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A device designed to remove embolic material-fragments of tissue that can be released into the bloodstream during transcatheter aortic valve replacement (TAVR)—did not result in a reduction in the rate of stroke, according to a randomized trial presented at the American College of Cardiology’s Annual Scientific Session (ACC.25).

The BHF PROTECT-TAVI trial is the largest randomized trial assessing the use of a cerebral embolic protection device during TAVR, also known as transcatheter aortic valve implantation or TAVI.

“This large, well-conducted, appropriately powered clinical trial has addressed the question of whether the SENTINEL Cerebral Protection System is effective in an unselected cohort of TAVI patients,” said Rajesh Kharbanda, MD, associate professor of cardiovascular medicine at the University of Oxford, United Kingdom, and the study’s first author. “In our population, a routine strategy of cerebral embolic protection did not reduce the rate of stroke. Our study provides convincing evidence that there is no value in the routine use of this device during TAVI.”

TAVR is a common procedure carried out to treat patients with aortic stenosis, a condition in which the aortic valve becomes narrowed, preventing blood from flowing properly. During TAVR a prosthetic valve is implanted in the diseased valve between the aorta and the heart’s left ventricle. While TAVR carries a good safety record overall, around 2% to 4% of patients have a stroke during or shortly after the procedure, sometimes because calcium or tissue fragments are released when the replacement valve is deployed. About half of such strokes result in permanent disabilities.

Cerebral embolic protection devices are designed to capture embolic material that enters the bloodstream during TAVR, preventing it from reaching the brain and causing a stroke. SENTINEL, the device used in the trial, is the most frequently used embolic protection device in TAVR procedures.

The BHF PROTECT-TAVI trial enrolled 7,635 patients undergoing TAVR for aortic stenosis at 33 centers in the United Kingdom between 2020-2024, representing about 30% of all UK patients who received the procedure in those years. Participants had an average age of 81 years and just under 40% were female. Participants were randomized 1:1 to undergo TAVR with the SENTINEL device or TAVR without cerebral embolic protection.

In a third planned interim analysis, the trial’s primary endpoint-the incidence of stroke at 72 hours post-TAVR or at the time of hospital discharge, if sooner-occurred in 2.1% of patients assigned to the SENTINEL device and in 2.2% of patients assigned to the control group, showing no evidence of a difference between the two study arms. Results for secondary endpoints including all-cause mortality, stroke severity, disabling stroke and cognitive outcomes were also similar between groups. Recruitment for the trial was stopped after the interim analysis based on these findings.

No differences in outcomes were seen in any subgroups that were analyzed.

Researchers said the stroke risk associated with TAVR has decreased over the past decade due to improvements in TAVR devices, implantation techniques and procedural protocols and as operators have become more experienced with the procedure. Although the trial showed current cerebral embolic protection devices do not improve outcomes, Kharbanda said it is possible that next-generation embolic protection devices could potentially reduce stroke risk for certain groups, but further trials would be needed to demonstrate this.

“We need to understand which patients are at higher risk of stroke during TAVR and whether a more stratified approach to delivering therapy to those people is beneficial,” Kharbanda said.

Although the study was limited to the UK, researchers said the broad, national rollout of the trial and its representative patient population likely make the results generalizable to other countries.

Reference:

Embolic protection device shows no effect on stroke risk with TAVR, American College of Cardiology, Meeting: American College of Cardiology’s Annual Scientific Session.

China: A recent study published in the International Journal of General Medicine has explored the prognostic value of the Systemic Immune Inflammation Index (SII) and the Prognostic Nutritional Index (PNI) in predicting prolonged Intensive Care Unit (ICU) stays in patients with pneumonia complicated by respiratory failure.

A study finds that factors beyond a person’s control, like socioeconomic status and whether their mom smoked or was obese, can influence whether they are overweight or obese as teenagers or adults. Glenna Nightingale of the University of Edinburgh, UK and colleagues report these findings on March 26, 2025 in the open-access journal PLOS One.

Obesity is considered to be a global public health concern, but experts still disagree about the precise origins and causes of rising obesity rates. One topic under debate is whether a person’s individual genetics and behaviors are more or less important than environmental factors, like socioeconomic status, in developing obesity.

