MRI can save rectal cancer patients from surgery, study suggests

Magnetic resonance imaging (MRI) can spare many patients with rectal cancer from invasive surgery that can carry lifelong side effects, new research indicates.

The findings, from UVA Cancer Center’s Arun Krishnaraj, MD, MPH, and collaborators, indicate that MRI can predict patient outcomes and the risk of the tumor reccurring or spreading for patients who have undergone chemotherapy and radiation.

That information could be extremely useful in determining the best course of treatment and deciding whether a patient can avoid surgery in favor of a “watch and wait” approach, the researchers say. In watch-and-wait, doctors continue to monitor patients for cancer reccurrence or spread, holding off on surgery but potentially leaving them uncertain and anxious about the future.

The information MRI can provide would be both useful for doctors and comforting for patients, the new findings suggest.

“After undergoing chemotherapy and radiation for rectal cancer, patients are understandably concerned whether their cancer is gone or whether there may be some leftover disease. Using newer MRI techniques, we are now able to predict much better than in the past whether any cancer remains and, if so, whether it will come back and spread,” said Krishnaraj, a radiologist and imaging expert who is director of UVA Health’s Division of Body Imaging, among other leadership positions. “No one wants to get surgery if they can avoid it. Now we have a powerful tool to help patients and their doctors predict who would benefit from surgery after initial chemotherapy and radiation and who can likely avoid surgery.”

Better Care for Rectal Cancer

Colorectal cancer is increasing among younger adults-those under 50-even as it has been decreasing among older people. It’s estimated that the disease will strike approximately 1 in 23 men and 1 in 25 women, according to the American Cancer Society.

Rectal cancer is typically treated at first with radiation and chemotherapy, but some patients require what is known as “total mesorectal excision” – the removal of a substantial portion of their bowel. This can be lifesaving but it can also be life-changing: Side effects can include the need for a permanent colostomy bag and sexual dysfunction.

To help patients make the best choices and get the best outcomes, Krishnaraj and his collaborators wanted to see if MRI could serve as a crystal ball for the effects of watch-and-wait. To do this, they analyzed the results of the Organ Preservation in Rectal Adenocarcinoma (OPRA) trial to see how MRI results aligned with patient outcomes. In total, they reviewed outcomes from 277 patients, with an average age of 58, who had the stage of their rectal cancer determined by MRI. The average length of the follow-up period was slightly more than 4 years.

After crunching the numbers, the researchers determined MRI was an effective tool for predicting the patients’ overall survival, the risk of their cancer returning and their chances for keeping their bowel intact.

The promising MRI crystal ball can likely be made even more effective by combining it with data from endoscopies (visual inspections) after treatment, the OPRA Consortium researchers say. They are urging additional research on the potential of the combination, which they believe could offer doctors and patients a powerful new tool.

“I am optimistic that continued advancement in MRI and other tools like endoscopy will provide better information about future outcomes,” Krishnaraj said. “Ultimately, I would love to get close to 99% predictive probability in better informing our patients about their potential risk for recurrence or spread of their cancers following treatment. We may not be there quite yet, but that is our goal.”

Developing new ways to improve patient care is an essential mission for UVA Cancer Center, one of only 57 cancer centers designated as “comprehensive” by the National Cancer Institute. The designation honors elite cancer centers with the finest cancer care and research programs in the nation.

Reference:

Hannah Williams, Dana M. Omer, Hannah M. Thompson, Sabrina T. Lin, Floris S. Verheij, Joao Miranda, MRI Predicts Residual Disease and Outcomes in Watch-and-Wait Patients with Rectal Cancer, Radiology,https://doi.org/10.1148/radiol.232748.

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New AHA Guidelines Highlight Strategies to Prevent First Strokes: Emphasis on Lifestyle Changes, Screening

USA: In a significant update, the American Heart Association (AHA) and American Stroke Association (ASA) have released the 2024 Guideline for the Primary Prevention of Stroke, the first major revision in a decade. The new guideline replaces the 2014 version and aims to provide healthcare professionals with the latest strategies for preventing strokes in individuals with no prior history of the condition. The guideline emphasizes the importance of lifestyle management, risk factor control, and primary care screening.

