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Ischemic Heart Disease . ....a major cause of mortality and morbidity worldwide. prognosis of patients with Acute Myocardial Infarction remains dismal. Stem Cell Therapy. The impact on: LEFT VENTRICULAR FUNCTION INFARCT SIZE LV DIMENSIONS ….remains unclear.
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Ischemic Heart Disease ....a major cause of mortality and morbidity worldwide
prognosis of patients with Acute Myocardial Infarction remains dismal
The impact on: • LEFT VENTRICULAR FUNCTION • INFARCT SIZE • LV DIMENSIONS • ….remains unclear. IMPACT OF INTRACORONARY STEM CELL THERAPY IN ACUTE MYOCARDIAL INFARCTION
OUTCOME OF INTRACORONARY STEM CELL THERAPY IN ACUTE MYOCARDIAL INFARCTION: META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS Arvisminda Luz G. Fernandez, MD. Chong Hua Hospital – Heart Institute May 24, 2012
OBJECTIVES GENERAL OBJECTIVE General Objectives: To perform a meta-analysis on the impact of intracoronary bone marrow stem cell therapy in acute myocardial infarction
OBJECTIVES SPECIFIC OBJECTIVES to assess if there is significant difference in the LV ejection fraction in patients with acute myocardial infarction who received bone marrow therapy versus control. to assess if there is significant difference in the LV end systolic volume in patients with acute myocardial infarction who received bone marrow therapy versus control.
METHODS REVIEW QUESTION AND STUDY PROTOCOL “What is the outcome of bone marrow stem cell transplantation in patients with acute myocardial infarction following percutaneous coronary intervention? This is a protocol-driven systematic review according to Quality of Reporting of Metaanalysis (QUOROM)
METHODS ELIGIBILITY CRITERIA INCLUSION CRITERIA • RCTs with comparison of intracoronary stem cell transplantation versus control in patients with acute myocardial infarction • Intention- to- treat analysis • Follow-up ≥ 3 months from therapy EXCLUSION CRITERIA • Use of cytokines for mobilization of BMCs • Irretrievable or unclear data • Treatment of old myocardial infarction (>14 days) • Lack of control group • Duplicate reports • Ongoing or unpublished studies
METHODS SEARCH STRATEGY PubMed databases (2005-2010) Cochrane Central Registry of Controlled Trials (2005-2010) Clinicaltrials.gov Registry (2005-2010) keywords: “stem cells, acute myocardial infarction, randomized controlled trials”
METHODS DATA ABSTRACTION • Primary endpoint: • - change in left ventricular ejection fraction (LVEF) from baseline to follow-up • Secondary endpoint: • - change in left ventricular end systolic volumes Study features extracted: outcome definitions. imaging modalities, patient baseline characteristics, and procedural data
METHODS QUALITY OF ASSESSMENT The criteria by Jüni et al
METHODS DATA ANALYSES Dichotomous variables as proportion and percentages. Continuous variables as mean ± standard deviation or median. Meta-regression and sensitivity analyses to explore heterogeneity. Statistical significance for hypothesis testing set at the 0.05, 2-tailed level.
METHODS REVIEW PROCESS 47 Citations Retrieved 31 Titles/Abstracts non-relevant 16 Complete Articles Assessed Based on Criteria • 4 • 1 used cytokines for BMC • mobilization • 2 had MI treatment > 14 days • 1 irretrievable data 12 Studies finally included in the systematic review
RESULTS Characteristics of Studies Included in the Meta-analysis N = 934
RESULTS Characteristics of Studies Included in the Meta-analysis Range of patients: 20-204 Follow-up Duration Range: 3-18 months Average Timing of Cell Transplantation after PCI : 1-18 days # of Stem cell Use: 24.6±9.4x106 cells
RESULTS Quality of Assessment Scale for Randomized Controlled Trials Included in the Meta-Analysis
RESULTS Forrest plot of unadjusted difference in mean (with 95% confidence intervals [CIs]) improvement in left ventricular ejection fraction (LVEF) in patients treated with bone marrow–derived cells (BMCs) compared with controls Increase in LVEF of .72% p value < 0.0001
RESULTS Forrest plot of unadjusted difference in mean (with 95% confidence intervals [CIs]) improvement in left ventricular end systolic volume (LVESV) in patients treated with bone marrow–derived cells (BMCs) compared with controls Decrease in LVESV of 0.425 mL p value < 0.0118 Standard Mean Difference
RESULTS Intracoronary bone marrow stem cell resulted in: modest yet significant increase in LV ejection fraction significant decrease in LV end systolic volume ….in patients with acute myocardial infarction
THANK YOU and GOOD DAY! INTRACORONARY BONE MARROW STEM CELL THERAPY INCREASE LVEF AND DECREASE LVESV IN ACUTE MYOCARDIAL INFARCTION