Archive for category: News

In a major, international study, named SELECT2, a University Hospitals (UH) research team found that patients with large strokes had a dramatically better recovery after endovascular thrombectomy plus medical management at long-term follow-up, than patients who only received standard medical management.

Endovascular thrombectomy is mechanical recovery of a clot that is blocking blood flow in an artery. Size of a stroke is determined by the range of damaged brain tissue seen through CT or MRI scans. While thrombectomy has proven effective in smaller strokes, patients with large strokes have been considered too high risk for the procedure.

The SELECT2 study was a tremendous, global team effort, spearheaded by UH as the coordinating center. A total of 352 patients, ages 18 to 85, with large ischemic strokes were randomized at 31 hospitals in North America, Europe, Australia and New Zealand. The primary findings of SELECT2 trial were published last year in the New England Journal of Medicine, demonstrating better clinical outcomes in patients receiving thrombectomy at the 90-day follow-up. Those findings, along with other trials, established efficacy and safety of endovascular thrombectomy in patients with large core strokes.

However, long-term outcomes for these patients were not explored before. As these patients have suffered large strokes, it remains plausible that they will take a longer time to achieve optimal stroke outcomes. The SELECT2 research team opted to address this question and analyzed patient outcomes after one year. The study published today in The Lancet to coincide with its presentation at the International Stroke Conference (ISC 2024) in Phoenix.

Patients receiving thrombectomy procedure demonstrated close to three times higher rates of independent living and twice the rates of independent walking. For every six patients treated, one achieved better outcomes as compared to medical management only. For a comparison, balloon angioplasty for heart attack only benefits one in 20-50 patients. Patients also demonstrated better quality of life scores.

Global Principal Investigator and Lead Author of the study, Amrou Sarraj, MD, said, “Throughout our research and clinical trials over the past three years, we’ve established that endovascular thrombectomy for patients with large ischemic stroke is safe and effective. However, until now, long-term outcomes for these patients remained widely unknown.” Dr. Sarraj is also the Stroke Center and System Director, the George M. Humphrey II Chair in Neurology at University Hospitals, and Professor of Neurology at Case Western Reserve University School of Medicine.

The SELECT2 results represent a major advancement in stroke therapy worldwide, and will bring hope for patients and families in a subgroup of patients who previously would have been thought not to benefit. The study proved that a higher quality of life for these patients persists for at least one year following intervention.

“Now that we have been able to follow these patients for a full year, we have confirmed the long-term benefits of thrombectomy in patients with large core strokes,” Dr. Sarraj explained. “With the evidence that improvement continues, exploration of how we can further improve these outcomes, including efforts on supportive care, such as rehabilitation and adjunctive therapies, becomes very important.”

“University Hospitals is thrilled to have served as the coordinating site for the transformative, international SELECT2 study expanding the indications for thrombectomy in large strokes,” said Daniel Simon, MD, President, Academic & External Affairs, Chief Scientific Officer, and Ernie and Patti Novak Distinguished Chair in Health Care Leadership at University Hospitals. “The results of this study will impact thousands of patients worldwide, significantly improving their quality of life. We look forward to implementing this practice changing treatment for stroke in our health system.” Dr. Simon is also Professor of Medicine and Senior Associate Dean for Academic Affairs at Case Western Reserve School of Medicine.

Reference:

Amrou Sarraj, Ameer E. Hassan, Michael G. Abraham, Santiago Ortega-Gutierrez, Scott E. Kasner, M. Shazam Hussain, Michael Chen, Spiros Blackburn, Clark W. Sitton, Leonid Churilov, Sophia Sundararajan, Trial of Endovascular Thrombectomy for Large Ischemic Strokes,New England Journal of Medicine, DOI: 10.1056/NEJMoa2214403.

The Lancet Child & Adolescent HealthAn enthusiastic response to food in early childhood may be linked to a higher likelihood of experiencing eating disorder symptoms in adolescence, according to a new study led by researchers at UCL and Erasmus University Rotterdam.

The study, published in The Lancet Child & Adolescent Health, looked at survey data from 3,670 young people in the UK and the Netherlands to investigate how appetite traits in early childhood might relate to the likelihood of developing eating disorder symptoms up to 10 years later.

The researchers found that a particularly high food responsiveness, defined as the urge to eat when you see, smell or taste palatable food, at the ages of four and five was linked to a higher likelihood of reporting a range of eating disorder symptoms at ages 12 to 14.

The team also found that a slower pace of eating and feeling full more quickly (high sensitivity to satiety) in early childhood may be protective against developing some eating disorder symptoms later.

Co-lead author Dr Ivonne Derks (UCL Institute of Epidemiology & Health Care) said: “Although our study cannot prove causality, our findings suggest food cue responsiveness may be one predisposing risk factor for the onset of eating disorder symptoms in adolescence.