According to the guidelines, adopting healthy lifestyle behaviors—such as maintaining good nutrition, quitting smoking, and staying physically active—can significantly reduce the risk of having a first stroke. Alongside these lifestyle changes, regular health screenings and effective management of cardiovascular disease and stroke risk factors through medication are crucial. Ideally, screening for stroke risk and educating individuals on how to lower their chances of experiencing a stroke should start with their primary care provider and incorporate evidence-based recommendations.

The guidelines, published in the journal Stroke, highlight that over 500,000 Americans experience their first stroke each year, with up to 80% of strokes being preventable. “This guideline is crucial because new evidence has emerged since the last update, allowing us to better identify individuals at risk for their first stroke,” said Dr. Cheryl D. Bushnell, chair of the writing group and a professor at Wake Forest University School of Medicine, said in a press release. The guideline aligns with the AHA’s “Life’s Essential 8,” a framework for promoting cardiovascular health.

One of the notable additions is the recommendation for glucagon-like peptide 1 receptor agonists (GLP-1s), which have shown strong evidence for reducing stroke risk in patients with diabetes and high cardiovascular risk. These medications, which include semaglutide (Ozempic or Wegovy), are recognized for their dual benefits in managing diabetes and promoting weight loss. However, the guideline stresses the need for further studies to confirm their efficacy in stroke prevention when used solely for weight management.

The updated guidelines also underscore the significance of addressing social determinants of health—factors such as education, economic stability, and access to care—that can influence stroke risk. The authors advocate for screening these determinants in clinical settings, recommending evidence-based interventions to tackle their adverse effects. Such measures include ensuring patient education is accessible and relevant, advocating for effective medications, and connecting patients to community resources to address health-related needs like food and housing insecurity.

In addition, the guideline introduces specific recommendations for women’s health. It highlights the need for screening for stroke risks associated with oral contraceptives, endometriosis, and early-onset menopause. The authors emphasize the importance of managing hypertensive disorders during pregnancy to prevent maternal intracerebral hemorrhage.

Blood pressure management is another critical focus. The guidelines recommend that most patients requiring antihypertensive medications for stroke prevention should be prescribed at least two medications, as studies have shown that a single medication is often insufficient.

The guidelines also recognize the increased stroke risk among transgender individuals undergoing estrogen therapy and call for careful evaluation and modification of their risk factors.

Dr. Bushnell noted that implementing these recommendations could substantially reduce the incidence of first strokes and even lower the risk of dementia, another serious condition associated with vascular health. As clinicians adopt these guidelines, the hope is to see a marked decline in stroke incidence, paving the way for healthier communities.

Reference:

Bushnell C, et al “2024 guideline for the primary prevention of stroke: a guideline from the American Heart Association/American Stroke Association” Stroke 2024; DOI: 10.1161/STR.0000000000000475.

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Model predicts number of MII oocytes needed to obtain at least one euploid blastocyst: Study

Female age is significantly and directly related to embryo
aneuploidy rates. The current delay in motherhood has led to a large proportion
of women of advanced maternal age seeking infertility treatment, thus
presenting significantly higher embryo aneuploidy rates. Consequently, these
patients are characterized by lower chances of success in in vitro
fertilization (IVF) treatments with their own oocytes and many of them are
finally encouraged to enter the oocyte donation program.

In the assumption of the statement ‘‘the older the patient,
the lower the number of euploid blastocysts,’’ there is a frequently asked
question in the day-to-day operations of an infertility clinic: how many
oocytes each of our patients’ needs, according to female age, to have the
highest chances of obtaining at least one euploid blastocyst in their IVF
treatment cycles? The answer to this question would constitute useful
information for both the clinician and the patient. On the one hand, the
clinician may be able to better assess each patient’s possibilities and the
feasibility of their treatment cycle because it will be easier to explain the
patient’s options. On the other hand, the patient will understand this
information more easily, helping her to cope emotionally with treatment. This
is nowadays feasible because predicting ovarian response with high precision
before starting treatment has become possible with the use of novel biomarkers,
such as antimullerian hormone levels and/or antral follicle count.

