New Insights from the AMIKINHAL Trial: Advancing Prevention Strategies for Ventilator-Associated Pneumonia

USA: A recent editorial published in the Journal of Cardiothoracic and Vascular Anesthesia offers valuable insights into the AMIKINHAL Trial and provides an update on strategies for preventing ventilator-associated pneumonia (VAP).

Ventilator-associated pneumonia remains a significant challenge in critical care settings, affecting an estimated 5% to 40% of patients on mechanical ventilation for more than 48 hours. The incidence of VAP can vary widely based on factors, including geographic location, patient demographics, and diagnostic criteria. The condition is often caused by a range of pathogens, including methicillin-sensitive Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, Escherichia coli, Serratia spp., Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus spp.

The emergence of multidrug-resistant organisms complicates the clinical landscape, especially in certain patient populations with specific risk factors. VAP is linked to numerous negative outcomes, including increased hospital costs, extended lengths of stay, longer durations of mechanical ventilation, and elevated mortality rates. Additionally, inappropriate or excessive antimicrobial use can lead to further complications, including adverse effects and increased resistance.

In light of these challenges, the AMIKINHAL trial offers promising insights into the prevention of VAP. The clinical study investigates the efficacy of inhaled aminoglycosides in preventing the onset of VAP in mechanically ventilated patients. By targeting pathogens directly in the lungs, inhaled treatments aim to reduce the incidence of VAP and its associated complications.

According to the article, ventilator-associated pneumonia remains a critical challenge in intensive care units, impacting a significant number of patients on mechanical ventilation. In response to this issue, preventive “bundles” of interventions have been developed over the past two decades. Initially introduced by the Institute for Healthcare Improvement (IHI), these bundles included head-of-bed elevation, stress ulcer prophylaxis, and sedation interruptions. The Intensive Care Society (ICS) later expanded on these interventions by incorporating evidence-based practices such as daily spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs), which have shown promise in reducing VAP rates.

A significant development in VAP prevention is the use of inhaled antimicrobials. The AMIKINHAL trial explored the effectiveness of inhaled amikacin in preventing VAP. The multicenter, double-blind trial, conducted across 19 French ICUs, involved patients undergoing mechanical ventilation for at least 72 hours. Results indicated a lower incidence of VAP in patients receiving amikacin compared to placebo (15% versus 22%). While these findings are encouraging, the limitations of the trial included a potential overestimation of VAP incidence due to sensitive diagnostic criteria.

The AMIKINHAL trial highlights the potential of inhaled antibiotics to deliver high drug concentrations directly to the lungs, potentially reducing bacterial burden without the systemic side effects commonly associated with traditional antibiotics. However, the number needed to treat (NNT) suggests that broader adoption may be limited, especially in settings with lower VAP rates.

“Future research should refine VAP diagnostic criteria and explore alternative antibiotics and innovative nonpharmacologic interventions. Recent evidence points to the effectiveness of selective digestive decontamination (SDD) and early mobilization, which may offer additional strategies for reducing VAP incidence. Overall, the AMIKINHAL trial serves as a vital step forward in the ongoing effort to enhance VAP prevention and improve patient outcomes in critical care settings,” the article concluded.

Reference:

Paul J, Patel M, Moitra V. The AMIKINHAL Trial and an Update on Prevention of Ventilator-Associated Pneumonia. J Cardiothorac Vasc Anesth. 2024 Oct;38(10):2163-2165. doi: 10.1053/j.jvca.2024.07.011. Epub 2024 Jul 11. PMID: 39107219.

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Effects of exposure to alcohol in early pregnancy can be detected in placenta, suggests study

A new study led by Pr. Serge McGraw, researcher at CHU Sainte-Justine and professor at Université de Montréal, shows that the effects of alcohol exposure on an embryo prior to implantation in the uterus can be detected in the late-gestation placenta. Using a mouse model well suited for this type of exposure, the researcher and his team observed significant molecular changes in the placenta, including the expression of numerous genes and DNA methylation, an epigenetic marker that influences gene expression by acting as a switch. Since the placenta plays a central role in the development and health of the fetus, these changes could have major consequences for the child’s future. The study also shows that these DNA methylation alterations could provide a robust molecular signature for detecting alcohol exposure in early pregnancy. This proof of concept paves the way for the development of diagnostic tests in humans enabling early detection of alcohol exposure from the very first days of a newborn’s life.

