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Emergency Medicine

RCT: Invasive Strategy Does Not Significantly Improve Cardiovascular Outcomes Over Conservative Management in Older Adults with NSTEMI

7 Sep, 2024 | 13:25h | UTC

Study Design and Population: This was a prospective, multicenter, randomized trial conducted across 48 sites in the UK, enrolling 1,518 patients aged 75 years or older with non-ST-segment elevation myocardial infarction (NSTEMI). Patients were randomly assigned to receive either the best available medical therapy alone (conservative strategy) or in combination with invasive treatment (coronary angiography and revascularization). The population included individuals who were frail or had high comorbidities, with a mean age of 82 years.

Main Findings: Over a median follow-up of 4.1 years, the primary outcome (a composite of cardiovascular death or nonfatal myocardial infarction) occurred in 25.6% of the invasive-strategy group and 26.3% of the conservative-strategy group (HR, 0.94; 95% CI, 0.77–1.14; P=0.53), showing no significant difference. Cardiovascular death rates were similar between the two groups, but nonfatal myocardial infarction was lower in the invasive group (11.7% vs. 15.0%; HR, 0.75; 95% CI, 0.57–0.99). Procedural complications were rare, affecting less than 1% of patients.

Implications for Practice: This trial suggests that in older adults with NSTEMI, an invasive strategy does not significantly reduce the risk of cardiovascular death or nonfatal myocardial infarction compared to a conservative approach. The findings support the consideration of conservative management in frail elderly patients or those with significant comorbidities, given the minimal additional benefit of invasive treatment.

Reference: Kunadian, V., Mossop, H., Shields, C., Bardgett, M., Watts, P., Teare, M. D., Pritchard, J., et al. (2024). Invasive treatment strategy for older patients with myocardial infarction. New England Journal of Medicine. http://doi.org/10.1056/NEJMoa2407791

Link: https://www.nejm.org/doi/10.1056/NEJMoa2407791

 


Systematic Review: Nasogastric Feeding Increases Diarrhea and Pain Compared to Nasojejunal Feeding in Acute Pancreatitis – BMC Gastroenterol

18 Aug, 2024 | 19:23h | UTC

Study Design and Population: This systematic review and meta-analysis compared the safety and efficacy of nasogastric (NG) versus nasojejunal (NJ) feeding initiated within 48 hours of hospital admission in patients with moderate to severe acute pancreatitis. The analysis included four randomized controlled trials (RCTs) involving a total of 217 patients.

Main Findings: The review found no significant difference in mortality between NG and NJ feeding groups. However, NG feeding was associated with a higher incidence of diarrhea (RR 2.75, P = 0.02) and pain (RR 2.91, P = 0.002). The risk of infection was also higher in the NG group (6.67% vs. 3.33%, P = 0.027). No significant differences were observed in the need for surgical intervention, the requirement for parenteral nutrition, or the success rates of feeding procedures.

Implications for Practice: The findings suggest that while NG feeding does not increase mortality in acute pancreatitis, it is associated with higher rates of certain complications, particularly diarrhea and pain. Clinicians should consider these risks when choosing a feeding strategy for patients with acute pancreatitis, especially within the critical early 48-hour period post-admission.

Reference: Wang M, Shi H, Chen Q, Su B, Dong X, Shi H, Xu S. (2024). Comparative safety assessment of nasogastric versus nasojejunal feeding initiated within 48 hours post-admission versus unrestricted timing in moderate or severe acute pancreatitis: a systematic review and meta-analysis. BMC Gastroenterology, 24(207), 1-11. DOI: 10.1186/s12876-024-03290-z.

 


Randomized Noninferiority Trial: Oral Vonoprazan Noninferior to IV Proton Pump Inhibitors in Preventing Rebleeding of High-Risk Peptic Ulcers – Gastroenterology

18 Aug, 2024 | 18:32h | UTC

Study Design and Population: This multicenter, randomized, open-label, noninferiority trial was conducted in Thailand across six centers, including both university and community hospitals. A total of 194 patients with high-risk peptic ulcer (PU) bleeding who had achieved successful endoscopic hemostasis were randomized to receive either vonoprazan or intravenous proton pump inhibitors (PPI). The study aimed to compare the efficacy of vonoprazan, a potassium-competitive acid blocker, with that of high-dose PPIs in preventing rebleeding.

Main Findings: The trial found that the 30-day rebleeding rate in the vonoprazan group was 7.1%, compared to 10.4% in the PPI group. This demonstrated noninferiority of vonoprazan within a 10% margin (risk difference: -3.3%, 95% CI: -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates were also noninferior. Secondary outcomes, including mortality rates, the need for rescue therapy, blood transfusion requirements, and length of hospital stay, were comparable between the two groups. Adverse events were similar in both groups.

Implications for Practice: Vonoprazan presents a viable alternative to intravenous PPIs for preventing rebleeding in patients with high-risk PU after endoscopic hemostasis. The availability of vonoprazan in oral form could potentially reduce hospital stays. However, further studies in multiethnic populations are needed to confirm these findings and assess the cost-effectiveness of vonoprazan in this setting.

Reference: Geeratragool T, Kaosombatwattana U, Boonchote A, et al. (2024). Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology, -(-), 1-10. DOI: https://doi.org/10.1053/j.gastro.2024.03.036.

 


Non-Inferiority Trial: Burr-Hole Drainage Without Irrigation Results in Higher Reoperation Rate in Chronic Subdural Hematoma – The Lancet

18 Aug, 2024 | 18:17h | UTC

Study Design and Population: This Finnish, nationwide, multicentre, randomised, controlled non-inferiority trial (FINISH) evaluated whether subdural irrigation during burr-hole drainage for chronic subdural haematoma could be omitted without compromising outcomes. The trial enrolled 589 adults (165 women, 424 men) requiring burr-hole drainage, randomly assigned to receive drainage with or without irrigation.

