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Background The PRADO‐IC (Programme de Retour à Domicile après une Insuffisance Cardiaque) is a transition care program designed to improve the coordination of care between hospital and home that was generalized in France in 2014. The PRADO‐IC consists of an administrative assistant who visits patients during hospitalization to schedule follow‐up visits. The aim of the present study was to evaluate the PRADO‐IC program based on the hypotheses provided by health authorities. Methods and Results The PRADOC study is a multicenter, controlled, randomized, open‐label, mixed‐method trial of the transition program PRADO‐IC versus usual management in patients hospitalized with heart failure (standard of care group; NCT03396081). A total of 404 patients were recruited between April 2018 and May 2021. The mean patient age was 75 years (±12 years) in both groups. The 2 groups were well balanced regarding severity indices. At discharge, patients homogeneously received the recommended drugs. There was no difference between groups regarding hospitalizations for acute heart failure at 1 year, with 24.60% in the standard of care group and 25.40% in the PRADO‐IC group during the year following the index hospitalization (hazard ratio, 1.04 [95% CI, 0.69–1.56]; P=0.85) or cardiovascular mortality (hazard ratio, 0.67 [95% CI, 0.34–1.31]; P=0.24). Conclusions The PRADO‐IC has not significantly improved clinical outcomes, though a trend toward reduced cardiovascular mortality is evident. These results will help in understanding how transitional care programs remain to be integrated in pathways of current patients, including telemonitoring, and to better tailor individualized approaches. REGISTRATION URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03396081.

Conclusion: Despite a higher risk profile of patients in the SC group, SC and PC approaches appear safe and effective in TF TAVR, with a high success rate. SC may be considered when vascular access is anticipated as complex, but this strategy might be confirmed in a randomized study.

Introduction Long-term follow-up after an acute coronary syndrome (ACS) presents a crucial challenge due to the high residual cardiovascular risk and the potential for major bleeding events. Although several treatment strategies are available, this article focuses on patients who have undergone percutaneous coronary intervention (PCI) for ACS, which represent a frequent clinical situation. This position paper aims to support physicians in daily practice to improve the management of ACS patients. Material and methods A group of recognized international and French experts in the field, provides an overview of current evidence-based recommendations − supplemented by expert opinion where such evidence is lacking − and a practical guide for the management of patients with ACS after hospital discharge. Results The International Collaborative Group underlines the need of a shared collaborative approach, and a care plan individualized to the patient’s risk profile for both ischemia and bleeding. Each follow-up appointment should be viewed as an opportunity to optimize the personalized approach, to reduce adverse clinical outcomes and improve quality of life. As risks – both ischaemic and haemorrhagic – evolve over time, the risk–benefit balance should be assessed in an ongoing dynamic process to ensure that patients are given the most suitable treatment at each time point. Conclusions This Expert Opinion aims to help clinicians with a practical guide underlying the proven strategies and the remaining gaps of evidence to optimize the management of coronary patients.

Abstract Aims Transition care programmes are designed to improve coordination of care between hospital and home. For heart failure patients, meta‐analyses show a high efficacy but with moderate evidence level. Moreover, difficulties for implementation of such programmes limit their extrapolation. Methods and results We designed a mixed‐method study to assess the implementation of the PRADO‐IC, a nationwide transition programme that aims to be offered to every patient with heart failure in France. This programme consists essentially in an administrative assistance to schedule follow‐up visits and in a nurse follow‐up during 2 to 6 months and aims to reduce the annual heart failure readmission rate by 30%. This study assessed three quantitative aims: the cost to avoid a readmission for heart failure within 1 year (primary aim, intended sample size 404 patients), clinical care pathways, and system economic outcomes; and two qualitative aims: perceived problems and benefits of the PRADO‐IC. All analyses will be gathered at the end of study for a joint interpretation. Strengths of this study design are the randomized controlled design, the population included in six centres with low motivation bias, the primary efficiency analysis, the secondary efficacy analyses on care pathway and clinical outcomes, and the joint qualitative analysis. Limits are the heterogeneity of centres and of intervention in a control group and parallel development of other new therapeutic interventions in this field. Conclusions The results of this study may help decision‐makers to support an administratively managed transition programme.

