Several case series have highlighted the ADVOS hemodialysis system’s efficacy in eliminating water-soluble and protein-bound substances across diverse patient populations, such as multiorgan failure, acute-on-chronic liver failure (ACLF), acidosis, and even COVID-19. The EMOS-Registry, a non-interventional, multi-center patient registry, amassed real-world evidence, culminating in the largest patient cohort treated with ADVOS to date. This study aims to present and analyze the final performance and safety outcomes from the entire dataset comprising 282 participants. Data spanning from January 18, 2017, to August 31, 2020, were collected from five German hospitals, encompassing subsets of patients with acidosis and ACLF grade 3. Performance and safety were assessed through vital signs, clinical laboratory parameters and blood gas analyses. The SOFA Score-Standardized Mortality Ratio (SMR) served to evaluate patient outcomes in the absence of a control group. Participants, with a median age of 58 years, predominantly male (64%), exhibited a high requirement for mechanical ventilation (68%) and vasopressors (82%) with a median SOFA Score of 15. Notably, a median of 3 (IQR 2, 5) ADVOS sessions per patient were administered. Following the initial treatment, significant reductions were observed in bilirubin (−1.9 [CI 95% −1.3, −2.5]), creatinine (−0.5 [−0.4, −0.6]), and blood urea nitrogen (−13.1 mg/dL [−10.3, −16.0]) levels. Moreover, there were marked improvements in blood pH (7.34 vs. 7.41, p < 0.001), HCO3- (19.4 vs. 24.6 mmol/l, p < 0.001) and base excess (−5.6 vs. 0.2 mmol/l, p < 0.001). The observed mortality rate (66%) was notably lower than the expected rate based on SOFA Score (84%), resulting in a SMR of 0.79 (95% CI: 0.66–0.93), with a calculated number needed to treat (NNT) of 5.8. This study emphasizes the ADVOS system’s efficacy in eliminating water-soluble and protein-bound substances and correcting acid-base imbalances across a diverse cohort with multiorgan failure. However, further validation through randomized controlled trials is warranted to solidify these findings.Trial registrationDRKS00017068. Registered 29 April 2019 – Retrospectively registered, https://drks.de/search/en/trial/DRKS00017068

Contralateral exploration or not during open inguinal hernia repair in infants aged 0-6 months to prevent recurrent hernia surgery: a multicenter randomized controlled trial (HERNIIA-trial) in infants aged 0-6 months.

The European Society of Cardiology (ESC) guidelines are foundational for diagnosing, treating, and managing cardiovascular conditions, emphasizing efficacy through the Class of Recommendation (COR) and Level of Evidence (LOE) system. However, these guidelines do not systematically integrate considerations on economic feasibility and implementation complexity, crucial for decision-making in resource-limited settings. This paper reflects the work and discussion of the ESC Clinical Practice Guidelines Committee to address these gaps and proposes a novel framework which integrates two metrics: the number needed to treat (NNT) at five years as a measure of clinical effectiveness, and a qualitative assessment of implementation complexity. A three-dimensional grid visualises these metrics alongside disease prevalence, providing policymakers and healthcare resource planners with a structured tool for prioritising interventions.The framework is intended as a tool to support the implementation of guideline-based recommendations in specific health system contexts. Using the 2021/23 ESC heart failure (HF) guidelines and the focused update as a case study, the pilot framework evaluates pharmacological and device-based therapies with Class Of Recommendation I, LOE A, incorporating data from randomised trials underpinning the recommendations. NNT values are calculated for mortality and hospitalisation endpoints, while implementation complexity is assessed through a Delphi process, considering factors such as cost, infrastructure, and patient access. This approach offers a standardized method to compare interventions and their feasibility, bridging to current ESC guidelines. It could be particularly relevant in resource-constrained and high-cost environments, supporting informed decision-making and equitable adoption of evidence-based therapies. While promising, the framework requires further validation, and complexity assessments must be tailored to local contexts. By integrating clinical impact, implementation complexity, and disease prevalence, this proposed framework aims to bridge the gap between the guidelines' focus on treatment efficacy and the practical need for prioritisation in implementation and healthcare planning.

