DeWall R A, Schuster B, Hicks G, Pelletier C, Bonan R, Martineau J P, Panebianco A, Yip L
J Cardiovasc Surg (Torino). 1987 May-Jun;28(3):328-32.
Between August 1978 and September 1984, 440 patients were implanted with the Omniscience cardiac valve at three North American medical centers (210 aortic, AVR; 165 mitral, MVR; and 65 double valve replacements). Total follow-up was 1056 patient years; survivors were followed up to 76 months (mean 32), with 99% accountability. One hundred and eighty-six (42%) also underwent prior or concomitant major cardiac surgical procedures. Mean age was 56 +/- 12 years. Preoperatively, 3% were in New York Heart Association (NYHA) Class I, 18% II, 54% III, 26% IV. The 5 1/2 year actuarial survival rate for death from valve-related causes (thromboembolism, valve thrombosis, perivalvular leak) was 97% overall. The 5 1/2 year actuarial survival rate from all death causes was 78%. The complication rates, expressed as %/patient-year (endocarditis 0.7; anticoagulant-related hemorrhage 1.0; perivalvular leak 1.5; pannus/tissue overgrowth 0.6; and transient ischemic episode 1.2) demonstrate that advanced age at implant and additional major cardiac surgical procedures do not affect occurrence. Actuarial freedom from thrombotic complications (thromboembolism with residual deficit and valve thrombosis) at 5 1/2 years was 95% overall. Postoperatively, of 348 patients with known NYHA, 65% were in NYHA I, 28% II, 5% III, and 2% IV.
1978年8月至1984年9月期间，北美三个医疗中心为440例患者植入了Omniscience心脏瓣膜（210例主动脉瓣置换术，AVR；165例二尖瓣置换术，MVR；65例双瓣膜置换术）。总随访时间为1056患者年；存活者随访至76个月（平均32个月），随访率为99%。186例（42%）患者还曾接受过或同时接受过心脏大手术。平均年龄为56±12岁。术前，3%的患者属于纽约心脏协会（NYHA）I级，18%为II级，54%为III级，26%为IV级。瓣膜相关原因（血栓栓塞、瓣膜血栓形成、瓣周漏）导致死亡的5.5年精算生存率总体为97%。所有死亡原因导致的5.5年精算生存率为78%。并发症发生率以%/患者年表示（心内膜炎0.7；抗凝相关出血1.0；瓣周漏1.5；血管翳/组织过度生长0.6；短暂性脑缺血发作1.2），表明植入时年龄较大和额外的心脏大手术并不影响并发症的发生。5.5年血栓并发症（伴有残余缺损的血栓栓塞和瓣膜血栓形成）的精算无发生率总体为95%。术后，在已知NYHA分级的348例患者中，65%为NYHA I级，28%为II级，5%为III级，2%为IV级。
