OBJECTIVES: A lack of standardization in heart team implementation potentially leads to suboptimal decision-making quality and we previously established a modified heart team protocol to improve the decision-making quality. The present trial was to validate the effect of the modified heart team implementation protocol on improving the decision-making quality versus the conventional protocol in complex coronary artery disease (CAD). METHODS: Eligible interventional cardiologists (ICs), cardiac surgeons (CSs), and non-interventional cardiologists (NICs) were randomly allocated to the intervention or control arm and established 12 heart teams in each arm. 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. In each arm, each set of 80 cases were discussed independently by one pair of heart teams, with each case finally receiving 2 heart team decisions ("pairwise decisions"). The intervention arm conducted heart team decision-making according to the previously established protocol and the control arm based on guideline recommendations. The primary outcome was the overall % agreement (OPA) of the inter-team pairwise decisions. Decision-making appropriateness was further analyzed. RESULTS: A total of 36 CSs, 36 ICs and 12 NICs from 26 centers were enrolled. The OPA was significantly higher in the intervention arm than the control arm (72.1% vs 65.8%, P = 0.04
kappa 0.51 vs 0.37). Both team-level (19.4% vs 33.0%
P <
0.001) and specialist-level (ICs, 19.8% vs 37.7%, P <
0.001
CSs, 19.8% vs 28.7%, P <
0.001) inappropriateness rate of decision-making was significantly lower in the intervention arm than the control arm. CONCLUSIONS: The modified heart team implementation protocol improved the decision-making quality and appropriateness compared with the guideline-based protocol.