Low Cardiovascular Complications Observed in Post-COVID-19 Vaccine Myocarditis: JAMA

A recent study published in the Journal of American Medical Association unveiled the long-term outcomes of myocarditis in young individuals following COVID-19 mRNA vaccination which had generally favorable prognosis when compared to conventional myocarditis. However, the questions about ongoing management and the full scope of long-term complications remain unanswered.

The study was conducted using the French National Health Data System which analyzed data from 4,635 individuals. These participants were aged 12 to 49 years who were hospitalized for myocarditis between December 27, 2020 and June 30, 2022. The participants were categorized into 3 groups: those who developed myocarditis within seven days after receiving a COVID-19 mRNA vaccine (postvaccine myocarditis), those who developed myocarditis within 30 days of a SARS-CoV-2 infection (post–COVID-19 myocarditis) and those with conventional myocarditis unrelated to COVID-19 or vaccination.

The study revealed that patients with postvaccine myocarditis were predominantly younger men, with an average age of 25.9 years when compared to 31 years for post–COVID-19 myocarditis and 28.3 years for conventional myocarditis. The incidence of cardiovascular complications over an 18-month follow-up period was markedly lower in the postvaccine myocarditis group than in the conventional myocarditis group.

Also, only 32 out of 558 patients with postvaccine myocarditis underwent adverse cardiovascular events when compared to 497 out of 3,779 patients with conventional myocarditis. The weighted hazard ratio (HR) for these events was 0.55, indicating a 45% lower risk in the postvaccine group. In contrast, the patients with post-COVID-19 myocarditis had a similar risk of cardiovascular complications as the individuals with conventional myocarditis, with 36 out of 298 patients affected and a weighted hazard ratio of 1.04.

The study also analyzed the medical management of patients after hospital discharge. It found that the frequency of medical procedures and drug prescriptions in patients with postvaccine myocarditis was comparable to those with post–COVID-19 and conventional myocarditis. These findings reassure that myocarditis following COVID-19 mRNA vaccination generally leads to fewer long-term cardiovascular complications than conventional myocarditis. However, the need for extended medical management in young and otherwise healthy men highlighted the importance of continued monitoring and research.

As the long-term prognosis and optimal management strategies for postvaccine myocarditis remain uncertain, clinicians should remain vigilant in follow-up care, ensuring that any future complications are promptly addressed. Overall, this study illuminates the importance of ongoing research to fully understand the long-term implications of myocarditis related to COVID-19 vaccines and SARS-CoV-2 infection.

Source:

Semenzato, L., Le Vu, S., Botton, J., Bertrand, M., Jabagi, M.-J., Drouin, J., Cuenot, F., Zores, F., Dray-Spira, R., Weill, A., & Zureik, M. (2024). Long-Term Prognosis of Patients With Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2 Infection, or Conventional Etiologies. In JAMA. American Medical Association (AMA). https://doi.org/10.1001/jama.2024.16380

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Single blood test may predict 30-year cardiovascular disease risk for women: NEJM

Research supported by the National Institutes of Health has found that measuring two types of fat in the bloodstream along with C-reactive protein (CRP), a marker of inflammation, can predict a woman’s risk for cardiovascular disease decades later. These findings, presented as late-breaking research at the European Society of Cardiology Congress 2024, were published in the New England Journal of Medicine.

KEY TAKEAWAYS

The  researchers assessed data from more than 27,000 participants in the Women’s Health Study who were followed for 30 years.

An initial, one-time measure of three biological markers—hsCRP, LDL-cholesterol and lipoprotein(a)—in their blood predicted their risk of major cardiovascular events over the following decades.

The findings support universal screening for inflammation and lipoprotein(a) in addition to cholesterol, as well as earlier, aggressive use of targeted interventions, particularly among women for whom cardiovascular disease remains underdiagnosed and undertreated.

“We can’t treat what we don’t measure, and we hope these findings move the field closer to identifying even earlier ways to detect and prevent heart disease,” said Paul M. Ridker, M.D., M.P.H., a study author and the director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, Boston.

For the study, investigators collected blood samples and medical information from 27,939 healthcare providers living in the United States who participated in the Women’s Health Study. Women, who started the study between 1992-1995 at an average age of 55, were followed for 30 years. During this period, 3,662 study participants experienced a heart attack, stroke, surgery to restore circulation, or a cardiovascular-related death. Researchers assessed how high-sensitivity CRP, along with low-density lipoprotein (LDL) cholesterol and lipoprotein(a), or Lp(a), a lipid partly made of LDL, singularly and collectively predicted these events.

