Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial.

AIMS: The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment. METHODS AND RESULTS: Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient's opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm. CONCLUSIONS: For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications.

Update on the diagnosis of recurrence of lower limb deep vein thrombosis. A Consensus statement of the French Society for Vascular Medicine (SFMV).

An accurate diagnosis of lower limb deep vein thrombosis (DVT) recurrence is mandatory. The diagnosis is difficult and has not been well investigated. Our objective was to define the role of clinical probability assessment, D-dimer assay, venous ultrasound and other imaging methods in the diagnosis of this condition based on a review of published data. Our review did not find any clinical prediction rule (CPR) specific to the diagnosis of DVT recurrence. D-dimer assays have not been sufficiently validated or proved effective either alone or when combined with the assessment of clinical probability or with ultrasound. The only validated ultrasound criteria are a new non-compressible vein segment and a≥2mm or>4mm increase in diameter of the common femoral or popliteal vein under compression in the transverse plane between two examinations. Limitations of these criteria include poor inter-observer agreement, non-availability of previous ultrasound reports and measurements, a high percentage of non-diagnostic ultrasound results, lack of power in diagnostic accuracy and diagnostic management studies, and lack of external validation. The analysis of venous obstruction, thrombus appearance, vein diameter and blood flow based on colour Doppler ultrasound criteria has not yet been validated in studies. Magnetic resonance direct thrombus imaging (MRDTI) is a new promising diagnostic imaging method, but is hardly accessible, costly and needs large scale validation studies. Based on this review, an update of the guidance for clinical practice is proposed for the diagnostic management of patients with clinically suspected lower limb DVT recurrence.

Resuscitation of patients with durable mechanical circulatory support with acutely altered perfusion or cardiac arrest: A scoping review.

BACKGROUND: There is an increasing prevalence of durable mechanical circulatory supported patients in both the in-and-out of hospital communities. The scientific literature regarding the approach to patients supported by durable mechanical circulatory devices who suffer acutely impaired perfusion has not been well explored. METHODS: The International Liaison Committee on Resuscitation Advanced, Basic, and Pediatric Life Support Task Forces conducted a scoping review of the literature using a population, context, and concept framework. RESULTS: A total of 32 publications that included patients who were receiving durable mechanical circulatory support and required acute resuscitation were identified. Most of the identified studies were case reports or small case series. Of these, 11 (34.4%) included patients who received chest compressions. A number of studies reported upon delays in the application of chest compressions resulting from complexity due to the expected pulselessness in some patients with continuous flow left-ventricular assist devices as well as from concern regarding potential dislodgement of the mechanical circulatory support device. Three observational studies identified worse outcomes in durable mechanical circulatory support receiving patients with cardiac arrest and acutely impaired perfusion who received chest compressions as compared to those who did not, however those studies were at high risk of bias. Of 226 patients across 11 studies and two published scientific abstracts who sustained cardiac arrest while supported by durable MCS and underwent chest compressions, there were no reported instances of device dislodgement and 71 (31.4%) patients had favorable outcomes. CONCLUSIONS: There is a scarcity of evidence to inform the resuscitation of patients with durable mechanical circulatory support (MCS) experiencing acute impairment in perfusion and cardiac arrest. Reports indicate that delays in resuscitation often stem from rescuers' uncertainty about the safety of administering chest compressions. Notably, no instances of device dislodgement have been documented following chest compressions, suggesting that the risk of harm from timely CPR in these patients is minimal.

Is cyberbullying perpetration associated with anxiety, depression and suicidal ideation among lebanese adolescents? Results from a cross-sectional study.

BACKGROUND: As cyberbullying is a new area of investigation, results worldwide point to the prevalence of cyberbullying perpetration. This study aimed to assess the association between cyberbullying perpetration, anxiety, depression and suicidal ideation among Lebanese adolescents. METHODS: This cross-sectional study was conducted between May and June 2021 and included a sample of adolescents aged between 13 and 16 years old, recruited from private schools chosen in a convenient way from all Lebanese districts. A total of 520 students accepted to participate in our study. To collect data, a questionnaire was shared by google form including: Cyber Bully/Cyber victim questionnaire; Lebanese Anxiety Scale; and Patient Health Questionnaire for Adolescents. RESULTS: The results of the linear regressions, taking anxiety and depression as dependent variables, showed that female gender, having kind of hard and very/extremely hard influence of problems on daily work, sexual cyberbullying in cyberspace, embarrassing and inserting malicious content in cyberspace and older age were significantly associated with more anxiety and depression. Having kind of hard influence of problems on daily work compared to not at all, higher anxiety, higher depression and higher household crowding index (lower socioeconomic status) were significantly associated with higher odds of having suicidal ideation in the last month. CONCLUSION: Cyberbullying perpetration and its associated factors reported in this study are significant enough to call for early detection and prevention strategies for Lebanese adolescents. At the school level, effective programs implemented in the school years are needed, aiming to develop social/emotional control, and conflict resolution skills as they might decrease engagement in cyberbullying perpetration among adolescents. Preventive interventions are needed to reduce the engagement of Lebanese adolescents in cyberbullying perpetration.

