Systematic review of clinical trials on antithrombotic therapy with factor XI inhibitors.

INTRODUCTION AND OBJECTIVE: Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favorable efficacy/safety profile compared to current antithrombotic therapies. The aim of this systematic review is to analyze the available evidence derived from these studies. METHODS: A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. In accordance with the PRISMA statement, results were reported. RESULTS: A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Phase 2 studies with factor XI inhibitors, overall, demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favorable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in the rate of bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed. CONCLUSIONS: Factor XI inhibitors offer new prospects in antithrombotic treatment and prophylaxis. Ongoing phase 3 studies will help define the most suitable drugs and indications.

On-site testing and treatment of sexually transmitted infections among female sex workers using molecular point-of-care testing integrated into harm reduction services in Madrid, Spain.

INTRODUCTION: This study aimed to evaluate the feasibility of molecular point-of-care testing for STIs, the prevalence of STIs and associated factors, and testing and treatment uptake among street-based female sex workers (FSWs) attending a mobile harm reduction unit in Madrid, Spain. METHODS: This was a prospective, longitudinal study. From August 15th to December 6th, 2022, participants were screened for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using molecular testing (Xpert) on self-collected urine samples at a mobile harm reduction unit. Additionally, rapid tests were used to screen participants for HIV, hepatitis C virus (HCV), and syphilis. On-site same-day results and treatment for those infected were offered. RESULTS: Among 77 FSWs included the median age was 40 (range, 33-48), 64 % were homeless, and 84 % reported drug use in the past six months. Four participants self-reported having HIV, of whom all were on antiretroviral therapy, and 14 (18 %) had HCV antibodies, including three with current infection. The prevalence of at least one STI was 66 %. When categorized by type of STI, the prevalences were as follows: 15 % for CT, 15 % for NG, 51 % for TV, and 21 % for syphilis. Notably, the prevalence of STIs was higher among FSW with recent drug use, with no cases of CT or NG detected among FSWs who did not recently use drugs. In adjusted analysis, drug use was associated an increased odds of having an STI (adjusted odds ratio, 10.47; 95 % CI: 1.67-65.42). All participants consented to screening, and all but one received on-site result-based linkage to treatment. CONCLUSIONS: This study demonstrates the feasibility, high STI prevalence, and high linkage to testing and treatment following point-of-care molecular testing among street-based FSWs who have recently used drugs in Madrid, Spain.

Acute phase characteristics and long-term complications of pulmonary embolism in COVID-19 compared to non-COVID-19 cohort: a large single-centre study.

BACKGROUND: To compare the severity of pulmonary embolism (PE) and the long-term complications between patients with and without COVID-19, and to investigate whether the tools for risk stratification of death are valid in this population. METHODS: We retrospectively included hospitalized patients with PE from 1 January 2016 to 31 December 2022. Comparisons for acute episode characteristics, risk stratification of the PE, outcomes, and long-term complications were made between COVID and non-COVID patients. RESULTS: We analyzed 116 (27.5%) COVID patients and 305 (72.4%) non-COVID patients. In patients with COVID-19, the traditional risk factors for PE were absent, and the incidence of deep vein thrombosis was lower. COVID patients showed significantly higher lymphocyte count, lactate dehydrogenase, lactic acid, and D-dimer levels. COVID patients had PE of smaller size (12.3% vs. 25.5% main pulmonary artery, 29.8% vs. 37.1% lobar, 44.7% vs. 29.5% segmental and 13.2% vs. 7.9% subsegmental, respectively; p < 0.001), less right ventricular dysfunction (7.7% vs. 17.7%; p = 0.007) and higher sPESI score (1.66 vs. 1.11; p < 0.001). The need for mechanical ventilation was significantly higher in COVID patients (8.6% vs. 1.3%; p < 0.001); However, the in-hospital death was less (5.2% vs. 10.8%; p = 0.074). The incidence of long-term complications was lower in COVID cohort (p < 0.001). PE severity assessed by high sPESI and intermediate and high-risk categories were independently associated with in-hospital mortality in COVID patients. CONCLUSION: The risk of in-hospital mortality and the incidence of long-term complications were lower in COVID-19. The usual tools for risk stratification of PE are valid in COVID patients.