Main Findings: The study found a 6.0 percentage point higher reoperation rate within 6 months in the non-irrigation group (18.3%) compared to the irrigation group (12.6%). There were no significant differences in secondary outcomes, including the proportion of patients with an unfavorable functional outcome (13.1% vs. 12.6%) or mortality (6.1% vs. 7.1%). Adverse events were comparable between the groups.

Implications for Practice: The trial results suggest that omitting subdural irrigation during burr-hole drainage increases the risk of reoperation, without improving functional outcomes or reducing mortality. The findings support the continued use of subdural irrigation in this procedure.

Reference: Raj, R., Tommiska, P., Koivisto, T., Leinonen, V., Danner, N., & Posti, J. P., et al. (2024). Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): A Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial. The Lancet, 403(10446), 2798-2806. DOI: https://doi.org/10.1016/S0140-6736(24)00686-X.

 


Innovative Antimicrobial Susceptibility Testing Bypasses Blood Culture, Promising Faster Sepsis Diagnosis – Nature

18 Aug, 2024 | 14:09h | UTC

Study Design and Population: This study introduces a novel ultra-rapid antimicrobial susceptibility testing (AST) method that bypasses the traditional blood culture process, potentially reducing diagnostic time by 40-60 hours. The method was evaluated using a cohort of 190 hospitalized patients in Korea with suspected sepsis, including those with blood cancers.

Main Findings: The new AST method identified bacterial species in all patients with positive blood infections, achieving a 100% match in species identification. For antimicrobial susceptibility, the method demonstrated a 94.9% categorical agreement with conventional AST methods, with a theoretical turnaround time of 13 ± 2.53 hours, significantly faster than current workflows.

Implications for Practice: This method could improve sepsis treatment by providing same-day results, potentially reducing sepsis-related mortality and the use of broad-spectrum antibiotics. However, further validation in a more diverse patient population is necessary to confirm its clinical efficacy and value.

Reference: Kim, T. H., Kang, J., Jang, H., Joo, H., Lee, G. Y., Kim, H., et al. (2024). Blood culture-free ultra-rapid antimicrobial susceptibility testing. Nature, (2024).

 


Review: Prevention and Management of Device-Associated Complications in the Intensive Care Unit – The BMJ

17 Aug, 2024 | 20:04h | UTC

Introduction:

This review article, published by experts from the David Geffen School of Medicine at UCLA, focuses on the complications associated with invasive devices commonly used in the Intensive Care Unit (ICU). While these devices are essential for managing critically ill patients, they also pose significant risks, necessitating a thorough understanding of their potential complications and strategies for prevention and management.

Key Points:

1 – Central Venous Catheters (CVCs):

– CVCs are widely used in ICU patients but carry risks like vascular injury, pneumothorax, thrombosis, and infection.

– Use of real-time ultrasound guidance and careful operator technique are crucial for minimizing these risks.

– Prompt removal of unnecessary CVCs is essential to reduce the risk of complications.

2 – Arterial Catheters:

– Commonly used for hemodynamic monitoring, these catheters can lead to complications such as vascular occlusion, nerve injury, and infection.

– Ultrasound guidance is recommended to reduce the risk of complications, and catheters should be discontinued as soon as clinically feasible.

3 – Airway Devices (Endotracheal Tubes and Tracheostomies):

– Complications include laryngeal injury, tracheal stenosis, and tracheomalacia.

– Strategies to reduce these risks include minimizing intubation attempts, ensuring proper tube placement, and managing cuff pressures carefully.

4 – Extracorporeal Membrane Oxygenation (ECMO):

– ECMO is associated with significant complications, including bleeding, thromboembolic events, and neurologic injuries.

– Proper cannulation technique and vigilant monitoring are essential to mitigate these risks.

5 – Infection Control:

– Strict adherence to aseptic techniques and the use of chlorhexidine-impregnated dressings are recommended to prevent device-associated infections.

Conclusion:

This review underscores the importance of judicious use and timely removal of invasive devices in the ICU to minimize complications. Healthcare professionals must remain vigilant and employ best practices to prevent and manage these complications effectively.

Reference: Hixson, R., Jensen, K. S., Melamed, K. H., & Qadir, N. (2024). Device associated complications in the intensive care unit. BMJ, 386, e077318. http://dx.doi.org/10.1136/bmj-2023-077318

 


Study: Novel Point-of-Care hs-cTnI Test Shows High Diagnostic Accuracy and Predictive Values for Myocardial Infarction – J Am Coll Cardiol

17 Aug, 2024 | 19:00h | UTC

Study Design and Population: This international, multicenter diagnostic study assessed the clinical and analytical performance of the new high-sensitivity cardiac troponin I (hs-cTnI)-SPINCHIP point-of-care (POC) test. The study involved 1,102 adult patients presenting with acute chest discomfort in emergency departments, with myocardial infarction (MI) diagnoses adjudicated by two independent cardiologists.

Main Findings: The hs-cTnI-SPINCHIP test exhibited strong diagnostic accuracy with an area under the receiver-operating characteristic curve of 0.94, similar to established central laboratory assays. The 0/1-hour algorithm of the test identified 51% of patients as low risk for MI with a sensitivity and negative predictive value of 100%, while it confirmed MI in 27% of patients with a specificity of 90.9% and a positive predictive value of 72.9%. Consistency was observed across different sample types.

Implications for Practice: The SPINCHIP hs-cTnI POC test provides a rapid and accurate option for diagnosing MI in emergency settings, aiding quicker decision-making for ruling out or confirming MI.

Reference: Koechlin L. et al. (2024). Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. JACC, 84(8), 726–740.

