Moritz A, Klepetko W, Rödler S, Föger A, Schreiner W, Grabenwöger F, Wolner E
Second Surgical Department, University of Vienna, Wien, Austria.
Eur J Cardiothorac Surg. 1993;7(2):84-90. doi: 10.1016/1010-7940(93)90186-f.
The Duromedics Edwards valve (DE) was designed with a self-irrigating hinge mechanism to reduce the rate of thromboembolic complications. This report presents a prospective follow-up of patients after valve replacement with this prosthesis in a university hospital. Five hundred seven patients had DE prostheses implanted in the aortic (n = 268), mitral (n = 183) or aortic and mitral positions (n = 56). The perioperative mortality was 6.9%. Follow-up was 98% complete, comprising 2009 patient years for a mean follow-up of 48 months: (range 27-84). The actuarial freedom from complications is calculated as follows (linearized rates in parentheses): late mortality 81.0 +/- 2.3% (3.4%/patient year), thromboembolism 93.5 +/- 1.5% (1.1%/patient year), anticoagulation-related hemorrhage 89.5 +/- 2.0% (1.9%/patient year), prosthetic valve endocarditis 96.0 +/- 1.2% (0.7%/patient year), valve-related mortality 93 +/- 1.8% (1.5%/patient year), valve failure 89 +/- 2.0% (2%/patient year), treatment failure 88.0 +/- 2.0% (2.2%/patient year) and all valve-related morbidity and mortality 74.0 +/- 2.8% (5.3%/patient year). Two events of leaflet escape were observed in the study group (0.09%/patient year). Both patients were reoperated successfully. Mechanical hemolysis was subclinical in all cases. The DE shows a complication rate comparable to other modern mechanical valve prostheses. After solving the problem of durability, reconsideration of this valve is worthwhile due to its low risk of thromboembolic complications.
Duromedics Edwards瓣膜（DE）设计有自冲洗铰链机制，以降低血栓栓塞并发症的发生率。本报告介绍了一家大学医院中使用该假体进行瓣膜置换术后患者的前瞻性随访情况。507例患者在主动脉瓣（n = 268）、二尖瓣（n = 183）或主动脉瓣和二尖瓣位置（n = 56）植入了DE假体。围手术期死亡率为6.9%。随访完成率为98%，共2009患者年，平均随访48个月（范围27 - 84个月）。并发症的精算无事件生存率计算如下（括号内为线性化率）：晚期死亡率81.0±2.3%（3.4%/患者年），血栓栓塞93.5±1.5%（1.1%/患者年），抗凝相关出血89.5±2.0%（1.9%/患者年），人工瓣膜心内膜炎96.0±1.2%（0.7%/患者年），瓣膜相关死亡率93±1.8%（1.5%/患者年），瓣膜功能衰竭89±2.0%（2%/患者年），治疗失败88.0±2.0%（2.2%/患者年）以及所有瓣膜相关的发病率和死亡率74.0±2.8%（5.3%/患者年）。研究组观察到2例瓣叶脱出事件（0.09%/患者年）。两名患者均成功接受了再次手术。所有病例中的机械性溶血均为亚临床状态。DE显示出与其他现代机械瓣膜假体相当的并发症发生率。在解决耐久性问题后，鉴于其血栓栓塞并发症风险较低，值得重新考虑使用该瓣膜。