Utility of probability scores for the diagnosis of pulmonary embolism in patients with SARS-CoV-2 infection: A systematic review.

BACKGROUND AND OBJECTIVE: Clinical prediction models determine the pre-test probability of pulmonary embolism (PE) and assess the need for tests for these patients. Coronavirus infection is associated with a greater risk of PE, increasing its severity and conferring a worse prognosis. The pathogenesis of PE appears to be different in patients with and without SARS-CoV-2 infection. This systematic review aims to discover the utility of probability models developed for PE in patients with COVID-19 by reviewing the available literature. METHODS: A literature search on the PubMed, Scopus, and EMBASE databases was carried out. All studies that reported data on the use of clinical prediction models for PE in patients with COVID-19 were included. Study quality was assessed using the Newcastle-Ottawa scale for non-randomized studies. RESULTS: Thirteen studies that evaluated five prediction models (Wells score, Geneva score, YEARS algorithm, and PERC and PEGeD clinical decision rules) were included. The different scales were used in 1,187 patients with COVID-19. Overall, the models showed limited predictive ability. The two-level Wells score with low (or unlikely) clinical probability in combination with a D-dimer level <3000ng/mL or a normal bedside lung ultrasound showed an adequate correlation for ruling out PE. CONCLUSIONS: Our systematic review suggests that the clinical prediction models available for PE that were developed in the general population are not applicable to patients with COVID-19. Therefore, their use is in clinical practice as the only diagnostic screening tool is not recommended. New clinical probability models for PE that are validated in these patients are needed.

[Utility of probability scores for the diagnosis of pulmonary embolism in patients with SARS-CoV-2 infection: A systematic review]. / Utilidad de las escalas de predicción diagnósticas de embolia de pulmón en pacientes con infección por SARS-CoV-2: una revisión sistemática.

Background and objective: Clinical prediction models determine the pre-test probability of pulmonary embolism (PE) and assess the need for tests for these patients. Coronavirus infection is associated with a greater risk of PE, increasing its severity and conferring a worse prognosis. The pathogenesis of PE appears to be different in patients with and without SARS-CoV-2 infection. This systematic review aims to discover the utility of probability models developed for PE in patients with COVID-19 by reviewing the available literature. Methods: A literature search on the PubMed, Scopus, and EMBASE databases was carried out. All studies that reported data on the use of clinical prediction models for PE in patients with COVID-19 were included. Study quality was assessed using the Newcastle-Ottawa scale for non-randomized studies. Results: Thirteen studies that evaluated five prediction models (Wells score, Geneva score, YEARS algorithm, and PERC and PEGeD clinical decision rules) were included. The different scales were used in 1,187 patients with COVID-19. Overall, the models showed limited predictive ability. The two-level Wells score with low (or unlikely) clinical probability in combination with a D-dimer level < 3000 ng/mL or a normal bedside lung ultrasound showed an adequate correlation for ruling out PE. Conclusions: Our systematic review suggests that the clinical prediction models available for PE that were developed in the general population are not applicable to patients with COVID-19. Therefore, their use is in clinical practice as the only diagnostic screening tool is not recommended. New clinical probability models for PE that are validated in these patients are needed.

Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms with Endovascular Therapy (MACAARET): safety and efficacy study according to morphological considerations and spatial orientations.

AIM: To analyse the safety and efficacy parameters of endovascular treatment of anterior communicating artery (ACoA) aneurysms, according to their morphological considerations and three-dimensional orientation in a multicentric registry. MATERIALS AND METHODS: A retrospective analysis was undertaken of a prospective database of consecutive patients that underwent endovascular embolisation for ACoA aneurysm in four high-volume neuroradiology interventional departments. The study has been registered in ClinicalTrial.gov. Data were collected regarding the clinico-demographic variables of the patients, anatomical variations of the circle of Willis, morphological considerations and spatial orientation of ACoA aneurysms were recorded. Safety and efficacy variables were also recorded. Associations between anatomical variations of the circle of Willis, morphological considerations, and spatial orientation of the ACoA aneurysms and safety and efficacy variables were assessed. RESULTS: Data from 122 consecutive patients were collected in the MACAARET study (mean age (±SD) was 55 (±14) and 50.8% (62/122) were male). One hundred and five patients (86.1%) presented with subarachnoid haemorrhage (SAH). ACoA aneurysms with a neck size of >4 mm had less chance of having successful endovascular treatment than those of ≤4 mm (19.8% versus 46.7%; p=0.002) and were also more likely to recanalise during follow-up (61.5% versus 19.5%; p=0.003). Moreover, ACoA aneurysms with an aspect ratio of >1.7 had more chance of having immediate therapeutic success than those with a ratio of ≤1.7 (70.7% versus 44.8%; p=0.012). There were no other associations between the anatomical variables of the ACoA aneurysms and the safety-efficacy variables. CONCLUSION: ACoA aneurysms are suitable for both endovascular and microsurgical approaches, but more data are required to determine which is the best approach regarding the morphological and spatial orientation of the aneurysm and the anatomical variations of the circle of Willis.

