Baron et al. – The CoreValve US Extreme Risk trial evaluated the durability of quality of life benefits of transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis (AS) at extreme surgical risk who underwent TAVR. Results demonstrated that TAVR resulted in large initial health status benefits that sustained through 3–year follow–up in extreme risk patients with severe AS; TAVR also offers substantial and durable health status improvements in surviving patients.

Methods

• A total of 639 patients with severe AS at extreme surgical risk underwent TAVR in the CoreValve US Extreme Risk trial.
• The Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short–Form–12, and the EuroQoL–5D were used to evaluate the health status at baseline and at 1, 6, 12, 24, and 36 months.
• Analyses were performed using pattern mixture models to account for both death and missing data; patients were stratified by iliofemoral (IF) and non–iliofemoral (non–IF) access.

Results

• A substantial health status improvement in disease–specific and generic scales by 6 to 12 months after TAVR was observed.
• Despite the small declines in health status after 12months, the initial benefits of TAVR largely sustained through 3 years for both IF and non–IF cohorts (change from baseline in KCCQ overall summary score: 19.0 points in IF patients and 14.9 points in non–IF patients).
• At 3 years, clinically meaningful (≥10 point) improvements in the KCCQ overall summary score were observed in 85.0% and 83.4% of IF and non–IF surviving patients, respectively.