BACKGROUND:The management of calcified coronary lesions remains challenging. Although several devices for advanced plaque modification are available, their relative efficacy is debated. AIMS:We aimed to compare intravascular lithotripsy (IVL)- and rotational atherectomy (RA)-based strategies for calcified plaque preparation during percutaneous coronary interventions (PCI). METHODS:This multicentre, prospective, randomised non-inferiority trial compared IVL with RA for plaque preparation in moderate-to-severe stable calcified coronary lesions. All interventions were guided by optical frequency domain imaging. A non-inferiority margin of 0.75 mm2 was prospectively defined based on prior intracoronary imaging studies, and the sample size calculation was based on a standard deviation of 1.9 mm2, a one-sided alpha risk of 5%, and a power of 80%, under the assumption of no true difference between groups. The primary endpoint was the minimal stent area (MSA) following stent implantation. The target lesion failure (TLF) rate was analysed after 12 months. RESULTS:A total of 169 patients (RA: n=86, IVL: n=83; 81.1% male; mean age 71.8±8.2 years) were included in the final analysis. The baseline characteristics of each group were balanced. Calcified nodules were identified in 48% of the patients. IVL was not inferior to RA for the primary endpoint (6.0±2.3 mm2 vs 5.9±2.2 mm2, respectively; p for non-inferiority<0.05). Adequate geometrical stent expansion was similar in both groups (RA: 65.1%, IVL: 65.1%; p=0.994), whereas major strut malapposition was more frequently observed in the RA group (RA: 80.2% vs IVL: 57.8%; p=0.002). There was no difference between groups in terms of periprocedural complications. The TLF rates between groups after 12 months were equivalent (RA: 1.2%, IVL: 2.4%; p=0.61). CONCLUSIONS:In this trial, the IVL strategy was non-inferior to the RA strategy regarding MSA for PCI in moderate-to-severe calcified coronary lesions, with a comparable safety profile and equivalent clinical outcomes.
BACKGROUND:Cerebral complications in patients with infective endocarditis (IE) are common and worsen prognosis. Determining the optimal timing for cardiac surgery in this context remains challenging. In this study we describe the characteristics and outcomes of IE patients with cerebral complications who were managed either surgically or medically. METHODS:We analyzed all consecutive patients with IE-related cerebral complications enrolled in a prospective cohort study in Aquitaine, France (2013-2021). Patients were classified as operated or nonoperated. The primary outcome was all-cause mortality at 1 month; secondary outcomes included all-cause mortality up to 1 year and the impact of cerebral lesion type and surgical timing. RESULTS:Among 1230 IE patients, 288 had cerebral complications (age 65 ± 14 years, 74% male). Ischemic and hemorrhagic cerebral lesions occurred in 76% and 19% of patients, respectively. Severe valvular damages were present in 43% and cardiac surgery was indicated in 86% of cases. One-month mortality was significantly higher among nonoperated vs operated patients (27% vs 5.9%, P < 0.001). Multivariate analysis identified heart failure, coma, and cardiac surgery (odds ratio 0.24, 95% confidence interval 0.10-0.56, P < 0.001) as independent predictors of mortality. Neither the type of cerebral lesion nor surgical timing appeared to affect prognosis. CONCLUSIONS:When indicated, cardiac surgery should be systematically discussed in IE patients with cerebral complications. Early intervention guided by a multidisciplinary endocarditis team with neurology expertise may improve outcomes.
