Callaghan J C, Teijeira F J, Bonneau D, Gelfand E T, Casey P, Drutz J
J Cardiovasc Surg (Torino). 1986 Jul-Aug;27(4):500-2.
A total of 228 Omniscience cardiac valve prostheses were implanted in 210 patients at two hospitals in Canada from November, 1979 to August, 1984. The 184 operative survivors were followed for a mean duration of 28.5 months (maximum 62.7 months) and for a total of 438 patient-years. Actuarial analysis for AVR, MVR, and all patients showed survival probabilities at five years of 97.2%, 98.9%, and 97.0% respectively. The five-year actuarial probabilities of remaining free of any thrombotic complications were 96.9% for AVR, 96.4% for MVR, and 95.7% overall. When considering only serious thrombotic complications (thromboembolism with deficit or valve thrombosis), the event-free rates are 100% for AVR, 98.9% for MVR, and 98.6% for the overall patient group at five years. These rates for survival and freedom from thrombotic complication demonstrate the clinical safety and effectiveness of the Omniscience prosthesis. In addition, there were no cases of structural failure or intrinsic mechanical malfunction of the prosthesis.
1979年11月至1984年8月期间，加拿大两家医院的210名患者共植入了228个全知型心脏瓣膜假体。184名手术幸存者的随访平均时长为28.5个月（最长62.7个月），总计438患者年。主动脉瓣置换术（AVR）、二尖瓣置换术（MVR）以及所有患者的精算分析显示，五年生存率分别为97.2%、98.9%和97.0%。AVR、MVR以及总体患者五年内无任何血栓并发症的精算概率分别为96.9%、96.4%和95.7%。仅考虑严重血栓并发症（伴有缺损的血栓栓塞或瓣膜血栓形成）时，AVR、MVR以及总体患者组五年内无事件发生率分别为100%、98.9%和98.6%。这些生存率和无血栓并发症率证明了全知型假体的临床安全性和有效性。此外，没有假体结构故障或内在机械故障的病例。