Different impacts depending on sex

For a long time, it was thought that exposure to alcohol during the preimplantation phase-when the fertilized oocyte goes from a single-cell to an embryo of a hundred or so cells-had no effect on the unborn baby, provided the embryo succeeded in implanting in the uterus. However, over the last few years, Serge McGraw’s team has demonstrated that this isn’t the case. The young embryo may survive this exposure, but brain development may be altered to varying degrees. The study published today reveals for the first time that the harmful effects of alcohol on fetal development aren’t directly attributable to placental abnormalities. However, molecular changes, particularly in gene expression due to changes in DNA methylation profiles, could play an important role in these deleterious effects.

Interestingly, the epigenetic impact of alcohol exposure varies by sex. In male embryos, the regulation of growth-related genes was more affected, corroborating data showing that males are more vulnerable to growth retardation after preimplantation alcohol exposure. In females, it was mainly the regulation of genes involved in the metabolism of serotonin-an essential neurotransmitter for brain development and function-that was affected. This suggests that a disruption in this signalling pathway could contribute to the brain morphological defects observed in their model.

It should be noted that this study is based on high alcohol consumption, the human equivalent of five or six drinks in an hour. This model is particularly relevant given that around half of all pregnancies are unplanned and that alcohol intake among women is on the rise worldwide according to the World Health Organization. “Our model seeks to reproduce and understand the effects of a situation in which a woman, about a week pregnant-and therefore carrying an embryo of just a few cells-consumes a large quantity of alcohol rapidly, at a party or bar for example, without necessarily knowing that she’s pregnant,” explains the researcher.

Towards early screening?

Although these results have yet to be confirmed in humans, the team believes that DNA methylation profiles could be a good indicator of whether a baby has been exposed to alcohol during gestation. “There’s no molecular diagnostic test for prenatal alcohol exposure at the moment,” explains Serge McGraw. “So, unless a child is very severely affected, difficulties often go unnoticed until school age or even adolescence. These youths may, for example, have concentration or behavioural problems that can hinder their progress at school.” A screening test based on this molecular memory of exposure, found in the placenta, would ensure appropriate medical follow-up from an early age.

Reference:

Lisa-Marie Legault, Thomas Dupas, Mélanie Breton-Larrivée, Fannie Filion-Bienvenue, Anthony Lemieux, Alexandra Langford-Avelar, Serge McGraw, Sex-specific DNA methylation and gene expression changes in mouse placentas after early preimplantation alcohol exposure, Environment International, https://doi.org/10.1016/j.envint.2024.109014.

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Risk of operative vaginal delivery lower with open-glottis pushing compared to closed-glottis pushing among parous women: Study

The impact of closed- or open-glottis active second-stage pushing on obstetric outcomes is unclear for both women who have and haven’t given birth before. Consequently, global recommendations advocate for women to have the freedom to choose their preferred pushing technique due to the absence of substantial evidence. Recent study examined the association between open- or closed-glottis pushing and obstetrical outcomes among women with an attempted singleton vaginal birth at or near term. It was an ancillary planned cohort study of the TRAAP randomized controlled trial, conducted in 15 French maternity units.

Key Objectives and Data Collection

The key objectives were to assess the association between open- or closed-glottis pushing and mode of delivery, maternal morbidity, and maternal satisfaction. The study design involved prospective data collection on labor and delivery characteristics, with a specific focus on active second-stage pushing. Women were classified into two groups based on the recorded assessment of the attending provider: open-glottis pushing (n=578, 19.0%) or closed-glottis pushing (n=2463, 81.0%). The main findings were: – Among nulliparous women, the risk of operative vaginal delivery did not differ between the open- and closed-glottis pushing groups, after adjusting for confounders. – Among parous women, the risk of operative vaginal delivery was significantly lower in the open-glottis pushing group compared to the closed-glottis group (adjusted OR 0.43, 95% CI 0.19-0.90). – Other maternal and neonatal outcomes, including severe perineal laceration, episiotomy, postpartum hemorrhage, and severe neonatal morbidity, did not differ between the two pushing groups in either nulliparous or parous women. – Maternal satisfaction and psychological status at 2 months postpartum were also similar between the two pushing groups.