INTRODUCTION:Embolic events (EEs) in infective endocarditis (IE) are frequent and associated with poor prognosis. Follow-up imaging is not standardized despite the risk of persistent extracardiac foci. We aimed to assess the therapeutic impact of imaging reassessment before antibiotic discontinuation. METHODS AND RESULTS:Prospective multicentre study including patients with definite or possible IE complicated by EEs (2013-2022). Asymptomatic or clinically stable patients who underwent follow-up imaging before antibiotic discontinuation to reassess IE-related EEs were included, whereas those imaged for clinical reasons were excluded. The primary endpoint was therapeutic impact: antibiotic modification and/or intervention. Secondary endpoints included all-cause mortality. Overall, 54% (n = 700/1300) of the entire cohort had IE-related EEs. Among them, 554 patients (mean age 65.7 years, 76% male) under antibiotic therapy were included: 49% with cerebral and 79% with extracerebral EEs, mainly ischaemic stroke (42%) and splenic embolism (40%). Follow-up imaging before antibiotic discontinuation (median, 6 weeks) was performed in 51% (n = 281/554), leading treatment modification in 5.7% (16/281), mainly in patients with Staphylococcus aureus IE complicated by abscess. In-hospital and 5-year mortality were 9.4% and 30.8%, respectively. Haemodynamic instability and comorbidities were associated with long-term mortality, whereas only cardiac surgery was associated with improved survival. CONCLUSION:Imaging reassessment of IE-related EEs before stopping antibiotics may lead to therapeutic modification in asymptomatic or clinically stable patients using a risk-stratified individualized imaging strategy guided by the endocarditis teams, rather than a uniform approach. Prospective studies are needed to define standardized imaging algorithms.
Aims:Cardiovascular magnetic resonance imaging has become pivotal in the non-invasive assessment of the heart. Bright-blood sequences are used to retrieve information about cardiac anatomy and function. Concurrently, novel black-blood late gadolinium enhancement sequences have showcased potential for scar detection by uncovering scar patterns that may be confounded with blood. In the acute setting, T2 mapping allows for quantitative characterization of oedematous tissue. Nowadays, these images are acquired sequentially through multiple breath-holds, adding to the workload of medical professionals, reducing patient comfort, and hampering image analysis.Here, we assess the clinical value of SPOT-MAPPING, a sequence combining co-registered T2 mapping and joint black- and bright-blood imaging. Methods and results:Twenty-six patients (27% women, age 64 ± 12yo) with acute, chronic, ischaemic, non-ischaemic, and overlapping cardiomyopathies, prospectively underwent SPOT-MAPPING at 1.5T. Conventional PSIR images and T2 maps served as the reference standard. Left ventricular (LV) mass, scar mass, burden, and transmurality and T2 values were retrieved and compared between sequences. Acquisition times were recorded. Acquisition time for SPOT-MAPPING was in average twice shorter than combined reference sequences (5 min 55 s [5 min 14 s-6 min 30 s] vs. 11 min 56 s [10 min 39s-12 min 12 s]). High reproducibility was obtained with reference sequences for LV mass (ICC ≥ 0.93). Strong agreement was observed with PSIR in scar extraction (mean bias: mass +2.3 g, burden +1.1%LV mass, transmurality +1.4%). No significant difference with reference T2 mapping was observed in remote (P = 1.000) and oedematous myocardium (P = 0.883). Conclusion:SPOT-MAPPING demonstrated its efficacy in a wide range of patients, proving itself as a time-efficient and reproducible CMR method for the assessment of various cardiac diseases.
