Three-year outcomes following transcatheter versus surgical aortic valve replacement in younger, low surgical risk patients with severe aortic stenosis

Abstract

Abstract Background/Introduction Prior randomized studies in patients with severe aortic stenosis at low risk for surgery have shown comparable 3-year outcomes with transcatheter aortic valve implantation (TAVI) and surgery. Less is known about the intermediate term outcomes in younger (<75 years) patients at low risk for surgery treated with TAVI or surgery. Purpose To compare 3-year clinical outcomes in younger (<75 years) patients with severe aortic stenosis and low risk for surgery randomly assigned to TAVI or surgery. Methods The Evolut Low Risk randomized trial treated 1414 patients at low surgical risk with a supra-annular, self-expanding TAVI or surgery. Patients less than 75 years of age were selected for this analysis. The primary endpoint was the 3-year occurrence of all-cause mortality or disabling stroke (Kaplan-Meier estimates). Serial echocardiographic outcomes were also compared through 3-year follow-up. Results 703 younger (mean age, 69 years) low-surgical risk (STS PROM, 1.6%) aortic stenosis patients were treated with TAVI (N=352) and SAVR (N=351). At 3 years, the primary endpoint of all-cause mortality or disabling stroke was not different between TAVI (5.7%) or surgery (8.0%, p=0.241). TAVI was associated with lower incidence (0.6%) of disabling stroke compared with surgery (2.9%, p=0.019) and atrial fibrillation (13.3%) compared with surgery (36.4%, p<0.001) while surgery was associated with lower incidence of pacemaker implantation (7.1%) compared with TAVI (21.0%, p<0.001). Valve reintervention rates were low in both groups (1.5% with TAVI; 1.5% with surgery, p=0.962). Mean aortic gradients were significantly lower with TAVI (9.7 mmHg) compared with surgery (12.9 mmHg, p<0.001) and effective orifice areas were significantly larger with TAVI (2.2 cm²) compared with surgery (1.9 cm², p<0.001). There were no differences in the rates of residual moderate or greater paravalvular regurgitation (TAVI: 1.1% and surgery: 0.4%, p=0.626). Conclusion(s) Low risk patients less than 75 years age who underwent TAVI with a supra-annular, self-expanding TAVI had comparable clinical and haemodynamic outcomes with surgery through the 3-year follow-up; additional study through 10 years in these low risk patients is ongoing.