A Predictive and an Optimization Mathematical Model for Device Design in Cardiac Pulsed Field Ablation Using Design of Experiments

Figures

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  Figure 1. Illustration of a new solution being developed by AuriGen Medical (aurigenmedical.com) to help treat PeAF. The method involves combining ablation and occlusion of the left atrial appendage in order to treat AF and prevent clots that may have formed within the appendage from escaping and causing further problems, such as stroke [8]. (a) Ablation after inserting the occlude and (b) the occluder sealing the left atrial appendage after endothelization.

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  Figure 2. Alation probe design and fitting. (a) A custom-printed probe that represents the intended electrode design and spacing for the implant; and (b) the probe set up within the well for ablation.

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  Figure 3. Illustration of the measured responses for the DoE: (a) the reference fluorescent scanning image; (b) the ablation area; (c) the center width. These responses are relevant to the design of the ablation, as the area captures the ablated region in 2D, and the center width is used to help determine if the ablation is bridged or not, as well as to help control the size of the ablation between the electrodes.

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  Figure 4. Images of the 2D cell ablations in block 1 are labeled with corresponding run numbers. The ablation region can be seen in the center of the image and is marked by the black color. Live cells are marked by a green color. In this block, a fully bridged ablation was obtained for each run. Having a fully bridged ablation is important to electrically isolate the region for the intended application of ablating the left atrial appendage.

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  Figure 5. The Pareto charts for the ablation area (a) and the center width responses (b) indicate what factors have the largest effects on the response. All factors and interactions shown are significant, as the model was fully reduced by backward elimination. For the ablation area, the input voltage has the largest effect. The two-factor interactions have the least. The input voltage has the largest effect on the ablation area as well as the center width response. The two significant two-factor interactions have the least effect.

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  Figure 6. Main effects plot for (a) the ablation area and (b) the center width responses. Increasing each significant factor causes the ablation area to increase. Increasing either the input voltage or the number of ablation repeats causes the center width to increase. However, increasing electrode spacing causes the center width to decrease.