Summary and Implications

In summary, this study suggests that the risk of operative vaginal delivery may be lower with open-glottis pushing compared to closed-glottis pushing among parous women, while no difference was observed among nulliparous women. The findings will help inform shared decision-making regarding the mode of pushing during the second stage of labor.

Key Points

1. This was an ancillary planned cohort study of the TRAAP randomized controlled trial, conducted in 15 French maternity units. The study examined the association between open-glottis pushing and closed-glottis pushing with obstetrical outcomes among women attempting singleton vaginal birth at or near term.

2. The key objectives were to assess the association between open- or closed-glottis pushing and mode of delivery, maternal morbidity, and maternal satisfaction. Women were classified into two groups based on the recorded assessment of the attending provider: open-glottis pushing (n=578, 19.0%) or closed-glottis pushing (n=2463, 81.0%).

3. Among nulliparous women, the risk of operative vaginal delivery did not differ between the open- and closed-glottis pushing groups after adjusting for confounders. However, among parous women, the risk of operative vaginal delivery was significantly lower in the open-glottis pushing group compared to the closed-glottis group (adjusted OR 0.43, 95% CI 0.19-0.90).

4. Other maternal and neonatal outcomes, including severe perineal laceration, episiotomy, postpartum hemorrhage, and severe neonatal morbidity, did not differ between the two pushing groups in either nulliparous or parous women.

5. Maternal satisfaction and psychological status at 2 months postpartum were also similar between the two pushing groups.

6. The findings suggest that the risk of operative vaginal delivery may be lower with open-glottis pushing compared to closed-glottis pushing among parous women, while no difference was observed among nulliparous women. These results will help inform shared decision-making regarding the mode of pushing during the second stage of labor.

Reference –

Froeliger A, Deneux-Tharaux C, Madar H, Bouchghoul H, Le Ray C, Sentilhes L; TRAAP study group. Closed- or open-glottis pushing for vaginal delivery: a planned secondary analysis of the TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery study. Am J Obstet Gynecol. 2024 Mar;230(3S):S879-S889.e4. doi: 10.1016/j.ajog.2023.07.017. Epub 2023 Aug 24. PMID: 37633725.

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Retzius-Sparing Robot-Assisted Surgery Enhances Urinary Function and Quality of Life in Prostate Cancer Patients: Study

Belgium: A recent study comparing Retzius-sparing robot-assisted laparoscopic prostatectomy (rsRALP) with standard robot-assisted laparoscopic prostatectomy (sRALP) has yielded promising results, particularly in terms of urinary function and overall quality of life (QoL) for patients undergoing the procedure. The study followed patients over two years, focusing on patient-reported outcomes and oncological assessments.

The study, published in The Prostate Journal, showed that the rsRALP technique notably enhances both early and short-term urinary function and quality of life compared to sRALP. Although it is linked to less favorable characteristics regarding positive surgical margins (PSM), there was no significant decline in biochemical recurrence-free survival (BCR-free survival) observed with rsRALP.

As prostate cancer remains one of the most common cancers affecting men, advancements in surgical techniques are crucial. Considering this, Romain Diamand, Université Libre de Bruxelles, Brussels, Belgium, and colleagues aimed to assess the two-year functional and oncological outcomes of Retzius-sparing robot-assisted laparoscopic prostatectomy (rsRALP) compared to the standard approach (sRALP).

For this purpose, the researchers identified a total of 200 consecutive patients who underwent either sRALP (n = 100) or rsRALP (n = 100) for clinically localized prostate cancer at a single referral center in Europe between 2015 and 2020. This data was collected from a prospective cohort as part of the Belgian Cancer Registry.

