Simulation training for invasive cardiovascular procedures: the Heart-SIMS-1 randomized trial.

BACKGROUNDS: Interventional cardiology training has a long learning curve, with potential procedural risks to patients and clinicians. We aimed to assess whether mentored simulation-based training with 3D-printed models can improve the skills of beginners in coronary diagnostic procedures in a pilot randomized trial. METHODS: Twenty-nine final-year medical students recruited from a single University were lectured on the fundamentals of invasive coronary angiography (ICA) for one-hour, and then randomized to conventional or simulation training. Conventional training (n = 15) consisted of watching a 20-minute video demonstrating ICA steps performed in a 3D-printed coronary simulator. The simulation training group (n = 14) were offered, in pairs, the same content in a 20-minute hands-on session using a 3D-printed simulator. The co-primary endpoint was efficacy and safety of performing a simulated ICA in the angiography suite. Efficacy and safety were graded using a 13-point procedural checklist (0-100%) and the identification of five procedural “red flags” items, respectively. The secondary endpoint was theoretical knowledge (multiple-choice test). RESULTS: All participants completed the protocol. In both components of the co-primary endpoint, the simulation group scored higher: efficacy score of 91.5 ± 3.8% vs. 64.6 ± 8.3% (mean difference 95% CI [20.8, 30.8]) and safety score 100.0% (100.0-100.0%) vs. 62.5 (20.8–79.2%) (median difference 95% CI [20.8, 79.2]), p < 0.001. The median number of “red flags” were 2 (1–4) in conventional and 0 (0–0) in simulation training (p < 0.001). Also, simulation group obtained a higher score in the theoretical knowledge test: 85.7 ± 9.0% vs. 76.8 ± 12.7%, p = 0.039. CONCLUSION: Mentored simulation-based training using 3D-printed simulators significantly improved theoretical knowledge and basic procedural skills of ICA. These results suggest that simulation-based training should be pursued for improving patient safety and technical proficiency. TRIAL REGISTRATION: NCT06224101.