PMID- 35105522
OWN - NLM
STAT- MEDLINE
DCOM- 20220419
LR  - 20220531
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 28
IP  - 4
DP  - 2022 Apr
TI  - Percutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post 
      Myocardial Infarction: One-Year Evaluation of the Heartech First-in-man Study.
PG  - 604-613
LID - S1071-9164(21)00477-2 [pii]
LID - 10.1016/j.cardfail.2021.10.017 [doi]
AB  - BACKGROUND: This is first-in-man investigation of an implantable Heartech left 
      ventricular partitioning device (LVPD) therapy for chronic heart failure (HF) 
      after a myocardial infarction. METHODS AND RESULTS: Initially, 16 patients were 
      chosen from 3 cardiac centers within China. All patients were treated with 
      percutaneous ventricular restoration involving the Heartech LVPD implantation. 
      Major adverse cardiovascular and cerebrovascular events were documented. 
      Functional status, echocardiograph evaluation, European five-dimensional health 
      scale, 6-minute walk test before the procedure and at postoperative follow-ups 
      were recorded. We demonstrated successful implantation and device function with a 
      success rate of 93.75%. One patient suffered a fatal myocardial infarction within 
      the 12 +/- 1 month follow-up. However, other patients did not report any major 
      adverse cardiovascular and cerebrovascular events at their 12 +/- 1 month 
      follow-ups. After the operation, the average left ventricular end-systolic volume 
      index decreased dramatically (66.00 mL/m(2), interquartile range [IQR] 
      63.00-89.00 mL/m(2) vs 48.00 mL/m(2), IQR 32.25-68.25 mL/m(2), P = .001), along 
      with the left ventricular end-diastolic volume index (105.00 mL/m(2), IQR 
      90.00-130.00 mL/m(2) vs 76.50 mL/m(2), IQR 57.75-120.25 mL/m(2), P = .002). The 
      left ventricular ejection fraction (35.00%, IQR 27.00-38.00% vs 42.50%, IQR 
      34.75-50.25%, P = .003), 6-minute walk test (383.13 +/- 108.70 m vs 491.17 +/- 118.44 
      m, P = .01), and European five-dimensional health scale (65.93 +/- 11.25 vs 82.50 +/- 
      5.44, P < .001), in turn, improved significantly. CONCLUSIONS: In our study, the 
      Heartech LVPD was demonstrated as both safe and effective in reducing LV volume, 
      enhancing LV function after implantation. These results remain constant at least 
      till the 12 month follow-up. (Trial Registration: NCT02938637.).
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Zhu, Zhengbin
AU  - Zhu Z
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China; Cardiovascular Research institution, Shanghai Jiao 
      Tong University School of Medicine. Shanghai, China.
FAU - Zhu, Jinzhou
AU  - Zhu J
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China; Cardiovascular Research institution, Shanghai Jiao 
      Tong University School of Medicine. Shanghai, China.
FAU - Yu, Jiwei
AU  - Yu J
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China.
FAU - Xu, Kai
AU  - Xu K
AD  - Department of Cardiology, The General Hospital of Shenyang Military. Shenyang, 
      China.
FAU - Tang, Yimin
AU  - Tang Y
AD  - Department of Cardiology, Zhejiang Hospital. Hangzhou, China.
FAU - Fang, Yuehua
AU  - Fang Y
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China; Cardiovascular Research institution, Shanghai Jiao 
      Tong University School of Medicine. Shanghai, China.
FAU - Gu, Shengjia
AU  - Gu S
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China.
FAU - Su, Xiuxiu
AU  - Su X
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China.
FAU - Ding, Fenghua
AU  - Ding F
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China; Cardiovascular Research institution, Shanghai Jiao 
      Tong University School of Medicine. Shanghai, China.
FAU - Ali, Walid Ben
AU  - Ali WB
AD  - Structural valve program, Montreal Heart Institute, Quebec, Canada.
FAU - Modine, Thomas
AU  - Modine T
AD  - Visiting Professor Program, Shanghai Jiao Tong University School of Medicine. 
      Shanghai, China; Institut Coeur Poumon, CHRU de Lille. Lille, France.
FAU - Zhang, Ruiyan
AU  - Zhang R
AD  - Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School 
      of Medicine. Shanghai, China; Cardiovascular Research institution, Shanghai Jiao 
      Tong University School of Medicine. Shanghai, China. Electronic address: 
      drzhangruiyan@sina.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02938637
PT  - Clinical Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220131
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
SB  - IM
CIN - J Card Fail. 2022 Apr;28(4):614-616. PMID: 35038596
MH  - *Heart Failure
MH  - Humans
MH  - *Myocardial Infarction/diagnosis/surgery
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - Ventricular Function, Left
MH  - Ventricular Remodeling
OTO - NOTNLM
OT  - Heart failure
OT  - acute myocardial infarction
OT  - left ventricular partitioning device
OT  - percutaneous ventricular restoration
EDAT- 2022/02/03 06:00
MHDA- 2022/04/20 06:00
CRDT- 2022/02/02 05:31
PHST- 2021/05/23 00:00 [received]
PHST- 2021/10/27 00:00 [revised]
PHST- 2021/10/27 00:00 [accepted]
PHST- 2022/02/03 06:00 [pubmed]
PHST- 2022/04/20 06:00 [medline]
PHST- 2022/02/02 05:31 [entrez]
AID - S1071-9164(21)00477-2 [pii]
AID - 10.1016/j.cardfail.2021.10.017 [doi]
PST - ppublish
SO  - J Card Fail. 2022 Apr;28(4):604-613. doi: 10.1016/j.cardfail.2021.10.017. Epub 
      2022 Jan 31.