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14 days) Lack of control group Duplicate reports Ongoing or unpublished studies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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GOOD DAY!