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Background Randomized controlled trials evaluating patent foramen ovale (PFO) percutaneous closure only included patients with recent embolic event. We aimed to evaluate outcomes following percutaneous PFO closure outcomes according to the delay from the last embolic episode. Methods This international ambispective cohort included consecutive patients from two centers in France and Canada undergoing PFO percutaneous closure for secondary prevention of paradoxical embolic event. The primary endpoint was the composite of stroke or transient ischemic attack (TIA). Logistic regression model was used to evaluate determinants of late PFO closure procedures. Results A total of 1,179 patients (mean age 49±12.7 years; 44.4% female) underwent PFO closure from 2001 to 2021 (Figure 1). The median delay from last embolic event to procedure was 6.0 (3.4–11.2) months. Determinants of late PFO closure procedure were the center (France versus Canada) adjusted Odds Ratio (aOR) 1.65 95% confidence interval (CI) 1.25–2.19, year of procedure (≥2018 versus Conclusion This analysis provides indirect evidence that delay from last ischemic event does not impact outcomes following PFO percutaneous closure for secondary prevention. Funding Acknowledgement Type of funding sources: None.

Aims The European Society of Cardiology (ESC) has released three consecutive guidelines within 5 years addressing cardiovascular prevention, risk scores, and cholesterol treatment. This study aims to evaluate whether the 2021 ESC guidelines improved the eligibility of individuals for primary prevention statin therapy before their first ST-segment elevation myocardial infarction (STEMI), and for intensive lipid-lowering treatments in secondary prevention. Methods and results The cardiovascular risk category of 2757 consecutive individuals admitted for a first STEMI was evaluated to assess whether they would have been eligible for primary prevention statins according to 2021 vs. 2019 and 2016 ESC guidelines. Eligibility for intensive lipid-lowering therapy in secondary prevention was assessed according to the real-life follow-up low-density lipoprotein cholesterol (LDL-C) and the expected follow-up LDL-C. More individuals would have been eligible for primary prevention statins according to 2021 and 2019 vs. 2016 guidelines (61.8% vs. 38.7% vs. 23.6%, P Conclusion The 2021 ESC guidelines improved the detection and treatment of individuals at risk for a first myocardial infarction. In secondary prevention, 70% of patients kept LDL-C levels above 55 mg/dL: increasing the statin dose and adding ezetimibe were the most frequently recommended therapeutic actions.

Infant social withdrawal is a risk factor for non-optimal child development; thus, it is important to identify risk factors associated with withdrawal. In a large community sample (N = 19,017), we investigate whether symptoms of maternal and partner postpartum depression (PPD; measured with the Edinburgh Postnatal Depression Scale) and prematurity are predictors of infant social withdrawal (measured with the Alarm Distress Baby Scale). Withdrawal was assessed at 2–3, 4–7 and 8–12 months postpartum. Linear regressions showed that prematurity predicted higher infant social withdrawal at all time points, and maternal symptoms of PPD were positively associated with withdrawal at 2–3 months. Logistic regressions showed that odds for elevated social withdrawal were increased with elevated levels of maternal symptoms of PPD at 2–3 and 8–12 months. Partner's symptoms of PPD were not associated with withdrawal. Future studies should investigate how PPD symptoms and prematurity may impact the individual development of social withdrawal. Infant social withdrawal is a risk factor for non-optimal child development; thus, it is important to identify risk factors associated with withdrawal. In a large community sample (N = 19,017), we investigate whether symptoms of maternal and partner postpartum depression (PPD; measured with the Edinburgh Postnatal Depression Scale) and prematurity are predictors of infant social withdrawal (measured with the Alarm Distress Baby Scale). Withdrawal was assessed at 2–3, 4–7 and 8–12 months postpartum. Linear regressions showed that prematurity predicted higher infant social withdrawal at all time points, and maternal symptoms of PPD were positively associated with withdrawal at 2–3 months. Logistic regressions showed that odds for elevated social withdrawal were increased with elevated levels of maternal symptoms of PPD at 2–3 and 8–12 months. Partner's symptoms of PPD were not associated with withdrawal. Future studies should investigate how PPD symptoms and prematurity may impact the individual development of social withdrawal.

BackgroundThe objective of this prospective, multidisciplinary and multicenter study was to explore the effect of a cleft lip, associated or not with a cleft palate, on parents, on parent-infant relationship, and on the baby’s relational development. It also highlighted how the type of cleft and the timing of the surgery could impact this effect.Method158 infants, with Cleft lip with or without Palate, and their parents participated in this multicenter prospective cohort. Clinical evaluations were performed at 4 and 12 months postpartum. The impact on the parents and on the parent-infant relationship was evaluated by the Parenting Stress Index (PSI), the Edinburgh Post-partum Depression Scale (EPDS) and the Impact-on-Family Scale (IOFS). The relational development of the infant was assessed using the Alarm Distress Baby Scale (ADBB). The main criteria used to compare the infants were the severity of cleft and the time of surgery.ResultsThe timing of surgery, the type of malformation or the care structure had no effect on social withdrawal behaviors of the child at 4 and 12 months postpartum (ADBB). Furthermore, early intervention significantly decreased maternal stress assessed with the PSI at 4 months. Parents for whom it had been possible to give a prenatal diagnosis were much better prepared to accept the waiting time between birth and the first surgical intervention (IOFS). Higher postpartum depression scores (EPDS) were found for both parents compared to the general population.ConclusionA joint assessment of the mental health of both infants and parents is required in the follow-up of cleft lip and palate. Even if most families are remarkably resilient faced with this major cause of stress, a significant proportion of them could require help to deal with the situation, especially during this first year of follow-up. An assessment of the child’s social withdrawal behaviour and of the parental stress and depression appears useful, in order to adapt care to infant and parent’s needs.Trial registrationClinicalTrials.gov Identifier:NCT00993993. Registered 10/14/2009

Background: Prior studies have reported an association between elevated white blood cell count (WBCc) and worse clinical outcomes after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). We assessed the prognostic impact of WBCc in patients undergoing revascularization for left main coronary artery disease (LMCAD). Methods: In Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL), 1905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. The 1895 patients with baseline WBCc available were grouped in tertiles of WBCc (mean 5.6 ± 0.8, 7.5 ± 0.5, and 10.1 ± 1.6 × 109/L). Results: Five-year rates of the primary endpoint (death, myocardial infarction or stroke) were similar across increasing WBCc tertiles (21.2, 18.9, and 21.6%; P = 0.46). Individual components of the primary endpoint, Bleeding Academic Research Consortium (BARC) 3-5 bleeding, stent thrombosis or graft occlusion and ischemia-driven revascularization were all similar across WBCc tertiles. By multivariable analysis, WBCc as a continuous variable was not an independent predictor of adverse events (hazard radio per 1 × 109/L: 1.02; 95% CI, 0.97-1.08; P = 0.43). Results were consistent in the PCI and CABG arms individually. Conclusion: There was no association between baseline WBCc and 30-day or 5-year clinical outcomes after PCI or CABG. The absence of a clear incremental increase in events with increasing WBCc in the current analysis indicates that WBCc should not routinely be used as a prognostic marker or to guide revascularization decisions in patients with LMCAD.