Incidence of pulmonary embolism in non-critically ill COVID-19 patients. Predicting factors for a challenging diagnosis.

Recent studies suggest that thrombotic complications are a common phenomenon in the novel SARS-CoV-2 infection. The main objective of our study is to assess cumulative incidence of pulmonary embolism (PE) in non critically ill COVID-19 patients and to identify its predicting factors associated to the diagnosis of pulmonary embolism. We retrospectevely reviewed 452 electronic medical records of patients admitted to Internal Medicine Department of a secondary hospital in Madrid during Covid 19 pandemic outbreak. We included 91 patients who underwent a multidetector Computed Tomography pulmonary angiography(CTPA) during conventional hospitalization. The cumulative incidence of PE was assessed ant the clinical, analytical and radiological characteristics were compared between patients with and without PE. PE incidence was 6.4% (29/452 patients). Most patients with a confirmed diagnosed with PE recieved low molecular weight heparin (LMWH): 79.3% (23/29). D-dimer peak was significatly elevated in PE vs non PE patients (14,480 vs 7230 mcg/dL, p = 0.03). In multivariate analysis of patients who underwent a CTPA we found that plasma D-dimer peak was an independen predictor of PE with a best cut off point of > 5000 µg/dl (OR 3.77; IC95% (1.18-12.16), p = 0.03). We found ninefold increased risk of PE patients not suffering from dyslipidemia (OR 9.06; IC95% (1.88-43.60). Predictive value of AUC for ROC is 75.5%. We found a high incidence of PE in non critically ill hospitalized COVID 19 patients despite standard thromboprophylaxis. An increase in D-dimer levels is an independent predictor for PE, with a best cut-off point of > 5000 µg/ dl.

Usefulness of CT angiography for characterizing cerebral arteriovenous malformations presenting as hemorrhage: comparison with digital subtraction angiography. / Utilidad de la angio-TC para la caracterización de malformaciones arteriovenosas cerebrales con presentación hemorrágica comparada con la angiografía por sustracción digital.

OBJECTIVE: To compare the usefulness of CT angiography against the gold standard, digital subtraction angiography (DSA), in the characterization of cerebral arteriovenous malformations (AVM) that present with bleeding. MATERIAL AND METHODS: We retrospectively analyzed patients with intracranial bleeding due to an AVM who were included in a prospective database in the period comprising January 2007 through December 2012. We reviewed radiologic variables such as the characteristics of the AVM (size, location, presence of deep venous drainage), involvement of eloquent areas, and the presence of associated aneurysms. Two neuroradiologists blinded to clinical and radiological information analyzed the CT and DSA in consensus. RESULTS: A total of 22 patients were included in the study. CT angiography correctly classified 15 of the 16 cases of AVM measuring less than 3cm (93.75% sensitivity). All cases of deep venous drainage and all those located in eloquent areas were correctly detected (100% sensitivity). The presence of any type of aneurysm related with the AVM was detected in 13 of 15 cases (86.6% sensitivity); 7 of 9 of the intranidal aneurysms were detected (77.78% sensitivity), as were 6 of the 9 flow aneurysms (66.67% sensitivity). CONCLUSION: CT angiography is highly sensitive in the characterization of cerebral AVMs measuring less than 3cm, of those located in eloquent areas, and of those with deep venous drainage; it is also highly sensitive in detecting aneurysms related with AVMs. However, CT angiography is less sensitive in detecting intranidal and flow aneurysms related with AVMs.