The aim of the present study by Cristina Rodríguez-Varela et
al was to design a similar tool to determine the number of metaphase II (MII)
oocytes needed to obtain at least one euploid blastocyst regarding female age
in IVF treatment cycles, considering our own data from the last 5 years using
next-generation sequencing (NGS) on TE biopsies. This information will help to decide
the best strategy for each patient and her individual situation.

Eligible patients were undergoing their first IVF-PGT-A
treatment cycle, in which at least one MII oocyte was obtained, regardless of
oocyte and semen origin. Oocyte donation cycles were included in the donor
group (≤34
years old). Treatment cycles from women with their own oocytes were selected only
when the oocytes were aged ≥35 years (patient group). Only
trophoectoderm biopsies performed on days 5 or 6 of development and analyzed using
next-generation sequencing were included. Preimplantational genetic testing for
aneuploidy cycles because of a known abnormal karyotype were excluded.

A total of 2,660 IVF-PGT-A treatment cycles were performed
in the study period in the eligible population (patients group = 2,462; donors
group =198). The mean number of MII oocytes needed to obtain one euploid
blastocyst increased with age, as did the number of treatment cycles that did
not get at least one euploid blastocyst. An adjusted multivariate binary
regression model was designed using 80% of the patient group sample (n = 2,462;
training set). A calculator for the probability of obtaining at least one
euploid blastocyst was created using this model. The validation of this model
in the remaining 20% of the patient group sample (n = 493; validation set)
showed that it could estimate the event of having at least one euploid
blastocyst with an accuracy of 72.0%

The minimum number of MII oocytes needed to have high
chances of obtaining at least one euploid blastocyst increases with increasing
maternal age. Study model estimates with an accuracy of 74% the probability of
having at least one euploid blastocyst, considering oocyte age and the number
of MII oocytes. This model has been created with the largest database of
IVF-PGT-A treatment cycles ever used for this purpose, including only PGT-A
treatment cycles using NGS on TE biopsies. Once this model has been validated
prospectively and in multicenter studies, it may be useful for both the
clinician and the patient coming to an infertility clinic, whether or not a
PGT-A analysis is performed. The clinician may use this data to propose the
best strategy for each patient, whereas the patient may use this information to
better understand the likelihood of obtaining an euploid blastocyst, helping
her to cope emotionally with IVF treatment. Nevertheless, to this day, this
model has limited clinical value. It should be further validated and optimized
to use it as a clinical support tool, in our own clinic and in many others.

Source: Cristina Rodríguez-Varela, M.Sc.,a Juan Manuel
Mascaros, M.Sc., a Elena Labarta; Fertil
Steril® Vol. 122, No. 4, October 2024

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Air pollution linked to peanut allergy during childhood, unravels study

Exposure to higher levels of air pollution as a baby is linked to having a peanut allergy throughout childhood, according to a new study. And policies aimed at tackling poor air quality could potentially reduce the prevalence and persistence of peanut allergies, it stated.

The research, led by Murdoch Children’s Research Institute (MCRI) and the University of Melbourne, found being exposed to higher levels of air pollution from infancy was associated with increased odds of developing a peanut allergy and having the allergy persist across the first 10 years of life. However, the same association was not seen for egg allergy or eczema.

Published in the Journal of Allergy and Clinical Immunology, the study is the first to explore the link between air pollution and challenge-proven food allergy over the first decade of life.

The research involved 5,276 children in Melbourne from the HealthNuts study, recruited at age one and followed-up at four, six and 10 years. The research team used estimates of the annual average concentration of fine particulate matter (PM2.5) and nitrogen dioxide (NO2) at each participant’s residential address at the time of each follow up.

MCRI Associate Professor Rachel Peters said the study found that higher levels of air pollution was a risk factor for the development and persistence of peanut allergies. And this was despite Melbourne having generally good air quality compared to our international counterparts, she said.

“The rise in allergy prevalence has occurred at a similar time to increased urbanisation, leading to the belief that environmental factors may be contributing to high allergy rates,” Associate Professor Peters said.

“Eczema and food allergy most often develop in infancy. Both immune conditions can naturally resolve over time, but for some they can persist throughout adolescence and into adulthood.”

“This is the first study to use an oral food challenge, the gold-standard of food allergy diagnosis, to investigate the relationship between food allergy and air pollution.”