Aims The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population. Methods and results BRAVO-3 trial randomized 802 patients undergoing trans-femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE – death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days. Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p = 0.48) and acute kidney injury (19.7% vs. 15.1%, p = 0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p = 0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p = 0.03) and life-threatening bleeding both in-hospital (OR 1.50, p = 0.046) and at 30-days (OR 1.50, p = 0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients. Conclusions Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR.

Background The impact of ECG presentations of acute myocardial infarction (AMI) in cardiogenic shock is unknown. Research Question In myocardial infarction with cardiogenic shock, is there a difference in the outcomes and effect of revascularization strategies between non-ST-segment elevation myocardial infarction (NSTEMI) and left bundle branch block myocardial infarction (LBBBMI) vs ST-segment elevation myocardial infarction (STEMI)? Study Design and Methods Cardiogenic shock patients from the CULPRIT-SHOCK trial with NSTEMI or LBBBMI were compared with STEMI patients for 30-day and 1-year all-cause mortality. The interaction between ECG presentation and the effect of revascularization strategies on outcomes was evaluated. Results Of 665 cardiogenic shock patients analyzed, 55.9% demonstrated STEMI, 29.3% demonstrated NSTEMI, and 14.7% demonstrated LBBBMI. Patients differed in mean age (68.0 years in STEMI patients, 71.0 years in NSTEMI patients, and 73.5 years in LBBBMI patients; P = .015), cardiovascular risk factors, and angiographic severity. No difference was found in the 30-day risk of death between NSTEMI and STEMI patients (48.7% vs 43.0%; adjusted OR [aOR], 1.05; 95% CI, 0.66-1.67; P = .85), nor between LBBBMI and STEMI patients (59.2% vs 43.0%; aOR, 1.31; 95% CI, 0.73-2.34; P = .36). Although the univariate risk of death by 1 year was higher in NSTEMI and LBBBMI patients compared with STEMI patients, ECG presentation was not an independent risk factor of mortality after adjustment (NSTEMI vs STEMI: 56.4% vs 46.8%; aOR, 1.21; 95% CI, 0.76-1.92; P = .42; LBBBMI vs STEMI: 69.4% vs 46.8%; aOR, 1.59; 95% CI, 0.89-2.84; P = .12). ECG presentation did not modify the effect of the revascularization strategy on 30-day and 1-year mortality (P = .91 and P = .97 for interaction). Interpretation In patients with cardiogenic shock, NSTEMI and LBBBMI presentations reflect higher-risk profiles than STEMI presentations, but are not independent risk factors of mortality. ECG presentations did not modify the treatment effect, supporting culprit-lesion-only percutaneous coronary intervention as the preferred strategy across the AMI spectrum.

BACKGROUND The underlying mechanisms of exercise intolerance in sickle cell anaemia (SCA) patients are complex and not yet completely understood. While latent heart failure at rest could be unmasked upon exercise, most previous studies assessed cardiac function at rest. We aimed to investigate exercise cardiovascular reserve as a potential contributor to exercise intolerance in adult SCA patients. METHODS In this observational prospective study, we compared prospectively 60 SCA patients (median age 31 years, 60% women) to 20 matched controls. All subjects underwent symptom-limited combined exercise echocardiography and oxygen uptake (VO2 ) measurements. Differences between arterial and venous oxygen content (C(a-v)O2 ) were calculated. Cardiac reserve was defined as the absolute change in cardiac index (Ci) from baseline to peak exercise. RESULTS Compared to controls, SCA patients demonstrated severe exercise intolerance (median peakVO2 , 34.3 vs. 19.7 ml/min/kg, respectively, p

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. Background: Data on pacemaker insertion complicating TAVR in women are scarce. Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85–7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30–0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9–16] days in PPI vs. 9 [7–14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adjHR 0.95, 95% CI 0.60–1.52, p = 0.84 and adjHR 1.22, 95% CI 0.83–1.79, p = 0.31, respectively). Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Quality of attachment relationships is believed to be an important early indicator of infant mental health as it is considered a vital component of social and emotional development in the early years. As a result, there has been a growing call for the development of early intervention attachment research programs. In this brief overview, we summarize what we consider to be the state-of-the-art of intervention programs targeted to increase the prevalence of secure attachment and to reduce the level of disorganized attachment among infants with a wide range of psychological risks.The themes in the literature covered by the article are as follows: recent results of the main preventive parent-young child interaction interventions to promote optimal attachment; recent metaanalysis on efficiency of these early attachment-based programs; intermediate variables on intervention effects; and benefits of specific therapeutic approaches focused on maternal psychopathology. Globally, early attachment-informed interventions show positive effects, both for mothers and infants.Our revision stresses the importance of formally assessing the underlying mechanisms of change within interventions in research programs to open the path to improve and target these preventive approaches and consequently promote optimal attachment.

