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中文摘要
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摘要 尽管介入心脏手术在治疗心律失常方面取得了全球成功,但从解剖角度来看, 心脏标测(EAM)有明显的缺陷。这个程序很慢,而且容易注册 错误,很大程度上对治疗一过性心律失常无效,如室性心动过速,并表现为 空间分辨率相对较差。由于首次干预的成功率只有50%,这些 局限性会导致多次错误的消融、重复手术和增加并发症 病人。这一阶段的SBIR建议开发和验证4D声电心脏成像 (ACI)技术,用于在活体猪心内标测电流。ACI是一项专利技术, 提供实时功能和卓越的空间分辨率(<2 mm),可快速定位心律失常 在消融治疗期间。我们的初步研究表明,ACI将提供以下好处 传统的EAM:1)心脏电流密度的4D实时成像;2)高空间分辨率 由US焦点(0.2-2 mm)确定;3)持续和瞬时的准确定位 心律失常;4)电流密度(ACI)与心脏解剖和运动的融合(脉冲超声)。这个 第一阶段SBIR的主要目标是演示和验证ACI用于活体标测 活体猪的心电图和心脏激动波。项目合作伙伴ElectrSonix LLC与 亚利桑那大学加强ACI平台并评估活体测绘的性能 野生型猪模型中的电流。我们的终极愿景是开发一种可移动甚至便携的 基于专有ACI技术的平台(即硬件、信号处理、数据分析和 集成)用于快速、实时地标测心律失常,远远优于最先进的电学技术 心脏标测技术。在猪心(第一阶段)的成功演示将导致 扩展的第二阶段项目直接将ACI与商业EAM系统(例如GE Carto)进行比较 影像引导消融在心律失常治疗中的应用最重要的目标是提高成功 通过限制再同步化治疗的次数和减少并发症的机会 不必要的消融和重复手术。这将有效地减少医疗保健的机会。 并改善接受治疗的患者的生活质量。此SBIR的值将为 实现完全集成的ACI医疗设备商业化的第一步。
英文摘要
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.
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