 


News Release – FDA Approves First Nasal Spray for Anaphylaxis Treatment: Neffy (Epinephrine Nasal Spray) – U.S. Food and Drug Administration

17 Aug, 2024 | 15:43h | UTC

The U.S. Food and Drug Administration (FDA) has approved Neffy, the first epinephrine nasal spray for the emergency treatment of anaphylaxis and other severe allergic reactions (Type I) in both adults and pediatric patients weighing at least 30 kilograms (approximately 66 pounds). This approval introduces a non-injectable option for the rapid administration of epinephrine, which is critical in managing life-threatening allergic reactions.

Key Points for Healthcare Providers:

– Alternative to Injection: Neffy provides a new option for patients who may delay or avoid epinephrine injections due to needle phobia. This could be particularly beneficial for children and others reluctant to use injectable epinephrine.

– Efficacy and Safety: Neffy’s approval is supported by studies comparing its pharmacokinetics and pharmacodynamics to traditional epinephrine injections. These studies showed comparable blood epinephrine levels and similar physiological effects, such as increased blood pressure and heart rate.

– Administration: Neffy is a single-dose nasal spray, administered into one nostril. If symptoms do not improve or worsen, a second dose may be administered in the same nostril. Patients should still seek emergency medical care to monitor the anaphylactic reaction.

– Warnings: Certain nasal conditions, such as nasal polyps or a history of nasal surgery, may impair Neffy’s absorption. In these cases, injectable epinephrine might be a more reliable option. The product also carries typical warnings for epinephrine use, particularly in patients with coexisting conditions.

– Side Effects: Common side effects include throat irritation, nasal discomfort, headaches, and jitteriness. Healthcare professionals should discuss these with patients to ensure informed use.

Clinical Implications:

Neffy may reduce barriers to the timely treatment of anaphylaxis, potentially improving outcomes by increasing the likelihood of rapid epinephrine administration. Healthcare providers should consider Neffy as an alternative for patients who are needle-averse or have difficulty using injectable epinephrine, while also ensuring patients understand the importance of prompt medical attention following its use.

Approval Background:

Neffy was granted Fast Track designation by the FDA, emphasizing the need for an alternative to injectable epinephrine. The approval was awarded to ARS Pharmaceuticals.

Source: FDA News Release: FDA Approves First Nasal Spray for Treatment of Anaphylaxis

 


New AHA Guidelines for Managing Elevated Blood Pressure in Acute Care Settings – Hypertension

13 Aug, 2024 | 13:13h | UTC

Introduction:

The American Heart Association (AHA) has released a scientific statement focusing on the management of elevated blood pressure (BP) in acute care settings. This guideline addresses the significant variation in practice due to a lack of robust evidence for managing BP in such environments, particularly in emergencies or when elevated BP is asymptomatic.

Key Points:

1 – Classification of Elevated BP: Elevated BP in acute care settings is categorized into asymptomatic elevated BP and hypertensive emergency, the latter requiring immediate treatment due to acute target-organ damage.

2 – Hypertensive Emergency: Immediate treatment is necessary for patients with BP >180/110–120 mm Hg and evidence of new or worsening target-organ damage, typically using intravenous antihypertensive medications in a closely monitored environment.

3 – Asymptomatic Elevated BP: In cases where elevated BP is present without symptoms or target-organ damage, the use of antihypertensive medications should be approached cautiously. Recent studies suggest potential harm from aggressive treatment, highlighting the importance of verifying BP readings and identifying reversible causes before intervention.

4 – Proper BP Measurement: Accurate BP measurement is crucial. The guidelines stress using recently calibrated devices and following correct measurement techniques to avoid unnecessary treatment due to erroneous readings.

5 – PRN Orders: The use of “as needed” (PRN) antihypertensive medications for asymptomatic elevated BP is discouraged due to the risks of overtreatment and variability in BP control, which can lead to adverse outcomes.

6 – Treatment Thresholds: The guidelines recommend a high threshold for initiating or intensifying antihypertensive treatment in asymptomatic patients, emphasizing the need for repeated measurements and assessment of underlying causes.

7 – Post-Discharge Care: It is crucial to maintain prehospital antihypertensive regimens and avoid intensification at discharge unless clearly indicated. Effective care coordination and patient education are vital for successful transitions from hospital to home care.

Conclusion:

These guidelines represent a significant step toward standardizing BP management in acute care settings. By focusing on accurate measurement, cautious treatment of asymptomatic elevated BP, and proper follow-up, clinicians can reduce unnecessary interventions and improve patient outcomes.

Guideline Reference: Bress, A.P., et al. (2024). “The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement from the American Heart Association.” Hypertension, 81–e106.

 


IDSA 2024 Guidelines for Managing Complicated Intra-abdominal Infections – Clin Infect Dis

10 Aug, 2024 | 22:10h | UTC

Introduction: The Infectious Diseases Society of America (IDSA) has updated its clinical practice guidelines for managing complicated intra-abdominal infections in adults, children, and pregnant individuals. The update focuses on risk assessment, diagnostic imaging, and microbiological evaluation, with recommendations grounded in systematic literature reviews and the GRADE approach for rating evidence.

Key Points:

1 – Risk Stratification:

– For adults with complicated intra-abdominal infections, the APACHE II score is recommended for risk stratification within 24 hours of hospital or ICU admission. The WSES Sepsis Severity Score is an acceptable alternative.

– No specific severity scoring system is recommended for pediatric patients.

2 – Diagnostic Imaging for Appendicitis:

– In non-pregnant adults, CT is suggested as the initial imaging modality for suspected acute appendicitis.

– For children, an abdominal ultrasound (US) is preferred initially, with MRI or CT recommended if the US is inconclusive.

