A randomized study of transendocardial injection of autologous bone marrow mononuclear cells and cell function analysis in ischemic heart failure (FOCUS-HF) - 06/08/11
, Guilherme V. Silva, MD a, b, Timothy D. Henry, MD c, Maria G. Cabreira-Hansen, PhD a, Warren H. Moore, MD d, Stephanie A. Coulter, MD b, J. Patrick Herlihy, MD e, Marlos R. Fernandes, MD a, Benjamin Y.C. Cheong, MD f, Scott D. Flamm, MD g, Jay H. Traverse, MD c, Yi Zheng, MD a, Deirdre Smith, RN, CCRC a, Sandi Shaw, RN, BSN a, Lynette Westbrook, RN, MS, CCRC a, Rachel Olson, RN, MS, CCRC c, Dipsu Patel, MD a, Amir Gahremanpour, MD a, John Canales, MD a, William K. Vaughn, PhD h, James T. Willerson, MD a, bRiassunto |
Background |
Autologous bone marrow mononuclear cell (ABMMNC) therapy has shown promise in patients with heart failure (HF). Cell function analysis may be important in interpreting trial results.
Methods |
In this prospective study, we evaluated the safety and efficacy of the transendocardial delivery of ABMMNCs in no-option patients with chronic HF. Efficacy was assessed by maximal myocardial oxygen consumption, single photon emission computed tomography, 2-dimensional echocardiography, and quality-of-life assessment (Minnesota Living with Heart Failure and Short Form 36). We also characterized patients' bone marrow cells by flow cytometry, colony-forming unit, and proliferative assays.
Results |
Cell-treated (n = 20) and control patients (n = 10) were similar at baseline. The procedure was safe; adverse events were similar in both groups. Canadian Cardiovascular Society angina score improved significantly (P = .001) in cell-treated patients, but function was not affected. Quality-of-life scores improved significantly at 6 months (P = .009 Minnesota Living with Heart Failure and P = .002 physical component of Short Form 36) over baseline in cell-treated but not control patients. Single photon emission computed tomography data suggested a trend toward improved perfusion in cell-treated patients. The proportion of fixed defects significantly increased in control (P = .02) but not in treated patients (P = .16). Function of patients' bone marrow mononuclear cells was severely impaired. Stratifying cell results by age showed that younger patients (≤60 years) had significantly more mesenchymal progenitor cells (colony-forming unit fibroblasts) than patients >60 years (20.16 ± 14.6 vs 10.92 ± 7.8, P = .04). Furthermore, cell-treated younger patients had significantly improved maximal myocardial oxygen consumption (15 ± 5.8, 18.6 ± 2.7, and 17 ± 3.7 mL/kg per minute at baseline, 3 months, and 6 months, respectively) compared with similarly aged control patients (14.3 ± 2.5, 13.7 ± 3.7, and 14.6 ± 4.7 mL/kg per minute, P = .04).
Conclusions |
ABMMNC therapy is safe and improves symptoms, quality of life, and possibly perfusion in patients with chronic HF.
Il testo completo di questo articolo è disponibile in PDF.Mappa
| RCT reg no. NCT00203203. |
Vol 161 - N° 6
P. 1078 - Giugno 2011 Ritorno al numero
Articolo precedente
- Late gadolinium enhancement on cardiac magnetic resonance and phenotypic expression in hypertrophic cardiomyopathy
- Maria Rosa Conte, Sergio Bongioanni, Amedeo Chiribiri, Stefano Leuzzi, Elisabetta Lardone, Paolo Di Donna, Alfredo Pizzuti, Stefania Luceri, Federico Cesarani, Barbara Mabritto, Giuseppe Biondi Zoccai, Rodolfo Bonamini, Fiorenzo Gaita
- Patterns of left ventricular remodeling in chronic heart failure: Prevalence and prognostic implications
- Frank Lloyd Dini, Paola Capozza, Francesca Donati, Anca Simioniuc, Anca Irina Corciu, Paolo Fontanive, Andrea Pieroni, Vitantonio Di Bello, Mario Marzilli
Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.
Già abbonato a @@106933@@ rivista ?