Novel catheter treatment of valve disease

新型导管治疗瓣膜疾病

• 批准号: 9353118
• 负责人: Robert J Lederman
• 金额: $ 64.69万
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9353118
• 关键词: Agreement; Aneurysm; Animal Model; Animals; Anterior; Aorta; Blood; Businesses; Catheters; Chest; Complication; Contracts; Coronary; Development; Devices; Disease; Evaluation; Family suidae; Funding; Heart; Human; Implant; Inferior vena cava structure; Korea; Laboratories; Left; Life; Mitral Valve; Mitral Valve Insufficiency; Modeling; Obstruction; Operative Surgical Procedures; Patients; Physicians; Procedures; Safety; Techniques; Testing; Translations; Tricuspid Valve Insufficiency; Venous; Ventricular; Work; abdominal aorta; aortic valve replacement; implantation; ischemic cardiomyopathy; novel; novel strategies; prevent; repaired; research and development; success

We are continuing development of transcatheter mitral cerclage annuloplasty, a novel technique which establishes circumferential tension around the mitral valve annulus by exploiting both natural (coronary venous) and un-natural (intramyocardial septal) trajectories. We have established proof-of-principal in a porcine model of ischemic cardiomyopathy that cerclage annuloplasty reduces secondary ("functional") mitral valve regurgitation. While we refine devices, we are working to issue new contracts to small businesses to fund collaborative translation of this novel technique into patients. We are analyzing the results of a first-in-human test performed by our laboratory alumnus and close collaborator in Pusan Korea. We have conceived a wholly new approach to treat tricuspid valve regurgitation called transauricular intrapericardial tricuspid annuloplasty (TRAIPTA). We have demonstrated the success of TRAIPTA to reduce functional tricuspid regurgitation in a new animal model. We recently entered into a Collaborative Research and Development Agreement with a large catheter company to develop this technique for testing in patients. Work continues apace. We have developed a new technique to introduce large implants into the aorta for transcatheter aortic valve replacement and related procedures, by crossing from the inferior vena cava into the abdominal aorta. This challenges the long-held paradigm that the aortic wall must remain inviolate during non-surgical procedures. The technique has proven lifesaving in over three dozen patients. We are sponsoring a multicenter evaluation of the technique while we develop purpose-built devices to close the access port. We have been educating physicians and their teams in this technique on three continents, where it has been applied successfully in 240 patients to date. We are analyzing the results of a multicenter test that we conducted of the safety and efficacy of this technique throughout the USA. In addition to the broader application of transcaval access for transcatheter aortic valve replacement in patients, we have helped collaborators apply this technique for transcaval thoracic aortic endovascular aneurysm repair in patients. We have developed and tested a completely new approach to prevent a life-threatening complication of the transcatheter mitral valve implantation. In as many as a third of patients, the transcatheter mitral valve forces the natural mitral leaflet to block blood as it leaves the heart, a condition called left ventricular outflow tract obstruction. We developed a technique called LAMPOON to split the native anterior mitral leaflet and showed how it works in animals. It has been successfully applied in 7 patients so far.

我们正在持续开发经导管二尖瓣环闭环成形术，这是一种新型技术，它通过利用天然（冠状静脉）和非自然（心脏内膜）轨迹来建立二尖瓣环周围的圆周张力。 我们已经在缺血性心肌病的猪模型中建立了原本证明，该模型可减少二颗（“功能”）二尖瓣反流的次级（“功能”）。 当我们精炼设备时，我们正在努力向小型企业签订新合同，以资助将这种新技术的合作翻译为患者。 我们正在分析我们的实验室校友和密切合作者在韩国进行的首次人类测试的结果。 我们已经构思了一种全新的方法，可以治疗三尖瓣反流，称为经尾脑脑内三尖瓣环形成形术（Traipta）。 我们已经证明了创伤的成功，以减少新动物模型中的功能性三尖瓣反流。 最近，我们与一家大型导管公司签订了一项合作研究和开发协议，以开发患者进行测试的技术。 工作继续前进。 我们已经开发了一种新技术，将大型植入物引入主动脉主动脉瓣置换板和相关程序，通过从下腔静脉杂志越过腹主动脉。 这挑战了长期以来的范式，即主动脉壁在非手术过程中必须保持不可抗解。 该技术已证明了三十多名患者的救生。 当我们开发专用设备以关闭访问端口时，我们正在赞助该技术的多中心评估。 我们一直在三大洲的这项技术中教育医生及其团队，迄今为止，它已成功应用于240名患者。 我们正在分析我们在整个美国进行该技术的安全性和功效的多中心测试的结果。 除了在患者中更广泛地应用经经导管主动脉瓣置换术的经诊断途径外，我们还帮助合作者将此技术应用于经胸腔主动脉内血管内血管内血管内动脉瘤修复。 我们已经开发并测试了一种全新的方法，以防止经导管二尖瓣植入的生命并发症。 在多达三分之一的患者中，经导管二尖瓣迫使天然二尖瓣在离开心脏时阻塞血液，这种病被称为左心室流出道障碍。 我们开发了一种称为Lampoon的技术来分裂天然的前二尖瓣，并展示了它在动物中的工作方式。到目前为止，它已成功应用于7名患者。