– In pregnant individuals, US or MRI can be considered, with MRI suggested if initial US results are inconclusive.

3 – Imaging for Acute Cholecystitis and Cholangitis:

– For non-pregnant adults, US is recommended initially. If inconclusive, a CT scan is suggested.

– For pregnant individuals, US or MRI can be used, but the guidelines do not specify a preferred modality due to a knowledge gap.

4 – Blood Cultures:

– Blood cultures are recommended in adults and children with suspected intra-abdominal infections presenting with severe symptoms such as hypotension or tachypnea, especially when antibiotic-resistant organisms are a concern.

– Routine blood cultures are not recommended for patients without these risk factors.

5 – Intra-abdominal Fluid Cultures:

– In complicated intra-abdominal infections requiring source control procedures, obtaining intra-abdominal cultures is advised to guide antimicrobial therapy.

– In uncomplicated appendicitis cases, routine cultures are not recommended unless the patient is immunocompromised or complicated disease is suspected during surgery.

Conclusion: These guidelines provide evidence-based recommendations to improve the management of complicated intra-abdominal infections, emphasizing appropriate risk stratification, targeted diagnostic imaging, and the selective use of cultures to guide therapy.

Reference: Bonomo, R. A., et al. (2024). “2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on Complicated Intra-abdominal Infections: Risk Assessment, Diagnostic Imaging, and Microbiological Evaluation in Adults, Children, and Pregnant People.” Clinical Infectious Diseases. DOI: 10.1093/cid/ciae346.

 


Cluster RCT: AI-ECG Shows Potential to Reduce Door-to-Balloon Time and Cardiac Deaths in STEMI Patients – NEJM AI

10 Aug, 2024 | 21:57h | UTC

Study Design and Population: This open-label, cluster randomized controlled trial assessed the impact of AI-powered electrocardiogram (AI-ECG) on reducing treatment delays for ST-elevation myocardial infarction (STEMI). The study involved 43,234 patients, with an average age of 60 years, at Tri-Service General Hospital in Taiwan. Patients were randomized 1:1 into an intervention group (AI-ECG-assisted STEMI detection) or a control group receiving standard care.

Main Findings: AI-ECG significantly reduced the median door-to-balloon time for emergency department patients (82.0 vs. 96.0 minutes, P=0.002) and the ECG-to-balloon time across all settings (78.0 vs. 83.6 minutes, P=0.011). While the AI-ECG intervention did not significantly affect all-cause mortality or new-onset heart failure, it led to a notable reduction in cardiac death rates (85 vs. 116 cases; odds ratio, 0.73; P=0.029).

Implications for Practice: AI-ECG can expedite the critical time to treatment for STEMI patients, potentially reducing cardiac death. Although overall mortality remained unchanged, the reduction in cardiac deaths suggests that AI-ECG could be a valuable tool in emergency and inpatient settings to improve outcomes for STEMI patients.

Reference: Lin C. et al. (2024). Artificial Intelligence–Powered Rapid Identification of ST-Elevation Myocardial Infarction via Electrocardiogram (ARISE) — A Pragmatic Randomized Controlled Trial. NEJM AI, 1(7). DOI: 10.1056/AIoa2400190.

 


IDSA 2024 Guidelines for Treatment of Antimicrobial-Resistant Gram-Negative Infections – Clin Infect Dis

10 Aug, 2024 | 20:16h | UTC

Introduction:

The Infectious Diseases Society of America (IDSA) has released updated guidelines in 2024 addressing the treatment of infections caused by antimicrobial-resistant (AMR) Gram-negative bacteria. These guidelines cover pathogens including extended-spectrum β-lactamase-producing Enterobacterales (ESBL-E), AmpC β-lactamase-producing Enterobacterales (AmpC-E), carbapenem-resistant Enterobacterales (CRE), difficult-to-treat Pseudomonas aeruginosa (DTR P. aeruginosa), carbapenem-resistant Acinetobacter baumannii (CRAB), and Stenotrophomonas maltophilia.

Key Points:

1 – ESBL-E Infections:

– Preferred treatment for uncomplicated cystitis includes nitrofurantoin and TMP-SMX. Fluoroquinolones and carbapenems are alternatives but should be reserved to prevent resistance.

– For pyelonephritis or complicated urinary tract infections (cUTI), TMP-SMX, ciprofloxacin, or levofloxacin are preferred. Carbapenems are recommended when resistance precludes other options.

2 – AmpC-E Infections:

– Cefepime is suggested for treating infections caused by organisms at moderate risk of significant AmpC production (e.g., Enterobacter cloacae complex, Klebsiella aerogenes, and Citrobacter freundii).

– The use of cephamycins (e.g., cefoxitin, cefotetan) for treating ESBL-E infections is not recommended due to insufficient clinical outcome data.

3 – CRE Infections:

– Acknowledgement of increased prevalence of metallo-beta-lactamase (MBL)-producing CRE in the U.S.

– The combination of ceftazidime-avibactam and aztreonam is suggested for MBL-producing CRE, with updated dosing recommendations provided.

4 – DTR Pseudomonas aeruginosa:

– Traditional β-lactams (e.g., cefepime) with high-dose extended-infusion therapy are recommended.

– Tobramycin or amikacin, administered once daily, are alternatives for pyelonephritis or cUTI.

5 – CRAB and Stenotrophomonas maltophilia Infections:

– Sulbactam-durlobactam with meropenem or imipenem-cilastatin is the preferred treatment for CRAB.

– The order of preference for agents treating S. maltophilia includes cefiderocol, ceftazidime-avibactam, and aztreonam, among others.

Conclusion:

The 2024 IDSA guidelines provide critical updates on managing AMR Gram-negative infections, emphasizing the importance of selecting the appropriate antibiotic based on susceptibility, resistance mechanisms, and patient-specific factors. These guidelines are essential for optimizing treatment outcomes in the face of increasing antimicrobial resistance.

