Tommi Pätilä1, Miia Lehtinen1, Antti Vento1, Jukka Schildt2, Juha Sinisalo3, Mika Laine3, Pekka Hämmäinen1, Anne Nihtinen4, Riitta Alitalo5, Päivi Nikkinen2, Aapo Ahonen2, Miia Holmström6, Kirsi Lauerma6, Reino Pöyhiä7, Markku Kupari3, Esko Kankuri8, Ari Harjula9. 1. Department of Cardiothoracic Surgery. 2. Division of Nuclear Medicine, Department of Clinical Physiology. 3. Division of Cardiology, Department of Medicine. 4. Department of Hematology. 5. Stem Cell Laboratory, Department of Clinical Chemistry and Hematology, HUSLAB. 6. Department of Radiology. 7. Department of Anesthesiology and Intensive Care, Helsinki University Central Hospital, Helsinki. 8. Institute of Biomedicine, Pharmacology, University of Helsinki, Helsinki, Finland. 9. Department of Cardiothoracic Surgery; Institute of Biomedicine, Pharmacology, University of Helsinki, Helsinki, Finland. Electronic address: ari.harjula@hus.fi.
Abstract
BACKGROUND:Bone marrow mononuclear cell (BMMC) transplantation for heart failure has shown inconsistent therapeutic efficacy. METHODS: We enrolled 104 ischemic heart failure patients scheduled forcoronary artery bypass surgery (CABG). After 4- to 12-week pharmacotherapy optimization, 39 patients with left ventricular ejection fraction (LVEF) of ≤45% receivedinjections of BMMC or vehicle intra-operatively into the myocardial infarction border area in a randomized, double-blind manner. RESULTS: The median number of cells injected was 8.4 × 10(8) (interquartile range [IQR]: 5.2 × 10(8) to 13.5 × 10(8)). We measured LV function and myocardial scar size by magnetic resonance imaging (MRI), and viability by positron emission tomography (PET) and single-photon emission computed tomography (SPECT), pre-operatively and after 1-year follow-up. LVEF, the pre-defined primary end-point measure, improved by a median of 5.6% in the control group (IQR 0.2 to 10.1) and by 4.8% in the BMMC group (IQR -0.5 to 8.2) (p = 0.59). Wall thickening in injected segments rose by a median of 4.5% among controls (IQR -18.1 to 23.9) and by 5.5% in the BMMC group (IQR -6.6 to 26.5) (p = 0.68). Changes in viability by PET and SPECT did not differ between groups. Myocardial scar size by MRI in injected segments rose by a median of 5.1% among controls (IQR -3.3 to 10.8), but fell by 13.1% in the BMMC group (IQR -21.4 to -6.5) (p = 0.0002). CONCLUSIONS:BMMC therapy combined with CABG failed to improve LV systolic function, or viability, despite reducing myocardial scar size.
RCT Entities:
BACKGROUND: Bone marrow mononuclear cell (BMMC) transplantation for heart failure has shown inconsistent therapeutic efficacy. METHODS: We enrolled 104 ischemic heart failurepatients scheduled for coronary artery bypass surgery (CABG). After 4- to 12-week pharmacotherapy optimization, 39 patients with left ventricular ejection fraction (LVEF) of ≤45% received injections of BMMC or vehicle intra-operatively into the myocardial infarction border area in a randomized, double-blind manner. RESULTS: The median number of cells injected was 8.4 × 10(8) (interquartile range [IQR]: 5.2 × 10(8) to 13.5 × 10(8)). We measured LV function and myocardial scar size by magnetic resonance imaging (MRI), and viability by positron emission tomography (PET) and single-photon emission computed tomography (SPECT), pre-operatively and after 1-year follow-up. LVEF, the pre-defined primary end-point measure, improved by a median of 5.6% in the control group (IQR 0.2 to 10.1) and by 4.8% in the BMMC group (IQR -0.5 to 8.2) (p = 0.59). Wall thickening in injected segments rose by a median of 4.5% among controls (IQR -18.1 to 23.9) and by 5.5% in the BMMC group (IQR -6.6 to 26.5) (p = 0.68). Changes in viability by PET and SPECT did not differ between groups. Myocardial scar size by MRI in injected segments rose by a median of 5.1% among controls (IQR -3.3 to 10.8), but fell by 13.1% in the BMMC group (IQR -21.4 to -6.5) (p = 0.0002). CONCLUSIONS:BMMC therapy combined with CABG failed to improve LV systolic function, or viability, despite reducing myocardial scar size.
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