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Background: The optimal strategy in prosthetic heart valve thrombosis (PVT) remains controversial, with no randomized trials and conflicting observational data. We performed a systematic review and meta-analysis of evidence comparing systemic thrombolysis and cardiac surgery in PVT., Methods and Results: We searched PubMed, the Cochrane Library, and Embase for studies on treatment strategies in patients with left-sided PVT since 2000. The primary outcome was death, and the secondary outcomes were major bleeding and thromboembolism during follow-up (International Prospective Register of Systematic Reviews No. CRD42022384092). We identified 2298 studies, of which 16 were included, comprising 1389 patients with PVT (mean age, 50.4±9.3 years; 60.0% women). Among them, 67.2% were New York Heart Association stage III/IV at admission. Overall, 48.1% were treated with systemic thrombolysis and 51.9% with cardiac surgery. The mortality rate was 10.8% in the thrombolysis group and 15.3% in the surgery group. The pooled risk difference for death with systemic thrombolysis was 1.13 (exact CI, 0.74-1.79; ζ 2 =0.89; P <0.001) versus cardiac surgery. Rates of both transient ischemic attack and non-central nervous system embolism were higher in the thrombolysis group ( P =0.002 and P =0.02, respectively). Treatment success, major bleeding, and stroke were similar between groups. Sensitivity analysis including studies that used low-dose or slow-infusion thrombolysis showed that the mortality rate was lower, and treatment success was higher, in patients referred to systemic thrombolysis, with similar rates of other secondary outcomes., Conclusions: There is evidence to suggest that thrombolysis might be the preferred option for the management of PVT without cardiogenic shock, pending future randomized controlled trials or larger observational studies.

Introduction: Clinical events may occur after percutaneous coronary intervention (PCI), particularly in complex lesions and complex patients. The optimization of PCI result, using pressure guidewire and intracoronary imaging techniques, may reduce the risk of these events. The hypothesis of the present study is that the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with an unrestricted use of intracoronary tools that allow PCI optimization., Methods and Analysis: Observational prospective multicenter international study, with a follow-up of 12 months, including 1064 patients treated with a cobalt‑chromium everolimus-eluting stent. Inclusion criteria include any of the following: Lesion length > 28 mm; Reference vessel diameter < 2.5 mm or > 4.25 mm; Chronic total occlusion; Bifurcation with side branch ≥2.0 mm;Ostial lesion; Left main lesion; In-stent restenosis; >2 lesions stented in the same vessel; Treatment of >2 vessels; Acute myocardial infarction; Renal insufficiency; Left ventricular ejection fraction <30 %; Staged procedure. The control group will be comprised by a similar number of matched patients included in the "extended risk" cohort of the XIENCE V USA study. The primary endpoint will be the 1-year rate of target lesion failure (TLF) (composite of ischemia-driven TLR, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel). Secondary endpoints will include overall mortality, cardiovascular mortality, acute myocardial infarction, TVR, TLR, target vessel failure, and definitive or probable stent thrombosis at 1 year., Implications: The ongoing OPTI-XIENCE study will contribute to the growing evidence supporting the use of intra-coronary imaging techniques for stent optimization in patients with complex coronary lesions., Competing Interests: Declaration of competing interest The following authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The rest of the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

USE OF THE CALCIUM SCORE IN DAILY PRACTICE. The calcium score has become extremely widespread in routine practice. It is a simple tool for detecting and quantifying the burden of calcification in the coronary arteries and has become a key component of cardiovascular risk stratification in primary prevention. Its value is correlated with the development of coronary atheroma, and its prognostic value has been well established. In practice, the measure of the calcium score is of value in estimating individual risk in "apparently healthy" patients, on top of the classic variables. In patients whose risk is estimated to be "intermediate" using risk scores, the calcium score may enable reclassification of the risk, either to higher or to a lower category. In the doctor-patient relationship, it also contributes to raising awareness about the need for preventive measures, by documenting coronary atherosclerosis that may have been previously undetected in that patient. However, caution is advised, lest the calcium score become a victim of its own success: It does not necessarily translate the presence of coronary stenosis, and cannot be used in a simplistic fashion as a marker of the progression of atherosclerosis or myocardial ischemia., Competing Interests: M. Besutti déclare n’avoir aucun lien d’intérêts. F. Schiele déclare des liens d’intérêts avec les laboratoires Amarin, Amgen, AstraZeneca, Bayer, BMS, MSD, NovoNordisk, Novartis, Pfizer, Lilly, Mylan, Recordati, Sanofi et Servier.

