A minimalistic approach for transfemoral transcatheter aortic valve implantation therapy: a prospective “real-world” study

Background: Optimized pathways for transcatheter aortic valve implantation (TAVI) have been reported over the past decade, but they considered specific devices and selected populations. Objectives: The aim of this study was to assess the safety and efficacy of a comprehensive, minimalistic approach to TAVI utilizing all available devices in all-comers, real-world population. Methods: This is a prospective, single-center, single-arm clinical study. The primary endpoint of the study was a composite of 30-day all-cause mortality, disabling stroke, major bleedings, major vascular complications, stage 3 acute kidney injury (AKI), and permanent pacemaker implantation (PPI). Outcomes were compared to those of an historical cohort of patients undergoing TAVI following a standard approach, by selecting pairs of patients selected through a 1:1 propensity score matching (PSM). A cost analysis of TAVI hospitalization was performed considering costs related to procedural complications and post-procedural length of stay (LoS). Results: Between January 2020 and December 2023, a total of 997 patients underwent TAVI following an optimized, minimalistic pathway. Device success was reported in 88.2% patients, with low procedural complications. The primary endpoint occurred in 21.1% of patients. After PSM, TAVI patients following the minimalistic pathway had higher device success (91.4% vs 84.2%, p = 0.004), and lower major vascular complications (4.5% vs. 10.3%, p = 0.004) compared to those following the standard approach. Median LoS was shorter (1.0 day vs. 2.0 days, p < 0.001) and the rate of next-day discharge was higher (46.7% vs. 19.0%, p < 0.001) in patients following the minimalistic pathway, with lower hospitalization costs (median € 2200 vs. 3150; p < 0.001). At 30-day, the primary endpoint was significantly lower in patients following the minimalistic pathway (17.2% vs 23.9%, p = 0.034). Conclusions: The minimalistic TAVI care pathway was associated with favorable outcomes in an unselected, real-world population. The shorter post-procedural LoS of the minimalistic approach led to a significant cost-saving.