BackgroundHemodynamic impact of commissural alignment (CA) with self‐expandable transcatheter aortic valves (TAVR) has not been investigated yet.AimsTo determine hemodynamic impact of CA with self‐expandable TAVR.MethodsMulticentric ambispective study comparing patients who underwent self‐expandable TAVR in seven centers with the Evolut Pro/Pro+ (EP) (Medtronic) and Acurate neo2 (AN2) (Boston Scientific) with and without CA strategies. The degree of commissural misalignment (CMA) was assessed by computed tomography/angiography and 1‐year transvalvular gradients/regurgitation evaluated by echocardiography. A matched comparison according to annular dimensions/eccentricity, prosthesis size/type, and baseline left ventricular function and gradients was performed.ResultsA total of 557 patients, mean age 80.7 ± 6.6 years, 61.4% men, and STS score of 4.3 ± 3.1% were analyzed. A CA technique was attempted in 215 patients (38.6%), including 113 patients with AN2 and 102 patients with EP. None/mild CMA was found in 158 (73.5% vs. 43.6% if no CA attempted, p < 0.001) with no differences between devices (AN2:75.2%; EP:71.6%, p = 0.545). Patients with moderate/severe CMA had a greater aortic peak gradient (22.3 ± 8.7 vs. 19.7 ± 8.5, p = 0.001), significantly greater progression of both peak (p = 0.002) and mean gradients (p = 0.001) after matching, and higher rate of central aortic regurgitation (1.2% vs. 0.4%, p = 0.005) at 1‐year, but not a greater proportion of patients with mean gradient ≥ 10 mmHg.ConclusionsThe use of CA strategies significantly reduced the rate of CMA for the self‐expandable TAVR devices ACN2 and EP which was associated to lower transvalvular gradients and intra‐prosthetic regurgitation progression at 1‐year although no criteria of structural deterioration were met at this follow up. Clinicaltrials.org: NCT05097183.

中文翻译：

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连合对齐对超环自扩张经导管主动脉瓣血流动力学性能的影响


背景尚未研究连合对齐 (CA) 与自扩张式经导管主动脉瓣 (TAVR) 的血流动力学影响。目的是确定 CA 对自扩张式 TAVR 的血流动力学影响。方法多中心双向研究比较在七个中心接受自扩张 TAVR 的患者使用带有或不带有 CA 策略的 Evolut Pro/Pro+ (EP) (Medtronic) 和 Acurate neo2 (AN2) (Boston Scientific)。通过计算机断层扫描/血管造影评估连合错位（CMA）的程度，并通过超声心动图评估一年跨瓣膜梯度/反流。根据环形尺寸/偏心度、假体尺寸/类型以及基线左心室功能和梯度进行匹配比较。 结果共有 557 名患者，平均年龄 80.7 ± 6.6 岁，61.4% 为男性，STS 评分为 4.3 ± 3.1%进行了分析。 215 名患者 (38.6%) 尝试了 CA 技术，其中包括 113 名 AN2 患者和 102 名 EP 患者。 158 例中发现无/轻度 CMA（73.5% vs. 43.6%，如果没有尝试 CA，p < 0.001），设备之间没有差异（AN2：75.2%；EP：71.6%，p = 0.545）。中度/重度 CMA 患者的主动脉峰值梯度更大（22.3 ± 8.7 与 19.7 ± 8.5，p = 0.001），匹配后峰值梯度（p = 0.002）和平均梯度（p = 0.001）的进展显着更大，并且1 年时中央主动脉瓣反流发生率较高（1.2% vs. 0.4%，p = 0.005），但平均压差≥ 10 mmHg 的患者比例并未增加。结论 使用 CA 策略显着降低了自扩张 TAVR 装置 ACN2 和 EP 的 CMA 发生率，这与 1 年时较低的跨瓣梯度和假体内反流进展相关，尽管在本次随访中没有满足结构恶化的标准。临床试验.org：NCT05097183。