University of Melbourne’s Dr Diego Lopez said the co-exposure of peanut allergens in the environment and air pollutants could be increasing the allergy risk.

“Air pollutants have an irritant and inflammatory effect that may boost the immune systems pro-allergic response, potentially triggering the development of food allergies,” he said.

“However, the underlying mechanisms of how air pollution increases the risk of a peanut allergy, and why eczema and egg allergy aren’t impacted in the same way, need to be explored further.”

Allergic disease is one of Australia’s greatest public health challenges, with one in 10 developing a food allergy in their first year of life.

Associate Professor Peters said policies aimed at tackling air pollution could potentially reduce the development and persistence of peanut allergy.

“The research highlights the importance of early-life interventions aimed at reducing exposure to air pollution, which could potentially prevent peanut allergies and other poor child health outcomes,” she said.

“Improving city design to support greater air quality regulation, better promoting public transport and switching to non-combustion fuels may help turn the tide on peanut allergy.”

Mae, 8, was diagnosed with peanut, diary and egg allergies at 8 months old after an allergic reaction saw her breakout in hives across her entire body. She has since gone onto have several anaphylaxis reactions.

Her mum, Eleanor Jenkin, said the most severe episode occurred five years ago during a food challenge at The Royal Children’s Hospital to check Mae’s tolerance for adding egg back into her diet.

“She was eating cupcakes as part of the challenge until she started to refuse to eat anymore,” she said. We thought she was just being fussy, but she began vomiting and lost consciousness. It was her first anaphylaxis and while it was scary, she returned to her normal self a few minutes after being given an adrenaline shot.”

Since then, Mae has carried an EpiPen with her at all times.

“We were hopeful she would grow out of the food allergies but now we have come to accept that Mae will be living with serious and ongoing allergies,” Eleanor said.

“Her allergies are always going to be in the back of her mind, influencing the decisions that she makes every time she eats at a restaurant, orders takeaway or goes to a birthday party. As a family we are learning to manage this new normal as best we can.”

Living in Melbourne’s west, Eleanor said the new MCRI research showed why it was important to tackle air pollution.

“There is a whole suite of reasons why we should be addressing air pollution and its link with peanut allergy just adds to that,” she said.

“Multiple factors are behind the allergy epidemic and if higher levels of air pollution are impacting the prevalence and persistence then that’s an important discovery for families.

“We want to see the quality of life improve for children living with allergies as well as fewer children having to go through what Mae has experienced. The more we know about how to prevent allergies the better.”

The GenV study, tracking the health and wellbeing of Victorians from birth to old age, is also starting to look at the impact of air pollution and climate change on children’s health. GenV has gathered data from more than 120,000 participants, including 48,000 babies.

MCRI researchers are linking information on heat vulnerability with perinatal and child health data from the GenV cohort and are seeking to include temperature extremes and climate related disaster evidence in the future.

Associate Professor Suzanne Mavoa said this would improve our understanding of how climate change impacts the health of children and families, identify those most at risk and test policies and interventions to better protect against severe weather events.

Reference:

Diego J. Lopez, Caroline J. Lodge, Dinh S. Bui, Nilakshi T.Waidyatillake, John C.Su, Luke D. Knibbs, Rushani Wijesuriya, Kirsten P Perrett, Jennifer J Koplin, Victoria X Soriano, Kate Lycett, Yichao Wang, Suzanne Mavoa, Shyamali C. Dharmage, Adrian J. Lowe and Rachel L. Peters. ‘Early life air pollution is associated with persistent peanut, but not egg allergy, across the first ten years,’ Journal of Allergy and Clinical Immunology: In Practice. DOI: 10.1016/j.jaci.2024.08.018,

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Hemodiafiltration may reduce mortality in maintenance hemodialysis patients compared to conventional hemodialysis: Study

Researchers have discovered that a significant reduction in mortality occurs in patients with end-stage renal disease (ESRD) when hemodiafiltration (HDF), is used instead of conventional hemodialysis. A recent study was conducted by Yifan and colleagues published in BMC Nephrology.

