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18th November 2022
A model combining features of an ECG and radiomics data derived from cardiovascular magnetic resonance imaging improved the detection of atrial fibrillation (AF) in women to a greater extent than either model alone according to the findings of a study by Spanish and UK researchers.
Atrial fibrillation is the most common cardiac arrhythmia, characterised by an irregular heart rhythm and an often abnormally rapid heart rate and globally has been estimated to affect 0.51% of the population. AF is diagnosed from an ECG in which typically, P-waves are absent and there is both a chaotic baseline and an irregular ventricular rate. Cardiac magnetic resonance (CMR) is the reference imaging modality for assessment of cardiac structure and function and CMR radiomics has the potential to improve diagnostic accuracy. Moreover, Cardiac MRI of the atrial substrate is not only a tool for management and treatment of arrhythmia, but also to individualise the prevention of stroke and major cardiovascular events. But what remains unclear is whether the use of a CMR-based radiomics model can identify patients with AF and more importantly, if addition of a model that uses ECG-derived data, would further enhance the potential to detect AF.
In the present study, researchers examined the feasibility of combining a CMR-derived radiomics model and one based on ECG data. The team used information from the UK Biobank and identified patients who had both an ECG and CMR scan and compared their findings with healthy controls. Models were assessed using the area under the receiver operating characteristics curve (AUC) and associated sensitivity and specificity.
ECG and radiomics model and atrial fibrillation detection
A total of 32,121 participants with a mean age of 63 years (51% female) were included and of whom, 495 (63% male) had AF.
Overall, the AUC for the combined model was similar to the ECG-model (0.87 vs 0.86), i.e., adding the radiomics model did not significantly improve predictive power. In fact, when comparing the predictive power of models between the sexes, the AUC for the ECG-model was less predictive for women than men (0.77 vs 0.88, p < 0.05). However, although accuracy improved for women when combined with the CMR-model, but this only improved to the level of the ECG-model for men (0.87 vs 0.88, women vs men). Finally, when considering AF patients who had a normal ECG, the combined model had an AUC of 0.61.
The authors concluded that their integrative radiomics-ECG model presents a potential novel approach for earlier detection of AF.
Citation
Pujadas ER et al. Atrial fibrillation prediction by combining ECG markers and CMR radiomics. Sci Rep 2022
17th November 2022
The small interfering RNA olpasiran has been found to virtually eliminate lipoprotein A in patients with atherosclerotic cardiovascular disease according to the findings of a randomised, placebo-controlled trial by US researchers.
Lipoprotein A (LPA) is a large glycoprotein attached to a low-density lipoprotein-like particle, that is associated with a risk of coronary heart disease and stroke. Lipoprotein A is produced by the apo(a) gene and levels are genetically determined with higher levels increasing the risk of atherosclerotic disease via mechanisms associated with increased atherogenesis, inflammation, and thrombosis. Despite this known link and therefore risk of cardiovascular disease, there are currently no pharmacological therapies available to reduce its levels. Olpasiran is a small interfering molecule that interrupts the expression of the LPA gene by degrading the messenger RNA that encodes the apo(a) protein. In a preclinical study with mice, olpasiran reduced LPA concentrations by 80% from baseline for 5 – 8 weeks after administration of a single dose. Based on these findings, the US researchers undertook the Olpasiran Trials of Cardiovascular Events and Lipoprotein[a] Reduction–Dose Finding Study to assess the efficacy and safety of repeated administration of the product.
Individuals aged 18 to 80 with serum LPA levels higher than 150nmol/L and a history of atherosclerotic cardiovascular disease were included. These participants were randomised 1:1:1: 1:1 to receive four doses of olpasiran administered subcutaneously (10 mg, 75 mg, 225 mg every 12 weeks) and 225 mg every 24 weeks or matching placebo, for a period of 48 weeks. The primary endpoint was the percentage change in the LPA concentration from baseline to week 36 whereas the secondary outcome was the change at the end of the trial.