Participants were grouped into five categories-ranging from those with the highest to lowest levels-to measure each of the three markers. Researchers found that women with the highest levels of LDL cholesterol had a 36% increased associated risk for heart disease compared to those with the lowest levels. Those with the highest levels of Lp(a) had a 33% increased associated risk, and those with the highest levels of CRP had a 70% increased associated risk.

When all three measures-LDL cholesterol, Lp(a), and CRP-were assessed together, participants with the highest levels had more than a 1.5-times increased associated risk for stroke and more than a 3-times increased associated risk for coronary heart disease compared to women with the lowest levels.

The researchers note that while only women were assessed in this study, they would expect to find similar results in men.

“In recent years, we’ve learned more about how increased levels of inflammation can interact with lipids to compound cardiovascular disease risks,” said Ahmed A.K. Hasan, M.D., Ph.D., a medical officer and program director at the National Heart, Lung, and Blood Institute (NHLBI). “This helps explain why lower levels are often better.”

Immune cells, which help the body repair itself from wounds or infection, can also sense the accumulation of extra cholesterol in cells or become activated in response to the build-up of plaque and send out inflammatory signals. This creates a hyperinflammatory environment where plaque can form, become larger, or even rupture — and cause cardiovascular events.

To support optimal cardiovascular health, the researchers emphasize primary prevention. This includes getting regular physical activity, eating a heart-healthful diet, managing stress, and avoiding tobacco or quitting smoking. Other measures for people with increased risks may include using medication to lower cholesterol and/or reduce inflammation. Researchers have also found that steps people take earlier in life to support their heart and vascular health can add up over time and correlate with better health outcomes years and even decades later.

LDL cholesterol, which is routinely measured by healthcare providers, can be treated with widely-available therapies, such as statins. However, standard Lp(a) and CRP screening recommendations can vary.

Some countries recommend screening for Lp(a) since elevated levels are often due to inherited risks. In areas without universal Lp(a) screenings, like the U.S., physicians can order tests for people with heart disease or who have a family history of it. Some therapies are available for those with elevated levels and researchers are testing new approaches to personalize and improve treatment options.

Testing for CRP also varies. Screening often depends on a person’s underlying risks or is up to the discretion of the provider. Colchicine, an anti-inflammatory therapy previously used for gout, was approved by the Food and Drug Administration in 2023 to offset risks for cardiovascular disease among people with atherosclerosis. Additional anti-inflammatory therapies and approaches are being studied.

Reference:

Paul M. Ridker, M. Vinayaga Moorthy, Nancy R. Cook, Nader Rifai, I-Min Lee, Inflammation, Cholesterol, Lipoprotein(a), and 30-Year Cardiovascular Outcomes in Women, New England Journal of Medicine, DOI: 10.1056/NEJMoa2405182.

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Short, intense bursts of exercise more effective after stroke than steady, moderate exercise

One-minute, short bursts of high-intensity interval training for 19 minutes may be more effective for improving fitness among people six months or more after a stroke than traditional, 20-30 minutes of moderate-intensity exercise sessions, according to research published today in Stroke, the peer-reviewed scientific journal of the American Stroke Association, a division of the American Heart Association.

“This study shows that people with stroke can also benefit from high-intensity interval training,” said Kevin Moncion, Ph.D., a physiotherapist who led this study as part of his doctoral studies at McMaster University in Hamilton, Ontario, Canada. “With the right support and guidance, stroke survivors can safely and effectively engage in high-intensity interval training, significantly improving their overall health and recovery.”

The multi-site trial took place between September 2018 and March 2024 and included stroke survivors between six months to 5 years after a stroke. Researchers randomly grouped participants to receive either three days per week of 12 weeks of high-intensity interval training or three days per week of 12 weeks of traditional moderate exercise sessions. The high-intensity interval training protocol involved ten 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for 19 minutes total. The moderate intensity continuous training involved 20 to 30 minutes of steady exercise at moderate intensity.

Researchers then compared fitness levels, cardiovascular risk factors such as blood pressure and stiffness of blood vessels, walking speeds and distances between the two groups. All assessments were repeated one final time 8 weeks after the exercise interventions to evaluate whether the changes were sustained over time.

