TAVR Unload: TAVR in Moderate Aortic Stenosis and Ventricular Function Deterioration

Aortic Stenosis (AS) significantly contributes to valvulo-arterial impedance in patients with heart failure and reduced ejection fraction (HFrEF), making it a relevant therapeutic target in this population. Aortic valve replacement (either transcatheter or surgical) is recommended for patients with HFrEF, although this indication does not extend to moderate stenosis patients, unless there were another surgical reason.

These observational studies have shown moderate AS is associated to higher mortality in the long term, with worse myocardial adaptation (fibrosis), which suggests its treatment could reduce adverse events.

Researchers aimed to assess whether transcatheter aortic valve replacement (TAVR) in patients with HFrEF and moderate AS, under optimal medical treatment (OMT), could see improved clinical outcomes and quality of life by reducing afterload, vs clinical aortic stenosis surveillance (CASS), with aortic valve replacement upon progression to severe AS.

An international, investigator-initiated, randomized, open-label study was designed, including symptomatic patients (NYHA II-IV) with 20% to 50% ejection fraction, on OMT for at least one month prior randomization. Moderate AS was defined as aortic valve area (AVA) >1 and ≤1.5 cm², or cases with AVA <1 and >0.6 index, or AVA >1.5 with <0.9 index.

Read also: TAVI and Hypertrophic Cardiomyopathy: An Increasingly Common Association.

Los pacientes fueron aleatorizados 1:1 a TAVI con válvula de balón expandible o a CASS, con posibilidad de cruce a TAVI si la estenosis progresaba. El punto final primario fue un compuesto jerárquico que incluyó mortalidad por cualquier causa, ictus incapacitante, hospitalizaciones por insuficiencia cardíaca y cambio en la calidad de vida (QoL) según el cuestionario de Kansas.

Entre enero de 2017 y diciembre de 2022, se incluyeron 178 pacientes con una media de seguimiento de 23 meses. La edad promedio fue de 77.4 años, el 20.8% eran mujeres, el puntaje STS fue de 4.4% y el 27% fueron considerados frágiles. El 55.6% se encontraban en clase funcional III o IV, con una fracción de eyección promedio de 39%. En el grupo CASS, el 43% de los pacientes requirió TAVI durante el primer año de seguimiento debido a la progresión de la valvulopatía.

In the analysis of the primary composite outcome, pairings showed a gain in favor of TAVI in 47.6% of cases, CASS in 36.3%, and a tie in 16.1%, resulting in a “win ratio” of 1.31 (95% CI: 0.91–1.88; p=0.143), without statistical significance. Although TAVI showed greater benefits in each individual component of the composite, the differences were not significant.

Read also: Mechanical Circulatory Support in Complex Anatomies and Severe Deterioration of Left Ventricular Function.

As regards quality of life, Kansas scores increased immediately after TAVR, remained stable during the first year, and resulted superior at 2 and 3 years, though with no statistical significance.

Conclusiones

TAVR Unload is the first randomized study to assess TAVR in HFrEF patients under OMT. Although no significant differences were observed in the composite endpoint during a mean follow-up of 23 months, an immediate and sustained improvement in quality of life was evident, highlighting the potential benefit of this intervention to this subgroup of patients.

Original Title: Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD.

Reference: Van Mieghem NM, Elmariah S, Spitzer E, Pibarot P, Nazif TM, Bax JJ, Hahn RT, Popma A, Ben-Yehuda O, Kallel F, Redfors B, Chuang ML, Alu MC, Lindeboom W, Kolte D, Zahr FE, Kodali SK, Strote JA, Hermanides RS, Cohen DJ, Tijssen JGP, Leon MB. Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD. J Am Coll Cardiol. 2025 Mar 11;85(9):878-890. doi: 10.1016/j.jacc.2024.10.070. Epub 2024 Oct 28. PMID: 39480381.