Overview of the current use of levosimendan in France: a prospective observational cohort study

Abstract Background Following the results of randomized controlled trials on levosimendan, French health authorities requested an update of the current use and side-effects of this medication on a national scale. Method The France-LEVO registry was a prospective observational cohort study reflecting the indications, dosing regimens, and side-effects of levosimendan, as well as patient outcomes over a year. Results The patients included ( n = 602) represented 29.6% of the national yearly use of levosimendan in France. They were treated for cardiogenic shock ( n = 250, 41.5%), decompensated heart failure ( n = 127, 21.1%), cardiac surgery-related low cardiac output prophylaxis and/or treatment ( n = 86, 14.3%), and weaning from veno-arterial extracorporeal membrane oxygenation ( n = 82, 13.6%). They received 0.18 ± 0.07 µg/kg/min levosimendan over 26 ± 8 h. An initial bolus was administered in 45 patients (7.5%), 103 (17.1%) received repeated infusions, and 461 (76.6%) received inotropes and or vasoactive agents concomitantly. Hypotension was reported in 218 patients (36.2%), atrial fibrillation in 85 (14.1%), and serious adverse events in 17 (2.8%). 136 patients (22.6%) died in hospital, and 26 (4.3%) during the 90-day follow-up. Conclusions We observed that levosimendan was used in accordance with recent recommendations by French physicians. Hypotension and atrial fibrillation remained the most frequent side-effects, while serious adverse event potentially attributable to levosimendan were infrequent. The results suggest that this medication was safe and potentially associated with some benefit in the population studied

Apport des paramètres hémodynamiques dans le dépistage du rejet cellulaire ou humoral chez les patients transplantés cardiaques de plus de six mois

CAEN-BU Médecine pharmacie (141182102) / SudocSudocFranceF

Evaluation of Left Main Coronary Artery Using Optical Frequency Domain Imaging and Its Pitfalls

International audienceObjectives: We aimed to assess the quality of optical frequency domain imaging (OFDI) of the left main (LM) arterial wall and describe and analyse potential artefacts in this setting.Background: OFDI is increasingly used to assess ambiguous lesions and optimize LM percutaneous coronary intervention. However, its ability to provide artefact-free high-quality images of coronary ostia and large segments such as the LM remains uncertain.Methods: We included 42 consecutive patients who underwent OFDI, including LM imaging. Each OFDI frame was subdivided into four quadrants and analysed. The number of quadrants with artifacts was calculated within the proximal, mid, and distal LM and the first 5 mm of the left anterior descending artery (LAD) and/or left circumflex artery (LCX).Results: The quadrants analysis showed an overall artifact rate of 8.9%, mostly out-of-field (45.1%) or residual blood (44.7%) artefacts. Most artifacts were located in the proximal LM (18.6%) with a stepwise reduction of artifact rates towards distal segments (mid LM 5.8%; distal LM 3.6%, ostial LAD 2.6%, and ostial LCX 0%; p 90% of the quadrants of the LM and the ostia of its bifurcation branches. However, artifacts mainly located in the proximal LM and decreasing distally in a stepwise fashion should be considered in the interpretation of OFDI in this setting

Effects of highest dose of sacubitril/valsartan association compared to lower doses on mortality and ventricular arrhythmias

Background: Sudden cardiac death is a major healthcare issue in reduced ejection fraction heart failure (HFrEF) patients. Recently, the new association of sacubitril/valsartan showed a reduction of both ventricular arrhythmias (VA) and mortality even at low dose compared to enalapril in HF patients. The purpose of our study was to assess whether the highest dose of sacubitril/valsartan compared to lower doses may improve the rate of death and VA in a population of patients with HFrEF and with an implantable cardiac defibrillator (ICD). Methods: 104 HF patients with reduced EF under sacubitril/valsartan with an ICD were divided in 2 groups: the first one with the lower doses of sacubitril/valsartan (24/26 mg or 49 mg/51 mg twice daily) and the second with the maximal dose (97mg/103mg twice daily). The primary outcome was a composite of death or appropriate ICD therapy for VA. Results: After a median follow-up of 14 months, 39 patients were treated with lower doses and 65 patients with the highest dose. Patients from the lower doses group were older (70 [60-80] vs. 66 [60-70]; p = 0,03), more symptomatic at initiation (NYHA 3: 44% vs. 19%; p < 0,01) and more often in atrial fibrillation (31% vs. 12%; p = 0,04). The primary composite endpoint occurred in 14 patients (36%) in the low doses group versus 7 patients (11%) in high dose group (p < 0,01). This difference was particularly observed in the subgroup of patients with ischemic cardiomyopathy. In a multivariable analysis, the higher dose was independently associated with the primary outcome with an HR = 2,934 [IC 95% 1,147 – 7,504]; p = 0,03. Kaplan-Meier curve showed an early effect of the highest dose of sacubitril/valsartan association. Conclusion: Patients with HFrEF under the highest dose of sacubitril/valsartan showed better clinical outcomes with a decrease of both mortality or appropriated ICD therapies related to ventricular arrhythmias

Usefulness of a personalized algorithm-based discharge checklist in patients hospitalized for acute heart failure