BackgroundThere is a dearth of updated epidemiological data on the prevalence and annual incidence of coronary artery disease (CAD) and lower extremity artery disease (LEAD) in Western countries.AimsTo describe the incidence and prevalence of CAD and LEAD, associated medication patterns and long-term outcomes in France.MethodsThis was a retrospective cohort study using French claims data from a representative sample of the French general population. Any hospitalization or long-term disease status for CAD or LEAD between January 2010 and December 2016 was collected to identify incident cases.ResultsOf the 763,338 patients screened in the study period, 8559 incident cases of CAD and 4399 of LEAD were identified, with an overall mean follow-up of 2.9 ± 2.0 years. The incidence of CAD, LEAD and CAD or LEAD remained stable over the years, and in 2016 were at 33.5 per 10,000 person-years, 15.1 per 10,000 person-years and 42.5 per 10,000 person-years, respectively. The prevalence of CAD increased from 3.1% in 2010 to 4.2% in 2016, and LEAD from 1.6% to 2.4%. Most patients received guideline-recommended medication with antithrombotic drugs and lipid-lowering drugs following the index event. However, most of the medications initiated were subsequently discontinued during follow-up. Incident CAD or LEAD was associated with considerable morbidity–particularly an incidence of all-cause hospitalization of 7976.9 per 10,000 person-years–and all-cause mortality, with an incidence of 542.8 per 10,000 person-years.ConclusionIn recent years, the prevalence of CAD or LEAD has increased progressively, resulting in considerable morbidity and mortality., ContexteIl existe un manque de données épidémiologiques récentes concernant la prévalence et l’incidence des cardiopathies ischémiques (CPI) et artériopathies oblitérantes des membres inférieurs (AOMI) dans les pays occidentaux.ObjectifDécrire l’incidence et la prévalence des CPI et AOMI, les médications et le devenir clinique associés au long cours.MéthodesIl s’agit d’une étude rétrospective sur une cohorte représentative de la population française. Toutes les hospitalisations et demandes de statut d’affection de longue durée pour CPI ou AOMI entre janvier 2010 et décembre 2016 ont été collectées pour identifier les cas incidents.RésultatsSur les 763 338 patients évalués, un total de 8559 et 4399 cas incidents de CPI et AOMI ont été identifiés, respectivement, avec un suivi moyen de 2,9 ± 2,0 années. Les incidences de CPI, AOMI et CPI ou AOMI sont restés stables au cours du temps et se situaient en 2016 à 33,5 pour 10 000 patients-années, 15,1 pour 10,000 patients-années et 42,5 pour 10 000 patients-années, respectivement. Les prévalences des CPI et AOMI ont augmenté de 3,1 % et 1,6 % en 2010 à 4,2 % et 2,4 % en 2016, respectivement. La plupart des patients étaient traités selon les recommandations, après l’évènement index, par des agents antiplaquettaires et hypolipémiants. Cependant, la plupart des traitements initiés étaient interrompus durant le suivi. Le diagnostic de CPI ou d’AOMI était associé à une morbi-mortalité considérable, avec une incidence d’hospitalisation à 7976,9 pour 10 000 patients-années et de décès à 542,8 pour 10 000 patients-années.ConclusionLa prévalence des CPI et AOMI a augmenté ces dernières années en France, à l’origine d’une morbi-mortalité significative.

Objective We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. Background There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. Methods We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. Results We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. Conclusion In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Background: Data on the impact of residual inflammatory risk (RIR) in patients undergoing percutaneous coronary intervention (PCI) with baseline low-density lipoprotein cholesterol (LDL-C) ≤70 mg/dl are scarce. Objectives: The purpose of this study was to characterize the prevalence and impact of persistent high RIR after PCI in patients with baseline LDL-C ≤70 mg/dl. Methods: All patients undergoing PCI between January 2009 and December 2016 in a single tertiary center, with baseline LDL-C ≤70 mg/dl and serial high-sensitivity C-reactive protein (hsCRP) assessments (at least 2 measurements ≥4 weeks apart) were retrospectively analyzed. High RIR was defined as hsCRP >2 mg/l. Patients were categorized as persistent low RIR (first low then low hsCRP), attenuated RIR (first high then low hsCRP), increased RIR (first low then high hsCRP), or persistent high RIR (first high then high hsCRP). Primary endpoint of interest was major adverse cardiac and cerebrovascular accident (MACCE) (death, myocardial infarction, or stroke), within 1 year of the second hsCRP measurement. Results: A total of 3,013 patients were included, with persistent low, attenuated, increased, and persistent high RIR in 1,225 (41.7%), 414 (13.7%), 346 (11.5%), and 1,028 (34.1%) patients, respectively. Overall, there was a stepwise increase in the incidence rates of MACCE, transitioning from the persistent low to the attenuated, increased, and persistent high RIR (respectively, 64.4 vs. 96.6 vs. 138.0 vs. 152.4 per 1,000 patient-years; p < 0.001). After adjustment, the presence of persistent high RIR remained strongly associated with MACCE (adjusted hazard ratio: 2.10; 95% confidence interval: 1.45 to 3.02; p < 0.001). Conclusions: Among patients undergoing PCI with baseline LDL-C ≤70 mg/dl, persistent high RIR is frequent and is associated with increased risk of MACCE. Targeting residual inflammation in patients with optimal LDL-C control may further improve outcomes after PCI.

Background: Data on the associations between serum osmolality (sOsmo) and acute kidney injury (AKI) as well as short- and long-term mortality in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) are limited. Objectives: To investigate the association between sOsmo and development of AKI and clinical outcomes in patients undergoing PCI. Methods: We investigated 1,927 consecutive patients undergoing PCI from the registry of a single center. Patients were divided into quartiles according to sOsmo at admission (Q1–Q4). sOsmo was calculated using the following equation: (1.86 × serum sodium [mmol/L]) + (glucose [mg/dL] / 18) + (blood urea nitrogen [mg/dL] / 2.8) + 9. The primary endpoint was AKI, per Kidney Disease: Improving Global Outcomes (KDIGO) definition. The secondary endpoints were 30-day and 1-year all-cause mortality. Results: Patients with the highest sOsmo (Q4) were older and more likely female, with significantly more cardiovascular risk factors and comorbidities compared to those with lower sOsmo (Q1–Q3). Incidence of AKI was highest in Q4 and lowest in Q2. In the multivariate logistic regression model, high sOsmo independently predicted the development of AKI (OR 2.00, 95% CI 1.26–3.19, p = 0.003). Patients with Q4 had a higher risk of 1-year mortality compared to patients with Q2 (HR 2.11, 95% CI 1.10–4.15; p = 0.031), but not after adding AKI to the multivariate model (HR 1.71, 95% CI 0.87–3.39; p = 0.12). Conclusion: sOsmo is a valid and easily obtainable predictor of AKI after PCI. High sOsmo is associated with increased risk of AKI and 1-year mortality in patients undergoing PCI. Further research is warranted to clarify whether the use of an sOsmo-directed hydration protocol might reduce the incidence of AKI in patients undergoing PCI.

Summary Available data on clinical presentation and mortality of coronavirus disease‐2019 (COVID‐19) in heart transplant (HT) recipients remain limited. We report a case series of laboratory‐confirmed COVID‐19 in 39 HT recipients from 3 French heart transplant centres (mean age 54.4 ± 14.8 years; 66.7% males). Hospital admission was required for 35 (89.7%) cases including 14/39 (35.9%) cases being admitted in intensive care unit. Immunosuppressive medications were reduced or discontinued in 74.4% of the patients. After a median follow‐up of 54 (19–80) days, death and death or need for mechanical ventilation occurred in 25.6% and 33.3% of patients, respectively. Elevated C‐reactive protein and lung involvement ≥50% on chest computed tomography (CT) at admission were associated with an increased risk of death or need for mechanical ventilation. Mortality rate from March to June in the entire 3‐centre HT recipient cohort was 56% higher in 2020 compared to the time‐matched 2019 cohort (2% vs. 1.28%, P = 0.15). In a meta‐analysis including 4 studies, pre‐existing diabetes mellitus (OR 3.60, 95% CI 1.43–9.06, I 2 = 0%, P = 0.006) and chronic kidney disease stage III or higher (OR 3.79, 95% CI 1.39–10.31, I 2 = 0%, P = 0.009) were associated with increased mortality. These findings highlight the aggressive clinical course of COVID‐19 in HT recipients.