Olpasiran and Lipoprotein A levels
A total of 281 participants with a mean age of 61.9 years (32% female) were enrolled and randomised to one of the five arms (between 54 and 58 per arm). The overall median baseline LPA level was 260.3 nmol/L and 88% of participants were taking a statin and 23% a proprotein convertase subtilisinkexin type 9 (PCSK9) inhibitor.
At week 36, the LPA level increased by 3.6% in the placebo group but was significantly reduced in each of the active treatment arms. For example, the placebo-adjusted change in the 10 mg group was -70.5%, -97.4% in the 75 mg group and -101.1% in the 225 mg group and -100.5% in the 225 mg arm when administered every 24 weeks (p < 0.001 for all comparisons with the baseline value).
In addition, LDL cholesterol levels were also reduced with placebo-adjusted reductions ranging from -22.6% to -24.8%.
Adverse effects were generally similar across the groups.
The authors concluded that olpasiran significantly reduced lipoprotein(a) concentrations in patients with established atherosclerotic cardiovascular disease and called for future trials to assess the impact of treatment on cardiovascular disease.
Citation
O’Donoghue ML et al. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Eng J Med 2022
A systematic review by UK researchers, which is currently available as a preprint, has concluded that the monoclonal antibody combination tixagevimab/cilgavimab is effective against COVID-19 breakthrough infections, hospitalisation, intensive care unit (ITU) admission and both all-cause and COVID-19 specific mortality.
Tixagevimab/cilgavimab (Evusheld) is licensed as a pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with COVID-19, without a known recent exposure to an infected individual infected as well as those who are unlikely to mount an adequate immune response to the vaccination against the virus and finally in those where vaccination is not recommended. Both monoclonal antibodies simultaneously bind to distinct, non-overlapping epitopes of the COVID-19 spike-protein receptor-binding domain to potently neutralise the virus. Trial data in those who were at an increased risk of an inadequate response to vaccination showed that COVID-19 occurred in only 0.2% of those given tixagevimab/cilgavimab compared to 1% of patients receiving placebo. Furthermore, combination treatment has also been found to be effective in protection against progression to severe COVID-19 or death compared to placebo in unvaccinated individuals with mild to moderate disease.
Despite these positive findings, there is limited evidence from a real-world setting and against COVID-19 variants such as Omicron. Moreover, while Evusheld has been approved for use in many countries, the UK government recently took the decision that there is insufficient evidence available to support procurement and deployment of Evusheld through emergency procedures. In an attempt to provide more data on the effectiveness of tixagevimab/cilgavimab in those who are immunocompromised, in the present study the UK researchers sought to assess the efficacy against breakthrough infections, hospitalisation, ITU admission and mortality.
They searched for randomised, controlled trials, observational or cohort studies where the combination was used as prophylaxis and in studies where breakthrough infections were reported. Secondary outcomes reported upon were hospitalisations, ITU admissions and death.
Tixagevimab/cilgavimab outcomes among immunocompromised patients
A total of 17 studies with 24,773 immunocompromised participants of whom, 10,775 had received the combination therapy were included in the analysis.
Overall, the clinical effectiveness of the combination against breakthrough infections compared to control patients was 40.47% (95% CI 29.82 – 49.67, p < 0.0001). The combination was also significantly more effective than control against hospital admissions (69.23%, 95% CI 50.78 – 81.64, p < 0.00001). Moreover, the effectiveness against ITU admission was also very high at 87.89% (95% CI 47.12 – 98.66, p = 0.0008).
In relation to both all-cause and COVID-19-related mortality, tixagevimab/cilgavimab was also very effective with overall values of 81.29% (p < 0.0001) and 86.36% (p = 0.035) respectively.
The authors concluded that their study, based on real-world evidence showed that tixagevimab/cilgavimab proved to be highly effective, particularly during the Omicron wave and called for future trials to evaluate the on-going certain of this benefit.
