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Left ventricular remodeling (LVR) is common and associated with adverse outcome after ST-elevation myocardial infarction (STEMI). We aimed to investigate the association between left atrial (LA) mechanical function using speckle tracking imaging and early LVR at follow-up in STEMI patients.Baseline 3D thoracic echocardiograms were performed within 48 h following admission and at a median follow-up of 7 months after STEMI. A 20% increase in the left ventricular (LV) end-diastolic volume compared to baseline at follow-up was defined as LVR. LA global longitudinal strain was evaluated for the reservoir, conduit, and contraction (LASct) phases.A total of 121 patients without clinical heart failure (HF) were prospectively included, between June 2015 and October 2018 (age 58.3 ± 12.5 years, male 98 (81%)). Baseline and follow-up LV ejection fraction (LVEF) were 46.8% [41.0, 52.9] and 52.1% [45.8, 57.0] respectively (p .001). Compared to other patients, those with LVR had significantly lower values of LASct at baseline (-7.4% [-10.1, -6.5] vs. -9.9% [-12.8, -8.1], p .01), both on univariate and baseline LV volumes-adjusted analyses. Baseline LA strain for reservoir and conduit phases were not associated with significant LVR at follow-up. Intra- and interobserver analysis showed good reproducibility of LA strain.Baseline LASct may help identifying patients without HF after STEMI who are at higher risk of further early LVR and subsequent HF and who may benefit from more intensive management.

Aims In symptomatic patients with heart failure and reduced ejection fraction (HFrEF), recent international guidelines recommend initiating four major therapeutic classes rather than sequential initiation. It remains unclear how this change in guidelines is perceived by practicing cardiologists versus heart failure (HF) specialists. Methods and results An independent academic web-based survey was designed by a group of HF specialists and posted by email and through various social networks to a broad community of cardiologists worldwide 1 year after the publication of the latest European HF guidelines. Overall, 615 cardiologists (38 [32-47] years old, 63% male) completed the survey, of which 58% were working in a university hospital and 26% were HF specialists. The threshold to define HFrEF was

In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients.The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE.Two hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p 0.0001).The risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication.NCT02323503.

Background Acute heart failure (AHF) is a common serious condition that contributes to about 5% of all emergency hospital admissions in Europe. Hypothesis To assess the type and chronology of the first AHF symptoms before hospitalization and to examine the French healthcare system pathways before, during and after hospitalization. Material and Methods A retrospective observational study including patients hospitalized for AHF Results 793 patients were included, 59.0% were men, 45.6% identified heart failure (HF) as the main cause of hospitalization; 36.0% were unaware of their HF. Mean age was 72.9 ± 14.5 years. The symptoms occurring the most before hospitalization were dyspnea (64.7%) and lower limb edema (27.7%). Prior to hospitalization, 47% had already experienced symptoms for 15 days; 32% of them for 2 months. Referral to hospital was made by the emergency medical assistance service (SAMU, 41.6%), a general practitioner (GP, 22.3%), a cardiologist (19.5%), or the patient (16.6%). The modality of referral depended more on symptom acuteness than on type of symptoms. A sudden onset of AHF symptoms led to making an emergency call or to spontaneously attending an emergency room (ER), whereas cardiologists were consulted when symptoms had already been present for over 15 days. Cardiologists referred more patients to cardiology departments and fewer patients to the ER than general practitioners or the SAMU. Conclusion This study described the French healthcare system pathways before, during and after hospitalization AHF. AHF clinic network should be developed to provide adequate care for all HF patients and create awareness regarding AHF symptoms.

OBJECTIVES We sought to investigate the safety and potential benefit of administrating glycoprotein IIb-IIIa inhibitors (GPIs) on top of more potent P2Y12 inhibitors. BACKGROUND A number of clinical trials, performed at a time when pretreatment and potent platelet inhibition was not part of routine clinical practice, have documented clinical benefits of GPI in ST-segment elevation myocardial infarction (STEMI) patients at the cost of a higher risk of bleeding. METHODS We used the data of a prospective, ongoing registry of patients admitted for STEMI in our center. For the purpose of this study only patients presenting for primary percutaneous coronary intervention and pretreated with new P2Y12 inhibitors (prasugrel or ticagrelor) were included. We compared patients who received GPI with those who did not. RESULTS Eight hundred twenty-four STEMI patients were included in our registry; GPIs were used in 338 patients (41%). GPI patients presented more often with cardiogenic shock and Thrombolysis in myocardial infarction (TIMI) flow grade

Background An accurate estimation of the duration of atrial fibrillation is critical for its safe management. Recent studies suggested that copeptin, carbohydrate antigen-125, galectin-3 and growth differentiation factor-15 are increased in atrial fibrillation. We examined the ability of these markers to identify patients presenting with atrial fibrillation of ≤48 versus >48 h duration. Methods Retrospective analysis of a prospective study that included patients with atrial fibrillation of known duration. Results A total of 98 patients were analysed, 47 with atrial fibrillation ≤48 h and 51 with >48 h. In patients presenting with atrial fibrillation of ≤48 versus >48 h duration, the mean carbohydrate antigen-125 concentration was 16.9 ± 12.5 versus 30.9 ± 36.3 U/mL ( P = 0.01), and growth differentiation factor-15 concentration was 1320 ± 889 versus 2608 ±2163 pg/mL ( P Conclusion The plasma concentrations of carbohydrate antigen-125, growth differentiation factor-15 and copeptin, but not galectin-3, are higher in patients presenting with atrial fibrillation of >48 h duration than in those with atrial fibrillation ≤48 h. The ability to discriminate recent atrial fibrillation offered by carbohydrate antigen-125 and growth differentiation factor-15 seems high.

