Real-World Outcomes Reported for Edwards' Sapien 3 TAVR Device in Intermediate-Risk Patients
June 4, 2018—Edwards Lifesciences recently announced that 30-day data of outcomes in patients undergoing transcatheter aortic valve replacement with the company's Sapien 3 device were presented by E. Murat Tuzcu, MD, at the EuroPCR 2018 conference held May 22–25 in Paris, France.
The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. The data involve approximately 2,000 severe symptomatic aortic stenosis patients at intermediate risk with open heart surgery treated at more than 450 commercial centers in the United States. The findings demonstrated consistency with results achieved in earlier controlled clinical trials in a limited number of hospitals.
In the company's press release, Dr. Tuzcu commented, "These data comparing real-world outcomes with clinical study results in intermediate-risk patients treated with the Edwards Sapien 3 transcatheter heart valve demonstrated comparably positive outcomes including high survival rates and low rates of stroke." Dr. Tuzcu is Chief Academic Officer and the Chief of Cardiovascular Medicine at the Heart & Vascular Institute at Cleveland Clinic Abu Dhabi in the United Arab Emirates.
As summarized by Edwards Lifesciences, outcomes in a total of 1,956 intermediate-risk patients in the STS/ACC TVT Registry were compared with those of 652 intermediate-risk patients enrolled in the PARTNER II S3i study and 652 patients enrolled in the Sapien 3 intermediate-risk continued access program (S3iCAP) at 30 days. All patients were treated via transfemoral access.
In the S3i group (n = 652), the S3iCAP group (n = 652), and the TVT Registry intermediate-risk group (n = 1,956), 30-day all-cause mortality was 0.9%, 0.9%, and 0.8%, respectively, and 30-day all-cause stroke was 2%, 2.3%, and 2.2%, respectively.
The company noted that in addition to the survival and stroke rates, the postapproval data from the TVT Registry demonstrated a low rate of moderate to severe paravalvular leak and a 2-day average length of stay.
The Sapien 3 valve has been available in Europe since 2014 and in the United States since 2015. In 2016, both European and United States regulatory approval was expanded to include intermediate-risk patients, stated Edwards Lifesciences.