Literature DB >> 21982659

Is the measurement of left ventricular ejection fraction the proper end point for cell therapy trials? An analysis of the effect of bone marrow mononuclear stem cell administration on left ventricular ejection fraction after ST-segment elevation myocardial infarction when evaluated by cardiac magnetic resonance imaging.

Jay H Traverse1, Timothy D Henry, Lemuel A Moye'.   

Abstract

BACKGROUND: The measurement of left ventricular (LV) ejection fraction (LVEF) is a strong predictor of cardiovascular adverse events and mortality in patients with LV dysfunction and has become the most common primary end point in cardiovascular cell therapy trials after ST-segment elevation myocardial infarction (STEMI). Multiple small trials have been performed using bone marrow mononuclear stem cells (BMCs) in this setting with several meta-analyses demonstrating that BMC administration results in a small improvement in LVEF and may attenuate adverse LV remodeling. However, individual trial results have not been uniform, and the measurement of LVEF in these trials has relied on a variety of imaging techniques including LV angiograpnhy, single-photon emission computed tomography, echocardiography, or cardiac magnetic resonance imaging (cMRI).
METHODS: Because cMRI provides the most accurate measurement of LVEF, LV volumes, and infarct size in patients after STEMI, we reviewed all randomized cardiovascular stem cell trials (N = 10) that administered intracoronary BMCs versus placebo/control to 686 patients after primary percutaneous coronary intervention treatment of STEMI that used cMRI as their principal imaging measurement of LVEF at baseline and 3 to 6 months later.
RESULTS: Administration of BMCs was associated with a nonsignificant 0.9% ± 0.8% absolute increase in LVEF compared with placebo or control (95% CI -0.7 to 2.4) with a small but nonsignificant decrease LV end-diastolic and LV end-systolic volumes (LV end-diastolic volume -1.1 ± 1.5 mL/m(2), LV end-systolic volume -1.6 ± 1.4 mL/m(2)). Although infarct size uniformly decreased over time, the reduction was not improved by BMC administration (-0.3 ± 1.7 g).
CONCLUSIONS: The benefit of BMC administration after STEMI on LVEF, LV volumes, and infarct size is small when assessed by cMRI.
Copyright © 2011 Mosby, Inc. All rights reserved.

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Year:  2011        PMID: 21982659     DOI: 10.1016/j.ahj.2011.06.019

Source DB:  PubMed          Journal:  Am Heart J        ISSN: 0002-8703            Impact factor:   4.749


  14 in total

Review 1.  Using biomaterials to improve the efficacy of cell therapy following acute myocardial infarction.

Authors:  Jay H Traverse
Journal:  J Cardiovasc Transl Res       Date:  2011-11-17       Impact factor: 4.132

2.  Human erythropoietin gene delivery for cardiac remodeling of myocardial infarction in rats.

Authors:  Youngsook Lee; Arlo N McGinn; Curtis D Olsen; Kihoon Nam; Minhyung Lee; Sug Kyun Shin; Sung Wan Kim
Journal:  J Control Release       Date:  2013-06-25       Impact factor: 9.776

Review 3.  An update on stem cell therapies for acute coronary syndrome.

Authors:  Peter J Psaltis; Daniel B Spoon; Dennis T L Wong; Rajiv Gulati
Journal:  Curr Cardiol Rep       Date:  2014-09       Impact factor: 2.931

4.  TIME Trial: Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis.

Authors:  Jay H Traverse; Timothy D Henry; Carl J Pepine; James T Willerson; Atul Chugh; Phillip C Yang; David X M Zhao; Stephen G Ellis; John R Forder; Emerson C Perin; Marc S Penn; Antonis K Hatzopoulos; Jeffrey C Chambers; Kenneth W Baran; Ganesh Raveendran; Adrian P Gee; Doris A Taylor; Lem Moyé; Ray F Ebert; Robert D Simari
Journal:  Circ Res       Date:  2017-12-05       Impact factor: 17.367

Review 5.  The dynamics of the coronary collateral circulation.

Authors:  Marco Zimarino; Mariangela D'Andreamatteo; Ron Waksman; Stephen E Epstein; Raffaele De Caterina
Journal:  Nat Rev Cardiol       Date:  2014-01-07       Impact factor: 32.419

6.  Human Mesenchymal Stem Cell Delivery System Modulates Ischemic Cardiac Remodeling With an Increase of Coronary Artery Blood Flow.

Authors:  Young Sook Lee; Wan Seok Joo; Hyun Soo Kim; Sung Wan Kim
Journal:  Mol Ther       Date:  2016-01-19       Impact factor: 11.454

7.  Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial.

Authors:  Jay H Traverse; Timothy D Henry; Stephen G Ellis; Carl J Pepine; James T Willerson; David X M Zhao; John R Forder; Barry J Byrne; Antonis K Hatzopoulos; Marc S Penn; Emerson C Perin; Kenneth W Baran; Jeffrey Chambers; Charles Lambert; Ganesh Raveendran; Daniel I Simon; Douglas E Vaughan; Lara M Simpson; Adrian P Gee; Doris A Taylor; Christopher R Cogle; James D Thomas; Guilherme V Silva; Beth C Jorgenson; Rachel E Olson; Sherry Bowman; Judy Francescon; Carrie Geither; Eileen Handberg; Deirdre X Smith; Sarah Baraniuk; Linda B Piller; Catalin Loghin; David Aguilar; Sara Richman; Claudia Zierold; Judy Bettencourt; Shelly L Sayre; Rachel W Vojvodic; Sonia I Skarlatos; David J Gordon; Ray F Ebert; Minjung Kwak; Lemuel A Moyé; Robert D Simari
Journal:  JAMA       Date:  2011-11-14       Impact factor: 56.272

8.  Consistently Inconsistent-Bone Marrow Mononuclear Stem Cell Therapy Following Acute Myocardial Infarction: A Decade Later.

Authors:  Timothy D Henry; Lem Moyé; Jay H Traverse
Journal:  Circ Res       Date:  2016-07-22       Impact factor: 17.367

9.  Intramyocardial implantation of autologous bone marrow-derived stem cells combined with coronary artery bypass grafting in patients with ischemic cardiomyopathy: a pilot study.

Authors:  P Antonitsis; K Anastasiadis; G Koliakos; C Vaitsopoulou; K Kouzi-Koliakou; A Doumas; H Argiriadou; P Tossios
Journal:  Hippokratia       Date:  2012-10       Impact factor: 0.471

Review 10.  Clinical Studies of Cell Therapy in Cardiovascular Medicine: Recent Developments and Future Directions.

Authors:  Monisha N Banerjee; Roberto Bolli; Joshua M Hare
Journal:  Circ Res       Date:  2018-07-06       Impact factor: 17.367

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