In ESRD, a patient always requires dialysis for the removal of the waste products and excess fluids from the blood. Standard treatment is conventional hemodialysis, but in the last few years, HDF has been investigated concerning its apparent advantages regarding mortality as it is a modified form of dialysis that increases toxin removal by combining diffusion and convection.

The researchers systematically searched PubMed, Embase, and the Cochrane Library for RCTs comparing HDF with conventional HD up until January 14, 2024, to collect credible evidence. A total of 10 randomized controlled trials involving 4654 patients were included. The analysis was performed using Review Manager 5.3 software, enabling the assessment of relevant data and the quality of the evidence. The study results focused on four main outcomes: all-cause mortality, cardiovascular mortality, sudden death, and infection-related mortality.

Key Findings

The meta-analysis led to several key findings regarding the impact of HDF compared to conventional HD

  • All-cause mortality: The all-cause mortality was lower with HDF than with HD by 16%, (RR 0.84, 95% CI 0.72–0.99, P = 0.04).

  • Cardiovascular mortality: HDF decreased cardiovascular mortality by 26%, (RR 0.74, 95% CI 0.61–0.90, P = 0.002).

  • Sudden death: The risk of sudden death was not significantly different between the groups (RR 0.92, 95% CI 0.64–1.34, P = 0.68).

  • Death from infection: While the point estimate indicated a reduction in infection-related mortality with HDF, the change was not significant (RR 0.70, 95% CI 0.47–1.03, P = 0.07).

  • HDF had significant superiority to high-flux HD for all-cause mortality (RR 0.81, 95% CI 0.69–0.96, P = 0.01), but not over low-flux HD (RR 0.93, 95% CI 0.77–1.12, P = 0.44).

  • Convective volume: HDF with a convective volume of 22 L or more was superior to the control in lowering both all-cause mortality (RR 0.76, 95% CI 0.65–0.88, P = 0.0002) and cardiovascular mortality (RR 0.73, 95% CI 0.54–0.94, P = 0.01).

The meta-analysis supports the fact that HDF significantly decreases mortality in ESRD patients compared to the conventional method of hemodialysis, with higher volumes of convection. Such preliminary evidence may eventually lead to increased adoption of HDF as a more regular procedure in the treatment of ESRD patients.

Reference:

Zhu, Y., Li, J., Lu, H., Shi, Z., & Wang, X. (2024). Effect of hemodiafiltration and hemodialysis on mortality of patients with end-stage kidney disease: a meta-analysis. BMC Nephrology, 25(1). https://doi.org/10.1186/s12882-024-03810-9

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23-Fold Increase in Heart Attack Risk among Women with Gestational Diabetes and Hypertension, reveals research

France: A recent nationwide cross-sectional cohort study has highlighted alarming insights into the long-term cardiovascular risks faced by women who experience gestational diabetes mellitus (GDM) and gestational hypertension (GH) during pregnancy. The findings were published online in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 

The findings were striking: women with a history of both GDM and GH were found to have a staggering 23-fold increased risk of experiencing a myocardial infarction within the first 5 years of their postnatal lives.

Cardiovascular disease ranks as the leading cause of death among women globally. While the connection between a history of hypertensive disorders during pregnancy or gestational diabetes (GDM) and subsequent cardiovascular events is well documented, the implications of experiencing both gestational hypertension (GH) and GDM together are less clearly understood. To address this gap, Laurent Fauchier, Service de Cardiologie, Centre Hospitalier Universitaire et Faculté de Médecine, Université de Tours, France, and colleagues examined the relationship between GDM and GH, evaluating their individual and combined effects on future cardiovascular risks. 

For this purpose, the researchers identified all female patients discharged from French hospitals in 2013 who had complete follow-ups for five years. These patients were categorized based on their history of gestational diabetes, gestational hypertension, both conditions, or neither. After applying propensity score matching, those with GDM and/or GH were matched 1:1 with patients who had no history of these conditions. The analysis adjusted hazard ratios (HR) for cardiovascular events during the follow-up period, accounting for the patient’s age at baseline.

