The Role of Intraoperative Transesophageal Echocardiography During Isolated Coronary Artery Bypass Graft Surgery

术中经食管超声心动图在离体冠状动脉搭桥手术中的作用

• 批准号: 10738059
• 负责人: Emily Jane Mackay
• 金额: $ 19.35万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-25 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10738059
• 关键词: Aorta; Cardiac; Cardiac Surgery procedures; Clinical; Clinical Trials; Comparative Effectiveness Research; Coronary Artery Bypass; Data; Decision Making; Dedications; Disease; Effectiveness; Enrollment; Equipoise; Foundations; Funding; Future; Goals; Health Policy; Health Services; Heart Valves; Hospitals; Imaging Techniques; Incidence; Injury; Institution; Intervention; Interview; Intraoperative Care; Intraoperative Complications; Medical center; Mentors; Mentorship; Methodology; Methods; Modification; Monitor; Multi-Institutional Clinical Trial; Multicenter Trials; Operative Surgical Procedures; Outcome; Patients; Pattern; Perioperative; Population; Postoperative Period; Presbyterian Church; Procedures; Provider; Qualitative Research; Randomized; Randomized, Controlled Trials; Research; Research Personnel; Research Training; Risk; Role; Sampling; Societies; Standardization; Structure; Subgroup; Surgeon; Testing; Thoracic Surgeon; Training; Transesophageal Echocardiography; Trees; US State; Work; arm; clinical efficacy; comparative effectiveness; comparative effectiveness study; design; heart imaging; hemodynamics; improved; improved outcome; learning strategy; patient population; preference; prospective; randomized trial; randomized, clinical trials; recruit; risk/benefit ratio; satisfaction; statistical learning; treatment effect; trial comparing; ultrasound

PROJECT ABSTRACT Transesophageal echocardiography (TEE) is an ultrasound-based cardiac imaging procedure frequently used to facilitate informed surgical decision making and manage intraoperative complications during the quarter million cardiac surgeries performed in the US each year. And yet, there is no randomized evidence to support the use of intraoperative TEE in any type of cardiac surgery. This lack of randomized evidence is particularly problematic in isolated coronary artery bypass graft (CABG) surgery because observational comparative effectiveness studies are conflicted regarding the association between improved postoperative outcomes with (vs without) intraoperative TEE. Complicating matters, TEE is an invasive procedure where its unconfirmed clinical benefits may not outweigh its confirmed risks of gastroesophageal injury. The questions surrounding the unclear clinical efficacy, unknown real-world effectiveness, and undefined risk-benefit ratio of intraoperative TEE during isolated CABG surgery is a critical evidence gap with clinical equipoise that has resulted in widespread practice pattern variability and a near 50/50 split in TEE (vs no TEE) intraoperatively. Thus, the overall objectives of this K23 research will leverage this existing clinical equipoise and practice pattern variability to generate the required foundational data necessary to inform a future, multicenter, randomized controlled trial (RCT) that could resolve the questions surrounding the clinical efficacy, effectiveness, and risk- benefit ratio of intraoperative TEE use (vs lack of use) during isolated CABG surgery. To that end, three aims will test the central hypothesis that among a routine isolated CABG surgery population (i.e. a population suitable for randomization given the absence of valve disease), the treatment effects of intraoperative TEE on postoperative clinical outcomes after isolated CABG surgery will vary among subgroups (aim 1) and that randomizing routine isolated CABG surgery patients to either default (i.e. obligatory) or as-needed (i.e. backup) intraoperative TEE will garner adequate participation by stakeholders (aim 2), and demonstrate enough practical feasibility in a single-center, pilot RCT conducted at the Candidate’s institution (aim 3), to accomplish on a larger scale in a future, multicenter RCT. The information gained from completion of these three aims will provide the preliminary data required to inform subsequent, multicenter clinical trial(s) comparing perioperative clinical outcomes among routine isolated CABG surgery patients randomized to default vs as-needed intraoperative TEE. In combination with a structured course of mentoring, and a research training plan heavily focused on the how to plan, design, and conduct randomized clinical trials, this K23 will be the foundation for the Candidate’s progression toward becoming a leading clinical trialist and comparative effectiveness researcher dedicated to improving clinical outcomes in the cardiac surgical patient population.

项目摘要 经食管超声心动图 (TEE) 是一种经常使用的基于超声的心脏成像程序 促进本季度明智的手术决策并管理术中并发症 美国每年进行数百万例心脏手术，但没有随机证据支持。 术中 TEE 在任何类型的心脏手术中的使用尤其缺乏随机证据。 孤立性冠状动脉旁路移植术（CABG）手术中存在问题，因为观察性比较 关于术后结果改善与 （与没有）术中 TEE 使事情变得复杂的是，TEE 是一种侵入性手术，其未经证实。 临床益处可能不会超过其已证实的胃食管损伤风险。 临床疗效不明确、现实世界的有效性未知以及术中风险效益比不明确 孤立 CABG 手术期间的 TEE 是与临床平衡的一个关键证据差距，导致 术中实践模式存在广泛的变异性，TEE（与无 TEE）的比例接近 50/50。 这项 K23 研究的总体目标将利用现有的临床平衡和实践模式 可变性来生成所需的基础数据，为未来、多中心、随机 对照试验（RCT）可以解决围绕临床功效、有效性和风险的问题 孤立 CABG 手术期间术中 TEE 使用（与不使用）的效益比 为此，我们制定了三个目标。 将检验中心假设，即在常规隔离 CABG 手术人群（即人群 考虑到不存在瓣膜疾病，适合随机分组），术中 TEE 对患者的治疗效果 单独 CABG 手术后的术后临床结果因亚组而异（目标 1），并且 将常规孤立 CABG 手术患者随机分配为默认（即强制性）或按需（即备用） 术中 TEE 将获得利益相关者的充分参与（目标 2），并展示足够的 在候选人所在机构进行的单中心试点随机对照试验的实际可行性（目标 3），以实现 未来更大规模的多中心随机对照试验将通过完成这三个目标获得的信息。 提供比较围手术期的后续多中心临床试验所需的初步数据 常规孤立 CABG 手术患者随机分为默认治疗与按需治疗的临床结果 术中 TEE 与结构化指导课程和研究培训计划相结合。 K23 专注于如何规划、设计和进行随机临床试验，将成为 候选人成为领先临床试验员的进展和比较效果 研究人员致力于改善心脏手术患者群体的临床结果。