Researchers found:

  • The high-intensity interval training group’s cardiorespiratory fitness levels (rate of oxygen consumed at peak exercise) improved twice as much as the moderate intensity continuous training group: 3.5 milliliters of oxygen consumed in one minute, per kilogram of body weight (mL/kg/min) compared to 1.7 mL/kg/min.
  • The improvement in the high intensity interval training group stayed above clinically important thresholds even at the 8-week follow-up (1.71 mL/kg/min), whereas the moderate intensity continuous training group did not (0.67 mL/kg/min).
  • Both the high intensity interval training and moderate intensity continuous training groups gained improvement in walking endurance, as measured by distance walked over 6 minutes. At baseline both groups could walk about 355 meters (the approximate distance of three American football fields) over 6 minutes. After 12 weeks of exercise both groups increased their walking distance by 8 meters and after the 8-week follow-up they increased their walking distance by 18 meters.

“This is the first randomized trial to examine a time-efficient, high intensity interval training program to incorporate a phased and progressive approach,” said senior author Ada Tang, Ph.D., a physiotherapist, professor and assistant dean of Rehabilitation Science at McMaster University. “We also used an adaptive recumbent stepper, which we believe allowed more people to participate in high-intensity interval training, even those who cannot walk fast enough or long enough on a treadmill.”

The limitations of the study include that study participants were higher functioning stroke survivors from a physical standpoint who were at lower risk for heart disease. Study minimum criteria included the ability to walk 10 meters without physical assistance of another person, although the use of cane or walker was permitted. Outcome assessments were unblinded at follow-up, which may have influenced results. Lastly, enrollment and exercise for the trial was halted two years for COVID-19 lockdowns, thus inflating the rate of participants who left the study and potentially limiting the statistical power of the analysis.

In 2021, there were 7.44 million deaths attributable to stroke worldwide, according to the American Heart Association’s Heart Disease and Stroke Statistics 2024 Update.

Future research should examine stroke survivors with more severe impairment in physical function or heart disease risk, according to the study authors.

“Stroke rehabilitation professionals now have evidence to support implementing short, high-intensity interval training protocols in clinical practice. We showed our program is safe and effective at improving fitness and walking distance in people after stroke, which are important outcomes for stroke survivors,” Tang said.

Study details and background:

  • The study conducted at McGill University in Montreal and McMaster University in Hamilton, Canada included 82 predominantly white adults, (50 men, 32 women), ages 40 to 80. All had mild or minimal disability from a stroke about 1.8 years earlier.
  • Participants exercised on adaptive recumbent steppers that allow for stroke survivors with a wide range of abilities to exercise at high intensities.
  • Assessments were done 3 times in total: before starting exercise training (baseline, 0 weeks), immediately after exercise (post, 12 weeks), follow up 8 weeks after the intervention ended (i.e. 20 weeks from baseline).
  • At each assessment, researchers measured cardiovascular health fitness levels, including resting blood pressure, stiffness of arteries, waist-hip ratio (calculated by waist circumference at the belly button and hip circumference at the hip bone), and mobility (walking speed and distance).
  • No participants experienced any adverse effects, including feeling tired, shortness of breath, muscle soreness, cramps or lightheadedness during exercise.

Reference:

Kevin Moncion, Lynden Rodrigues, Bernat De Las Heras, Kenneth S. Noguchi, Elise Wiley, MSc, Janice J. Eng, Cardiorespiratory Fitness Benefits of High-Intensity Interval Training After Stroke: A Randomized Controlled Trial, Stroke, https://doi.org/10.1161/STROKEAHA.124.046564.

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New human-centered AI tool may improve sepsis management: Study

A proposed artificial intelligence tool to support clinician decision-making about hospital patients at risk for sepsis has an unusual feature: accounting for its lack of certainty and suggesting what demographic data, vital signs and lab test results it needs to improve its predictive performance.

The system, called SepsisLab, was developed based on feedback from doctors and nurses who treat patients in the emergency departments and ICUs where sepsis, the body’s overwhelming response to an infection, is most commonly seen. They reported dissatisfaction with an existing AI-assisted tool that generates a patient risk prediction score using only electronic health records, but no input data from clinicians.

Scientists at The Ohio State University designed SepsisLab to be able to predict a patient’s sepsis risk within four hours – but while the clock ticks, the system identifies missing patient information, quantifies how essential it is, and gives a visual picture to clinicians of how specific information will affect the final risk prediction. Experiments using a combination of publicly available and proprietary patient data showed that adding 8% of the recommended data improved the system’s sepsis prediction accuracy by 11%.

“The existing model represents a more a traditional human-AI competition paradigm, generating numerous annoying false alarms in ICUs and emergency rooms without listening to clinicians,” said senior study author Ping Zhang, associate professor of computer science and engineering and biomedical informatics at Ohio State.

