title: Sustained quality of life improvement after intracoronary injection of autologous bone marrow cells in the setting of acute myocardial infarction: results from the BONAMI trial.
abstract: Cardiac cell therapy is a promising treatment for acute myocardial infarction (AMI), leading to cardiac function improvement. However, whether it translates into quality of life (QoL) improvement is unclear. We hypothesized that administration of bone marrow cells (BMC) to patients with AMI improves QoL.
  
  
  
  In the multicenter BONAMI trial (NCT00200707), patients with reperfused AMI and decreased myocardial viability were randomized to intracoronary autologous BMC infusion (n = 52) or state-of-the-art therapy (n = 49). QoL data, derived from the Minnesota Living with Heart Failure questionnaire (MLHFQ), were obtained 1, 3, and 12 months after AMI and analyzed using a Rasch-family model.
  
  
  
  Using this model, QoL improved over time in the BMC group (p = 0.025) but not in the control group. Furthermore, the BMC-group patients displayed a better QoL than the control-group patients at 3 and 12 months post-AMI (p = 0.034 and p = 0.003, respectively). These findings were not detected when analyzing MLHFQ data using a standard method. Cardiac function, myocardial viability, mortality, and number of major adverse cardiac events did not differ between treatment groups.
  
  
  
  Our results suggest that BMC therapy can improve QoL, stressing the need for confirmation trials and for systematic QoL assessment in cardiac cell therapy trials .
authors.affiliation: INSERM, UMR1087, CNRS, UMR 6291, l'institut du thorax, Clinique cardiologique, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Lamirault
authors.affiliation: EA4275 SPHERE "bioStatistics, Pharmacoepidemiology and Human sciEnces REsearch", Université de Nantes, Nantes, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: de Bock
authors.affiliation: EA4275 SPHERE "bioStatistics, Pharmacoepidemiology and Human sciEnces REsearch", Université de Nantes, Nantes, France.|Plateforme méthodologie et biostatistique, CHU de Nantes, Nantes, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Sébille
authors.affiliation: INSERM, UMR1087, CNRS, UMR 6291, l'institut du thorax, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France.
authors.forename: Béatrice
authors.initials: B
authors.lastname: Delasalle
authors.affiliation: Service de Cardiologie A, CIC-Biothérapies, I2MC, INSERM 1048, CHU de Toulouse, Toulouse, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Roncalli
authors.affiliation: Department of Hematology and Transfusion, Lille University Hospital, EA 2693, Lille-II-University, Lille, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Susen
authors.affiliation: Cardiologie interventionnelle, Clinique du Millénaire, 34000, Montpellier, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Piot
authors.affiliation: INSERM, UMR1087, CNRS, UMR 6291, l'institut du thorax, Clinique cardiologique, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France.
authors.forename: Jean-Noël
authors.initials: JN
authors.lastname: Trochu
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Fédération de Cardiologie et Centre d'Investigation Clinique 1430, Hôpitaux Universitaires Henri Mondor, 94010, Créteil, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.affiliation: Pole Thorax et Vaisseaux, CHU de Grenoble, La Tronche, France.
authors.forename: Yannick
authors.initials: Y
authors.lastname: Neuder
authors.affiliation: INSERM, UMR1087, CNRS, UMR 6291, l'institut du thorax, Clinique cardiologique, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Le Tourneau
authors.affiliation: EA4650, Department of Imaging, CHU de Caen, GIP CYCERON, Université de Caen Basse-Normandie, Caen, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Manrique
authors.affiliation: EA4275 SPHERE "bioStatistics, Pharmacoepidemiology and Human sciEnces REsearch", Université de Nantes, Nantes, France.|Plateforme méthodologie et biostatistique, CHU de Nantes, Nantes, France.
authors.forename: Jean-Benoît
authors.initials: JB
authors.lastname: Hardouin
authors.affiliation: INSERM, UMR1087, CNRS, UMR 6291, l'institut du thorax, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France. patricia.lemarchand@univ-nantes.fr.
authors.forename: Patricia
authors.initials: P
authors.lastname: Lemarchand
mesh_terms: D000208:Acute Disease; D001854:Bone Marrow Cells / Q000166:cytology / Q000378:metabolism*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000523:psychology*; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Acute myocardial infarction; Bone marrow mononuclear cells; Cardiac cell therapy; Heart failure; Quality of life; Rasch-family model