Cardioscopy New Platform for Less Invasive Surgery on the Beating Heart

描述（由申请人提供）：传统心脏手术为结构性心脏缺陷的矫正提供了良好的入路和可视化;然而，它需要打开胸部并对停跳、非跳动的心脏进行手术。虽然内窥镜手术已成功地用于腹部和胸部手术，但难以在血液中获得清晰和广泛的视野，阻碍了其在心脏手术中的应用。我们已经开发了一种新的方法，使用灵活的光纤心脏镜和两个体外循环回路，在跳动的心脏心内解剖结构清晰可视化。主要心肺转流回路通过提供全身和冠状动脉灌注来确保血流动力学稳定性。第二个成像回路用于通过灌注透明液体通过心脏腔室将心脏与体循环隔离，以实现心内可视化。保持正常的心脏运动和心内结构的清晰可视化应允许更安全和更有效的外科干预，同时避免心脏骤停时可能发生的心肌损伤风险。可在心内功能评估指导下，在跳动的心脏内进行迭代手术干预，而不会出现突然血流动力学受损的风险。在瓣膜修复/置换和瓣环成形术中，临床医生可以在介入前后评价瓣环收缩期间的瓣膜功能和形态。本提案的目标是建立临床适用的、微创的、经皮的心内手术方法，在跳动的心脏中直接可视化。为了实现我们的目标，我们有三个具体目标。具体目标1是开发和测试一种简化的成像旁路回路和插管，以使用侵入性较小的手术和经皮LV入路可视化心脏左侧的心内结构。成像旁路电路将位于肺动脉（PA）（出口）和左心室（LV）（返回）之间。将使用从外周静脉置入的PA球囊套管封堵PA，将LV与右心室隔离，并使用透明成像液将血液从肺循环冲洗到LV中。将成像液回流套管和心脏镜放入LV中。具体目标2和3是确认微创和经皮可视化系统将允许在动物模型中的跳动心脏上安全有效地执行心内手术。这些包括二尖瓣修复术和左心室间隔壁部分切除术。将通过小胸廓切开术或剑突下小切口或通过颈动脉或股动脉经皮入路穿过主动脉瓣，将内窥镜放置在左心室心尖附近。这项研究的成功完成将为临床医生提供一个多功能的微创平台，用于心脏跳动中的闭胸、心内手术或电生理干预。这种技术可以取代许多需要胸骨切开术的侵入性外科手术，消除再手术的额外风险，并为高风险和老年瓣膜返流患者提供更安全的方法。 公共卫生相关性：传统的心脏手术为结构性心脏缺陷的矫正提供了良好的进入和可视化;然而，它需要打开胸部，对停止跳动的心脏进行手术。本提案的目的是在血流动力学稳定的跳动心脏环境中，使用柔性光纤心脏镜和体外透明成像液体旁路回路，在直接心脏可视化下建立临床适用的、微创的经皮心内手术方法。这项研究的成功完成将为临床医生提供一个多功能的平台，用于在跳动的心脏内进行贲门外科手术，治疗各种结构性心脏病，包括瓣膜、先天性和电生理干预，并有可能提供真实的 心内瓣膜的时间可视化和手术室中的LV壁性能反馈。该技术可能取代许多需要胸骨切开术的侵入性外科手术，消除与再次手术相关的额外风险，并为高风险患者和瓣膜返流老年患者提供更安全的方法。

DESCRIPTION (provided by applicant): Conventional cardiac surgery provides excellent access and visualization for correction of structural heart defects; however, it requires opening the chest and operating on an arrested, non-beating heart. Although endoscopic surgery has been successfully used in abdominal and thoracic surgery, difficulties in obtaining a clear and wide field of vision in blood have prevented its use in cardiac surgery. We have developed a novel approach for clear visualization of intracardiac anatomy in the beating heart using a flexible fiberoptic cardioscope and two extracorporeal bypass circuits. The primary cardiopulmonary bypass circuit secures hemodynamic stability by providing systemic and coronary perfusion. The second imaging circuit is used to isolate the heart from the systemic circulation by perfusing a clear fluid through the heart chambers for intracardiac visualization. Preservation of normal heart movement and clear visualization of intracardiac structures should allow for safer and more effective surgical interventions while avoiding the risk of myocardial injury that can occur in an arrested heart. Iterative surgical interventions can be performed within a beating heart guided by functional intracardiac evaluation without the risk of sudden hemodynamic compromise. In valve repair/replacement and annuloplasty procedures, the clinician can evaluate valve function and morphology during annular contractions before and after intervention. The goal of this proposal is to establish clinically applicable, less invasive nd percutaneous approaches to intracardiac surgery under direct visualization in the beating heart. To achieve our goal, we have three specific aims. Specific Aim 1 is to develop and test a simplified imaging bypass circuit and cannulae to visualize intracardiac structures on the left side of the heart using less invasive surgical and percutaneous approaches to the LV. The imaging bypass circuit will be between the pulmonary artery (PA) (outlet) and the left ventricle (LV) (return). A PA balloon cannula placed from a peripheral vein will be used to occlude the PA, isolate the LV from the right ventricle and flush blood out of the pulmonary circulation into the LV using a clear imaging fluid. The imaging fluid return cannula and the cardioscope will be placed into the LV. Specific Aim 2 and 3 are to validate that both a less invasive and percutaneous visualization system will allow for the safe and effective performance of intracardiac surgeries on a beating heart in an animal model. These include mitral valve repair and the resection of parts of the LV septal wall. The Cardioscope will be placed near the LV apex via a small thoracotomy or small subxiphoid incision or across the aortic valve via the carotid or femoral artery percutaneous approach. The successful completion of this research will provide clinicians with a versatile less invasive platform for closed-chest, intracardiac surgery o electrophysiological interventions in a beating heart. This technique could replace many invasive surgical procedures that require a sternotomy, eliminate added risks from re-operations and provide a safer approach for high risk and elderly patients with valve regurgitation. PUBLIC HEALTH RELEVANCE: Conventional cardiac surgery provides excellent access and visualization for correction of structural heart defects; however, it requires opening the chest an operating on an arrested, non-beating heart. The goal of this proposal is to establish clinically applicable, less invasive and percutaneous approaches to intracardiac surgery under direct cardiac visualization in a hemodynamically stable beating heart environment using a flexible fiberoptic cardioscope and an extracorporeal clear imaging fluid bypass circuit. The successful completion of this research will provide clinicians with a versatile platform for conducting cardia surgical procedures within a beating heart for a wide range of structural heart diseases including valvular, congenital, and ectrophysiological interventions as well as the potential to provide real time visualization of intracardiac valves and LV wall performance feedback in the operating room. This technique could potentially replace many invasive surgical procedures that require a sternotomy, eliminate the added risks associated with re-operations and provide safer approach for high risk patients and elderly patients with valve regurgitation.