Prospective Human Validation of Artificial Intelligence Interventions in Cardiology: A Scoping Review.

Background: Despite the potential of artificial intelligence (AI) in enhancing cardiovascular care, its integration into clinical practice is limited by a lack of evidence on its effectiveness with respect to human experts or gold standard practices in real-world settings. Objectives: The purpose of this study was to identify AI interventions in cardiology that have been prospectively validated against human expert benchmarks or gold standard practices, assessing their effectiveness, and identifying future research areas. Methods: We systematically reviewed Scopus and MEDLINE to identify peer-reviewed publications that involved prospective human validation of AI-based interventions in cardiology from January 2015 to December 2023. Results: Of 2,351 initial records, 64 studies were included. Among these studies, 59 (92.2%) were published after 2020. A total of 11 (17.2%) randomized controlled trials were published. AI interventions in 44 articles (68.75%) reported definite clinical or operational improvements over human experts. These interventions were mostly used in imaging (n = 14, 21.9%), ejection fraction (n = 10, 15.6%), arrhythmia (n = 9, 14.1%), and coronary artery disease (n = 12, 18.8%) application areas. Convolutional neural networks were the most common predictive model (n = 44, 69%), and images were the most used data type (n = 38, 54.3%). Only 22 (34.4%) studies made their models or data accessible. Conclusions: This review identifies the potential of AI in cardiology, with models often performing equally well as human counterparts for specific and clearly scoped tasks suitable for such models. Nonetheless, the limited number of randomized controlled trials emphasizes the need for continued validation, especially in real-world settings that closely examine joint human AI decision-making.