Wheatley D J, Crawford F A, Kay P H, Chandler J G, Strong M D, Strom J A, Shah P M, Keon W J, Copeland G, Lewis S S
Department of Cardiothoracic Surgery, Glasgow Royal Infirmary, Scotland, UK.
Eur J Cardiothorac Surg. 1994;8(10):541-8. doi: 10.1016/1010-7940(94)90073-6.
Seven hundred and eight adults (age > or = 16 years) with isolated aortic (n = 433) or mitral (n = 275) Ionescu-Shiley Low-Profile (ISLP) pericardial valves were followed at 14 implanting centres in Canada, the United Kingdom, and the United States for a mean of 6.7 years, providing 4,729 patient-years of clinical data. The operative mortality rate was 3.0% for aortic valve replacement (AVR) and 5.5% for mitral valve replacement (MVR) (p = ns). Actuarial patient survival following AVR at 5 years was 81.6%, and 62.9% at 10 years; for MVR patients it was 78.1% at 5 years and 59.6% at 10 years. The ISLP valve appears to have durability comparable to other contemporary bioprosthetic valves. For aortic prostheses, the freedom from structural deterioration was 96.5% at 5 years and 73.7% at 10 years, and 89.7% at 5 years and 62.4% at 10 years for mitral prostheses. Structural deterioration was significantly more frequent following MVR than after AVR (p < 0.05). Structural deterioration was the principal cause for reoperation, but sudden deterioration precluding safe reoperation was not a dominant feature of this series. The ISLP valve appeared to engender more thrombo-embolic events than would be anticipated from earlier studies of pericardial bioprostheses, but was indistinguishable from other tissue valves in its incidence of other valve-related complications. We conclude that ISLP valves now implanted for 7 years or more are entering a phase of increasing structural deterioration, indicating the need for regular clinical and echocardiographic surveillance, and that long-term anticoagulation should be instituted for relatively minimal indications in these patients.
708名成人（年龄≥16岁）植入了伊奥内斯库-希利低轮廓（ISLP）心包瓣膜，其中433人植入主动脉瓣，275人植入二尖瓣，这些患者在加拿大、英国和美国的14个植入中心接受了平均6.7年的随访，提供了4729患者年的临床数据。主动脉瓣置换术（AVR）的手术死亡率为3.0%，二尖瓣置换术（MVR）为5.5%（p值无统计学意义）。AVR术后5年的患者精算生存率为81.6%，10年为62.9%；MVR患者5年为78.1%，10年为59.6%。ISLP瓣膜的耐用性似乎与其他当代生物瓣膜相当。对于主动脉假体，5年时无结构恶化的比例为96.5%，10年为73.7%；二尖瓣假体5年时为89.7%，10年为62.4%。MVR后结构恶化明显比AVR更频繁（p<0.05）。结构恶化是再次手术的主要原因，但导致无法安全再次手术的突然恶化并非该系列的主要特征。ISLP瓣膜似乎比心包生物瓣膜早期研究预期的产生更多血栓栓塞事件，但其其他瓣膜相关并发症的发生率与其他组织瓣膜无差异。我们得出结论，目前植入7年或更长时间的ISLP瓣膜正进入结构恶化加剧的阶段，这表明需要定期进行临床和超声心动图监测，并且对于这些患者，应在相对较少的指征下进行长期抗凝。
