The expansion of TAVI into younger and lower surgical-risk populations has sparked a new debate: beyond mortality and stroke, which strategy provides better functional status and quality of life in the long term? The NOTION-2 subanalysis, presented by Ole De Backer during EuroPCR 2026, evaluated clinical health status following TAVI versus surgical aortic valve replacement (SAVR) in young, low-risk patients with symptomatic severe aortic stenosis.
The study enrolled 370 patients between 60 and 75 years of age, randomized in a 1:1 ratio to TAVI (n=187) or SAVR (n=183), with clinical follow-up extending to 3 years. The population represented a low-risk cohort, with a mean STS-PROM score of 1.1%.
The primary NOTION-2 analysis had previously demonstrated no significant differences in death or disabling stroke between the two strategies at 3 years, with rates of 5.4% for TAVI and 4.9% for surgery (p=0.4).
This new analysis incorporated an endpoint focused on achieving excellent quality of life and the absence of significant physical limitations, integrating results from the Kansas City Cardiomyopathy Questionnaire (KCCQ) together with NYHA functional class. In parallel, the primary safety endpoint remained freedom from death and disabling stroke.
At one year, the proportion of patients considered to be in “excellent” health status was higher in the TAVI group (55%) compared with the SAVR group (46.8%). This difference persisted at 3 years, with rates of 50% versus 45%, respectively. In terms of safety, approximately 95% of patients in both groups remained alive and free from disabling stroke at 3 years (94.6% for TAVI vs. 95.1% for SAVR).
Although the study was not powered to demonstrate superiority, a consistent trend toward better clinical and functional outcomes with TAVI was observed in more complex patient subgroups, including those with bicuspid valves, chronic pulmonary disease, coronary artery disease, impaired left ventricular function, or a prior history of stroke.
TAVI and Surgery: Similar Outcomes, Better Quality of Life with TAVI
This NOTION-2 subanalysis demonstrated that both TAVI and SAVR provide excellent 3-year clinical outcomes in young, low-risk patients, with approximately 95% survival free from disabling stroke. However, TAVI showed a favorable trend regarding quality of life and functional status, particularly among clinically complex patients. These findings reinforce the importance of considering not only surgical risk and valve durability when selecting a treatment strategy, but also functional recovery and the patient’s perception of health and well-being.
Original Title: Health status after TAVI vs. SAVR in young low-risk patients with aortic stenosis: a NOTION-2 sub-analysis.
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