Cardiothoracic Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, Netherlands.
Global Clinical Operations, Coronary and Structural Heart, Medtronic, Endepolsdomein 5, 6229 GW, Maastricht, Netherlands.
Eur Heart J Cardiovasc Imaging. 2020 Oct 1;21(10):1116-1122. doi: 10.1093/ehjci/jeaa044.
Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM.
In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi ≤0.85 cm2/m2, and severe PPM was defined as EOAi ≤0.65 cm2/m2. The reference values obtained from the training set ranged from 1.27 cm2 for size 19 mm up to 1.81 cm2 for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%.
The use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications.
指数有效瓣口面积（EOAi）图用于确定主动脉瓣置换（AVR）后人工瓣膜-患者不匹配（PPM）的可能性。本研究旨在验证基于超声心动图正常参考值的这些 EOAi 图是否可以准确预测 PPM。
在 PERIcardial SurGical AOrtic Valve ReplacemeNt（PERIGON）关键性试验中，986 例主动脉瓣狭窄/反流患者接受了 Avalus 瓣膜的 AVR。患者随机分为训练组和测试组（50:50）。从训练组中每个瓣膜尺寸的平均测量 EOAs 用于创建 Avalus EOAi 图。随后，该图表用于预测测试集中的 PPM，并评估诊断准确性的度量（敏感性、特异性、阴性和阳性预测值）。EOAi≤0.85cm2/m2 定义为 PPM，EOAi≤0.65cm2/m2 定义为严重 PPM。从训练组获得的参考值范围从 19mm 尺寸的 1.27cm2 到 27mm 尺寸的 1.81cm2。测试组 PPM 的发生率为 66%，严重 PPM 的发生率为 24%。EOAi 图不准确地预测了 30%的患者发生 PPM 和 22%的患者发生严重 PPM。对于 PPM 的预测，敏感性为 87%，特异性为 37%。对于严重 PPM 的预测，敏感性为 13%，特异性为 98%。
由于分类错误的比例较大，使用超声心动图正常参考值的 EOAi 图来预测 PPM 是不可靠的。