Importance:Anterior acute myocardial infarction is associated with increased risk of left ventricular (LV) thrombus. The benefit and risk of adding an oral anticoagulant to dual antiplatelet therapy (DAPT) in preventing LV thrombus remain uncertain. Objective:To determine whether the addition of low-dose rivaroxaban to DAPT reduces the incidence of LV thrombus at 1 month in patients with anterior ST-segment elevation myocardial infarction (STEMI). Design, Setting, and Participants:This multicenter, open-label, blinded-end point randomized clinical trial was performed in 29 centers in France. The trial was nested in the ongoing FRENCHIE (French Cohort of Myocardial Infarction Evaluation) registry. Between October 2021 and January 2023, patients with anterior STEMI were enrolled. The last date of participant follow-up was in March 2023. Data analysis was performed from September 2024 to July 2025. Interventions:Patients were randomized to receive either DAPT plus rivaroxaban, 2.5 mg, twice daily for 4 weeks (n = 283) or DAPT alone (aspirin ≤100 mg per day and either clopidogrel, 75 mg per day, or ticagrelor, 90 mg twice a day [n = 277]), as soon as possible following completion of the initial percutaneous coronary intervention or angiography procedure. Main Outcomes and Measures:The primary end point was presence of LV thrombus on contrast-enhanced cardiac magnetic resonance imaging at 1 month. Results:Among 560 patients with anterior STEMI enrolled (mean [SD] age, 61.1 [11.6] years; 121 female patients [21.6%]), LV thrombus was detected in 38 patients (13.7%) receiving rivaroxaban and 47 patients (16.6%) with DAPT alone (difference, -2.9%; 95% CI, -8.9% to 3.2%; P = .34). No difference was observed between the 2 groups regarding the largest diameter of LV thrombus or the incidence of major adverse cardiovascular events. The incidence of major bleeding events (Bleeding Academic Research Consortium [BARC] ≥type 2) was also comparable (4 [1.5%] with DAPT plus rivaroxaban vs 2 [0.7%] with DAPT alone; difference, 0.7%; 95% CI, -1.3% to 3.1%), whereas minor bleeding events (BARC type 1) occurred more frequently in the DAPT plus rivaroxaban group (45 [16.4%] vs 20 [7.2%]; difference, 9.3%; 95% CI, 3.6%-14.8%). Conclusions and Relevance:In this multicenter randomized clinical trial among patients with anterior STEMI, the addition of low-dose rivaroxaban to DAPT did not demonstrate a statistically significant reduction in LV thrombus formation at 1 month but did increase minor bleeding. Given the limited power of the study, these findings should be interpreted with caution, as a modest effect cannot be excluded. Trial Registration:ClinicalTrials.gov Identifier: NCT05077683.
Background: Although several risk-stratification models have been developed for patients with refractory cardiogenic shock requiring temporary mechanical circulatory support, most primarily predict short- and long-term mortality and do not reliably identify patients who can be successfully weaned from support. Cardiac troponin is routinely measured during the acute phase of myocardial infarction. Cumulative troponin exposure, quantified by the troponin area under the concentration–time curve (T-AUC), correlates with the extent of myocardial necrosis. The objective of this study was to evaluate whether T-AUC could improve prediction of temporary mechanical circulatory support weaning failure. Methods: We conducted a single-centre retrospective cohort study including consecutive adults admitted to our cardiac intensive care unit between January 2014 and September 2025 with acute myocardial infarction-related cardiogenic shock requiring temporary mechanical circulatory support. From serial daily troponin I measurements, cumulative troponin exposure was reconstructed as T-AUC. The primary endpoint was temporary mechanical circulatory support weaning failure, defined as death, durable mechanical circulatory support, or heart transplantation during support or within 30 days after explantation. Results: Among the 159 included patients, 97 (61.0%) reached the primary endpoint. In the adjusted time-dependent Cox model, higher cumulative troponin exposure was independently associated with temporary mechanical circulatory support weaning failure (hazard ratio [HR] 1.40 per 1,000,000 ng/L·day increase, 95% confidence interval [CI] 1.19–1.65; p < 0.0001). Restoration of TIMI 3 flow after revascularisation was associated with a significantly lower risk of failure (HR 0.50, 95% CI 0.31–0.80; p = 0.004). Addition of day-5 T-AUC to the clinical model provided the greatest improvement in discrimination (AUC 0.862, 95% CI 0.797–0.926), followed by peak troponin (AUC 0.848, 95% CI 0.779–0.918). Conclusions: In patients with acute myocardial infarction-related cardiogenic shock requiring temporary mechanical circulatory support, cumulative troponin exposure, quantified by T-AUC, was independently associated with failure to wean from support and provided incremental predictive value beyond established clinical risk factors.