“However, high responsiveness to food is also a normal and very common behaviour and should be seen as just one potential risk factor among many rather than something to cause parents worry.”

Higher food responsiveness was linked to a 16% to 47% increase in the odds of reporting eating disorder symptoms, including binge eating symptoms, uncontrolled eating, emotional eating, restrained eating and compensatory behaviours.

The 47% increase was found for binge eating symptoms (eating a very large amount of food and/or experiencing the feeling of loss of control over eating), meaning that adolescents whose parents rated them highest on food responsiveness were almost three times more likely to report binge eating symptoms compared to adolescents whose parents scored them lowest.

A 16% increase in odds was found for restrained eating, whereby a person restricts their intake of food to lose weight or avoid weight gain.

Just like food responsiveness, emotional overeating in early childhood was also linked with higher odds of engaging in compensatory behaviours, which are intended to avoid weight gain, such as skipping meals, fasting and excessive exercise.

In turn, some appetite traits seemed to be protective against developing eating disorder symptoms later. Higher satiety responsiveness – that is, feeling full more quickly after eating, and feeling full for longer – was linked to lower odds of uncontrolled eating (defined as the extent to which someone feels out of control and eats more than usual) and compensatory behaviours.

A slower pace of eating, meanwhile, was linked to lower odds of compensatory behaviours and restrained eating.

The researchers also found that appetite traits such as food fussiness, emotional undereating (eating less due to low mood), and enjoyment of food in early childhood were not linked to later eating disorder symptoms in adolescence.

For the study, the researchers looked at data from two separate longitudinal studies: Generation R, following children born in Rotterdam, the Netherlands, between 2002 and 2006, and Gemini, which follows twins born in England and Wales in 2007.

Appetite traits were assessed based on parents’ questionnaire responses when the children were aged four or five. Eating disorder symptoms were self-reported by the then adolescents themselves at ages 12 to 14, when eating disorder symptoms typically start to emerge.

About 10% of the adolescents reported binge eating symptoms, where people eat an unusual amount of food and/or experience the feeling of loss of control over eating. Next to that, 50% reported at least one behaviour to compensate their food intake or to avoid gaining weight, such as skipping a meal.

Co-senior author Dr Clare Llewellyn (UCL Institute of Epidemiology & Health Care) said: “While the role of appetite in the development of obesity has been studied for many decades, this is the first study to comprehensively examine the role of appetite traits in the development of eating disorder symptoms.

“Eating disorders can be harder to treat effectively once they develop and so it would be better to prevent them from occurring in the first place. Our work in identifying risk factors in early life aims to support the development of possible prevention strategies. These could, for instance, involve providing extra support to children at higher risk.”

Appetite traits indicate how we respond to food and the opportunity to eat, and the extent to which we want to eat more or less when experiencing negative emotions. They are divided into food approach appetitive traits (e.g. food responsiveness, enjoyment of food, emotional overeating) and food avoidance traits (e.g. satiety responsiveness, food fussiness, slowness in eating, emotional undereating).

Co-senior author Professor Pauline Jansen of Erasmus University Rotterdam said: “Overall, our findings suggest that developing and testing prevention strategies may be a worthwhile effort. Although appetite has a substantial genetic component, we also know that there are environmental influences that offer opportunities for behaviour change.”

The researchers indicate that a healthy food environment and responsive parental feeding strategies may help to lower the risk of developing eating disorders.

Co-lead author Dr Zeynep Nas (UCL Institute of Epidemiology & Health Care) explained: “A healthy food environment is an environment in which healthy foods are available and more prominent, salient and affordable than less healthy options. This also includes wider access to food such as what types of food outlets are available in our neighbourhood and what food we see on TV.

“Responsive feeding is about providing nutritious food at set mealtimes and snack times, and then allowing the child to decide what to eat and how much to eat (if anything at all) without pressuring them.”

In a separate paper, accepted for publication in the International Journal of Eating Disorders, a similar research team looked at the same two cohorts, Generation R and Gemini, to investigate how parental feeding practices in early childhood might affect likelihood of eating disorder symptoms in adolescence.

The researchers found that non-responsive feeding practices, such as putting pressure on children to eat or using food as a reward or to soothe emotions, were linked to a higher likelihood of specific eating disorder symptoms later. However, the associations were small and varied between the two cohorts, and the researchers said further replication studies were needed.

Reference:

vonne P M Derks, Zeynep Nas, Holly A Harris, Alice R Kininmonth, Prof Janet Treasure, Prof Pauline W Jansen, Early childhood appetitive traits and eating disorder symptoms in adolescence: a 10-year longitudinal follow-up study in the Netherlands and the UK, The Lancet Child & Adolescent Health, DOI:https://doi.org/10.1016/S2352-4642(23)00342-5.

