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

项目摘要 经食管超声心动图（TEE）是一种基于超声的心脏成像程序， 促进知情的手术决策，并管理本季度的术中并发症 每年在美国进行的心脏手术。然而，没有随机证据支持 在任何类型的心脏手术中使用术中TEE。这种缺乏随机证据的情况尤其严重。 在孤立性冠状动脉旁路移植术（CABG）中存在问题，因为观察比较 有效性研究在术后结果改善与 (vs无）术中TEE。更复杂的是，TEE是一种侵入性手术， 临床受益可能不会超过其确认的胃食管损伤风险。围绕的问题 不清楚的临床疗效，未知的真实世界的有效性，和不确定的风险-受益比的术中 孤立CABG手术期间的TEE是临床平衡的关键证据差距，导致 广泛的实践模式变异性和术中TEE（与无TEE相比）接近50/50的分裂。因此 K23研究的总体目标将利用现有的临床平衡和实践模式 变异性，以生成必要的基础数据，为未来的多中心、随机 对照试验（RCT），可以解决围绕临床疗效，有效性和风险的问题- 在单独CABG手术期间使用术中TEE的受益比（vs.未使用TEE）。为此，我们有三个目标： 将检验中心假设，即在常规孤立CABG手术人群（即， 考虑到没有瓣膜疾病，适合随机分组），术中TEE对 孤立性CABG手术后的术后临床结局在亚组之间存在差异（目的1）， 将常规孤立CABG手术患者随机分为默认（即强制性）或按需（即备用） 术中TEE将获得利益相关者的充分参与（目标2）， 在候选人所在机构进行的单中心、试点RCT的实际可行性（目标3），以实现 在未来的多中心随机对照试验中进行更大规模的研究。从完成这三个目标中获得的信息将 提供所需的初步数据，以告知后续的多中心临床试验， 随机分配至默认组与按需组的常规孤立CABG手术患者的临床结局 术中TEE。结合指导的结构化课程和研究培训计划， K23的重点是如何计划、设计和进行随机临床试验，它将成为 候选人朝着成为领先的临床试验者和比较有效性的方向发展 致力于改善心脏手术患者人群的临床结局的研究人员。

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.