A Real-World Comparison of Outcomes and Healthcare Resource Utilization of Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR)

OBJECTIVES: This study aims to assess and compare the real-world outcomes and healthcare resource utilization of Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) procedures, acknowledging the challenges associated with medical device evaluations.

METHODS: Using individual-level administrative data from the Tuscany region of Italy, we identified two cohorts of patients who underwent TAVI and SAVR procedures between 2016 and 2021. Patients were followed up to one-year post-procedure to assess outcomes and costs. Propensity scores were calculated using logistic regression, considering treatment type and adjusting for age, sex, Charlson Comorbidity Index (CCI), education, and year of observation. Clinical indicators were selected based on the Valve Academic Research Consortium-2 (VARC-2) consensus document. A two-part model approach was employed to analyze healthcare expenditure data. Follow-up costs, in euros (€), were calculated for each patient from the perspective of the Italian National Healthcare System.

RESULTS: The TAVI cohort, with a higher mean age and more balanced gender distribution, experiences shorter hospital stays due to the less invasive nature of the procedure. TAVI exhibited an increase in conduction disturbances at 1 year and pacemaker implantation at both 30 days and 1 year. No other significant distinctions in outcomes were found. For follow-up costs, TAVI showed slightly higher overall costs compared to SAVR patients, with a €330 difference in total expenses over one year. Although TAVI patients use more medication, this resulted in an increase of €94 in comparison to SAVR patients. Lastly, TAVI-related emergency room admissions significantly raise costs, with TAVI at €822 versus €612 for SAVR.

CONCLUSIONS: The study explores the potential use of Real-World Evidence to generate evidence for the clinical and economical evaluation of new technologies and procedures. The study differs from some prior randomized controlled trial-based studies, highlighting the impact of diverse analytical approaches and patient populations.