Saito Tsutomu, Misawa Yoshio, Fuse Katsuo, Konishi Hiroaki
Division of Cardiovascular Surgery, Department of Surgery, Jichi Medical School, 3311-1 Yakushiji, Minami-kawachi, Tochigi, 329-0498, Japan.
J Artif Organs. 2005;8(1):51-5. doi: 10.1007/s10047-004-0275-7.
At Jichi Medical School Hospital, three types of mechanical prosthetic valves (CarboMedics, Omnicarbon, Bicarbon) were used without randomization from 1991 to 2000. A retrospective study of valve replacements done between June 1991 and November 2000 utilizing 180 CarboMedics valves in 145 patients who had not previously undergone prosthetic valve replacement or aortic root and/or arch replacement was conducted to evaluate midterm patient outcomes to assess the future continuous use of CarboMedics valves. Women made up 47.6% of the patients and the mean age was 57.5 years (range 12-80 years). Preoperative New York Heart Association functional class was III or IV in 92.4% (134/145) of patients. Mean follow-up of 4.5 years (range 0-10.0 years) was 95.9% complete, with a total of 628 patient-years (PY). Early (within 30 postoperative days) mortality was 5.5% (8 of 145): 3 from hemorrhage, 3 from nonvalve-related heart failure, 1 from infection, and 1 from arrhythmia. There were 16 late deaths (2.54%/PY): 1 from hemorrhage, 4 from unknown causes/sudden death, 4 from nonvalve-related heart failure, and 7 from other noncardiac causes. A total of 121 patients (83.0%) were alive at the last follow-up, done in November 2000. The linearized death rate was 3.82%/year (including 1.11%/year for valve-related deaths). Linearized death rates from various causes were: bleeding, 0.96%/year; thromboembolism, 1.11%/year; thrombosis, 0.39%/year; perivalvular leak, 0.96%/year; endocarditis, 0%/year; hemolysis, 0%/year; and reoperation, 0.63%/year. No structural valve failure was observed. Comparative early mortality rates of valve replacement without aortic root replacement or arch replacement, excluding repeat valve replacement operations, in our institute, were 3.5% (12/307) for all valve types used contemporaneously, 2.6% (2/76) for Omnicarbon valves, and 2.3% (2/86) for Bicarbon valves. Although the CarboMedics valve had a rather high mortality rate of 5.5% (8/145) compared with the total early mortality rate of 3.5%, the low incidence of valve-related complications might support the continued use of the CarboMedics valve for valve replacement.
1991年至2000年期间，在秩父纪念医院，三种类型的机械人工瓣膜（CarboMedics、Omnicarbon、Bicarbon）未经随机分配便被使用。对1991年6月至2000年11月期间进行的瓣膜置换手术进行回顾性研究，该研究纳入了145例此前未接受过人工瓣膜置换或主动脉根部和/或弓部置换的患者，共使用了180个CarboMedics瓣膜，以评估中期患者的预后情况，从而评估CarboMedics瓣膜未来的持续使用情况。患者中女性占47.6%，平均年龄为57.5岁（范围12 - 80岁）。术前纽约心脏协会心功能分级为III或IV级的患者占92.4%（134/145）。平均随访4.5年（范围0 - 10.0年），随访完成率为95.9%，总计628患者年（PY）。早期（术后30天内）死亡率为5.5%（145例中有8例）：3例死于出血，3例死于非瓣膜相关心力衰竭，1例死于感染，1例死于心律失常。有16例晚期死亡（2.54%/PY）：1例死于出血，4例死因不明/猝死，4例死于非瓣膜相关心力衰竭，7例死于其他非心脏原因。在2000年11月进行的最后一次随访中，共有121例患者（83.0%）存活。线性化死亡率为3.82%/年（包括瓣膜相关死亡的1.11%/年）。各种原因的线性化死亡率分别为：出血，0.96%/年；血栓栓塞，1.11%/年；血栓形成，0.39%/年；瓣周漏，0.96%/年；心内膜炎，0%/年；溶血，0%/年；再次手术，0.63%/年。未观察到结构性瓣膜故障。在我们研究所，不包括再次瓣膜置换手术的情况下，未进行主动脉根部置换或弓部置换的瓣膜置换的比较早期死亡率，同期使用的所有瓣膜类型为3.5%（12/307），Omnicarbon瓣膜为2.6%（2/76），Bicarbon瓣膜为2.3%（2/86）。尽管与总早期死亡率3.5%相比，CarboMedics瓣膜的死亡率相当高，为5.5%（8/145），但瓣膜相关并发症的低发生率可能支持继续使用CarboMedics瓣膜进行瓣膜置换。