The primary outcomes focused on functional results and QoL, evaluated using validated patient-reported outcome measures (PROMs) at 1, 3, 12, and 24 months following surgery. Secondary outcomes included oncological results, specifically PSM and five-year biochemical recurrence (BCR) rates. The researchers employed Kaplan-Meier analysis with log-rank tests and multivariable Cox regression for their statistical evaluation.

The study led to the following findings:

  • The median follow-up period was 60 months, and there were no significant differences between the two surgical approaches regarding patient and tumor characteristics.
  • Patients who underwent Retzius-sparing robot-assisted laparoscopic prostatectomy reported significantly better urinary function and quality of life at all follow-up intervals. However, sexual function did not show a significant difference 12 months post-surgery.
  • There was no notable difference in the rate of positive surgical margins between the two approaches (31% for rsRALP versus 32% for sRALP).
  • rsRALP was associated with longer positive surgical margins (5 mm versus 2.5 mm), a higher rate of multifocality (34% versus 13%), and a greater occurrence of organ-confined disease (59% versus 39%), as well as more cases at anterior locations (37% versus 16%).
  • Five-year biochemical recurrence-free survival did not differ significantly between the groups, and the surgical approach was not found to be a predictor of biochemical recurrence.

As prostate cancer remains one of the most common cancers affecting men, advancements in surgical techniques are crucial. The study’s results offer valuable insights for clinicians and patients, encouraging a more personalized approach to prostate cancer treatment.

“The findings from this study may help shape future practices in the management of prostate cancer, enhancing patient care and outcomes,” the researchers concluded.

Reference:

Diamand, R., Bernard, L., Mjaess, G., Benijts, J., Assenmacher, C., & Assenmacher, G. Retzius-sparing versus standard robot-assisted laparoscopic prostatectomy: A two-year patient-reported and oncological assessment. The Prostate. https://doi.org/10.1002/pros.24807

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Around 40% of postmenopausal hormone positive breast cancers linked to excess body fat: Study

Around 40% of postmenopausal hormone positive breast cancer cases may be linked to excess body fat, suggests Spanish research published online in the Journal of Epidemiology & Community Health.

This proportion is significantly higher than 1 in 10 such cases currently attributed to excess weight, using the widely used measure of body mass index (BMI), and indicates that the real impact of obesity on breast cancer risk has likely been underestimated, say the researchers.

BMI isn’t necessarily a very accurate measure of body fat, particularly in older women, because it doesn’t account for age, sex, or ethnicity, they point out.

They therefore compared BMI with the CUN-BAE (Clínica Universidad de Navarra–Body Adiposity Estimator), a validated measure of body fat that does account for age and sex, in 1033 White postmenopausal women with breast cancer and 1143 free of the disease, but matched for age, sex, and geographical region.

All the women were taking part in the multicase-control (MCC)-Spain study, which aims to evaluate the environmental and genetic factors associated with bowel, breast, stomach, and prostate cancers and chronic lymphocytic leukaemia among 20-85 year olds.

All participants were quizzed on potentially influential risk factors: sociodemographics; lifestyle; and personal/family medical and reproductive histories.

Dietary information was collected through a validated semi structured 140-item Food Frequency Questionnaire, and a self-administered questionnaire was used to gather information on usual alcohol intake between the ages of 30 and 40.

The CUN-BAE categorises body fat as: less than 35%; 35%–39.9%; 40%–44.9%; and 45% and above. BMI classifies weight as: less than 25 kg/m2; 25–29.9; 30–34.9; and 35 and above.

Average BMI was just over 26 in the comparison group and just over 27 in the women with breast cancer. Average CUN-BAE was just under 40% and almost 40.5%, respectively.

A BMI below 25 (reference) was observed in 45% of women in the comparison group and in 37% of those with breast cancer. A BMI of 30 or above, which signifies obesity, was observed in 20% and in just over 24%, respectively.