“The idea is we need to involve AI in every intermediate step of decision-making by adopting the ‘AI-in-the-human-loop’ concept. We’re not just developing a tool – we also recruited physicians into the project. This is a real collaboration between computer scientists and clinicians to develop a human-centered system that puts the physician in the driver’s seat.”

The research was published in KDD ’24: Proceedings of the 30th ACM SIGKDD Conference on Knowledge Discovery and Data Mining and will be presented orally Wednesday (Aug. 28) at SIGKDD 2024 in Barcelona, Spain.

Sepsis is a life-threatening medical emergency – it can rapidly lead to organ failure – but it’s not easy to diagnose because its symptoms of fever, low blood pressure, increasing heart rate and breathing problems can look like a lot of other conditions. This work builds upon a previous machine learning model developed by Zhang and colleagues that estimated the optimal time to give antibiotics to patients with a suspected case of sepsis.

SepsisLab is designed to come up with a risk prediction quickly, but produces a new prediction every hour after new patient data has been added to the system.

“When a patient first comes in, there are many missing values, especially for lab tests,” said first author Changchang Yin, a computer science and engineering PhD student in Zhang’s Artificial Intelligence in Medicine lab.

In most AI models, missing data points are accounted for with a single assigned value – a process called imputation – “but the imputation model could suffer from uncertainty that can be propagated to the downstream prediction model,” Yin said.

“If the imputation model cannot accurately impute the missing value and it’s a very important value, the variable should be observed. Our active sensing algorithm aims to find such missing values and tell clinicians what additional variables they might need to observe – variables that can make the prediction model more accurate.”

Equally important to removing uncertainty from the system over the passage of time is providing clinicians with actionable recommendations. These include lab tests rank-ordered based on their value to the diagnostic process and estimates of how a patient’s sepsis risk would change depending on specific clinical treatments.

Experiments showed adding 8% of the new data from lab tests, vital signs and other high-value variables reduced the propagated uncertainty in the model by 70% – contributing to its 11% improvement in sepsis risk accuracy.

“The algorithm can select the most important variables, and the physician’s action reduces the uncertainty,” said Zhang, also a core faculty member in Ohio State’s Translational Data Analytics Institute. “This fundamental mathematics work is the most important technical innovation – the backbone of the research.”

Zhang sees human-centered AI as part of the future of medicine – but only if AI interacts with clinicians in a way that makes them trust the system.

“This is not about building an AI system that can conquer the world,” he said. “The center of medicine is hypothesis testing and making decisions minute after minute that are not just ‘yes’ or ‘no.’ We envision a person at the center of the interaction using AI to help that human feel superhuman.”

Reference:

Changchang Yin, Pin-Yu Chen, Bingsheng Yao, Dakuo Wang, Jeffrey Caterino, Ping Zhang, SepsisLab: Early Sepsis Prediction with Uncertainty Quantification and Active Sensing, https://doi.org/10.1145/3394486.3403129.

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Combining Two Diabetes Drugs Helps Promote Weight Loss and Blood Sugar Control, suggests study

New research finds a combination of drugs improves weight loss, glucose control and insulin resistance better than either drug alone. Using two diabetes medications together, such as a semaglutide like Ozempic or Rybelsus, with a second, newer class of drug, may offer a noninvasive solution to help people with Type 2 diabetes lose weight. This could also help them manage their condition without the need for bariatric surgery. The study is published ahead of print in the American Journal of Physiology-Endocrinology and Metabolism and has been chosen as an APSselect article for August.

Type 2 diabetes and obesity, particularly when they occur together, carry the long-term risk of cardiovascular disease. Studies have shown that losing at least 15% of a person’s body weight can improve metabolic factors associated with diabetes and reduce associated health risks. Glucagon-like peptide-1 receptor agonists (GLP-1 analogs) medications such as semaglutide reduce blood sugar on their own. However, researchers are exploring newer treatments that combine different classes of drugs to improve weight loss and obesity-related conditions in people with Type 2 diabetes. One of these additional drug classes is called dual amylin and calcitonin receptor agonists, or DACRAs.

In a new study, researchers from Denmark studied a rat model of obesity and diabetes. For seven months, adult rats were treated with either semaglutide alone, a DACRA called KBP-336 alone or a combination of the two drugs. During the first three months of the trial, all treatment groups lost a significant amount of weight. But in the latter half of the study, the combination group had a more sustained and continued weight loss than either of the single-drug treatment groups. The animals receiving the combination therapy also had less visceral fat. Visceral fat can be especially dangerous because it surrounds the organs and can affect how they function.

