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Atraumatic Non-fibrotic Epicardial Pacing with E-Bioadhesive Devices

使用电子生物粘附装置进行无创伤性非纤维化心外膜起搏

基本信息

批准号：
10637562
负责人：
Leigh Gareth Griffiths
金额：
$ 49.65万
依托单位：
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-01 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10637562
关键词：
Acceleration Address Adhesions Adhesives Arrhythmia Benchmarking Biomedical Engineering Bradyarrhythmias Bradycardia Cardiac Cardiac Surgery procedures Cardiac conduction system Cessation of life Chest wall structure Clinical Communication Data Degree Completion Devices Electric Conductivity Electrodes Electrophysiology (science)Ensure Epicardium Equipment Malfunction Evaluation Excision FDA approved Failure Family suidae Fibrosis Foreign Bodies Heart Heart Atrium Heart Block Hemorrhage Hospitalization Implant In Vitro Inflammation Inflammatory Response Joints Lead Left Life Microfluidics Nature Operative Surgical Procedures Organ Patient Care Patients Perforation Performance Perioperative Physiologic pulse Postoperative Period Process Publications Risk Rodent Rodent Model Safety Series System Technology Tissue Adhesives Tissues Translating Translational Research Trauma bioelectronics capsule cardiac pacing clinical translation clinically relevant design fabrication heart rhythm implantation improved in vivo patient safety porcine model pre-clinical preservation prevent response standard of care translational medicine

项目摘要

Project Summary Almost a million patients undergo heart surgery annually in the US, and perioperative heart rhythm abnormalities including bradycardia and complete-degree heart block are one of the most common and fatal complications of cardiac surgery. Implantation of temporary epicardial pacing leads is the standard of care for patients undergoing cardiac surgery to provide on-demand pacing of the heart. Such leads prove necessary to control potentially life-threatening bradyarrhythmias in approximately 15% of all post-operative cardiac surgery patients. The current temporary epicardial pacing leads suffer from two major limitations: 1) Traumatic implantation and removal processes. At implantation, the conventional leads in form of wires are pierced into the epicardium to be anchored. This approach puts patients at risk of local hemorrhage, possibly cardiac chamber perforation, and tamponade. After 1-2 weeks, the risk of these complications is even higher following the removal of the pacing leads, by pulling them out of the epicardium. 2) Inflammation-induced capture threshold elevation and early device failure. Trauma and foreign body response cause fibrous capsule formation at the lead-tissue interface, which leads to loss of capture and early device failure. For instance, 60% of right and 80% of left atrial leads fail by the 15th postoperative day. To address the abovementioned challenges, we propose to develop an electrically conductive bioadhesive (e-bioadhesive) device that can offer: 1) robust atraumatic integration and on-demand atraumatic removal, and 2) no fibrous capsule formation at the device-tissue interface, therefore providing stable and effective pacing capability and improving patient safety throughout the hospitalization. Preliminary data from joint publications of the MPIs in Nature, Nature Materials, Nature Biomedical Engineering, and Science Translational Medicine validate that our e-bioadhesives can form instant, robust, and electrically conductive adhesion to wet dynamic organs and also offer on-demand detachment. Here we aim to conduct a series of in vitro, ex vivo, and rodent and porcine in vivo studies to develop and systematically benchmark our e-bioadhesive devices in direct comparison to commercially used temporary epicardial leads. We will thoroughly assess and optimize the e-bioadhesives’ attachment and detachment mechanisms, sensing and pacing capabilities, and evaluate the tissue response to the e-bioadhesive. The design of the proposed e-bioadhesive devices should allow for easy incorporation into existing clinical scenarios for temporary cardiac pacing, further accelerating the clinical translation of this technology.

项目总结