One-Year Follow-Up of Feasibility and Safety of the First US, Randomized, Controlled Study Using 3-Dimensional Guided Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ischemic Cardiomyopathy (CAuSMIC Study)
One-Year Follow-Up of Feasibility and Safety of the First US, Randomized, Controlled Study Using 3-Dimensional Guided Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ischemic Cardiomyopathy (CAuSMIC Study)
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DOI：
10.1016/j.jcin.2008.11.003
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发表时间：
2009-01-01
影响因子：
11.3
通讯作者：
Diethrich, Edward
中科院分区：
文献类型：
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作者：
Dib, Nabil;Dinsmore, Jonathan;Diethrich, Edward
目的本研究的目的是测试使用Biosense-NOGA（钻石吧，加州）三维引导的肌内膜输送系统进行成肌细胞移植的安全性和可行性。背景先前的I期试验显示了心外膜注射成肌细胞的可行性。然而，基于导管的交付有几个优点：它可以应用于高风险的患者，该程序可以重复，它是与发病率和mortals.Methods 23个主题，与以前的心肌梗死和心力衰竭，纽约心脏协会（NYHA）功能分级II至IV级，被招募，11个对照组和12个治疗组。为了评估安全性，体格检查，心电图，连续心律监测，生活质量评估和心功能进行了评价，在基线和随访，直到1 year.Results有良好的安全性：组间心律失常没有差异，没有死亡。与对照组受试者相比，治疗组受试者的NYHA和明尼苏达心力衰竭生活问卷（MLHFQ）显示出持续改善（NYHA，治疗组为-1.0分，对照组为+0.3分，p < 0.0004; MLHFQ，治疗组为-14分，对照组为+1分，p = 0.004）。设盲核心实验室超声心动图评价显示，治疗组与对照组相比，舒张末期直径（-0.03 cm vs. +0.05 cm，p = 0.07）和收缩末期直径（-0.05 cm vs. +0.1 cm，p = 0.07）持续降低。最后，NOGA电压映射证明了改进的电压测量（+1.0。结论经导管移植成肌细胞治疗心力衰竭是安全可行的。接受治疗的患者显示NYHA、MLHFQ、心室活力改善，并有逆转心室重构的证据。这些数据证明了积极的安全性结局，并保证启动更大规模的II期、双盲、安慰剂对照临床试验。（美国科尔心脏病学杂志2009;2：9-16）（C）2009年美国心脏病学会基金会
Objectives The aim of this study was to test safety and feasibility of myoblast transplantation with the Biosense-NOGA (Diamond Bar, California) 3-dimensional-guided endomyocardial delivery system.Background Previous Phase-1 trials showed feasibility of epicardial injection of myoblasts. However, catheter-based delivery has several advantages: it can be applied on high-risk patients, the procedure can be repeated, and it is associated with less morbidity and mortality.Methods Twenty-three subjects, with previous myocardial infarction and heart failure, New York Heart Association (NYHA) functional class II to IV, were enrolled, 11 control and 12 treatment subjects. To assess safety, physical exam, electrocardiogram, continuous rhythm monitoring, quality of life assessments, and heart function were evaluated at baseline and follow-up until 1 year.Results There was favorable safety: no difference between groups in arrhythmias, and no deaths. Treated subjects showed sustained improvements in NYHA and Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared with control subjects (NYHA, -1.0 point in treatment vs. +0.3 point in control group, p < 0.0004; MLHFQ, -14 point in treatment vs. +1 point in the control group, p = 0.004). Blinded core laboratory echocardiography evaluations showed sustained reductions in the treatment versus control in end diastolic diameter (-0.03 cm vs. +0.05 cm, p = 0.07) and end systolic diameter (-0.05 cm vs. +0.1 cm, p = 0.07). Finally, NOGA voltage mapping demonstrated improved voltage measurements (+1.0. mV, p = 0.008).Conclusions This trial of myoblast transplantation via catheter into heart failure patients demonstrated safety and feasibility. Treated patients showed improvement in NYHA, MLHFQ, ventricular viability, and evidence of reverse ventricular remodeling. These data demonstrate positive safety outcomes and warrant initiation of larger phase 2, double-blind, placebo-controlled clinical trials. (J Am Coll Cardiol Intv 2009;2:9-16) (C) 2009 by the American College of Cardiology Foundation