Nakano K, Koyanagi H, Hashimoto A, Kitamura M, Endo M, Nagashima M, Tokunaga H
Department of Cardiovascular Surgery, Tokyo Women's Medical College, Japan.
Ann Thorac Surg. 1994 Mar;57(3):697-702; discussion 702-3. doi: 10.1016/0003-4975(94)90570-3.
Since July 1978, 1,284 patients have received the St. Jude Medical prosthesis (425 aortic, 636 mitral, and 223 double aortic-mitral), and the results in these patients were reviewed according to guidelines of the Society of Thoracic Surgeons. Follow-up was complete in 98%. Of 80 late deaths, 29% were valve related. The actuarial survival rate, including operative deaths, at 12 years was 81.7% and 87.1%, respectively, for aortic and mitral valve replacement, and it was 82.6% at 11 years after double valve replacement. All patients were anticoagulated with warfarin to maintain the thrombotest value between 10% and 25%, which is equivalent to between 2.8 and 1.6 times the control according to the international normalized ratio of the prothrombin time. The linearized rate of complication for aortic, mitral, and double valve replacement, respectively (expressed as the percent per patient-year), was as follows: structural deterioration, 0; non-structural dysfunction, 0.16, 0.30, and 0.20; valve thrombosis, 0.05, 0.09, and 0; thromboembolism, 1.35, 1.63, and 0.79; anticoagulant-related hemorrhage, 0.10, 0.18, and 0.10; and prosthetic valve endocarditis, 0.21, 0.06, and 0.20. Reoperation was performed in 16 patients. The freedom from reoperation rate at 12 years was 99.5% and 98.0% for aortic and mitral valve replacement, respectively, and it was 99.1% at 11 years for double valve replacement. Thus, during the 12-year follow-up in patient who received the St. Jude Medical prosthesis, the valve performed satisfactorily and with an acceptable risk of late complication even though patients were anticoagulated using a lower dose of warfarin.
自1978年7月以来，1284例患者接受了圣犹达医疗公司的人工瓣膜（425例为主动脉瓣，636例为二尖瓣，223例为主动脉瓣 - 二尖瓣联合置换），并根据胸外科医师协会的指南对这些患者的结果进行了回顾。98%的患者完成了随访。在80例晚期死亡病例中，29%与瓣膜相关。主动脉瓣和二尖瓣置换术后12年的精算生存率（包括手术死亡）分别为81.7%和87.1%，双瓣膜置换术后11年为82.6%。所有患者均使用华法林抗凝，以使凝血酶原时间检测值维持在10%至25%之间，根据国际标准化比值，这相当于对照值的2.8至1.6倍。主动脉瓣、二尖瓣和双瓣膜置换的并发症线性化发生率（以每患者年的百分比表示）如下：结构恶化，0；非结构功能障碍，0.16、0.30和0.20；瓣膜血栓形成，0.05、0.09和0；血栓栓塞，1.35、1.63和0.79；抗凝相关出血，0.10、0.18和0.10；人工瓣膜心内膜炎，0.21、0.06和0.20。16例患者进行了再次手术。主动脉瓣和二尖瓣置换术后12年的再次手术免发生率分别为99.5%和98.0%，双瓣膜置换术后11年为99.1%。因此，在接受圣犹达医疗公司人工瓣膜的患者12年随访期间，即使使用较低剂量的华法林进行抗凝，该瓣膜的表现仍令人满意，且晚期并发症风险可接受。