The research team found that the newer drug, KBP-336, was effective both alone and together with semaglutide, in stabilizing fasting blood sugar levels. It also reduced endotrophin-a product derived from collagen that is expressed in fat tissue. High endotrophin levels can be a marker for both heart and liver failure. The combination therapy also provided a measure of glucose tolerance and lower insulin levels than either drug alone.

“In obesity and Type 2 diabetes, the treatment gap between pharmacotherapies and bariatric surgeries is narrowing: however, to finally bridge it, combination therapies are needed,” the researchers wrote. “Altogether, KBP-336 is a promising candidate for the treatment of obesity and Type 2 diabetes both alone an in combination with GLP-1 analogs.”

Reference:

Gabriela Batitucci,Otávio G. Almeida,Elaine C. P. De Martinis,Isabela Solar,Dennys E. Cintra,Ellen Cristini de Freitas, Intermittent fasting and high-intensity interval training do not alter gut microbiota composition in adult women with obesity, American Journal of Physiology-Endocrinology and Metabolism, https://doi.org/10.1152/ajpendo.00310.2023.

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Recent recreational drug use triples risk of repeat serious cardiovascular event, suggests study

New research presented at this year’s ESC Congress 2024 in London, UK (30 Aug – 2 Sept) shows that, among patients admitted to the intensive cardiac care unit (ICCU), those with a recent history of recreational drug use are three times more likely than those with no history to experience a repeat serious cardiovascular event within one year.

“Among patients admitted to the intensive cardiac care unit (ICCU), systematic screening for recreational drugs evidenced a significant prevalence – 11% – of recent use,” said study author Dr Raphael Mirailles, Hospital Lariboisiere, Paris, France. “Recreational drug use was associated with triple the risk of a repeat serious cardiovascular event within one year.”

Previous work by the same group showed that this recent history of recreational drug use was associated with a higher rate in-hospital outcomes. However, long-term cardiovascular consequences of recreational drug use remain uncertain.

In this study the authors aimed to evaluate the prognostic impact of recreational drugs use at 1-year follow-up to predict serious cardiovascular events (including death) in consecutive patients admitted to ICCUs for acute cardiovascular events from the Addiction in Intensive Cardiac Care Units (ADDICT-ICCU) study.

All consecutive patients admitted to ICCUs over two weeks in April 2021 at 39 centres across France were included. Screening for recreational drugs use was performed by systematic urinary testing. All patients provided written informed consent for participation and therefore approved urinary testing. One-year follow-up consisted of a clinical visit or direct contact with the patient and the referring cardiologist. The primary composite outcome was the occurrence of a serious cardiac event – cardiovascular death, non-fatal heart attack (MI) or stroke. Subgroup analysis was performed in patients hospitalised at baseline for acute coronary syndrome (non-fatal heart attack / angina lasting more than 20 minutes).

Of the 1499 consecutive patients screened, 1392 (93%) patients (mean age 63 years, 70% males) had a complete 1-year follow-up. Among them, 157 (11%) had an initial positive test for recreational drug use (cannabis, opioids, cocaine, amphetamines, 3,4-methylenedioxymethamphetamine [MDMA]). Among these positive results the following drugs were found: cannabis: n=136, 9.8%; heroin and other opioids: n=32, 2.3%; cocaine: n=23, 1.7%; amphetamines: n=9, 0.6% MDMA (active ingredient of ecstacy: n=9, 0.6%). More than one quarter of patients (n=45, 28.7%) tested positive for two or more of these drugs.

The test deployed for each drug simply provided a positive or negative result, but the amount required to give a positive test was substantial. The urine drug assay that was used continues to be positive 2 to 6 days after substance use, therefore it shows mainly recent exposure rather than regular use. On the other hand, an increase in major adverse events at one year might indicate chronic use.

After 1-year of follow-up, 94 (7%) patients experienced a serious cardiovascular event (including death). Patients with positive testing exhibited a higher rate of serious cardiovascular events than non-users (13% vs 6%, respectively, a statistically significant finding). The data were then adjusted for multiple factors – including age, sex, diabetes, current smoking status, history of cardiovascular disease before hospitalisation, known chronic kidney disease, history of cancer, the main admission diagnosis, baseline systolic blood pressure, and baseline heart rate. Following this adjustment recreational drug use was independently associated with a three times higher risk of serious cardiovascular events.

ln the subgroup analysis of 713 patients hospitalised at baseline for acute coronary syndrome, 96 (14%) had a positive recreational drug test and 50 (7%) experienced serious cardiovascular events. Using computer modelling in this population, recreational drug use was still independently associated with a three times higher risk of serious cardiovascular events after adjustment for traditional prognosticators.

