Rosenzveig Akiva, Ramu Shivabalan Kathavarayan, Besir Besir, Lomaia Tamari, Rajendran Judah, Badwan Osamah, Agrawal Ankit, Reed Grant, Yun James, Puri Rishi, Krishnaswamy Amar, Kapadia Samir R
Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Struct Heart. 2025 Mar 27;9(9):100464. doi: 10.1016/j.shj.2025.100464. eCollection 2025 Sep.
Paravalvular leak (PVL) remains a frequent complication of transcatheter aortic valve replacement (TAVR). The long-term consequences of mild PVL on outcomes have been debated. This study aimed to investigate the clinical and hemodynamic outcomes of mild PVL over a 2-year period.
We conducted a retrospective cohort study of 2601 adult patients who underwent TAVR at the Cleveland Clinic between January 2016 and July 2021. Patients were categorized based on postprocedural PVL severity (mild vs. no/trace PVL). Differences in 2-year clinical outcomes, including all-cause mortality and heart failure hospitalizations, were assessed using Cox regression analysis, while hemodynamic changes were analyzed with a linear mixed model.
Mild PVL was present in 140 patients (5%). Compared to those with no/trace PVL, these patients were older, had a lower body mass index, higher prevalence of concentric left ventricular hypertrophy, and more frequent significant mitral regurgitation. Hemodynamic parameters, including transvalvular aortic mean gradient, left ventricular ejection fraction, and ventricular dimensions, remained similar between groups at 30 days, 1 year, and 2 years. Multivariate Cox regression showed no significant association between mild PVL and 2-year all-cause mortality (hazard ratio: 1.24, 95% CI: 0.65 to 2.39, = 0.51) or heart failure hospitalization (hazard ratio: 1.19, 95% CI: 0.53 to 2.66, = 0.67).
Mild PVL after TAVR is not associated with adverse long-term clinical outcomes or significant impairment in cardiac remodeling within the first 2 years postprocedure compared to no/trace PVL.
瓣周漏（PVL）仍是经导管主动脉瓣置换术（TAVR）常见的并发症。轻度PVL对预后的长期影响一直存在争议。本研究旨在调查轻度PVL在2年期间的临床和血流动力学结局。
我们对2016年1月至2021年7月在克利夫兰诊所接受TAVR的2601例成年患者进行了一项回顾性队列研究。根据术后PVL严重程度（轻度与无/微量PVL）对患者进行分类。使用Cox回归分析评估2年临床结局的差异，包括全因死亡率和心力衰竭住院率，同时使用线性混合模型分析血流动力学变化。
140例患者（5%）存在轻度PVL。与无/微量PVL的患者相比，这些患者年龄更大，体重指数更低，同心性左心室肥厚的患病率更高，显著二尖瓣反流更常见。在30天、1年和2年时两组之间的血流动力学参数，包括跨瓣主动脉平均梯度、左心室射血分数和心室尺寸仍相似。多变量Cox回归显示轻度PVL与2年全因死亡率（风险比：1.24，95%置信区间：0.65至2.39，P = 0.51）或心力衰竭住院率（风险比：1.19，95%置信区间：0.53至2.66, P = 0.67）之间无显著关联。
与无/微量PVL相比，TAVR术后轻度PVL在术后前2年内与不良长期临床结局或心脏重塑的显著损害无关。
