Potentially futile outcome after uncomplicated TAVI: insights from the TRITAVI registry

BACKGROUND: Patients with Aortic Stenosis (AS) undergoing Transcatheter Aortic Valve Implantation (TAVI) are still exposed to a not negligible risk of death during the first year after the procedure, despite a not-complicated procedure. However, few data are still available about timing and kind of death after the procedure. METHODS: Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI; NCT03740425) is an international, investigator-initiated registry designed to collect data on patients with symptomatic severe aortic stenosis undergoing TAVI at 18 European sites. The primary end point of the study was all-cause death occurring in patients between 30 days and 1 year without major peri-procedural complications (major vascular complications, stage 2 to 3 acute kidney injury (AKI) and transfusions) during the procedure. RESULTS: A total of 11,246 patients were included (mean age 82 years; 52% female). Among them, 454 (4%) died between 1 and 12 months without major peri-procedural complications. Patients who died were also elderly (mean age 82 years) and 50% were female. Of these, 78 (0.7%) died for cardiovascular reasons, while 376 (3.3%) died for non-cardiovascular reasons. COPD (HR: 1.35, 95% CI: 1.05 - 1.73, p = 0.002), Atrial Fibrillation (HR: 1.46, 95% CI: 1.16 - 1.84, p = 0.001), severe Chronic Kidney Disease (CKD) (HR: 1.70, 95% CI: 1.10 - 2.62, p = 0.018), moderate and severe reduction of LVEF (respectively HR: 1.42, 95% CI: 1.07-1.90, p 0.017 and HR 1.62, 95% CI 1.17-2.23, p 0.003) were associated with and increased risk of the primary end point. At competitive risk analysis, risk of non CV death appeared to be more relevant and to steadily increase across the year, while risk of CV death was lower. Consistently, baseline creatinine (HR: 1.2, 95% CI: 1.1 - 1.4, p = 0.002) and AF (HR: 1.4, 95% CI: 1.1 - 1.8, p = 0.008) related to increased risk of non CV death, while higher baseline LVEF related to lower risk (HR: 0.9, 95% CI: 0.8 - 0.99, p <0.001). CONCLUSION: Risk of death between 30 days and 1 year after non-complicated TAVI is not negligible even for patients without major peri-procedural complications. It appears mainly driven by non-CV reasons and predicted by baseline renal function, baseline LVEF, and atrial fibrillation.