Among the 1392 patients screened, there were 64 (4.6%) cardiovascular deaths, 55 (4.5%) among non-users and 9 (5.7%) among recreational drugs users. Considering heart attack, there were 24 (1.7%) non-fatal heart attacks overall, 16 (1.3%) among non-users and 8 (5.1%) among drug users. Considering stroke, there were 10 (0.7%) strokes, and 7(0.6%) for non-users and 3 (1.9%) for drug users.

Among recreational drugs tested, MDMA (4.1 times increased risk), heroin and other opioids (3.6 times) and cannabis (1.8 times) were significantly associated with serious cardiovascular events. The other drug types did not have a statistically significant relationship with serious cardiovascular events.

Dr Mirailles said: “ln a large cohort of consecutive patients admitted to intensive care cardiac units for acute cardiovascular events, the prevalence of recreational drug use was 11%. Recreational drug use was associated with a tripling of the risk of a repeat serious cardiovascular event within one-year.”

He added: “There is an increasing amount of data regarding worst prognosis associated with recreational drug use, not only in cardiac intensive care units but also in conventional intensive care units. Despite high rate of underreporting of recreational drug use, systematic screening is not recommended by the current guidelines. It might improve risk stratification of patients and personalised care to favour drug withdrawal. Therefore, systemic screening should be considered in intensive care.” 

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Newly designed 3D-printed lattice hemipelvis prosthesis improves osteointegration and favorable limb function: study

Lattice structure refers to a 3D framework characterized by a network of interconnected struts or beams arranged in a repeating pattern. In medical devices and implants, lattice porous structures can provide lightweight, excellent interconnectivity, and good mechanical strength. Recent studies have shown that irregular lattice structures facilitate osteointegration due to the biomimetic property.

Li et al conducted study to biomimetic design a new 3D-printed lattice hemipelvis prosthesis with irregular porous structures and evaluate its clinical efficiency for pelvic reconstruction following tumor resection, focusing on feasibility, osseointegration, and patient outcomes.

12 patients with pelvic tumors underwent tumor resection and subsequently received 3D-printed lattice hemipelvis prostheses for pelvic reconstruction were included in the study.The prosthesis was strategically incorporated with lattice structures and solid to optimize mechanical performance and osseointegration. The pore size and porosity were analyzed. Patient outcomes were assessed through a combination of clinical and radiological evaluations.

Key findings of the study were:

• Multiple pore sizes were observed in irregular porous structures, with a wide distribution range (approximately 300–900 μm).

• The average follow-up was 34.7 months, ranging 26 from to 43 months.

• One patient with Ewing sarcoma died of pulmonary metastasis 33 months after surgery while others were alive at the last follow-up.

• Postoperative radiographs showed that the prosthesis’s position was consistent with the preoperative planning. T-SMART images showed that the host bone was in close and tight contact with the prosthesis with no gaps at the interface.

• The average MSTS score was 21 at the last follow-up, ranging from 18 to 24.

• There was no complication requiring revision surgery or removal of the 3D-printed hemipelvis prosthesis, such as infection, screw breakage, and prosthesis loosening.

The authors concluded that – “The newly designed 3D-printed lattice hemipelvis prosthesis created multiple pore sizes with a wide distribution range and resulted in good osteointegration and favorable limb function.”

Further reading:

Biomimetic design and clinical application of Ti-6Al-4V lattice hemipelvis prosthesis for pelvic reconstruction

Li et al. Journal of Orthopaedic Surgery and Research (2024) 19:210 https://doi.org/10.1186/s13018-024-04672-5

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Brain electrical stimulation suppresses appetite. A new frontier in obesity treatment?

The R&D on neuromodulation technology for the treatment and management of metabolic syndrome conducted by a team led by Dr. Ki-young Shin of Human Care Electro-Medical Device Research Center, Electro-Medical Equipment Research Division of KERI is underway smoothly.

Metabolic syndrome is a complex of multiple metabolic abnormalities, including obesity, high blood pressure, and high triglycerides, often caused by poor diet and lack of exercise. According to the World Health Organization (WHO), one in eight people worldwide is overweight, making obesity treatment one of the most prominent markets currently.

There are various types of obesity treatments including drug injections and pharmaceuticals, but such chemical treatments often come with potential side effects when taken over for a long period. Accordingly, the team led by Dr. Shin of KERI has proposed a novel approach which is to suppress appetite by stimulating cerebral cortex electrically through scalp.

The official name of the electrical stimulation technique is transcranial random noise stimulation (tRNS). Through years of research, the team identified the possibility that non-invasive electrical stimulation of the dorsolateral prefrontal cortex with tRNS technology could induce appetite suppression.