In the new study, researchers estimated the impact of several factors on a person’s weight, including societal factors, like a person’s job type, as well as early life factors, like a person’s birth order, how they were delivered and whether their mother smoked or was obese. They looked specifically at whether a person was overweight, obese or severely obese at age 16 and age 42. They also looked at participants’ weight between ages 16 to 42, a range that spans the rise in obesity rates in the United Kingdom. The data came from the 1958 National Child Development Study, a long-term study that followed the lives of more than 17,000 people born in a single week in March 1958 across England, Scotland and Wales.

The analysis showed that if a mother was obese or if she smoked, her child was more likely to be obese or severely obese at each of the ages examined. The findings demonstrate that these early life factors can have a persistent effect on a person’s weight. Notably, these factors were just as powerful before and after the start of the rise in obesity rates in the UK, suggesting that the impact of individual factors, like behaviors, likely did not change during that time.

The results suggest that societal and early-life risk factors could be used to target obesity prevention programs for children and adults. The researchers also conclude that, since individual risk factors have not changed as obesity rates have risen, new studies are needed to identify societal factors that may have caused the current obesity pandemic.

The authors add: “Our research shows that the effect of maternal influences persists through to age 42 and that strikingly, those predictors were just as powerful (and prevalent) in the era before the current obesity pandemic began. This suggests that, as Geoffrey Rose pointed out, novel studies are needed of factors at the community/societal level that may have caused the current obesity pandemic, since individual-level risk factors appear not to have changed over the time period spanning the pandemic’s onset and growth.”

Reference:

Glenna Nightingale ,Karthik Mohan,John Frank,Sarah Wild,Sohan Seth, Sociodemographic and early-life predictors of being overweight or obese in a middle-aged UK population– A retrospective cohort study of the 1958 National Child Development Survey participants, PLOS One, https://doi.org/10.1371/journal.pone.0320450

Wearable mobile health technology could help people with Type 2 Diabetes (T2D) to stick to exercise regimes that help them to keep the condition under control, a new study reveals.

Researchers studied the behaviour of recently-diagnosed T2D patients in Canada and the UK as they followed a home-based physical activity programme – some of whom wore a smartwatch paired with a health app on their smartphone.

They discovered that MOTIVATE-T2D participants were more likely to start and maintain purposeful exercise at if they had the support of wearable technology- the study successfully recruited 125 participants with an 82% retention rate after 12 months.

Publishing their findings in BMJ Open today (27 Mar), an international group of researchers reveal a range of potential clinical benefits among participants including improvements in blood sugar levels and systolic blood pressure.

Co-author Dr Katie Hesketh, from the University of Birmingham, commented: “Our findings support the feasibility of the MOTIVATE-T2D intervention – paving the way for a full-scale randomised controlled trial to further investigate its clinical and cost-effectiveness.

“We found that using biometrics from wearable technologies offered great promise for encouraging people with newly diagnosed T2D to maintain a home-delivered, personalised exercise programme with all the associated health benefits.”

Researchers found that, as well as the encouraging data for blood sugar and systolic blood pressure, the programme could help to lower cholesterol and improve quality of life.

The programme saw participants gradually increasing purposeful exercise of moderate-to-vigorous intensity – aiming for a target of 150 minutes per week by the end of 6 months and supported by an exercise specialist-led behavioural counselling service delivered virtually.

MOTIVATE-T2D used biofeedback and data sharing to support the development of personalised physical activity programmes. Wearable technologies included a smartwatch, featuring a 3D accelerometer and optical heart rate monitor, synced with an online coaching platform for the exercise specialist and web/smartphone app for participants.

“The programme offered a variety of workouts, including cardio and strength training, that could be done without the need for a gym,” added Dr Hesketh. “Its goal is to make exercise a sustainable part of daily life for people with Type 2 Diabetes, ultimately improving their physical and mental health.”

The feasibility trial recruited participants aged 40-75 years, diagnosed with T2D within the previous 5-24 months and managing their condition through lifestyle modification alone or Metformin.  

Reference:

Hesketh K, Low J, Andrews R, et alMobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): a decentralised feasibility randomised controlled trial delivered across the UK and CanadaBMJ Open 2025;15:e092260. doi: 10.1136/bmjopen-2024-092260