Aim: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores. Methods and results: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score >2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2. Conclusions: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial. Clinical trial registration: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007.

Background: Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding complications may be reduced with BAV performed without heparin. Methods: This randomized, double-blind, placebo-controlled study was conducted from January 2013 to September 2016. Patients were randomly assigned to placebo or intravenous unfractionated heparin (UH) 50 IU/kg bolus during the procedure. The primary endpoint included major vascular, bleeding and ischemic complications (stroke, transient ischemic attack, myocardial infarction) according to VARC-2 criteria. Results: Among 89 randomized patients, 82 completed the study (n = 39 in the UH group and n = 43 in the placebo group). At baseline, diabetes, sex male and renal failure were more frequent in the UH group and peripheral artery disease was more frequent in the placebo group. The primary endpoint was achieved in 7 patients (8.5%), 1 in the placebo group (2.3%) versus 6 in the UH group (15.4%). After adjustment on diabetes, sex, renal failure, peripheral artery disease, percutaneous closure device and chronic obstructive pulmonary disease, UH utilization was associated with a significant risk of major vascular, bleeding and ischemic complications (primary endpoint) (adjOR: 11.9; 95%CI: 1.2–117.2; p = 0.03). Hospitalization length was lower in the placebo group compared to the UH group (p = 0.03). Conclusions: BAV without per procedural UH was associated with a reduction of major VC and bleeding events without increasing the ischemic risk and with a shorter hospitalization length.

BackgroundFirst medical contact (FMC)-to-balloon time is associated with outcome of ST-elevation myocardial infarction (STEMI). We assessed the impact on mortality and the determinants of indirect vs. direct transfer to the cardiac catheterization laboratory (CCL).MethodsWe analyzed data from 2,206 STEMI patients consecutively included in a prospective multiregional percutaneous coronary intervention (PCI) registry. The primary endpoint was 1-year mortality. The impact of indirect admission to CCL on mortality was assessed using Cox models adjusted on FMC-to-balloon time and covariables unequally distributed between groups. A multivariable logistic regression model assessed determinants of indirect transfer.ResultsA total of 359 (16.3%) and 1847 (83.7%) were indirectly and directly admitted for PCI. Indirect admission was associated with higher risk features, different FMCs and suboptimal pre-PCI antithrombotic therapy.At 1-year follow-up, 51 (14.6%) and 137 (7.7%) were dead in the indirect and direct admission groups, respectively (adjusted-HR 1.73; 95% CI 1.22–2.45). The association of indirect admission with mortality was independent of pre-FMC and FMC characteristics. Older age, paramedics- and private physician-FMCs were independent determinants of indirect admission (adjusted-HRs 1.02 per year, 95% CI 1.003–1.03; 5.94, 95% CI 5.94 3.89–9.01; 3.41; 95% CI 1.86–6.2, respectively).ConclusionsOur study showed that, indirect admission to PCI for STEMI is associated with 1-year mortality independent of FMC to balloon time and should be considered as an indicator of quality of care. Indirect admission is associated with higher-risk features and suboptimal antithrombotic therapy. Older age, paramedics-FMC and self-presentation to a private physician were independently associated with indirect admission. Our study, supports population education especially targeting elderly, more adequately dispatched FMC and improved pre-CCL management.

Background: Increased risk of new-onset atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials without however systematic AF screening. We aimed to evaluate the incidence of AF within 6-month following PFO closure with serial 24-hour ambulatory electrocardiogram (AECG) monitoring. Methods: All patients undergoing PFO closure were prospectively included in 2 centers. AF was defined as irregular rhythm without discernible P waves > 30 s on AECG at day 0, 1-month and 6-month follow-up. Primary endpoint was the incidence of AF within the study period. Secondary endpoints evaluated clinical outcomes within 6-month follow-up. Results: Between February 2018 and March 2019, 62 patients underwent PFO closure including 40 male (64.5%) with a mean age of 48 ± 9.5. Atrial septal aneurysm was observed in 37 patients (64.9%), 57 patients (91.9%) received an Amplatzer Occluder device (Abbott Vascular) and 5 (8.1%) an Occlutech device (Occlutech). After a mean follow-up of 7.7 ± 2.8 months, new-onset AF occurred in 3 patients (4.8%), all within the first month following PFO closure, including one per-procedural, all were asymptomatic and paroxysmal. Two patients with AF (3.2%) required chronic oral anticoagulant therapy. No adverse outcomes occurred at follow-up. No predictive factors of AF were highlighted. A total of 16 patients (25.8%) reported palpitations without AF on the AECGs. Conclusion: In highly selected patients, incidence of AF, evaluated with 3 systematic 24-hour AECG within 6-month following PFO closure, was low (

