What is the clinical evidence from this study?

Study design: Cohort. Population: Severe symptomatic aortic stenosis (n=428). Intervention: Transcatheter aortic valve replacement (TAVR). Primary outcome: Objective functional improvement at 6 months (≥10% increase in 6-min walk test distance or ≥50% reduction in NT-proBNP).

March 2, 2023Open Access

A new integrative approach to assess aortic stenosis burden and predict objective functional improvement after TAVR

JHJosé M. de la Torre HernándezInterventional / Structural Cardiology GFGabriela Veiga FernándezUniversidad de Cantabria EBEyal Ben–AssaInterventional Cardiology

Key Result

Transcatheter aortic valve replacement resulted in objective functional improvement in 80% of patients at 6 months, which was associated with a significantly lower 2-year mortality rate (9% vs. 31%, p=0.0002).

Study Design

Type

Cohort (n=428)

Multicenter

Structured PICO

Does a multiparametric score predict objective functional improvement at 6 months in patients undergoing TAVR for severe symptomatic aortic stenosis?

Population

428 patients (212 in derivation cohort, 216 in validation cohort) with significant and symptomatic aortic stenosis scheduled for transcatheter aortic valve replacement (TAVR) via femoral artery access.

Intervention

Transcatheter aortic valve replacement (TAVR) via femoral artery access using balloon-expandable prosthetic valves.

Outcome

Objective functional improvement 6 months after TAVR, defined as an increase of at least 10% in the distance covered during the 6-min walk test, or a reduction of at least 50% in NT-proBNP blood levels with respect to pre-TAVR.surrogate

A novel integrative score (GAPA) utilizing baseline clinical, anatomical, and physiological parameters can effectively predict objective functional improvement and 2-year mortality in patients undergoing TAVR.

Limitations

Not a large cohort, requiring validation in a larger population of patients currently treated with TAVR.
The definition of objective functional improvement was specific to the study and may be questionable.
The validity of non-invasive assessment of central pressures, pulse wave velocity, and aortic pressure curves in the context of aortic stenosis has been debated.
The assessment time of 6 months may be affected by the concurrence or progression of other unrelated pathological processes in an elderly population.

Abstract

Background: A non-negligible rate of patients undergoing transcatheter aortic valve replacement (TAVR) do not report symptomatic improvement or even die in the short-midterm. We sought to assess the degree of objective functional recovery after TAVR and its prognostic implications and to develop a predictive model. Methods: In a cohort of patients undergoing TAVR, a prospective evaluation of clinical, anatomical, and physiological parameters was conducted before and after the procedure. These parameters were derived from echocardiography, non-invasive analysis of arterial pulse waves, and cardiac tomography. Objective functional improvement 6 months after TAVR was assessed using a 6-min walk test and nitro-terminal pro-brain natriuretic peptide (NT-proBNP) levels. The derived predictive model was prospectively validated in a different cohort. A clinical follow-up was conducted at 2 years. Results: of ≥45%, the posterior wall thickness of ≤12 mm, and absence of atrial fibrillation. A simple integer-based point score was developed (GAPA score), which showed an area under the curve of 0.81 for the overall cohort and 0.78 for the low-gradient subgroup. In a validation cohort of 216 patients, these values were 0.75 and 0.76, respectively. Conclusion: A total of 80% of patients experienced objective functional improvement after TAVR, showing a significantly lower 2-year mortality rate. A predictive score was built that showed a good discriminative performance in overall and low-gradient populations.

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