AimsNo data exist concerning the clinical performances of the subcutaneous implantable cardioverter-defibrillator (S-ICD) atrial fibrillation (AF) detection algorithm. We aimed to study the performances and implications of the latter in a ‘real-world’ setting.Methods and resultsBetween July 2017 and August 2019, 155 consecutive S-ICD recipients were included. Endpoint of the study was the incidence of de novo or recurrent AF using a combined on-site and remote-monitoring follow-up approach. After a mean follow-up of 13 ± 8 months, 2531 AF alerts were generated for 55 patients. A blinded analysis of the 1950 subcutaneous electrocardiograms available was performed. Among them 47% were true AF, 23% were premature atrial contractions or non-sustained AF, 29% were premature ventricular contractions or non-sustained ventricular tachycardia, and 1% were misdetection. Fourteen percent (21/155) patients had at least one correct diagnosis of AF by the S-ICD algorithm. One patient presented symptomatic paroxysmal AF not diagnosed by the S-ICD algorithm (false negative patient). Patient-based sensitivity, specificity, positive, and negative predictive values were respectively 95%, 74%, 38%, and 99%. Among patients with at least one correct diagnosis of AF, 38% (8/21) had subsequent clinical implications (anticoagulation initiation or rhythm control therapies).ConclusionThe S-ICD AF detection algorithm yields a high sensitivity for AF diagnosis. Low specificity and positive predictive value contribute to a high remote monitoring-notification workload and underline the necessity of a manual analysis. Atrial fibrillation diagnosis by the S-ICD AF detection algorithm might lead to significant therapeutic adjustments.

An increase in left ventricular volumes between baseline and follow-up imaging is the main criteria for the quantification of left ventricular remodelling (LVR) after ST-elevation myocardial infarction (STEMI), but without consensual definition. We aimed to review the criteria used for the definition of LVR based on cardiac magnetic resonance imaging (CMR) in STEMI patients. A systematic literature search was conducted using MEDLINE and the Cochrane Library from January 2010 to August 2019. Thirty-seven studies involving 4209 patients were included. Among these studies, 30 (81%) used a cut-off value for defining LVR, with a pooled LVR prevalence estimate of 22.8%, 95% CI [19.4-26.7%] and a major between-study heterogeneity (I2 = 82%). The seven remaining studies (19%) defined LVR as a continuous variable. The definition of LVR using CMR following STEMI is highly variable, among studies including highly selected patients. A 20% increase or a 15% increase in left ventricular volumes between a baseline and a follow-up CMR imaging were the two most common criterion (13 [35%] and 9 [24%] studies, respectively). The most frequent LVR criterion was a 20% increase in end-diastolic volumes or a 15% increase in end-systolic volumes. A composite cut-off value of a 12 to 15% increase in end-systolic volume and a 12 to 20% increase in end-diastolic volume using a follow-up CMR imaging 3 months after STEMI might be proposed as a consensual cut-off for defining adverse LVR for future large-sized, prospective studies with serial CMR imaging and long-term follow-up in unselected patients.

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)

Purpose We aimed to compare different methods for semi-quantitative analysis of cardiac retention of bone tracers in patients with cardiac transthyretin amyloidosis (ATTR). Methods Data from 67 patients with ATTR who underwent both conventional whole-body scan and a CZT myocardial SPECT (DSPECT, Spectrum Dynamics) 3 h after injection of 99mTc-labeled bone tracer were analyzed. Visual scoring of cardiac retention was performed on whole-body scan according to Perugini 4-point grading system from 0 (no uptake) to 3 (strong cardiac uptake with mild/absent bone uptake). A planar heart-to-background (H:B) ratio was calculated using whole-body scan (wb-H:B). CZT SPECT was quantified using three methods: planar H:B ratio calculated from anterior reprojection (ant-H:B), left anterior oblique reprojection (LAO-H:B), and 3D-H:B ratio calculated from transaxial slices as mean counts in a VOI encompassing the heart divided by background VOI in the contralateral lung. Interventricular septal thickness was obtained using echocardiography. Results H:Bs obtained from planar and reprojected data were not statistically different (wb-H:B, 2.05 ± 0.64, ant-H:B, 1.97 ± 0.61, LAO-H:B, 2.06 ± 0.64, all p = ns). However, 3D-H:B was increased compared to planar H:Bs (3D-H:B, 4.06 ± 1.77, all p r = 0.45, p Conclusion 3D semi-quantitative analysis of CZT SPECT optimized the assessment of 99mTc-labeled bone tracer myocardial uptake in patients with cardiac amyloidosis.