Aims The aim of this study is to evaluate the usefulness of a personalized discharge checklist (PCL) based on simple baseline characteristics on mortality, readmission for heart failure (HF), and quality of care in patients hospitalized for acute HF. Methods and results We designed an algorithm to generate PCL, based on 2016 HF European Society of Cardiology Guidelines and the screening of common comorbidities in elderly HF patients. We prospectively included 139 patients hospitalized for HF from May 2018 to October 2018. A PCL was fulfilled for each patient at admission and 24 to 48 hours before the planned discharge. A control cohort of 182 consecutive patients was retrospectively included from May 2017 to October 2017. The primary composite endpoint was mortality or readmission for HF at 6 months. The secondary endpoints were mortality, readmission for HF, and quality of care (evidence-based medications, management of HF comorbidities, and planned care plan). There was no difference among baseline characteristics between PCL and control cohorts; mean age was 78.1 +/- 12.2 vs. 79.0 +/- 12.5 years old (P = 0.46) and 61 patients (43.9%) vs. 63 (34.6%) had HF with left ventricular ejection fraction (LVEF) = 40%) LVEF showed no significant difference among groups. There was a non-significant trend toward a reduction in HF readmission rate in the PCL group [38 patients (27.3%) vs. 64 patients (35.2%), HR: 0.73, 95%CI (0.49-1.09), P = 0.13]. There was no difference regarding survival or the use of evidence-based medications. A higher proportion of patients were screened and treated for iron and vitamin D deficiencies (53.2% vs. 35.7%, P < 0.01 and 73.4% vs. 29.7%, P < 0.01, respectively), as well as malnutrition supplemented in the PCL group. There was a higher referral to HF follow-up programme in the PCL group but not to telemedicine or cardiac rehabilitation programs. Conclusions In this preliminary study, the use of a PCL did not improve outcomes at 6 months in patients hospitalized for acute HF. There was a non-significant trend towards a reduction in HF readmission rate in the PCL group. In addition, the management of HF comorbidities was significantly improved by PCL with a better referral to follow-up programme. A multicentre study is warranted to assess the usefulness of a simple costless personalized checklist in a large HF patients' population

Safety and efficacy of IIb/IIIa inhibitors in combination with highly active oral antiplatelet regimens in acute coronary syndromes: A meta-analysis of pivotal trials

<p>The risk and benefit of GP-IIb/IIIa Inhibition (GPI) in combination with recent antiplatelet regimens in acute coronary syndromes (ACS) remain unassessed. The advent of fast-acting highly active oral P2Y₁₂ inhibitors questions the additional value and risk of their association with GPI. We studied the effect of GPI in combination with prasugrel and ticagrelor, compared to clopidogrel on major bleeding in pivotal randomized controlled trials in the setting of ACS, using a meta-analytic approach. A similar analysis, further including the comparison of a double versus standard dose clopidogrel regimen, was performed for the risk of the primary efficacy endpoint. The combination of GPI and recent P2Y₁₂ inhibitors was associated with a similar risk of bleeding as compared with GPI and the standard clopidogrel regimen (RR 0.92 [0.74; 1.13]). The benefit of recent regimens, including double dose clopidogrel, in reducing the primary ischemic endpoint (RR 0.86 [0.78; 0.94]) persisted in those treated with GPI. Although GPI use was associated with a consistent increase in the risk of bleeding in both recent (RR 1.27 [1.05–1.55]) and standard regimens (RR 2.01 [1.64–2.47]), the relative magnitude of such an increase was lower in association with prasugrel or ticagrelor as compared with clopidogrel. The risk of bleeding using a combination of GPI and oral antiplatelet regimens is mainly related to the use of GPI and not the oral antiplatelet regimen. Considering the absence of increased risk of bleeding and the persistence of the benefit of recent P2Y₁₂ regimens in combination with GPI as compared with the standard clopidogrel regimen, the use of such a combination within the guidelines is supported by our findings.</p

Remote haemodynamic-guided heart failure management in France: Results from the CardioMEMS HF System Post-Market Study (COAST) French cohort

International audienceBackground: Previous studies have demonstrated the benefit of a haemodynamic-guided management strategy with the CardioMEMS™ HF System. No data from French patients have been published.Aims: To analyse the feasibility, safety and clinical benefit of the CardioMEMS™ HF System in 103 French patients included in the CardioMEMS HF System Post-Market Study (COAST).Methods: Prospective open-label cohort of New York Heart Association class III patients with at least one heart failure hospitalization in the 12 months before enrolment, regardless of left ventricular ejection fraction. The primary safety endpoints assessed the freedom from device/system-related complications and from pressure sensor failure at 2 years after implantation. The primary efficacy endpoint was evaluated comparing the rate of heart failure hospitalization during the year before and the year after implantation.Results: At 2 years, there were no device/system-related complications or pressure sensor failures (P &lt; 0.0001). There were 179 heart failure hospitalizations in the year before implantation compared with 79 in the year after implantation (risk reduction 50.3%; rate ratio 0.50, 95% confidence interval 0.38–0.66; P &lt; 0.0001). During the 2 years of follow-up, pulmonary artery pressures were lowered significantly (mean pulmonary artery pressure –3.7 ± 6.3 mmHg; P &lt; 0.0001), with a significant improvement in functional class and quality of life.Conclusions: In the French cohort of the COAST study, we have demonstrated that the CardioMEMS™ HF System is a reliable device, with no device/system-related complications or pressure sensor failures. Patients in this open-label cohort had a significant reduction in pulmonary artery pressures, with an improvement in New York Heart Association classification and quality of life, and a 50% reduction in the heart failure hospitalization rate in the year following implantation compared with the previous year