One-Year TAVR Outcomes Reported With Edwards SAPIEN 3 System

May 19, 2015—Edwards Lifesciences Corporation announced that results were presented for the first high-risk European patients to receive the Edwards SAPIEN 3 transcatheter aortic valve replacement (TAVR) system via transfemoral delivery. John Webb, MD, presented the CE Mark study data at the EuroPCR 2015, which is being held May 19–22 in Paris, France.

The independently adjudicated data from the CE Mark SAPIEN 3 study showed that a 1-year survival rate of 91.6%, as well as low rates of stroke and paravalvular leak. Percentages are Kaplan-Meier estimates. The device was associated with a disabling stroke rate of 1.1%. In addition, only 2% of patients had moderate paravalvular leaks, and there were no reports of severe leaks. There were also no observations of structural valve deterioration. 

The SAPIEN 3 trial is a prospective, multicenter, nonrandomized study. The 1-year analysis documented outcomes of the first 150 patients treated with the SAPIEN 3 valve between January 2013 and November 2013 at 16 centers in Canada, France, Germany, Italy, and United Kingdom.

Access approaches included transfemoral (n = 96) and transapical/transaortic (n = 54), as determined by the Heart Team. At baseline, the patients in the alternative access group were significantly sicker than the transfemoral group. All-cause mortality in the alternative access group was reported as 24.3% in the as-treated population. The SAPIEN 3 Trial is designed to evaluate patients annually for 5 years.

Dr. Webb, who served as a principal investigator in the trial, is Director of Interventional Cardiology and Cardiac Catheterization Laboratories at St. Paul’s Hospital, Vancouver, and professor of cardiology at the University of British Columbia in Vancouver, Canada.

In the company’s press release, Dr. Webb commented, “The 1-year survival rate in the transfemoral cohort is the highest reported in a multicenter, fully adjudicated TAVR study to date. These results set a new standard of care for patients at high risk for surgical aortic valve replacement. The results of the SAPIEN 3 trial via the transfemoral approach also raise the question of whether transcatheter valve replacement should be considered for approval for all elderly patients with severe aortic stenosis.”

According to Edwards Lifesciences, the SAPIEN 3 valve can be delivered through a low-profile 14-F expandable sheath. The device has an outer skirt—a cuff of fabric that provides a seal at the bottom of the frame that is designed to reduce paravalvular aortic regurgitation. 

The SAPIEN 3 valve was approved in Europe in January 2014 for the treatment of high-risk and nonoperable patients with severe aortic stenosis. In the United States, the valve is an investigational device not yet commercially available and is currently being evaluated in the PARTNER II trial.