Grec V, Goy J J, Payot M, Sadeghi H, Sigwart U
Schweiz Med Wochenschr. 1984 Nov 17;114(46):1655-60.
The St. Jude Medical cardiac valve is a low-profile, bileaflet, central-flow prosthesis made of pyrolitic carbon. During a 39-month period (October 1, 1979 to December 31, 1982) a total of 169 St. Jude valves were implanted in 155 patients. While 141 patients received one valve, 95 in the aortic, 45 in the mitral and 1 in the tricuspid position, 14 patients had a double (aortic and mitral) valve replacement. The perioperative mortality rate was 3.2%. All surviving patients had anticoagulation treatment with acenocoumarol and there was a 98% follow-up during a period of 19.5 +/- 4.5 months. The late mortality rate was 4.7%. Substantial clinical improvement resulted with the St. Jude valve: whereas 81.9% of patients were in NYHA functional class III or IV preoperatively, 87.1% were in class I or II after valve replacement. The patients generally had a slight increase in LDH levels but hemolysis was responsible for moderate anemia only in 5 cases. There were 10 nonfatal neurological accidents, probably due to thromboembolic events, resulting in a risk of thromboembolism of 4.04% per patient year; 4 of the 10 patients were incompletely anticoagulated and 3 had cardiac arrhythmia. There were 5 hemorrhagic complications, one of which was fatal (subarachnoidal hemorrhage). Endocarditis occurred in 4 patients and death ensued in one of these. Seven patients developed perivalvular leak which was moderate in 5 cases and severe in 2 cases. In conclusion, these results are promising and the St. Jude Medical cardiac valve appears to be a valid alternative in surgical therapy of valvular heart disease. However, the risk of thromboembolism justifies long-term anticoagulation.
圣犹达医疗心脏瓣膜是一种低轮廓、双叶、中心血流的假体,由热解碳制成。在1979年10月1日至1982年12月31日的39个月期间,共有169个圣犹达瓣膜植入了155例患者体内。其中141例患者植入了一个瓣膜,95例植入主动脉瓣,45例植入二尖瓣,1例植入三尖瓣,14例患者接受了双瓣膜置换(主动脉瓣和二尖瓣)。围手术期死亡率为3.2%。所有存活患者均接受了醋硝香豆素抗凝治疗,在19.5±4.5个月的时间里随访率为98%。晚期死亡率为4.7%。圣犹达瓣膜带来了显著的临床改善:术前81.9%的患者处于纽约心脏协会(NYHA)功能分级III或IV级,瓣膜置换术后87.1%的患者处于I或II级。患者的乳酸脱氢酶(LDH)水平通常略有升高,但只有5例患者因溶血导致中度贫血。发生了10起非致命性神经意外事件,可能是由于血栓栓塞事件,导致每位患者每年的血栓栓塞风险为4.04%;10例患者中有4例抗凝不完全,3例患有心律失常。发生了5起出血并发症,其中1例致命(蛛网膜下腔出血)。4例患者发生心内膜炎,其中1例死亡。7例患者出现瓣周漏,5例为中度,2例为重度。总之,这些结果很有前景,圣犹达医疗心脏瓣膜似乎是瓣膜性心脏病外科治疗的有效选择。然而,血栓栓塞风险证明长期抗凝是合理的。