Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure： Three-Month Primary End-point Results of PARACHUTE China Study

作     者：Yue-Jin Yang Yong Huo Ya-Wei Xu Jian-An Wang Ya-Ling Han Jun-Bo Ge Rui-Yan Zhang Xiao-Yan Yan Run-Lin Gao Yang Yue-Jin;Huo Yong;Xu Ya-Wei;Wang Jian-An;Han Ya-Ling;Ge Jun-Bo;Zhang Rui-Yan;Yan Xiao-Yan;Gao Run-Lin

作者机构：Department of Cardiology Fu Wai Hospital National Center for Cardiovascular Diseases Chinese Academy of Medical Sciences Belling 100037 China Department of Cardiology Peking University First Hospital Beijing 100034 China Department of Cardiology Shanghai Tenth People's Hospital Tongji University Shanghai 200072 China Department of Cardiology The Second Affiliated Hospital of Zhejiang University Hangzhou Zhejiang 310009 China Department of Cardiology The General Hospital of Shenyang Military Region Shenyang Liaoning 110000 China Department of Cardiology Fudan University Zhongshan Hospital Shanghai 200032 China Department of Cardiology School of Medicine Shanghai Jiaotong University Ruijin Hospital Shanghai 200025 China Department of Biostatistics Peking University Clinical Research Institute Beijing 100191 China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2016年第129卷第17期

页      面：2058-2062页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：funded by the CardioKinetix, Inc., USA Zhuhai Haite Medical Equipment Co. Ltd., China 

主　　题：lschemic Heart Failure Left Ventricle Remodeling Percutaneous Ventricular Restoration Structural Heart 

摘      要：Background： The primary cause of ischemic heart failure （HF） is myocardial infarction （MI） resulting in left ventricle （LV） wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device （CardioKinetix, lnc., CA, USA） in ischemic HF patients as a result of LV remodeling after anterior wall M1. Methods： Thirty-one patients with New York Heart Association （NYHA） Class I1, I11 ischemic HF, ejection traction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin tbr at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index （LVESVI） against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-SD and visual analog scale （VAS）. For quantitative data comparison, paired t-test （normality data） and signed-rank test （abnormality data） were used： application of signed-rank test was tbr the ranked data comparison. Results： A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ~ 20.0 ml/m-＇ to 53,1 ~ 17.0 ml/m-＂ （P 〈 0.0001 ）, The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than halfa class at 3 months （P 〈 0.001 ）. Quality of life assessed by the VAS value increased 11.5 points （P 〈 0.01 ）, demonstrating im