Milano A, Bortolotti U, Mazzucco A, Mossuto E, Testolin L, Thiene G, Gallucci V
Department of Cardiovascular Surgery, University of Padova Medical School, Italy.
J Thorac Cardiovasc Surg. 1992 Feb;103(2):267-75.
From 1978 to 1988, 697 patients with a mean age of 48 +/- 11 years (range 5 to 75 years) received a Sorin tilting-disc prosthesis; 358 had had aortic valve replacement, 247 mitral valve replacement, and 92 mitral and aortic valve replacement. Operative mortality rates were 7.8%, 11.3%, and 10.8%, respectively, in the three groups. Cumulative duration of follow-up is 1650 patient-years for aortic valve replacement (maximum follow-up 11.4 years), 963 patient-years for mitral valve replacement (maximum follow-up 9.9 years) and 328 patient-years for mitral and aortic valve replacement (maximum follow-up 9.4 years). Actuarial survival at 9 years is 72% +/- 4% after mitral valve replacement, 70% +/- 3% after aortic valve replacement, and 50% +/- 12% after mitral and aortic valve replacement, and actuarial freedom from valve-related deaths is 97% +/- 2% after mitral valve replacement, 92% +/- 2% after aortic valve replacement, and 62% +/- 15% after mitral and aortic valve replacement. Thromboembolic events occurred in 21 patients with aortic valve replacement (1.3% +/- 0.2%/pt-yr), in 12 with mitral valve replacement (1.2% +/- 0.3% pt-yr), and in seven with mitral and aortic valve replacement (2.1% +/- 0.8%), with one case of prosthetic thrombosis in each group; actuarial freedom from thromboembolism at 9 years is 92% +/- 3% after mitral valve replacement, 91% +/- 3% after aortic valve replacement, and 74% +/- 16% after mitral and aortic valve replacement. Anticoagulant-related hemorrhage was observed in 15 patients after aortic valve replacement (0.9% +/- 0.2%/pt-yr), in 9 after mitral valve replacement (0.9% +/- 0.3%/pt-yr), and in 6 with mitral and aortic valve replacement (0.9% +/- 0.5%/pt-yr); actuarial freedom from this complication at 9 years is 94% +/- 2% after aortic valve replacement, 91% +/- 4% after mitral valve replacement, and 68% +/- 16% after mitral and aortic valve replacement. Actuarial freedom from reoperation at 9 years is 97% +/- 2% after mitral and aortic valve replacement, 92% +/- 4% after mitral valve replacement, and 89% +/- 3% after aortic valve replacement, with no cases of mechanical fracture. The Sorin valve has shown a satisfactory long-term overall performance, comparable with other mechanical prostheses, and an excellent durability that renders it a reliable heart valve substitute for the mitral and aortic positions.
1978年至1988年期间,697例平均年龄为48±11岁(范围5至75岁)的患者接受了索林倾斜碟瓣人工瓣膜置换术;其中358例为主动脉瓣置换,247例为二尖瓣置换,92例为二尖瓣和主动脉瓣联合置换。三组患者的手术死亡率分别为7.8%、11.3%和10.8%。主动脉瓣置换患者的累计随访时长为1650患者年(最长随访11.4年),二尖瓣置换患者为963患者年(最长随访9.9年),二尖瓣和主动脉瓣联合置换患者为328患者年(最长随访9.4年)。二尖瓣置换术后9年的精算生存率为72%±4%,主动脉瓣置换术后为70%±3%,二尖瓣和主动脉瓣联合置换术后为50%±12%;二尖瓣置换术后9年免于瓣膜相关死亡的精算概率为97%±2%,主动脉瓣置换术后为92%±2%,二尖瓣和主动脉瓣联合置换术后为62%±15%。主动脉瓣置换患者中有21例发生血栓栓塞事件(1.3%±0.2%/患者年),二尖瓣置换患者中有12例(1.2%±0.3%/患者年),二尖瓣和主动脉瓣联合置换患者中有7例(2.1%±0.8%),每组各有1例人工瓣膜血栓形成;二尖瓣置换术后9年免于血栓栓塞的精算概率为92%±3%,主动脉瓣置换术后为91%±3%,二尖瓣和主动脉瓣联合置换术后为74%±16%。主动脉瓣置换术后有15例患者发生抗凝相关出血(0.9%±0.2%/患者年),二尖瓣置换术后有9例(0.9%±0.3%/患者年),二尖瓣和主动脉瓣联合置换术后有6例(0.9%±0.5%/患者年);主动脉瓣置换术后9年免于该并发症的精算概率为94%±2%,二尖瓣置换术后为91%±4%,二尖瓣和主动脉瓣联合置换术后为68%±16%。二尖瓣和主动脉瓣联合置换术后9年免于再次手术的精算概率为97%±2%,二尖瓣置换术后为92%±4%,主动脉瓣置换术后为89%±3%,且无机械故障案例。索林瓣膜显示出令人满意的长期总体性能,与其他机械瓣膜相当,并且具有出色的耐用性,使其成为二尖瓣和主动脉瓣位置可靠的心脏瓣膜替代品。