Emery Robert W, Krogh Christopher C, McAdams Sean, Emery Ann M, Holter Arlen R
Division of Cardiovascular Surgery, St. Joseph's Hospital, St. Paul, MN 55102, USA.
J Heart Valve Dis. 2010 Jul;19(4):473-84.
Between June 1978 and September 2002, a total of 440 reoperative open-heart patients (mean age 62 +/- 14 years; range: 18-91 years), following various primary cardiac operations, underwent single-valve replacement with the St. Jude Medical (SJM) heart valve. Of 241 patients having aortic replacement (AVR) and 199 mitral valve replacement (MVR), 86 (35%) and 42 (21%), respectively, underwent concomitant coronary artery bypass grafting. The study aim was to document patient survival and valve-related events in an experience extending up to 24 years after reoperative open-heart surgery with a single model cardiac valve prosthesis.
The Cardiac Surgical Associates Research Foundation (CSARF) has maintained an independent database of those patients with the SJM prosthesis since the world's first implant in October 1977. Patients were contacted by questionnaire and/or telephone between November 2002 and June 2003. The hospital course and valve-related events were verified by patient chart review and/or physician contact.
Follow up was 94% complete, for a total of 3,114 patient-years (1,671 pt-yr after AVR; 1,443 pt-yr after MVR). The average follow up was 7 +/- 6 years (range: 0.1-24.3 years). The operative mortality was 9% (10% AVR, 8% MVR). Five deaths (13%) were valve-related. Freedom from all late mortality at 10 and 20 years, respectively, was 57% and 35% for AVR and 52% and 22% for MVR, and for valve-related mortality was 89% and 77% for AVR and 84% and 22% for MVR. Freedom from thromboembolic events at 10 and 20 years, respectively, was 93% and 93% after AVR and 92% and 81% after MVR; from anticoagulant-related hemorrhage it was 78% and 76% after AVR and 81% and 67% after MVR; and from reoperation it was 94% and 94% after AVR and 95% and 89% after MVR.
Reoperative valve replacement carries a significant operative morbidity and mortality. Long-term results with the SJM valve demonstrated a durable prosthetic valve, excellent long-term patient survival, and freedom from valve-related events followed reoperative open-heart valve replacement surgery. However, the early postoperative period carried an increased risk for valve-related events.
1978年6月至2002年9月期间，共有440例再次接受心脏手术的患者（平均年龄62±14岁；范围：18 - 91岁），在接受各种初次心脏手术后，使用圣犹达医疗（SJM）心脏瓣膜进行了单瓣膜置换。在241例行主动脉瓣置换（AVR）的患者和199例行二尖瓣置换（MVR）的患者中，分别有86例（35%）和42例（21%）同时接受了冠状动脉旁路移植术。本研究的目的是记录再次心脏手术后长达24年使用单一型号心脏瓣膜假体的患者生存率和瓣膜相关事件。
自1977年10月世界首例植入SJM假体以来，心脏外科协会研究基金会（CSARF）一直维护着这些患者的独立数据库。2002年11月至2003年6月期间，通过问卷调查和/或电话联系患者。通过查阅患者病历和/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94%，总计3114患者年（AVR后1671患者年；MVR后1443患者年）。平均随访时间为7±6年（范围：0.1 - 24.3年）。手术死亡率为9%（AVR为10%，MVR为8%）。5例死亡（13%）与瓣膜相关。AVR患者10年和20年的全因远期生存率分别为57%和35%，MVR患者分别为52%和22%；AVR患者瓣膜相关死亡率10年和20年分别为89%和77%，MVR患者分别为84%和22%。AVR患者10年和20年血栓栓塞事件发生率分别为93%和93%，MVR患者分别为92%和81%；抗凝相关出血发生率AVR患者10年和20年分别为78%和76%，MVR患者分别为81%和67%；再次手术发生率AVR患者10年和20年分别为94%和94%，MVR患者分别为95%和89%。
再次瓣膜置换手术具有显著的手术发病率和死亡率。SJM瓣膜的长期结果显示，假体瓣膜耐用，患者长期生存率高，再次心脏瓣膜置换手术后无瓣膜相关事件。然而，术后早期瓣膜相关事件风险增加。