International audience; BackgroundThe impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear.MethodsThis is a pre-specified analysis from the culprit-lesion-only PCI vs multivessel PCI in CS (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and 1 year were assessed using multivariate logistics models.ResultsA noninfarct related CTO was present in 157 of 667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at 1 year was also increased but did not reach statistical significance (adjusted Odds ratio 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (Odds ratio 0.79 95%CI 0.42-1.49 and Odds ratio 0.67 95%CI 0.48-0.96, respectively), without significant interaction (P = .68).ConclusionsIn patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO.

Despite many improvements in its prevention and management, acute coronary syndrome (ACS) remains a major cause of morbidity and mortality in the developed world. Lipid management is an important part of secondary prevention after ACS, but many patients currently remain undertreated and do not attain guideline‐recommended levels of low‐density lipoprotein cholesterol reduction. This review details the current state of evidence on lipid management in patients presenting with ACS, provides directions for identification of patients who may benefit from early escalation of lipid‐lowering therapy, and discusses novel lipid‐lowering medication that is currently under investigation in clinical trials. Moreover, a treatment algorithm aimed at attaining guideline‐recommended low‐density lipoprotein cholesterol levels is proposed. Despite important advances in the initial treatment and secondary prevention of ACS, ≈20% of ACS survivors experience a subsequent ischemic cardiovascular event within 24 months, and 5‐year mortality ranges from 19% to 22%. Knowledge of the current state of evidence‐based lipid management after ACS is of paramount importance to improve outcomes after ACS.

Data on ischemic and bleeding outcomes after percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with chronic kidney disease (CKD) are scarce. We aimed to evaluate the association between CKD and ischemic and bleeding outcomes in HBR patients who underwent PCI. Among 10,502 patients in the four post-approval registries evaluating patients undergoing PCI, 2,300 patients presented with at least one major or two minor ARC-HBR criteria. CKD was defined as eGFR

International audience; Background: The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.Methods: This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.Results: Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).Conclusions: In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.

Objectives The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (DES). Background Whether contemporary DES have improved the long-term prognosis after percutaneous coronary intervention in lesions with severe CAC is unknown. Methods Individual patient data were pooled from 18 randomized trials evaluating DES, categorized according to the presence of angiography core laboratory–confirmed moderate or severe CAC. Major endpoints were the patient-oriented composite endpoint (death, myocardial infarction [MI], or any revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac death, target vessel MI, or ischemia-driven target lesion revascularization). Multivariate Cox proportional regression with study as a random effect was used to assess 5-year outcomes. Results A total of 19,833 patients were included. Moderate or severe CAC was present in 1 or more target lesions in 6,211 patients (31.3%) and was associated with increased 5-year risk for the patient-oriented composite endpoint (adjusted hazard ratio [adjHR]: 1.12; 95% confidence interval [CI]: 1.05 to 1.20) and target lesion failure (adjHR: 1.21; 95% CI: 1.09 to 1.34), as well as death, MI, and ischemia-driven target lesion revascularization. In patients with CAC, use of second-generation DES compared with first-generation DES was associated with reductions in the 5-year risk for the patient-oriented composite endpoint (adjHR: 0.88; 95% CI: 0.78 to 1.00) and target lesion failure (adjHR: 0.73; 95% CI: 0.61 to 0.87), as well as death or MI, ischemia-driven target lesion revascularization, and stent thrombosis. The relative treatment effects of second-generation compared with first-generation DES were consistent in patients with and without moderate or severe CAC, although outcomes were consistently better with contemporary devices. Conclusions In this large-scale study, percutaneous coronary intervention of target lesion moderate or severe CAC was associated with adverse patient-oriented and device-oriented adverse outcomes at 5 years. These detrimental effects were mitigated with second-generation DES.

Background Women have been associated with higher rates of recurrent events after percutaneous coronary intervention than men, possibly attributable to advanced age at presentation and greater comorbidities. These factors also put women at higher risk of bleeding, which may influence therapeutic strategies and clinical outcomes. Methods and Results We performed a patient‐level pooled analysis of 4 postapproval registries to evaluate sex‐related differences in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. HBR required fulfillment of at least 1 major or 2 minor criteria of the Academic Research Consortium definition. Outcomes of interest were major bleeding and major adverse cardiac events (composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis). Of the total 10 502 patients, 2832 (27.0%) were women. The prevalence of HBR was higher in women compared with men (29.0% versus 20.5%, P P P =0.82) and remained consistent after adjustment (hazard ratio, 0.64; 95% CI, 0.32–1.28). Conclusions The prevalence of HBR was higher in women compared with men, with considerable differences in the distribution of criteria. Women at HBR experienced higher rates of major bleeding but similar major adverse cardiac event rates compared with men at HBR at 4 years.

Background: Whether the underlying risk of bleeding influences the associations between patterns of dual antiplatelet therapy (DAPT) cessation and adverse events after percutaneous coronary intervention is unknown. Methods: Patients enrolled in the prospective, international, multicenter PARIS registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients) were categorized according to their risk of bleeding using the PARIS bleeding risk score. We evaluated the incidence, patterns, and association between modes of DAPT cessation and outcomes across bleeding risk groups. Modes of DAPT cessations were defined as physician-guided DAPT discontinuation, brief interruption ( Results: From a total of 5018 patients, 513 (10.2%) were classified as high, 2058 (41.0%) as intermediate, and 2447 (48.8%) as low risk for bleeding. High bleeding risk (HBR) patients were older and had greater prevalence of comorbidities. Compared with non-HBR, HBR patients had higher rates of both ischemic and bleeding events. The cumulative incidence of DAPT cessation was higher in HBR patients, mostly driven by physician-guided discontinuation and disruption. Of note, DAPT disruption occurred in 17.7%, 10.4%, and 7.8% at 1 year and 22.0%, 15.1%, and 12.0% at 2 years ( P Conclusions: Patients at HBR remain at higher risk of adverse events. Disruption of DAPT is associated with an increased risk of major adverse cardiac events irrespective of the underlying bleeding risk. Physician-guided discontinuation of DAPT appears to be safe, irrespective of HBR.

Background: Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent implantation. Methods: We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates. Results: Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76–5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93–6.41]), as well as after MB (HR 4.92 [95% CI, 3.82–6.35]). Of note, this effect was consistent across the spectrum of bleeding risk ( P -interaction test 0.97 and 0.06, respectively). Conclusions: Compared with the non-HBR population, HBR patients experienced worse 4-year outcomes after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk.