Introduction: After closure of patent foramen ovale (PFO) due to stroke, atrial fibrillation (AF) occurs in up to one in five patients. However, data are sparse regarding the possible pre-existence of AF in these patients prior to PFO closure, and about recurrence of AF in the long term after the procedure. No prospective study to date has investigated these topics in patients with implanted cardiac monitor (ICM). The PFO-AF study (registered with ClinicalTrials.gov under the number NCT04926142) will investigate the incidence of AF occurring within 2 months after percutaneous closure of PFO in patients with prior stroke. AF will be identified using systematic ICM. Secondary objectives are to assess incidence and burden of AF in the 2 months prior to, and up to 2 years after PFO closure., Methods and Analysis: Prospective, multicentre, observational study including 250 patients with an indication for PFO closure after stroke, as decided by interdisciplinary meetings with cardiologists and neurologists. Patients will undergo implantation of a Reveal Linq device (Medtronic). Percutaneous PFO closure will be performed 2 months after device implantation. Follow-up will include consultation, ECG and reading of ICM data at 2, 12 and 24 months after PFO closure. The primary endpoint is occurrence of AF at 2 months, defined as an episode of AF or atrial tachycardia/flutter lasting at least 30 s, and recorded by the ICM and/or any AF or atrial tachycardia/flutter documented on ECG during the first 2 months of follow-up., Ethics and Dissemination: The study was approved by the Ethics Committee 'Comité de Protection des Personnes (CPP) Sud-Méditerranéen III' on 2 June 2021 and registered with ClinicalTrials.gov (NCT04926142). Findings will be presented in national and international congresses and peer-reviewed journals., Trial Registration Number: NCT04926142., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective:  D-dimer measurement is a safe tool to exclude pulmonary embolism (PE), but its specificity decreases in coronavirus disease 2019 (COVID-19) patients. Our aim was to derive a new algorithm with a specific D-dimer threshold for COVID-19 patients., Methods:  We conducted a French multicenter, retrospective cohort study among 774 COVID-19 patients with suspected PE. D-dimer threshold adjusted to extent of lung damage found on computed tomography (CT) was derived in a patient set ( n  = 337), and its safety assessed in an independent validation set ( n  = 337)., Results:  According to receiver operating characteristic curves, in the derivation set, D-dimer safely excluded PE, with one false negative, when using a 900 ng/mL threshold when lung damage extent was <50% and 1,700 ng/mL when lung damage extent was ≥50%. In the derivation set, the algorithm sensitivity was 98.2% (95% confidence interval [CI]: 94.7-100.0) and its specificity 28.4% (95% CI: 24.1-32.3). The negative likelihood ratio (NLR) was 0.06 (95% CI: 0.01-0.44) and the area under the curve (AUC) was 0.63 (95% CI: 0.60-0.67). In the validation set, sensitivity and specificity were 96.7% (95% CI: 88.7-99.6) and 39.2% (95% CI: 32.2-46.1), respectively. The NLR was 0.08 (95% CI; 0.02-0.33), and the AUC did not differ from that of the derivation set (0.68, 95% CI: 0.64-0.72, p  = 0.097). Using the Co-LEAD algorithm, 76 among 250 (30.4%) COVID-19 patients with suspected PE could have been managed without CT pulmonary angiography (CTPA) and 88 patients would have required two CTs., Conclusion:  The Co-LEAD algorithm could safely exclude PE, and could reduce the use of CTPA in COVID-19 patients. Further prospective studies need to validate this strategy., Competing Interests: T.M. reports personal fees and nonfinancial support from Bayer Healthcare SAS, personal fees and nonfinancial support from Incyte Biosciences, France, nonfinancial support from Alexion Pharma, France, nonfinancial support from Abbott, France, nonfinancial support from Amgen SAS, nonfinancial support from Boehringer Ingelheim, France, nonfinancial support from Bristol-Myers Squibb, no-financial support from MSD France, outside the submitted work; F.C. reports grants from Pfizer, personal fees from Bayer, other from Boehringer; grants, personal fees, and other from BMS; personal fees and other from Astra-Zeneca, other from GSK, personal fees from LEO-Pharma, other from Actelion, outside the submitted work; S.S. reports grants from LEO-Pharma, personal fees from Bayer, personal fees from BMS Pfizer, outside the submitted work; N.G. reports