A CUN-BAE below 35% (reference) was observed in 20.5% of women in the comparison group and in 16% of those with breast cancer. A CUN-BAE of 40% or above was observed in just over 46% of women in the comparison group and in 53% of those with breast cancer.

A CUN-BAE of 45% or above was associated with a more than doubling in the risk of postmenopausal breast cancer compared with a CUN-BAE of below 35%.

No similar trend was observed for BMI, prompting the researchers to estimate that 23% of breast cancer cases were attributable to excess body fat using BMI, but 38% using the CUN-BAE.

But these differences were only apparent for hormone positive cancers (680 cases) for which the estimated proportions attributable to excess body fat were 20% (BMI) and 42% (CUN-BAE).

Causal factors can’t be established from the findings of this case-control study, say the researchers, who also acknowledge that the CUN-BAE formula was calculated from a sample of sedentary people; and the number of breast cancers that weren’t hormone positive was small.

Nevertheless, they conclude: “The results of our study indicate that excess body fat is a significant risk factor for hormone receptor positive breast cancer in postmenopausal women.

“Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered when estimating the cancer burden attributable to obesity in postmenopausal breast cancer.”

This is crucial for planning effective prevention initiatives, they add.

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SSRIs May Boost Verbal Memory by Lowering 5-HT4 Receptor Levels in Depression, Study Reveals

Denmark: A recent study published in Biological Psychiatry has shed light on the impact of antidepressant treatment on 5-HT4 receptor binding in patients with moderate to severe major depressive disorder (MDD) and its associations with clinical outcomes, particularly verbal memory.

“Antidepressants such as escitalopram and duloxetine have been found to enhance verbal memory in individuals with moderate to severe depression. This clinical effect is associated with alterations in serotonin 4 (5-HT4) receptor levels in the brain, as observed through PET imaging,” the researchers stated. The findings indicate that specifically targeting the 5-HT4 receptor may play a key role in enhancing verbal memory in individuals with depression.

According to the authors, the study represents the largest single-site PET trial to date examining serotonergic neurotransmission in major depressive disorder throughout antidepressant treatment.

In untreated patients with Major Depressive Disorder (MDD), levels of brain serotonin 4 receptors (5-HT4R) are lower and associated with verbal memory performance. Vibe G. Frokjaer, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark, and colleagues explored the relationship between 5-HT4R, clinical outcomes, and cognitive function in patients with MDD who begin treatment with selective serotonin reuptake inhibitors (SSRIs).

For this purpose, ninety patients with moderate to severe depression underwent molecular brain imaging to assess 5-HT4R binding before starting treatment with escitalopram. The researchers evaluated pretreatment 5-HT4R binding to predict treatment outcomes at weeks 4, 8, and 12.

In a subset of 40 patients who were rescanned eight weeks after beginning treatment, changes in cerebral 5-HT4R binding were found to correlate with improvements in verbal memory and reductions in depressive symptoms, as measured by the Hamilton Depressive Rating Scale 6 (HAMD6).

The study led to the following findings:

  • After eight weeks of serotonergic intervention, neostriatal 5-HT4R binding was reduced by 9%.
  • Global change in 5-HT4R binding from baseline was associated with verbal memory outcomes but not overall clinical depressive symptom outcomes.
  • Pretreatment 5-HT4R binding did not predict clinical recovery status at week 8, nor was it associated with a change in HAMD6.

The authors concluded that in patients with moderate to severe MDD, SSRI treatment leads to a downregulation of neostriatal 5-HT4 receptor levels, supporting the idea that these medications enhance cerebral extracellular serotonin. They found that greater reductions in global brain 5-HT4 receptor levels following SSRI treatment were associated with improved verbal memory. This underscores the potential significance of 5-HT4 receptors as a therapeutic target in MDD.

“The findings provide valuable insights into the mechanisms behind antidepressant effects and suggest new pathways for precision medicine approaches in treating MDD,” they wrote.

