国产GK-2型人造心脏瓣膜20年临床应用的随访观察

目的总结20年间应用413枚GK2型人造心脏瓣膜的治疗效果,评价国产GK2型单叶式机械瓣膜的远期疗效。方法对1985年初至2004年间施行的327例心脏瓣膜替换术患者进行随访观察,男123例,女204例。年龄1.6～68岁(38.62岁±10.14岁)。心功能Ⅱ级21例,Ⅲ级216例,Ⅳ90例。术式为二尖瓣置换(MVR)205例(62.69%),二尖瓣及主动脉瓣置换(DVR)86例(26.30%),主动脉瓣置换(AVR)31例(9.48%),三尖瓣置换(TVR)5例(1.52%)。共使用GK2型二尖瓣296枚,主动脉瓣117枚。随访0.5～19.6年(9.05年±4.59年),总随访人年数为2440.7患者年。结果早期死亡11例,死亡率为3.36%(11/327)。远期死亡24例,死亡率0.98%患者年。5年、10年、15年生存率分别为93.31%±0.03%、89.59%±2.1%及83.61%±6.09%。12例发生出血事件(0.49%患者年),7例发生瓣膜血栓形成或栓塞(0.29%患者年)。91.98%的患者(241/262)心功能恢复至(NYHA)I、II级。结论连续20年的临床应用和长期随访表明,该型瓣膜具有多项优点,瓣膜相关事件发生率处于较低水平,远期效果满意。

GK-2 prosthetic heart valve: a 20-year clinical experience

OBJECTIVE: The aim of this study is to analyze our 20-year clinical results with 413 GK-2 mechanical heart valves. METHODS: 123 men and 204 women with a mean age of 38.62 +/- 10.14 years accepted cardiac valve replacements. Ninety-one percent had NYHA class III or IV heart function. The mitral position was in 205 patients, aortic position in 31 patients, aortic and mitral in 86 patients, and tricuspid position in 5. Altogether 296 mitral prosthetic valves and 117 aortic prosthetic valves were implanted. Follow-up is 91% and extended 0.5 to 19.6 years with cumulative 2440.7 patient-years. RESULTS: The early mortality was 3.36% (11/327). There were 24 late deaths (0.98% per patient-year). The actuarial probability of survival was 93.31% +/- 0.03% at 5 years, 89.59 +/- 2.1% at 10 years, 83.61% +/- 6.09% at 15 years. The linesrized rate of thromboembolism was 0.29% pt-yr, the rate of bleeding event 0.49% pt-yr. In 91.98% of survivors NYHA functional performance have improved to class II or I. CONCLUSION: Early and long-term results in our hospital demonstrate that the GK-2 prosthetic heart valve exhibits excellent hemodynamic properties, mechanical durability and a low incidence of valve-related complications.