Adverse events following transcatheter aortic valve implantation (TAVI) in patients with amyloidosis: observations from a global federated network

Abstract Background A high proportion of patients with aortic stenosis are affected by cardiac amyloidosis, but there is a paucity of data describing the effect of amyloidosis on the clinical course of patients who underwent transcatheter aortic valve implantation (TAVI). Purpose To assess the one-year risk of adverse events following TAVI in patients with amyloidosis. Methods Retrospective study using data from a large multinational electronic health record network (TriNetX). Patients aged 18 years or older who underwent TAVI between 2005 and 2022 were included in the analysis. The patients were categorised in two groups based on the presence of amyloidosis (ICD-10-cm code E85). Primary outcome was the one-year risk of the composite of emergency department (ED) admission, acute heart failure (HF), stroke, conduction system disease, pacemaker (PM) implantation, acute kidney injury, and all-cause death. Secondary outcomes were the risks for each component of the composite outcome. We used Cox regression analysis to calculate hazard ratio (HR) and 95% confidence interval (CI) after propensity score matching (PSM) 1:1. Results We identified 477 TAVI recipients with a diagnosis of amyloidosis (age 78.6±8.1 years, 31.4% females) and 43,379 TAVI patients without a diagnosis of amyloidosis (78.1±8.8, 40.2% females). Before PSM, patients affected by amyloidosis were more likely to be Black or African American and had a higher prevalence of cardiovascular risk factors compared to TAVI patients without amyloidosis. After PSM, patients with a diagnosis of amyloidosis showed a higher one-year risk of composite outcome (HR 1.28, 95%CI 1.10-1.49) compared to those who underwent TAVI without amyloidosis. Regarding secondary outcomes, amyloidosis patients had a higher risk of ED admission (HR 1.41, 95%CI 1.13-1.75), acute HF (HR 1.56, 1.23-1.99), stroke (HR 1.55, 1.04-2.32), conduction system disease (HR 1.27, 1.04-1.55), PM implantation (HR 1.55, 1.06-2.28), but not acute kidney injury (HR 1.11, 0.84-1.48) and all-cause death (HR 0.98, 0.66-1.45). Conclusion Among patients undergoing TAVI, those affected by amyloidosis are at higher risk of adverse events in the first year after TAVI. More studies are needed to define the exact role of amyloid fibrils in structural valve deterioration and to elucidate whether subtypes of amyloidosis have a different impact on patients’ outcomes following TAVI.Risk of composite outcome following TAVI