Background

The increase in cardiovascular disease cases that require minimally invasive treatment is inducing a new need to train physicians to perform them safely and effectively. Nevertheless, adaptation to simulation-based training has been slow, especially for complex procedures.

Objectives

We describe a newly developed mitral valve repair (MVR) simulator, equipped with new objective performance assessment methods, with an emphasis on its use for training the MitraClip™ procedure.

Methods

The MVR contains phantoms of all anatomical structures encountered during mitral valve repair with a transvenous, transseptal approach. In addition, several cameras, line lasers, and ultraviolet lights are used to mimic echocardiographic and fluoroscopic imaging and with a remote eye tracker the cognitive behaviour of the operator is recorded. A pilot study with a total of 9 interventional cardiologists, cardiac surgeons and technical experts was conducted. All participants performed the MitraClip procedure on the MVR simulator using standard interventional tools. Subsequently, each participant completed a structured questionnaire to assess the simulator.

Results

The simulator functioned well, and the implemented objective performance assessment methods worked reliably. Key performance metrics such as x-ray usage were comparable with results from studies assessing these metrics in real interventions. Fluoroscopy imaging is realistic for the transseptal puncture but reaches its limits during the final steps of the procedure.

Conclusion

The functionality and objective performance assessment of the MVR simulator were demonstrated. Especially for complex procedures such as the MitraClip procedure, this simulator offers a suitable platform for risk-free training and education.

中文翻译：

---

配备基于眼动追踪的性能评估能力的经导管二尖瓣修复模拟器：一项试点研究

背景

需要微创治疗的心血管疾病病例的增加引发了对培训医生安全有效地执行治疗的新需求。然而，对基于模拟的培训的适应一直很慢，特别是对于复杂的程序。

目标

我们描述了一种新开发的二尖瓣修复 (MVR) 模拟器，该模拟器配备了新的客观性能评估方法，重点是其用于训练 MitraClip™ 程序。

方法

MVR 包含在二尖瓣修复过程中遇到的所有解剖结构的模型，采用经静脉、经间隔方法。此外，数台摄像机、线激光器和紫外线灯用于模拟超声心动图和荧光透视成像，并通过远程眼动仪记录操作员的认知行为。对总共 9 名介入心脏病专家、心脏外科医生和技术专家进行了一项试点研究。所有参与者使用标准介入工具在 MVR 模拟器上执行 MitraClip 程序。随后，每位参与者完成了一份结构化问卷以评估模拟器。

结果

模拟器运行良好，实施的客观性能评估方法运行可靠。X 射线使用等关键绩效指标与评估这些指标在实际干预中的研究结果具有可比性。透视成像对于经间隔穿刺来说是现实的，但在手术的最后步骤中达到了极限。

结论

演示了 MVR 模拟器的功能和客观性能评估。特别是对于 MitraClip 程序等复杂程序，该模拟器为无风险培训和教育提供了合适的平台。