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

项目摘要 经食道超声心动图是一种常用的基于超声的心脏成像方法。 促进知情的手术决策，并在本季度处理术中并发症 美国每年进行百万次心脏手术。然而，没有随机的证据来支持 术中TEE在任何类型心脏手术中的应用。这种随机证据的缺乏尤其是 隔离冠状动脉旁路移植(CABG)手术存在问题，因为观察性比较 有效性研究在改善术后结果与 (VS)术中TEE。更复杂的是，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确认的胃食道损伤风险。围绕着的问题 术中临床疗效不明确，现实效果未知，风险-收益比不明 单纯冠脉搭桥术中的TEE是与临床平衡的关键证据差距，导致 术中TEE(与非TEE)之间存在广泛的操作模式差异和近50/50的比例。因此， 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，以生成所需的基础数据，为未来的、多中心、随机的 对照试验(RCT)，可以解决围绕临床疗效、有效性和风险的问题- 单纯冠脉搭桥术中术中使用TEE与不使用TEE的受益率。为此，有三个目标 将检验中心假设，在常规孤立的CABG手术人群(即人群)中 适合在无瓣膜病的情况下随机选择)，术中TEE对心脏瓣膜病变的治疗效果 单纯冠脉搭桥术后的临床结果在不同亚组之间会有所不同(目标1)，而且 将常规孤立CABG手术患者随机分为默认(即强制性)或按需(即备份) 术中TEE将获得利益相关者的充分参与(目标2)，并充分展示 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 在未来更大的范围内，多中心的RCT。从完成这三个目标中获得的信息将 提供所需的初步数据，以便为后续的多中心临床试验(S)比较围手术期 常规孤立冠脉搭桥术患者随机分为默认组和按需组的临床结果 术中T恤。与结构化的指导课程和大量的研究性培训计划相结合 专注于如何计划、设计和进行随机临床试验，K23将成为 候选人成为领先的临床试验和比较有效性的进展 致力于改善心脏外科患者群体的临床结果的研究人员。

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.