BACKGROUND: The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65–69 years, absolute risk reduction, 13%; P =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75–79 years, 5.9%; 70–74 years, 5.1%; 65–69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P =0.73). Approximately one-third of younger patients (65–69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age ( P =0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.
Abstract 12855: Early vs. Late Transcatheter Aortic Valve Replacement in Acute Heart Failure Hospitalizations: National Inpatient Sample (2015-2020)
Introduction: Data on clinical outcomes of early transcatheter aortic valve replacement (TAVR) (<48 hours) compared to late (≥48 hours) TAVR in patients hospitalized with acute heart failure (AHF) and aortic stenosis (AS) remains limited. We aim to evaluate the differences between early vs. late TAVR regarding major clinical outcomes using a real-world US database. Hypothesis: There is no differences in the clinical outcomes based on the timing of TAVR procedural intervention in patients with acute heart failure. Methods: We used the National Inpatient Sample database by utilizing ICD-10 codes to identify all hospitalizations with a diagnosis of AHF and TAVR (2015-2020). The associations between the time of TAVR and outcomes were examined using multivariable logistic regression. Propensity-score matched (PSM) analysis was utilized to determine the adjusted odds ratio (aOR) of major clinical outcomes. Results: A total of 25,285 weighted hospitalizations of AHF were identified, of which 6,855 patients (27.1%) underwent early TAVR and 18,430 (72.9%) had late TAVR. Compared with early TAVR, Late TAVR was associated with less need for mechanical circulatory support (MCS) (aOR 0.97 [0.96-0.98], p<0.01) and acute hypoxic respiratory failure (aOR 0.99 [0.98-0.99], p<0.01), but higher odds of developing septic shock (aOR 2.06 [1.52-2.80], p <0.01). However, there was no significant difference between both procedures regarding in-hospital mortality (aOR 1.01 [1.00-1.02], p=0.14), cardiac arrest (aOR 0.99 [0.98-1.00], p=0.21), and stroke (aOR 1.01 [1.00-1.02], p=0.18). Conclusions: Most patients with AHF and AS undergo TAVR after 48 hours of their presentation. After PSM, there was no difference in inpatient mortality, cardiac arrest, and stroke between both procedures. Late TAVR was associated with lower odds for MCS and acute hypoxic respiratory failure. The optimal timing of TAVR in patients with AHF and AS needs further study.