Bloomfield P, Wheatley D J, Prescott R J, Miller H C
Department of Cardiology, Royal Infirmary of Edinburgh, Scotland.
N Engl J Med. 1991 Feb 28;324(9):573-9. doi: 10.1056/NEJM199102283240901.
Patients undergoing heart-valve replacement may receive a mechanical prosthesis, necessitating lifelong anticoagulant treatment, or a porcine bioprosthesis, which involves no absolute need for anticoagulants.
We carried out a randomized, prospective trial to compare the durability of the Bjork-Shiley mechanical prosthesis (spherical tilting-disk model) and the incidence of valve-related complications with those variables in the Hancock and the Carpentier-Edwards porcine prostheses. The mitral valve was replaced in 261 patients, the aortic valve in 211, and both in 61; the survivors have been followed up for a mean of 12 years.
We found a trend toward improved actuarial survival after 12 years with the Bjork-Shiley prosthesis, but this trend was not statistically significant (group with Bjork-Shiley valve vs. group with porcine valve [mean +/- SE], 51.5 +/- 3.2 vs. 44.4 +/- 3.2 percent; P = 0.08). There was no significant difference in the actuarial incidence of reoperation after 5 years, but after 12 years significantly more patients with a porcine prosthesis had undergone reoperation (8.5 +/- 2.0 vs. 37.1 +/- 4.1 percent, P less than 0.001). An analysis combining death and reoperation as end points for an actuarial assessment of survival with the original prosthesis intact confirmed that the patients with Bjork-Shiley Shiley prostheses had improved survival (48.6 +/- 3.2 vs. 30.0 +/- 3.0 percent after 12 years, P less than 0.001). Bleeding requiring hospitalization or blood transfusion was significantly more frequent in the patients with Bjork-Shiley prostheses (18.6 +/- 3.2 vs. 7.1 +/- 2.3 percent after 12 years, P less than 0.01). There was no significant difference after 12 years in the actuarial occurrence of embolism (Bjork-Shiley vs. porcine, 21.1 +/- 3.1 vs. 26.4 +/- 3.5 percent) or endocarditis (3.7 +/- 1.4 vs 4.6 +/- 1.6 percent).
Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting-disk prosthesis than among patients with porcine bioprostheses, but use of the Bjork-Shiley valve carries an attendant increased risk of bleeding associated with the need for anticoagulant treatment.
接受心脏瓣膜置换术的患者可选用机械瓣膜，这需要终身抗凝治疗；也可选用猪生物瓣膜，这种瓣膜并非绝对需要抗凝治疗。
我们进行了一项随机、前瞻性试验，比较了比约克-希利机械瓣膜（球形倾斜盘模型）的耐用性以及瓣膜相关并发症的发生率与汉考克猪生物瓣膜和卡朋蒂埃-爱德华兹猪生物瓣膜的这些变量。261例患者置换了二尖瓣，211例置换了主动脉瓣，61例同时置换了二尖瓣和主动脉瓣；对存活者平均随访了12年。
我们发现，使用比约克-希利瓣膜12年后精算生存率有提高的趋势，但这一趋势无统计学意义（比约克-希利瓣膜组与猪生物瓣膜组[均值±标准误]，分别为51.5±3.2%和44.4±3.2%；P = 0.08）。5年后再次手术的精算发生率无显著差异，但12年后，接受猪生物瓣膜置换的患者再次手术的比例显著更高（分别为8.5±2.0%和37.1±4.1%，P<0.001）。将死亡和再次手术作为评估原瓣膜完整情况下生存情况的精算终点进行分析，结果证实使用比约克-希利瓣膜的患者生存率更高（12年后分别为48.6±3.2%和30.0±3.0%，P<0.001）。比约克-希利瓣膜置换患者中需要住院治疗或输血的出血情况显著更频繁（12年后分别为18.6±3.2%和7.1±2.3%，P<0.01）。12年后，栓塞的精算发生率（比约克-希利瓣膜组与猪生物瓣膜组分别为21.1±..1和26.4±3.5%）或心内膜炎的发生率（分别为3.7±1.4%和4.6±1.6%）无显著差异。
使用比约克-希利球形倾斜盘瓣膜的患者中瓣膜完整时的生存率高于使用猪生物瓣膜的患者，但使用比约克-希利瓣膜伴随因抗凝治疗而增加的出血风险。
