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Published on: May 25, 2020
Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of
Mariann Gyöngyösi1, Evgeny Pokushalov2, Aleksander Romanov3
1Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, Austria.
Insights
Percutaneous transendocardial cell therapy improves survival and cardiac function in patients with ischemic heart failure. This regenerative cell therapy is safe and effective, particularly for male patients with comorbidities.
Area of Science:
- Cardiology
- Regenerative Medicine
- Clinical Trials
Background:
- Ischemic heart failure (iHF) treatment remains a challenge, with variable outcomes from cell-based therapies.
- Previous studies on intracoronary cell therapy for acute myocardial infarction showed insufficient effects.
- Percutaneous endocardial, surgical, transvenous, or intracoronary cell delivery methods have yielded inconsistent results in iHF.
Purpose of the Study:
- To evaluate the safety and efficacy of percutaneous transendocardial cell therapy in patients with ischemic heart failure.
- To combine individual patient data (IPD) and aggregate data for a comprehensive meta-analysis.
- To identify predictive factors for treatment safety and efficacy through post hoc analyses.
Main Methods:
- A meta-analysis combining IPD (8 studies) and publication-based aggregate data (10 studies) including 1715 patients with chronic iHF.
- Data extraction performed by two independent investigators following PRISMA guidelines.
- Primary endpoints: all-cause mortality and changes in global ejection fraction; Secondary endpoints: major adverse events, hospitalization, and changes in cardiac volumes.
Main Results:
- Cell therapy significantly favored survival, reduced major adverse events, and decreased hospitalization rates.
- A mean increase in ejection fraction of 2.51% and a significant decrease in end-systolic volume were observed.
- IPD analysis revealed improvements in NYHA and CCS classes, with benefits more pronounced in male patients, those with diabetes, hypertension, hyperlipidemia, prior myocardial infarction, and lower baseline ejection fraction.
Conclusions:
- Catheter-based transendocardial delivery of regenerative cells is safe and effective for improving mortality and cardiac performance in iHF.
- Significant benefits in ejection fraction and reduced mortality were demonstrated.
- The greatest improvements were seen in male patients with significant atherosclerotic comorbidities.
Abstract:
Individual patient data (IPD)-based meta-analysis (ACCRUE, meta-analysis of cell-based cardiac studies, NCT01098591) revealed an insufficient effect of intracoronary cell-based therapy in acute myocardial infarction. Patients with ischemic heart failure (iHF) have been treated with reparative cells using percutaneous endocardial, surgical, transvenous or intracoronary cell delivery methods, with variable effects in small randomized or cohort studies. The objective of this meta-analysis was to investigate the safety and efficacy of percutaneous transendocardial cell therapy in patients with iHF. Two investigators extracted the data. Individual patient data (IPD) (n = 8 studies) and publication-based (n = 10 studies) aggregate data were combined for the meta-analysis, including patients (n = 1715) with chronic iHF. The data are reported in accordance with PRISMA guidelines. The primary safety and efficacy endpoints were all-cause mortality and changes in global ejection fraction. The secondary safety and efficacy endpoints were major adverse events, hospitalization and changes in end-diastolic and end-systolic volumes. Post hoc analyses were performed using the IPD of eight studies to find predictive factors for treatment safety and efficacy. Cell therapy was significantly (p < 0.001) in favor of survival, major adverse events and hospitalization during follow-up. A forest plot analysis showed that cell therapy presents a significant benefit of increasing ejection fraction with a mean change of 2.51% (95% CI: 0.48; 4.54) between groups and of significantly decreasing end-systolic volume. The analysis of IPD data showed an improvement in the NYHA and CCS classes. Cell therapy significantly decreased the end-systolic volume in male patients; in patients with diabetes mellitus, hypertension or hyperlipidemia; and in those with previous myocardial infarction and baseline ejection fraction ≤ 45%. The catheter-based transendocardial delivery of regenerative cells proved to be safe and effective for improving mortality and cardiac performance. The greatest benefit was observed in male patients with significant atherosclerotic co-morbidities.
