2 Minute Medicine Rewind August 16, 2021

Evaluation of early vs standard liver transplant for alcohol-associated liver disease

1. In a cohort of patients with alcoholic liver disease, adherence to a 6-month abstinence period prior to liver transplant was not associated with improved post-surgical outcomes.

Evidence Rating Level: 2 (Good)

Although alcohol-associated liver disease is a leading indication for liver transplant, patients are often denied access due to pre-transplantation abstinence requirements. This cohort study sought to evaluate survival outcomes of early versus standard liver transplants. Early liver transplant was defined as less than 180 days of alcohol abstinence prior to the surgery, while standard was defined as 180 days or more. The study included 163 participants (mean [SD] age at transplant, 52[10] years; 108 [66%] male). From this cohort, 88 (54%) participants underwent early liver transplant while 75 (46%) received standard liver transplant. There was no difference between the groups in term of age or sex. The median (IQR) days of abstinence for the early group was significantly lower than the standard group (66.5 [35.0-116.0] days vs. 481.0 [280.0-850.0] days; P<0.001). The outcomes measured in this study were patient, allograft, relapse-free and hazardous relapse-free survival for patients from both groups. The study found that the early and standard transplant groups had similar 1-year and 3-year survival rates (94.1% [95% CI, 86.3%-97.5%] vs. 95.9% [95% CI, 87.8%-98.7%]; P=0.60). The allograft survival rate at 3-years was also similar amongst the early and standard group (81.7% [95% CI, 69.4%-89.4%] vs 74.7% [95% CI, 59.2%-85.0%]; P = 0.42). Relapse-free survival and hazardous relapse-free survival did not show any significant differences between the two groups. Therefore, the study concluded that adherence to the 6-month abstinence rule is not associated with improved outcomes. However, this was one of the largest studies evaluating early versus standard liver transplants, and similar studies are needed to further validate the results.


Sex differences in procedural outcomes among patients undergoing left atrial appendage occlusion

1. In this large cohort study, women had a significantly higher risk of in-hospital adverse events after undergoing a percutaneous left atrial appendage occlusion when compared to men.

Evidence Rating Level: 2 (Good)

Atrial fibrillation is the most common sustained arrythmia and it is associated with significant morbidity and mortality, including an increased stroke risk. Given that the most important cardiac source of thromboemboli is the left atrial appendage (LAA), a non-pharmacologic approach that involves occlusion of the LAA (LAAO) has emerged as an alternative to anticoagulation. Previous studies of invasive cardiac procedures have demonstrated that women are at a higher risk than men for adverse events, however, this has not been studied in the LAAO procedure. Therefore, this cohort study sough to evaluate sex differences among patients undergoing LAAO. 49 537 patients were included in the study, of which 20 388 (41.3%) were women. The most common indications for LAAO in both women and men was increased thromboembolic risk and history of major bleeding. The primary outcome measured was in-hospital events and length of stay. The study found that rates of any adverse event were higher for women than men (1284 [6.3%] vs 1144 [3.9%]; P < 0.001). Specifically, major bleeding (349 [1.7%] vs 244 [0.8%]; P < 0.001) and pericardial effusion requiring drainage (241 [1.2 %] vs 144 [0.5%]; P < 0.001) were significantly more common for women than men. Length of hospitalization more than 1 day was more frequent in women than men (3273 [16.0%] vs 3355 [11.6 %]; P < 0.001). The secondary outcome measured was differences in postimplant antithrombotic therapy. The study found that women were more likely than men to receive a direct oral anticoagulant only (OR, 1.07; 95% CI, 1.01 – 1.13; P = 0.02) and warfarin only (OR, 1.12; 95% CI, 1.05 – 1.19; P < 0.001). They were less likely to receive clinical-trial recommended combined oral anticoagulant and single antiplatelet therapy (OR, 0.91; 95% CI, 0.87 – 0.95; P < 0.001). This study had a large sample size and accounted for many confounding factors, thus demonstrating good validity. Future studies should focus on identifying the reasons for sex-based differences in outcomes after LAAO and evaluate strategies to reduce this disparity.


COVID-19 vaccinations during pregnancy: coverage and safety

1. In a cohort of pregnant women in the United Kingdom, COVID-19 vaccines did not alter perinatal outcomes.

Evidence Rating Level: 2 (Good)

