissue and an outer sealing skirt to reduce paravalvular leaks. The system received approval from the U.S. Food and Drug Administration in June of this year.

The results of the SAPIEN 3 trial showed that between 30 days and one year, the incidence of disabling stroke and paravalvular aortic regurgitation remained low and stable, with an overall survival rate of 85.6 percent in the high-risk patient cohort.

According to Hermann, et al., “these excellent one-year follow-up data with SAPIEN 3 support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis.”

The study is an update to research presented at ACC.15 in San Diego, CA, this past March. The authors note that the one-year outcomes of the intermediate risk cohort will be presented at ACC.16 in Chicago, IL, April 2 – 4, 2016.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Transcatheter Cardiovascular Therapeutics, Aortic Valve, Heart Valve Prosthesis, Aortic Valve Insufficiency, Aortic Valve Stenosis, Echocardiography, Morbidity, Stroke, Survival Rate, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration


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