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Background: Heart failure with preserved ejection fraction (HFpEF) is a complex syndrome at the crossroads of multiple co-morbidities; there is no valid treatment for this condition. Defining new phenotypes could play a role in improving treatment and prognosis., Aim: To identify groups with different pathophysiologies by applying a clustering approach to a multicentric cohort of patients with HFpEF., Methods: A total of 538 patients from the multicentre KaRen study were included. Accurate clinical, biological and ultrasound data are available, with a mean follow-up of 28 months. Based on a clustering analysis, the population was separated into groups based on 55 variables, comparing distribution of deaths and hospitalizations between groups., Results: Three clusters were identified from 356 analysable patients (mean age 76.1±9.31 years; 43.5% men): cluster 1 (n=128) comprised overweight, relatively young men at high cardiovascular risk, in sinus rhythm, with altered renal function; cluster 2 (n=134) comprised women, most of whom had conserved left ventricular function; cluster 3 (n=94) had the highest incidence of mitral regurgitation, atrial remodelling and rhythm disorders. There were no significant differences, only a trend towards early mortality in cluster 3., Conclusions: Clustering analysis seems to be effective at individualizing subgroups with different physiopathologies in HFpEF. The clinical relevance of these phenotypes needs to be studied, and may concern treatment strategy more than prognostic differences., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: Heart failure with preserved ejection fraction (HFpEF) is associated with poor quality of life (QoL), or patient reported outcome (PRO). Despite female predominance in HFpEF, sex-specific differences in PROs remain poorly studied. We assessed PRO measures and their association with HF-severity and outcome in HFpEF by sex., Methods and Results: In 378 patients with HFpEF from the KaRen study, EQ-5D-3L® and Minnesota Living with Heart Failure Questionnaire® (MLHFQ) were assessed. Characteristics and comorbidities were largely similar in women (n = 212, 57%) and men. Women expressed worse QoL in EQ-5D-3L®(EQ-VAS), independent of age and HF-severity, mean (SD), 57 (20) vs. 61 (19), p = 0.010. There was no difference in MLHFQ, 31 (21) vs. 29 (21), p = 0.269. Spearman's correlations with HF-severity (NYHA-class) were for MLHFQ in women r s 0.37 vs. men 0.41, p for both <0.001, and for EQ-VAS r s -0.28, p = 0.001 vs. -0.45, p < 0.001. Correlations with natriuretic peptides were for MLHFQ r s 0.21, p = 0.003 in women vs. men 0.27, p < 0.001, and for EQ-VAS r s -0.17 vs. -0.27, p both < 0.001. Associations between PRO and the composite of HF hospitalisation or all-cause death were present in men only, adjusted HR per 5 units increase in MLHFQ 1.06, 95% confidence interval (CI) 1.01-1.11, p = 0.02 and EQ-VAS, HR 0.93, 95% CI 0.88-0.98, p = 0.010., Conclusion: In HFpEF, women had worse general but similar disease specific QoL compared to men. QoL was more strongly associated with HF-severity in men, and associated with outcomes only in men. In women with HFpEF, QoL appears less determined by HF itself and potentially more by other unknown factors., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: Pulmonary vein isolation (PVI) using second-generation cryoballoon (CB2) is associated with improved outcomes compared with first generation (CB1). We aimed at investigating the characteristics of left and right PV reconnections after CB1 and CB2 ablations in patients with clinical recurrences requiring redo ablation., Methods and Results: From 2010 to 2016, 776 patients underwent 28-mm cryoballoon PVI for symptomatic paroxysmal atrial fibrillation (AF) in 3 centres, 279 with CB1 and 497 with CB2. Among them, 94 patients (12.1%) had symptomatic AF recurrences requiring a redo ablation [43 (15.4%) CB1 and 51 (10.3%) CB2]. The benefit of CB2 over CB1 was compared for each PV. Durable PVI was confirmed in 7 CB1 (16.3%) and 14 CB2 (27.4%) patients, and 2.7 ± 2.1 and 1.4 ± 1.4 gaps per patient were found, respectively (P = 0.002). Significantly more left superior and left inferior PVs were found to be isolated in CB2 compared with CB1 group (78.4% vs. 48.8%, P = 0.005 and 78.4% vs. 46.5%, P = 0.003, respectively) while the rate of durable right superior and right inferior PVs isolation were similar (68.6% vs. 60.5%, P = 0.542 and 66.7% vs. 55.8%, P = 0.387, respectively). Significantly fewer gaps were found in left PVs in CB2 patients, while there was no significant difference for right PVs. Gaps localization was similar in both groups., Conclusion: Fewer reconnection gaps are observed during redo ablations of paroxysmal AF in patients primarily ablated with CB2. This difference is driven by less reconnection gaps observed in both left PVs, while no difference was observed for right PVs.

