Unresolved long-term risks and generalizability limitations: transcatheter vs aortic valve replacement from the RHEAI trial

This commentary refers to ‘Transcatheter vs surgical aortic valve replacement in women: the RHEIA trial’, by D. Tchetche et al., https://doi.org/10.1093/eurheartj/ehaf133. Tchetche et al.'s1 RHEIA trial results, which compared transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) solely in women with severe aortic stenosis, caught our attention. RHEIA is an important development in cardiovascular research since it is the first randomized controlled trial specifically designed to assess sex-specific outcomes in aortic valve intervention. For the primary composite endpoint of all-cause death, stroke, or rehospitalization at 1 year, the study showed that TAVI outperformed SAVR (8.9% vs 15.6%; P = .034). Even though these results add significant evidence to the field, some methodological and analytical aspects need to be carefully taken into account. A major drawback for assessing valve interventions is the 1-year follow-up period. Evidence from longer-term studies suggests that these initial benefits may not persist. For instance, Bianco et al.2 demonstrated that at 5 years, TAVI patients who were generally older and had more comorbidities experienced significantly higher rates of cardiac readmissions, particularly for heart failure, compared with SAVR patients (58.7% vs 42.1%). Similarly, the surgical group's superior haemodynamic performance (mean gradient 10.9 vs 13.6 mmHg; P value < .001) could have significant long-term clinical ramifications for the durability and functional status of the valve.3,4 Furthermore, because pacemaker dependency is linked to an increased risk of heart failure over time, the higher rate of pacemaker implantation with TAVI (8.8% vs 2.9%)1 calls for longer follow-up.5