QuestionDoes adding low-dose rivaroxaban to dual antiplatelet therapy (DAPT) reduce left ventricular (LV) thrombus formation in patients with anterior acute myocardial infarction?FindingsIn this randomized clinical trial of 560 patients with anterior ST-segment elevation myocardial infarction (STEMI), adding low-dose rivaroxaban to DAPT did not significantly reduce LV thrombus formation at 1 month but did increase minor bleeding.MeaningIn this study, in patients with anterior STEMI, the addition of low-dose rivaroxaban to DAPT did not demonstrate a statistically significant reduction in LV thrombus formation at 1 month but increased minor bleeding; given the limited power of the study, these findings should be interpreted with caution. ImportanceAnterior acute myocardial infarction is associated with increased risk of left ventricular (LV) thrombus. The benefit and risk of adding an oral anticoagulant to dual antiplatelet therapy (DAPT) in preventing LV thrombus remain uncertain.ObjectiveTo determine whether the addition of low-dose rivaroxaban to DAPT reduces the incidence of LV thrombus at 1 month in patients with anterior ST-segment elevation myocardial infarction (STEMI).Design, Setting, and ParticipantsThis multicenter, open-label, blinded-end point randomized clinical trial was performed in 29 centers in France. The trial was nested in the ongoing FRENCHIE (French Cohort of Myocardial Infarction Evaluation) registry. Between October 2021 and January 2023, patients with anterior STEMI were enrolled. The last date of participant follow-up was in March 2023. Data analysis was performed from September 2024 to July 2025.InterventionsPatients were randomized to receive either DAPT plus rivaroxaban, 2.5 mg, twice daily for 4 weeks (n = 283) or DAPT alone (aspirin <= 100 mg per day and either clopidogrel, 75 mg per day, or ticagrelor, 90 mg twice a day [n = 277]), as soon as possible following completion of the initial percutaneous coronary intervention or angiography procedure.Main Outcomes and MeasuresThe primary end point was presence of LV thrombus on contrast-enhanced cardiac magnetic resonance imaging at 1 month.ResultsAmong 560 patients with anterior STEMI enrolled (mean [SD] age, 61.1 [11.6] years; 121 female patients [21.6%]), LV thrombus was detected in 38 patients (13.7%) receiving rivaroxaban and 47 patients (16.6%) with DAPT alone (difference, -2.9%; 95% CI, -8.9% to 3.2%; P = .34). No difference was observed between the 2 groups regarding the largest diameter of LV thrombus or the incidence of major adverse cardiovascular events. The incidence of major bleeding events (Bleeding Academic Research Consortium [BARC] >= type 2) was also comparable (4 [1.5%] with DAPT plus rivaroxaban vs 2 [0.7%] with DAPT alone; difference, 0.7%; 95% CI, -1.3% to 3.1%), whereas minor bleeding events (BARC type 1) occurred more frequently in the DAPT plus rivaroxaban group (45 [16.4%] vs 20 [7.2%]; difference, 9.3%; 95% CI, 3.6%-14.8%).Conclusions and RelevanceIn this multicenter randomized clinical trial among patients with anterior STEMI, the addition of low-dose rivaroxaban to DAPT did not demonstrate a statistically significant reduction in LV thrombus formation at 1 month but did increase minor bleeding. Given the limited power of the study, these findings should be interpreted with caution, as a modest effect cannot be excluded.Trial RegistrationClinicalTrials.gov Identifier: NCT05077683 This multicenter randomized clinical trial conducted in France determines whether the addition of low-dose rivaroxaban to dual antiplatelet therapy reduces the incidence of left ventricular thrombus at 1 month in patients with anterior ST-segment elevation myocardial infarction.
PURPOSE:Myocardial scar quantification is key for patient prognosis. Black-blood late gadolinium enhancement (LGE) imaging improves scar visualization by nulling both blood and myocardium, solving the blood-scar interface contrast issue of bright-blood LGE. With no consensus on semi-automatic methods, scar segmentation is often manual, and therefore time-consuming and operator-dependent. We evaluate semi-automatic scar segmentation algorithms on co-registered bright- and black-blood LGE images. METHOD:Twenty patients with ischemic heart disease were included. Breath-held short-axis 2D whole-heart joint bright- and black-blood SPOT and reference PSIR images were collected on a 1.5 T system in mid-diastole. Left ventricle wall and scar were manually segmented by two experts on both images. The n-SD (n from 2 to 15), FWHM and Otsu thresholding scar segmentation methods were applied to black-blood SPOT images. Dice Similarity Coefficient (DSC), scar extent, volume and transmurality were measured for all segmentations. RESULTS:Manual scar segmentation DSCs are higher on SPOT than PSIR images at both intra- (DSC: 87.9%[85.1%-88.8%]) and interobserver (87.3% [79.4%-89.4%]) levels. SPOT and PSIR yielded similar scar extent and volumes with moderate to good agreement (0.59 < ICC < 0.77). The 6-SD achieved the highest DSC (81.3%[73.7%-76.8%]), the most accurate scar extent (bias(SD): -0.8%(9.6%)), scar volume (bias(SD): 0.5 mL(7.1 mL)) and scar transmurality (bias(SD): -0.29%(10.70%)) for 7-, 8- and 3-SD, respectively. CONCLUSION:Conventional semi-automatic scar segmentation algorithms developed for bright-blood imaging can be applied to black-blood imaging. Validation in larger populations is needed to determine and refine the most accurate approach.