Citation
Suribhatla R et al. Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients. MedRxiv 2022.
15th November 2022
Nirsevimab, the first broadly protective option against respiratory syncytial virus (RSV) for newborns and infants, has received approval for use in Europe, the manufacturer AstraZeneca has announced.
The vaccine, which has the brand name Beyfortus, has been approved by the European Commission for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season.
The product represents the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
Approximately two-thirds of infants are infected with RSV during the first year of life, and 90% have been infected one or more times by two years of age. Moreover, the rate of hospitalisation for primary infection is approximately 0.5% but can be as high as 25%.
Produced by a collaborative effort from AstraZeneca and Sanofi, the terms of which were agreed in 2017, AstraZeneca leads all development and manufacturing activities for nirsevimab, and Sanofi leads commercialisation activities and records revenue.
Nirsevimab is a long-acting, antiviral monoclonal antibody which binds to the RSV F (fusion) protein and effectively locks the protein into the pre-fusion conformation and thus inhibiting entry of free virions into cells, as well as inhibiting spread of cell-associated virus by cell fusion. The drug is designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose.
In a phase IIb trial, infants were randomised in a 2:1 ratio to receive nirsevimab, at a dose of 50mg in a single intramuscular injection, or placebo at the start of an RSV season. The results showed that the incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower with nirsevimab prophylaxis compared to placebo.
Further data came in a second trial in which infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nirsevimab or placebo (in a 2:1 ratio) before the start of an RSV season. The primary efficacy end point was medically attended RSV-associated lower respiratory tract infection through 150 days after the injection.
Medically attended RSV-associated lower respiratory tract infection occurred in 1.2% of those given nirsevimab 5.0% in the placebo group, corresponding to an efficacy of 74.5% (95% CI 49.6 – 87.1, p < 0.001).
Moreover, hospitalisation for RSV-associated lower respiratory tract infection occurred in 0.6% of those given nirsevimab compared to 1.6% in the placebo group. However, this was associated with a lower efficacy (62.1%), and which was not significant (p = 0.07).
According to the EMA, nirsevimab should be given before the RSV season or as soon as possible after birth for those infants born during the RSV season.
The use of pemafibrate in patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia and low levels of HLD cholesterol, failed to lower the incidence of adverse cardiovascular outcomes compared to placebo according to a randomised, doubler-blind, placebo-controlled trial by US researchers.
Elevated levels of triglycerides confer an increased risk of cardiovascular disease but whether reducing levels also reduces adverse cardiovascular events such as myocardial infarction is actually less clear. For example, in a trial with fenofibrate while there was a 25% reduction in mean triglyceride levels, there was no difference in the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke. Pemafibrate is a peroxisome proliferator-activated receptor modulator which lowers plasma triglycerides and increase HDL cholesterol and both of these effects are associated with cardiovascular benefit. Moreover, the drug is superior to fenofibrate at lowering serum triglycerides and has a good renal and hepatic safety profile.
But whether the drug also reduced adverse cardiovascular outcomes in patients with type 2 diabetes is uncertain and was the subject of the present trial. Included patients had triglyceride levels between 2.3 and 5.6 mmol/l and HDL cholesterol levels < 1 mmol/l. The primary endpoint was the first occurrence of a major adverse cardiovascular event and which was a composite that included myocardial infarction, ischaemic stroke and hospitalisation for unstable angina.
Pemafibrate and cardiovascular outcomes
A total of 10,497 patients with a median age of 64 years (27.5% female) were included and randomised to pemafibrate (5,240) or placebo. and followed by a median of 3.4 years. Two thirds of those enrolled were a secondary prevention cohort and 95% of the whole study population were prescribed a statin.
The median reduction in triglyceride levels was 31.1% in the pemafibrate group and 6.9% in the placebo group. In addition, HDL cholesterol levels rose by 8.3% in those taking pemafibrate but only 3.1% in the placebo arm.
