Scheduled intermittent inotropes for Ambulatory Advanced Heart Failure. The RELEVANT-HF multicentre collaboration

RELEVANT-HF study group

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)255-259
Number of pages5
JournalInternational Journal of Cardiology
Volume272
DOIs
Publication statusPublished - Dec 1 2018

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Heart Failure
Hospitalization
Length of Stay
Life Expectancy
Diuretics
Registries
Cardiac Arrhythmias
Emergencies
Therapeutics
Randomized Controlled Trials
Transplants
Safety
Survival
simendan

Keywords

  • Ambulatory Advanced Heart Failure
  • Hospitalizations
  • Levosimendan
  • Outcome

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Scheduled intermittent inotropes for Ambulatory Advanced Heart Failure. The RELEVANT-HF multicentre collaboration. / RELEVANT-HF study group.

In: International Journal of Cardiology, Vol. 272, 01.12.2018, p. 255-259.

Research output: Contribution to journalArticle

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title = "Scheduled intermittent inotropes for Ambulatory Advanced Heart Failure. The RELEVANT-HF multicentre collaboration",
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.",
keywords = "Ambulatory Advanced Heart Failure, Hospitalizations, Levosimendan, Outcome",
author = "{RELEVANT-HF study group} and Fabrizio Oliva and Enrico Perna and Marco Marini and Daniele Nassiacos and Antonio Cir{\`o} and Gabriella Malfatto and Fabrizio Morandi and Ivan Caico and Gianpiero Perna and Sabina Meloni and Antonella Vincenzi and Alessandra Villani and Vecchi, {Andrea Lorenzo} and Chiara Minoia and Alessandro Verde and {De Maria}, Renata",
year = "2018",
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T1 - Scheduled intermittent inotropes for Ambulatory Advanced Heart Failure. The RELEVANT-HF multicentre collaboration

AU - RELEVANT-HF study group

AU - Oliva, Fabrizio

AU - Perna, Enrico

AU - Marini, Marco

AU - Nassiacos, Daniele

AU - Cirò, Antonio

AU - Malfatto, Gabriella

AU - Morandi, Fabrizio

AU - Caico, Ivan

AU - Perna, Gianpiero

AU - Meloni, Sabina

AU - Vincenzi, Antonella

AU - Villani, Alessandra

AU - Vecchi, Andrea Lorenzo

AU - Minoia, Chiara

AU - Verde, Alessandro

AU - De Maria, Renata

PY - 2018/12/1

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N2 - 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.

AB - 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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KW - Outcome

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