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Research Letter

Outpatient 6-Hour Levosimendan Treatment as a Bridge to Heart Transplant

António Valentim Gonçalves et al. João Pedro Reis Ana Teresa Timóteo Rui Soares … Tiago Pereira-da-Silva Valdemar Gomes Rita Ilhão Moreira Delmira Pombo Tiago Carvalho Catarina Correia Claudia Santos Rui Cruz Ferreira

Heart transplantation is the treatment of choice for selected patients with advanced heart failure (HF), improving quality of life and conferring a survival benefit compared to conventional management. However, heart transplantation depends on a donor’s presence, necessitating bridge strategies. Infusion of inotropes was suggested as one of these treatments, but a meta-analysis of randomized trials found increased mortality with long-term inotropic support, and HF guidelines do not now endorse this strategy.

The inodilator Levosimendan has arisen as a treatment option: its inotropic action can continue for up to 2 weeks while being less pro-arrhythmic than traditional inotropes. It was traditionally administered as a 24-hour infusion. Nonetheless, a 24-hour infusion necessitates at least a two-day stay in the hospital. Recently, two randomized placebo-controlled, double-blind clinical trials evaluated 6-hour cycles of Levosimendan therapy in ambulatory patients with advanced HF and demonstrated that it reduces NT-proBNP levels and admissions for acute decompensated HF.^,

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Effect of levosimendan in patients with severe systolic heart failure and worsening renal function

Ali Zorlu et al. Hasan Yücel Osman Can Yontar Oguz Karahan … Izzet Tandogan Nurkay Katrancioglu Mehmet Birhan Yilmaz

BACKGROUND: Levosimendan, a calcium sensitizer, increases the sensitivity of the heart to calcium, thus increasing myocardial contractility without a rise in intracellular calcium. It was recently shown that levosimendan is beneficial in improving renal function. However, it remains to be established that the beneficial effect is differentially related to renal status during index event. OBJECTIVE: The purpose of the current study was to determine whether levosimendan could improve renal outcome in acute decompensated heart failure patients with and without worsening renal function. METHODS: Forty-five consecutive patients who had a reduced glomerular filtration rate and had at least two consecutive data regarding renal function prior to administration of levosimendan were enrolled in the study. Patients were classified into two groups as those with and without worsening renal function based on an increase in serum creatinine >0.3 mg/dL. RESULTS: A significant improvement was noted in renal function in patients with worsening renal function (serum creatinine from 1.4±0.16 to 1.21±0.23 mg/dL, p=0.001 and glomerular filtration rate level from 48.9±15 to 59.3±21.8 mL/min/m², p=0.011), while there was no significant improvement in those without worsening renal function (serum creatinine from 1.29±0.33 to 1.37±0.66 mg/dL, p=0.240 and glomerular filtration rate level from 53.7±17.6 to 52.9±21.4 mL/min/m², p=0.850). CONCLUSION: Levosimendan appears to provide a renal-enhancing effect in patients with severe, acute decompensated systolic heart failure and worsening renal function. Consideration of this differential effect might help obtain beneficial renal outcomes. (Arq Bras Cardiol. 2012; [online].ahead print, PP.0-0)

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Acute effects of levosimendan and dobutamine on QRS duration in patients with heart failure

Osman Can Yontar et al. Mehmet Birhan Yilmaz Kenan Yalta Alim Erdem Izzet Tandogan

BACKGROUND: Levosimendan is a novel inotropic agent that enhances cardiac contractility without increasing cellular calcium intake, so that it is not supposed to cause intracellular calcium overload and related arrhythmias. In patients with heart failure, prolonged QRS duration is associated with increased risk of mortality and sudden cardiac death. Structural changes in the left ventricle may lead to asynchronous contraction, causing conduction delay and a prolonged QRS on the surface electrocardiogram. OBJECTIVE: We aimed to compare the acute effects of levosimendan and dobutamine on QRS duration in patients with severe heart failure and sinus rhythm. METHODS: Sixty consecutive patients with ischemic heart failure were enrolled for the study and randomized into two groups for levosimendan (n=37) or dobutamine (n=23) infusions. 67.2 % were male; mean age was 66.4±9.2 years for all patients. Baseline QRS durations in levosimendan and dobutamine groups were, 120.44 ± 23.82 ms vs 116.59 ± 13.80 ms respectively. Baseline ejection fractions were both depressed (23.15 ± 8.3% vs 24.56 ± 7.5%). RESULTS: In the levosimendan group, QRS duration shortened from baseline value to 116.47 ± 24.56 msec (p=0.006), whereas dobutamine group showed no significant change (p=0.605). Both drugs caused an increase in ejection fraction, but only the levosimendan group showed significance (27.95 ± 8.9% p=0.003 vs 26.67 ± 7.6%, p=0.315). CONCLUSION: We suggest that the administration of levosimendan, not dobutamine, shortens QRS duration on the surface ECG, possibly by means of providing collective contraction in the left ventricle muscle fibers. The molecular basis of this effect remains to be clarified.

