First-in-man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction.
Aged
Cardiac Catheterization
/ adverse effects
China
Chronic Disease
Exercise Tolerance
Female
Heart Failure
/ diagnostic imaging
Humans
Male
Middle Aged
Myocardial Infarction
/ complications
Prospective Studies
Recovery of Function
Stroke Volume
Time Factors
Treatment Outcome
Ventricular Function, Left
acute myocardial infarction
heart failure
left ventricular partitioning device
percutaneous ventricular restoration
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
15 Nov 2019
15 Nov 2019
Historique:
received:
11
01
2019
revised:
26
04
2019
accepted:
28
05
2019
pubmed:
25
6
2019
medline:
26
8
2020
entrez:
25
6
2019
Statut:
ppublish
Résumé
This first-in-man (FIM) study aimed to determine the safety and efficacy of the Heartech® left ventricular partitioning device (LVPD) in patients with chronic heart failure (HF) postmyocardial infarction. Sixteen patients were enrolled from three cardiac intervention centers in China. All patients underwent percutaneous ventricular restoration (PVR) procedures with implantation of the Heartech® LVPD. Safety and immediate success rates were recorded. Major adverse cardiovascular and cerebrovascular events (MACCEs) including all-cause mortality, myocardial infarction, stroke, emergent or selective surgery or interventional therapy, renal failure requiring hemodialysis, and major bleeding were recorded. Efficacy features included functional status, echocardiographic characteristics, life quality characteristics including peak oxygen consumption of cardiopulmonary exercise testing (CPET), European five-dimensional health scale (EQ-5D), 6-min walk test (6MWT) at baseline and during follow-up (NCT02938637). The device success rate was 93.75% (15 successes in 16 patients) with 100% safety. During follow-up of 36 ± 4.5 days, no MACCEs were found. The left ventricular end-systolic volume index decreased significantly (LVESVi, 72.47 ± 22.77 mL/m Heartech® LVPD appeared to be safe and effective for treatment of HF postmyocardial infarction.
Banques de données
ClinicalTrials.gov
['NCT02938637']
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
845-853Subventions
Organisme : Science and Technology Commission of Shanghai Municipality
ID : 15DZ1942002
Organisme : Shanghai Municipal Commission of Health and Family Planning
ID : 20154Y0108
Organisme : Shanghai Shen Kang Hospital Development Center
ID : 16CR3080B
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 Wiley Periodicals, Inc.
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