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Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI.

Publication ,  Journal Article
Povsic, TJ; Losordo, DW; Story, K; Junge, CE; Schatz, RA; Harrington, RA; Henry, TD
Published in: Am Heart J
November 2012

BACKGROUND: Cell therapy is a promising therapeutic for a variety of cardiovascular conditions including refractory angina. Elevation of cardiac biomarkers during cell delivery has been frequently described, but the clinical implications have never been studied. METHODS: ACT34-CMI was a randomized double-blind study assessing the use of intramyocardial delivery of autologous CD34(+) cells for the treatment of refractory angina. Patients (n = 167) underwent G-CSF-mediated (5 μg/[kg day] × 5 days) stem cell mobilization, apheresis, and intramyocardial injection of 1 × 10(5)/kg or 5 × 10(5)/kg CD34(+) cells or placebo. Troponin and creatinine kinase MB were assessed at baseline (n = 161), after cell mobilization and apheresis (n = 153 and 143, respectively), and post-intramyocardial injection (n = 155 and 141, respectively). Major adverse cardiac events (MACE) included death, myocardial infarction, acute congestive heart failure, urgent revascularization, or sustained ventricular arrhythmia. RESULTS: Seven (4.3%) subjects had troponin above the upper limits of normal (ULN) at baseline. Thirty-four (22.2%) and 11 (7.2%) subjects had troponin levels > ULN or >3× ULN after cell mobilization and apheresis, whereas 72 (46.1%) and 39 (25.2%) subjects had troponin elevations > ULN or >3× ULN, respectively, after intramyocardial injections. Age, but no other preprocedural factors, was predictive of troponin elevation. Periprocedural troponin elevation was not associated with an increased risk of MACE during 1 year, especially in cell therapy-treated patients. CONCLUSIONS: Troponin elevation is common during stem cell harvesting and intramyocardial administration, is usually asymptomatic, and does not appear to be associated with long-term MACE in subjects undergoing stem cell mobilization and intramyocardial injection.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

November 2012

Volume

164

Issue

5

Start / End Page

689 / 697.e3

Location

United States

Related Subject Headings

  • Troponin I
  • Transplantation, Autologous
  • T-Lymphocytes
  • Stem Cell Transplantation
  • Randomized Controlled Trials as Topic
  • Myocardium
  • Middle Aged
  • Male
  • Logistic Models
  • Incidence
 

Citation

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Chicago
ICMJE
MLA
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Povsic, T. J., Losordo, D. W., Story, K., Junge, C. E., Schatz, R. A., Harrington, R. A., & Henry, T. D. (2012). Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI. Am Heart J, 164(5), 689-697.e3. https://doi.org/10.1016/j.ahj.2012.06.022
Povsic, Thomas J., Douglas W. Losordo, Kenneth Story, Candice E. Junge, Richard A. Schatz, Robert A. Harrington, and Timothy D. Henry. “Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI.Am Heart J 164, no. 5 (November 2012): 689-697.e3. https://doi.org/10.1016/j.ahj.2012.06.022.
Povsic TJ, Losordo DW, Story K, Junge CE, Schatz RA, Harrington RA, et al. Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI. Am Heart J. 2012 Nov;164(5):689-697.e3.
Povsic, Thomas J., et al. “Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI.Am Heart J, vol. 164, no. 5, Nov. 2012, pp. 689-697.e3. Pubmed, doi:10.1016/j.ahj.2012.06.022.
Povsic TJ, Losordo DW, Story K, Junge CE, Schatz RA, Harrington RA, Henry TD. Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI. Am Heart J. 2012 Nov;164(5):689-697.e3.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

November 2012

Volume

164

Issue

5

Start / End Page

689 / 697.e3

Location

United States

Related Subject Headings

  • Troponin I
  • Transplantation, Autologous
  • T-Lymphocytes
  • Stem Cell Transplantation
  • Randomized Controlled Trials as Topic
  • Myocardium
  • Middle Aged
  • Male
  • Logistic Models
  • Incidence