International audience

International audience; Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.Funding: ACTION Study Group and AstraZeneca.

Background Although several variables have been identified as bleeding determinants (BDs), their occurrence and predictive value in patients undergoing percutaneous coronary intervention (PCI) in the real world remain unclear. We aimed to characterize the rate of BDs in patients undergoing PCI with stent implantation in a large volume tertiary centre. Methods We included patients undergoing coronary stenting at our institution from January 2012 to December 2016, and defined post-discharge bleeding (PDB) as bleeding requiring hospitalization or transfusion. Several BDs, identified by the PARIS bleeding and PRECISE-DAPT scores and inclusion criteria of the LEADERS FREE trial, were analysed. Results In a population of 10,406 subjects who underwent PCI, 2,938 patients (28.2%) had 1, 2,367 (22.8%) had 2 and 2,913 (28.0%) had ≥3 pre-specified BD. Compared with patients without PDB, subjects who experienced PDB were older (70.43 ± 11.94 vs. 65.90 ± 11.54 years, p Conclusion Many risk factors predispose to PDB; they were often clustered together and conferred additive PDB risk at 1-year of follow-up.

This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS).The prognostic value of the SYNTAX score in this high-risk setting remains unclear.The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (22SS≤32) and high SYNTAX score (SS32). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression.Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes.In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality.

ObjectivesContrast-induced acute kidney injury (CI-AKI) is a common and potentially severe complication in patients with ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). There is no consensus on the best definition of CI-AKI to identify patients at risk of haemodialysis or death. The objective of this study was to assess the association of CI-AKI, using four definitions, on inhospital mortality, mortality or haemodialysis requirement over 1-year follow-up, in patients with STEMI treated with pPCI.MethodsIn this prospective, observational study, all patients with STEMI referred for pPCI were included. We identified independent variables associated with CI-AKI and mortality.ResultsWe included 1114 consecutive patients with STEMI treated by pPCI. CI-AKI occurred in 18.3%, 12.2%, 15.6% and 10.5% of patients according to the CIN, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) Modification of Diet in Renal Disease (MDRD) and RIFLE Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) definitions, respectively. The RIFLE (CKD-EPI) definition was the most discriminant definition to identify patients at higher risk of inhospital mortality (27.1% vs 4.0%; adjusted OR 2.7 (95% CI 1.4 to 5.1), p=0.003), 1-year mortality (27.4% vs 6.6%; adjusted OR 2.8 (95% CI 1.5 to 5.3), p=0.002) and haemodialysis requirement at 1-year follow-up (15.6% vs 2.7%; adjusted OR 6.7 (95% CI 3.3 to 13.6), p=0.001). Haemodynamic instability, cardiac arrest, preexisting renal failure, elderly age and a high contrast media volume were independently associated with 1-year mortality. Of interest, contrast-media volume was not correlated to increase of creatininaemia (r=0.06) or decrease in estimated glomerular filtration rate (r=0.05) after percutaneous coronary intervention in our population.ConclusionsCI-AKI is a frequent and serious complication of STEMI treated by pPCI. The RIFLE definition is the most accurate definition to identify patients with CI-AKI at high risk of mortality or haemodialysis.

The present study aims to determine to which extent social withdrawal at 1 year is associated with the child's IQ at the end of the preschool period. Children (N = 1045) from the EDEN mother-child cohort were assessed for social withdrawal behaviours at 1 year by trained midwives using the Alarm Distress BaBy (ADBB) scale. Midwives also examined infants' language and motor development at 1 year. At the age 5-6 years, IQ scores were based on the WPPSI-III. Linear regression models were used to determine the association between IQ and ADBB, adjusted for a broad range of pre- and postnatal environmental factors and for language and motor skills scores at 1 year. After adjusting for environmental factors, children with social withdrawal at 1 years (ADBB ≥5; N = 195) had significantly lower IQ scores at 5-6 years (-2.81 IQ points; p value 0.007) compared to children without social withdrawal (ADBB

International audience; Background and aimIt was hypothesized that the pattern of coronary occlusion (thrombus composition) might contribute to the onset of ventricular arrhythmia and sudden cardiac death (SCD) in myocardial infarction (MI).MethodsThe TIDE (Thrombus and Inflammation in sudden DEath) study included patients with angiographically-proven acute coronary occlusion as the cause of a ST elevation MI (STEMI) complicated by Sudden Cardiac Death (SCD group) or not (STEMI group). Thrombi were obtained by thrombo-aspiration before primary percutaneous coronary stenting and analyzed with a quantitative method using scanning electron microscopy. We compared the composition of the thrombi responsible for the coronary occlusion between the two groups and evaluated factors influencing its composition.ResultsWe included 121 patients and found that thrombus composition was not different between the SCD group (n = 23) and the STEMI group (n = 98) regarding content of fibrin fibers (60.3 ± 18.4% vs. 62.4 ± 18.4% respectively, p = 0.68), platelets (16.3 ± 19.2% vs. 15.616.7 ±%, p = 0.76), erythrocytes (14.6 ± 12.5% vs. 13 ± 12.1%, p = 0.73) and leukocytes (0.6 ± 0.9% vs. 0.8 ± 1.5%, p = 0.93). Thrombus composition did not differ between patients receiving upstream-use of glycoprotein IIb/IIIa platelet receptor inhibitors (GPI) and patients free of GPI. The only factor found to influence thrombus composition was the ischemic time from symptom onset to primary PCI, with a decreased content in fibrin fibers (57.8 ± 18.5% vs. 71.9 ± 10.1%, p = 0.0008) and a higher platelet content (19.2 ± 19.1% vs. 7.9 ± 5.7% p = 0.014) in early presenters (6 h of ischemic time).ConclusionComposition of intracoronary thrombi in STEMI patients does not differ between those presenting with and without SCD. Time from symptom onset to coronary reperfusion seems to be the strongest factor influencing thrombus composition in M

