Makkar, R

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.

Importance Sex-related disparities affect diagnosis, referral, and prognosis of aortic valvular diseases. Contemporary US data on transcatheter aortic valve implantation (TAVI) by sex are limited. Objective To characterize 10-year trends in TAVI use, periprocedural complications, and long-term outcomes among Medicare beneficiaries, stratified by sex. Design, Setting, and Participants This nationwide, retrospective, population-based cohort study used US Medicare claims data from fee-for-service beneficiaries discharged after TAVI from January 1, 2013, to December 31, 2022. The median follow-up time was 2.19 (IQR, 0.94-3.79) years. Exclusions included patients who had concomitant valve surgery, infective endocarditis, valve-in-valve TAVI, transapical TAVI, TAVI for pure aortic insufficiency, or later conversion to Medicare Advantage. Analyses were conducted between October 1, 2024, and April 1, 2025. Exposure TAVI. Main Outcomes and Measures The primary outcome was all-cause mortality. Secondary outcomes included periprocedural mortality, vascular complications, acute kidney injury, major or life-threatening bleeding, stroke, acute myocardial infarction (AMI), permanent pacemaker implantation (PPI), and hospitalization for heart failure (HF). Adjusted odds ratios (AORs) and hazard ratios (AHRs) with 95% CIs were estimated. Results The study included 314 123 patients (141 233 women [45.0%] and 172 890 men [55.0%]). Women were older than men (mean [SD] age, female: 80.3 [7.8] years; male: 79.4 [7.7] years; standardized mean difference, 12%). The proportion of female patients who underwent TAVI declined from 47.6% in 2013 to 43.6% in 2022 ( P < .001). Compared with men, women had higher periprocedural mortality (2.5% vs 2.2%; AOR, 1.20 [95% CI, 1.14-1.26]), vascular complications (5.8% vs 3.6%; AOR, 1.65 [95% CI, 1.60-1.71]), and bleeding (10.4% vs 6.8%; AOR, 1.67 [95% CI, 1.62-1.71]) but less PPI (16.9% vs 20.0%; AOR, 0.81 [95% CI, 0.79-0.82]). Long-term mortality was lower in female patients (AHR, 0.92; 95% CI, 0.91-0.93), although their risks of HF hospitalization, AMI, stroke, and bleeding were higher. Conclusions and Relevance Among Medicare beneficiaries, women constituted a progressively declining proportion of patients treated with TAVI, experienced more periprocedural complications, and demonstrated modestly better long-term survival compared with men. Further work is needed to understand factors influencing these trends and to refine sex-specific strategies for optimal outcomes.