Reference:

Tamma, P. D., Heil, E. L., Justo, J. A., Mathers, A. J., Satlin, M. J., & Bonomo, R. A. (2024). Infectious Diseases Society of America Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clinical Infectious Diseases.

 


RCT: Liberal vs. Restrictive Transfusion Strategy Shows No Significant Difference in Neurologic Outcomes for Traumatic Brain Injury Patients – N Engl J Med

3 Aug, 2024 | 19:06h | UTC

Study Design and Population: This randomized clinical trial evaluated the effects of liberal versus restrictive red cell transfusion strategies in 742 adults with moderate to severe traumatic brain injury (TBI) and anemia. Participants were randomized to either a liberal transfusion strategy (initiated at hemoglobin ≤10 g/dL) or a restrictive strategy (initiated at hemoglobin ≤7 g/dL). The primary outcome was an unfavorable neurologic outcome at 6 months, assessed using the Glasgow Outcome Scale–Extended.

Main Findings: The study found that 68.4% of patients in the liberal-strategy group and 73.5% in the restrictive-strategy group experienced an unfavorable outcome (adjusted absolute difference of 5.4 percentage points; 95% CI, −2.9 to 13.7). No significant difference in mortality or depression was observed between the two groups. Although some functional independence and quality of life measures were better in the liberal group among survivors, venous thromboembolic events and acute respiratory distress syndrome rates were comparable.

Implications for Practice: The findings indicate that a liberal transfusion strategy does not significantly improve neurologic outcomes at 6 months in critically ill TBI patients compared to a restrictive strategy. Clinicians may consider maintaining a restrictive transfusion strategy, given the similar outcomes and potential for fewer transfusions. Further research is needed to explore specific subgroups that might benefit from different transfusion strategies.

Reference: Turgeon AF, Fergusson DA, Clayton L, et al. (2024). Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. New England Journal of Medicine, 390(24), 1234-1245. DOI: 10.1056/NEJMoa2404360.


RCT: Tenecteplase Reduces Disability but Not Mortality in Ischemic Stroke 4.5 to 24 Hours Post-Onset – N Engl J Med

3 Aug, 2024 | 19:03h | UTC

Study Design and Population: This randomized clinical trial was conducted in China to assess the efficacy and safety of tenecteplase in patients with ischemic stroke caused by large-vessel occlusion. The study included 516 patients who were randomly assigned to receive either tenecteplase (264 patients) or standard medical treatment (252 patients) within 4.5 to 24 hours after stroke onset. All patients had salvageable brain tissue confirmed by perfusion imaging and did not have access to endovascular thrombectomy.

Main Findings: The primary outcome, absence of disability (modified Rankin scale score of 0 or 1) at 90 days, was achieved by 33.0% of patients in the tenecteplase group compared to 24.2% in the standard treatment group (relative rate, 1.37; 95% CI, 1.04 to 1.81; P=0.03). Mortality at 90 days was similar between the two groups (13.3% for tenecteplase vs. 13.1% for standard treatment). Symptomatic intracranial hemorrhage within 36 hours occurred in 3.0% of tenecteplase-treated patients compared to 0.8% of those receiving standard treatment.

Implications for Practice: The study suggests that tenecteplase administered 4.5 to 24 hours post-stroke onset can reduce disability in patients with large-vessel occlusion who do not have access to endovascular thrombectomy. However, the increased risk of symptomatic intracranial hemorrhage warrants cautious consideration. Further research may be needed to optimize patient selection and timing of administration to balance benefits and risks.

Reference: Xiong Y et al. (2024). Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. New England Journal of Medicine, 390(24), 2980-2992. DOI: 10.1056/NEJMoa2402980.


RCT: Reteplase More Likely to Achieve Excellent Functional Outcome Than Alteplase in Acute Ischemic Stroke – N Engl J Med

3 Aug, 2024 | 19:00h | UTC

Study Design and Population: This randomized clinical trial compared the efficacy and safety of reteplase versus alteplase in patients with acute ischemic stroke. The study involved 1,412 patients who presented within 4.5 hours of symptom onset. Patients were randomly assigned in a 1:1 ratio to receive either intravenous reteplase or intravenous alteplase.

Main Findings: The primary efficacy outcome, an excellent functional outcome (modified Rankin scale score of 0 or 1) at 90 days, was achieved in 79.5% of the reteplase group compared to 70.4% of the alteplase group (risk ratio, 1.13; 95% CI, 1.05 to 1.21; P<0.001 for noninferiority and P=0.002 for superiority). The primary safety outcome, symptomatic intracranial hemorrhage within 36 hours, was similar between groups (2.4% for reteplase vs. 2.0% for alteplase; risk ratio, 1.21; 95% CI, 0.54 to 2.75). However, reteplase was associated with a higher incidence of any intracranial hemorrhage at 90 days (7.7% vs. 4.9%; risk ratio, 1.59; 95% CI, 1.00 to 2.51) and more adverse events (91.6% vs. 82.4%; risk ratio, 1.11; 95% CI, 1.03 to 1.20).

Implications for Practice: Reteplase shows superior efficacy in achieving excellent functional outcomes compared to alteplase in acute ischemic stroke, making it a viable alternative thrombolytic agent. However, the higher risk of intracranial hemorrhage and adverse events necessitates careful patient selection and monitoring. Further research may be needed to refine dosage and administration protocols to mitigate these risks.

Reference: Li, S., Gu, H-Q., Li, H., Wang, X., Jin, A., Guo, S., Lu, G., et al. (2024). Reteplase versus Alteplase for Acute Ischemic Stroke. New England Journal of Medicine, 390(24), 2264-2273. DOI: 10.1056/NEJMoa2400314.


