PMID- 27569231
OWN - NLM
STAT- MEDLINE
DCOM- 20170313
LR  - 20181113
IS  - 2542-5641 (Electronic)
IS  - 0366-6999 (Print)
IS  - 0366-6999 (Linking)
VI  - 129
IP  - 17
DP  - 2016 Sep 5
TI  - 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.
PG  - 2058-62
LID - 10.4103/0366-6999.189048 [doi]
AB  - 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, Inc., CA, 
      USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. 
      METHODS: Thirty-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. 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/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. CONCLUSION: The 
      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 REGISTRATION: ClinicalTrials.gov, NCT02240940; 
      https://clinicaltrials.gov/ct2/show/NCT02240940.
FAU - Yang, Yue-Jin
AU  - Yang YJ
AD  - Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular 
      Diseases, Chinese Academy of Medical Sciences, Beijing 100037, China.
FAU - Huo, Yong
AU  - Huo Y
AD  - Department of Cardiology, Peking University First Hospital, Beijing 100034, 
      China.
FAU - Xu, Ya-Wei
AU  - Xu YW
AD  - Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University, 
      Shanghai 200072, China.
FAU - Wang, Jian-An
AU  - Wang JA
AD  - Department of Cardiology, The Second Affiliated Hospital of Zhejiang University, 
      Hangzhou, Zhejiang 310009, China.
FAU - Han, Ya-Ling
AU  - Han YL
AD  - Department of Cardiology, The General Hospital of Shenyang Military Region, 
      Shenyang, Liaoning 110000, China.
FAU - Ge, Jun-Bo
AU  - Ge JB
AD  - Department of Cardiology, Fudan University, Zhongshan Hospital, Shanghai 200032, 
      China.
FAU - Zhang, Rui-Yan
AU  - Zhang RY
AD  - Department of Cardiology, School of Medicine, Shanghai Jiaotong University, 
      Ruijin Hospital, Shanghai 200025, China.
FAU - Yan, Xiao-Yan
AU  - Yan XY
AD  - Department of Biostatistics, Peking University Clinical Research Institute, 
      Beijing 100191, China.
FAU - Gao, Run-Lin
AU  - Gao RL
AD  - Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular 
      Diseases, Chinese Academy of Medical Sciences, Beijing 100037, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02240940
PT  - Journal Article
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
SB  - IM
MH  - Aged
MH  - China
MH  - Female
MH  - Heart Failure/physiopathology/*surgery
MH  - Heart Ventricles/physiopathology/*surgery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Prosthesis Implantation/adverse effects/methods
MH  - Stroke Volume/physiology
MH  - Treatment Outcome
MH  - Ventricular Remodeling/physiology
PMC - PMC5009588
EDAT- 2016/08/30 06:00
MHDA- 2017/03/14 06:00
PMCR- 2016/09/05
CRDT- 2016/08/30 06:00
PHST- 2016/08/30 06:00 [entrez]
PHST- 2016/08/30 06:00 [pubmed]
PHST- 2017/03/14 06:00 [medline]
PHST- 2016/09/05 00:00 [pmc-release]
AID - ChinMedJ_2016_129_17_2058_189048 [pii]
AID - CMJ-129-2058 [pii]
AID - 10.4103/0366-6999.189048 [doi]
PST - ppublish
SO  - Chin Med J (Engl). 2016 Sep 5;129(17):2058-62. doi: 10.4103/0366-6999.189048.