Background Certain telemedicine programmes for heart failure (HF) have been shown to reduce all-cause mortality and heart failure-related hospitalisations, but their cost-effectiveness remains controversial. The SCAD programme is a home-based interactive telemonitoring service for HF, which is one of the largest and longest-running telemonitoring programmes for HF in France. The objective of this cost-utility analysis was to evaluate the cost-effectiveness of the SCAD programme with respect to standard hospital-based care in patients with HF. Methods A Markov model simulating hospitalisations and mortality in patients with HF was constructed to estimate outcomes and costs. The model included six distinct health states (three ‘not hospitalised’ states, two ‘hospitalisation for heart failure’ states, both depending on the number of previous hospitalisations, and one death state). The model lifetime in the base case was 10 years. Model inputs were based on published literature. Outputs (costs and QALYs) were compared between SCAD participants and standard care. Deterministic and probabilistic sensitivity analyses were performed to assess uncertainty in the input parameters of the model. Results The number of quality-adjusted life years (QALYs) was 3.75 in the standard care setting and 4.41 in the SCAD setting. This corresponds to a gain in QALYs provided by the SCAD programme of 0.65 over the 10 years lifetime of the model. The estimated total cost was €30,932 in the standard care setting and €35,177 in the SCAD setting, with an incremental cost of €4245. The incremental cost-effectiveness ratio (ICER) for the SCAD programme over standard care was estimated at €4579/QALY. In the deterministic sensitivity analysis, the variables that had the most impact on the ICER were HF management costs. The likelihood of the SCAD programme being considered cost-effective was 90% at a willingness-to-pay threshold of €11,800. Conclusions Enrolment of patients into the SCAD programme is highly cost-effective. Extension of the programme to other hospitals and more patients would have a limited budget impact but provide important clinical benefits. This finding should also be taken into account in new public health policies aimed at encouraging a shift from inpatient to ambulatory care.

Summary Background The use of a discharge checklist may decrease heart failure readmission rate. Aims We aimed to evaluate the usefulness of a checklist in patients hospitalized for heart failure, in terms of mortality, cardiovascular mortality and readmission rates, and quality of care, including therapeutic optimization and careplan planning. Methods We prospectively used a discharge checklist in 103 patients hospitalized for heart failure between July 2015 and January 2016. Quality of care and outcomes were compared with a retrospective cohort of 137 patients with same inclusion criteria, hospitalized between June 2014 and December 2014. The primary endpoints were total and cardiovascular mortality and readmissions for heart failure at 6 months. The secondary endpoint was quality of care rendered, measured by evidence-based medications, appropriate medication uptitration and planned discharge care. Results At 6 months, there were no differences between the checklist and control cohorts in the rates of all-cause mortality (10.7% vs. 13.1%; P = 0.57), cardiovascular mortality (8.7% vs. 10.9%; P = 0.58) and readmission (29.1% vs. 32.1%; P = 0.62). Follow-up after discharge was better planned in the checklist group. The use of the checklist yielded therapeutic optimization with a higher dose of beta-blockers and renin-angiotensin-aldosterone system blockers, especially in patients with a reduced left ventricular ejection fraction ( Conclusions The use of a simple discharge checklist in patients with acute heart failure showed no benefit in terms of readmission and mortality rates; however, it yielded better quality of care, including therapeutic optimization and careplan planning.

Aims The risk and incidence of cardiovascular (CV) immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) in cancer patients remain unknown. Methods and results We systematically reviewed all randomized clinical trials (RCTs) including at least one ICI-containing arm and available CV adverse event (CVAE) data in cancer patients in the ClinicalTrials.gov registry, Medline, and the Cochrane CENTRAL Register of Controlled Trials, up to 31 August 2020 (CRD42020165672). The primary outcome was the summary risk of 16 different CVAEs associated with ICI exposure vs. controls (placebo and non-placebo) in RCTs. CVAEs with an increased risk associated with ICI exposure were considered as CV irAEs. Summary incidences of CV irAEs identified in our primary outcome analyses were computed using all RCTs including at least one ICI-containing arm. We used a random-effects meta-analysis to obtain Peto odds ratios (ORs) with 95% confidence intervals (CIs) and logit transformation and inverse variance weighting to compute summary incidences. Sixty-three unique RCTs with at least one ICI-containing arm (32 518 patients) were retrieved, among which 48 (29 592 patients) had a control arm. Among the 16 CVAEs studied, ICI use was associated with an increased risk of 6 CV irAEs including myocarditis, pericardial diseases, heart failure, dyslipidemia, myocardial infarction, and cerebral arterial ischaemia with higher risks for myocarditis (Peto OR: 4.42, 95% CI: 1.56–12.50, P Conclusion In RCTs, ICI use was associated with six CV irAEs, not confined to myocarditis and pericarditis.