1) The frontal lobe is located in the front of the brain and consists of three parts: the medial prefrontal lobe (motivation, initiation and maintenance of behavior), the dorsolateral prefrontal cortex (execution function, planning, flexibility, and abstract thinking), and the orbitofrontal cortex (impulse control and detecting danger).

2) Cortex: A collection of nerve cells covering the surface of the cerebrum.

Three key technologies are required for such studies. 

• A technology that can accurately deliver the right electrical stimulation to the specific area of interest.

• An electrode technology that can penetrate into the space between the hairs and make contact with the scalp. 

• A monitoring technology that can confirm that the electrical stimulation has been delivered to the target point and has triggered a change in brain activity. All of these are currently under development by Dr. Shin’s team and the team possesses an advanced level of technologies.

KERI conducted a clinical trial with professor Hyung-jin Choi’s team at Seoul National University Hospital to demonstrate the clinical utility of tRNS stimulation using commercially available electrical stimulators. The goal of the clinical trial was to prove that tRNS stimulation is effective in reducing appetite. The trial included 60 female volunteers, 30 in the tRNS group and 30 in the active sham group. The trial consisted of six sessions of electrical stimulation with two to three days of interval for two weeks. The electrical stimulation utilized a barely perceptible current of 2 mA for 20 minutes per session.

The results showed that the tRNS treatment group was effective in reducing appetite, willingness to eat, and hunger compared to the placebo group. The clinical trial also showed that tRNS can help treat emotional eating, meaning that the tendency to eat to process or relieve emotions such as stress, depression, anxiety, and joy was significantly reduced. As the trial was conducted only for two weeks, long-term weight loss effect was not confirmed but participants reported significant appetite suppression.

Dr. Shin said, “Although the technology is not yet complete and needs further research and verification, if this electrostimulation treatment equipment with far fewer side effects than existing obesity treatments is commercialized and can be used at home instead of in hospitals, it will provide an easy and simple method for daily appetite suppression management.“ He added, “Especially when people are under stress or difficulty, many people eat food due to emotional hunger, and if digital healthcare technology that combines electrostimulation treatment and exercise therapy is introduced, it will enhance weight loss effects and help individuals manage their health more effectively.“

The research team is scheduled to complete the first phase of the project (2022-2024) this year, and aims to validate the developed technology academically and clinically through follow-up research, including the second phase of the project, and promote technology transfer to companies.

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Want to feel less stressed? Try Mediterranean diet, suggests study

Following the Mediterranean diet versus the traditional Western diet might make you feel like you’re under less stress, according to new research conducted by a team from Binghamton University, State University of New York.

The findings suggest that people can lower their perception of how much stress they can tolerate by following a Mediterranean diet, said Lina Begdache, associate professor of health and wellness studies.

“Stress is recognized to be a precursor to mental distress, and research, including our own, has demonstrated that the Mediterranean diet lowers mental distress,” she said. “Thus, one element of the puzzle may be explained by the fact that the Mediterranean diet may be associated with a decrease in the negative components of perceived stress and an improvement in its positive attributes.”

The Mediterranean diet is plant-based with healthy fats and mostly includes wholesome food and a spectrum of natural colors. The diet stands in sharp contrast to the Western diet, which is known for its high concentration of high-glycemic and low-quality processed foods.

While the Mediterranean diet is known for its benefits to both mental health and physical health, little is known about its effect on perceived stress, which is the idea of how much stress you are under at any particular time.

To assess this, Begdache and her students conducted a survey of over 1,500 people, asking them what types of foods they ate and assessing their levels of perceived stress. Using a machine learning model, the results show that consuming components of the Mediterranean diet is associated with lower levels of perceived stress and mental distress, while consuming Western dietary components is correlated with perceived stress and mental distress.

Begdache said that these results close a gap in the literature because the majority of studies on diet and stress focused on how stress affects dietary choices and quality. She and her team are looking at different aspects of brain function and behaviors in relation to dietary patterns.

Reference:

Chowdhury U, Bubis S, Nagorny K, Welch M, Rosenberg L, Begdache L. Effects of Mediterranean and Western dietary patterns on perceived stress and mental distress. Nutrition and Health. 2024;0(0). doi:10.1177/02601060241263375.

