Department of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Cardiovascular and Thoracic Surgery, UPMC Central Pennsylvania, Harrisburg, Pennsylvania.
Ann Thorac Surg. 2024 Jul;118(1):173-179. doi: 10.1016/j.athoracsur.2023.11.036. Epub 2023 Dec 21.
This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves.
Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area.
Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts.
Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.
本研究通过 5 年的随访，评估 RESILIA 组织（爱德华生命科学公司）在治疗原发性二叶式主动脉瓣患者中的安全性和有效性。研究结果与三叶式主动脉瓣患者进行了比较。
在来自 COMMENCE（前瞻性、非随机、多中心）试验的 689 名接受研究瓣膜的患者中，有 645 名患者具有记录在案的原发性瓣膜形态和核心实验室可评估的术后任何一次随访的超声心动图，这些数据用于建模 5 年内的血流动力学结果。线性混合效应模型用于估计平均梯度和有效瓣口面积的纵向变化。
与三叶式主动脉瓣患者（n=458）相比，原发性二叶式主动脉瓣患者的年龄小了十多岁（59.8±12.4 岁 vs. 70.2±9.5 岁；P<0.001）。5 年内，二叶式主动脉瓣组未出现结构性瓣膜恶化，瓣周漏和瓣中反流的发生率较低（分别为 0.7%和 2.9%[均为轻度]，5 年时）。这些结果与原发性三叶式主动脉瓣患者相似。经年龄、体表面积和生物瓣尺寸校正后，模型估计的术后平均梯度和有效瓣口面积以及这些结果的变化率在两组间无差异。
在二叶式主动脉瓣患者中，RESILIA 组织瓣膜在 5 年内表现出优异的结果，包括无结构性瓣膜恶化和极低的瓣周漏和瓣中反流发生率。这些结果令人鼓舞，提示 RESILIA 组织在年轻患者中具有良好的耐久性。
