Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris - A prospective, open-label, multicenter, safety feasibility first-in-man study
Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris - A prospective, open-label, multicenter, safety feasibility first-in-man study
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DOI：
10.1016/j.jacc.2007.01.061
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发表时间：
2007-05-01
影响因子：
24
通讯作者：
Keren, Gad
中科院分区：
文献类型：
--
作者：
Banai, Shmuel;Ben Muvhar, Shmuel;Keren, Gad
目的本研究旨在评价冠状静脉窦减压器(Neovasc Medical，Inc.，或Yehuda，以色列)作为一种潜在的替代疗法治疗顽固性心绞痛的安全性。背景：增加冠状静脉窦(CS)压力可以通过将血液从非缺血区重新分配到缺血区来减少心肌缺血。冠状静脉窦复位器是一种经皮植入装置，旨在建立CS狭窄和升高CS压力。在临床前实验中，植入复位器是安全的，并与改善缺血参数有关。本研究旨在评价冠状静脉窦复位器在不适合血管再通的顽固性心绞痛患者中的安全性和可行性。方法选择15例严重心绞痛和可逆性缺血的冠心病患者应用冠状静脉窦复位器。在植入前和植入后6个月分别进行临床评估、多巴酚丁胺超声心动图、铊单光子发射计算机断层扫描和心绞痛问卷调查。术后2天和6个月分别进行心脏CT检查。在围手术期和随访期内未发生与手术相关的不良事件。14例患者中有12例心绞痛评分改善。加拿大心血管学会的平均评分在基线时为3.07分，在随访时为1.64分(n=14，p<；0.0001)。应激性ST段压低在9例患者中有6例减少，在这6例患者中有2例消除(p=0.047)。多巴酚丁胺超声心动图和铊单光子发射计算机断层扫描显示心肌缺血程度和严重程度均有不同程度的降低(p=0.004[n=13]和p=0.042[n=10])。结论冠状静脉窦复位器植入是安全可行的。这些发现，以及观察到的临床改善，支持进一步评估Reducer作为不适合冠状动脉血运重建的慢性顽固性心绞痛患者的替代治疗。
Objectives This study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures.Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization.Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation.Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p < 0.0001). Stress-induced ST-segment depression was reduced in 6 of 9 patients and was eliminated in 2 of these 6 (p = 0.047). The extent and severity of myocardial ischemia by dobutamine echocardiography and by thallium single-photon emission computed tomography was reduced (p = 0.004 [n = 13] and p = 0.042 [n = 10], respectively).Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.