复杂冠状动脉粥样硬化性心脏病（简称“冠心病”），包括冠状动脉三支病变（Triple-Vessel Disease, 3VD）和左主干病变（left main disease, LMD），常伴有多种合并症，血运重建是其主要治疗方式。目前常见的血运重建方式有冠状动脉旁路移植术（Coronary artery bypass grafting, CABG）和经皮冠状动脉介入治疗（Percutaneous coronary intervention, PCI）。近年来，两种技术不断进展，适应证不断更新。

冠心病领域的团队决策存在其特殊性。其一，心脏外科和介入心脏病学之间的发展存在一定的竞争性，对于患者血运重建治疗决策，容易出现学科偏倚；其二，不同学科之间存在技术鸿沟。介入医生在血运重建时更加关注患者的病变复杂程度和手术的即刻效果，心外科医生在血运重建时更加关注外科手术风险、远端血管情况以及竞争血流的风险。各专科分科细化，学科知识迅速发展，加之有限的学科交流，使得学科之间认知鸿沟出现；其三，复杂冠心病血运重建决策仍然存在决策灰区。虽然2018年欧洲心脏病学会（European Society of Cardiology, ESC）/欧洲心胸外科协会（European Association for Cardio-Thoracic Surgery, EACTS）颁布的血运重建指南和2021年美国心脏病学院（American College of Cardiology, ACC）/美国心脏协会（American Heart Association, AHA）中对3VD/LMD患者PCI和CABG的适应证给予了相应的循证推荐，但随着学科技术的进步和适应证的不断扩大，血运重建决策受多方面主观因素的影响，依然存在决策灰区。综上，3VD和LMD患者病情复杂，单一学科决策存在局限性。因此，2018年欧洲血运重建指南（I类推荐，C级证据）和2021年美国血运重建指南（I类推荐，B级证据）均推荐复杂冠心病需要由多学科心脏团队讨论以确保最佳决策，团队成员应至少由一名心外科专家、一名介入心脏病专家、一名非介入心脏病专家组成。

目前，国际上对心脏团队实践方案仍然缺乏具有普适性的规范化探索，指南也尚未给出具体的心脏团队实践指导细则。在美国、英国和欧洲的部分地区，曾报道过单中心的心脏团队实践经验，但各地区对于团队成员的选择、组织流程、讨论的病例类型等仍缺乏标准化方案。在中国，心脏团队实践仍为空白。同时，现有心脏团队实践发现与会人员的身份显著影响团队决策效果，团队决策的可重复性欠佳。目前尚无研究评价同期进行心脏团队决策时不同团队之间的决策一致性，且优化的心脏团队实践流程有待探索和验证。

针对上述问题，本研究旨在基于指南的推荐的组织原则，组建心脏团队并进行病例讨论，评价心脏团队质量并进行心脏团队优化实践流程的探索和验证。第一部分，按照指南推荐的心脏团队组织原则组建心脏团队，评价不同心脏团队之间决策的一致性，并通过序贯解释性定性-定量混合方法学设计，明确心脏团队决策的潜在影响因素，并给出团队组建的优化推荐，探索出一套优化的心脏团队实践流程。第二部分，通过随机对照设计，进一步比较优化的心脏团队实践流程和指南推荐的心脏团队组建原则对决策一致性的影响，进而明确优化的心脏团队实践流程对临床实践的影响。

主要的研究内容及结果如下：

第一部分 复杂冠心病血运重建心脏团队决策质量评价及规范化实践流程的探索

目的

当前指南推荐复杂冠心病应该由心脏团队制定最佳血运重建决策。但是，既往研究缺乏心脏团队决策质量评价，且尚缺乏对团队决策影响因素和规范化心脏团队实践流程的探索。本部分研究对心脏团队决策一致性进行评价并发现影响团队决策质量的因素，探索一套优化的心脏团队实践流程。

方法

本序贯解释性定量-定性混合方法学研究包括两部分：（1）第一部分采用横断面研究设计，根据指南推荐的组织原则组建心脏团队，由心脏团队针对2016年8月至2017年8月在阜外医院行冠脉造影的3VD或LMD的复杂冠心病病例进行血运重建决策，评价团队决策一致性；（2）第二部分采用定性-定量混合方法学研究，使用半结构化访谈，探索影响各心脏团队成员决策的影响因素，并给出优化心脏团队实践的推荐，探索规范化的心脏团队实践流程。研究的主要终点是团队间决策一致性的Kappa系数。定性资料采用扎根理论和主题分析的方式开展。