Reference:

Dam, V. H., Köhler-Forsberg, K., Ozenne, B., Larsen, S. V., Ip, C. T., Jorgensen, A., Stenbæk, D. S., Madsen, J., Svarer, C., Jørgensen, M. B., Knudsen, G. M., & Frokjaer, V. G. (2024). Effect of antidepressant treatment on 5-HT4 receptor binding and associations with clinical outcomes and verbal memory in major depressive disorder. Biological Psychiatry. https://doi.org/10.1016/j.biopsych.2024.08.009

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Lamotrigine safe treatment alternative for rare neurological disorder,reports study

The study, published in Lancet Neurology, detailed the “head-to-head” trial implemented by the researchers to test two drugs, mexiletine and lamotrigine, on people with the condition.

The trial, which was conducted at the UCL Queen Square Multidisciplinary Centre for Neuromuscular Diseases and the National Hospital for Neurology and Neurosurgery, UCLH, involved 60 adults with confirmed non-dystrophic myotonia.

Patients were randomly assigned to receive either mexiletine for eight weeks followed by lamotrigine for eight weeks, or the reverse order, with a seven-day break in between treatments. Neither the participants nor the researchers knew which treatment was being given at any time.

At the end of the trial, lamotrigine was found to reduce stiffness – the main symptom of non-dystrophic myotonia – by around the same amount as mexiletine.

Chief investigator, Dr Vino Vivekanandam (UCL Queen Square Institute of Neurology and consultant neurologist), said: “Approximately one in 17 people in the UK have a rare disease and the majority have no treatment. Many are neurological diseases and rarity makes clinical trials to develop treatments very difficult. Head-to-head trials comparing drugs are important in order to allow us to identify which treatments are ideal.

“The trial results are very exciting and important for patients with this muscle channelopathy.”

Non-dystrophic myotonias are life-changing muscle disorders caused by problems with ion channels in the muscles. Symptoms (such as muscle stiffness, pain, weakness, and fatigue) usually start in childhood and can cause significant disability – reducing quality of life and employability. There is currently no cure.

In 2012, the same UCL team led a multi-centred international trial that repurposed mexiletine – a sodium channel blocker – and showed it was effective in treating non-dystrophic myotonia and improving quality of life.

As a result, mexiletine became the first-line treatment for non-dystrophic myotonias world-wide.

However, not all patients respond to the treatment and one third developed significant side-effects, the most common being reflux or gastrointestinal side effects. Additionally, mexiletine can’t be prescribed during pregnancy, when myotonia often worsens.

Lamotrigine provides an alternative solution, as the trial showed that the drug was well tolerated by patients, and has additional advantages as it can be used in pregnancy and is cheaper. No serious side effects were reported.

Senior author Professor Michael Hanna (UCL Queen Square Institute of Neurology Director and consultant neurologist) said: “Drug repurposing is an important strategy in developing treatments for rare diseases. This is the first head-to-head trial in this rare muscle disease and the results will directly inform patient care and provide more ‘real-world’ options for patients.”

This research will impact clinical practice globally as mexiletine is often not accessible in develoThe Lancet Neurologyping countries or is expensive in developed countries. The results demonstrate that lamotrigine is a comparable treatment and therefore provides an excellent treatment option for affected patients.

Dr Vivekanandam said: “Based on this trial data, we have already developed a personalised treatment algorithm for clinical practice which is already in use in our clinical service, which takes into consideration several aspects of the trial and the mechanism of actions of lamotrigine and mexiletine as well as local economic considerations.”

Reference:

Vivekanandam, Vinojini et al.Mexiletine versus lamotrigine in non-dystrophic myotonias: a randomised, double-blind, head-to-head, crossover, non-inferiority, phase 3 trial, The Lancet Neurology, DOI:10.1016/S1474-4422(24)00320-X.

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Lipid screening in Adolescence fails to Improve Cardiovascular Risk Prediction, reveals research

Researchers have found that the risk factors for cardiovascular events in adulthood can be predicted by non laboratory-based adolescent risk factors alone. This conclusion came from a study based in the United States, Australia, and Finland. The study was published in the journal Pediatrics conducted by Nuotio and colleagues.

