Prospective assessment of clinical outcomes of transcatheter aortic valve implantation in a cohort of patients based on their risk profile

ABSTRACT Introduction and objectives: Transcatheter aortic valve implantation (TAVI) is an increasingly used procedure to treat severe aortic stenosis (AS) that should be monitored in the real-world routine clinical practice. We assessed TAVI outcomes (SAPIEN 3) in terms of the patient's health-related quality of life (HRQoL), clinical endpoints, and resource utilization considering a valid risk score. Methods: This was an observational prospective study including all consecutive patients with severe AS treated with TAVI (Edwards SAPIEN 3, transfemoral access) conducted during the calendar year of 2018. A systematic assessment of the patients' HRQoL (EQ-5D-5L, the 36-item Short Form Health Survey, and the Kansas City Cardiomyopathy Questionnaire), clinical endpoints, and resource utilization (length of stay at the hospital/intensive care unit setting) was implemented. Assessment was scheduled before the procedure (baseline), at discharge, and 1, 6, and 12 months after implantation. Multivariate regression models were applied to test outcomes while controlling the patients' risk (eg, Society of Thoracic Surgeons risk score). Results: A total of 76 patients (50% female) with a mean age of 82.05 ± 4.76 years, and 55% with intermediate-high risk were included. The rates of successful impantation and cardiac death were 97.37% and 2.63%, respectively, at 1 year. Significant reductions in mean and maximum gradients were achieved and maintained at follow-up. The mean length of stay at the hospital (5.2 6 ± 4.05) and intensive care unit setting (0.22 ± 0.64) was short. Significant improvements (all adjusted P < .05) were detected in the Kansas City Cardiomyopathy Questionnaire overall summary scores, EQ-5D-5L, and the 36-item Short Form (physical component summary). Conclusions: This research highlights how positive clinical outcomes translated into significant improvements in relation to the patients' HRQoL. Use of resources -generally low- was based on the Society of Thoracic Surgeons risk score. (SARU Study; code: 2017-01, Murcia, Spain).