Background In the absence of head-to-head analyses, indirect treatment comparisons (ITCs) can be used for comparative treatment evaluations. A previous ITC of atogepant and rimegepant assessed outcomes from US trials for the preventive treatment of migraine. We expand those initial analyses, and use an ITC to evaluate the efficacy, safety, and tolerability, and estimate the number needed to treat (NNT) per additional ≥50% responder for atogepant and rimegepant in Japanese participants. Methods RELEASE (M22-056) and BHV3000-309 were randomized, double-blind, placebo-controlled studies evaluating atogepant compared with placebo and rimegepant compared with placebo for the preventive treatment of episodic migraine (EM) in Japanese participants, respectively. An ITC using a random effects model compared the efficacy, safety, and tolerability of atogepant 60 mg once daily and rimegepant 75 mg once every other day. Estimates of mean differences with 95% confidence intervals (CIs) are presented for monthly migraine days (MMDs), acute medication use days, Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ v2.1) Role Function-Restrictive (RFR) domain score, Migraine Disability Assessment (MIDAS), and European Quality of Life Visual Analog Scale (EQ VAS). Safety and tolerability results are presented as hazard ratios and 95% CIs. The NNT resulting in one additional person achieving a ≥ 50% reduction from baseline in mean MMDs/monthly headache days was analyzed across three responder definitions. Results Atogepant demonstrated significantly higher mean monthly acute medication use days reduction (−1.68, 95% CI: −2.72 to −0.64; P &lt; 0.002) at weeks 1 to 12 and significantly greater improvement in MSQ v2.1 RFR domain score (5.13, 95% CI: 1.10 to 9.16; P = 0.01) at week 12. Additionally, atogepant demonstrated numerically higher mean MMD reduction at weeks 1 to 12, numerically greater reduction (improvement) in MIDAS at week 12, and numerically lower improvement in EQ VAS at week 12 relative to rimegepant (all P &gt; 0.05). Atogepant demonstrated numerically lower likelihood of treatment-emergent adverse events (TEAEs) (0.70, 95% CI: 0.45 to 1.09) and adverse events (AEs) leading to discontinuation (0.50, 95% CI: 0.03 to 9.46) compared with rimegepant (both P &gt; 0.05). The median NNT (95% CI) versus placebo for a ≥ 50% reduction from baseline in mean MMDs across weeks 1 to 12 was 2.5 (1.9 to 4.1) for atogepant and 16.6 (6.7 to ∞) for rimegepant. Additional responder definitions were consistent. Conclusions Among Japanese participants with EM, atogepant 60 mg demonstrated significantly or numerically greater improvements in four of five efficacy outcomes and numerically lower TEAEs and AEs leading to discontinuation compared with rimegepant 75 mg. Atogepant 60 mg had substantially lower NNTs per additional ≥50% responder versus placebo than rimegepant 75 mg. Trial Registrations: These studies are registered with ClinicalTrials.gov (NCT05861427, NCT05399485).

The aim of this meta-analysis was to evaluate the effects of targeted treatments for transthyretin amyloid cardiomyopathy (ATTR-CM) on clinical outcomes by integrating clinical trial and real-world data. A systematic literature search of PubMed was conducted up to 30 June 2025. A total of 714 relevant records were identified; out of 51 potentially eligible studies, 10 randomized placebo-controlled and non-randomized control comparison studies were selected, with available outcome data on all-cause mortality and cardiovascular hospitalizations. The estimates were extrapolated to real-world outcome data of untreated ATTR-CM patients to estimate absolute risk reduction (ARR) and number needed to treat (NNT). Ten studies comprising 5203 patients were included. ATTR-targeted treatments reduced mortality by 39% [risk ratio (RR) 0.61, 95% confidence interval (CI): 0.52 to 0.70, I2=35%, P=0.13]. A sensitivity subgroup analysis for RCT only confirmed a 28% reduction in all-cause mortality (RR 0.72, 95% CI: 0.60 to 0.86, I2=0%, P=0.56). The random effects model for cardiovascular hospitalizations demonstrated a 31% reduction in the ATTR-targeted treatment group compared with control (RR: 0.69, 95% CI: 0.53 to 0.89, I2=68%, P=0.01). By applying these estimates to published large-scale epidemiological data on the natural disease course from 18238 untreated patients, the estimated NNT of ATTR-CM therapeutics to prevent one death is an NNT of 10 at 2years and an NNT of 5 at 5years. Targeted treatments for ATTR-CM significantly reduce mortality and cardiovascular hospitalizations. When extrapolated to population-level data, these treatments show clinical benefits, emphasizing the importance of early diagnosis and therapeutic intervention.