Data analysis was carried out on all 11,550 participants: who had their risk factors assessed during their adolescent periods with non laboratory factors being among them including, body mass index, blood pressure and smoking status while lipid factors included among others, total cholesterol, and triglycerides. Participants were then followed into adulthood; cardiovascular events, including fatal and nonfatal events, were monitored after age 25. All events were medically adjudicated to ensure proper diagnosis.

The primary aim was to find whether the introduction of lipid measurements (total cholesterol and triglycerides) increased the predictability of the occurrence of future cardiovascular events by nonlaboratory factors which include age, sex, blood pressure, BMI, and smoking. Hazard ratios for all these risk factors were estimated based on multivariable Cox regression models and the discrimination ability of every model was assessed through the use of C-statistics.

  • Of the 11,550 participants, 513 people (4.4%) had a confirmed cardiovascular event during adulthood.

  • Non-laboratory-based risk factors that included high blood pressure (hazard ratio [HR] 1.25; 95% confidence interval [CI], 1.03–1.52), being overweight (HR 1.76; 95% CI, 1.42–2.18), obese (HR 2.19; 95% CI, 1.62–2.98), smoking (HR 1.63; 95% CI, 1.37–1.95), and high total cholesterol (HR 1.79; 95% CI, 1.39–2.31) had all emerged as significant predictors of cardiovascular events (P < .05).

  • Adding lipid measures (total cholesterol and triglycerides) to the non laboratory-based model was not associated with a significant improvement in the ability to predict cardiovascular events. The C-statistic for the model including lipids was 0.75 (SD 0.07), the same as for the non laboratory model without lipids 0.75 [SD 0.07]; P = .82). That is, adding lipid measurements did not improve discriminatory power.

This study reports that adolescent non laboratory-based risk factors, such as blood pressure, BMI, and smoking, independently predict cardiovascular events in adulthood. The addition of lipid measurements, including total cholesterol and triglycerides, failed to improve the accuracy of predictions. These data suggest what is required is inclusion of non laboratory-based risk models for predicting long-term cardiovascular risk, and routine lipid testing may be less than clearly indicated for cardiovascular risk assessment in adolescence.

Reference:

Nuotio, J., Laitinen, T. T., Magnussen, C. G., Sinaiko, A. R., Bazzano, L. A., Daniels, S. R., Jacobs, D. R., Jr, Kartiosuo, N., Koskinen, J., Burgner, D. P., Kähönen, M., Raitakari, O. T., Steinberger, J., Urbina, E. M., Venn, A. J., Viikari, J. S. A., Woo, J. G., Dwyer, T., & Juonala, M. (2024). Predictors in youth of adult cardiovascular events. Pediatrics. https://doi.org/10.1542/peds.2024-066736

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Cemented restorations exhibit higher complications, bleeding on probing than Screw-retained restorations: Study

Cemented restorations exhibit higher complications, and bleeding on probing than Screw-retained restorations suggests a study published in the Clinical Oral Implants Research.

A study was done to compare marginal bone levels, biological, and technical outcomes of screw-retained versus cemented all-ceramic implant-supported zirconia-based single crowns after an observation period of 7.5 years. Forty-four single implants in the esthetic zone in 44 patients (22 females, 22 males) were randomly assigned to two types of restorations: SR (screw-retained); veneered one-piece zirconia abutment and CR (cement-retained); veneered lithium disilicate crown intraorally cemented on a one-piece zirconia abutment. Patients were recalled annually up to 7.5 years and survival rates, biological, and technical parameters assessed. Results: A total of 31 patients attended the 7.5-year follow-up visit (17 SR group, 14 CR group). The survival rate on the restorative level was 77.5% (74.0% CR, 81.0% SR, p = .6399). Median marginal bone loss (MBL) values yielded −0.073 mm (−0.305; 0.238) in the CR and −0.215 mm (−0.500; 0.555) in the SR group (intergroup p = .6194). Mean bleeding on probing (BoP) values were significantly in favor of group SR with 20 ± 17% compared to 40 ± 22% in group CR (p = .011). The overall biological complication rate amounted to 27.5% (42.1% CR, 14.3% SR, p = .0775), whereas the technical complication rate was 32.5% (42.1% CR, 23.8% SR, p = .314). In total, CR restorations showed significantly more complications (84.2% for CR, 38.1% for SR, p = .0041). One-piece zirconia-based single crowns on two-piece dental implants exhibited a high rate of technical and biological complications at 7.5 years of follow-up. Cemented restorations revealed significant higher rates of bleeding on probing and total complications compared to screw-retained restorations.

