The 30-day results of the Sapien 3 study, which evaluated the use of the Sapien 3 transcatheter aortic valve implantation (TAVI) device in patients with aortic stenosis who were at high or intermediate surgical risk, indicate that transfemoral implantation of the valve is associated with a low rate of mortality, a low rate of stroke, and no incidences of severe paravalvular leak. This indicates that the device could be used to manage aortic stenosis patients who are at intermediate surgical risk.
According to John Webb (University of British Columbia, Vancouver, Canada), who presented the data at EuroPCR (20–23 May, Paris, France), there are several differences between the Sapien 3 valve (Edwards Lifesciences) and an earlier generation of the Sapien valve (Sapien XT). He explained that the Sapien 3 valve was “easier for physicians” to use because it was taller and noted: “It also has more open cells at the top of the valve to enable easier access to the left coronary artery with high placement, the frame design allows it to be crimped very tightly and, very importantly, it has an expandable skirt [at the bottom of the valve] to reduce paravalvular leak.”
The aim of the Sapien 3 study was to assess the safety and efficacy of the device in high- and intermediate-risk patients who were eligible for surgical aortic valve replacement, with patients being evaluated at 30 days, one year, and annually for five years. The primary endpoint of the study was all-cause mortality of the valve-implant population (ie, those patients who actually received a device rather than all those enrolled in the study) at 30 days.
Of the 150 patients enrolled in the study, 100 were at intermediate surgical risk (Society of Thoracic Surgeons score ≥4 to <8; Logistic EuroSCORE ≥10 to ≥15) or high surgical risk (STS score ≥8; Logistic EuroSCORE ≥15) and the remaining 50 patients were at high surgical risk. Ninety-six received the valve via transfemoral access and 54 received it through transapical or transaortic access.
Webb reported that the rate of all-cause mortality was “dramatically low” at 30 days in patients receiving the valve through transfemoral access (2.1%). In this group of patients, the rate of stroke was also low (1%) and so was the rate of major vascular complications (5.2%). He said that the results of the transapical/aortic group were “mostly similar” to those of the transfemoral group, but added that the rate of all-cause mortality was higher (11.1%). In both groups, compared with baseline levels, there were significant clinical improvements—for example, New York Heart Association class and quality of life.
Webb commented that the incidence of moderate paravalvular leak was 2.6% in the transfemoral arm and 5.1% in the transapical/aortic arm, noting: “There were no incidences of severe paravalvular leak in either arm. That means that 96.6% of patients in the study had mild or no paravalvular leak as, overall, only 3.4% had moderate paravalvular leak.”
Concluding, Webb said that the outcomes with the transfemoral Sapien 3 at 30 days were “excellent” and that “It is reasonable to say that Sapien 3 transcatheter heart valve may enable treatment of patients with intermediate-risk patients with aortic stenosis.”