Minimizing radiographic contrast administration during coronary angiography using a novel contrast reduction system: A multicenter observational study of the DyeVert™ plus contrast reduction system
Minimizing radiographic contrast administration during coronary angiography using a novel contrast reduction system: A multicenter observational study of the DyeVert™ plus contrast reduction system
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DOI：
10.1002/ccd.27935
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发表时间：
2019-06-01
影响因子：
2.3
通讯作者：
Kumar, Gautam
中科院分区：
文献类型：
--
作者：
Gurm, Hitinder S.;Mavromatis, Kreton;Kumar, Gautam
目的评价DyeVert（TM）Plus造影剂减少系统（DyeVert Plus System，Osprey Medical）在诊断性冠状动脉造影（CAG）和/或经皮冠状动脉介入（PCI）手术中手动注射节省的造影剂（CM）体积（CMV）。背景目前的指南提倡监测和最小化接受侵入性心脏手术的慢性肾脏病（CKD）患者的CM总量。DyeVert Plus系统是一种FDA批准的器械，旨在减少血管造影期间输送的CMV，并允许实时CMV监测。方法采用多中心、单组、观察性研究。符合条件的受试者年龄≥ 18岁，基线估计肾小球滤过率（eGFR）为20-60 mL/min/1.73 m（2）。主要终点为整个手术中CMV保存率%。次要目的是评价与DyeVert Plus系统或CM使用相关的不良事件（AE）。结果8个中心共入组114例受试者。平均年龄为72 +/- 9岁，72%为男性，平均体重指数为29 +/- 5。基线eGFR为43 ± 11 mL/min/1.73 m（2）。65%的病例仅进行了CAG。105例受试者可评价主要终点。尝试的平均CMV为112 +/- 85 mL（范围22-681），输送的平均CMV为67 +/- 51 mL（范围12-403），导致每次手术的总体CMV节省40.1 +/- 8.8%（95% CI 38.4，41.8; P < 0.0001）。除了一个关闭系统进行一次注射的情况外，所有情况下的图像质量都得到了保持。未报告DyeVert Plus系统相关AE。急性肾损伤（阿基;定义为血清肌酐从基线升高>0.3 mg/dL），其中7例发生在基线eGFR < 30的受试者中，3例阿基事件归因于CM。阿基发生率随CMV/eGFR比值升高而升高。结论这些数据表明，在接受CAG和/或PCI的CKD患者中使用DyeVert Plus系统可在保持图像质量的同时实现具有临床意义的CMV节省。
Objective To evaluate contrast media (CM) volume (CMV) saved using the DyeVert (TM) Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections. Background Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring. Methods We performed a multicenter, single-arm, observational study. Eligible subjects were >= 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m(2). The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use. Results A total of 114 subjects were enrolled at eight centers. Mean age was 72 +/- 9 years, 72% were male, and mean body mass index was 29 +/- 5. Baseline eGFR was 43 +/- 11 mL/min/1.73 m(2). CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 +/- 85 mL (range 22-681) and mean CMV delivered was 67 +/- 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 +/- 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased. Conclusions These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.