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Development, safety and efficacy of a novel circular-irrigated deca-channel mapping and ablation catheter for pulmonary vein isolation

机译:新型圆形灌溉十通道标测和消融导管用于肺静脉隔离的开发,安全性和有效性

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Pulmonary vein isolation (PVI), a cornerstone for catheter ablation of atrial fibrillation (AF), remains a complex and time-consuming procedure. Present study introduces a novel, circular-irrigated, deca-channel mapping and ablation catheter (CIDMA), describes the in vitro test results on feasibility, safety, and acute efficacy of the CIDMA catheter. An assembled CIDMA catheter was subjected to a number of in vitro tests. With this catheter, ablation procedures were first performed in a pig’s myocardial strips in vitro to determine the effects in unipolar or bipolar configuration. Three catheters were assembled. The adjustable circular diameter was changed from initial state of 32.41?±?0.61?mm into controlled state of 28.61?±?0.47?mm (P?=?0.013). In the plastic model, the push-ability, torque-ability, and kink resistance of CIDMA catheter were shown to be satisfactory. In vitro, our findings showed that ablation could produce obvious ablation lesions, and unipolar ablation (at length, width and depth of 5.0?±?1.3, 4.6?±?0.7, and 4.2?±?0.6?mm, respectively) was more effective than bipolar (at length, width and depth of 2.8?±?0.2, 4.2?±?0.5, and 2.3?±?0.4?mm, respectively) (P?
机译:肺静脉隔离(PVI)是消融心房颤动(AF)的基础,仍然是一个复杂而耗时的过程。本研究介绍了一种新型的圆形灌溉,十通道映射和消融导管(CIDMA),描述了CIDMA导管的可行性,安全性和急性功效的体外测试结果。组装好的CIDMA导管接受了许多体外测试。使用这种导管,首先在猪的心肌条中进行消融手术,以确定单极或双极配置的效果。组装了三个导管。可调圆直径从初始状态的32.41±±0.61μmm改变为控制状态的28.61±±0.47μmm(P = 0.013)。在塑料模型中,CIDMA导管的推入能力,扭矩能力和抗扭结性均令人满意。在体外,我们的研究结果显示,消融可产生明显的消融灶,单极消融(长,宽和深分别为5.0?±?1.3、4.6?±?0.7和4.2?±?0.6?mm)更大。比双极有效(长度,宽度和深度分别为2.8?±?0.2、4.2?±?0.5和2.3?±?0.4?mm)(P 0.01)。在体外,我们的初步数据表明,CIDMA导管可产生最佳的消融灶,尤其是在单极消融模式下。将来有必要进行体内动物和临床研究,以在实际情况下测试该导管的功效。

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