The primary endpoint occurred in a similar number of patients and the difference was not significant (Hazard ratio, HR = 1.03, 95% CI 0.91 – 1.15, p = 0.67). Mortality from any cause was also similar and non-significant (HR = 1.04, 95% CI 0.91 – 1.20).
The authors concluded that while pemafibrate reduced triglyceride levels by over 30% in patients with type 2 diabetes, there was no significant reduction in the risk of adverse cardiovascular events.
Citation
Das Pradham A et al. Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk N Eng J Med 2022
The use of the anti-diabetic agents, glucagon-like peptide 1 (GLP-1) receptor agonists and sodium-glucose co-transport-2 (SGLT-2) inhibitors, gave rise to a significant reduction in the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD) and type 2 diabetes compared to sulfonylureas, according to an analysis by Canadian researchers. In contrast, a third group, the dipeptidyl peptidase 4 (DPP-4) inhibitors, produced only a modest and non-significant reduction in the risk of exacerbations.
The oral anti-diabetic agents, GLP-1 receptor agonists and DPP-4 inhibitors have become well established treatments in the management of type 2 diabetes. In addition, the newest class of drugs, the SGLT-2 inhibitors, in addition to providing diabetic control, also appear to have some positive benefits on cardiovascular endpoints. In addition, to the anti-diabetic agents, there is emerging evidence to suggest that drugs within these classes also have the potential for a positive impact on lung function. For example, animal studies have revealed how the GLP-1 receptor agonists have potential therapeutic value in the treatment of obstructive pulmonary diseases. Similarly, given that dipeptidyl peptidase 4 expression is increased in the lungs of those with COPD, leading to inflammation, the DPP-4 inhibitors have a possible role in the disease through a reduction in lung inflammation. Finally, as COPD is characterised by increased retention of alveolar CO2 and given how SGLT-2 inhibitors lower serum glucose levels, reducing its availability for, there is also a commensurate reduction in the endogenous production of CO2. It is conceivable therefore that SGLT-2 inhibitors may be beneficial for patients with diabetes and concomitant pulmonary disease who retain CO2.
In practice however, the extent to which these purported benefits actually reduce COPD exacerbations is unknown and was the subject in the present study. The Canadian team undertook a population cohort study in which they linked a clinical and hospital episode database to explore whether prescription of each of the three oral anti-diabetic drug classes was associated with a reduced risk of COPD exacerbations in patients with both type 2 diabetes and COPD. The primary outcome was the time to the first episode of a severe COPD exacerbation during follow-up and patients prescribed drugs from each of the different classes were matched with patients prescribed sulfonylureas.
Oral anti-diabetic drugs and COPD exacerbations
A total of 1252 participants prescribed GLP-1 receptor agonists were followed for a median of 1 year. The use of GLP-1 agonists was associated with a 30% lower risk of a severe COPD exacerbation compared to sulfonylureas (Hazard ratio, HR = 0.70, 95% CI 0.49 – 0.99) and a 37% reduced risk of a moderate exacerbation (HR = 0.63, 95% CI 0.43 – 0.94).
After propensity matching, participants prescribed DPP-4 inhibitors had a reduced, but non-significant reduction in severe (HR = 0.91, 95% CI 0.82 – 1.02) and moderate COPD exacerbations (HR = 0.93, 95% CI 0.82 – 1.07).
For SGLT-2 inhibitors, the mean reduction in severe exacerbations was 38% lower (HR = 0.62, 955 CI 0.48 – 0.81) but the reduction for moderate severity exacerbations was non-significant (HR = 1.02, 95% CI 0.83 – 1.27).
The authors concluded that the use of both GLP-1 receptor agonists and SGLT-2 inhibitors were associated with a significantly reduced risk of severe exacerbations compared with sulfonylureas in patients with chronic obstructive pulmonary disease and type 2 diabetes. In contrast, while exacerbations rates were reduced with DPP-4 inhibitors, these reductions were not statistically significant.