Background: High-degree atrioventricular block (HAVB) is a common complication of ST segment elevation myocardial infarction (STEMI). HAVB in STEMI is historically considered as a marker of worse outcome but overall data about HAVB in the contemporary era of mechanical reperfusion and potent antiplatelet therapies are scarce., Aim: Analysing incidence, clinical correlates and impact on inhospital outcomes of HAVB in a large prospective registry (Observatoire Régional Breton sur l'Infarctus, ORBI) of modern management of STEMI with a special focus on potential differences between patients with HAVB on admission and those who developed HAVB during hospitalisation., Methods: All patients enrolled in ORBI between June 2006 and December 2013 were included in the present analysis and were divided into 3 groups: patients without HAVB at any time, patients with HAVB on admission and those who developed HAVB during hospitalisation., Results: A total of 6662 patients (age: 62.0 (52.0-74.0) years; male: 76.3%) were included in the present analysis. HAVB was documented in 3.5% of patients, present on admission in 63.7% of patients and occurring during hospitalisation in 36.3%. Patients with HAVB on admission or occurring during the first 24 h of hospitalisation had higher inhospital mortality rates (18.1% and 28.6%, respectively) than patients without (4.5%) or with HAVB occurring beyond the first 24 h of hospitalisation (8.0%). However by multivariable analysis, HAVB was not independently associated with inhospital mortality contrarily to age, presentation as cardiac arrest, anterior STEMI location, reperfusion therapy, cardiogenic shock, mechanical ventilation and occurrence of sustained ventricular tachyarrhythmias or mechanical complication., Conclusions: Patients with HAVB had a higher mortality rate than patients without. However HAVB is not an independent predictor of inhospital mortality., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Aims: The prevalence of cardiovascular and non-cardiovascular co-morbidities and their relative importance for outcomes in heart failure with preserved ejection fraction (HFPEF) remain poorly characterized. This study aimed to investigate this., Methods and Results: The Karolinska-Rennes (KaRen) Study was a multinational prospective observational study designed to characterize HFPEF. Inclusion required acute HF, defined by the Framingham criteria, LVEF ≥ 45%, and NT-pro-BNP ≥ 300 ng/L or BNP ≥ 100 ng/L. Detailed clinical data were collected at baseline and patients were followed prospectively for 18 months. Predictors of the primary (HF hospitalization or all-cause mortality) and secondary (all-cause mortality) outcomes were assessed with multivariable Cox regression. A total of 539 patients [56% women; median (interquartile range) age 79 (72-84) years; NT-pro-BNP/BNP 2448 (1290-4790)/429 (229-805) ng/L] were included. Known history of HF was present in 40%. Co-morbidities included hypertension (78%), atrial fibrillation/flutter (65%), anaemia (51%), renal dysfunction (46%), CAD (33%), diabetes (30%), lung disease (25%), and cancer (16%). The primary outcome occurred in 268 patients [50%; 106 deaths (20%) and 162 HF hospitalizations (30%)]. Important independent predictors of the primary and/or secondary outcomes were age, history of non-cardiovascular syncope, valve disease, anaemia, lower sodium, and higher potassium, but no cardiovascular co-morbidities. Renin-angiotensin system antagonist and mineralocorticoid receptor antagonist use predicted improved prognosis., Conclusion: HFPEF was associated with higher age, female gender, hypertension, atrial fibrillation/flutter, and numerous non-cardiovascular co-morbidities. Prognosis was determined by non-cardiovascular co-morbidities, but use of conventional heart failure medications may still be associated with improved outcomes., (© 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.)