Background Left ventricular remodelling that frequently occurs after acute myocardial infarction is associated with an increased risk of heart failure and cardiovascular death. Although several risk factors have been identified, there is still no marker in clinical use to predict left ventricular remodelling. Plasma concentration of coenzyme Q10, which plays a key role in mitochondrial energy production and as an antioxidant, seems to be negatively correlated with left ventricular function after acute myocardial infarction. Objective The goal of our study was to determine whether the plasma coenzyme Q10 baseline concentrations at time of the ST-elevation myocardial infarction (STEMI) could predict left ventricular remodelling at six months’ follow-up. Methods Sixty-eight patients who were admitted to hospital for STEMI and successfully revascularized with primary percutaneous coronary intervention were recruited. All patients underwent a 3D-echocardiography examination within the first four days after percutaneous coronary intervention and six months later then divided into two groups based on the presence or not of left ventricular remodelling. Plasma coenzyme Q10 concentration at the time of percutaneous coronary intervention was determined using high-performance liquid chromatography-tandem mass spectrometry. Results While we found similar plasma coenzyme Q10 concentrations compared with other studies, no association was evidenced between coenzyme Q10 concentrations and left ventricular remodelling ( P = 0.89). Conclusion We found no evidence for using plasma coenzyme Q10 concentration as an early prediction marker of left ventricular remodelling after STEMI.

Background/Introduction Left ventricular remodeling (LVR) remains common and is associated with outcomes in patients with ST-elevation myocardial infarction (STEMI). Left atrial (LA) volume has been described as a predictor of outcomes in the latter population. Purpose To investigate the association between LA mechanical function using speckle tracking imaging and LVR at follow-up in STEMI patients. Methods Baseline 3D transthoracic echocardiograms were performed in 121 STEMI patients. LA global longitudinal strain was reported separately for the reservoir (LASr), conduit (LAScd), and contraction (LASct) phases. Follow-up echocardiograms were performed at 6 months. Results Mean age was 58.3±12.5 years and 98 (81%) were men. Baseline left ventricular ejection fraction (LVEF) was 46.8% [41.0, 52.9] and significantly improved to 52.1% [45.8, 57.0] at follow-up, (p Conclusion(s) The three components of baseline LA strain were associated with LVEF at follow-up in patients with STEMI. Some of these components were also significantly associated with lower LVEF at baseline or predictive of a significant increase in left ventricular volumes during follow-up, indicating LVR. Funding Acknowledgement Type of funding source: None

Background/Introduction An increase in left ventricular volumes between baseline and follow-up imaging is the main criteria for the quantification of left ventricular remodeling after ST-elevation myocardial infarction, but without consensual definition. Purpose We aimed to review the criterion used for the definition of left ventricular remodeling based on cardiac magnetic resonance imaging in studies including patients with ST-elevation myocardial infarction. Methods A systematic literature search was conducted using MEDLINE and the Cochrane Library from January 2010 to August 2019. Thirty-seven studies involving a total of 4209 patients were included. Results The median age of the patients was 59 years, 82% were male, and 93% underwent primary percutaneous coronary intervention. The median follow-up duration was 6 months (range, 3–12), and the second cardiac magnetic resonance session was performed at 6 months in 14 (38%) studies. Among these studies, 30 (81%) used a cut-off value for defining left ventricular remodeling, with a pooled left ventricular remodeling prevalence estimate of 22.8%, 95%-CI[19.4%-26.7%], and a major between-study heterogeneity (I2=82%). The seven remaining studies (19%) defined left ventricular remodeling as a continuous variable. A 20% increase in end-diastolic volumes or a 15% increase in end-systolic volumes between a baseline and a follow-up cardiac magnetic resonance imaging were the two most common criterion (13 [35%] and 9 [24%] studies, respectively). Seven studies used both end-diastolic and end-systolic vleft ventricular volumes. Conclusion(s) The definition of left ventricular remodeling using cardiac magnetic resonance following ST-elevation myocardial infarction is highly variable, among studies including highly selected patients. The most frequent left ventricular remodeling criterion were a 20% increase in end-diastolic volumes or a 15% increase in end-systolic volumes. A composite cut-off value of a 12% to 15% increase in end-systolic volume and a 12% to 20% increase in end-diastolic volume using a follow-up cardiac magnetic resonance imaging 1 to 3 months after myocardial infarction might be proposed as a consensual cut-off for defining adverse left ventricular remodeling for future large-sized, prospective studies with serial cardiac magnetic resonance imaging and long-term follow-up in unselected patients. Funding Acknowledgement Type of funding source: None