Citation
Pradham R et al. Novel antihyperglycaemic drugs and prevention of chronic obstructive pulmonary disease exacerbations among patients with type 2 diabetes: population based cohort study. BMJ 2022
14th November 2022
A malarial monoclonal antibody with an extended half-life has been shown to provide a high level of efficacy against Plasmodium falciparum.
The malarial monoclonal antibody CIS43LS has shown a high level of efficacy after 6 months against plasmodium falciparum during the malaria season in Mali according to the findings of a study by researchers from the Mali Malaria mAb trial team.
Malaria is caused by four members of the plasmodium species including Plasmodium falciparum, P. vivax, P. ovale, and P. malariae and is transmitted after being bitten by an infective female Anopheles mosquito producing a febrile illness.
Malaria is an extremely common infection, which, according to the World Health Organization (WHO), led to 241 million cases in 2020 (up from 227 million in 2019) and an estimated 627 000 deaths.
The infection disproportionately affects individuals on the African continent and WHO estimates that in 2020, 95% of all malaria cases and 96% of deaths occurred within the region with children under 5 years of age accounting for about 80% of all malaria deaths.
A study published in 2015 found that a candidate malaria vaccine prevented a substantial number of cases of clinical malaria over a three-to-four-year period in young infants and children when administered with or without a booster dose.
As well as vaccines, a malarial monoclonal antibody, CIS43LS has been developed and which targets the circumsporozoite protein which covers the surface of the infecting sporozoites and has a critical role in sporozoite development in the mosquito, and invasion of hepatocytes necessary for initiation of malaria infection.
CIS43LS binds with the circumsporozoite protein, inhibiting its action and is therefore highly effective for passive prevention of malaria. In a phase 1 trial, administration of CIS43LS to adults who had never had malaria infection or vaccination, prevented malaria after controlled infection.
Based on these early and positive findings, researchers undertook a phase 2 trial to assess the efficacy and safety of CIS43LS in healthy adults in Mali during a 6-month malaria season. After an initial dose ranging study, individuals were randomised 1:1:1 to receive CIS43LS doses of either 10 mg/kg/bodyweight, 40 mg or placebo.
The primary efficacy endpoint was the first detection of P. falciparum infection in blood smear examination, and which was checked every 2 weeks for a total of 24 weeks. Prior to the study, all participants were given artemether–lumefantrine for treatment of any existing malarial infection.
A total of 330 individuals with a median age of 34.6 years (43% female) were equally randomised to either 10, 40 mg/kg dose of CIS43LS or placebo. At enrolment, plasmodium infection was still present in 12.7% of those receiving 10 mg, 7.3% in the 40 mg group and a similar proportion of placebo participants.
The primary efficacy, i.e., P. falciparum infection, was seen in 35.5% of those receiving 10 mg, 18.2% in the 40 mg group but in 78.2% of placebo participants. At 6 months the efficacy of the 40 mg/kg dose (compared to placebo) was 88.2% and 75% for the 10 mg dose and both comparisons were statistically significant.
In terms of safety, the risk of a moderate headache was 3.3 times as high with the 40 mg/kg dose compared to placebo.
The authors concluded that CIS43LS was effective over a 6-month malaria season and without any evidence of safety concerns.
Citation
Kayentoa K et al. Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali. N Engl J Med 2022.
Vaccine confidence appears to be declining since the start of the COVID-19 pandemic according to the finding of a repeated patient survey.
Vaccine confidence has reduced compared to pre-pandemic levels, according to the findings of a recent, repeated public survey by researchers from the School of Biological Sciences, University of Portsmouth, UK.
The World Health Organization describes immunisation as a global health and development success story. In 2020, the development of a vaccine against COVID-19 occurred very rapidly yet previously, the fastest vaccine development from viral sampling to approval had been four years, for mumps in the 1960s.