In the groundbreaking INBUILD trial, researchers discovered that nintedanib
can significantly improve the lives of patients suffering from progressive
pulmonary fibrosis (PPF). Nintedanib
holds promise not only in reducing the progression of dyspnea, fatigue, and
cough but also in mitigating the overall impact of ILD over 52 weeks in
patients grappling with PPF.

The trial results were published in the journal European Respiratory Journal. 

Pulmonary fibrosis, a
condition characterized by scarring of the lungs, often leads to symptoms such
as dyspnea (shortness of breath) and cough, profoundly impacting patients’
daily lives. Hence, researchers conducted a trial, that focused on the effects
of nintedanib on PPF symptoms using the Living with Pulmonary Fibrosis (L-PF)
questionnaire to assess changes in patients’ conditions.

The trial included 663 patients with fibrosing interstitial lung
disease (ILD), excluding idiopathic pulmonary fibrosis, but with more than 10%
lung involvement on high-resolution computed tomography (HRCT) scans and
evidence of ILD progression within the past 24 months. Patients were randomly
assigned to receive either nintedanib or a placebo, with researchers analyzing
L-PF questionnaire scores from baseline to week 52 using mixed models for
repeated measures.

Findings:         

• The results revealed a significant positive
  impact of nintedanib on patients’ lives compared to the placebo group.
• Those receiving nintedanib experienced smaller
  increases (worsenings) in adjusted mean L-PF questionnaire total scores (0.5
  versus 5.1) at week 52.         
• This trend was also observed in symptom scores
  (1.3 versus 5.3), dyspnea (4.3 versus 7.8), and fatigue (0.7 versus 4.0).          
• One notable finding was the decrease in L-PF
  questionnaire cough score in the nintedanib group, in stark contrast to the
  placebo group where cough scores increased (-1.8 versus 4.3).          
• Additionally, the impacts of ILD, as assessed
  by the L-PF questionnaire impact score, decreased slightly in the nintedanib
  group while increasing in the placebo group (-0.2 versus 4.6).       
• These positive outcomes were consistent across
  different patient subgroups, including those with a usual interstitial
  pneumonia-like fibrotic pattern on HRCT and those with other fibrotic patterns
  on HRCT.
  

The findings suggest that nintedanib has the potential to not only
reduce the worsening of dyspnea, fatigue, and cough but also mitigate the
overall impact of ILD over 52 weeks in patients with progressive pulmonary
fibrosis.

This breakthrough offers hope to individuals grappling with the
debilitating effects of pulmonary fibrosis, as it paves the way for improved
treatment strategies and enhanced quality of life for those affected by this
challenging respiratory condition. As researchers continue to unravel the
complexities of pulmonary fibrosis, advancements like these represent a
significant step forward in the pursuit of better therapeutic options and
increased well-being for patients.

Further reading: Effects of nintedanib on symptoms in patients with progressive pulmonary fibrosis. DOI: 10.1183/13993003.00752-2023

Recently published study aimed to assess the association between nutrition intake and 28-day mortality in critically ill patients receiving exclusive enteral nutrition (EN) during the first week of ICU admission and the potential impact of lactate levels on this association. The study was a post hoc analysis of a cluster-randomized clinical trial and included 1322 patients who received exclusive EN during their first week of ICU stay. The findings showed that increased energy and protein delivery during the first week were associated with a significant reduction in 28-day mortality. However, this association was observed only in patients with lactate concentration ≤ 2 mmol/L and not in those with lactate concentration > 2 mmol/L. The study also highlighted that the nutrition therapy provided was suboptimal, with most patients receiving only approximately 50% of their energy and protein requirements.

Findings and Association with Mortality

The study addressed the potential impact of using ideal body weight instead of actual body weight and found that the results remained stable in different models. The authors acknowledged limitations of the study, such as the post hoc nature, differences in patient populations, and the inability to weigh the importance of energy and protein delivery due to multicollinearity. The study concluded that enhanced nutrition delivery was associated with reduced 28-day mortality in critically ill patients receiving exclusive EN during the first week of ICU admission, particularly in patients with lactate concentration ≤ 2 mmol/L. The findings suggest that further prospective studies are needed to confirm these results and address the limitations identified in this study.

Reference 

Chen, Y., Liu, Z., Wang, Q. et al. Enhanced exclusive enteral nutrition delivery during the first 7 days is associated with decreased 28-day mortality in critically ill patients with normal lactate level: a post hoc analysis of a multicenter randomized trial. Crit Care 28, 26 (2024). https://doi.org/10.1186/s13054-024-04813-6.