Cardiology Division, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy; Università Vita Salute San Raffaele, Milano, Italy.
Cardiology Division, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.
Int J Cardiol. 2023 Oct 15;389:131236. doi: 10.1016/j.ijcard.2023.131236. Epub 2023 Jul 31.
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).
Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA.
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.
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.
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.
水平主动脉（HA）定义为主动脉成角（AA）≥48°，与较差的预后相关，尤其是在自膨式（SE）经导管心脏瓣膜（THV）植入后。尽管 SE ACURATE Neo THV 在 HA 患者中显示出较好的手术成功率，但仍与不可忽视的中重度瓣周漏（PVL）发生率相关。
本研究旨在评估 ACURATE Neo2 在 HA 患者中的表现。
我们对接受 Neo 或 Neo2 THV 经导管主动脉瓣置换术（TAVR）的严重主动脉瓣狭窄合并 HA 的患者进行了多中心队列分析，这些患者来自 ITAL-neo 注册研究。主要终点是根据 Valve Academic Research Consortium-3（VARC-3）标准评估的 30 天内早期安全性和临床疗效的复合终点。次要终点包括中重度 PVL 的发生和 90 天的临床结局。
在 ITAL-neo 注册研究中纳入的 900 例患者中，407 例存在 HA；其中 300 例植入 Neo THV，107 例植入 Neo2 THV。HA 是植入任何 THV 后发生≥中度 PVL 的独立危险因素。两组患者的 30 天技术和器械成功率相当。然而，与 Neo 相比，Neo2 与较低的≥中度 PVL 发生率相关（5% vs. 15%；p<0.001），这一结果在 90 天随访时也得到了证实。此外，在 Neo2 组中，≥中度 PVL 与 AA 之间没有相关性，而在 Neo 组中，PVL 程度与 AA 呈比例增加。
在 HA 患者中，新一代 Acurate Neo2 THV 与可比较的器械成功率相关，与前一代相比，其发生≥中度 PVL 的发生率显著降低。