Patient’s reluctance to receive vaccination, or vaccine hesitancy, is influenced by several factors, with a 2021 narrative review finding that COVID-19 vaccine acceptance ranged from 77.6% in the general population to 86.1% among students.
A further factor affecting vaccine hesitancy is what might be termed ‘vaccine confidence’, which has been largely driven by the rapidity of vaccine development and subsequent uncertainties over safety.
In November and December 2019 when the first cases of infection were being reported in China, the UK researchers undertook a patient survey and which was repeated in January/February 2022.
In light of the pandemic, the most recent iteration of the survey was modified to include two questions: one on the number of vaccines individuals had received and the second, enquiring about an individual’s confidence in vaccines (whether it had increased/stayed the same/decreased) since the pandemic.
For the survey, the researched calculated a vaccine confidence score (VCS) which was compared between the two surveys.
The original 2019 survey included 739 participants (19.6% male) and of whom, 45.5% were aged 18 – 24 and only 4.2% aged 60 years and over. For the 2022 survey, a total of 270 respondents (27.8% male) were included but this time, the majority (68.8%) were in the 18 to 24 age range and only 3.4% were aged 60 years and older.
The median VCS in 2019 was 22 and significantly reduced to 20 in the follow-up survey (p = 0.001) with lower values seen across all age groups, between the sexes and based on graduate status.
In contrast however, the 2022 survey observed a significant association between the number of COVID-19 vaccines received and vaccine confidence score, which became higher as the number of doses received increased.
Finally, in the 2022 survey, 23.8% of respondents stated that their confidence in vaccines had decreased compared to 21.6% who stated that confidence had increased, whereas it remained unchanged at 54.6%.
The authors concluded that despite the success of the COVID-19 vaccination program, vaccine confidence had significantly declined since the onset of the pandemic.
Citation
Siani A et al. Is vaccine confidence an unexpected victim of the COVID-19 pandemic? Vaccine 2022.
Assessment of S100B levels in low-risk head injury patients seen in an emergency department is a potential diagnostic marker to rule-out serious intracranial pathology that reduces the need for a CT-head scan in more than a quarter of cases according to a study by New Zealand researchers.
In a 2016 study it was estimated that globally, there were 27·08 million new cases of traumatic brain injury (TBI) caused primarily by falls and road injuries. Moreover, assessing patients with a head injury in an emergency department (ED) takes time with and has been estimated at 6.6 hours with the time related to head CT responsible for about half of the total length of stay.
Despite increased availability of CT scans and its potential value as a diagnostic tool, over 90% of head CT scans in those referred from ED to exclude a significant intracranial injury have been found to be normal prompting the search for alternative assessment tools. One potential biomarker protein is S100B, which has been described as a useful neuro-biochemical marker of brain damage such as in circulatory arrest, stroke and traumatic brain injury.
However, a recent systematic review concluded that the diagnostic accuracy of single biomarkers as a rule out for significant intracranial injury seen on CT head scans in ED patients with TBI is low. Nevertheless, the authors of the review added that S100B is the only single biomarker with a validated clinical platform making it the biomarker of choice. Despite this, there is little evidence on the diagnostic performance of S100B, particularly in low-risk head injury patients, where it is likely to be of greatest value in reducing the need for a CT-head scan.
In the present study, the New Zealand team examined the diagnostic value of the biomarker for excluding significant intracranial pathology in patients who presented at an ED within 6 and 24 hours of their head injury. Included patients were those able to give consent and without signs of post-traumatic amnesia and blood samples were taken to measure S100B levels.
All patients were assessed and sent for a CT-head scan when deemed clinically appropriate and categorised as CT-positive (i.e., needing a scan) or CT-negative. The primary outcome was the diagnostic accuracy of S100B within 6 hours after a head injury.