Randomized Controlled Trial: Mixed results with Andexanet Alfa for Factor Xa inhibitor-associated acute intracerebral hemorrhage – N Engl J Med

27 May, 2024 | 20:26h | UTC

Study Design and Population: This randomized controlled trial involved 530 patients with acute intracerebral hemorrhage who had taken factor Xa inhibitors within 15 hours before the event. They were randomly assigned to receive either andexanet alfa or usual care.

Main Findings: Hemostatic efficacy was achieved in 67% of patients receiving andexanet compared to 53.1% receiving usual care. Andexanet significantly reduced anti-factor Xa activity by 94.5%, compared to 26.9% with usual care. However, thrombotic events were more frequent in the andexanet group, including ischemic stroke.

Implications for Practice: Andexanet alfa is effective in controlling hematoma expansion in patients with factor Xa inhibitor-associated intracerebral hemorrhage but has an increased risk of thrombotic events. Further research is needed to balance efficacy and safety.

 

Reference (link to abstract – $ for full-text):

Connolly SJ, Sharma M, Cohen AT, et al. (2024). Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage. New England Journal of Medicine, 390(19), 1745-1755. DOI: 10.1056/NEJMoa2313040.

 


RCT: Thrombectomy improves outcomes in acute stroke with large infarcts – N Engl J Med

25 May, 2024 | 19:35h | UTC

Study Design and Population: This randomized clinical trial investigated the efficacy of thrombectomy in combination with standard medical care versus medical care alone in patients with acute stroke and large infarcts. Participants included 333 patients with proximal cerebral vessel occlusion in the anterior circulation, presenting within 6.5 hours of symptom onset. They were randomized in a 1:1 ratio to either undergo thrombectomy or receive only medical care. An Alberta Stroke Program Early Computed Tomographic Score of ≤5 was used to define large infarcts.

Main Findings: The primary outcome, assessed by the modified Rankin scale score at 90 days, showed a median score of 4 in the thrombectomy group compared to 6 in the control group, indicating better functional outcomes with thrombectomy (generalized odds ratio, 1.63; 95% CI, 1.29 to 2.06; P<0.001). Mortality at 90 days was significantly lower in the thrombectomy group (36.1%) compared to the control group (55.5%) with an adjusted relative risk of 0.65. However, thrombectomy was associated with a higher rate of symptomatic intracerebral hemorrhage (9.6% vs. 5.7% in the control group).

Implications for Practice: The findings suggest that thrombectomy, when added to standard medical care, can significantly improve functional outcomes and reduce mortality in patients with large infarct strokes. However, the increased risk of symptomatic intracerebral hemorrhage must be considered when deciding on this intervention. These results support the broader use of thrombectomy in clinical settings with similar patient profiles but underscore the need for careful risk-benefit analysis due to the potential for serious hemorrhagic complications.

 

Reference (link to abstract – $ for full-text):

Costalat, V. et al. (2024). Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size. N Engl J Med, 390(18), 1677-1689. DOI: 10.1056/NEJMoa2314063

 


RCT: Early minimally invasive surgery may improve outcomes in selected patients with intracerebral hemorrhage – N Engl J Med

25 May, 2024 | 18:58h | UTC

Study Design and Population: This multicenter randomized clinical trial investigated the efficacy of early minimally invasive surgical removal of intracerebral hemorrhage compared to medical management alone. The trial enrolled 300 patients within 24 hours of symptom onset, who had either lobar or anterior basal ganglia hemorrhages, with hematoma volumes ranging from 30 to 80 ml. An adaptation rule was applied partway through the trial, resulting in the exclusive enrollment of patients with lobar hemorrhages after 175 patients were initially enrolled.

Main Findings: Patients in the surgery group achieved a significantly higher mean score on the utility-weighted modified Rankin scale at 180 days (0.458) compared to the control group (0.374), with a difference of 0.084 and a posterior probability of superiority of 0.981. Notably, the benefit of surgery was pronounced among patients with lobar hemorrhages (mean difference 0.127), whereas no benefit was observed in patients with anterior basal ganglia hemorrhages. Additionally, the surgery group experienced a lower 30-day mortality rate (9.3%) compared to the control group (18.0%).

Implications for Practice: The results suggest that early minimally invasive surgery for intracerebral hemorrhage, particularly for lobar hemorrhages, offers significant functional benefits over medical management alone. These findings support the selective use of this surgical approach in clinical settings, potentially leading to improved patient outcomes. Further studies could explore the differential impact of hemorrhage location on surgical outcomes to refine treatment guidelines.

 

Reference (link to abstract – $ for full-text):

Pradilla, G. et al. (2024). Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med, 390(14), 1277-1289. DOI: 10.1056/NEJMoa2308440.

 


Guidelines on the use of intravenous albumin in various clinical settings – CHEST

25 May, 2024 | 18:49h | UTC

The International Collaboration for Transfusion Medicine Guidelines provides comprehensive guidelines on the use of intravenous albumin across various clinical settings, including critical care, cardiovascular surgery, kidney replacement therapy, and complications of cirrhosis. The guideline emphasizes that there are few evidence-based indications supporting the routine use of albumin to improve patient outcomes. Key findings include:

 

1 – Critical Care: Limited recommendations for using albumin in adult, pediatric, and neonatal critical care, primarily advising against its routine use for volume replacement or managing hypoalbuminemia due to low or very low certainty of evidence.

2 – Cardiovascular Surgery: No recommendations for using albumin to prime cardiovascular bypass circuits or for volume replacement due to moderate to very low certainty of evidence.

3 – Kidney Replacement Therapy: Albumin is not suggested for preventing or managing intradialytic hypotension or improving ultrafiltration due to very low certainty of evidence.

