The last generation of the balloon expandable valve resulted superior to surgery in intermediate riskpatients, in a registry analyzis. Patients treated with the SAPIEN 3 valve showed lower rates of death, stroke and paravalvular leak at one year than patients undergoing surgery.
This third generation improves the SAPIEN XT with a skirt designed to prevent paravalvular leak, improved coaxial alignment with the annulus and more precise positioning.
In 2015 results at 30 days had been presented and now results at one year confirm non inferiority and superiority of the valve compared to surgery in 1077 intermediate risk patients matched with propensity score.
Patients in this registry were compared to those undergoing surgery from the PARTNER 2A trial.
Mortality at one year resulted 7.4% for TAVI vs 13% for surgery (p<0.001); strokeresulted4.6% vs. 8.2% respectively (p=0.04) and moderate paravalvular leak, more than 1.5% vs 1.2% respectively (p=0.0149).
Aortic stenosis symptoms improved significantly with 94% of patients inNYHAfunctional class I or II compared to the 73% in NYHAfunctional class III or IV at baseline.
13% of those undergoing TAVI required definite pacemaker vs. 12% in the surgery group from PARTNER 2A.