Intermittent inotropic infusions for the treatment of refractory end stage heart failure: a randomized clinical study
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1 Intermittent inotropic infusions for the treatment of refractory end stage heart failure: a randomized clinical study M. Bonios, J. Terrovitis, S. Drakos H. Pozios, F. Katsaros, C. Pantsios, J. Kanakakis, G. Alexopoulos, S. Toumanidis, S. Nanas, M. Anastasiou-Nana, J. Nanas 3 rd Cardiology Dept. University of Athens, Medical School
2 Introduction The steady worldwide increase in prevalence of heart failure represents a major health concern. Despite the progress made in pharmacological therapy (bblockers, ACE-I, Spironolactone), the prognosis of patients with advanced heart failure remains poor. Therapeutic options CRT-ICD Htx Chronic mechanical circulatory support Bridge to transplantation Bridge to recovery Destination therapy Intermittent inotrope infusion?
3 Chronic intermittent dobutamine infusion and mortality The European Journal of Heart Failure (2002)
4 Dobutamine +Amiodarone Placebo + Amiodarone JN Nanas et al, Chest 2004
5 Levosimendan is a novel inotropic agent with unique pharmacologic properties increase the calcium sensitivity (calcium sensitizer). Vasodilatory properties Levosimendan In acute decompensated heart failure patients, refractory to therapy with dobutamine, simultaneous infusion of levosimendan improved hemodynamics Nanas et al. Am J Cardiol 2004 A. Delaney et al. Int J Cardiol,2008
6 Aim In this randomized study, we compared the safety and efficacy of intermitent intravenous infusions of levosimendan and dobutamine, administered alone or in combination, in patients treated with amiodarone, who presented with decompensated refractory end-stage heart failure Survival free from death or emergency LVAD implantation at 6 months, was the primary end point of the study
7 Methods(I) Protocol design 63 patients with decompensated end stage heart failure refractory to standard therapy, admitted to the hospital hr continuous dobutamine infusion Stabilization Randomization ILI Group, (n=21) ILI (6 h/ week for 6 mo) mg Amiodarone/day IDI Group, (n=21) IDI (6 h/ week for 6 mo) mg Amiodarone/day ILDI Group, (n=21) ILDI (6 h/ week for 6 mo) mg Amiodarone/day ILI: Intermittent Levosimendan Infusion (0.3 μg/kg/min) IDI: Intermittent Dobutamine Infusion (10 μg/kg/min) ILDI: Intermittent Levosimendan (0.2μg/kg/min) + Dobutamine Infusion (10 μg/kg/min)
8 Methods (ΙΙ) Clinical, hemodynamic and laboratory parameters recorded at the entrance of the patients in III and after 3 months Systolic arterial blood pressure Pulmonary Capillary Wedge Pressure Cardiac Index Mean Pulmonary Arterial Pressure Serum Creatinine Serum Sodium Hemoglobulin Left Ventricle Ejection Fraction
9 Results (Ι) Patients baseline characteristics Group IDI ILI ILDI p Patients (ν) ICM(%)/IDC(%) 11/10/ 10/11 11/10 NS Men/ Women 20/1 20/1 19/2 NS Age (Y) 53±13 55±12 61±11 NS ΝΥΗΑ (class) 4±0 4±0 4±0 NS SAP (mmhg) 102±13 101±9 95±9 NS LVEF (%) 21±5 23±7 24±6 NS PCWP (mmhg) 31±9 26±7 28±7 NS CI(L/min/m2) 1.7± ± ±0.4 NS Na (mεq/l) 135±5 137±5 134±7 NS Cr (mg/dl) 1.4± ± ± Fourosemide/d(mg) 408± ± ±120 NS IDCM:Idiopathic Dilated, ICM: Ischemic Cardiomyopathy, CI: Cardiac Index, LVEF: Left Ventricle Ejection Fraction, PCWP: Pulmonary Capilary Wedge Presure, SAP: Systolic Arterial Pressure, ΝΥΗΑ: Νew York Heart Association Class, Νa: Serum Sodium, Cr: Serum Creatinine ILI: Intermittent Levosimendan Infusion (0.3 μg/kg/min) IDI: Intermittent Dobutamine Infusion (10 μg/kg/min) ILDI: Intermittent Levosimendan (0.2μg/kg/min) + Dobutamine Infusion (10 μg/kg/min)
10 Results(ΙIΙ) Event=Death+Urgent LVAD implantation
11 Results (ΙΙ) Changes in functional and hemodynamic parameters 3mo after study treatment onset ILI IDI ILDI Baseline 4.0±0 27±4 41±6 1.5±0.3 3 mo 2.8±1.0 19±8 30±7 2.1±0.3 Baseline 4.0±0 30±7 43±10 1.8±0.5 3 mo 2.7±0.8 24±9 37±10 2.0±0.3 baseline 4.0±0 27±6 44±9 1.8±0.4 3 mo 2.7±0.8 23±13 39±15 1.8±0.4 ΝΥΗΑ PCWP MPAP CI ILI: Intermittent Levosimendan Infusion (0.3 μg/kg/min) IDI: Intermittent Dobutamine Infusion (10 μg/kg/min) ILDI: Intermittent Levosimendan (0.2μg/kg/min) + Dobutamine Infusion (10 μg/kg/min)
12 Results(ΙV) Modes of death, hospitalization, urgent and total LVAD implantation rates at 6 months of follow-up Modes of death (% of deaths) Dobutamine (n=21 ) Levosimendan (n=21 ) Dobutamine + levosimendan (n=21 ) Progressive pump failure Sudden cardiac LVADs* Urgent left ventricular assist device implantation Total left ventricular assist device implantation Hospitalizations* *Values are % of patients in the corresponding group
13 Conclusion In patients with end-stage heart failure, refractory to standard medical therapy, the intermittent infusion of Levosimendan improved the outcome in comparison to the Intermittent infusion of Dobutamine or Levosimendan plus dobutamine These results suggest an adverse effect of dobutamine, when added to levosimendan, in these patients
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