背景:半自动软件对于经导管主动脉瓣置换术(TAVR)前的计划和假体选择至关重要。缺少有关用于规划TAVR的软件程序的可用性的可靠数据。这项研究的目的是比较软件程序“瓣膜辅助2”(GEHealthcare)和3mensio“结构性心脏”(PieMedicalImaging)在程序经验不足的用户中假体尺寸选择的可用性和准确性。
方法:招募了31名参与者(n=31),并分为无项目经验的用户(初学者)(n=22)和专家(n=9)。经过软件培训,初学者在2个测试日(T1,T2)使用瓣膜辅助2(n=11)或结构性心脏(n=11)在129个测量中评估了3例患者(n=129)。测试后使用系统可用性量表(SUS)和ISONORM9241/110-S(ISONORM)问卷。将每个初学者选择的瓣膜尺寸与从专家组选择的瓣膜尺寸进行比较。
结果:瓣膜辅助2具有更高的SUS评分:中位数78.75(第25位,第75百分位数:67.50,85.00)与结构性心脏:中位数65.00(第25位,第75百分位数:47.50,73.75),(p<0,001,r=0.557)。此外,瓣膜辅助2显示出较高的ISONORM评分:中位数1.05(第25位,第75百分位数:-0.19,1.71)与结构心脏相比,中位数为0.05(第25位,第75百分位数:-0.49,0.13),(p=0.036,r=0.454)。使用瓣膜辅助装置2,正确选择的瓣膜尺寸随时间稳定:72.73%至69.70%,而结构心脏程序:93.94%至40%(χ2(1)=21.10,p<0.001,φ=0.579)。
结论:该研究显示,在没有项目经验的用户中,与3mensioStructuralHeart相比,瓣膜辅助2的可用性得分明显更好。
BACKGROUND: Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of software programs for planning a TAVR is missing. The aim of this study was to compare software programs \'Valve Assist 2\' (GE Healthcare) and 3mensio \'Structural Heart\' (Pie Medical Imaging) regarding usability and accuracy of prosthesis size selection in program-inexperienced users.
METHODS: Thirty-one participants (n = 31) were recruited and divided into program-inexperienced users (beginners) (n = 22) and experts (n = 9). After software training, beginners evaluated 3 patient cases in 129 measurements (n = 129) using either Valve Assist 2 (n = 11) or Structural Heart (n = 11) on 2 test days (T1, T2). System Usability Scale (SUS) and ISONORM 9241/110-S (ISONORM) questionnaire were used after the test. The valve size selected by each beginner was compared with the valve size selected from expert group.
RESULTS: Valve Assist 2 had higher SUS Score: median 78.75 (25th, 75th percentile: 67.50, 85.00) compared to Structural Heart: median 65.00 (25th, 75th percentile: 47.50, 73.75), (p < 0,001, r = 0.557). Also, Valve Assist 2 showed a higher ISONORM score: median 1.05 (25th, 75th percentile: - 0.19, 1.71) compared to Structural Heart with a median 0.05 (25th, 75th percentile: - 0.49, 0.13), (p = 0.036, r = 0.454). Correctly selected valve sizes were stable over time using Valve Assist 2: 72.73% to 69.70% compared to Structural Heart program: 93.94% to 40% (χ2 (1) = 21.10, p < 0.001, φ = 0.579).
CONCLUSIONS: The study shows significant better usability scores for Valve Assist 2 compared to 3mensio Structural Heart in program-inexperienced users.