BACKGROUND:Although recent work has shown that recent recreational drug use is associated with in-hospital outcomes in patients admitted to the intensive cardiac care unit (ICCU), its cardiovascular consequences after hospitalization for an acute cardiovascular event are not well established. We aimed to evaluate the prognostic impact of recreational drug use at 1-year follow-up on major adverse cardiovascular and cerebrovascular events (MACCE) in patients admitted to the ICCU. METHODS:The ADDICT-ICCU study (Addiction in Intensive Cardiac Care Units) is a prospective multicentric study including all consecutive patients admitted to the ICCU over 2 weeks in April 2021 at 39 French centers. Patients were excluded in cases of scheduled hospitalization, hospitalization within 24 hours before ICCU admission, or in-hospital death. Screening for recreational drug use was performed by a systematic urinary testing upon admission. The primary composite outcome was 1-year MACCE defined as cardiovascular death, nonfatal myocardial infarction, or stroke. Outcomes were adjudicated by 2 senior cardiologists after patient contact and review of anonymized records. A multivariable Cox regression analysis adjusted for traditional prognostic factors was performed to assess the independent association between overall recreational drug use and clinical outcomes. RESULTS:Of the 1392 patients assessed (63±15 years, 69.9% men), 157 (11.3%) had an initial positive test (cannabis or opioids, cocaine, amphetamines, or 3,4-methylenedioxymethamphetamine). After 1-year of follow-up, 94 (6.7%) patients experienced MACCE, with a higher incidence observed among drug users compared with nonusers (12.7% versus 6.0%; risk difference, 6.7% [95% CI, 1.5%-12.2%]). Cannabis or opioid use alone was also associated with MACCE (hazard ratio, 1.77 [95% CI, 1.02-3.08] for cannabis, and hazard ratio, 3.60 [95% CI, 1.57-8.23], for opioids). After adjustment for traditional prognostic factors, recreational drug use remained independently associated with MACCE (hazard ratio, 2.91 [95% CI, 1.68-5.05]). CONCLUSIONS:Recreational drug use markedly increases the risk of 1-year adverse cardiovascular outcomes in ICCU patients highlighting the need for targeted, tailored interventions. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT05063097.
AIMS:Although predominant in routine practice, non-ischaemic cardiogenic shock (NICS) remains underrepresented in past studies, mainly focused on ischaemic cardiogenic shock (CS). This study aims to describe the current NICS picture and define its independent correlates of short- and long-term outcomes. METHODS AND RESULTS:FRENSHOCK is a prospective registry including 772 CS patients from 49 centers. One-year mortality was the primary outcome. One-month mortality and the composite of 1-year mortality, heart transplantation (HTx), or ventricular assistance device (VAD) were secondary outcomes. Within 772 patients included, 492 (63.7%) were NICS. One-month and 1-year mortality rates were 25.6% and 45.7%, with a combined endpoint of 1-year mortality, HTx, or VAD of 53.9%. Multivariate analysis showed five independent factors for 1-year mortality: age (per year: aHR 1.03 [1.01-1.05], P < 0.01), chronic kidney disease (CKD) (aHR 1.87 [1.25-2.80], P < 0.01), norepinephrine use (aHR 1.52 [1.02-2.26], P = 0.04), active cancer (aHR 1.91 [1.07-3.42], P = 0.03) and acute renal replacement therapy (aHR 1.57 [1.01-2.46], P = 0.049). Age, CKD and norepinephrine were also predictive of 1-month mortality and 1-year mortality and/or HTx and/or VAD. Additionally, 1-month mortality was associated with septic triggers, and 1-year mortality and/or HTx and/or VAD with acute mechanical circulatory support, NYHA stage ≥ 3 and fluid administration. CONCLUSIONS:In this large study, NICS accounted for almost two-thirds of all CS cases, with substantial rates of short- and long-term mortality. Future studies should evaluate interventions to improve early stratification and management. NCT02703038.
