Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data
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...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-06-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/11/3205 |
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| author | Mariann Gyöngyösi Evgeny Pokushalov Aleksander Romanov Emerson Perin Joshua M. Hare Jens Kastrup Francisco Fernández-Avilés Ricardo Sanz-Ruiz Anthony Mathur Wojcieh Wojakowski Enca Martin-Rendon Noemi Pavo Imre J. Pavo Rayyan Hemetsberger Denise Traxler Andreas Spannbauer Paul M. Haller |
| author_facet | Mariann Gyöngyösi Evgeny Pokushalov Aleksander Romanov Emerson Perin Joshua M. Hare Jens Kastrup Francisco Fernández-Avilés Ricardo Sanz-Ruiz Anthony Mathur Wojcieh Wojakowski Enca Martin-Rendon Noemi Pavo Imre J. Pavo Rayyan Hemetsberger Denise Traxler Andreas Spannbauer Paul M. Haller |
| author_sort | Mariann Gyöngyösi |
| collection | DOAJ |
| description | 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) (<i>n</i> = 8 studies) and publication-based (<i>n</i> = 10 studies) aggregate data were combined for the meta-analysis, including patients (<i>n</i> = 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 (<i>p</i> < 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. |
| first_indexed | 2024-03-10T01:10:16Z |
| format | Article |
| id | doaj.art-6a2abbab06bf4f6f9d3bfcdde626399c |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T01:10:16Z |
| publishDate | 2022-06-01 |
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| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-6a2abbab06bf4f6f9d3bfcdde626399c2023-11-23T14:18:38ZengMDPI AGJournal of Clinical Medicine2077-03832022-06-011111320510.3390/jcm11113205Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate DataMariann Gyöngyösi0Evgeny Pokushalov1Aleksander Romanov2Emerson Perin3Joshua M. Hare4Jens Kastrup5Francisco Fernández-Avilés6Ricardo Sanz-Ruiz7Anthony Mathur8Wojcieh Wojakowski9Enca Martin-Rendon10Noemi Pavo11Imre J. Pavo12Rayyan Hemetsberger13Denise Traxler14Andreas Spannbauer15Paul M. Haller16Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, AustriaCenter of the New and Modern Medical Technologies, 630090 Novosibirsk, RussiaE. Meshalkin National Medical Research Center, 630055 Novosibirsk, RussiaStem Cell Center and Adult Cardiology, Texas Heart Institute, Houston, TX 37660, USAInterdisciplinary Stem Cell Institute, Cardiovascular Division, University of Miami Miller School of Medicine, Miami, FL 33136, USACardiology Stem Cell Centre, The Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Copenhagen University Hospital Rigshospitalet, 2100 Copenhagen, DenmarkCIBERCV, Instituto de Salud Carlos III, 28029 Madrid, SpainCIBERCV, Instituto de Salud Carlos III, 28029 Madrid, SpainCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London EC1M 6BQ, UKDepartment of Cardiology and Structural Heart Diseases, Medical University of Silesia, 40-635 Katowice, PolandR&D Division, National Health Service (NHS)-Blood and Transplant, Oxford Centre, Oxford OX3 9DU, UKDivision of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, AustriaDepartment of Pediatrics, Medical University of Vienna, 1090 Vienna, AustriaDivision of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, AustriaDivision of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, AustriaDivision of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, AustriaDepartment of Cardiology, University Heart and Vascular Center UKE Hamburg, 20246 Hamburg, GermanyIndividual 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) (<i>n</i> = 8 studies) and publication-based (<i>n</i> = 10 studies) aggregate data were combined for the meta-analysis, including patients (<i>n</i> = 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 (<i>p</i> < 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.https://www.mdpi.com/2077-0383/11/11/3205cell-based regeneration therapystem cellsACCRUEpercutaneous transendocardial cell deliveryhuman clinical trialsmeta-analysis |
| spellingShingle | Mariann Gyöngyösi Evgeny Pokushalov Aleksander Romanov Emerson Perin Joshua M. Hare Jens Kastrup Francisco Fernández-Avilés Ricardo Sanz-Ruiz Anthony Mathur Wojcieh Wojakowski Enca Martin-Rendon Noemi Pavo Imre J. Pavo Rayyan Hemetsberger Denise Traxler Andreas Spannbauer Paul M. Haller Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data Journal of Clinical Medicine cell-based regeneration therapy stem cells ACCRUE percutaneous transendocardial cell delivery human clinical trials meta-analysis |
| title | Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data |
| title_full | Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data |
| title_fullStr | Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data |
| title_full_unstemmed | Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data |
| title_short | Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data |
| title_sort | meta analysis of percutaneous endomyocardial cell therapy in patients with ischemic heart failure by combination of individual patient data ipd of accrue and publication based aggregate data |
| topic | cell-based regeneration therapy stem cells ACCRUE percutaneous transendocardial cell delivery human clinical trials meta-analysis |
| url | https://www.mdpi.com/2077-0383/11/11/3205 |
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