The study led to the following findings:

  • Women with a history of gestational hypertension exhibited a significantly increased risk of cardiovascular death, with a hazard ratio (HR) of 5.46.
  • Women with a history of gestational diabetes mellitus did not show a significant difference in the risk of cardiovascular events:
    • Myocardial infarction risk (HR 0.88) was not significantly elevated.
    • Cardiovascular death risk (HR 1.25) was also not significantly different.
  • Women with a history of both GDM and GH faced a markedly higher risk of myocardial infarction, with a hazard ratio of 23.33.

In the largest contemporary analysis of hospitalized female patients to date, we present the first findings on the combined cardiovascular risk associated with gestational diabetes mellitus and gestational hypertension within five years postpartum.

“Our results indicate that women with a history of both conditions face a staggering 23-fold increased risk of myocardial infarction. Therefore, those who experience both GDM and GH during pregnancy should be referred for specialized ongoing cardiology care and classified as high risk when presenting with acute symptoms indicative of potential cardiac ischemia,” the researchers concluded. 

Reference:

Bullough, S., Lip, G. Y., Fauchier, G., Herbert, J., Sharp, A., Bisson, A., Ducluzeau, P. H., & Fauchier, L. (2024). The impact of gestational diabetes and gestational hypertension on future cardiovascular events: A nationwide cross-sectional cohort study. European Journal of Obstetrics & Gynecology and Reproductive Biology, 301, 216-221. https://doi.org/10.1016/j.ejogrb.2024.08.021

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Prophylactic infusion of norepinephrine may prevent hypotension during vertebroplasty, reports research

Prophylactic infusion of norepinephrine may prevent hypotension during vertebroplasty, reports research published in the BMC Surgery.

Transient hypotension is a common occurrence during the implantation of bone cement. This placebo-controlled randomized clinical trial study investigated the effect of prophylactic infusion of norepinephrine on the incidence of hypotension in senior patients who underwent vertebroplasty. The trial recruited patients who were greater than or equal to 65 years of age, had an American Society of Anesthesiologist physical status classification of I to III, and underwent vertebroplasty from August 2020 to August 2021 at the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine in China. The patients were randomly grouped according to whether they received either a norepinephrine infusion of 0.05 µg/kg/min or an equivalent volume of saline 10 min before implantation of bone cement. Intraoperative hemodynamics were monitored continuously by the MostCare system at the following 7 time points: 10 min before implantation of bone cement and immediately, 30 s, 1, 3, 5, and 10 min after implantation of bone cement. We also recorded the number of hypotensive episodes and the total number of vasopressors after implantation of bone cement. Multivariable logistic regression was used to assess the risk factors associated with hypotension after implantation of bone cement. Results: A total of 63 patients were randomized to the control group (n = 31; median [IQR] age, 74 [69–79] years) and the norepinephrine group (n = 32; median [IQR] age, 75 [71–79] years). The incidence of hypotension in the norepinephrine group was significantly lower than that in the control group after implantation of bone cement (12.5% vs. 45.2%; relative risk [RR], 3.61 [95% CI, 1.13–15.07]; P = 0.005). Moreover, the median (IQR) number of hypotensive episodes (0 [0–0] vs. 0 [0–2]; P = 0.005) and the total number of vasopressors (0 [0–0] vs. 0 [0–1]; P = 0.004) in the norepinephrine group were significantly lower than those in the control group. Furthermore, compared with the baseline, the MAP significantly decreased at 1 min (P = 0.007) and 3 min (P < 0.001) after bone cement implantation in the control group. However, the MAP at 3 min in the norepinephrine group was significantly higher than that in the control group (P < 0.001). The incidence of complications was not different between the groups. In multivariable logistic regression, the FRAIL score (OR, 2.29; 95% CI, 1.21–4.31) was identified as a risk factor associated with hypotension. Prophylactic infusion of norepinephrine before bone cement implantation can stabilize hemodynamics and reduce the incidence of hypotension after implantation of bone cement.

