Rábago G, Martinell J, Fraile J, Andrade I G, Montenegro R
J Thorac Cardiovasc Surg. 1984 Jan;87(1):136-40.
A clinical trial with the Omniscience heart valve was conducted from June, 1980, until May, 1981. In this period 166 patients underwent heart valve replacement: mitral valve replacement (MVR) 70 patients, aortic valve replacement (AVR) 37, and combined mitral-aortic valve replacement (M/AVR) 59 patients. There were 20 hospital deaths, for a mortality of 12%. Total follow-up was 226 patient-years (range 6 to 28 months, mean 18 months). There were eight late deaths (MVR 4.6%, AVR 3.1%, and M/AVR 8.1%). All patients were taking oral anticoagulants. The incidence of valve-related complications (expressed as events per 100 patient-years) was as follows: Systemic embolism--MVR 2, AVR 4.7, and M/AVR 2.5; and anticoagulant complications--MVR 1.9, AVR 2.3, and M/AVR 0. The incidence of valvular dysfunction (expressed as events per 100 patient-years) was as follows: valvular thrombosis--MVR 4.8, AVR 0, and M/AVR 1.2; perivalvular leakage--MVR 1.9, AVR 2.3, and M/AVR 2.5; and infective endocarditis--MVR 0.96, AVR 0, and M/AVR 1.2. The actuarial probability of being free of valvular dysfunction 30 months postoperatively is 73% for the MVR group, 90% for the AVR group, and 71% for the M/AVR group. Despite a short follow-up, the incidence of valvular dysfunction has been significant. For this reason, we have discontinued using these prostheses for heart valve replacement.
1980年6月至1981年5月期间进行了一项使用全知心脏瓣膜的临床试验。在此期间，166例患者接受了心脏瓣膜置换术：二尖瓣置换术（MVR）70例，主动脉瓣置换术（AVR）37例，二尖瓣-主动脉瓣联合置换术（M/AVR）59例。有20例住院死亡，死亡率为12%。总随访时间为226患者年（范围6至28个月，平均18个月）。有8例晚期死亡（MVR为4.6%，AVR为3.1%，M/AVR为8.1%）。所有患者均服用口服抗凝剂。瓣膜相关并发症的发生率（以每100患者年的事件数表示）如下：系统性栓塞——MVR为2，AVR为4.7，M/AVR为2.5；抗凝剂并发症——MVR为1.9，AVR为2.3，M/AVR为0。瓣膜功能障碍的发生率（以每100患者年的事件数表示）如下：瓣膜血栓形成——MVR为4.8，AVR为0，M/AVR为1.2；瓣周漏——MVR为1.9，AVR为2.3，M/AVR为2.5；感染性心内膜炎——MVR为0.96，AVR为0，M/AVR为1.2。MVR组术后30个月无瓣膜功能障碍的精算概率为73%，AVR组为90%，M/AVR组为71%。尽管随访时间较短，但瓣膜功能障碍的发生率一直很高。因此，我们已停止使用这些假体进行心脏瓣膜置换。
