One-year hemodynamic and clinical outcomes in self-expanding valves: Comparison of ACURATE neo2 versus ACURATE neo.

Background/purpose: Transcatheter aortic valve replacement (TAVR) with ACURATE neo2 showed better hemodynamic outcomes by mitigating paravalvular leakage (PVL) compared with ACURATE neo, and revealed promising one-year outcomes in single-arm studies. However, studies comparing the hemodynamic and clinical outcomes of the two valves are still scarce. Therefore, this study aimed to compare the one-year hemodynamic and clinical outcomes between the neo2 and neo.

Methods/materials: We analyzed 562 patients who underwent TAVR with ACURATE neo2 (n = 207) or ACURATE neo (n = 355). The primary outcome was one-year all-cause mortality. The secondary outcomes were hemodynamic outcomes at hospital discharge, 3-month, and one-year post-procedure.

Results: In propensity score matching comparison (172 pairs), there was no significant difference in one-year all-cause mortality between the two groups (neo2: 7.0 % vs. neo: 6.4 %, Log-rank p = 0.8101). While the mean aortic valve pressure gradient was significantly higher in the neo2 group at discharge, the difference was not detected after one year (8.1 ± 3.8 mmHg vs. 8.2 ± 3.7 mmHg, p = 0.8862). The PVL grade did not differ between the two groups at any time point. However, the incidence of moderate or severe PVL significantly decreased at one-year post-procedure compared with that at discharge only in the neo2 group (discharge: 7.2 % vs. one year: 1.5 %, p = 0.0455).

Conclusions: The one-year all-cause mortality rate for ACURATE neo2 was similar to that of ACURATE neo. ACURATE neo2 showed the subsequent improvement of significant PVL, which might result in better long-term clinical outcomes than ACURATE neo.

Summary for annotated table of contents: This study compared one-year all-cause mortality and hemodynamic outcomes after TAVR between ACURATE neo2 and ACURATE neo implantation. One-year all-cause mortality rate and significant improvement in the mean APG after TAVR for ACURATE neo2 were similar to those of ACURATE neo. ACURATE neo2 revealed the subsequent improvement of significant PVL for one year, which might result in better long-term clinical outcomes than ACURATE neo.