personal fees and nonfinancial support from Boehringer Ingelheim, personal fees and nonfinancial support from Bayer, personal fees from Bristol-Myers Squibb/Pfizer, personal fees from LEO-Pharma, personal fees from Aspen, outside the submitted work; O.S. reports grants, personal fees, and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from BMS; personal fees and nonfinancial support from Sanofi Aventis; personal fees and nonfinancial support from Boston Scientifics; personal fees from Pfizer; grants, personal fees, and nonfinancial support from MSD; grants and personal fees from Boehringer Ingelheim; grants from Daiichi Sankyo; personal fees from Chiesi; personal fees and nonfinancial support from BTG, outside the submitted work; L.K. reports personal fees from Bristol-Myers Squibb/Pfizer, outside the submitted work; M.A.S. reports personal fees and nonfinancial support from Bristol-Myers Squibb/Pfizer, personal fees and nonfinancial support from Bayer SA, grants, personal fees, and nonfinancial support from Leo-Pharma, personal fees from Aspen, outside the submitted work; R.C. reports personal fees from Aspen, outside the submitted work; D.M.S. reports grants from Boehringer Ingelheim, personal fees from Bayer, personal fees from Bristol-Myers Squibb/Pfizer, personal fees from Leo-Pharma, personal fees from Aspen, personal fees from Carmat, outside the submitted work; E.M. reports personal fees and nonfinancial support from Bayer, personal fees from Bristol-Myers Squibb/Pfizer, personal fees from Novartis, outside the submitted work; . N.M. reports grants and personal fees from Bayer Healthcare, grants and personal fees from BMS Pfizer, personal fees from Astra-Zeneca, personal fees from Terumo, grants and personal fees from Abbott, outside the submitted work; L.F. reports personal fees from Janssen, personal fees from Sanofi, personal fees from General Electrics, nonfinancial support from Guerbet, grants from Invectys, nonfinancial support from Philips, nonfinancial support from Ariana Pharma, nonfinancial support from Evolucare, outside the submitted work. All the other authors have nothing to declare., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Aim: We estimated the proportion and severity of cognitive disorders in an unselected population of patients referred for transcatheter aortic valve implantation (TAVI). Second, we describe clinical and cognitive outcomes at 1 year., Methods: Eligible patients were aged ≥ 70 years, with symptomatic aortic stenosis and an indication for TAVI. The Montreal Cognitive Assessment (MoCA) was used to assess cognitive dysfunction (CD), defined as no CD if score ≥ 26, mild CD if 18-25; moderate CD if 10-18, and severe CD if < 10. We assessed survival and in-hospital complications at 6 months and 1 year., Results: Between June 2019 and October 2020, 105 patients were included; 21 (20%) did not undergo TAVI, and thus, 84 were analyzed; median age 85 years, 53.6% females, median EuroScore 11.5%. Median MoCA score was 22 (19-25); CD was excluded in 18 (21%), mild in 50 (59.5%), moderate in 15 (19%) and severe in 1. Mean MoCA score at follow-up was 21.9(± 4.69) and did not differ significantly from baseline (21.79 (± 4.61), p = 0.73). There was no difference in success rate, in-hospital complications, or death across CD categories., Conclusion: The clinical course of patients with mild or moderate CD is not different at 1 year after TAVI compared to those without cognitive dysfunction., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background Pulmonary embolism (PE) has a long-term risk of adverse events, which can be prevented by extended anticoagulation. We compared clinical characteristics and outcomes between patients treated with 2-year extended anticoagulation and those who were not, in a population who had completed an initial phase of 3 to 6 months of anticoagulant therapy after acute PE. Methods and Results Observational cohort analysis of patients with PE who survived an initial phase of 3 to 6 months anticoagulation. Primary efficacy outcome was all-cause death or recurrent venous thromboembolism. Primary safety outcome was major bleeding. In total, 858 (71.5%) patients were treated with and 341 (28.5%) were treated without extended anticoagulant therapy during the active study period. Age <65 years, intermediate-high or high-risk index PE, normal platelet count, and the absence of concomitant antiplatelet treatment were independently associated with the prescription of extended anticoagulation. The