4 – Cirrhosis Complications: Some conditional recommendations for using albumin in specific scenarios like large-volume paracentesis and spontaneous bacterial peritonitis due to low certainty of evidence; however, it is generally not suggested for other complications of cirrhosis.

 

Overall, the guidelines advise a cautious approach to albumin use, highlighting the need for more robust evidence to support its broader application in clinical practice.

 

Reference (link to free full-text):

Callum J et al. (2024). Use of Intravenous Albumin: A Guideline From the International Collaboration for Transfusion Medicine Guidelines. CHEST, 2024. DOI: https://doi.org/10.1016/j.chest.2024.02.049.

 


Cluster Randomized Trial: Hyperangulated video laryngoscopy reduces intubation attempts in surgical patients – JAMA

11 May, 2024 | 13:39h | UTC

Study Design and Population: This cluster randomized multiple crossover clinical trial was conducted at a single U.S. academic hospital to compare the effectiveness of hyperangulated video laryngoscopy versus direct laryngoscopy in reducing the number of intubation attempts during surgery. The study involved 7,736 adult patients, aged 18 years or older, undergoing elective or emergent cardiac, thoracic, or vascular surgical procedures that required single-lumen endotracheal intubation for general anesthesia. The trial randomized two sets of 11 operating rooms on a weekly basis to use either video laryngoscopy or direct laryngoscopy for the initial intubation attempt from March 2021 to December 2022.

Main Findings: Hyperangulated video laryngoscopy significantly decreased the number of intubation attempts compared to direct laryngoscopy. Specifically, 1.7% of surgical procedures using video laryngoscopy required more than one intubation attempt versus 7.6% for direct laryngoscopy, with an estimated proportional odds ratio of 0.20 (95% CI, 0.14-0.28; P < .001). Furthermore, intubation failure was markedly lower with video laryngoscopy (0.27%) compared to direct laryngoscopy (4.0%). However, there was no significant difference in the rates of airway and dental injuries between the two methods.

Implications for Practice: The findings indicate that hyperangulated video laryngoscopy enhances initial intubation success and reduces the need for multiple intubation attempts in a variety of surgical settings. This suggests that video laryngoscopy could be considered a preferable technique for endotracheal intubation in the operating room, potentially improving patient outcomes and efficiency. Further research might explore the generalizability of these results to other medical centers and different patient populations.

 

Reference (link to abstract – $ for full-text):

Ruetzler, K. et al. (2024). Cluster Randomized Trial: Hyperangulated Video Laryngoscopy Reduces Intubation Attempts in Surgical Patients. JAMA, 331(15), 1279-1286. DOI: 10.1001/jama.2024.0762

 


RCT: Video laryngoscopy improves first-attempt intubation success in neonates compared to direct laryngoscopy – N Engl J Med

11 May, 2024 | 13:37h | UTC

Study Design and Population: This single-center randomized clinical trial investigated the efficacy of video laryngoscopy versus direct laryngoscopy for urgent intubation in neonates. A total of 226 neonates requiring intubation either in the delivery room or neonatal intensive care unit (NICU) were enrolled and stratified by gestational age into two groups: less than 32 weeks and 32 weeks or more. The study primarily focused on the success rate of the first intubation attempt, monitored through exhaled carbon dioxide detection.

Main Findings: The trial included 214 neonates, analyzing the success of intubation on the first attempt. Video laryngoscopy significantly outperformed direct laryngoscopy, achieving a first-attempt success rate of 74% (95% confidence interval [CI], 66 to 82) compared to 45% (95% CI, 35 to 54) in the direct laryngoscopy group. Moreover, the median number of attempts for successful intubation was lower in the video-laryngoscopy group (1 attempt, 95% CI, 1 to 1) versus the direct-laryngoscopy group (2 attempts, 95% CI, 1 to 2). Additionally, neonates in the video laryngoscopy group experienced higher median lowest oxygen saturations and heart rates during intubation.

Implications for Practice: The findings suggest that video laryngoscopy could be more effective than direct laryngoscopy for urgent neonatal intubation, particularly in increasing the likelihood of success on the first attempt. These results recommend reconsidering current intubation techniques in neonatal care settings to incorporate video laryngoscopy, potentially leading to safer and more efficient intubation processes in this vulnerable population.

 

Reference (link to abstract – $ for full-text):

Geraghty, L.E. et al. (2024). Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2402785.

 


Review: Acute and complicated inflammatory pericarditis – Mayo Clin Proc

6 May, 2024 | 18:03h | UTC

The article provides a comprehensive review of current approaches to the diagnosis and management of inflammatory pericardial disease, with a particular focus on acute and complicated cases of pericarditis. Here’s a summary tailored for a medical audience:

Key Points:

1 – Epidemiology and Presentation:

– Acute pericarditis is relatively common, particularly among younger populations.

– It can be effectively managed in most cases but poses a significant risk of recurrence and morbidity if not properly treated.

– Presentations can vary, with chest pain being a predominant symptom, which improves upon leaning forward and worsens in the supine position.

2 – Diagnostic Evaluation:

– Diagnosis hinges on a combination of clinical signs (e.g., chest pain, pericardial rub), ECG changes, imaging findings, and laboratory markers (elevated CRP and white blood cell count).

– Multimodality imaging plays a critical role in diagnosis and management, including echocardiography, CT, and MRI to evaluate pericardial effusion and inflammation.

3 – Management Strategies:

– The treatment landscape has evolved with the introduction of targeted anti-inflammatory therapies and a more systematic approach to care.

– Management includes NSAIDs as first-line therapy, colchicine to reduce recurrence rates, and corticosteroids for severe cases. Recent advancements include the use of interleukin-1 receptor blockers for complicated cases.

