Fabrizio Oliva1, Enrico Perna1, Marco Marini2, Daniele Nassiacos3, Antonio Cirò4, Gabriella Malfatto5, Fabrizio Morandi6, Ivan Caico7, Gianpiero Perna2, Sabina Meloni3, Antonella Vincenzi4, Alessandra Villani5, Andrea Lorenzo Vecchi6, Chiara Minoia7, Alessandro Verde1, Renata De Maria8. 1. Cardiothoracic and Vascular Department, ASST-Great Metropolitan Hospital Niguarda, Milan, Italy. 2. Department of Cardiovascular Sciences, Ospedali Riuniti, Ancona, Italy. 3. Cardiology Department, ASST Valle Olona, Saronno General Hospital, Saronno, Italy. 4. Cardiology ASST Monza, San Gerardo Hospital, Monza, Italy. 5. Department of Cardiology, San Luca Hospital, Istituto Auxologico Italiano IRCCS, Milan, Italy. 6. Department of Cardiovascular Diseases, Ospedale di Circolo and Macchi Foundation, University of Insubria, Varese, Italy. 7. Cardiology Department, ASST Valle Olona, Gallarate Hospital, Gallarate, Italy. 8. CNR Clinical Physiology Institute, Cardiothoracic and Vascular Department, ASST-Great Metropolitan Hospital Niguarda, Milan, Italy. Electronic address: renata.demaria@ospedaleniguarda.it.
Abstract
BACKGROUND: Ambulatory Advanced Heart Failure (AAHF) is characterized by recurrent HF hospitalizations, escalating diuretic requirements, intolerance to neurohormonal antagonists, end-organ dysfunction, short-term reduced life expectancy despite optimal medical management (OMM). The role of intermittent inotropes in AAHF is unclear. The RELEVANT-HF registry was designed to obtain insight on the effectiveness and safety of compassionate scheduled repetitive 24-hour levosimendan infusions (LEVO) in AAHF patients. METHODS: 185 AAHF NYHA class III-IV patients, with ≥2 HF hospitalizations/emergency visits in the previous 6 months and systolic dysfunction, were treated with LEVO at tailored doses (0.05-0.2 μg/kg/min) without prior bolus every 3-4 weeks. We compared data on HF hospitalizations (percent days spent in hospital, DIH) in the 6 months before and after treatment start. RESULTS: Infusion-related adverse events occurred in 23 (12.4%) patients the commonest being ventricular arrhythmias (16, 8.6%). During follow-up, 37 patients (20%) required for clinical instability treatment adjustments (decreases in infusion dose, rate of infusion or interval). From the 6 months before to the 6 months after treatment start we found lower DIH (9.4 (8.2) % vs 2.8 (6.6) %, p < 0.0001), cumulative number (1.3 (0.6) vs 1.8 (0.8), p = 0.0001) and length of HF admissions (17.4 (15.6) vs 21.6 (13.4) days, p = 0.0001). One-year survival was 86% overall and 78% free from death/LVAD/urgent transplant. CONCLUSIONS: In AAHF patients, who remain symptomatic despite OMM, LEVO is well tolerated and associated with lower overall length of hospital stay during six months. This multicentre clinical experience underscores the need for a randomized controlled trial of LEVO impact on outcomes in AAHF patients.
BACKGROUND: Ambulatory Advanced Heart Failure (AAHF) is characterized by recurrent HF hospitalizations, escalating diuretic requirements, intolerance to neurohormonal antagonists, end-organ dysfunction, short-term reduced life expectancy despite optimal medical management (OMM). The role of intermittent inotropes in AAHF is unclear. The RELEVANT-HF registry was designed to obtain insight on the effectiveness and safety of compassionate scheduled repetitive 24-hour levosimendan infusions (LEVO) in AAHF patients. METHODS: 185 AAHF NYHA class III-IV patients, with ≥2 HF hospitalizations/emergency visits in the previous 6 months and systolic dysfunction, were treated with LEVO at tailored doses (0.05-0.2 μg/kg/min) without prior bolus every 3-4 weeks. We compared data on HF hospitalizations (percent days spent in hospital, DIH) in the 6 months before and after treatment start. RESULTS: Infusion-related adverse events occurred in 23 (12.4%) patients the commonest being ventricular arrhythmias (16, 8.6%). During follow-up, 37 patients (20%) required for clinical instability treatment adjustments (decreases in infusion dose, rate of infusion or interval). From the 6 months before to the 6 months after treatment start we found lower DIH (9.4 (8.2) % vs 2.8 (6.6) %, p < 0.0001), cumulative number (1.3 (0.6) vs 1.8 (0.8), p = 0.0001) and length of HF admissions (17.4 (15.6) vs 21.6 (13.4) days, p = 0.0001). One-year survival was 86% overall and 78% free from death/LVAD/urgent transplant. CONCLUSIONS: In AAHF patients, who remain symptomatic despite OMM, LEVO is well tolerated and associated with lower overall length of hospital stay during six months. This multicentre clinical experience underscores the need for a randomized controlled trial of LEVO impact on outcomes in AAHF patients.
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Authors: Martín J García-González; Ana Aldea Perona; Antonio Lara Padron; José Luis Morales Rull; Manuel Martínez-Sellés; Manuel de Mora Martin; Javier López Díaz; Silvia López Fernandez; Pilar Ortiz Oficialdegui; Alejandro Jiménez Sosa Journal: ESC Heart Fail Date: 2021-10-30