Background SCAD is a 3-month telemonitoring program for HF patients, associated with therapeutic education, proposed after an acute HF episode. SCAD is based on an interactive algorithm allowing to generate educative messages and alarms based on patients' responses registered on a digital tablet. It is funded by the French Health Insurance through a pilot program: ETAPES (470€/patient). Purpose To describe the profile of patients using SCAD & assess the medico-economic impact of the SCAD system. Methods Multicenter retrospective cohort study using SCAD data matched with French Health Insurance data. All patients telemonitored by SCAD in 7 centers have been included, since 01/01/2010 to 12/31/2016. Only direct costs were considered, estimated from a societal perspective limited to reimbursements. Analyses were performed to assess the difference in healthcare consumptions and costs between the year before and the year after inclusion in the SCAD program. Patients who died in the 12 months after SCAD initiation were excluded. Results 627 patients benefited from SCAD program between 01/01/2010 and 12/31/2016 and were retrieved in French Health Insurance data through probabilistic matching. Out of the 627 patients, 99 died in the 12 months after SCAD initiation. Analyses were performed on 528 patients.72.2% were male, mean age was 66.0 years old and mean BMI 28.2. HFrEF represented 51.9% of patients, HFmrEF 25.9% and HFpEF 22.2%. 58.0% were in NYHA class 2 at baseline, 29.2% in class 3, 8.5% in class 1 and 4.3% in class 4. Mean Charlson Comorbidity Index score was 2.6 at baseline. Patients reported their level of fatigue (10 representing significant fatigue) and morale (10 = good morale) at baseline: mean fatigue=4.0/10 & mean morale=7.4/10. Medico economic results are presented in table 1 and show an important & significant decrease of hospitalizations costs and some transfer of cost toward ambulatory care. Conclusion On the year following remote monitoring, total health expenditure has been reduced by 18% on average (mean=3 210€/patient) and 42% in median (5 500€/patient) vs 12 months before. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This analysis has been funded through an institutional grant from Amgen

International audience; Importance Limited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after an immune-related adverse event (irAE). Objective To identify the recurrence rate of the same irAE that prompted discontinuation of ICI therapy after an ICI rechallenge in patients with cancer and to identify the clinical features associated with such recurrences. Design, Setting, and Participants This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from the World Health Organization database VigiBase, which contains case reports from more than 130 countries. Case reports were extracted from database inception (1967) to September 1, 2019. All consecutive ICI cases with at least 1 associated irAE were included. Main Outcomes and Measures The primary outcome was the rate of recurrence of the initial irAE after an ICI rechallenge. Secondary outcomes included the factors associated with the recurrence after a rechallenge among informative rechallenges, the recurrence rate according to the ICI regimen (anti-programmed cell death 1 or anti-programmed cell death ligand 1 monotherapy, anti-cytotoxic T-lymphocyte antigen-4 monotherapy, or combination therapy), and the rate of occurrence of a different irAE after a rechallenge. Results A total of 24 079 irAE cases associated with at least 1 ICI were identified. Among the irAEs, 452 of 6123 irAEs associated with ICI rechallenges (7.4%) were informative rechallenges. One hundred thirty recurrences (28.8%; 95% CI, 24.8-33.1) of the initial irAE were observed. In a rechallenge, colitis (reporting odds ratio [OR], 1.77; 95% CI, 1.14-2.75; P = .01), hepatitis (reporting OR, 3.38; 95% CI, 1.31-8.74; P = .01), and pneumonitis (reporting OR, 2.26; 95% CI, 1.18-4.32; P = .01) were associated with a higher recurrence rate, whereas adrenal events were associated with a lower recurrence rate (reporting OR, 0.33; 95% CI, 0.13-0.86; P = .03) compared with other irAEs. Conclusions and Relevance This cohort study found a 28.8% recurrence rate of the same irAE associated with the discontinuation of ICI therapy after a rechallenge with the same ICI. Resuming ICI therapy could be considered for select patients, with appropriate monitoring and use of standard treatment algorithms to identify and treat toxic effects.

Aims The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF. Methods and results A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody. Conclusion Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.

Background/Introduction Left ventricular remodeling following ST-elevation myocardial infarction (STEMI) is associated with poor outcome. Neprilysin inhibition leads to improved outcome in patients with altered left ventricular ejection fraction (LVEF). Purpose We aimed to assess the association between serum levels of neprilysin and left ventricular (LV) volumes, function and remodeling in STEMI patients with successful myocardial reperfusion. Methods Sixty-eight patients were admitted for STEMI and had both plasma neprilysin measurement at baseline and 3D transthoracic echocardiogram at baseline and at follow-up (7 months). We compared 3 groups: a group with a low-level of plasma neprilysin ( Results Median age was 58.5±12.8 years and 56 (82.4%) were men. Median LVEF was 45.0±8.5%. Baseline characteristics were comparable among groups. At baseline there was a non-significant trend towards lower end-diastolic volume (p=0.07) but significantly lower LVEF in the high neprilysin group (46.4±8.3%, 47.1±8.1% and 39.1±6.9%, p Conclusion(s) Initial high neprilysin levels may identify patients with stunned myocardium early after STEMI, with a recovery of contractility leading to improved LVEF at follow-up. Funding Acknowledgement Type of funding source: None

We aimed to investigate the association between use of anticancer drugs and cardiovascular-related hospitalization (CVRH) among patients with metastatic colorectal cancer (mCRC). A cohort study, the Anticancer Vigilance of Cardiac Events (AVOCETTE) Study, was conducted using data from the digestive tumor registry of a French county, the Département du Calvados. Incident mCRC cases diagnosed between 2008 and 2014 were included. The follow-up end date was December 31, 2016. Data from the county hospital center pharmacy and medical information departments were matched with the registry data. A competing-risks approach was used. Statistical tests were 2-sided. A total of 1,116 mCRC patients were included, and they were administered 12,374 rounds of treatment; fluorouracil, oxaliplatin, irinotecan, and bevacizumab were most common drugs used. A total of 208 CVRH events occurred in 145 patients (13.0%). The International Cancer Survival Standards type 1 standardized incidence was 84.0 CVRH per 1,000 person-years (95% confidence interval: 72.6, 95.5). Anticancer drugs were not associated with a higher incidence of CVRH. Male sex, increasing age, a prior history of CVRH, and a higher Charlson comorbidity index score were associated with a higher incidence of CVRH. CVRH was significantly associated with higher all-cause mortality (multivariable hazard ratio = 1.58, 95% confidence interval: 1.28, 1.95). In this study, anticancer drugs were not associated with a higher incidence of CVRH in mCRC patients.