Background: Karolinska Rennes (KaRen) is a prospective observational study to characterize heart failure patients with preserved ejection fraction (HFpEF) and to identify prognostic factors for long-term mortality and morbidity., Aims: To report characteristics and echocardiography at entry and after 4-8 weeks of follow-up., Methods: Patients were included following an acute heart failure presentation with B-type natriuretic peptide (BNP)>100 ng/L or N-terminal pro-BNP (NT-proBNP)>300 ng/L and left ventricular ejection fraction (LVEF)>45%., Results: The mean ± SD age of 539 included patients was 77 ± 9 years and 56% were women. Patient history included hypertension (78%), atrial tachyarrhythmia (44%), prior heart failure (40%) and anemia (37%), but left bundle branch block was rare (3.8%). Median NT-proBNP was 2448 ng/L (n=438), and median BNP 429 ng/L (n=101). Overall, 101 patients did not return for the follow-up visit, including 13 patients who died (2.4%). Apart from older age (80 ± 9 vs. 76 ± 9 years; P=0.006), there were no significant differences in baseline characteristics between patients who did and did not return for follow-up. Mean LVEF was lower at entry than follow-up (56% vs. 62%; P<0.001). At follow-up, mean E/e' was 12.9 ± 6.1, left atrial volume index 49.4±17.8mL/m(2). Mean global left ventricular longitudinal strain was -14.6 ± 3.9%; LV mass index was 126.6 ± 36.2g/m(2)., Conclusions: Patients in KaRen were old with slight female dominance and hypertension as the most prevalent etiological factor. LVEF was preserved, but with increased LV mass and depressed LV diastolic and longitudinal systolic functions. Few patients had signs of electrical dyssynchrony (ClinicalTrials.gov.- NCT00774709)., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Aims: Limited data are available on long-term prognosis or causes-of-death analysis among survivors of acute myocardial infarction (MI) according to whether or not they developed ventricular fibrillation (VF) during the acute stage of MI., Methods and Results: Among 3670 MI patients hospitalized in France in 2005 and enrolled in this prospective follow-up cohort study, we assessed in-hospital mortality and 5-year cause of death among those who survived to hospital discharge, according to whether they developed VF (116 cases) or not, during the acute stage. 94.5% of patients had complete follow-up at 5 years. In-hospital mortality was significantly higher among VF patients (adjusted OR 7.38, 95% CI 4.27-12.75, P < 0.001). Among 3463 survivors at hospital discharge, 1024 died during a mean follow-up of 52 ± 2 months. The overall survival rate at 5 years was 74.4% (95% CI 72.8-76.0). In Cox multivariate analysis, occurrence of VF during the acute phase of MI was not associated with an increased mortality at 5 years (HR 0.78, 95% CI 0.38-1.58, P = 0.21). The distribution of causes of death at 5 years did not statistically differ according to the presence or absence of VF, especially for sudden cardiac death (13.1% in VF group vs.12.9% in non-VF group), despite a very low rate of implantation of cardioverter defibrillator in both groups (Overall rate 1.2%)., Conclusion: Patients developing VF in the setting of acute MI are at higher risk of in-hospital mortality. However, VF is not associated with a higher long-term all-cause or sudden cardiac death mortality.

Introduction: The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid-septal versus apical implantable defibrillator (ICD) lead placement., Methods and Results: SEPTAL is a randomized, noninferiority trial, which randomly assigned patients to implantation of ICD leads in the RV mid-septum versus apex, with a primary objective of comparing the implant success rate of implant at each site, based on strict electrical predefined criteria. We also compared the (1) pacing lead characteristics, (2) rates of appropriate and inappropriate ICD therapies, and (3) all-cause mortality between the 2 sites at 1 year. The trial enrolled 215 patients (mean age = 59.7 ± 12.4 years, mean LVEF = 34.0 ± 14.2%, 84.2% men), of whom 148 (68.8%) presented with ischemic heart disease. The ICD indication was primary prevention in 117 patients (54.4%). The lead was successfully implanted in 96/107 patients (89.7%) assigned to the RV mid-septum, and in 99/108 (91.7%) assigned to the apex (ns). The 1-year rate of lead-related adverse events was similar in both groups. A total of 8 first inappropriate ICD therapies (7.9%) were delivered in the RV mid-septal group, versus 8 (7.8%) in the apical group (ns), while first appropriate therapies were delivered to 22 (21.4%) and 24 patients (23.8%), respectively (ns). All-cause mortality was 7.9% in the RV mid-septal versus 2.9% in the RV apical group (ns)., Conclusion: This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid-septum versus the apex., (© 2012 Wiley Periodicals, Inc.)

Aims: The Cardiac Resynchronization-Heart Failure (CARE-HF) study helped establish an important role for cardiac resynchronization therapy (CRT) in the management of selected patients with heart failure. We now report the long-term outcome during and subsequent to the randomized trial., Methods and Results: Enrollment was completed in March 2003. After reporting the main study results in 2005, investigators were asked to inform patients of the results and implant a CRT device if still appropriate. Subsequently, investigators were asked to consent patients for long-term follow-up until 30 September 2009. Of 813 patients originally enrolled, 343 (42%) died prior to re-consent, 111 patients (14%) were not or could not be contacted, 50 (6%) were alive but declined to participate, and 309 (38%) consented to long-term follow-up. Of patients originally assigned to the control group, > 95% of survivors had received CRT by the time of re-consent. From the time of randomization, 222 patients originally assigned to pharmacological therapy and 192 originally assigned to CRT were known to have died. The hazard ratio for mortality in patients originally assigned to CRT compared with those originally assigned to the control group was 0.77 (95% confidence interval 0.63-0.93; P = 0.007). No subgroup interactions were observed., Conclusion: The effect of CRT on mortality observed during the randomized CARE-HF trial persisted during long-term follow-up. A high rate of CRT device implantation in the control group after completion of the randomized phase of the study may have prevented further divergence of the survival curves.