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Evaluation of inflammatory parameters beneficial in follow-up of PCOS, Study finds

PCOS is a metabolic and endocrine disorder affecting 6-21% of women. In the recent research paper, “Evaluation of Oxidative Stress and Inflammation in Patients with Polycystic Ovary Syndrome,” the authors examine the relationship between oxidative stress, inflammation, and polycystic ovary syndrome (PCOS), a prevalent endocrine and metabolic disorder characterized by hyperandrogenism, hyperinsulinemia, and insulin resistance. The study aimed to compare patients with PCOS to healthy volunteers and assess changes in oxidative stress and inflammatory parameters. The authors observed that the prevalence of PCOS is increasing worldwide and is suspected to be closely related to inflammation and oxidative stress.

Measurements and Findings

The study included 30 patients diagnosed with PCOS and 30 healthy volunteers with similar demographic characteristics. The researchers measured clinical parameters using immunoassays and evaluated oxidative stress biomarkers such as total oxidant (TOS), total antioxidant (TAS), total thiol (TT), native thiol (NT) levels, and inflammatory parameters including interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α). They found that TT and NT levels were lower in patients with PCOS compared to those in the healthy group, while TAS, TOS, OSI, DIS, IL-1β, IL-6, and TNF-α levels were significantly higher in the patients with PCOS. The paper discusses the significance of oxidative stress and inflammation in the context of PCOS and its associated symptoms, including hyperandrogenism, hirsutism, oligomenorrhea, amenorrhea, and anovulation. The authors emphasize insulin resistance as a major cause of metabolic disorders and reproductive abnormalities in patients with PCOS. They note that oxidative stress, characterized by an imbalance between oxidants and antioxidants, is closely associated with PCOS and can lead to cellular damage. In particular, the study revealed elevated levels of oxidant biomarkers and reduced levels of antioxidant biomarkers in patients with PCOS compared to healthy controls.

Relationship with Obesity and Insulin Resistance

Moreover, the authors discuss the interplay between oxidative stress, inflammation, and PCOS, highlighting the association of PCOS with obesity, insulin resistance, metabolic syndrome, and type 2 diabetes mellitus. They found that inflammatory biomarkers such as TNF-α, IL-1β, and IL-6 were higher in women with PCOS compared to healthy volunteers, especially in cases of obesity and insulin resistance. However, they acknowledge the limitations of the study, including a small sample size and the lack of data on clinical parameters in the healthy control group.

Implications and Conclusion

In conclusion, the paper emphasizes the importance of evaluating oxidative stress and inflammatory parameters in patients with PCOS. The findings suggest that monitoring these parameters may be beneficial for the disease’s diagnosis and management. The authors declare no conflict of interest and obtained ethics committee approval for the study.

Key Points

– The research paper evaluates the relationship between oxidative stress, inflammation, and polycystic ovary syndrome (PCOS), a prevalent endocrine and metabolic disorder characterized by hyperandrogenism, hyperinsulinemia, and insulin resistance.

– The study includes 30 patients diagnosed with PCOS and 30 healthy volunteers with similar demographic characteristics. Clinical parameters and oxidative stress biomarkers (total oxidant, total antioxidant, total thiol, native thiol levels) and inflammatory parameters (interleukin-1β, interleukin-6, tumor necrosis factor-α) were measured.

– Patients with PCOS exhibited lower total thiol and native thiol levels compared to the healthy group, while total oxidant, total antioxidant, oxidative stress index, oxidative stress index, and inflammatory biomarker levels were significantly higher in the PCOS group.

– The paper highlights the significance of oxidative stress and inflammation in PCOS and its associated symptoms, such as hyperandrogenism, hirsutism, oligomenorrhea, amenorrhea, and anovulation. Insulin resistance is emphasized as a major cause of metabolic disorders and reproductive abnormalities in PCOS patients.

– There is a discussion on the interplay between oxidative stress, inflammation, and PCOS, particularly in relation to obesity, insulin resistance, metabolic syndrome, and type 2 diabetes mellitus. Inflammatory biomarkers were found to be higher in women with PCOS, especially in cases of obesity and insulin resistance.

– The paper concludes by emphasizing the importance of evaluating oxidative stress and inflammatory parameters in patients with PCOS for diagnosis and management, and highlights the implications of monitoring these parameters for the disease’s diagnosis and management. Ethical approval was obtained for the study, and no conflict of interest was declared by the authors.

Reference –

Sen B, Gonultas S, Albayrak C, Temur S, Acar I, Ozkan BN, Islek HS, Yilmaz MB, Kale E, Guler EM. Evaluation of oxidative stress and inflammation in patients with polycystic ovary syndrome. Obstet Gynecol Sci. 2024 Jul;67(4):414-420. doi: 10.5468/ogs.24031. Epub 2024 May 17. PMID: 38757191; PMCID: PMC11266846.

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