Clinical research in cardiology : official journal of the German Cardiac Society · 2025
A minimalistic approach for transfemoral transcatheter aortic valve implantation therapy: a prospective "real-world" study.
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Barbanti Marco, Costa Giuliano, Frittitta Valentina, Dipietro Elena, Comis Alessandro, Calì Mariachiara, Sammartino Sofia, Deste Wanda, La Rosa Luigi, Garretto Valeria, Inserra Cristina, Cannizzaro Maria Teresa, Sgroi Carmelo, Veroux Pierfrancesco, Capodanno Davide, Tamburino Corrado
Аннотация
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.
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.