Otaki M, Kitamura N
Osaka National Hospital, Japan.
Cardiovasc Surg. 1993 Oct;1(5):594-8.
Between January 1985 and March 1990, isolated Omnicarbon valve replacement operations were performed on 90 patients aged 25-72 years. There were 53 aortic valve replacements (AVR) and 37 mitral valve replacements (MVR). The cumulative follow-up was 320 patient-years, with a mean(s.d.) follow-up of 3.7(1.4) years. There were three operative and hospital deaths (3.3%) resulting from retrograde aortic dissection during cardiopulmonary bypass, postoperative renal failure and postoperative mediastinitis. Seven patients died during the late postoperative period, four from valve-related causes. Two of these patients died from prosthetic valve endocarditis, and the others died from thromboembolism and valve thrombosis. The mean(s.d.) actuarial survival rate at 6 years was 86.2(4.3)% (98.8(0.8)% for AVR, 82.1(4.8)% for MVR). The mean(s.d.) actuarial survival rate of freedom from all valve-related mortality at 6 years was 93.5(2.6)% (100% for AVR, 88.1(2.9)% for MVR). There were two thromboembolic events (one mesenteric artery thrombosis and one valve thrombosis). The standardized incidence of thromboembolism was 0.63% per patient-year. Prosthetic valve endocarditis occurred in three patients (0.94% per patient-year). One patient (0.31% per patient-year) was found to have a paravalvular leak resulting from aortitis syndrome. The mean(s.d.) actuarial rate of freedom from all valve-related complications at 6 years was 89.2(2.0)% (98.6(1.0)% for AVR, 86.4(2.2)% for MVR). There were no instances of anticoagulant-related haemorrhage, valve-related haemolysis, or structural failure. Results of a follow-up period of 6 years indicated that good clinical results and a low incidence of valve-related complications can be demonstrated with the Omnicarbon valve.
1985年1月至1990年3月期间，对90例年龄在25至72岁的患者进行了单纯Omnicarbon瓣膜置换手术。其中主动脉瓣置换术（AVR）53例，二尖瓣置换术（MVR）37例。累计随访320患者年，平均（标准差）随访时间为3.7（1.4）年。有3例手术及住院死亡（3.3%），原因分别为体外循环期间逆行性主动脉夹层、术后肾衰竭和术后纵隔炎。7例患者在术后晚期死亡，4例死于瓣膜相关原因。其中2例死于人工瓣膜心内膜炎，其他死于血栓栓塞和瓣膜血栓形成。6年时平均（标准差）精算生存率为86.2（4.3）%（AVR为98.8（0.8）%，MVR为82.1（4.8）%）。6年时无所有瓣膜相关死亡的平均（标准差）精算生存率为93.5（2.6）%（AVR为100%，MVR为88.1（2.9）%）。发生了2例血栓栓塞事件（1例肠系膜动脉血栓形成和1例瓣膜血栓形成）。血栓栓塞的标准化发生率为每年0.63%。人工瓣膜心内膜炎发生在3例患者中（每年0.94%）。1例患者（每年0.31%）因主动脉炎综合征出现瓣周漏。6年时无所有瓣膜相关并发症的平均（标准差）精算率为89.2（2.0）%（AVR为98.6（1.0）%，MVR为86.4（2.2）%）。未发生抗凝相关出血、瓣膜相关溶血或结构故障的情况。6年随访结果表明，Omnicarbon瓣膜可取得良好的临床效果且瓣膜相关并发症发生率较低。