Reference:

Fu, Q., Liu, S., Sun, Y. et al. Effect of prophylactic infusion of norepinephrine on the prevention of hypotension during vertebroplasty: a randomized clinical trial. BMC Surg 24, 333 (2024). https://doi.org/10.1186/s12893-024-02640-8

Keywords:

Prophylactic, infusion, norepinephrine, may, prevent, hypotension, during, vertebroplasty, reports, research, Fu, Q., Liu, S., Sun, Y, Hypotension, Norepinephrine, Vertebroplasty, Hemodynamics, Bone cement implantation

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Study Reveals ABO Blood Group Incongruence Linked to Lower Risk of Newborn Infections After 90 Days

Canada: A recent cohort study published in JAMA Network Open has examined the relationship between maternal-newborn ABO blood group incongruence and the risk of bacterial infections in newborns.

The study found no link between maternal-newborn ABO blood group mismatches and the risk of bacterial infections in newborns during the first 30 and 7 days after birth. However, such mismatches were associated with a reduced risk of bacterial infection within the first 90 days of life.

Newborn immunity is primarily dependent on the transfer of antibodies from mother to fetus during pregnancy. While mismatches in ABO blood groups between mothers and their infants may offer some protection against serious infections, there is a lack of specific data regarding bacterial infections in newborns. To address this gap, Emily Ana Butler, Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada, and colleagues aimed to explore the relationship between maternal-newborn ABO blood group incongruence and a reduced risk of bacterial infections in newborns.

For this purpose, the researchers conducted a cohort study using linked patient-level datasets of all singleton live births in Ontario, Canada, from January 1, 2014, to December 31, 2020. The study focused on maternal-newborn pairs with known ABO blood groups. Data analysis occurred between February and May 2024.

The primary outcome measured was bacterial infection in newborns within 30 days of birth, with secondary outcomes at 7 and 90 days. Modified Poisson regression was used to calculate adjusted relative risks, accounting for neonatal sex and preterm birth.

A total of 138,207 maternal-newborn pairs were analyzed. The findings include:

  • Maternal Age: Average age was 31.8 years for those with ABO blood group incongruence and 31.5 years for those with congruence.
  • Newborn Gestational Age: Average gestational age was 38.5 weeks for the incongruent group and 38.4 weeks for the congruent group.
  • Gender Distribution: 51.3% of males in the incongruent group and 51.9% in the congruent group.
  • ABO Blood Group Distribution: 37,953 pairs (27.5%) had ABO blood group incongruence, while 100,254 pairs (72.5%) had congruency.
  • Bacterial Infections Within 30 Days:
    • Incongruent group: 328 infections (8.6 per 1,000).
    • Congruent group: 1,029 infections (10.3 per 1,000).
    • Adjusted relative risk (ARR) for infection: 0.91.
  • ARRs for Bacterial Infections:
    • Within 7 days: 0.89.
    • Within 90 days: 0.86.

“The findings showed that maternal-newborn ABO blood group incongruence did not correlate with a reduced risk of infection within the first 30 or 7 days after birth. However, there was a noted association indicating that incongruence was linked to a lower risk of bacterial infection in infants within 90 days of birth,” the researchers concluded.

Reference:

Butler EA, Ray JG, Cohen E. Maternal-Newborn ABO Blood Groups and Risk of Bacterial Infection in Newborns. JAMA Netw Open. 2024;7(10):e2442227. doi:10.1001/jamanetworkopen.2024.42227

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Methotrexate first line, viable treatment option for effective mycosis fungoides, finds study

A new study published in the Journal of the European Academy of Dermatology and Venereology found that methotrexate (MTX) has a favorable benefit/risk ratio and is a good therapy choice for Mycosis fungoides (MF) when administered as a first-line treatment. A uncommon and varied subtype of non-Hodgkin lymphomas, cutaneous T-cell lymphomas (CTCLs) are distinguished by their distinct T-cell phenotype and clinical presentation.

The two most common main CTCL subtypes are Sézary syndrome (SS) and Mycosis fungoides. As a folate antagonist, methotrexate (MTX) works by blocking the enzyme dihydrofolate reductase, which is necessary for DNA synthesis. It is one of the most common chemotherapeutic options used to treat a variety of cancers, including CTCLs. This study by Vasiliki Nikolaou and colleagues was set out with the intention of summarizing and reporting the clinical experience of MF patients treated with low-dose MTX in tertiary experienced centers in Greece.

MF participants from 5 Greek cutaneous lymphoma referral centers participated in this retrospective multicenter investigation. Information about safety and efficacy was examined. The median (IQR) age of diagnosis for the 211 MF patients who were enrolled (68.3% of whom were male) was 68.3 (56–75) years.

