Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Thorac Cardiovasc Surg. 2023 Oct;71(7):511-518. doi: 10.1055/s-0042-1757241. Epub 2022 Oct 10.
This study was conducted to evaluate the mid-term outcomes of rapid-deployment aortic valve replacement (AVR) using Edwards Intuity.
A total of 215 patients underwent rapid-deployment AVR using Edwards Intuity at our institution. The median follow-up duration was 22 months (interquartile range, 8-36). Primary outcomes were overall survival, cumulative incidence of cardiac death, and major adverse cardiac events. Secondary outcomes were early and 1-year hemodynamic performances of the bioprosthetic valve.
The mean age was 68.6 ± 10.5 years, and EuroSCORE II was 3.09 ± 4.5. The study population included 113 patients (52.6%) with bicuspid valves (24 patients with type 0 bicuspid valves), 20 patients (9.3%) with pure aortic regurgitation, and 3 patients (1.4%) with infective endocarditis. Isolated AVR was performed in 70 patients (32.4%) and concomitant procedures were performed in 146 patients (67.6%), including aorta surgery (42.3%) and mitral valve procedure (22.3%). Operative mortality was 2.8%. Complete atrioventricular block occurred in 12 patients, but most of them were transient and only 3 patients received permanent pacemaker implantation before discharge. Overall survival at 3 years was 92.3%. Early hemodynamic data showed mean pressure gradients of 15.5 ± 5.0 and 12.7 ± 4.2 mm Hg in the 19 and 21 mm valve, respectively. One-year hemodynamics were also excellent with mean pressure gradients of 14.7 ± 5.3 and 10.7 ± 3.6 mm Hg in the 19 and 21 mm valve, respectively.
Based on a real-world all-comers population, rapid-deployment AVR using Edwards Intuity could be performed for various indications, including bicuspid valve, pure aortic regurgitation, and infective endocarditis, and the clinical and hemodynamic outcomes were excellent.
本研究旨在评估使用 Edwards Intuity 进行快速部署主动脉瓣置换术（AVR）的中期结果。
在我们的机构中，共有 215 例患者接受了 Edwards Intuity 快速部署 AVR。中位随访时间为 22 个月（四分位距，8-36）。主要结局是总体生存率、心脏死亡的累积发生率和主要不良心脏事件。次要结局是生物瓣的早期和 1 年血流动力学性能。
平均年龄为 68.6±10.5 岁，EuroSCORE II 为 3.09±4.5。研究人群包括 113 例（52.6%）二叶式主动脉瓣患者（24 例为 0 型二叶式主动脉瓣），20 例（9.3%）单纯主动脉瓣反流患者和 3 例（1.4%）感染性心内膜炎患者。70 例（32.4%）患者接受单纯 AVR，146 例（67.6%）患者接受联合手术，包括主动脉手术（42.3%）和二尖瓣手术（22.3%）。手术死亡率为 2.8%。12 例患者发生完全性房室传导阻滞，但大多数为一过性，仅 3 例患者在出院前植入永久性起搏器。3 年总生存率为 92.3%。早期血流动力学数据显示，19 毫米和 21 毫米瓣膜的平均压力梯度分别为 15.5±5.0 和 12.7±4.2 毫米汞柱。1 年的血流动力学也非常优秀，19 毫米和 21 毫米瓣膜的平均压力梯度分别为 14.7±5.3 和 10.7±3.6 毫米汞柱。
基于真实世界的所有患者人群，使用 Edwards Intuity 进行快速部署 AVR 可用于多种适应症，包括二叶式主动脉瓣、单纯主动脉瓣反流和感染性心内膜炎，临床和血流动力学结果均非常出色。