Pathological studies have revealed spontaneous recanalized coronary thrombi as a frequent evolution of coronary occlusions; however, they are poorly recognized on coronary angiography, and the optimal therapeutic strategy for clinical evolution is unknown. We report the role of optical coherence tomography in identifying a recanalized coronary thrombus causing myocardial ischemia after 11 years of follow-up. (Level of Difficulty: Intermediate.)

There are currently one million heart failure (HF) patients in France and the rate is progressively increases due to population aging. Acute decompensation of HF is the leading cause of hospitalization in people over 65 years of age with a 25% re-hospitalization rate in the first month. Expenses related to the management of HF in France in 2013 amounted to more than one billion euros, of which 65% were for hospitalizations alone. The management of acute decompensation is a challenge, due to the complexity of clinical and laboratory evaluation leading to therapeutic errors, which in turn leads to longer hospitalization, high early re-hospitalization and complications. Therapeutic adjustment, especially diuretic, in the acute phase (during hospitalization) affects early re-hospitalization rates (within 30 days). These adjustments can be based on clinical estimation and laboratory parameters, but echocardiography has been shown to be superior in estimating filling pressures (FP) compared to clinical and laboratory parameters.We hypothesize that a simple daily bedside echocardiographic assessment could provide a reproducible estimation of FP with an evaluation of mitral inflow and the inferior vena cava (IVC). This could allow a more reliable estimate of the true blood volume of the patient and thus lead to a more suitable therapeutic adjustment. This in turn should lead to a decrease in early re-admission rate (primary endpoint) and potentially decrease six-month mortality and rate of complications. Keywords: Heart failure, Doppler echocardiography, Diuretics, Filling pressure, Cava venous, Trans-mitral doppler, Left ventricular ejection fraction

Background: A reduction of admission for MI has been reported in most countries affected by COVID-19. No clear explanation has been provided. Methods: To report the incidence of myocardial infarction (MI) admission during COVID-19 pandemic and in particular during national lockdown in two unequally affected French provinces (10-million inhabitants) with a different media strategy, and to describe the magnitude of MI incidence changes relative to the incidence of COVID-19-related deaths. A longitudinal study to collect all MIs from January 1 until May 17, 2020 (study period) and from the identical time period in 2019 (control period) was conducted in all centers with PCI-facilities in northern “Hauts-de-France” province and western “Pays-de-la-Loire” Province. The incidence of COVID-19 fatalities was also collected. Findings: In “Hauts-de-France”, during lockdown (March 18–May 10), 1500 COVID-19-related deaths were observed. A 23% decrease in MI-IR (IRR=0.77;95%CI:0.71–0.84, p

Introduction: Direct oral anticoagulants (DOACs) also influence cell signaling in various cell types, thus affecting biological systems other than coagulation, whose markers are uncertain. Material and methods: To perform a pilot study of variations in plasma protein by means of Liquid chromatography–high resolution tandem mass spectrometry (LC-HRMS/MS) in 5 patients with newly-diagnosed non-valvular atrial fibrillation (NVAF) starting rivaroxaban anti-FXa DOAC treatment. Results: A total of 260 proteins could be identified in plasma samples obtained before treatment and at one month of treatment. A significant sustained variation in their concentrations (doubling or halving) was evidenced in at least one patient. These variations were heterogeneous and inconstant from one patient to another. Their most striking feature was the downregulation of proteins participating in the inflammatory system reaction, and of proteins related to intravascular hemolysis. Other variations were rarer and more erratic. Conclusions: Individual rivaroxaban treatment-associated variations in protein were evidenced in patients with NVAF starting rivaroxaban. This should now be tested and confirmed with a large series of carefully annotated patients. Confirming these established variations would open the door to the search for clinically-relevant correlations and consequences, if any.

Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon‐expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open‐label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High‐sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high‐sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1‐month adverse events (all‐cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high‐sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78–87 years), with 129 men (61.1%). Mean postprocedure high‐sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (P=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (P=0.004). BAV increased by 2.8‐fold (95% CI, 1.4–5.8) myocardial injury probability. Myocardial injury was associated with 1‐month adverse events (P=0.03). Conclusions BAV increased the incidence and magnitude of myocardial injury after TAVR with new‐generation balloon‐expandable valves. Myocardial injury was associated with 1‐month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation. Registration URL: https://www.Clinicaltrials.gov; Unique identifier: NCT02729519.

Abstract Background Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. Discussion This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. Trial registration ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.

BackgroundCurrently, cardiovascular disease (CVD) is widely acknowledged to be the first leading cause of fatality in the world with 31% of all deaths worldwide and is predicted to remain as such in 2030. Furthermore, CVD is also a major cause of morbidity in adults worldwide. Among these diseases, the coronary artery disease (CAD) is the most common cause, accounting for over 40% of CVD deaths. Despite a decline in mortality rates, the consequences of more effective preventive and management programs, the burden of CAD remains significant. Indeed, the rise in the prevalence of modifiable risk factors due to changes in lifestyle and health behaviors has further increased the burden of this epidemic. Our objective was to evaluate the hospital burden of CAD via MI trends and Percutaneous Coronary Intervention (PCI) in the French Prospective Payment System (PPS).MethodsMI/PCI were identified in the national PPS database from 2009 to 2014 for patients aged 20 to 99, living in metropolitan France. We examined hospitalisation, readmission and mortality trends using standardised rates.ResultsOver the six-year period, we identified 678,021 patients, representing 900,121 stays of which, 215,224 had a MI and a PCI. Admission trends increased by nearly 25%. Acute MI cases increased every year, with an alarming increase in women, and more specifically in young women. Men were 3 times more hospitalised than women, who were older. A North-South divide was noted. Twenty seven percent of patients experienced readmission within 1 month. Trajectories of care were significantly different by sex and age. Overall in-hospital death was 3.3%, decreasing by 15% during the period. The highest adjusted mortality rates were observed for inpatients aged 80.ConclusionWe outlined the public health burden of this condition and the importance of improving the trajectories of care as an aid for better care.

BackgroundMorphine is commonly used to treat chest pain during myocardial infarction, but its effect on cardiovascular outcome has never been directly evaluated. The aim of this study was to examine the effect and safety of morphine in patients with acute anterior ST‐segment elevation myocardial infarction followed up for 1 year. Methods and ResultsWe used the database of the CIRCUS (Does Cyclosporine Improve Outcome in ST Elevation Myocardial Infarction Patients) trial, which included 969 patients with anterior ST‐segment elevation myocardial infarction, admitted for primary percutaneous coronary intervention. Two groups were defined according to use of morphine preceding coronary angiography. The composite primary outcome was the combined incidence of major adverse cardiovascular events, including cardiovascular death, heart failure, cardiogenic shock, myocardial infarction, unstable angina, and stroke during 1 year. A total of 554 (57.1%) patients received morphine at first medical contact. Both groups, with and without morphine treatment, were comparable with respect to demographic and periprocedural characteristics. There was no significant difference in major adverse cardiovascular events between patients who received morphine compared with those who did not (26.2% versus 22.0%, respectively; P=0.15). The all‐cause mortality was 5.3% in the morphine group versus 5.8% in the no‐morphine group (P=0.89). There was no difference between groups in infarct size as assessed by the creatine kinase peak after primary percutaneous coronary intervention (4023±118 versus 3903±149 IU/L; P=0.52). ConclusionsIn anterior ST‐segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention, morphine was used in half of patients during initial management and was not associated with a significant increase in major adverse cardiovascular events at 1 year.