Key result
ACURATE neo2 linked to ~69% greater PVL improvement at 3 months post-TAVR vs ACURATE neo.
Why the study?
Differences in subsequent paravalvular leakage improvement and the underlying improvement mechanism between the ACURATE neo2 and ACURATE neo valves after TAVR remained unclear.
Does TAVR with ACURATE neo2 improve paravalvular leakage compared to ACURATE neo in patients undergoing TAVR?
Observational (n=403)
No
Does TAVR with ACURATE neo2 improve paravalvular leakage compared to ACURATE neo in patients undergoing TAVR?
ACURATE neo2 is associated with a significantly higher rate of paravalvular leakage improvement at 3 months compared to ACURATE neo, with leaflet calcification being an independent predictor of improvement.
The paravalvular leakage (PVL) incidence immediately after transcatheter aortic valve replacement (TAVR) is reportedly lower with ACURATE neo2 than with ACURATE neo. However, the difference in the subsequent PVL improvement between these valves and the improvement mechanism remain unclear. This study aimed to compare the incidence of and changes in the PVL between these valves and investigate the factors associated with PVL improvement. We included 403 patients who underwent TAVR with ACURATE neo2 (n = 134) or ACURATE neo (n = 269). The study endpoint was PVL improvement, defined as a reduction in the PVL grade from mild or higher at discharge to none/trace at 3 months. The PVL incidence of mild grade or higher was significantly lower with ACURATE neo2 than with ACURATE neo at 3 months (15.7% vs. 25.7%; p = 0.0234) but did not differ significantly at discharge (33.3% vs. 27.5%; p = 0.2291). A significant decrease in the PVL was observed only with ACURATE neo2 (p < 0.0001). Multivariate analysis demonstrated that ACURATE neo2 and calcium volume of the aortic leaflets were independent predictors of PVL improvement. The incidence of mild grade or higher PVL was lower with ACURATE neo2 than with ACURATE neo at 3 months due to the subsequent improvement. Patient selection focusing on leaflet calcification is important for preventing PVL because severe calcification impedes PVL improvement.
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Sugiyama et al. (2025) conducted an observational in Severe aortic stenosis (n=403). ACURATE neo2 vs. ACURATE neo was evaluated on Paravalvular leakage (PVL) improvement (reduction from mild or higher at discharge to none/trace at 3 months) (RR 1.69, 95% CI 1.22-2.34, p=0.0043). ACURATE neo2 significantly increased the rate of paravalvular leakage improvement compared to ACURATE neo (60.8% vs 36.7%, RR 1.69) at 3 months after transcatheter aortic valve replacement.
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