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.

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

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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.

Author: Yue-Jin YANG ¹ ; Yong HUO ² ; Ya-Wei XU ³ ; Jian-An WANG ⁴ ; Ya-Ling HAN ⁵ ; Jun-Bo GE ⁶ ; Rui-Yan ZHANG ⁷ ; Xiao-Yan YAN ⁸ ; Run-Lin GAO ¹
Author Information

1. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing 100037, China.
2. Department of Cardiology, Peking University First Hospital, Beijing 100034, China.
3. Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University, Shanghai 200072, China.
4. Department of Cardiology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang 310009, China.
5. Department of Cardiology, The General Hospital of Shenyang Military Region, Shenyang, Liaoning 110000, China.
6. Department of Cardiology, Fudan University, Zhongshan Hospital, Shanghai 200032, China.
7. Department of Cardiology, School of Medicine, Shanghai Jiaotong University, Ruijin Hospital, Shanghai 200025, China.
8. Department of Biostatistics, Peking University Clinical Research Institute, Beijing 100191, China.
Publication Type:Journal Article
MeSH: Aged; China; Female; Heart Failure; physiopathology; surgery; Heart Ventricles; physiopathology; surgery; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Implantation; adverse effects; methods; Stroke Volume; physiology; Treatment Outcome; Ventricular Remodeling; physiology
From: Chinese Medical Journal 2016;129(17):2058-2062
CountryChina
Language:English
Abstract:
BACKGROUNDThe 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, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI.
METHODSThirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction 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 for 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-5D 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 for the ranked data comparison.
RESULTSA 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/m2 to 53.1 ± 17.0 ml/m2 (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 half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months.
CONCLUSIONThe favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients.
TRIAL REGISTRATIONClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.