mean duration of the active phase was 2.1±0.3 years. The adjusted rate of the primary efficacy outcome was 2.1% in the extended group and 7.7% in the nonextended group ( P <0.001) for patients treated with extended anticoagulant therapy. Rate of bleeding were similar between the extended anticoagulant group and the nonextended group. Conclusions Extended oral anticoagulation over 2 and a half years after index PE seems to provide a net clinical benefit compared with no anticoagulation in patients with PE selected to receive extended anticoagulation. Randomized clinical trials are warranted to explore the potential benefit of extended anticoagulation in patients with PE, especially those with transient provoking factors but residual risk.

Background: Improved prediction of the risk of early major bleeding in pulmonary embolism (PE) is needed to optimize acute management., Research Question: Does a simple scoring system predict early major bleeding in acute PE patients, identifying patients with either high or low probability of early major bleeding?, Study Design and Methods: From a multicenter prospective registry including 2,754 patients, we performed post hoc multivariable logistic regression analysis to build a risk score to predict early (up to hospital discharge) major bleeding events. We validated the endpoint model internally, using bootstrapping in the derivation dataset by sampling with replacement for 500 iterations. Performances of this novel score were compared with that of the VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), and BACS (Bleeding, Age, Cancer, and Syncope) models., Results: Multivariable regression identified three predictors for the occurrence of 82 major bleeds (3.0%; 95% CI, 2.39%-3.72%): Syncope (+1.5); Anemia, defined as hemoglobin <12 g/dL (+2.5); and Renal Dysfunction, defined as glomerular filtration rate <60 mL/min (+1 point) (SARD). The PE-SARD bleeding score was calculated by summing all the components. Overall, 52.2% (95% CI, 50.29%-54.11%) of patients were classified as low bleeding-risk (score, 0 point), 35.2% (95% CI, 33.39%-37.04%) intermediate-risk (score, 1-2.5 points), and 12.6% (95% CI, 9.30%-16.56%) high-risk (score >2.5 points). Observed bleeding rates increased with increasing risk group, from 0.97% (95% CI, 0.53%-1.62%) in the low-risk to 8.93% (95% CI, 6.15%-12.44%) in the high-risk group. C-index was 0.74 (95% CI, 0.73-0.76) and Brier score 0.028 in the derivation cohort. Similar values were calculated from internal bootstrapping. Performance of the PE-SARD score was better than that observed with the VTE-BLEED, RIETE, and BACS scores, leading to a high proportion of bleeding-risk reclassification in patients who bled and those who did not., Interpretation: The PE-SARD bleeding risk score is an original, user-friendly score to estimate risk of early major bleeding in patients with acute PE., (Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

We aimed to compare six available bleeding scores, in a real-life cohort, for prediction of major bleeding in the early phase of pulmonary embolism (PE). We recorded in-hospital characteristics of 2754 PE patients in a prospective observational multicenter cohort contributing 18,028 person-days follow-up. The VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), ORBIT (Outcomes Registry for Better Informed Treatment), HEMORR 2 HAGES (Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol) scores were assessed at baseline. International Society on Thrombosis and Haemostasis (ISTH)-defined bleeding events were independently adjudicated. Accuracy of the overall original 3-level and newly defined optimal 2-level outcome of the scores were evaluated and compared. We observed 82 first early major bleedings (3.0% (95% CI, 2.4-3.7)). The predictive power of bleeding scores was poor (Harrel's C-index from 0.57 to 0.69). The RIETE score had numerically higher model fit and discrimination capacity but without reaching statistical significance versus the ORBIT, HEMORR 2 HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C-index, integrated discrimination improvement, and net reclassification improvement compared to the others. The rate of observed early major bleeding in score-defined low-risk patients was high, between 15% and 34%. Current available scoring systems have insufficient accuracy to predict early major bleeding in patients with acute PE. The development of acute-PE-specific risk scores is needed to optimally target bleeding prevention strategies.

