Björk V O
Med Instrum. 1977 Mar-Apr;11(2):80-1.
After observing a high residual gradient and a high mortality in patients with a narrow aortic root undergoing aortic valve replacement with a small ball valve during the period 1962-1965, it was most gratifying to find a much smaller gradient in similar patients with the Wada-Cutter valve in 1968. A tilting disc valve seemed a solution, particularly for patients with narrow aortic root, but the disc had to rotate to eliminate localized wear in a hinge mechanism. Together with Donald P. Shiley, I tested a tilting disc valve with a rotating disc of Delrin, for wear and also in a pulse duplicator in 1968. Because the function was much better than that of the clinically popular Starr-Edwards ball valve prosthesis, the Björk-Shiley valve was first inserted in a patient on January 19, 1969. My clinical experience and judgement justified the omission of animal trial; such trial would have been irrelevant.
在观察到1962年至1965年期间,接受小球瓣主动脉瓣置换术的主动脉根部狭窄患者存在高残余梯度和高死亡率后,1968年发现使用和田-卡特瓣膜的类似患者的梯度要小得多,这非常令人欣慰。倾斜盘瓣似乎是一种解决方案,特别是对于主动脉根部狭窄的患者,但盘片必须旋转以消除铰链机构中的局部磨损。1968年,我与唐纳德·P·希利一起测试了一种带有聚甲醛旋转盘的倾斜盘瓣,测试其磨损情况,并在脉搏复制器中进行测试。由于其功能比临床上常用的斯塔尔-爱德华兹球瓣假体要好得多,比约克-希利瓣膜于1969年1月19日首次植入一名患者体内。我的临床经验和判断证明省略动物试验是合理的;这样的试验是无关紧要的。