Mas-Peiro Silvia, Alperi Alberto, Regueiro Ander, Cruz-Gonzalez Ignacio, Angellotti Domenico, Campelo-Parada Francisco, Urena Marina, Avanzas Pablo, Vidal-Cales Pablo, Barreira de Sousa Gilles Jose, Esposito Giovanni, Tamir Mehdi, Suc Gaspard, Poulin Anthony, Mohammadi Siamak, Avvedimento Marisa, Rodés-Cabau Josep
Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (S.M.-P., A.P., S.M., M.A., J.R.-C.).
Cardiology Department, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain (A.A., P.A.).
Circ Cardiovasc Interv. 2025 Jun;18(6):e014916. doi: 10.1161/CIRCINTERVENTIONS.124.014916. Epub 2025 Apr 14.
Paravalvular leaks (PVLs) after transcatheter aortic valve replacement have a significant prognostic impact, and valve oversizing, particularly with self-expanding valves, may prevent postprocedural PVL occurrence. Recent iterations of the Evolut valve system are intended to reduce PVL, but the effects of oversizing with such valves on PVL are largely unknown. We aimed to assess, in a real-world contemporary setting, the impact of Evolut valve oversizing on PVL after transcatheter aortic valve replacement.
This was a multicenter observational ambispective study of patients undergoing transcatheter aortic valve replacement with the Evolut PRO/PRO+/FX valves. Aortic annulus perimeter, as determined by multidetector computed tomography, was used to estimate the oversizing degree. The primary end point was the presence of PVL (mild/moderate-severe), as determined by echocardiography at hospital discharge. Secondary end points included in-hospital outcomes as defined by the Valve Academic Research Consortium-3 recommendations.
A total of 762 patients were included (Evolut PRO/PRO+/FX, 55.5%/34.8%/9.7%), and the median valve oversizing was 20 (17-25)%, with no differences in baseline characteristics between low (≤20%, n=381) and high (>20%, n=381) valve oversizing recipients. In-hospital mortality and stroke rates were 2.4% and 4.3%, respectively, with no oversizing-related differences in clinical outcomes. Permanent pacemaker rates were similar in patients with low (19.4%) and high (15.8%) valve oversizing, =0.21. PVL was found in 35.6% of patients (mild: 32.6%, moderate-severe: 3.0%), with a higher incidence of PVL in patients with low (40.9%) versus high (30.2%) oversizing, =0.002. In a multivariable analysis, a higher oversizing degree was associated with a lower risk of PVL (odds ratio, 0.95 [0.92-0.99] for each 1% increase in oversizing, =0.006).
In transcatheter aortic valve replacement with recent Evolut valve iterations (PRO/PRO+/FX), a higher oversizing degree was associated with a lower frequency of PVL without increasing the risk of other complications (including permanent pacemaker). These data suggest that a low degree of valve oversizing should probably be avoided when using Evolut valves, particularly in borderline cases.
经导管主动脉瓣置换术后瓣周漏（PVL）对预后有重大影响，瓣膜尺寸过大，尤其是自膨胀瓣膜，可能会预防术后PVL的发生。Evolut瓣膜系统的最新版本旨在减少PVL，但这种瓣膜尺寸过大对PVL的影响在很大程度上尚不清楚。我们旨在评估在现实世界的当代环境中，Evolut瓣膜尺寸过大对经导管主动脉瓣置换术后PVL的影响。
这是一项对接受Evolut PRO/PRO+/FX瓣膜经导管主动脉瓣置换术患者的多中心观察性双向研究。通过多排计算机断层扫描确定的主动脉瓣环周长用于估计尺寸过大程度。主要终点是出院时经超声心动图确定的PVL（轻度/中度-重度）的存在情况。次要终点包括瓣膜学术研究联盟-3建议定义的住院结局。
共纳入762例患者（Evolut PRO/PRO+/FX，分别为55.5%/34.8%/9.7%），瓣膜尺寸过大的中位数为20（17-25）%，尺寸过小（≤20%，n=381）和尺寸过大（>20%，n=381）的瓣膜接受者之间的基线特征无差异。住院死亡率和卒中率分别为2.4%和4.3%，临床结局在尺寸过大方面无差异。永久起搏器植入率在尺寸过小（19.4%）和尺寸过大（15.8%）的患者中相似，P=0.21。35.6%的患者发现有PVL（轻度：32.6%，中度-重度：3.0%），尺寸过小的患者PVL发生率较高（40.9%），而尺寸过大的患者PVL发生率为（30.2%），P=0.002。在多变量分析中，尺寸过大程度越高，PVL风险越低（尺寸过大每增加1%，比值比为0.95[0.92-0.99]，P=0.006）。
在使用Evolut瓣膜的最新版本（PRO/PRO+/FX）进行经导管主动脉瓣置换时，尺寸过大程度越高，PVL发生率越低，且不增加其他并发症（包括永久起搏器）的风险。这些数据表明，使用Evolut瓣膜时，可能应避免瓣膜尺寸过小，尤其是在临界病例中。
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