What is the clinical evidence from this study?

Study design: Cohort. Population: Severe aortic stenosis with small aortic annulus (n=94). Intervention: Transcatheter aortic valve replacement (TAVR) with Sapien XT vs. Surgical aortic valve replacement (SAVR). Primary outcome: 2-year mortality (p=0.95).

November 19, 2018Open Access

Valve Hemodynamics and Clinical Outcomes After Transcatheter Aortic Valve Replacement for a Small Aortic Annulus

Resultado clave

TAVR with a Sapien XT resulted in similar 2-year mortality compared to SAVR (19.4% vs 19.2%, p=0.95) in high-risk patients with severe aortic stenosis and a small aortic annulus.

Diseño del estudio

Tipo

Cohort (n=94)

Multicéntrico

PICO estructurado

Does TAVR improve postprocedural valve hemodynamics and reduce prosthesis-patient mismatch compared to SAVR in high-risk patients with a small aortic annulus?

Población

94 high-risk patients (mean age 80.2 years, 93.6% female) with severe aortic stenosis and a small aortic annulus (≤20 mm) undergoing TAVR or SAVR, followed for a mean of 20.6 months.

Intervención

Transcatheter aortic valve replacement (TAVR) with a Sapien XT valve

Comparador

Surgical aortic valve replacement (SAVR)

Resultado

Postprocedural valve hemodynamics (peak transvalvular velocity, mean pressure gradient, aortic valve area) and severe prosthesis-patient mismatch (PPM)surrogate

In high-risk patients with a small aortic annulus, TAVR improves hemodynamics and reduces severe prosthesis-patient mismatch compared to SAVR, with similar 2-year mortality.

Resultado numérico

Tasa de eventos absoluta: 19.4% vs 19.2%

valor p: p=0.95

Limitaciones

Single-center, retrospective analysis with a small sample size.
Small aortic annulus criteria were defined by two-dimensional TEE rather than multidetector computed tomography or magnetic resonance imaging.
Only the Sapien XT 23-mm valve was used in all TAVR procedures.
Aortic annular enlargement or root replacement was not performed in the SAVR cohort.
The influence of paravalvular leakage was not considered due to its relatively low incidence in this study.

Resumen

The hemodynamics and outcomes in patients with a small aortic annulus (SAA) after transcatheter aortic valve replacement (TAVR) with a second-generation transcatheter heart valve remain unclear. We investigated whether TAVR with a Sapien XT (Edwards Lifesciences, Irvine, California) influences postprocedural valve hemodynamics and long-term outcome in high-risk SAA patients compared with surgical aortic valve replacement (SAVR).We retrospectively identified 94 SAA patients who underwent aortic valve replacement (TAVR = 35 and SAVR = 59). SAA was defined as an aortic annulus diameter ≤ 20 mm, measured by preprocedural transesophageal echocardiography.The mean age was 80.2 years. The mean Society of Thoracic Surgeons-Predicted Risk of Mortality was 6.8%. The post-procedural peak transvalvular velocity and mean pressure gradient were significantly lower in the TAVR cohort than in the SAVR cohort, whereas the postprocedural aortic valve area was significantly higher in the TAVR cohort. Severe prosthesis-patient mismatch (PPM) occurred less frequently after TAVR than SAVR (TAVR 2.9% versus SAVR 22.0%, P = 0.01). The two-year mortality in SAA patients was similar between the two groups.TAVR with a Sapien XT in SAA patients improved the valve hemodynamics and reduced the incidence of PPM compared with SAVR. TAVR patients had a similar 2-year mortality despite higher risk baseline characteristics. To avoid PPM and the consequent poor outcomes, TAVR can be considered an alternative option to SAVR in high surgical risk patients with SAA.

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