4D Acoustoelectric Cardiac Imaging for Fast and Accurate Mapping of Arrhythmias

摘要 尽管介入性心脏手术治疗心律失常在全球取得了成功，但电解剖 心脏的标测（EAM）具有显著的缺点。程序缓慢，容易出现注册问题 错误，对治疗短暂性心律失常（如室性心动过速）基本无效， 空间分辨率较差。由于首次干预的成功率仅为50%， 局限性导致多次错误消融、重复手术和增加的并发症， 病人本第1阶段SBIR建议开发和确认4D声电心脏成像 (ACI)用于在活体猪心脏中绘制电流的技术。ACI是一项专利技术， 提供实时能力和上级空间分辨率（<2 mm），用于快速定位心律失常 在消融治疗期间。我们的初步研究表明，ACI将提供以下好处， 常规EAM：1）心脏中电流密度的4D实时成像; 2）高空间分辨率 由US焦点（0.2 - 2 mm）确定; 3）持续和短暂的准确定位 心律失常; 4）电流密度（ACI）与心脏解剖和运动（脉冲回波US）的融合。的 第1阶段SBIR的主要目标是证明和验证ACI用于体内标测 心电图和心脏激动波。该项目的合作伙伴ElectroSonix LLC与 亚利桑那大学将增强ACI平台，并评估其在体内映射的性能。 在野生型猪模型中的电流。我们的最终愿景是开发一款移动的甚至是便携式的 基于专有ACI技术的平台（即，硬件、信号处理、数据分析和 积分），用于心律失常的快速、实时标测，远上级最先进的电 心脏标测技术。在猪心脏中的成功演示（第1阶段）将导致 扩展的第2阶段项目直接将ACI与商业EAM系统进行比较（例如，GE CARTO）， 在心律失常治疗过程中的图像引导消融。首要目标是提高 减少并发症的机会 不必要的消融和重复手术。这将有效地减少医疗风险。 错误，并改善接受治疗的患者的生活质量。此SBIR的值为 实现完全集成ACI医疗器械商业化的第一步。

Abstract Despite global success of interventional cardiac surgery for treatment of arrhythmias, electroanatomical mapping (EAM) of the heart has significant drawbacks. The procedure is slow and prone to registration errors, largely ineffective for treating transient arrhythmias, such as ventricular tachycardia, and exhibits relatively poor spatial resolution. With only a 50% success rate for first-time interventions, these limitations contribute to multiple erroneous ablations, repeat procedures, and increased complications for the patient. This Phase 1 SBIR proposes to develop and validate 4D Acoustoelectric Cardiac Imaging (ACI) technology for mapping electrical current in the in vivo pig heart. ACI is a patented technology that offers real-time capability and superior spatial resolution (<2 mm) for rapid localization of arrhythmias during ablation therapy. Our preliminary studies suggest that ACI would offer the following benefits over conventional EAM: 1) 4D real-time imaging of current densities in the heart; 2) high spatial resolution determined by the US focus (0.2 - 2 mm); 3) accurate localization of both sustained and transient arrhythmias; 4) fusion of current densities (ACI) with cardiac anatomy and motion (pulse echo US). The primary goal of the Phase 1 SBIR is to demonstrate and validate ACI for in vivo mapping of the electrocardiogram and cardiac activation wave in the live pig. The project partners ElectroSonix LLC with The University of Arizona to enhance the ACI platform and assess performance for in vivo mapping of electrical current in a wild type pig model. Our ultimate vision is to develop a mobile or even portable platform based on proprietary ACI technology (i.e., hardware, signal processing, data analysis and integration) for fast, real-time mapping of arrhythmias that is far superior to state-of-the-art electrical cardiac mapping techniques. A successful demonstration in the pig heart (Phase 1) would lead to an expanded Phase 2 project directly comparing ACI with a commercial EAM system (e.g., GE CARTO) for image-guided ablation during treatment of arrhythmias. The overarching goal is to improve the success rate of resynchronization therapy and reduce chances of complication by limiting the number of unnecessary ablations and repeat procedures. This would effectively reduce the chances for medical errors and improve the quality of life in patients who receive treatment. The value from this SBIR will be the first step towards commercializing a fully integrated ACI medical device realization.