结果

研究共入选了101位符合入排标准的已完成治疗的复杂冠心病病例，最终有16位心血管学科医生入选，并组成了4支心脏团队，其中两支队伍为3人团队，两支为5人团队。研究主要终点团队之间决策一致性中等（Kappa 0.58 [95%置信区间：0.58-0.58]）。研究共发现了影响心脏团队决策的3个主题和10个亚主题因素。3个主题包括成员素质、团队构成和会议过程。10个亚主题包括：决策思维、对疾病和证据的理解、对其他学科的理解、医生性格、学习曲线、技术水平和行政职务、团队成员总数、医生学科类型、各学科人员的比例以及会议过程。最后，基于定性-定量混合方法的发现、既往经验和指南推荐，研究提出了改善心脏团队决策一致性的五方面建议，包括成员选择、成员培训、团队构成、团队培训和会议过程，并探索出了一套优化的心脏团队实践流程。

结论

不同心脏团队对复杂冠心病血运重建决策一致性中等。影响心脏团队决策质量的因素主要包括3大主题（成员素质、团队构成和会议流程）及10个亚主题。优化后的心脏团队实践流程需要进一步的随机对照设计去验证其对改善心脏团队决策质量的效果。

第二部分 不同心脏团队决策流程对复杂冠心病血运重建决策质量的对比研究

目的

本团队在前期通过序贯解释性混合方法学设计，探索出了一套优化的心脏团队实践流程，但其对心脏团队决策质量的改善效果尚缺乏验证。本随机对照试验的目的是对比优化的心脏团队实践流程和指南推荐的基本组织原则对复杂冠心病血运重建决策一致性的改善效果。

方法

研究通过随机抽样的方式纳入480例于2016年8月至2017年8月期间，在阜外医院行冠脉造影的3VD或LMD的复杂冠心病病例用于心脏团队讨论和决策。研究随机入选符合手术例数要求和专业素质要求的心外科医生、介入心脏病医生和非介入心脏病医生，并对医生随机分组，分别按照优化的心脏团队实践流程组建12支心脏团队、进行团队培训并开展会议（干预组），或按照指南推荐的组建原则组建12支心脏团队并开展会议（对照组）。每支团队按照标准化心脏团队讨论流程进行团队讨论。在干预组和对照组内，12支心脏团队被随机分为6对，480例病例随机分为6组，同一对团队对相同的80例病例进行决策，每个病例最终获得两支心脏团队的决策。研究的主要终点为团队间决策一致性的整体一致率（Overall Percent Agreement, OPA）；次要终点包括：（1）决策一致性的Kappa系数，（2）决策不适宜率。

结果

研究共纳入480例3VD或LMD的复杂冠心病病例，入选符合标准的心外科医生36位、介入心脏病医生36位和非介入心脏病医生12位。优化的心脏团队流程组的OPA高于指南方案组（72.1% vs. 65.8%；优势比[Odds Ratio, OR] 1.16，95% 置信区间[Confidence Interval, CI]：1.01-1.34，P=0.04)。优化的心脏团队流程组团队决策不适宜率低于指南方案组（19.4% vs. 33.0% ; OR 0.59, 95% CI：0.50-0.69; P<0.001）。在亚组分析中，对于年龄大于65岁、身体质量指数≥30kg /m²、左心室射血分数≤40%、SYNTAX评分中等或以上、3VD、SYNTAX Ⅱ 评分推荐CABG的患者，按照优化流程组建的心脏团队决策一致性更优。

结论

本部分研究对比了优化的心脏团队实践流程和指南推荐的心脏团队基本组建原则对团队决策质量的影响，发现相比于按照指南基本原则组建的心脏团队，基于优化的实践流程组建的心脏团队决策一致性更好，决策的不适宜率更低。在老龄、肥胖、左心功能不全、SYNTAX评分中高危、3VD、SYNTAX Ⅱ 评分推荐为CABG的患者中，按照优化的心脏团队流程组建的心脏团队决策一致性更优。

Patients with complex coronary artery disease (CAD), including triple-vessel disease (3VD) and left main disease (LMD), often have multiple comorbidities. Revascularization (including Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Grafting [CABG]) is the main treatment method for these patients. With the continuous development of techniques and technologies, the indications for PCI/CABG have been constantly updated.