BACKGROUND:Patients in cardiogenic shock (CS) can benefit from temporary mechanical circulatory support (tMCS) but data in heterogeneous populations with diverse CS aetiologies are rare. AIMS:To compare baseline characteristics, management and independent correlates of 30-day and 1-year mortalities between patients managed with and without tMCS for CS. METHODS:The FRENSHOCK registry (NCT02703038) included 772 unselected patients with CS admitted in 49 French critical care units between April and October 2016. RESULTS:Among 770 patients with CS and available data, 135 (17.5%) received tMCS (63 extracorporeal life support, 35 intra-aortic balloon pump, 13 micro-axial flow pump and 24 combination), of whom 69.0% were implanted during the first 24hours. Patients with tMCS were less likely to present with histories of cardiac or peripheral artery diseases or chronic renal failure. An ischaemic or mechanical complication trigger for CS tripled the probability of receiving tMCS, while increased lactate doubled the probability. Thirty-day mortality was higher among patients with versus without tMCS (34.1% vs. 24.3%; P<0.001), but after adjustment for age and CS severity (LVEF and arterial lactates at admission, noradrenaline and invasive mechanical ventilation use), the difference was no longer significant (hazard ratio: 1.37, 95% confidence interval: 0.93-2.01). Among 30-day survivors, mortality was similar regardless of initial receipt of tMCS (P=0.312). CONCLUSION:In real-life practice, tMCS may not be associated with improvements in 30-day or 1-year mortality in an all-comers cohort of patients with CS. However, it should be noted that there were substantial differences in patient characteristics and management between patients who received tMCS and those who did not. Additional targeted studies should help to determine more precise algorithms for granting assistance within the complex and heterogeneous population of patients with CS.
Cardiogenic shock (CS) is a severe hemodynamic condition with high mortality. Although extremely frequent in daily practice, the impact of anemia in CS is largely unknown. This study focuses on the consequences of low hemoglobin (Hb) level on the outcomes of CS patients. FRENSHOCK is a prospective registry including 772 CS patients from 49 centers. One-month and one-year mortalities were analyzed according to the admission level of Hb. Among 754 patients, 71.8
Introduction: The risk stratification at admission to the intensive cardiac care unit (ICCU) is crucial and remains challenging. Objectives: We aimed to investigate the accuracy of a machine learning (ML)-model based on initial transthoracic echocardiography (TTE) to predict in-hospital major adverse events (MAEs) in a broad spectrum of patients admitted to ICCU. Methods: All consecutive patients hospitalized in ICCUs with a complete TTE performed within the first 24 hours of admission were included in this prospective multicenter study (39 centers). Sixteen TTE parameters were evaluated. The ML model involved automated feature selection by random survival forest and model building with an extreme gradient boosting (XGBoost) algorithm. The primary outcome was in-hospital MAEs defined as all-cause death, resuscitated cardiac arrest, or cardiogenic shock. Results: Of 1,499 consecutive patients (63 6 15 years, 70% male), MAEs occurred in 67 patients (4.5%). The 5 TTE parameters selected in the model were left ventricular outflow tract velocity-time integral, E/e' ratio, systolic pulmonary artery pressure, tricuspid annular plane systolic excursion, and left ventricular ejection fraction. Using the XGBoost, the ML model exhibited a higher area under the receiver operating curve compared with any existing scores (ML model, 0.83 vs logistic regression, 0.76, ACUTE-HF score:,0.66; thrombolysis in myocardial infarction score, 0.60; Global Registry of Acute Coronary Events score, 0.58, all P < .001). The ML model had an incremental prognostic value for predicting MAE over a traditional model including clinical and biological data (C index 0.80 vs 0.73, P = .012; chi-square 59.7 vs 32.4; P < .001). Conclusion: The ML model based on initial TTE exhibited a higher prognostic value to predict in-hospital MAEs compared with existing scores or clinical and biological data in the ICCU.