3D Printing, Augmented Reality, and Virtual Reality for the Assessment and Management of Kidney and Prostate Cancer: A Systematic Review.

Three-dimensional (3D) printing, augmented reality, and virtual reality technologies have an increasing presence in the management of prostate and kidney cancer. To assess the utility of 3D printing, augmented reality, and virtual reality for (1) quantitative outcomes, (2) surgical planning, (3) intraoperative guidance, (4) training and simulation, and (5) patient education for patients with kidney and prostate cancer a systematic literature review was performed. Existing evidence demonstrates improvement in clinical outcomes, surgical planning and intra-operative guidance, as well as training. Future studies are needed to assess the impact of 3D technologies on long-term patient-related outcomes.

Prognostic models in acute pulmonary embolism: a systematic review and meta-analysis.

OBJECTIVE: To review the evidence for existing prognostic models in acute pulmonary embolism (PE) and determine how valid and useful they are for predicting patient outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: OVID MEDLINE and EMBASE, and The Cochrane Library from inception to July 2014, and sources of grey literature. ELIGIBILITY CRITERIA: Studies aiming at constructing, validating, updating or studying the impact of prognostic models to predict all-cause death, PE-related death or venous thromboembolic events up to a 3-month follow-up in patients with an acute symptomatic PE. DATA EXTRACTION: Study characteristics and study quality using prognostic criteria. Studies were selected and data extracted by 2 reviewers. DATA ANALYSIS: Summary estimates (95% CI) for proportion of risk groups and event rates within risk groups, and accuracy. RESULTS: We included 71 studies (44,298 patients). Among them, 17 were model construction studies specific to PE prognosis. The most validated models were the PE Severity Index (PESI) and its simplified version (sPESI). The overall 30-day mortality rate was 2.3% (1.7% to 2.9%) in the low-risk group and 11.4% (9.9% to 13.1%) in the high-risk group for PESI (9 studies), and 1.5% (0.9% to 2.5%) in the low-risk group and 10.7% (8.8% to12.9%) in the high-risk group for sPESI (11 studies). PESI has proved clinically useful in an impact study. Shifting the cut-off or using novel and updated models specifically developed for normotensive PE improves the ability for identifying patients at lower risk for early death or adverse outcome (0.5-1%) and those at higher risk (up to 20-29% of event rate). CONCLUSIONS: We provide evidence-based information about the validity and utility of the existing prognostic models in acute PE that may be helpful for identifying patients at low risk. Novel models seem attractive for the high-risk normotensive PE but need to be externally validated then be assessed in impact studies.

Diagnostic management of pulmonary embolism using clinical assessment, plasma D-dimer assay, complete lower limb venous ultrasound and helical computed tomography of pulmonary arteries. A multicentre clinical outcome study.

The objective of the study was to assess the clinical validity of a non-invasive diagnostic strategy for acute pulmonary embolism using clinical assessment combined with both ELISA D-dimer and complete lower limb ultrasound (US) examination of proximal and distal veins, before single-detector helical computed tomography (CT) of pulmonary arteries. We expected the strategy to have a high diagnostic exclusion power and to safely decrease the number of CT scans. This prospective, multicenter outcome study included 274 consecutive outpatients. All underwent a priori clinical probability, D-dimer and bilateral complete lower limb US assessments. Only patients with a high clinical probability and both tests negative, or positive D-dimer and negative US assessments, underwent CT. This was deemed necessary in 114 patients (42%). At baseline, venous thromboembolism (VTE) was detected in 110 patients (40%), either by US showing proximal (n=65) or distal (n=36) thrombosis, or by CT (n=9). Anticoagulant was withheld in the remaining patients with negative results in both D-dimer and US but a non-high clinical probability (n=59), or in both US and CT (n=90), or with negative US (n=6) and inadequate CT (n=9). All patients underwent a three-month clinical follow-up. VTE occurred in one patient with inadequate CT, yielding an incidence of 0.6% [95% confidence interval: 0.1-3.4]. No patient died from VTE or had major bleeding. Using clinical probability, ELISA D-dimer and complete US before helical CT is a safe strategy resulting in a substantial reduction in CT scans.

Diagnostic performance of complete lower limb venous ultrasound in patients with clinically suspected acute pulmonary embolism.

