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.
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 TRIALSArvisminda Luz G. Fernandez, MD.
Chong Hua Hospital – Heart InstituteMay 24, 2012
General Objectives:To perform a meta-analysis on the
impact of intracoronary bone marrow stem cell therapy in acute myocardial infarction
OBJECTIVES
GENERAL OBJECTIVE
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.
OBJECTIVES
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.
SPECIFIC OBJECTIVES
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
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14 days) Lack of control group Duplicate reports Ongoing or unpublished studies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
ELIGIBILITY CRITERIA
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
SEARCH STRATEGY
Study features extracted: outcome definitions. imaging modalities, patient baseline characteristics, and procedural dataPrimary endpoint:
- change in left ventricular ejection fraction (LVEF) from baseline to follow-up
Secondary endpoint: - change in left ventricular end systolic volumes
METHODS
DATA ABSTRACTION
The criteria by Jüni et al
METHODS
QUALITY OF ASSESSMENT
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
DATA ANALYSES
47Citations Retrieved
16Complete Articles
Assessed Based on Criteria
12Studies finally included in the
systematic review
31Titles/Abstracts non-
relevant
4- 1 used cytokines for BMC mobilization-2 had MI treatment > 14 days- 1 irretrievable data
REVIEW PROCESSMETHODS
Characteristics of Studies Included in the Meta-analysis
N = 934
RESULTS
Range of patients: 20-204
Follow-up Duration Range:
3-18 monthsAverage Timing of Cell Transplantation after
PCI :1-18 days
# of Stem cell Use:24.6±9.4x106
cells
Characteristics of Studies Included in the Meta-analysis
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
Standard Mean Difference
Decrease in LVESV of 0.425
mLp value <
0.0118
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
RESULTS
DISCUSSION
INTRACORONARY BONE MARROW STEM CELL THERAPY INCREASE LVEF AND DECREASE LVESV IN ACUTE MYOCARDIAL
INFARCTION
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