Assessing Clinical Outcomes in Patients with Transcatheter Aortic Valve Implantation (TAVI) in the Tuscany Region, Italy

Author(s)

Moretti G1, Manetti S2, Passino C3, Vainieri M2
1Sant'Anna School of Advanced Studies, PISA, PI, Italy, 2Sant'Anna School of Advanced Studies, MeS Lab, Pisa, Italy, 3Sant'Anna School of Advanced Studies, Pisa, Italy

Presentation Documents

OBJECTIVES: Surgical aortic valve replacement (SAVR) is the conventional treatment for patients with severe, symptomatic aortic valve stenosis. TAVI are less invasive procedures originally developed for patients with high surgical risks. The study aims to provide empirical evidence on the evolution of outcome performance measures in the use of TAVI between 2016 and 2020.

METHODS: Applying the RECOD guidelines to administrative health data, we calculate treatment quality and efficiency indicators. Patients eligible for the study were identified according to TAVI-specific diagnosis and intervention codes. The clinical endpoints identified according to the Valve Academic Research Consortium-2 (VARC-2) consensus document are (a) 30-day all-cause mortality; (b) 1-year mortality; (c) 30-day stroke; (d) 30-day myocardial infarction and (e) 30-day conduction disturbances.

RESULTS: A total of 2,248 patients with TAVI procedures were identified, a 102% increase from 2016 to 2020. The mean values of 30-day outcomes over the 5-year study period were (a) 2.0%, all-cause mortality (c) 1.1%, 30-day stroke (d) 0.3%, 30-day myocardial infarction, and (e) 11.1%, conduction disorders. 1-year mortality rates were 11.0%. 30-day all-cause mortality rates decreased by 48% from 2016 to 2021, whereas 1-year mortality rates dropped by 52%. The reduction in mortality rates is a key outcome indicator, which depends mainly on the implementation of new technologies and interventional procedures. Conduction disturbances at 30 days show a 9% increase. Although present among clinical outcomes, they do not represent life-threatening conditions, but important long-term consequences related to TAVI.

CONCLUSIONS: The increase in TAVI procedures over the five-year study period reflects a change in patient eligibility criteria selection. This study uses real-world data to provide empirical evidence on the primary and secondary endpoints related to the increased use of TAVI. Further studies should be conducted to understand the causes of performance variability among health centers.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)

Code

CO185

Topic

Study Approaches

Topic Subcategory

Electronic Medical & Health Records

Disease

Surgery

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