International audience; BackgroundThe effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear.AimsTo evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation.MethodsAll patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1 year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥ 20 mmHg or an increase of ≥ 10 mmHg during echocardiographic follow-up.ResultsOf the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42–2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤ 30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58 patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤ 23 mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63–7.07).ConclusionsBaseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.; ContexteL’impact du traitement anticoagulant oral (TAO) sur les paramètres cliniques et hémodynamiques après TAVI demeure incertain.ObjectifsÉvaluer l’impact du TAO dans l’année suivant un TAVI.MéthodesTous les patients traités par TAVI dans deux centres français entre 2010 et 2016 furent prospectivement inclus. Le critère de jugement principal (CJP) était composé de la mortalité, accident vasculaire cérébrale, hospitalisation pour insuffisance cardiaque ou hémorragie sévères, défini selon les critères VARC-2. Une détérioration hémodynamique valvulaire prothétique (DHV) était définie par un gradient moyen transprothétique ≥ 20 mmHg ou par une majoration ≥ 10 mmHg durant le suivi échocardiographique.RésultatsUn TAO fut prescrit à 400 patients soit 35,1 % des 1139 patients inclus dans le registre. Le CJP est survenu plus fréquemment en cas de TAO post-TAVI qu’en son absence (29,4 % vs 17,3 % %; HR 1,83, IC à 95 % 1,42–2,35). Les facteurs de risque (FdR) du CJP étaient une pneumopathie chronique, une insuffisance rénale chronique, une fibrillation atriale, une FEVG ≤ 30 % après TAVI et un abord vasculaire extrafémoral. La prescription de TAO après un TAVI n’était pas un FdR indépendant du CJP. Une DHV fut relevée chez 58 patients, dont 11 (19 %) traités par TAO et 47 (81 %) non traités par TAO. Les FdR de DHV étaient l’absence de TAO après TAVI, un IMC augmenté, l’utilisation de bioprothèse expansible au ballon et un diamètre de bioprothèse ≤ 23 mm. Un crossover de TAO (défini comme un arrêt ou une initiation de TAO au cours du suivi) survenu chez 9,6 % des patients et était associé à la mortalité (HR ajusté 3,39, IC à 95 % 1,63–7,07).ConclusionsLes antécédents médicaux et non la prescription de TAO sont associés au devenir clinique après un TAVI. A l’inverse, la prescription de TAO est associée à une moindre survenue de DHV. Previous article in issue

International audience; Large registries and epidemiologic studies have demonstrated that elderly patients (≥ 75 years old) represent a growing proportion of the acute coronary syndrome (ACS) population and are exposed to a high risk of both bleeding and ischemic events. In this setting, most of the randomized trials excluded elderly patients while evaluating therapeutic strategies in ACS and only few trials specifically dedicated their design to the elderly population, leading to a paucity of data. Elderly patients are less likely to be treated with an invasive strategy or potent antithrombotic drugs compared with younger patients, while they are exposed to a greater risk of mortality. Nevertheless, the benefit of an invasive approach in ST-segment elevation myocardial infarction (STEMI) has been consistently demonstrated in non-dedicated large percutaneous coronary intervention randomized trials, regardless of the patient's age. European clinical practice guidelines recommend that STEMI in elderly patients should not be treated differently than in younger patients. However, the therapeutic decision should be based on a combined evaluation of both (1) the patient's frailty, including functional or cognitive impairment, and (2) the balance between bleeding and ischemic risks. This review outlines the evidence on the optimal reperfusion and antithrombotic strategies among STEMI elderly patients, suggesting a patient-centered approach to apprehend the balanced therapeutic decision in the very old patient.

Summary Background The incidence of and risk factors for readmission for heart failure after successful transcatheter aortic valve implantation (TAVI) are unclear. Aims We sought to evaluate the incidence of, risk factors for and clinical impact of readmission for heart failure after successful TAVI in an unselected patient population. Methods All patients who underwent successful TAVI in two high-volume French tertiary centres from February 2010 to December 2016 were included prospectively and followed up for 1 year. A Cox multivariable model was used to assess risk factors for readmission for heart failure and mortality. Results A total of 1139 patients (mean age 82.4 ± 7.7 years; 52.2% male sex) were included. Readmission for heart failure occurred in 99 (9.2%) patients. Risk factors for readmission for heart failure were previous atrial fibrillation (adjusted hazard ratio [adjHR] 1.62, 95% confidence interval [CI] 1.09–2.40), diabetes mellitus (adjHR 1.67, 95% CI 1.11–2.50), chronic kidney disease (adjHR 1.72, 95% CI 1.13–2.62), chronic pulmonary disease (adjHR 1.81, 95% CI 1.17–2.81) and left ventricular ejection fraction after TAVI ≤ 35% (adjHR 2.12, 95% CI 1.20–3.75). Readmission for heart failure was strongly associated with mortality (adjHR 3.11, 95% CI 1.95–4.94), along with increased Society of Thoracic Surgeons’ score (adjHR 1.07, 95% CI 1.03–1.12), chronic pulmonary disease (adjHR 1.45, 95% CI 1.00–2.09), previous atrial fibrillation (adjHR 2.11, 95% CI 1.52–2.93) and shock during the index hospitalization (adjHR 2.56, 95% CI 1.41–4.65). Conclusions Readmission for heart failure occurs in one in 10 patients after successful TAVI, and is a strong risk factor for mortality. Co-morbidities and left ventricular ejection fraction after TAVI ≤ 35% are the main risk factors for readmission for heart failure.

Background/Objective: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. Methods: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). Results: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p =.20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37–0.80; p

Background: High-intensity statins (HIS) are recommended for secondary prevention following percutaneous coronary intervention (PCI). We aimed to describe temporal trends and determinants of HIS prescriptions after PCI in a usual-care setting. Methods: All patients with age ≤75 years undergoing PCI between January 2011 and May 2016 at an urban, tertiary care center and discharged with available statin dosage data were included. HIS were defined as atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg, and simvastatin 80 mg. Results: A total of 10,495 consecutive patients were included. Prevalence of HIS prescriptions nearly doubled from 36.6% in 2011 to 60.9% in 2016 (P

Objectives: To evaluate the impact of coronary artery disease (CAD) with or without recent (≤ 30 days) percutaneous coronary intervention (PCI) in women undergoing transcatheter aortic valve replacement (TAVR). Background: Although women display a specific risk-profile for both PCI and TAVR, the impact of CAD and PCI in the setting of TAVR in women is unclear. Methods: The multinational Women's International Transcatheter Aortic Valve implantation registry enrolled consecutive female patients undergoing contemporary TAVR in 19 centers between 2013 and 2015. Patients with available coronary angiography or CT scan in the pre-operative assessment of TAVR were categorized as without CAD, with CAD but no recent PCI and CAD and recent PCI (≤30 days). All events were adjudicated according to the VARC-2 criteria. Results: A total of 787 patients were included in this analysis, among whom 459 (58.3%) had no CAD, 247 (31.4%) had CAD without recent PCI and 81 (10.3%) underwent recent PCI (≤ 30 days before TAVR). After multivariable adjustment, both groups of CAD patients, without and with recent PCI, presented with higher risk of death, myocardial infarction or stroke, compared with patients without CAD (adjHR 1.56, 95%CI 1.03–2.39, P = 0.038 and adjHR 1.96, 95% CI 1.1–3.5, P =.021, respectively). Patients with recent PCI had increased risk of all-cause death (adjHR 1.89, 95% CI 1.0–3.5, P = 0.04) and stroke (adjHR 3.7, 95% CI 1.0–13.5, P = 0.046) compared with patients without CAD. Conclusion: The presence of CAD in women undergoing TAVR, with or without recent PCI, was associated with long-term poorer outcomes.