S100B diagnostic value in low-risk head injury
A total of 265 patients of whom, 133 with a median age of 69.5 years (35.8% female) presented within 6 hours of their head injury were included in the study.
Among those presenting within 6 hours, the median S100B level in those who were CT-positive was 0.36 and compared to 0.15 in the CT-negative group (p < 0.01). The sensitivity of S100B in the 6-hour group was 93.8% and the specificity of 30.8%.
The authors calculated that using a clinically validated cut-off threshold for S100B of 0.1 μg/mL, if patients with levels below this threshold did not have a CT-head scan, the use of scans would be reduced by 27.1%. Similarly, for those attending within 24 hours of their head injury and using the same threshold, would lead to a 37.4% reduction in CT scans. In fact, the authors also determined that the risk of missing a significant injury with this approach would result in missing only 0.75% of significant injuries within 6 hours or 2.3% within 24 hours.
They concluded measurement of S100B performed well as a diagnostic aid to exclude significant intracranial injury in low-risk patients with a head injury.
Citation
Rogan A et al. Diagnostic performance of S100B as a rule-out test for intracranial pathology in head-injured patients presenting to the emergency department who meet NICE Head Injury Guideline criteria for CT-head scan Emerg Med 2022
The use of NEWS provides a similar prediction of 7-day intensive care unit (ICU) admission and 30-day mortality in patients with an acute pulmonary embolism when compared to both the pulmonary embolism severity index (PESI) and the simplified PESI according to the findings of a study by Dutch researchers.
The national early warning score (NEWS) is designed to identify patients at risk of clinical deterioration and hence allow staff to implement an intervention that will benefit the patient. In fact, the use of NEWS has been found to have a greater ability to discriminate between patients at risk of the combined outcome of cardiac arrest, unanticipated ICU admission or death within 24h of obtaining a NEWS value. The score incorporates six physiological measurements: respiratory rate; oxygen saturation; temperature; systolic blood pressure; heart rate and level of consciousness such that higher scores indicate a greater the clinical risk. Currently, patients with an acute pulmonary embolism (PE) require prognostic assessment since the course of recovery can rapidly deteriorate due to haemodynamic instability. The Pulmonary Embolism Severity Index (PESI) accurately classifies PE patients into five risk classes with increasing mortality although a simplified PESI has been developed with similar prognostic accuracy and clinical utility, but greater ease of use compared with the original PESI. But whether NEWS be used instead of either the PESI or simplified PESI as a single prognostic score for patients who present with an acute PE is uncertain and was examined in the current study.
Using data from the YEARS study undertaken in patients with a suspected acute PE, the researchers made use of information collected to calculate a NEWS, PESI and simplified PESI score. They used all-cause ICU admission within 7-days of presentation and 30-day all-cause mortality as the two outcomes of interest and evaluated each of the three tools based on the area under the receiver operating curves (AUC).
NEWS and pulmonary embolism outcomes
A total of 352 patients with a mean age of 59 years (53% female) presented with an acute PE and were included in the analysis. Among the entire cohort, 3.4% of patients were admitted to an ICU and 1.4% died.
The AUC for predicting 7-day ICU admission using NEWS was 0.80 (95% CI 0.66 – 0.94) and 0.92 (95% CI 0.82 – 1.00) for 30-day mortality. With PESI, the AUC for ICU admission was 0.64 and 0.94 for mortality. Finally, with the simplified PESI, the ICU admission AUC was 0.68 and 0.77 for 30-day mortality.
The authors concluded that NEWS was able to better predict both 7-day ICU admission than either of the current tools and provided a similar 30-day mortality prediction to PESI, but which was better than the simplified PESI, highlighting the potential relevance for clinical practice.
Citation
Bavalia R et al. Use of the National Early Warning Score for predicting deterioration of patients with acute pulmonary embolism: a post-hoc analysis of the YEARS Study. Emerg Med J 2022
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