– Pericardiectomy may be considered in chronic or recurrent cases that are refractory to medical management.

4 – Future Directions:

– Ongoing research is directed at improving diagnostic accuracy through advanced imaging techniques and refining treatment protocols to minimize recurrence and manage complicated cases effectively.

– The integration of novel biological agents and personalized medicine approaches is anticipated to enhance outcomes for patients with pericardial disease.

This article emphasizes the importance of a protocol-driven approach to the initial care, the use of targeted therapeutics based on individual patient profiles, and the integration of care pathways to manage acute and complicated pericarditis effectively.

 

Reference (link to free full-text):
Malik, A. A., Lloyd, J. W., Anavekar, N. S., & Luis, S. A. (2024). Acute and Complicated Inflammatory Pericarditis: A Guide to Contemporary Practice. Mayo Clinic Proceedings, 99(5), 795-811. https://doi.org/10.1016/j.mayocp.2024.01.012

 


Prospective Validation Study: High accuracy of PECARN rules in reducing unnecessary CT scans in pediatric blunt trauma – Lancet Child Adolesc Health

5 May, 2024 | 15:08h | UTC

Study Design and Population:

This multicenter prospective validation study tested the Pediatric Emergency Care Applied Research Network (PECARN) prediction rules aimed at reducing unnecessary CT scans for children presenting with blunt abdominal or minor head trauma. Over a nearly five-year period, children and adolescents under 18 from six U.S. emergency departments in cities including Sacramento, Dallas, and Los Angeles were enrolled. Exclusion criteria included pregnancy, pre-existing neurological disorders, penetrating trauma, injuries older than 24 hours, prior CT or MRI scans, or suspicion of non-accidental trauma.

 

Main Findings:

A total of 7,542 children with blunt abdominal trauma and 19,999 with minor head trauma were enrolled. The intra-abdominal injury rule demonstrated a sensitivity and negative predictive value (NPV) of 100%, confirming its reliability in detecting injuries requiring acute intervention. For head traumas, the sensitivity varied slightly with age; 100% for children under 2 years and 98.8% for those aged 2 years and older, with an NPV of 100% in both groups. Only two cases in the older cohort were misclassified, neither requiring neurosurgery.

 

Implications for Practice:

The validation of PECARN rules with high sensitivity and NPV supports their use as a safe guideline to minimize unnecessary CT scans in pediatric trauma cases, thereby promoting efficient use of resources and reducing exposure to radiation in children. These results suggest that implementation of these rules should be considered in emergency pediatric care to improve outcomes and healthcare efficiency.

 

Reference (link to abstract – $ for full-text):

Holmes, J. F. et al. (2024). PECARN prediction rules for CT imaging of children presenting to the emergency department with blunt abdominal or minor head trauma: a multicentre prospective validation study. The Lancet Child & Adolescent Health, May 2024, https://doi.org/10.1016/S2352-4642(24)00029-4.

 


Systematic Review: Comparing antibiotic treatment vs. appendectomy for the initial treatment of uncomplicated appendicitis – Cochrane Library

4 May, 2024 | 13:09h | UTC

Study Design and Population:

This Cochrane review analyzed 13 randomized controlled trials involving 3,358 participants to compare the efficacy of antibiotic treatment versus appendectomy in managing uncomplicated acute appendicitis. The included studies predominantly involved adult participants and utilized broad-spectrum antibiotics, with interventions ranging from open to predominantly laparoscopic appendectomy. Data collection spanned from hospital admission to up to seven years, with studies conducted across various global regions, including Asia, Europe, and North America.

 

Main Findings:

The primary outcomes revealed that antibiotic treatment might slightly increase the risk of unsuccessful treatment with 76 additional unsuccessful cases per 1,000 individuals compared to surgery, though these results did not reach clinical significance. Antibiotics reduced wound infections but possibly increased the average hospital stay by half a day. About 30.7% of participants treated with antibiotics required an appendectomy within one year. Secondary outcomes showed very uncertain evidence on antibiotics’ effect on intra-abdominal abscess or reoperation rates, and a slight increase in negative appendectomy rates was observed.

 

Implications for Practice:

The findings suggest that while antibiotics could serve as an initial treatment to avoid surgery in two-thirds of cases annually, a significant portion may still require surgical intervention. This information is crucial for clinicians in making informed treatment decisions, particularly considering patient preferences and the risk of surgery. Further research is needed to explore long-term outcomes and identify patient subgroups that may benefit most from either treatment.

 

Reference (link to abstract – $ for full-text):

Doleman B, Fonnes S, Lund JN, et al. (2024). Appendectomy versus antibiotic treatment for acute appendicitis. Cochrane Database of Systematic Reviews, (April 29), CD015038.pub2. DOI: https://doi.org/10.1002/14651858.CD015038.pub2.

 


RCT: Empagliflozin does not reduce heart failure hospitalization or death post-myocardial infarction

29 Apr, 2024 | 12:39h | UTC

This randomized, placebo-controlled trial assessed empagliflozin in preventing heart failure or death in patients recently hospitalized for acute myocardial infarction. Among 6,522 patients divided evenly into empagliflozin and placebo groups, there was no significant difference in the primary outcome—a composite of heart failure hospitalization or death—after 17.9 months. The empagliflozin group saw 8.2% experiencing the primary outcome versus 9.1% in the placebo group, yielding a non-significant hazard ratio of 0.90 (95% CI, 0.76 to 1.06; P=0.21). The results indicate that empagliflozin does not effectively reduce the risk of heart failure or mortality compared to placebo in this setting.

 

Reference (link to abstract – $ for full-text):

Butler, J. et al. (2024). Empagliflozin after Acute Myocardial Infarction. N Engl J Med, 390(16), 1455-1466. DOI: 10.1056/NEJMoa2314051

 


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