Background: Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL).
Objectives: Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA.
Methods: We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes.
Results: Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort.
Conclusion: In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.
Keywords: Horizontal aorta (HA); Paravalvular leak (PVL); Self-expanding Acurate Neo2; Transcatheter aortic valve replacement (TAVR); Transcatheter heart valve (THV).
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