Gottwik M, Fentrop T, Kobel K, Langsdorf S, Schlepper M, Kramer K, Hehrlein F W
Thorac Cardiovasc Surg. 1981 Oct;29(5):307-11. doi: 10.1055/s-2007-1023504.
A general lack of standardization of the pre-clinical testing of artificial valves leads to an actual comparison of different prosthetic models at the time of a first clinical trial, frequently with contradictory results. Therefore, a pulse duplicator was developed in order to compare different valves of comparable size under identical standardized conditions in aortic and mitral positions. Comparison of Björk-Shiley and St. Jude medical prostheses in the duplicator revealed a linear relationship between pump setting and stroke volume delivered (r less than or equal to 0.9) for both valves. Pressure loss across the mitral valves showed a linear relationship to stroke volume (less than or equal to 0.9) and frequency (less than or equal to 0.9). The gradient, expressed per milliliter stroke volume, for identical frequencies appeared as the simplest and most suitable parameter for comparison of the hydraulic function of different valves. Using this parameter, the valves showed individual differences over a wide physiological range of testing. The differences, however, are of a magnitude that can hardly be detected under clinical testing conditions.
人工心脏瓣膜临床前测试普遍缺乏标准化,这导致在首次临床试验时对不同假体模型进行实际比较,结果常常相互矛盾。因此,开发了一种脉动复制器,以便在主动脉和二尖瓣位置的相同标准化条件下比较不同尺寸相当的瓣膜。在脉动复制器中对Björk-Shiley和圣犹达医疗假体进行比较,结果显示两个瓣膜的泵设置与输送的每搏输出量之间呈线性关系(r≤0.9)。二尖瓣上的压力损失与每搏输出量(≤0.9)和频率(≤0.9)呈线性关系。对于相同频率,以每毫升每搏输出量表示的压力阶差似乎是比较不同瓣膜水力功能的最简单、最合适的参数。使用该参数,在广泛的生理测试范围内,瓣膜显示出个体差异。然而,这些差异的程度在临床测试条件下几乎难以检测到。