Revascularization decision-making for CAD patients has its particularity. Firstly, the development of cardiac surgery and interventional cardiology is competitive, which is prone to exist discipline-bias in the revascularization decision-making. Secondly, there is a technological gap between different disciplines. Interventional cardiologists pay more attention to the complexity of lesions and the immediate effect of PCI during the revascularization, while cardiac surgeons expose more emphasis on surgical risks, distal vascular conditions and the risk of competing blood flow during the revascularization. With the rapid development of discipline knowledge and the limited inter-discipline communication, the cognitive gap between disciplines appears. Thirdly, the grey area still exists in complex CAD revascularization decision-making. The 2018 European Society of Cardiology (ESC) / European Association for Cardio-Thoracic Surgery (EACTS) revascularization guideline and the 2021 American College of Cardiology (ACC) / American Heart Association (AHA) revascularization guideline have reported recommendations of the indications of PCI and CABG in patients with 3VD or LMD, however, with the progress of technology and the continuous expansion of indications, the revascularization decision-making is affected by various subjective factors, and grey areas still exists in the revascularization decision-making. In conclusion, patients with 3VD or LMD have complicated conditions, and single discipline decision-making is limited. Therefore, both the 2018 European revascularization guidelines (Class Ⅰ recommendation, Level C evidence) and the 2021 U.S. revascularization guidelines (Class Ⅰ recommendation, Level B evidence) recommend that patient with complex CAD should be discussed by a multidisciplinary heart team consisting of at least a cardiologist, an interventional cardiologist and a non-interventional cardiologist to make optimal revascularization decision.

At present, there is still a lack of exploration for a standardized heart team practice protocol in the world, and the guidelines have not yet given specific rules of heart team implementation protocol. Single-center heart team practice experiences have been reported in the United States, the United Kingdom and Europe, but there is still a lack of standardized protocols including specialist selection, organizational procedures, and the types of cases discussed. In China, heart team practice is still blank. At the same time, the existing heart team practice found that the hierarchy of team member significantly affected heart team recommendations, and the reproducibility of team decision-making was not well. At present, there are no effort to evaluate the consistency of decision-making between different heart teams or to explore and verify a standardized heart team implementation protocol.

In view of the above issues, the purpose of this study was to evaluate the decision-making quality of heart teams organized on guideline recommendations and to explore an optimized heart team implementation protocol. In the first part, heart teams were established based on guideline recommendations. The consistency of decision-making among different heart teams was evaluated, and the factors affecting the revascularization decision-making were clarified through a sequential explanatory of qualitative-quantitative mixed method design, and the recommendations of heart team implementation was summarized and an optimized heart team protocol was explored. In the second part, a randomized controlled design was used to further verify the impact of the optimized heart team protocol on the consistency of decision-making compared with the guideline-based heart team protocol, so as to clarify the impact of the optimized heart team implementation protocol on clinical practice.

The main research contents and results are as follows:

Part Ⅰ. Evaluation of Heart Team Decision-Making Quality and Exploring an Optimized Heart Team Protocol to Improve Decision-Making Quality for Complex Coronary Artery Disease

Objective

Current guidelines recommended the heart team approach for optimal revascularization decision-making for complex CAD. However, previous studies lacked the quality evaluation of heart team decision-making, and the potential influencing factors of heart team revascularization decision-making remained unknown. An optimal standardized heart team implementation protocol was still lacking. Part Ⅰ intended to assess the inter-team agreement of heart team decision-making and potential factors to inform the development of a heart team protocol.

Methods

This sequential, explanatory quantitative-qualitative mixed method study consisted of two stages: (1) a cross-sectional quantitative study to assess inter-team agreement on revascularization decisions for historic complex CAD cases and (2) a qualitative study that used semi-structured interviews with heart team members to identify factors influencing decision-making discrepancy. The primary endpoint of the study was the Kappa value of inter-team decision-making agreement. The qualitative data were analyzed by grounded theory and an inductive thematic analysis method.

