Mikaeloff P, Van Haecke P, Frieh J P, Convert G, Biron A, Amouroux C, Boivin J
Arch Mal Coeur Vaiss. 1981 Jul;74(7):799-807.
Between 1970-78, 302 mitral valve replacements with the SE 6120 prosthesis were performed, with an average postoperative follow-up of 50,7 months, using the 3 M size (206 cases) and 2 M (96 cases with small left ventricles). Early postoperative mortality was 5,6%, late postoperative mortality: 17,2%, the 5 year actuarial survival rate: 77,4% and the 9 year survival rate 71,8% (early mortality included). There was no significant difference in survival after mono- (143 cases) and polyvalvular replacement (159 cases); only a voluminous left atrium (p less than 0,05) and left atrial thrombosis (p less than 0,01) were statistically significant prognostic factors of global mortality. Late haemorrhage due to anticoagulant therapy (3%) (0,6 per 100 patient years). The most common complication was systemic embolism (3,7 per 100 patient years). Actuarial studies showed that 86,6% at 5 years and 80,1% at 9 years, escaped this complication. Statistically the favorising roles of permanent atrial fibrillation (p less than 0,05), the size of the left atrium (p less than 0,02) of isolated demonstrated. 90,4% of the survivors were clinically improved: the functional result was better when that 86,6% at 5 years and 80,1% at 9 years, escaped this complication. Statistically the favorising roles of permanent atrial fibrillation (p less than 0,05), the size of the left atrium (p less than 0,02) of isolated demonstrated. 90,4% of the survivors were clinically improved: the functional result was better when that 86,6% at 5 years and 80,1% at 9 years, escaped this complication. Statistically the favorising roles of permanent atrial fibrillation (p less than 0,05), the size of the left atrium (p less than 0,02) of isolated demonstrated. 90,4% of the survivors were clinically improved: the functional result was better when the valve replacement was not a reoperation (p less than 0,02), when the patient was not in functional Class IV (p less than 0,01), in permanent excessively dilated (p less than 0,01) and in patients without severe tricuspid regurgitation (p less than 0,01). There was no significant difference in global mortality, the percentage of embolic events and the quality of the functional postoperative result between patients with the 3 M and those with the 2 M SE 6120 prosthesis.
1970年至1978年间，采用SE 6120人工瓣膜进行了302例二尖瓣置换术，术后平均随访50.7个月，其中使用3M尺寸（206例）和2M尺寸（左心室较小的96例）。术后早期死亡率为5.6%，晚期死亡率为17.2%，5年精算生存率为77.4%，9年生存率为71.8%（包括早期死亡率）。单瓣膜置换（143例）和多瓣膜置换（159例）后的生存率无显著差异；只有巨大左心房（p<0.05）和左心房血栓形成（p<0.01）是总体死亡率的统计学显著预后因素。抗凝治疗导致的晚期出血（3%）（每100患者年0.6例）。最常见的并发症是全身性栓塞（每100患者年3.7例）。精算研究表明，5年时86.6%、9年时80.1%的患者未发生该并发症。统计学显示永久性房颤（p<0.05）、孤立左心房大小（p<0.02）具有促进作用。90.4%的幸存者临床症状改善：当瓣膜置换不是再次手术时（p<0.02）、患者不是功能IV级时（p<0.01）、左心房永久性过度扩张时（p<0.01）以及无严重三尖瓣反流的患者（p<0.01），功能结果更好。使用3M尺寸和2M尺寸SE 6120人工瓣膜的患者在总体死亡率、栓塞事件百分比和术后功能结果质量方面无显著差异。
