SBIR Phase II: An AI-Enhanced Angiographic System to Guide Endovascular Treatment of Intracranial Aneurysms

该小型企业创新研究（SBIR）II期项目的更广泛影响是改善接受神经血管内介入治疗颅内动脉瘤（IA）患者的手术结局。IA影响6%的人群，IA破裂导致致死性出血性卒中，尽管管理有所改善，但仍占脑血管死亡的约25%。大多数IA破裂患者（约65%）死于初始出血或其直接并发症。在幸存者中，约50%的人残疾，日常活动依赖他人。当颅内动脉瘤出现症状，药物治疗或生活方式改变无效时，治疗可能涉及神经血管内介入治疗。尽管这些手术入路提供了可靠和快速的病变入路，并发症比开颅手术少，但它们不能实现IA完全愈合，多达30%的病例需要重复干预。该项目开发的人工智能技术将通过分析血管造影单元获取的图像来实时评估手术进展。 该解决方案将提供患者离开手术室之前无法实现颅内动脉瘤愈合的可能性。这个小企业创新研究（SBIR）第二阶段项目将支持开发世界上第一个人工智能平台，该平台能够为图像引导的神经介入治疗颅内动脉瘤提供实时知情决策支持。该技术使用从图像引导血管内手术期间常规采集的血管造影片中提取的成像生物标志物和机器学习方法，以解释患者病理学、神经介入方法和成像设备特征的巨大异质性。该平台包括多个创新方面：1）识别IA的位置和范围的全自动方法，（2）成像生物标志物的即时提取，（3）在几分之一秒内的术后一年的手术结果的预后，以允许神经介入医生重新调整血管内治疗，和（4）与血管造影系统完全集成，无论制造商是谁。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is improving the surgical outcome for patients undergoing neuro-endovascular interventions for the treatment of intracranial aneurysms (IAs). IAs affect 6% of the population and IA rupture results in lethal hemorrhagic strokes, which account for ~25% of cerebrovascular deaths despite improvements in management. Most ruptured IA patients (~65%) die due to the initial bleed or its immediate complications. Of the survivors, ~50% are left disabled and dependent on others for daily activities. When IAs become symptomatic and medical therapy or lifestyle changes are ineffective, treatment could involve neuro-endovascular interventions. Although these surgical approaches provide reliable and fast access to the lesion with fewer complications than open skull surgery, they do not achieve complete IA healing, with as many as 30% of the cases requiring repeated interventions. The artificial intelligence technology developed in this project will allow real-time assessment of the surgery progress by analyzing images acquired through the angiographic unit. The solution will provide the odds of failure to achieve healing of the IAs before the patient leaves the surgical suite.This Small Business Innovation Research (SBIR) Phase II project will support development of the world’s first artificial intelligence platform that enables real-time informed decision support for image-guided neuro interventions to treat intracranial aneurysms. The technology uses imaging biomarkers extracted from routinely acquired angiograms during image-guided endovascular procedures and machine learning methods to account for large heterogeneity in patient pathology, neuro-interventionalist approach, and imaging equipment characteristics. The platform includes multiple innovative aspects: 1) a fully automated method to identify the location and extent of the IA, (2) instantaneous extraction of the imaging biomarkers, (3) prognosis of the surgical outcome at one-year post-procedure in a fraction of a second to allow neuro-interventionalist to readjust the endovascular therapy, and (4) full integration with the angiographic systems regardless of the manufacturer.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.