Intensive low-density lipoprotein cholesterol (LDL-C) reduction with statins is recommended after elective percutaneous coronary intervention (PCI). We aimed to evaluate adherence to guideline-recommended statin therapy (GRST) and the rate of residual cholesterol risk (RCR) at follow-up after elective PCI. All patients who underwent elective PCI between January 2010 and May 2016 were prospectively included in this single-center study. GRST was defined as high-intensity statin (HIS) therapy for patients ≤75 years old and moderate-intensity statin (MIS) or HIS therapy for patients75 years. RCR at follow-up was defined as50% decrease in LDL-C with HIS or30% with MIS for statin-naïve patients and as LDL-C70 mg/dL for nonstatin-naïve patients. A total of 2,653 patients were included, with 1,304 (49.2%) discharged with GRST. There was a significant increase in the number of patients discharged with GRST over time from 44.2% in 2010 to 63.0% in 2016 (p0.001). Conversely, RCR at follow-up was present in 1,120 patients (42.2%) overall and remained stable over time. Risk factors of RCR at follow-up were female gender (odds ratio [OR]: 1.38; 95% confidence interval [CI] 1.13 to 1.70), previous myocardial infarction (OR: 1.37; 95% CI 1.12 to 1.64), smoking (OR: 1.30; 95% CI 1.01 to 1.67), higher LDL-C level at baseline (OR: 1.22; 95% CI 1.18 to 1.25). The presence of RCR was associated with an increased adjusted risk of death within 1 year of the second LDL-C measurement (adjHR: 2.78; 95% CI 1.15 to 6.67). In conclusion, although the rate of GRST at discharge has improved significantly over time in patients who underwent elective PCI, the prevalence of RCR at follow-up has not changed appreciably suggesting that further implementation of guidelines as well as novel or more intensive pharmacotherapy may be warranted.

Although randomized interventions trials have been shown to reduce the incidence of disorganized attachment, no studies to date have identified the mechanisms of change responsible for such reductions. Maternal sensitivity has been assessed in various studies and shown to change with intervention, but in the only study to formally assess mediation, changes in maternal sensitivity did not mediate changes in infant security of attachment (Cicchetti, Rogosch, & Toth, 2006). Primary aims of the current randomized controlled intervention trial in a high-risk population were to fill gaps in the literature by assessing whether the intervention (a) reduced disorganization, (b) reduced disrupted maternal communication, and (c) whether reductions in disrupted maternal communication mediated changes in infant disorganization. The results indicated that, compared to controls (n= 52), both infant disorganization and disrupted maternal communication were significantly reduced in the intervention group (n= 65) that received regular home-visiting during pregnancy and the first year of life. Furthermore, reductions in disrupted maternal communication partially accounted for the observed reductions in infant disorganization compared to randomized controls. The results are discussed in relation to the societal cost effectiveness of early attachment-informed interventions for mothers and infants, as well as the importance of formally assessing underlying mechanisms of change in order to improve and appropriately target preventive interventions.

In this chapter, we briefly describe several modes of parent-infant-psychotherapy, an efficient way of treating parent-infant relationship disorders. We then focus on treatment for postnatally depressed mothers. Perinatal depression defines an episode of major or minor depression occurring during pregnancy or the first 12 months after birth. Attachment-based parent-infant interventions are particularly helpful in the context of maternal perinatal depression, as postpartum depression has a special link with unresolved trauma and losses in the mother's childhood. The goal of treatment is to improve the mother's mood but also to prevent or reduce the effects of postpartum depression on the child. Infants of perinatally depressed mothers are at risk for a large array of negative outcomes, including attachment insecurity (particularly disorganised attachment), social-skills deficits, cognitive difficulties, behaviour problems, and later psychopathology. The 'ghosts in the nursery' concept refers to the painful or disturbed early childhood experiences coming from the mother's past, which haunt the present mother-infant relationship. By addressing the mother's unresolved attachment conflicts (in her relationship to her own parents), it is believed that the development of a more adaptive parenting and a more secure and less disorganised attachment between the mother and her infant is facilitated. Changes in parent- infant interaction are not dependent on the port of entry (e.g. child's behaviour, parent's representation or parent-infant relationship). The perspective of attachment is key to install a therapeutic alliance with parents.

The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥10 mm Hg or new gradient ≥20 mm Hg.To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. Male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p 0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p 0.001) yielded higher risk of BVD.Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.

Aims: It remains unknown what percentage of patients treated with percutaneous coronary artery intervention (PCI) have high residual inflammatory risk (RIR). Moreover, the impact of RIR on clinical outcomes has not been established. The objective of this study is to determine the prevalence of patients with persistent high levels of inflammation after PCI and to evaluate clinical outcomes according to inflammatory response. Methods and results: This is a retrospective cohort study assessing patients undergoing PCI between 2009 and 2016 with serial inflammatory status assessment from a large, prospective, and single-centre PCI registry. Assessment of inflammation status with at least two high sensitive C-reactive protein (hsCRP) measurements at baseline and follow-up with >4 weeks apart. High RIR was defined as an hsCRP≥ 2 mg/L. Patients were divided into four groups: persistent high RIR, increased RIR (first low-, then high hsCRP), attenuated RIR (first high-, then low hsCRP), or persistent low RIR. The primary endpoint was all-cause mortality at 1 year follow-up. Occurrence of myocardial infarction (MI) was assessed as secondary outcome. Seven thousand and twenty-six patients were identified with serial hsCRP measurements (30.8% of all PCI patients). Of these patients 2654 (38%) had persistent high RIR, 719 patients (10%) had increased RIR, 1088 patients (15%) had attenuated RIR, and persistent low RIR was seen in 2565 patients (37%). All-cause mortality at 1 year was 2.6% in patients with persistent high RIR, compared with 1.0% in increased RIR, 0.3% in attenuated RIR, and 0.7% in persistent low RIR patients, P

Pre-existing atrial fibrillation (AF) is common among patients who underwent transcatheter aortic valve implantation (TAVI) and has been associated with adverse outcomes. The specific impact of AF at baseline in women who underwent TAVI, however, remains unknown. The Women's International Transcatheter Aortic Valve Implantation is a prospective, multinational registry evaluating the safety and performance of contemporary TAVI in women in 19 centers between January 2013 and December 2015. Patients with available electrocardiogram at baseline were compared according to the presence of AF. All events were adjudicated according to the Valve Academic Research Consortium 2 criteria. Associations between AF and outcomes were tested using multivariate Cox regression model. Of the 993 women with available baseline electrocardiogram included in the study, 200 (20.1%) presented with AF. Patients with AF at baseline had higher Euroscore I score values and more frequently had chronic kidney disease or prior stroke. Patients without AF more frequently had coronary artery disease. There was no difference regarding in-hospital events between the two groups aside from longer length of stay for patients with AF (13.3 ± 11 vs 11.5 ± 7.1 days, p = 0.01). In multivariate analysis, AF at baseline was associated with an increase of all-cause and cardiovascular death at 12 months (adjHR 1.67 95%CI 1.11 to 2.50, p = 0.013 and adjHR 1.85 95%CI 1.19 to 2.86, p = 0.006 respectively). In conclusion, in this prospective registry of women who underwent contemporary TAVI, the presence of AF at baseline was associated with significantly increased 12-month mortality.