Summary Background The risk of cardiovascular adverse events from rapidly accelerated fibrosarcoma B-type (BRAF) and mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors is not fully characterized. Aim To evaluate the cardiovascular adverse events risks related to BRAF and/or MEK inhibitors in randomized placebo-controlled clinical trials and in the real-life setting. Methods We used two approaches. First, we conducted a systematic review and meta-analysis of randomized placebo-controlled clinical trials reporting the incidence of cardiovascular adverse events for BRAF and/or MEK inhibitors in cancer patients. Second, we performed a disproportionality analysis, using age- and sex-adjusted reporting odds ratios (arORs) and their 95% confidence intervals (CIs) from the World Health Organization's pharmacovigilance database (VigiBase®) of anticancer drug-associated reports, to investigate real-life data. Results MEK inhibitors increased the risk of ejection fraction decrease (odds ratio [OR] 3.35, 95% CI 1.58–7.07), peripheral oedema (OR 2.87 95% CI 1.93–4.27) and syncope (OR 6.71, 95% CI 3.00–14.99) compared with placebo in randomized placebo-controlled clinical trials. BRAF and MEK inhibitor combination therapy further increased the risk of ejection fraction decrease. In the disproportionality analysis, we found over-reporting of ejection fraction decrease (arOR 8.42, 95% CI 7.03–10.09), peripheral oedema (arOR 1.39, 95% CI 1.17–1.66), syncope (arOR 1.56, 95% CI 1.22–1.99), torsade de pointes/QT prolongation (arOR 6.13, 95% CI 5.04–7.47) and supraventricular arrhythmias (arOR 1.50, 95% CI 1.21–1.85) for BRAF and MEK inhibitors. BRAF and MEK inhibitors were not associated with hypertension in either approach. Conclusions In conclusion, MEK inhibitors increase the risk of ejection fraction decrease, peripheral oedema and syncope in randomized placebo-controlled clinical trials. Real-life data confirm these findings, and suggested additional risks of torsade de pointes/QT prolongation and supraventricular arrhythmias with BRAF/MEK inhibitors.

Background Cardiac resynchronization therapy has been shown to benefit selected patients with heart failure and reduced ejection fraction. Older patients have been underrepresented in randomized trials. This study was conducted to determine whether predictive factors for cardiac resynchronization therapy outcomes differ in patients older and younger than 75 years of age. Methods Consecutive patients who received a cardiac resynchronization device cardiac resynchronization therapy between 2013 and 2016 in our center were retrospectively included in this cohort study. The primary endpoint was cardiac resynchronization therapy effectiveness, which was defined as survival for one year with both no heart failure hospitalization and improvement by one or more NYHA class. The secondary endpoints were mortality, complications, and device therapies. Results Among the 243 patients included, 102 were ≥ 75 years old. Cardiac resynchronization therapy effectiveness was observed in 70 patients (50%) p = 0.69). NYHA class ≥III (OR = 6.02; CI95% [1.33–18.77], p = 0.002) was a predictive factor for cardiac resynchronization therapy effectiveness only in the ≥75-year-old group, while atrial fibrillation was independently negatively associated with the primary endpoint in the p = 0.001). The one-year mortality rate was 14%, with no difference between age groups. Rescue cardiac resynchronization therapy and atrial fibrillation were independent predictive factors for mortality in both age groups. Eighty-two complications occurred in 45 patients (19%), with no difference between groups. Defibrillator use and QRS duration were independent predictive factors for complications in both age groups. There was no difference between groups considering device therapies. Conclusion At one year, cardiac resynchronization therapy response is not compromised by patient age. In older patients, highly symptomatic individuals with NYHA class ≥III have better outcomes after cardiac resynchronization therapy.

Background Mineralocorticoid receptor antagonists ( MRA s) have emerged as potential atrial fibrillation ( AF ) preventive therapy, but inconsistent results have been reported. We aimed to examine the effects of MRA s on AF occurrence and explore factors that could influence the magnitude of the effect size. Methods and Results PubMed, Embase, and Cochrane Central databases were used to search for randomized clinical trials and observational studies addressing the effect of MRA s on AF occurrence from database inception through April 03, 2018. We performed a systematic review and random effects meta‐analyses to compute odds ratios with 95% CI s. Meta‐regression was then applied to explore the sources of between‐study heterogeneity. We included 24 studies, 11 randomized clinical trials and 13 observational cohorts, representing a total number of 7914 patients (median age: 64.2 years; median left ventricular ejection fraction: 49.7%; median follow‐up: 12.0 months), 2843 (35.9%) of whom received MRA therapy. Meta‐analyses showed a significant overall reduction in AF occurrence in the MRA ‐treated patients versus the control groups (15.0% versus 32.2%; odds ratio, 0.55; 95% CI , 0.44–0.70 [ P AF episodes ( odds ratio , 0.42; 95% CI , 0.31–0.59 [ P I 2 =54%; P =0.0008). Meta‐regression analyses showed that effect size was significantly associated with older studies and higher AF occurrence rate in the control groups. Conclusions MRA s seem to be effective in AF prevention, especially regarding recurrent AF episodes.

