Today Edwards Lifesciences Coporation announced two positive outcomes from studies of the SAPIEN 3 Valve as part of a session entitled: “Transcatheter valve implantation: exceeding expectations?
In the opening talk, Professor Helene Eltchaninoff, Head of Cardiology Department, Rouen University Hospital, France, took a glimpse into the evolution of the transcatheter heart valve and how the reduction in diameter of the valves since 2002 from 24F to 14F seen in SAPIEN 3, has led to a significant reduction in vascular complications.
Professor John Webb, Director of Interventional Cardiology, St. Paul’s Hospital, Vancouver, Canada then talked about 1-year results in high-risk patients and 30-day results in intermediate-risk patients. These were results from the SAPIEN 3 Trial, a prospective, multicenter, non-randomised study designed to evaluate patients annually for five years.
The 30-day outcome results of 101 intermediate risk patients demonstrated very low mortality and stroke rates and no paravalvular leaks which were consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States. Summarising the SAPIEN 3 Trial, Webb said that “the one year survival rate in the transfemoral cohort (91.5%) is the highest reported in a multi-center, prospective, fully CEC adjudicated TAVI study.”
Other key points from the study included:
- Low incidence of stroke at 1 year (2.1%) in the transfemoral cohort
- No valve thrombosis, structural valve deterioration, migration and embolization
- The incidence of moderate paravalvular AR remained low at 1 year (2.1%) with no severe paravalvular AR
Webb suggested that these results set a new standard of care for patients at high risk of surgical AVR. “It questions whether TAVI should be the new standard of care in the elderly,” said Webb.
The one-year results, documented outcomes of the first 150 patients treated with the SAPIEN 3 valve between January 2013 and November 2013 at 16 centers in Europe and Canada. Webb revealed that the first high-risk European patients to receive the advanced Edwards SAPIEN 3 transcatheter aortic valve via transfemoral delivery (n-96) had a one-year survival rate of 91.6% as well as low rates of stroke and paravalvular leak. Patients in the alternative access group (transapical/transaortic; n-54) were significantly sicker than the transfemoral group.
Other study outcomes included:
- The transfemoral SAPIEN 3 transcatheter aortic valve replacement (TAVR) was associated with a disabling stroke rate of 1.1%.
- Only 2% of patients had moderate paravalvular leaks
- There were no reports of severe leaks
- No observations of structural valve deterioration
“The one-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 of 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,” said Webb, who served as principal investigator of the trial.