Berman Daniel S, Kang Xingping, Gransar Heidi, Gerlach James, Friedman John D, Hayes Sean W, Thomson Louise E J, Hachamovitch Rory, Shaw Leslee J, Slomka Piotr J, Yang Ling De, Germano Guido
Department of Imaging (Division of Nuclear Medicine), Cedars-Sinai Heart Institute, 8700 Beverly Boulevard, Room 1258, Los Angeles, CA 90048, USA.
J Nucl Cardiol. 2009 Jan-Feb;16(1):45-53. doi: 10.1007/s12350-008-9018-0. Epub 2009 Jan 20.
Current guidelines of Food and Drug Administration for the evaluation of SPECT myocardial perfusion imaging (MPI) in clinical trials recommend independent visual interpretation by multiple experts. Few studies have addressed whether quantitative SPECT MPI assessment would be more reproducible for this application.
We studied 31 patients (age 68 +/- 13, 25 male) with abnormal stress MPI who underwent repeat exercise (n = 11) or adenosine (n = 20) MPI within 9-22 months (mean 14.9 +/- 3.8 months) and had no interval revascularization or myocardial infarction and no change in symptoms, stress type, rest or stress ECG, or clinical response to stress on the second study. Visual interpretation per FDA Guidance used 17-segment, 5-point scoring by two independent expert readers with overread of discordance by a third expert, and percent myocardium abnormal was derived from normalized summed scores. The quantitative magnitude of perfusion abnormality was assessed by the total perfusion deficit (TPD), expressing stress, rest, and ischemic perfusion abnormality. High linear correlations were observed between visual and quantitative size of stress, rest, and ischemic defects (R = 0.94, 0.92, 0.84). Correlations of two tests were higher by quantitative than by visual methods for stress (R = 0.97 vs R = 0.91, P = 0.03) and rest defects (R = 0.94 vs R = 0.82, P = 0.03), respectively, and statistically similar for ischemic defects (R = 0.84 vs R = 0.70, P = ns).
In stable patients having serial SPECT MPI, quantification is more reproducible than visual for magnitude of perfusion abnormality, suggesting its superiority for use in randomized clinical trials and monitoring the effects of therapy in an individual patient.
美国食品药品监督管理局(FDA)现行的关于在临床试验中评估单光子发射计算机断层扫描(SPECT)心肌灌注成像(MPI)的指南推荐由多位专家进行独立的视觉解读。很少有研究探讨定量SPECT MPI评估在此应用中是否更具可重复性。
我们研究了31例(年龄68±13岁,25例男性)应激MPI异常的患者,这些患者在9至22个月(平均14.9±3.8个月)内接受了重复运动(n = 11)或腺苷(n = 20)MPI检查,且在此期间未进行血管重建或发生心肌梗死,症状、应激类型、静息或应激心电图以及第二次检查时对应激的临床反应均无变化。根据FDA指南进行的视觉解读采用17节段、5分制评分,由两位独立的专家读者进行,第三位专家对不一致情况进行复核,心肌异常百分比由标准化的总分得出。灌注异常的定量程度通过总灌注缺损(TPD)进行评估,包括应激、静息和缺血性灌注异常。在应激、静息和缺血性缺损的视觉和定量大小之间观察到高度线性相关性(R = 0.94、0.92、0.84)。对于应激缺损(R = 0.97 vs R = 0.91,P = 0.03)和静息缺损(R = 0.94 vs R = 0.82,P = 0.03),两种检查的相关性通过定量方法高于视觉方法,对于缺血性缺损在统计学上相似(R = 0.84 vs R = 0.70,P =无显著性差异)。
在进行系列SPECT MPI检查的稳定患者中,对于灌注异常的程度,定量评估比视觉评估更具可重复性,这表明其在随机临床试验和监测个体患者治疗效果方面具有优势。