Outcomes Reported for Edwards' Sapien 3 TAVR System in Intermediate-Risk Patients

May 20, 2015—Edwards Lifesciences Corporation announced that 30-day outcomes for intermediate-risk patients treated transfemorally with the Sapien 3 transcatheter aortic valve replacement (TAVR) system demonstrated very low mortality and stroke rates with no severe paravalvular leaks. Alec Vahanian, MD, presented the data at the EuroPCR 2015 conference in Paris, France. 

According to Edwards Lifescience, this is a prospective, multicenter, nonrandomized study of 101 intermediate-risk patients enrolled at 13 centers in Canada, France, Germany, Italy, and the United Kingdom. The trial is designed to evaluate patients annually for 5 years. 

This analysis, which was conducted to document the 30-day outcomes of these intermediate-risk patients, found that all-cause mortality was 1%. The frequency of other important complications was also low: the disabling stroke rate was 2%, the major vascular complications rate was 2% and the permanent pacemaker rate was 4%. The investigators also noted that treatment with the Sapien 3 valve resulted in very low incidence of significant paravalvular regurgitation, with 2.3% of patients having moderate paravalvular leaks, and no reported of severe leaks. 

The company stated that these independently adjudicated data are consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States. 

In Edwards Lifesciences’ press release, Dr. Vahanian commented, “Intermediate-risk patients treated with the Edwards Sapien 3 valve had remarkably low mortality at 30 days. There were very low rates of all other major complications, notably major vascular complications and new permanent pacemaker implantation. These results are meaningful since this study in multiple countries repeated the results in the large United States study.” Dr. Vahanian is chair of the cardiology department at Bichat University Hospital in Paris.