Background: Coronavirus disease 2019 (COVID-19) may predispose to venous thromboembolism. We determined factors independently associated with computed tomography pulmonary angiography (CTPA)-confirmed pulmonary embolism (PE) in hospitalised severe COVID-19 patients., Methods: Among all (n=349) patients hospitalised for COVID-19 in a university hospital in a French region with a high rate of COVID-19, we analysed patients who underwent CTPA for clinical signs of severe disease (oxygen saturation measured by pulse oximetry ≤93% or breathing rate ≥30 breaths·min -1 ) or rapid clinical worsening. Multivariable analysis was performed using Firth penalised maximum likelihood estimates., Results: 162 (46.4%) patients underwent CTPA (mean±sd age 65.6±13.0 years; 67.3% male (95% CI 59.5-75.5%). PE was diagnosed in 44 (27.2%) patients. Most PEs were segmental and the rate of PE-related right ventricular dysfunction was 15.9%. By multivariable analysis, the only two significant predictors of CTPA-confirmed PE were D-dimer level and the lack of any anticoagulant therapy (OR 4.0 (95% CI 2.4-6.7) per additional quartile and OR 4.5 (95% CI 1.1-7.4), respectively). Receiver operating characteristic curve analysis identified a D-dimer cut-off value of 2590 ng·mL -1 to best predict occurrence of PE (area under the curve 0.88, p<0.001, sensitivity 83.3%, specificity 83.8%). D-dimer level >2590 ng·mL -1 was associated with a 17-fold increase in the adjusted risk of PE., Conclusion: Elevated D-dimers (>2590 ng·mL -1 ) and absence of anticoagulant therapy predict PE in hospitalised COVID-19 patients with clinical signs of severity. These data strengthen the evidence base in favour of systematic anticoagulation, and suggest wider use of D-dimer guided CTPA to screen for PE in acutely ill hospitalised patients with COVID-19., Competing Interests: Conflict of interest: B. Mouhat has nothing to disclose. Conflict of interest: M. Besutti has nothing to disclose. Conflict of interest: K. Bouiller has nothing to disclose. Conflict of interest: F. Grillet has nothing to disclose. Conflict of interest: C. Monnin has nothing to disclose. Conflict of interest: F. Ecarnot has nothing to disclose. Conflict of interest: J. Behr has nothing to disclose. Conflict of interest: G. Capellier has nothing to disclose. Conflict of interest: T. Soumagne has nothing to disclose. Conflict of interest: S. Pili-Floury has nothing to disclose. Conflict of interest: G. Besch has nothing to disclose. Conflict of interest: G. Mourey has nothing to disclose. Conflict of interest: Q. Lepiller has nothing to disclose. Conflict of interest: C. Chirouze has nothing to disclose. Conflict of interest: F. Schiele has nothing to disclose. Conflict of interest: R. Chopard has nothing to disclose. Conflict of interest: N. Meneveau has nothing to disclose., (Copyright ©ERS 2020.)