A limited ultrasound (US) confined to the popliteal and femoral veins is usually performed to detect deep vein thrombosis (DVT) in patients with clinically suspected acute pulmonary embolism (PE). Our objective was to assess the diagnostic accuracy of complete lower limb US examining both the proximal and distal veins in this setting. In this prospective study, 210 consecutive patients were included. Complete US was performed by independent operators and compared blindly with a reference strategy combining clinical probability, ventilation perfusion scan and pulmonary angiography to a three-month clinical follow-up. Simultaneously, VIDAS D-dimer (DD) assay and helical computed tomography (HCT) of the lungs were assessed independently and blindly. PE was present in 74 patients (35%). Complete US detected DVT in 91 patients (43%), proximal in 51 and distal in 40. Sensitivity and specificity with a 0.95 confidence interval were respectively 0.93 [0.85 - 0.97] and 0.84 [0.77 - 0.89]. Limited US detected DVT in only 46 patients (22%). Sensitivity and specificity were respectively 0.55 [0.44 - 0.66] and 0.96 [0.92 - 0.98]. For DD they were 0.92 [0.83 - 0.96] and 0.24 [0.17 - 0.32] and for HCT 0.84 [0.73 - 0.90] and 0.87 [0.80 - 0.92]. Complete lower limb US has higher sensitivity and capacity to exclude PE than limited US, but a slightly lower specificity. Complete US results also compared favourably with those of HCT and DD. The utility of including this method in diagnostic strategies for PE needs to be assessed in cost-effectiveness analysis and in outcome studies.

A single complete ultrasound investigation of the venous network for the diagnostic management of patients with a clinically suspected first episode of deep venous thrombosis of the lower limbs.

In patients clinically suspected of deep-vein thrombosis (DVT) of the lower limbs, it is safe to withhold anticoagulant therapy after a negative ultrasound (US) limited to the popliteal and the femoral veins, provided that this can either be repeated or combined with other diagnostic procedures. To assess the safety of withholding anticoagulants after a single negative complete US, we performed a multicenter, prospective, cohort study including consecutive ambulatory outpatients from institutional and private practice settings, with a clinically suspected first episode of DVT. Patients fulfilling the inclusion criteria were enrolled after careful clinical assessment. A complete US examination of the proximal and the distal veins was performed according to a standardized and detailed protocol. Anticoagulant therapy was administered in patients with proximal or isolated distal DVT and withheld in those with negative results. The main outcome measure was the occurrence of objectively documented clinical thromboembolic events during a three-month follow-up after a negative US. Out of 623 patients, 401 (64.4%) had a baseline negative US, were not anticoagulated and could be followed-up for three months. Two patients presented a calf DVT within three months. The incidence of venous thromboembolic events, including distal DVT, was 0.5% [95% confidence interval: 0.1-1.8]. No proximal DVT, or non-fatal or fatal pulmonary embolism occurred (incidence: 0.0% [95% confidence interval: 0.0-0.9]). In conclusion, it is safe to withhold anticoagulant therapy in patients with clinically suspected DVT after a single, negative, complete US. Integrating this method within diagnostic strategies for DVT could improve management and be more acceptable for patients and physicians.

Comparison of the diagnostic performance of three soluble fibrin monomer tests and a D-dimer assay in patients with clinically suspected deep vein thrombosis of the lower limbs.

We assessed three soluble fibrin monomer (SFM) assays in 231 in and out-patients with clinically suspected deep-vein thrombosis. Thrombosis was confirmed or excluded by complete lower-limb ultrasound. SFM assay were less accurate than VIDAS D-dimer and in patients with small thrombosis or under anticoagulation. Specificity was lower for a similar sensitivity.

Determination of clinically relevant cutoffs for HIV-1 phenotypic resistance estimates through a combined analysis of clinical trial and cohort data.

BACKGROUND: Clinically relevant cutoffs are needed for the interpretation of HIV-1 phenotypic resistance estimates as predicted by "virtual" phenotype HIV resistance analysis. METHODS: Using a clinical data set containing 2596 treatment change episodes in 2217 patients in 8 clinical trials and 2 population-based cohorts, drug-specific linear regression models were developed to describe the relation between baseline characteristics (resistance, viral load, and treatment history), new treatment regimen selected, and 8-week virologic outcome. RESULTS: These models were used to derive clinical cutoffs (CCOs) for 6 nucleoside/nucleotide reverse transcriptase inhibitors (zidovudine, lamivudine, stavudine, didanosine, abacavir, and tenofovir), 3 unboosted protease inhibitors (PIs; indinavir, amprenavir, and nelfinavir), and 4 ritonavir-boosted PIs (indinavir/ritonavir, amprenavir/ritonavir, saquinavir/ritonavir, lopinavir/ritonavir). The CCOs were defined as the phenotypic resistance levels (fold change [FC]) associated with a 20% and 80% loss of predicted wild-type drug effect and depended on the drug-specific dynamic range of the assay. CONCLUSIONS: The proposed CCOs were better correlated with virologic response than were biological cutoffs and provide a relevant tool for estimating the resistance to antiretroviral drug combinations used in clinical practice. They can be applied to diverse patient populations and are based on a consistent methodologic approach to interpreting phenotypic drug resistance.