Clinical ultrasonography in the decision-making process in medicine point-of-care ultrasound in clinical decision making. / Ecografía clínica en el proceso de toma de decisiones en medicina.

Clinical ultrasonography has undergone significant development in recent years due to its considerable usefulness and equipment miniaturisation, which have enabled its use at the point of care. Clinical ultrasonography is a tool that supplements the classical anamnesis and physical examination, thereby increasing the practitioner's diagnostic power. This tool can be employed in numerous clinical scenarios and can be applied at all steps when making decisions about the patient. In the hands of the general practitioner, ultrasonography of the various areas of the body (multiorgan ultrasonography) optimises not only the diagnostic capacity but also the prognostic stratification and monitoring of progress after treatment has been applied. As with the systematic nature of conventional physical examinations, we need to establish an ultrasound examination protocol that supplements the physical examination, thereby redefining and boosting the classic examination.

Mechanical thrombectomy with a novel stent retriever with multifunctional zones: Initial clinical experience with the NeVa™ thrombectomy device.

BACKGROUND AND PURPOSE: The NeVa™ (Vesalio, Nashville, Tennessee) thrombectomy device is a CE-approved novel hybrid-cell stent retriever with offset enlarged openings coupled with functional zones and a closed distal end. The device was designed to incorporate and trap resistant emboli. The purpose was to determine the safety and efficacy of the NeVa™ stent. METHODS: Prospective data was collected on the first thirty consecutive patients treated at four stroke centers with NeVa™ as first line treatment between December 2017 and May 2018. Clinical outcome measures included re-perfusion scores after each pass, complications (per-procedural complications, device related adverse events, all intracerebral hemorrhage (ICH) and symptomatic ICH (sICH) on follow up imaging), 24 hour NIHSS, mRS at discharge and 90 days. Baseline data as well as treatment parameters were documented. RESULTS: Mean presenting NIHSS was 16. Sites of primary occlusion were 10 ICA, 16 M1-MCA, 3 M2-MCA and one basilar. There were five tandem occlusions. Reperfusion outcomes after each NeVa pass; TICI ≥ 2b after first pass 63%, after 1 or 2 passes 83%, after 1 to 3 passes 90%. TICI 2c-3 after first pass 47%, after 1-2 passes 57%, after 1-3 passes 60%. TICI ≥ 2b after final pass 93%; TICI 2c-3, 63%. There were no device related serious averse events and no sICH. Clot material was partially or completely incorporated into the device after 70% passes. The mean 24 hour NIHSS was 7 and the 90 day mRS was 0-2 in 53%. CONCLUSIONS: The NeVa™ device demonstrated a high rate of first pass complete reperfusion effect, a good safety profile and favorable 90 day clinical outcomes in this initial clinical experience.

Clinical ultrasonography in chronic obstructive pulmonary disease. / Ecografía clínica en la enfermedad pulmonar obstructiva crónica.

COPD is a highly prevalent disease and one of the most common reasons for hospitalization in Internal Medicine departments. COPD also has significant associated morbidity and mortality. In recent years, multiorgan clinical ultrasonography (pulmonary, cardiac and vascular) has emerged as a tool of considerable usefulness in managing patients with COPD in numerous situations, including the differential diagnosis of dyspnoea of uncertain origin, the assessment of the aetiology in episodes of exacerbation, detecting concomitant heart failure or associated pulmonary hypertension and as support in managing cardiovascular risk factors such as subclinical atherosclerosis. This study summarises the most important evidence regarding this approach and proposes future scenarios for the use of ultrasonography that will help improve the diagnosis, prognostic estimations and the selection of the optimal treatment for this type of patient.

Point-of-care ultrasound in internal medicine: A position paper by the ultrasound working group of the European federation of internal medicine.