The Coronavirus disease 2019 (COVID-19) has caused significant morbidity and mortality across the world. Mass vaccination has been a key strategy used by countries to help control the pandemic. Based off prior studies, COVID-19 vaccinations are concluded to be safe to administer during pregnancy. However, pregnant women are reluctant to receive the vaccines and guidance to healthcare providers has not been consistent. Therefore, this cohort study aimed to evaluate the uptake and safety of COVID-19 vaccines amongst pregnant women. The study retrospectively identified 1328 pregnant women that were eligible to receive a COVID-19 vaccine who delivered at St. George’s University Hospital between March and July 2021. The primary outcome measured was COVID-19 vaccine (Pfizer/BioNTech, Moderna, or Oxford Astra Zeneca) uptake among eligible women. Among this cohort, vaccination was accepted by 141 (28.7%) of 492 eligible women. Of those vaccinated, 128 received (90.8%) an mRNA vaccine (Pfizer/BioNTech or Moderna) and 13 (9.2%) received a viral vector vaccine (Oxford Astra Zeneca). Antenatal vaccine uptake was lower amongst women with maternal age below 30 years old (OR, 0.37; 95% CI, 0.15–0.90; P  =0.025), Afro-Caribbean ethnicity (OR, 0.25; 95% CI, 0.08–0.60; P = 0.005), and obesity (OR,  0.55;  95%  CI,  0.29–1.00;  P = 0.058). The secondary outcome measured was perinatal outcomes to assess safety, which included stillbirth, neonatal death, fetal abnormalities, intrapartum complications, birth weight, mode of birth, maternal intensive care unit admission, or neonatal intensive care unit admission. The study found that there were no significant differences in intrapartum complications or perinatal outcomes between women who did (versus those who did not) receive a COVID-19 vaccine during pregnancy. Although this study adds to the data supporting the safety of COVID-19 vaccination during pregnancy, larger randomized controlled trials involving pregnant women are needed to validate these results. Additionally, it demonstrates that public health measures need to be implemented to achieve better uptake rates in this population.


Impact of antibiotic pretreatment on cultures in children with osteomyelitis and septic arthritis: a retrospective review

1. In a cohort of hospitalized children, culture positivity was not associated with antibiotic pretreatment.

Evidence Rating Level: 2 (Good)

Osteomyelitis and septic arthritis require prompt diagnosis, long-term antimicrobial therapy, and sometimes surgical debridement to prevent significant morbidity and mortality in pediatric patients. Although empiric antibiotics are the mainstay of treatment, there is no consensus on timing of administration. Early initiation may decrease pathogen isolation and thus prevent targeted antimicrobial treatment, whereas delay in treatment may lead to increased complications. Therefore, this retrospective review sought to identify the effect of early antibiotics on culture yield. Of 584 included participants, 263 (45.0%) had osteomyelitis, 176 (30.1%) had septic arthritis, and 145 (24.8%) participants had both. The median age of the group was 6.1 years and 60.6% were male. The primary outcome measured was culture positivity.  Patients were treated with antibiotics prior to culture in 125 of 525 (23.8%) blood cultures, 51 of 90 (56.7%) bone cultures, 92 of 265 (34.7%) joint cultures, and 140 of 197 (71%) “other” (wound, abscess, or fluid other than joint fluid) cultures. 221 of 525 blood cultures were positive, from which 55 were pretreated and 166 were not (P = 0.62). 63 of 90 bone cultures were positive, from which 38 were pretreated and 25 did not receive treatment prior to antibiotics (P = 0.29). 103 of 265 joint cultures were found to be positive, from which 36 were treated with antibiotics while 67 were not (P = 0.95). Finally, 138 of 197 “other” cultures were found to be positive where 103 received antibiotics before culture and 35 did not (P = 0.09). Overall, the study concluded that there were no significant differences in culture positivity between patients pretreated with antibiotics and those that were not pretreated. This study was the largest study to examine the effect and timing of antibiotics on culture results in this population. Therefore, future studies, preferably prospective studies, are needed to further validate these results.


Oral ondansetron administration in children seeking emergency department care for acute gastroenteritis: a patient-level propensity-matched analysis

1. Among a cohort of children with gastroenteritis in the emergency department (ED), administration of oral ondansetron was associated with a reduction in index ED visit intravenous fluid administration.

Evidence Rating Level: 2 (Good)

Ondansetron is commonly used in pediatric patients with acute gastroenteritis to reduce vomiting, intravenous fluid rehydration and hospitalization. However, there are conflicting findings in the literature supporting this data. Therefore, this observational study sought to evaluate the association between oral ondansetron administration, oral and intravenous fluid use, hospitalization, and short-term clinical outcomes. It made use of data from children enrolled in 2 trials (PECARN and PERC). 1857 children from these trials were included in this substudy, the median age was 16.0 and 56% were male. Oral ondansetron was administered to nearly half of pediatric patients presenting with acute gastroenteritis. Its use was associated with older age, more vomiting episodes and treatment in the United States as opposed to Canada. The primary objective was to determine if oral ondansetron administration was associated with reduction of intravenous fluid administration, hospitalization at the index visit and within 72 hours, and alterations in the frequency of diarrhea and vomiting episodes during 24 hours following study enrollment. The study found that oral ondansetron administration was associated with a reduction in intravenous fluids at the index ED visit (OR, 0.5; 95% CI, 0.29 – 0.88). In a subset analysis, the study found that in children with dehydration, oral ondansetron administration was also associated with decreased intravenous fluids at index visit. Overall, this study helps support the use of ondansetron in children presenting with acute gastroenteritis. However, clinical trials are needed to further explore and identify children who are most likely to benefit from ondansetron administration.

Image: PD

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