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: The two cohorts of TAVI and SAVR patients were identified using individual-level administrative data in the Tuscany region of Italy from 2016 to 2021. Patients in treatment cohorts were followed for up to one-year post-procedure, with outcomes and costs assessed. Clinical indicators were selected from the Valve Academic Research Consortium-3 (VARC-3) consensus document. Follow-up costs, in euros (€), were calculated for each patient up to three years post-procedure, from the perspective of the Italian National Healthcare System. Results: No significant differences in 30-day and 1-year mortality were found between TAVI and SAVR, though TAVI showed a slight increase in 3-year mortality (OR 1.05, p = 0.004). TAVI patients had higher rates of conduction disturbances and pacemaker implantation at all time points. They also experienced more ER admissions and hospital readmissions at 3 years, but shorter hospital stays. At 1 year, TAVI incurred in €234 higher total costs, driven mainly by higher ER costs, while pharmaceutical costs were similar. At 3 years, total costs were €2132 for TAVI and €1915 for SAVR, with higher ambulatory and ER costs in the TAVI group but lower pharmaceutical costs. Conclusion: The study explores the potential of Real-World Evidence to inform the clinical and economic 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. Public interest abstract: Aortic stenosis (AS) is a common heart valve disease in the elderly, whose standard treatment consists of Surgical Aortic Valve Replacement (SAVR). For patients that are ineligible for surgery due to high risk or comorbidities, Transcatheter Aortic Valve Implantation (TAVI), has emerged as a less invasive option. This study used real-world data from Tuscany, Italy, to compare clinical outcomes and costs. We found no significant difference in mortality rates between TAVI and SAVR at 30 days and one year and higher mortality at 3 years. TAVI patients were more likely to experience conduction disturbances, often requiring pacemaker implantation. Cost differences were modest, with TAVI patients incurring €234 more in total healthcare expenses over one year and €217 at three years. These findings highlight the value of real-world evidence in assessing the safety, effectiveness, and financial sustainability of new treatments like TAVI.