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Levosimendan in acute decompensated heart failure: systematic review and meta-analysis

Rodrigo Antonini Ribeiro et al. Luis Eduardo Paim Rohde Carisi Anne Polanczyk

BACKGROUND: Congestive heart failure (CHF) is a rather prevalent condition with a high mortality rate. Levosimendan is one among the new drugs that have been tested for its management. OBJECTIVE: To undertake a systematic review and meta-analysis of the morbidity and mortality reduction associated with levosimendan in the treatment of CHF. METHODS: A bibliographic search was conducted in the Medline database for all randomized controlled trials (RCTs) that assessed the use of levosimendan in CHF. The outcomes were death from all causes, length of hospital stay, and hospital readmission for CHF. All RCTs with outcomes of interest were included. Methodological quality criteria, such as blinding and confidentiality of the list of allocation, were evaluated in sensitivity analysis. The main calculation was done with random effects. RESULTS: Of the 179 articles identified, 48 were RCTs, 19 of them with outcomes of interest. In the comparison with placebo (7 trials, 1,652 patients), the relative risk (RR) for overall death was 0.87 (95% confidence interval [CI]: 0.65 to 1.18). In comparison with dobutamine (10 trials, 2,067 patients), the RR was 0.87 (95% CI: 0.75-1.02). Three studies had data on length of stay, in which levosimendan showed a decrease of 2.27 and 2.30 days compared to placebo and dobutamine, respectively (p < 0.05 for both). No article presented data on readmission alone. CONCLUSION: The evidence available so far has shown no benefit in terms of mortality in association with the use of levosimendan, which only showed a small benefit in the time of hospitalization.

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Levosimendan in decompensated heart failure patients: efficacy in a Brazilian cohort. Results of the BELIEF study

Edimar Alcides Bocchi et al. Fábio Vilas-Boas Maria da Consolação Moreira Antonio Carlos Pereira Barretto … Silvia Lage Denilson Albuquerque Jader Baima Salvador Rassi Jorge Pinto Ribeiro

BACKGROUND: Levosimendan is a new inodilatory agent that enhances cardiac contractility via Ca(2+) sensitization and induces vasodilation through the activation of KATP/BKCa. OBJECTIVE: To study the efficacy and safety of levosimendan in a decompensated heart failure (DHF) Brazilian cohort, and in b-adrenergic agonist resistant patients. METHODS: The Brazilian Evaluation of Levosimendan Infusion Efficacy (BELIEF) study was prospective, multicenter, observational and included 182 high-risk DHF patients, all of which received open-label levosimendan. Primary end point was hospital discharge without additional inotropic therapy (responder). Secondary end points were changes in hemodynamics, clinical parameters, and brain natriuretic peptide (BNP). RESULTS: Mortality rate was 14.8%, and 139 of 182 patients were responders. In non responders it was 62.8%. Systolic blood pressure was a predictor of response. In b-adrenergic agonist resistant group, 55.8% were responders. Overall, 54 patients experienced at least one adverse event; most of them resolved either spontaneously or after levosimendan dose reduction. A significant improvement in quality of life was verified at 2-6 months of follow-up (p<0.0001). CONCLUSION: Our results suggest levosimendan infusion as an alternative therapy in the short term management of DHF patients. HF severity can influence the response to levosimendan treatment. Prospective studies are warranted in a Brazilian cohort including Chagas heart disease.

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Cost analysis of the treatment of acute decompensated heart failure: levosimendan versus dobutamine

Mucio Tavares Oliveira Jr et al. Wilson Follador Maria Lucia Orlandi Martins Roberta Canaviera … Rosana Lima Garcia Tsuji Airton Scipioni Antonio Carlos Pereira Barretto

OBJECTIVE: To assess whether the treatment with levosimendan is more expensive than the usual one with dobutamine, since price of medications does not usually represent the greatest expense in the treatment of cardiac decompensation. METHODS: The cost of treatment of 18 inpatients with cardiac decompensation, 9 of which treated with dobutamine (dobuta group) and 9 with levosimendan (levo group), was compared. Groups were similar concerning age, sex, functional class and cardiac function. RESULTS: Treatment costs were similar for both groups. In the levo group, the costs with the drug were higher than in the dobuta group, but those related to the length of stay in intensive care unit and to the material used during admission were lower. Levo – drug: R$ 5,414.00; material: R$ 399.90; hospital daily rates: R$ 5,061.20; professional honorarium: R$ 3,241.80; total costs: R$ 14,117.00. Dobuta – drug: R$ 2,320.10; materials: R$ 1,665.70; hospital daily rates: R$ 6,261.90; professional honorarium: R$ 3,894.30; total costs: R$ 14,142.00. CONCLUSION: Despite the higher price of levosimendan, the global cost of the treatment was similar for patients who were treated either with dobutamine or levosimendan. Patients who were treated with levosimendan had a shorter length of stay in intensive care unit.

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Outpatient 6-Hour Levosimendan Treatment as a Bridge to Heart Transplant

Effect of levosimendan in patients with severe systolic heart failure and worsening renal function

Acute effects of levosimendan and dobutamine on QRS duration in patients with heart failure

Levosimendan in acute decompensated heart failure: systematic review and meta-analysis

Levosimendan in decompensated heart failure patients: efficacy in a Brazilian cohort. Results of the BELIEF study

Cost analysis of the treatment of acute decompensated heart failure: levosimendan versus dobutamine

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