Division of Cardiovascular Surgery, Department of Surgery, Osaka University Graduate School of Medicine.
Circ J. 2018 Dec 25;83(1):110-116. doi: 10.1253/circj.CJ-18-0483. Epub 2018 Oct 25.
The aim of this single-center study was to report the midterm clinical outcomes and hemodynamic performance of the St Jude Medical Epic porcine bioprosthesis, a tricomposite glutaraldehyde-preserved porcine bioprosthesis, in mitral position.
Between January 2011 and March 2017, 117 patients (62 men, 55 women; mean age, 66.7±12.8 years) who underwent mitral valve replacement (MVR) with the Epic valve were retrospectively analyzed for early and mid-term morbidity and mortality. The mean follow-up period was 2.6±1.7 years. Three operative deaths occurred, and the operative mortality rate was 2.6%. Sixteen patients died during the follow-up period. On Kaplan-Meier analysis, freedom from all-cause death and major adverse cardiovascular and cerebrovascular events at 5-year follow-up were 80.9% and 54.8%, respectively. There were 6 reoperations: 2 for structural valve deterioration (SVD), 2 for prosthetic valve endocarditis, and 2 for thrombosis. Freedom from valve-related reoperation and SVD at 5 years were 89.0% and 93.1%, respectively. On multivariate analysis, age ≥71 years (HR, 6.78; 95% CI: 2.12-25.2, P<0.01), and NYHA functional class ≥III (HR, 3.20; 95% CI: 1.03-10.4, P=0.04) were independent predictors for all-cause death. Mean mitral pressure gradient at 1 year and 2 years were 5.1±1.9 mmHg and 4.5±1.4 mmHg, respectively.
Mid-term clinical results and durability of the Epic valve in the mitral position are satisfactory.
本单中心研究旨在报告三尖瓣复合戊二醛处理猪生物瓣圣犹达 Epic 在二尖瓣位置的中期临床结果和血液动力学性能。
2011 年 1 月至 2017 年 3 月,回顾性分析了 117 例行二尖瓣置换术(MVR)的 Epic 瓣膜患者的早期和中期发病率和死亡率。平均随访时间为 2.6±1.7 年。3 例手术死亡,手术死亡率为 2.6%。16 例患者在随访期间死亡。Kaplan-Meier 分析显示,5 年随访时全因死亡和主要不良心血管和脑血管事件的无事件生存率分别为 80.9%和 54.8%。有 6 例再次手术:2 例因结构性瓣膜退化(SVD),2 例因人工瓣膜心内膜炎,2 例因血栓形成。5 年瓣膜相关再次手术和 SVD 的无事件生存率分别为 89.0%和 93.1%。多变量分析显示,年龄≥71 岁(HR,6.78;95%CI:2.12-25.2,P<0.01)和 NYHA 心功能分级≥III(HR,3.20;95%CI:1.03-10.4,P=0.04)是全因死亡的独立预测因素。1 年和 2 年的平均二尖瓣压力梯度分别为 5.1±1.9mmHg 和 4.5±1.4mmHg。
Epic 瓣膜在二尖瓣位置的中期临床结果和耐久性令人满意。