The identification of cardiac sarcoidosis is challenging as there is no gold standard consensually admitted for its diagnosis. The aim of this study was to evaluate the diagnostic value of the assessment of cardiac dynamic 18F-fluoro-2-deoxyglucose positron emission tomography (18F-FDG PET/CT) and net influx constant (Ki) in patients suspected of cardiac sarcoidosis. Data obtained from 30 biopsy-proven sarcoidosis patients suspected of cardiac sarcoidosis who underwent a 50-min list-mode cardiac dynamic 18F-FDG PET/CT after a 24 h high-fat and low-carbohydrate diet were analyzed. A normalized coefficient of variation of quantitative glucose influx constant, calculated as the ratio: standard deviation of the segmental Ki (min−1)/global Ki (min−1) was determined using a validated software (Carimas® 2.4, Turku PET Centre). Cardiac sarcoidosis was diagnosed according to the Japanese Ministry of Health and Welfare criteria. Receiving operating curve analysis was performed to determine sensitivity and specificity of cardiac dynamic 18F-FDG PET/CT analysis to diagnose cardiac sarcoidosis. Six out of 30 patients (20%) were diagnosed as having cardiac sarcoidosis. Myocardial glucose metabolism was significantly heterogeneous in patients with cardiac sarcoidosis who showed significantly higher normalized coefficient of variation values compared to patients without cardiac sarcoidosis (0.513 ± 0.175 vs. 0.205 ± 0.081; p = 0.0007). Using ROC curve analysis, we found a cut-off value of 0.38 for the diagnosis of cardiac sarcoidosis with a sensitivity of 100% and a specificity of 91%. Our results suggest that quantitative analysis of cardiac dynamic 18F-FDG PET/CT could be a useful tool for the diagnosis of cardiac sarcoidosis.

Patients over 75 account for more than one third of those presenting with myocardial infarction and more than 50% of intrahospital mortality. There are no specific guidelines for the management of acute coronary syndromes (ACS) in the elderly. Although antithrombotic therapy seems to be effective and safe in such patients, it requires specific precautions and treatment adjustments because of the higher bleeding risk due to comorbidities such as renal function impairment and malnutrition. Scientific evidence concerning elderly patients is scarce as they are either excluded or underrepresented in most randomized trials. Overall, the antithrombotic therapy needs to be adapted to avoid complications, mainly bleeding complications, without compromising the effectiveness of the treatment in this high-risk population. In the present paper, we review the current treatment strategies in ACS while focusing on data concerning the elderly, according to available data in pivotal trials and in both AHA/ACC and ESC guidelines.

Background Despite the emergence of new therapies, Pulmonary Hypertension (PH) still has a high mortality. Several clinical, echocardiographic, biological or hemodynamic prognostic factors have been identified but are of limited predictive value for survival. We aimed to assess whether heart rate (HR) and all ECG abnormalities measured on a 12-lead ECG may help to better identify patients at high risk of death in this population. Methods and results 296 patients followed in a registry were included with all types of PH, except group 2 of the WHO clinical classification. After a median follow-up of 10 years, age, male sex, NYHA III/IV status and, among all ECG parameters, HR and corrected QT interval were associated with mortality. In multivariate analysis, HR, age and male sex remained significant independent predictors of mortality. HR has a higher predictive value in the 238 patients in sinus rhythm. In addition, only HR was significantly correlated with clinical and hemodynamic PH prognostic factors. Conclusion HR measured on a 12-lead ECG at the time of the diagnosis is a strong independent predictor of mortality in PH patients.

3094 Background: Venous thromboembolic event (VTE) is a frequent complication of cancer, as of some classical cancer therapy, like chemotherapy and surgery. The advent of new therapies such as immunotherapy and targeted therapies has meant that new therapies may be associated with VTE. Reliable data concerning the association between ADs and VTE are scarce. Methods: On March 1st, 2020 we utilized VigiBase (International pharmacovigilance database) and performed a disproportionality analysis using reporting odds ratios (ROR) to determine the association between the 206 FDA- or EMA-labeled ADs and VTE, defined as deep vein thrombosis and pulmonary embolism. RORs were adjusted (aRORs) on population characteristics including the cancer risk of VTE with the primary tumor site according to Khorana classification and metastatic status. Results: A total of 50,438 VTE cases associated with at least one AD were identified. Thirteen ADs were associated with higher reporting of VTE of which 2 represented new VTE associations not previously confirmed in the summary of product characteristics or literature including sipuleucel-t and megestrol. ADs more reported with VTE were lenalidomide (n:5,796), bevacizumab (n:2,780) and thalidomide (n:1,700). ADs associated-VTE occurred mainly during the first 6 months after AD initiation. Conclusions: Although cancer itself may generate VTE, we identified 13 ADs associated with VTE overreporting. Recognition of AD most likely to cause VTE can help raise practitioner awareness and lead to earlier diagnosis and treatment. Futures studies should include ADs in VTE risk evaluation and evaluate the management of VTE when recurrences occur under AD favoring VTE. ClinicalTrial registration number: NCT04696250.

