Podesser B K, Khuenl-Brady G, Eigenbauer E, Roedler S, Schmiedberger A, Wolner E, Moritz A
Department of Cardiothoracic Surgery, General Hospital, University of Vienna, Austria.
J Thorac Cardiovasc Surg. 1998 May;115(5):1121-9. doi: 10.1016/S0022-5223(98)70412-X.
The Edwards Duromedics valve (Baxter Healthcare Corp., Edwards Division, Santa Ana, Calif.) was designed with a self-irrigating hinge mechanism to reduce thromboembolic complications. After good initial clinical results, distribution was suspended in 1988 after reports of valve fracture after 20,000 valves had been implanted. The manufacturer conducted extensive studies to improve the Edwards Duromedics and reintroduced a modified version, which is available as Edwards Tekna. The purpose of the study was the evaluation of long-term results of the original Edwards Duromedics that might be important for the current version, the Edwards Tekna valve.
A prospective clinical 10-year follow-up was performed of 508 patients who underwent valve replacement with the Edwards Duromedics valve in the aortic (n = 268), mitral (n = 183), and aortic and mitral (n = 56) position.
The perioperative mortality rate was 6.9%; follow-up was 98% complete, comprising 3648 patient-years for a mean follow-up of 86 months (range: 33 to 144 months). The actuarial freedom from complications at the 10-year follow-up and the incidence rate (percent per patient-year) were as follows: late mortality rate, 69.2% +/- 2.4% (3.5% per patient-year); thromboembolism, 90.7% +/- 1.6% (0.96% per patient-year); anticoagulation-related hemorrhage, 87.7% +/- 1.7% (1.34% per patient-year); prosthetic valve endocarditis, 96.7% +/- 0.09% (0.38% per patient-year); valve-related mortality rate, 89.3% +/- 1.6% (1.21% per patient-year); valve failure, 86.2% +/- 1.85% (1.54% per patient-year); and valve-related morbidity and mortality rate, 71.1% +/- 2.3% (3.2% per patient-year). Three leaflet escapes were observed (one lethal, two successful reoperations; 99.1% +/- 0.05% freedom, 0.08% per patient-year). All patients functionally improved (86% in New York Heart Association classes I and II), and incidence of anemia was insignificant.
These results confirm that the Edwards Duromedics valve shows excellent performance concerning thromboembolism, hemolysis, and functional improvement and will serve as a reference for the last version, the Edwards Tekna valve, where comparable long-term data are currently not available.
爱德华兹杜罗梅迪克斯瓣膜（百特医疗保健公司，爱德华兹分部，加利福尼亚州圣安娜）设计有自冲洗铰链机制，以减少血栓栓塞并发症。在取得良好的初步临床结果后，1988年在植入20000个瓣膜后有瓣膜骨折的报告，随后该产品暂停销售。制造商进行了广泛研究以改进爱德华兹杜罗梅迪克斯瓣膜，并重新推出了改良版，即爱德华兹泰克纳瓣膜。本研究的目的是评估原始爱德华兹杜罗梅迪克斯瓣膜的长期结果，这些结果可能对当前版本的爱德华兹泰克纳瓣膜很重要。
对508例接受主动脉瓣（n = 268）、二尖瓣（n = 183）以及主动脉瓣和二尖瓣联合置换（n = 56）的患者，使用爱德华兹杜罗梅迪克斯瓣膜进行了为期10年的前瞻性临床随访。
围手术期死亡率为6.9%；随访完成率为98%，共3648患者年，平均随访86个月（范围：33至144个月）。10年随访时无并发症的精算自由度及发生率（每患者年百分比）如下：晚期死亡率为69.2%±2.4%（每患者年3.5%）；血栓栓塞为90.7%±1.6%（每患者年0.96%）；抗凝相关出血为87.7%±1.7%（每患者年1.34%）；人工瓣膜心内膜炎为96.7%±0.09%（每患者年0.38%）；瓣膜相关死亡率为89.3%±1.6%（每患者年1.21%）；瓣膜衰竭为86.2%±1.85%（每患者年1.54%）；瓣膜相关发病率和死亡率为71.1%±2.3%（每患者年3.2%）。观察到3例瓣叶脱出（1例致死，2例再次手术成功；无瓣叶脱出的精算自由度为99.1%±0.05%，每患者年0.08%）。所有患者功能均有改善（86%为纽约心脏协会I级和II级），贫血发生率较低。
这些结果证实，爱德华兹杜罗梅迪克斯瓣膜在血栓栓塞、溶血和功能改善方面表现出色，将为最新版本的爱德华兹泰克纳瓣膜提供参考，目前尚无该瓣膜类似的长期数据。
