Commercial Versus PARTNER Study Experience With the Transfemoral Edwards SAPIEN Valve for Inoperable Patients With Severe Aortic Stenosis

Abstract

In patients with aortic stenosis who cannot have surgery, transcatheter aortic valve replacement using the Edwards SAPIEN valve has been shown to improve survival rate and is approved for commercial use in the United States. This study aims to assess the clinical profile, procedural characteristics, and in-hospital complications in patients treated with a commercial SAPIEN valve outside the clinical trial context. We retrospectively analyzed 69 consecutive patients who underwent transcatheter aortic valve replacement with a commercial SAPIEN valve compared with 55 Placement of AoRTic traNscathetER valves (PARTNER) trial patients from cohort B enrolled in the same institution by the same Heart Team. Compared with the commercial group, patients in the PARTNER cohort B had higher mean Society of Thoracic Surgeons score (10 ± 5 vs 9 ± 4, p= 0.04) and a lower rate of peripheral arterial disease (19% vs 44%, p= 0.004). Most patients in the commercial group had the procedure under conscious sedation (83% vs 66%, p= 0.03). Planned surgical cut down for vascular access was rare in the commercial group (1.4% vs 46%, p <0.001). The overall rates of major vascular complications, life-threatening or major bleeding, and blood transfusions were lower in commercial group (7.2% vs 27%, p= 0.003; 2.9% vs 16%, p= 0.01; and 28% vs 60%, p <0.001, respectively). In-hospital all-cause mortality (5.8% vs 9.1%, p= 0.51) and stroke rates (7.2% vs 14.5%, p= 0.19) were not statistically different between groups. The median length of hospitalization (p <0.001) and postprocedural length of stay (p= 0.01) was shorter in the commercial group. In conclusion, transfemoral commercial use of the Edwards SAPIEN valve for inoperable patients shows similar in-hospital mortality and stroke rates compared with PARTNER cohort B. The refinements in the procedure such as more conscious sedation, experience of the operators, and careful vascular planning in the commercial group led to lesser vascular and bleeding complications and shorter length of stay.