Sander F Rodrigo1, Jan van Ramshorst1, Imke Mann1, Darryl P Leong1, Suzanne C Cannegieter2, Imad Al Younis3, Petra Dibbets-Schneider3, Albert de Roos4, Willem E Fibbe5, Jaap Jan Zwaginga6, Jeroen J Bax1, Martin J Schalij1, Saskia L Beeres1, Douwe E Atsma7. 1. Department of Cardiology, Leiden University Medical Center, Leiden,The Netherlands. 2. Department of Clinical Epidemiology, Leiden University Medical Center, Leiden,The Netherlands. 3. Department of Nuclear Medicine, Leiden University Medical Center, Leiden,The Netherlands. 4. Department of Radiology, Leiden University Medical Center, Leiden,The Netherlands. 5. Department of Immunohematology and Bloodtransfusion, Leiden University Medical Center, Leiden, The Netherlands. 6. Department of Immunohematology and Bloodtransfusion, Leiden University Medical Center, Leiden, The Netherlands; Jon J. van Rood Center for Clinical Transfusion Research, Sanquin, Leiden, The Netherlands. 7. Department of Cardiology, Leiden University Medical Center, Leiden,The Netherlands. Electronic address: d.e.atsma@lumc.nl.
Abstract
BACKGROUND: We previously showed that intramyocardial bone marrow cell (BMC) injection in patients with refractory angina and chronic myocardial ischemia improves myocardial perfusion, cardiac function and disease-related complaints. Treatment effect varied between patients, but the predictors of response remain to be identified. Therefore, the aim of the present study was to assess whether patient characteristics, procedural data and baseline measurements influence the response to intramyocardial BMC treatment in a large cohort of refractory angina patients. METHODS AND RESULTS: In 120 patients (64 ± 9 years, 88% men) with refractory angina, 97 ± 13× 10(6) BMCs were injected intramyocardially in regions with stress-inducible ischemia as assessed by single photon emission computed tomography (SPECT). Canadian Cardiovascular Society angina (CCS) class, quality-of-life score, exercise testing, SPECT and magnetic resonance imaging were performed at baseline and at 3 months follow-up demonstrating significant improvements in CCS class, quality-of-life, exercise capacity, myocardial perfusion and left ventricular function (all variables P<0.001). Multivariate analysis was performed to evaluate the influence of patient characteristics, procedural data and baseline measurements on BMC treatment response. Based on the improvement of myocardial perfusion at stress, diabetes and a large number of ischemic segments at baseline were shown to be independently associated with a large response to BMC therapy. CONCLUSION: The present study demonstrates that diabetes and a large number of ischemic segments are predictors of a large response to intramyocardial BMC injection in refractory angina and chronic ischemia. Furthermore, the safety and efficacy results of previous trials are now confirmed in a larger study population.
RCT Entities:
BACKGROUND: We previously showed that intramyocardial bone marrow cell (BMC) injection in patients with refractory angina and chronic myocardial ischemia improves myocardial perfusion, cardiac function and disease-related complaints. Treatment effect varied between patients, but the predictors of response remain to be identified. Therefore, the aim of the present study was to assess whether patient characteristics, procedural data and baseline measurements influence the response to intramyocardial BMC treatment in a large cohort of refractory anginapatients. METHODS AND RESULTS: In 120 patients (64 ± 9 years, 88% men) with refractory angina, 97 ± 13 × 10(6) BMCs were injected intramyocardially in regions with stress-inducible ischemia as assessed by single photon emission computed tomography (SPECT). Canadian Cardiovascular Society angina (CCS) class, quality-of-life score, exercise testing, SPECT and magnetic resonance imaging were performed at baseline and at 3 months follow-up demonstrating significant improvements in CCS class, quality-of-life, exercise capacity, myocardial perfusion and left ventricular function (all variables P<0.001). Multivariate analysis was performed to evaluate the influence of patient characteristics, procedural data and baseline measurements on BMC treatment response. Based on the improvement of myocardial perfusion at stress, diabetes and a large number of ischemic segments at baseline were shown to be independently associated with a large response to BMC therapy. CONCLUSION: The present study demonstrates that diabetes and a large number of ischemic segments are predictors of a large response to intramyocardial BMC injection in refractory angina and chronic ischemia. Furthermore, the safety and efficacy results of previous trials are now confirmed in a larger study population.
Authors: Julia Nesteruk; Natalia Voronina; Guenther Kundt; Peter Donndorf; Christian Klopsch; Alexander Kaminski; Henrick J Duckers; Gustav Steinhoff Journal: ESC Heart Fail Date: 2017-02-19