Cardiac involvement is well characterized in sickle cell anaemia (SCA) but cardiac features associated with Haemoglobin SC (HbSC) disease are mostly unknown. We compared 60 patients with HbSC disease (median age 31 years, 25 men) to 60 SCA patients and 60 controls matched for age and gender. Left ventricular ejection fraction (LVEF), left ventricle (LV) mass index (LVMi), cardiac index and peak tricuspid regurgitation velocity (TRV) were measured using echocardiography. LV filling pressures were assessed using the ratio of early diastolic transmitral velocity to tissue velocity (E/e' ratio). The LVMi was higher in both genotypes compared to controls. However, whereas LV hypertrophy was observed only in 3(5%) HbSC patients, this condition was diagnosed in 27(45%) SCA patients (P

Aims To assess the incidence, risk factors and prognosis of periprocedural myocardial infarction (MI) and myocardial injury in patients undergoing elective percutaneous coronary intervention (PCI). Methods and results We included all consecutive patients who underwent elective PCI with a negative troponin level at admission from 1 January 2014 to 31 December 2015. The primary endpoint was defined as the composite of periprocedural MI (Type 4a MI), stent thrombosis (Type 4b MI), and myocardial injury according to the Third universal definition of MI. Multivariable analysis was performed to identify independent predictors of periprocedural MI and myocardial injury and its relation to 30-day and 1-year clinical outcome. Of the 1390 elective PCI patients, the primary endpoint occurred in 28.7% of patients, including 7.0% of Type 4a MI, 0.14% of Type 4b MI, and 21.6% of myocardial injury. Independent risk factors for the occurrence of the primary endpoint were left main PCI, total stent length >30 mm, multiple stenting, chronic kidney disease (estimated glomerular filtration rate 75 years. At 30 days, patients with periprocedural MI and myocardial injury had a higher rate of cardiovascular events [5.5% vs. 1.2%, adjusted hazard ratio (adjHR) = 3.8, 95% confidence interval (CI) 1.9-6.9; P

Background Infant socioemotional development is often held under informal surveillance, but a formal screening program is needed to ensure systematic identification of developmental risk. Even when screening programs exist, they are often ineffective because health care professionals do not adhere to screening guidelines, resulting in low screening prevalence rates. Objectives To examine feasibility and acceptability of implementing universal screening for infant socioemotional problems with the Alarm Distress Baby Scale in primary care. The following questions were addressed: Is it possible to obtain acceptable screening prevalence rates within a 1-year period? How do the primary care workers (in this case, health visitors) experience using the instrument? Are attitudes toward using the instrument related to screening prevalence rates? Design A longitudinal mixed-method study (surveys, data from the health visitors' digital filing system, and qualitative coding of answers to open-ended questions) was undertaken. Setting and participants Health visitors in three of five districts of the City of Copenhagen, Denmark ( N =79). Methods We describe and evaluate the implementation process from the date the health visitors started the training on how to use the Alarm Distress Baby Scale to one year after they began using the instrument in practice. To monitor screening prevalence rates and adherence to guidelines, we used three data extractions (6, 9, and 12 months post-implementation) from the electronic filing system. Surveys including both quantitative and open-ended questions (pre- and post-implementation) were used to examine experiences with and attitudes towards the instrument. Descriptive and inferential statistical and qualitative content analyses were used. Results Screening prevalence rates increased during the first year: Six months after implementation 47% ( n = 405) of the children had been screened; 12 months after implementation 79% ( n =789) of the children were screened (the same child was not counted more than once). Most (92%) of the health visitors reported that the instrument made a positive contribution to their work. The majority (81%) also reported that it posed a challenge in their daily work at least to some degree. The health visitors' attitudes (positive and negative) toward the Alarm Distress Baby Scale, measured 7 months post-implementation, significantly predicted screening prevalence rates 12 months post-implementation. Conclusions Adding the Alarm Distress Baby Scale to an established surveillance program is feasible and accepTable Screening prevalence rates may be related to the primary care worker's attitude toward the instrument, i.e. successful implementation relies on an instrument that adds value to the work of the screener.

International audience; Individual supervision of home-visiting professionals has proved to be a key element for perinatal home-visiting programs. Although studies have been published concerning quality criteria for supervision in North American contexts, little is known about this subject in other national settings. In the context of the CAPEDP program (Compétences parentales et Attachement dans la Petite Enfance: Diminution des risques liés aux troubles de santé mentale et Promotion de la résilience; Parental Skills and Attachment in Early Childhood: Reducing Mental Health Risks and Promoting Resilience), the first randomized controlled perinatal mental health promotion research program to take place in France, this article describes the results of a study using the Delphi consensus method to identify the program supervisors' points of view concerning best practice for the individual supervision of home visitors involved in such programs. The final 18 recommendations could be grouped into four general themes: the organization and setting of supervision sessions; supervisor competencies; relationship between supervisor and supervisee; and supervisor intervention strategies within the supervision process. The quality criteria identified in this perinatal home-visiting program in the French cultural context underline the importance of clinical supervision and not just reflective supervision when working with families with multiple, highly complex needs.

OBJECTIVES Heart transplantation (HT) and ventricular assist devices (VAD) for the management of end-stage heart failure have not been directly compared. We compare the outcomes and use of resources with these 2 strategies in 2 European countries with different allocation systems. METHODS We studied 83 patients managed by VAD as the first option in Bad Oeynhausen, Germany (Group I) and 141 managed with either HT or medical therapy, as the first option, in Paris, France (Group II). The primary end-point was 2-year survival. Kaplan-Meier analyses were performed after the application of propensity score weights to mitigate the effects of non-random group assignment. The secondary end-points were resource utilization and costs. Subgroup analyses were performed for patients undergoing HT and patients treated with inotropes at the enrolment time. RESULTS The Group I patients were more severely ill and haemodynamically compromised, and 28% subsequently underwent HT vs 55% primary HT in Group II, P