International audience; Objectives: We conducted a retrospective study to characterize the cardiac complications in patients with genetically confirmed type 1 facioscapulohumeral dystrophy. Methods: We reviewed baseline cardiac investigations, including electrocardiogram, Holter electrocardiogram and echocardiogram, as well as cardiac complications that occurred during follow-up in 56 adult patients (37 men, mean duration of disease: 20 years). Results: Baseline evaluation revealed minor cardiac anomalies in 23 patients including incomplete right bundle branch block (iRBBB) in 13 patients (23%). Over a mean follow-up period of 7.2 years, there was no cardiac death, no patient developed cardiomyopathy, and 28 patients (50%) experienced cardiac anomalies. Among these patients, 3 had one or more major events (heart failure and/or atrial fibrillation). The remaining 25 patients presented minor cardiac anomalies of which iRBBB was the most frequent (25%). Conclusions: Cardiac anomalies identified during the follow-up of patients with type 1 facioscapulohumeral dystrophy are mainly minor anomalies, dominated by the iRBBB.

Background An accurate estimate of the duration of atrial fibrillation (AF) is critical for its safe and successful management. We examined the ability of midregional pro–atrial natriuretic peptide (MR-proANP) to identify patients presenting with AF of ≤48 vs >48 h in duration. Methods We prospectively studied 106 patients presenting with AF of known duration. We examined the predictive values of MR-proANP and N-terminal pro–brain natriuretic peptide (NT-proBNP) in the detection of recent-onset AF, in addition to other factors identified by multiple variable analyses. Results In patients presenting with AF of ≤48 vs >48 h in duration, the median MR-proANP plasma concentration was 147.7 [95.3–197.4] pmol/L vs 220.4 [154.0–303.1] pmol/L (P Conclusions A score based on a model including heart rate, dyspnea, and plasma MR-proANP concentration was helpful in identifying AF of ≤48 h in duration.

International audience; Background: Screening for Fabry disease is sub-optimal in non-specialised centres.Aim: To assess the diagnostic value of electrocardiographic scores of left ventricular hypertrophy and a combined electrocardiographic and echocardiographic model in Fabry disease.Methods: We retrospectively reviewed the electrocardiograms and echocardiograms of 61 patients (mean age 55.6±11.5 years; 57% men) with Fabry disease and left ventricular hypertrophy, and compared them with those from 59 patients (mean age 44.8±18.3 years; 66% men) with sarcomeric hypertrophic cardiomyopathy. Six electrocardiography criteria for left ventricular hypertrophy were specifically analysed: Sokolow-Lyon voltage index; Cornell voltage index; Gubner index; Romhilt-Estes score; Sokolow-Lyon product (voltage index×QRS duration); and Cornell product (voltage index×QRS duration).Results: Right bundle branch block was more frequent in patients with Fabry disease (54% vs. 22%; P=0.001). QRS duration, Gubner score and Sokolow-Lyon product were significantly higher in patients with Fabry disease. Maximal wall thickness was higher in patients with sarcomeric hypertrophic cardiomyopathy (21.9±5.1 vs. 15.5±2.9mm; P

Background Same-day home discharge after common atrial flutter catheter ablation (CAFCA) is a feasible, safe, and cost-effective practice, but there are currently no data for patients treated with direct oral anticoagulants (DOAs). Objective We evaluated the safety, efficacy, and feasibility of ambulatory CAFCA in patients treated with DOAs compared with those treated with vitamin K antagonists (VKAs). Methods Patients scheduled for isolated and elective ambulatory CAFCA in our tertiary university center between 2009 and 2019 were included. Propensity score for anticoagulant type was calculated from age, sex, body mass index, HAS-BLED and CHA2DS2-VASc scores, chronic kidney disease, associated antiplatelet treatment, procedure duration, and number of femoral venipunctures. Results Propensity score matching yielded 820 patients (mean age 67 ± 11 years). Catheter ablation was performed under uninterrupted VKA (n = 410; international normalized ratio 2.5 ± 0.6) or uninterrupted DOA (n = 410). The procedural success rate was 91%, and the effective same-day discharge rate was 93%. The occurrence of the primary end point, defined as any early and clinically significant bleeding (Bleeding Academic Research Consortium classification ≥ 2) at 1 week, was similar between patients treated with DOAs and those treated with VKAs (2.9% vs 3.7%; P = .70). Female sex, high HAS-BLED score, and prolonged procedure duration were independently associated with the primary end point. Conclusion Uninterrupted DOA regimens are safe for patients undergoing ambulatory CAFCA in a high-volume center with a dedicated ambulatory unit and standardized procedural and postoperative management.