Fernandez J, Laub G W, Adkins M S, Anderson W A, Chen C, Bailey B M, Nealon L M, McGrath L B
Deborah Heart and Lung Center, Department of Thoracic and Cardiovascular Surgery, Browns Mills, NJ 08015.
J Thorac Cardiovasc Surg. 1994 Feb;107(2):394-406; discussion 406-7.
From May 1982 to August 1991, 1200 patients underwent valve replacement with the St. Jude Medical (St. Jude Medical, Inc., St. Paul, Minn.) valve: 615 men (51%) and 585 women, mean age 58 years. Preoperatively, 830 patients (69%) were in functional class III or IV. A total of 611 patients (51%) had the aortic valve replaced, 490 (41%) the mitral valve, 2 (0.2%) the tricuspid valve, and 97 (8%) multiple valves. There were 81 hospital deaths (6.8%). Risk factors included older age (p = 0.0001), female gender (p = 0.02), higher preoperative left ventricular end-diastolic pressure (p = 0.05), previous cardiac operation (p = 0.003), longer aortic crossclamp time (p = 0.0001), and longer cardiopulmonary bypass time (p = 0.0001). Follow-up was 98% complete (3153 patient-years). There were 152 late deaths; 32 (21%) were considered valve-related: six thromboembolism, four valve thrombosis, five anticoagulant-related hemorrhage, eight prosthetic valve endocarditis, one paravalvular leak, and seven sudden death. The 5-year actuarial survival was 75%. Risk factors for late death included older age (p = 0.03), lower preoperative ejection fraction (p = 0.005), longer aortic crossclamp time (p = 0.001), longer cardiopulmonary bypass time (p = 0.0001), previous cardiac operation (p = 0.02), and higher preoperative functional class (p = 0.0001). Actuarial freedom at 5 years from major thromboembolic events and anticoagulant-related hemorrhage was 97% and 95%, respectively. This value for valve thrombosis was 99%, for reoperation 96%, for prosthetic valve endocarditis 98%, and for paravalvular leak 96%. Actuarial freedom from all valve-related events and valve-related death at 5 years was 74% and 94%, respectively. We conclude that the low incidence of valve-related events and low mortality supports the continued use of the St. Jude Medical valve.
1982年5月至1991年8月，1200例患者接受了圣犹达医疗公司（位于明尼苏达州圣保罗市）生产的瓣膜置换手术：男性615例（51%），女性585例，平均年龄58岁。术前，830例患者（69%）的心功能分级为III级或IV级。共有611例患者（51%）置换了主动脉瓣，490例（41%）置换了二尖瓣，2例（0.2%）置换了三尖瓣，97例（8%）置换了多个瓣膜。住院死亡81例（6.8%）。危险因素包括年龄较大（p = 0.0001）、女性（p = 0.02）、术前左心室舒张末期压力较高（p = 0.05）、既往心脏手术史（p = 0.003）、主动脉阻断时间较长（p = 0.0001）以及体外循环时间较长（p = 0.0001）。随访率为98%（3153患者年）。有152例晚期死亡；32例（21%）被认为与瓣膜相关：6例血栓栓塞、4例瓣膜血栓形成、5例抗凝相关出血、8例人工瓣膜心内膜炎、1例瓣周漏以及7例猝死。5年实际生存率为75%。晚期死亡的危险因素包括年龄较大（p = 0.03）、术前射血分数较低（p = 0.005）、主动脉阻断时间较长（p = 0.001）、体外循环时间较长（p = 0.0001）、既往心脏手术史（p = 0.02）以及术前心功能分级较高（p = 0.0001）。5年时主要血栓栓塞事件和抗凝相关出血的实际无事件生存率分别为97%和95%。瓣膜血栓形成的这一数值为99%，再次手术为96%，人工瓣膜心内膜炎为98%，瓣周漏为96%。5年时所有瓣膜相关事件和瓣膜相关死亡的实际无事件生存率分别为74%和94%。我们得出结论，瓣膜相关事件的低发生率和低死亡率支持继续使用圣犹达医疗公司的瓣膜。
