Jamieson W R, Pelletier L C, Gerein A N, Pomar J
Department of Surgery, University of British Columbia, Vancouver.
Can J Surg. 1992 Apr;35(2):159-64.
Between 1983 and 1987 the Mitroflow pericardial prosthesis was implanted in 354 patients, ranging in age from 14 to 94 years (mean 60.1 years). The early mortality was 5.7% and the late mortality 2.9% per patient-year. The total cumulative follow-up was 853 years (mean 2.4 years). Patient survival at 4 years for aortic valve replacement (AVR) was 81.5% and for mitral valve replacement (MVR) 74.8%. The overall rate of valve-related complications was 4.8% per patient-year (41 complications): thromboembolism, 15; hemorrhage related to antithromboembolic therapy, 1; prosthetic valve endocarditis, 15; nonstructural dysfunction, 3; and structural valve deterioration, 7. At 4 years the freedom from thromboembolism was 91.5% +/- 2.7% for AVR and 91.1% +/- 4.0% for MVR, from prosthetic valve endocarditis 93.5% +/- 2.3% for AVR and 94.0% +/- 2.9% for MVR, from structural valve deterioration 97.3% +/- 2.1% for AVR and 92.6% +/- 3.2% for MVR, from valve-related mortality 96.9% +/- 1.4% for AVR and 97.5% +/- 1.8% for MVR, and from reoperation 93.5% +/- 2.8% for AVR and 83.1% +/- 5.1% for MVR. The freedom from the composite of all valve-related complications at 4 years was 81.1% +/- 4.2% for AVR and 75.3% +/- 2.8% for MVR. The Mitroflow valve has provided satisfactory clinical performance at the 4-year evaluation. Structural valve deterioration is greater in the mitral position than in the aortic position. Long-term evaluation of the Mitroflow valve is necessary to determine the impact of structural valve deterioration on its clinical performance.
1983年至1987年间，354例年龄在14岁至94岁（平均60.1岁）的患者植入了Mitroflow心包瓣膜假体。早期死亡率为5.7%，晚期死亡率为每年每例患者2.9%。总累积随访时间为853年（平均2.4年）。主动脉瓣置换术（AVR）4年时患者生存率为81.5%，二尖瓣置换术（MVR）为74.8%。瓣膜相关并发症的总体发生率为每年每例患者4.8%（41例并发症）：血栓栓塞15例；抗血栓栓塞治疗相关出血1例；人工瓣膜心内膜炎15例；非结构性功能障碍3例；结构性瓣膜退变7例。4年时，AVR患者血栓栓塞的无事件生存率为91.5%±2.7%，MVR为91.1%±4.0%；人工瓣膜心内膜炎的无事件生存率AVR为93.5%±2.3%，MVR为x94.0%±2.9%；结构性瓣膜退变的无事件生存率AVR为97.3%±2.1%，MVR为92.6%±3.2%；瓣膜相关死亡率的无事件生存率AVR为96.9%±1.4%，MVR为97.5%±1.8%；再次手术的无事件生存率AVR为93.5%±2.8%，MVR为83. %±5.1%。4年时，AVR患者所有瓣膜相关并发症综合的无事件生存率为81.1%±4.2%，MVR为75.3%±2.8%。在4年评估中，Mitroflow瓣膜提供了令人满意的临床性能。二尖瓣位置的结构性瓣膜退变比主动脉瓣位置更严重。需要对Mitroflow瓣膜进行长期评估，以确定结构性瓣膜退变对其临床性能的影响。
