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European Heart Journal Advance Access published online on June 4, 2008
European Heart Journal, doi:10.1093/eurheartj/ehn233
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

Release of biomarkers of myocardial damage after direct intramyocardial injection of genes and stem cells via the percutaneous transluminal route

Federica Baldazzi1, Erik Jørgensen1, Rasmus S. Ripa1 and Jens Kastrup1,2,3,*

1 Cardiac Catheterisation Laboratory 2014, Department of Cardiology, The Heart Centre, Rigshospitalet, University Hospital Copenhagen, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark
2 Cardiac Stem Cell Research Laboratory, Department of Cardiology, The Heart Centre, Rigshospitalet, University Hospital Copenhagen, Copenhagen, Denmark
3 Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark

Received 12 October 2007; revised 9 May 2008; accepted 15 May 2008.

* Corresponding author. Tel: +45 3545 2819/2817, Fax: +45 3545 2705, Email: jkastrup{at}rh.regionh.dk

Aims: We aimed to quantify the release of biomarkers of myocardial damage in relation to direct intramyocardial injections of genes and stem cells in patients with severe coronary artery disease.

Methods and results: We studied 71 patients with ‘no-option’ coronary artery disease. Patients had, via the percutaneous transluminal route, a total of 11 ± 1 (mean ± SD) intramyocardial injections of vascular endothelial growth factor genes (n = 56) or mesenchymal stromal cells (n = 15). Injections were guided to an ischaemic area by electromechanical mapping, using the NOGATM/MyostarTM catheter system. Plasma CKMB (upper normal laboratory limit = 5 µg/L) was 2 µg/L (2–3) at baseline; increased to 6 (5–9) after 8 h (P < 0.0001) and normalized to 4 (3–5) after 24 h. A total of eight patients (17%), receiving a volume of 0.3 mL per injection, had CKMB rises exceeding three times the upper limit, whereas no patient in the group receiving 0.2 mL had a more than two-fold CKMB increase. No patient developed new ECG changes. There were no clinically ventricular arrhythmias and no death.

Conclusion: NOGA mapping followed by direct intramyocardial injections of stem cells or genes lead to measurable release of cardiac biomarkers compared with NOGA mapping alone. The increase in biomarkers was related to the injected volume.

Key Words: Stem cells therapy • Gene therapy • Myocardial enzymes • NOGA system • Intramyocardial injection


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