Ye Jian, Jamieson Wr Eric
Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, Vancouver, Canada.
Curr Opin Cardiol. 2006 Mar;21(2):106-12. doi: 10.1097/01.hco.0000210306.79607.1b.
The aim of this article is to evaluate the findings of clinical trials in cardiac valve surgery and to determine the real impact in standard of care. Also, publications on randomized clinical trials were reviewed as to integrity and validity. Nineteen randomized clinical trials were identified in 11 areas of operative and clinical management.
The Veterans Affairs and Edinburgh Heart Valve Trials confirmed the guidelines for indications for bioprostheses and mechanical prostheses. Even current prostheses have advanced technologies but the same valve-related complications determine indications. Randomized clinical trials of mechanical prostheses failed to determine prosthesis superiority. Bioprostheses of specific manufacturers contribute sub-optimal hemodynamics in small sizes. Two trials showed lack of superiority between aortic stented and stentless bioprostheses. Autografts, not allografts, are indicated for children because of structural valve deterioration of allografts. Atrial ablation surgery with concomitant mitral valve reconstruction/replacement is safe and efficacious with at least two energy sources. Minimally invasive aortic valve replacement does not provide superior results to conventional surgery. Patient-managed anticoagulation provides the most favourable thromboembolic and hemorrhagic rates with mechanical prostheses. Prosthesis sewing cuff impregnation with a bactericidal agent to reduce the incidence of prosthetic valve endocarditis was stopped because of increased incidence of major paravalvular leak requiring reoperation.
Randomized clinical trials, although limited in number, have provided advancement of the standard of care. Randomized clinical trials are indicated in the management of mild to moderate ischemic mitral regurgitation and evaluation of new transcatheter technologies to conventional surgery.
本文旨在评估心脏瓣膜手术临床试验的结果，并确定其对医疗标准的实际影响。此外，还对随机临床试验的完整性和有效性进行了综述。在手术和临床管理的11个领域共确定了19项随机临床试验。
退伍军人事务部和爱丁堡心脏瓣膜试验证实了生物瓣膜和机械瓣膜适应症的指南。即使目前的瓣膜技术有所进步，但相同的瓣膜相关并发症仍决定着适应症。机械瓣膜的随机临床试验未能确定哪种瓣膜更具优势。特定制造商生产的小尺寸生物瓣膜血流动力学效果欠佳。两项试验表明，主动脉带支架生物瓣膜和无支架生物瓣膜之间并无优势差异。由于同种异体移植物会出现结构性瓣膜退变，儿童应使用自体移植物而非同种异体移植物。至少采用两种能量源进行二尖瓣重建/置换术同期的心房消融手术安全有效。微创主动脉瓣置换术的效果并不优于传统手术。患者自我管理抗凝治疗时，机械瓣膜的血栓栓塞和出血发生率最为有利。用杀菌剂浸渍人工瓣膜缝合袖口以降低人工瓣膜心内膜炎发生率的试验已停止，因为需要再次手术的主要瓣周漏发生率增加。
随机临床试验数量虽有限，但推动了医疗标准的进步。随机临床试验适用于轻至中度缺血性二尖瓣反流的管理以及新的经导管技术与传统手术的对比评估。