Point-of-care ultrasound (POCUS) is increasingly used to assess medical patients. It has many uses in daily clinical practice, including improved diagnostic timeliness and accuracy, and providing information about a patient's prognosis and follow-up. It has been integrated into numerous specialities, but remains relatively undefined in internal medicine training programs. Ultrasonography is a useful tool in the standard clinical practice of internists in numerous clinical scenarios (Emergency Department, hospital ward, general and specific consultations, and home care). Although POCUS has been recently included in the European curriculum of internal medicine, there are differences between European internists in its use, ranging from not at all to well structured educational programs. The use of POCUS needs to be widespread in internal medicine departments, and to accomplish this we must encourage structured training. This document details the consensus-based recommendations by the European Federation of Internal Medicine (EFIM) Ultrasound working group. We establish POCUS core competencies and clinical settings for internists in a symptom-based approach. We also propose training requirements, providing a framework for training programs at a national level.

Balloon-Mounted Stents for Treatment of Refractory Flow Diverting Device Wall Malapposition.

BACKGROUND: As indications for flow diversion (FD) have expanded, new challenges in deployment of flow diverting devices (FDDs) have been encountered. We present 4 cases with aneurysms in which deployment of FDDs were complicated by device malapposition and compromised opening in regions of parent vessel stenosis. In all 4 cases, a balloon-mounted stent was ultimately deployed within the FDD. OBJECTIVE: To describe the use of balloon-mounted stents (BMS) within FDDs for correction of flow-limiting stenosis and device malapposition. METHODS: Patients undergoing FD for treatment of aneurysms complicated by refractory flow-limiting stenosis were identified through multi-center retrospective review. Those cases requiring use of BMS were identified. Further investigation in one of the cases was performed with a simulated pulsatile blood flow model. RESULTS: After attempts to perform balloon angioplasty proved unsuccessful, BMS deployment successfully opened the stenotic parent artery and improved FDD wall apposition in all 4 cases. Simulated pulsatile blood flow modeling confirmed improvements in the distribution of velocity, wall shear stress, oscillatory shear index, and flow pattern structure after stent deployment. One case was complicated by asymptomatic in-stent thrombosis. CONCLUSION: In cases of FDD deployment complicated by flow-limiting stenosis refractory to conventional techniques, a BMS deployed within the FD can provide radial support to open both the stenotic device and parent artery. Resulting improvements in device wall apposition may portend greater long-term efficacy of FD. In-stent occlusion can occur and may reflect a thrombogenic interaction between the devices.

Value of Posterior circulation ASPECTS and Pons-Midbrain Index on non-contrast CT and CT Angiography Source Images in patients with basilar artery occlusion recanalized after mechanical thrombectomy. / Valor de la escala ASPECTS de circulación posterior y del índice puente-mesencéfalo en imágenes de TC sin contraste y angiografía por TC en pacientes con oclusiones de la arteria basilar recanalizados tras trombectomía mecánica.

PURPOSE: Endovascular treatment with mechanical thrombectomy devices demonstrated high recanalization rates but functional outcome did not correlate with high rates of recanalization obtained. Patient selection prior to the endovascular treatment is very important in the final outcome of the patient. The primary aim of our study was to evaluate the prognostic value of posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) and Pons-Midbrain Index (PMI) scores in patients with Basilar Artery Occlusion (BAO) treated with successful angiographic recanalization after mechanical thrombectomy. METHODS: Retrospective single-center study including 18 patients between 2008 and 2013 who had acute basilar artery occlusion managed with endovascular treatment within 24hours from symptoms onset and with successful angiographic recanalization. The patients were initially classified into two groups according to clinical outcome and mortality at 90 days. For analysis we also divided patients into groups based on pc-ASPECTS (≥8vs.<8) and PMI (≥3vs.<3) on non-contrast CT (NCCT) and CT Angiography Source Images (CTASI). Imaging data were correlated to clinical outcome and mortality rate. RESULTS: CTASI pc-ASPECTS, dichotomized at <8 versus≥8, was associated with a favorable outcome (RR: 2.6; 95% CI: 1.3-5.2) and a reduced risk of death (RR: 6.5: 95% CI: 7.8-23.3). All patients that survived and were functionally independent had pc-ASPECTS score≥8. None of the 5 patients with CTASI pc-ASPECTS score less than 8 survived. CONCLUSION: PC-ASPECTS on CTASI is helpful for predicting functional outcome after BAO recanalization with endovascular treatment. These results should be validated in a randomized controlled trial in order to decide whether or not to treat a patient with BAO.