There were 124 individuals with late-stage (IIB-IVB) illness (59.3%). 112 (53.1%) patients received MTX monotherapy, whereas 99 patients received combination regimens that included phototherapy, interferon, and retinoids. In 103 patients, MTX was the first-line treatment (48.9%). There was a 55.5% overall response rate (ORR), with 29.9% of patients providing full answers.

With no discernible differences between monotherapy and combination therapy, MTX showed higher efficacy as a first-line treatment than in later usage. 3.8 months (IQR 2.3–9.9 months) was the median time to greatest response. The individuals with erythrodermic disease (Stage III) had improved ORRs when compared to the ones with tumor stage disease (Stage II).

The median progression-free survival (PFS) for early-stage disease was 17.1 months, for Stage IIB disease it was 5.7 months, for Stage III it was 46 months, and for Stage IV it was 9.6 months (0.7-.). Also, 14 (6.7%) of the individuals had serious adverse (Grade 3) events that resulted in treatment termination. A weekly median dosage of 15 mg of oral MTX was administered to all patients once a week. Overall, this study provides important insights into the real-world response rates of MF patients treated with MTX.

Source:

Nikolaou, V., Panou, E., Tsimpidakis, A., Koumprentziotis, I., Patsatsi, A., Siakantaris, M., Kruger‐Krasagakis, S., Marinos, L., Georgiou, E., Lampadaki, K., Velissari, A., Daponte, A., Doxastaki, A., Kaliampou, S., Vaiopoulos, A., Konstandinou, I., Koumourtzis, M., Lakiotaki, E., Pappa, V., … Papadavid, E. (2024). Effectiveness and safety of methotrexate in the treatment of mycosis fungoides: Real‐world data from a multicentre study. In Journal of the European Academy of Dermatology and Venereology. Wiley. https://doi.org/10.1111/jdv.20350

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Semaglutide 2.4 mg may significantly improve liver fibrosis and resolve MASH in ESSENCE trial

According to Headline results from part 1 of the phase 3 ESSENCE trial,  Semaglutide 2.4 mg may significantly improve  liver fibrosis and lead to  resolution of steatohepatitis in MASH patients compared to placebo.

The results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3) have been announced by Novo Nordisk. Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care for the first 800 randomised people at 72 weeks.

The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo. At week 72, 37.0% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo. 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis3 with no worsening of liver fibrosis compared to 34.1% on placebo.

In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.

“We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need.”

Novo Nordisk expects to file for regulatory approvals in the US and EU in the first half of 2025. The detailed results from ESSENCE will be presented at a scientific conference in 2024. Part 2 of the ESSENCE trial will continue with expected readout in 2029.

About MASH

Metabolic dysfunction-associated steatohepatitis (MASH) is a serious, progressive, metabolic disease affecting the liver, which can be fatal if not properly managed. More than 250 million people live with MASH and the number of individuals in advanced stages of the disease is expected to double by 2030. Of those who are currently overweight or living with obesity, more than one in three are also living with MASH. People living with MASH often experience few or no specific symptoms in the early stages of the disease, which often results in delayed diagnosis. The risk of progression to advanced liver disease, including liver cancer, is higher in people living with MASH than in the general population.

About the ESSENCE trial

ESSENCE is a phase 3 trial evaluating the effect of once-weekly subcutaneous semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis (stage 2 or 3). ESSENCE is a two-part trial where 1,200 planned participants were randomised 2:1 to receive semaglutide 2.4 mg or placebo, on top of standard of care for 240 weeks. In part 1, the objective was to demonstrate that treatment with semaglutide 2.4 mg improves liver histology at 72 weeks based on biopsy sampling from the first 800 randomised patients. In part 2, the objective is to demonstrate that treatment with semaglutide 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks.

About semaglutide 2.4 mg

Once-weekly subcutaneous semaglutide 2.4 mg is a GLP-1 receptor agonist marketed under the brand name Wegovy®. Wegovy® is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 kg/m2 or greater (obesity), adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition and paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity).

In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in adults and paediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition.

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