Emery Robert W, Krogh Christopher C, Arom Kit V, Emery Ann M, Benyo-Albrecht Kathy, Joyce Lyle D, Nicoloff Demetre M
Cardiac Surgical Associates, PA, St. Paul, Minnesota 55114, USA.
Ann Thorac Surg. 2005 Mar;79(3):776-82; discussion 782-3. doi: 10.1016/j.athoracsur.2004.08.047.
From October 1977 to October 2002, 4,480 patients (age range, 17 to 94 years; average, 64 +/- 13 years) underwent single valve replacement with the St. Jude Medical heart valve. Of 2,982 aortic (AVR) and 1,498 mitral valve replacements (MVR), concomitant coronary artery bypass grafting was performed on 42% and 33%, respectively.
Cardiac Surgical Associates has maintained an independent database of patients having valve replacement with the St. Jude Medical prosthesis since the world's first implant. Patients were contacted by questionnaire or phone from November 2002 through June 2003. Hospital course and valve-related events were verified by patient chart review or physician contact.
Follow-up was 95% complete. Operative mortality was 4% with AVR and 9% with MVR. Total follow-up was 32,190 patient-years (range, 1 month to 24.8 years; average, 7 +/- 5 years). During the study period, patient freedom from late mortality was 61% (AVR, 61%; MVR, 63%), and from valve-related mortality 92% (AVR, 93%; MVR, 91%). Freedom from thromboembolic events was 85% (86% AVR, 81% MVR), from bleeding events, 81% (81% AVR, 81% MVR), from reoperation, 98% (99% AVR, 97% MVR), from endocarditis, 98% (99% AVR, 98% MVR), and from valve thrombosis, 99% (99% AVR, 98% MVR). There was one MVR structural failure (0.06%).
The St. Jude Medical valve has proven to be an effective and durable valve prosthesis with a low event rate during the long term.
1977年10月至2002年10月，4480例患者（年龄范围17至94岁；平均64±13岁）接受了圣犹达医疗心脏瓣膜单瓣膜置换术。在2982例主动脉瓣置换术（AVR）和1498例二尖瓣置换术（MVR）中，分别有42%和33%的患者同时进行了冠状动脉旁路移植术。
自世界上首次植入圣犹达医疗假体以来，心脏外科协会一直维护着一个接受瓣膜置换患者的独立数据库。2002年11月至2003年6月通过问卷调查或电话联系患者。通过查阅患者病历或与医生联系核实住院过程和瓣膜相关事件。
随访完成率为95%。AVR的手术死亡率为4%，MVR为9%。总随访时间为32190患者年（范围1个月至24.8年；平均7±5年）。在研究期间，患者免于晚期死亡的比例为61%（AVR为61%；MVR为63%），免于瓣膜相关死亡的比例为92%（AVR为93%；MVR为91%）。免于血栓栓塞事件的比例为85%（AVR为86%，MVR为81%），免于出血事件的比例为81%（AVR为81%，MVR为81%），免于再次手术的比例为98%（AVR为99%，MVR为97%），免于心内膜炎的比例为98%（AVR为99%，MVR为98%），免于瓣膜血栓形成 的比例为99%（AVR为99%，MVR为98%）。有1例MVR发生结构性故障（0.06%）。
圣犹达医疗瓣膜已被证明是一种有效且耐用的瓣膜假体，长期事件发生率较低。
