Dr. Ahmet Karaduman

RHEIA - Transcatheter versus surgical aortic valve replacement in women with severe aortic stenosis

Link: https://www.jacc.org/doi/10.1016/j.jcin.2021.08.073

Background: Subgroup analyses from prior trials suggest that transcatheter aortic valve implantation (TAVI) may offer better outcomes compared to surgical aortic valve replacement (SAVR) in women with aortic valve stenosis. However, this hypothesis has not been directly tested in a dedicated trial focusing on an all-female population.

Objective: The RHEIA trial aimed to compare the outcomes of TAVI versus SAVR in women with severe aortic stenosis across all surgical risk categories, except those deemed prohibitive.

Methods: In this multicenter, randomized, controlled trial, 443 women with severe aortic valve stenosis were assigned in a 1:1 ratio to undergo either TAVI with a third-generation balloon-expandable valve system (Edwards Sapien, Sapien Ultra) via transfemoral access or SAVR with surgical valves (Edwards Magna Ease, Intuityn Livanova Perceval). The primary endpoint was a composite of all-cause mortality, stroke, and re-hospitalization for valve- or procedure-related symptoms or worsening heart failure at 1 year. Patients with bicuspid, unicuspid, or non-calcified valves and those with complex coronary artery disease or elevated procedural risk for TAVI or SAVR were excluded.

Results: At 1 year, a significantly lower percentage of patients in the TAVI group met the primary composite endpoint compared to the SAVR group (8.9% vs. 15.6%, p = 0.03), demonstrating both non-inferiority and superiority of TAVI. The difference was largely driven by reduced re-hospitalizations for valve- or procedure-related symptoms or worsening heart failure (4.8% for TAVI vs. 11.4% for SAVR, p = 0.02). TAVI was associated with lower rates of new-onset atrial fibrillation (3.3% vs. 28.8%, p < 0.001) and shorter hospital stays (4 days vs. 9 days). However, the pacemaker implantation rate was higher in the TAVI group (8.8% vs. 2.9%, p = 0.01). TAVI valves had higher mean gradients and lower effective orifice areas at both 1 month and 1 year. Mild paravalvular aortic regurgitation was more frequent in TAVI patients (15.5% vs. 2.4%, p < 0.001).

Conclusions: The RHEIA trial is the first to specifically assess TAVI versus SAVR in an all-female population, demonstrating that TAVI offers lower re-hospitalization rates and shorter hospital stays, but with a higher incidence of pacemaker implantation and mild paravalvular regurgitation. These findings highlight the need for further studies focusing on long-term outcomes and different valve platforms in women with severe aortic stenosis.

Interperations:
The RHEIA trial shows that TAVI may provide better outcomes than SAVR in women with severe aortic stenosis, particularly by reducing re-hospitalizations and shortening hospital stays. However, this benefit comes with a higher risk of pacemaker implantation and mild paravalvular regurgitation. These results suggest that TAVI, with the balloon-expandable devices used in the trial, could be considered the preferred option to treat women with severe aortic stenosis.