Reference:

Kraus, R. D., Hjerppe, J., Naenni, N., Balmer, M., Jung, R. E., & Thoma, D. S. (2024). A 7.5-year randomized controlled clinical study comparing cemented and screw-retained one-piece zirconia-based implant-supported single crowns. Clinical Oral Implants Research, 00, 1–7. https://doi.org/10.1111/clr.14346

Keywords:

Cemented, restorations, exhibit, higher, complications, bleeding, probing, than, Screw-retained, restorations, study, Kraus, R. D., Hjerppe, J., Naenni, N., Balmer, M., Jung, R. E., & Thoma, D. S, Clinical Oral Implants Research

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Increased maternal morbidity observed in pregnant women with hematologic malignancy, reports research

A new study published in The Lancet Haematology showed that pregnant women with hematologic malignancies were more likely to experience severe maternal morbidity and obstetric difficulties.

With occurrences ranging from 4.0 to 15.8 instances per 100,000 pregnancies, hematological malignancy during pregnancy is an uncommon but clinically relevant event. There are significant problems in both diagnosis and treatment due to this unusual combination of cancer and pregnancy. Due to the rarity of pregnancy-associated hematological malignancy, there are little data to inform treatment decisions. In order to assess the overall survival, incidence, maternal morbidity, and mortality of women with pregnancy-associated hematological malignancies, Pierre Pinson and colleagues carried out this study.

This research was carried out as a countrywide observational cohort analysis by utilizing the French National Healthcare Data System (SNDS), a health-care administrative database that includes up to 99% of the French population. They considered all pregnancies in France that ended between January 1, 2012 and December 31, 2022. The pregnancies with outpatient terminations or losses, as well as those who had a history of hematological malignancies prior to pregnancy, were excluded.

A Cox proportional hazards simulation was employed to assess overall survival, defined as the time from diagnosis of hematological malignancy until death or completion of the study follow-up, in the hematological malignancy while pregnant group versus the hematological malignancy post-pregnancy group. Births were categorized as extremely preterm (<32 weeks), preterm (32-36 weeks), and term (≥37 weeks) and compared between the hematological malignancy during pregnancy group and the reference group. Confounder correction was performed using inverse probability weighting (IPW), which included maternal age (categorized), socioeconomic status, comorbidities, as well as year of delivery.

The corrected odds of any serious maternal complications during hematologic cancer-associated pregnancies were approximately 23 times higher than those in the general population, and the risk of preterm delivery was nearly 12 times greater. However, after roughly 6 years of median follow-up, there was no difference in overall survival (OS) between women diagnosed with hematologic malignancy during or after pregnancy. The 5-year OS rates were 91.2% and 90.3%, respectively.

The hematological malignancies during pregnancy are a difficult scenario, with a significant risk of maternal and obstetric problems. And so, it is vital that these women get treatment in highly specialist facilities that have the personnel and technological resources to handle both hematological and maternal problems. Overall, there was no discernible difference in overall survival between women who have been diagnosed with hematological malignancies while pregnant and those who were not.

Reference:

Pinson, P., Boussaid, I., Decroocq, J., Chouchana, L., Birsen, G., Barrois, M., Tsatsaris, V., Godeberge, C., Zerbit, J., Burroni, B., Pene, F., Huynh, L., Charlier, C., Tamburini, J., Beeker, N., Collier, M., Bouscary, D., Treluyer, J. M., & Birsen, R. (2024). Maternal and obstetric outcomes in women with pregnancy-associated haematological malignancies: an observational nationwide cohort study. In The Lancet Haematology. Elsevier BV. https://doi.org/10.1016/s2352-3026(24)00288-6

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