Results

A total of eligible 101 cases with complex CAD were retrospectively enrolled. Sixteen cardiologists were enrolled and randomly assigned to 4 heart teams, two of which were 3-person teams and two were 5-person teams. The primary outcome kappa of inter-team decision-making agreement was moderate (kappa 0.58 [95% confidence interval: 0.58-0.58]). Factors influencing decision-making were summarized by 3 themes (specialist quality, team composition, and meeting process) and 10 subthemes. The 10 subthemes included: decision thought process, understanding of illness and evidence, understanding of other disciplines, personality, learning curve, technical and administrative positions, number of team members, discipline selection, ratio of different disciplines, and meeting process. Recommendations of heart team implementation were generated based on qualitative and quantitative data at five levels: specialist selection, specialist training, team composition, team training, and meeting process. A detailed optimized heart team protocol on the integration of guidelines, previous experience, and recommendations was generated to establish and deploy a qualified heart team.

Conclusion

Agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized in 3 themes (member quality, team composition and meeting process) and 10 subthemes. Five recommendations for heart team implementation were generated. An optimized heart team implementation protocol was designed and should be validated in future.

Part Ⅱ. A Comparative Study of Different Heart Team Protocols on the Quality of Revascularization Decision-Making in Complex Coronary Artery Disease

Objective

At the early stage of this study, we explored an optimized heart team implementation protocol based on a sequential explanatory mixed method study, but the effect of this optimized protocol on improving the heart team decision-making quality was not verified. The purpose of this randomized controlled trial was to verify the effect of the optimized heart team implementation protocol versus the guideline-based protocol on improving the consistency of revascularization decision-making.

Methods

We randomly selected 480 historic cases with stable complex CAD who were angiographically confirmed 3VD or LMD in Fuwai Hospital from August 2016 to August 2017 for heart team discussion. The study randomly selected eligible cardiac surgeons, interventional cardiologists and non-interventional cardiologists who met the requirements of the surgery volume and professional quality. The eligible specialists were randomized to an optimized heart team protocol group to establish 12 heart teams and receive team training according to the optimized protocol; or to a guideline-based group to establish 12 heart teams according to guideline recommendations. The 12 heart teams in each arm were randomly divided into 6 pairs, and 480 historic cases with complex CAD into 6 sets of 80 cases. Each set of 80 cases were discussed independently by a single pair of heart teams, with each case finally receiving 2 heart team decisions (“pairwise decisions”). The primary outcome was the overall percent agreement (OPA) of the pairwise decisions, and secondary outcomes included: (1) Kappa coefficient of decision-making agreement, (2) the inappropriateness rate of decision-making. Subgroup analysis was conducted according to physician discipline, case demographic characteristics, risk factors, and lesion complexity to compare the differences in OPA between the two groups in the specific subgroup.

Results

A total of 480 historic cases with 3VD or LMD were selected and 36 cardiac surgeons, 36 interventional cardiologists and 12 non-interventional cardiologists were enrolled. The OPA in the optimized protocol group was significantly higher than the guideline-based group (72.1% vs. 65.8%; Odds Ratio [OR] 1.16, 95% Confidence Interval [CI]: 1.01-1.34，P=0.04). The inappropriateness rate of team decision-making in the optimized heart team group was significantly lower than that of the guideline-based group (19.4% vs. 33.0% ; OR 0.59, 95% CI: 0.50-0.69; P<0.001). In subgroup analysis, the inter-team agreement in the optimized group was better than the guideline-based group when patients were older than 65 years, with body mass index ≥30kg /m², with left ventricular ejection fraction ≤40%, with moderate or high SYNTAX score, with 3VD, or with SYNTAX Ⅱ score recommending CABG.

Conclusion

Part Ⅱ compared the effect of the optimized heart team protocol and the guideline-based protocol on the quality of revascularization decision-making. The optimized heart team implementation protocol improved the decision-making stability and decreased the inappropriateness rate of decision-making compared with the guideline-based protocol. For patients with elder age, obesity, LVEF≤40%, moderate or high SYNTAX score, 3VD, or with SYNTAX Ⅱ score recommending CABG, the heart team organized by the optimized protocol performed better in the revascularization decision-making quality than the guideline-based protocol.