Comparison of Health Status After TAVI and SAVR in Younger Low-Risk Patients with Aortic Stenosis: a NOTION-2 Analysis

Abstract Background Several trials have shown that transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) yield non-inferior short- and mid-term clinical outcomes in low surgical risk patients. However, information on the health status achieved by these patients is lacking. Aims To compare the incidence of excellent health status after TAVI versus SAVR in younger, low-risk patients at three-year follow-up. Methods Aortic stenosis (AS) patients aged 60-75 years with low surgical risk (n=370) were randomised to TAVI or SAVR. For this pre-defined NOTION-2 analysis, the primary safety endpoint was freedom from all-cause mortality and disabling stroke at 3 years. The primary efficacy endpoint was excellent health status, defined as Kansas City Cardiomyopathy Questionnaire (KCCQ) score >90 and New York Heart Association (NYHA) class I at three years. Results Three-year follow-up data were available for 341 patients, with health status missing in 4.3% of SAVR and 1.6% of TAVI patients. The primary safety and efficacy endpoints were comparable between TAVI and SAVR (94.6% vs. 95.1%, p=0.9; and 50.0% vs. 45.0%, p=0.35, respectively). Among patients with chronic lung disease, bicuspid AS, coronary artery disease, reduced left ventricular systolic function, or prior stroke, non-significant trends suggested a better health status following TAVI, with % risk differences of +10.5%, +13.9%, +16.0%, +18.9%, and +19.7%, respectively; however, these differences did not reach statistical significance. Conclusions After three years, half of AS patients achieved excellent health status, regardless of TAVI or SAVR. Nonetheless, certain comorbidities predict less improvement in health status, particularly following SAVR. Clinical Trial Registration: ClinicalTrials.gov Identifier NCT02825134