Abstract Body (Do not enter title and authors here):
Background: To support the surgical decision-making for complex congenital heart disease (CHD), a novel computer-based cardiac simulator called "ped UT-Heart" has been developed, in which a patient-specific finite element model simulates cardiac functions and predicts hemodynamics of different virtual surgeries.
Objective: To validate the accuracy, usefulness, and safety of the “ped UT-Heart“ simulation system.
Methods: First, retrospective validation studies of pre- and post-operative simulation (n=10) were performed by comparing virtual simulation data with real patient catheter data. Subsequently, a single-arm, prospective, multicenter clinical study (jRCTs052210139) was conducted in 16 patients with complex CHD (Table 1). The primary endpoint was defined as an overall rating of essential or very useful on a 5-point Likert scale.
Results: Pre- and post-operative simulation data correlated well with patient catheter data (Figure 1). In the clinical trial, four patients were excluded due to delayed surgery, and the remaining 12 patients (median age, 2y8m) were assessed for usefulness. There were no adverse events associated with the simulation system. Nine of the twelve patients (>60%) were rated as “Essential” or “Very useful“, and the lower limit of the 95% CI was 42.8% (>30%), indicating that the results met the primary endpoint. As a representative case (ccTGA, 5y), the surgeon selected a double switch operation with VSD augmentation according to the post-operative simulation (Figure 2). The patient did well after the surgery with no significant hemodynamic problems.
Conclusions: The "ped UT-Heart" is a safe, reliable, and useful cardiac simulator for supporting decisions of surgical procedures in complex CHD.