Music intervention is effective in reducing perioperative anxiety, which occurs in a majority of hospitalized surgical patients. A calculated Number Needed to Treat (NNT) provides an intuitive means of conveying the effectiveness of an intervention that can help clinicians decide whether or not to implement said intervention. This study aimed to calculate an NNT to provide extra context to help clinicians consider the implementation of music intervention. To calculate the NNT of music intervention for perioperative anxiety, a systematic review and meta-analysis were performed. A comprehensive literature search was conducted in Medline ALL, Embase, Web of Science Core Collection, Cochrane, CINAHL Plus, and PsycINFO from inception until April 14, 2025. Studies describing randomized controlled trials comparing the effect of perioperative music intervention on perioperative anxiety, measured with any validated tool, were included. The revised Cochrane risk-of-bias handbook was used to determine the quality of the included studies. The NNT was calculated with Furukawa's method, converting a calculated Cohen's d to an NNT. Twenty papers were included in the review and meta-analysis. All studies used either the Visual Analog Scale for Anxiety or the 6-item State-Trait Anxiety Index. Standardized mean difference of anxiety reduction after music interventions was -0.72 (95% confidence interval [CI], -0.92 to -0.53), which equals a moderate-to-large effect size. The NNT for perioperative music intervention is 4. This indicates that 4 patients need to listen to music perioperatively, to reduce the Visual Analog Scale for Anxiety for 1 patient by 12 mm, or the State-Trait Anxiety Index by 5.7 points. This meta-analysis shows that a relatively low number of patients need to be treated with music intervention to reduce perioperative anxiety with an effectiveness similar to benzodiazepines.

Background Early lactation failure among mothers of moderate preterm infants poses a persistent public health concern. This study identified key predictors and developed a risk stratification tool. Methods We conducted a prospective cohort study of 3,210 mother-infant dyads (32.0–34.9 weeks gestation) at a tertiary hospital in China (February 2022–April 2025). Early lactation failure was defined as absence of direct breastfeeding with documented latch or provision of &amp;lt; 5 ml cumulative expressed breast milk within 72 h postpartum. Data included psychosocial assessments [breastfeeding self-efficacy scale-short form (BSES-SF), Edinburgh postnatal depression scale (EPDS), family support], obstetric factors, neonatal characteristics, and early care variables. Missing data was imputed using multiple chained equations (50 datasets). Multilevel logistic regression with ward-level random intercepts identified predictors, with bootstrap validation (1,000 resamples) assessing performance. Results Among 3,210 mother-infant dyads enrolled, 716 (22.3%) experienced early lactation failure within 72 h postpartum. Key predictors included higher BSES-SF scores [adjusted odds ratio (aOR) = 0.96 per point, 95% confidence interval (CI): 0.94–0.98], higher EPDS scores (aOR = 1.08, 95% CI: 1.04–1.12), cesarean delivery (aOR = 1.42, 95% CI: 1.15–1.75), neonatal respiratory support (aOR = 1.28, 95% CI: 1.05–1.56), and shorter kangaroo care duration (aOR = 0.92 per 10 min, 95% CI: 0.87–0.97). A five-factor risk tool stratified mothers into low-risk (13.0% failure rate), moderate-risk (20.5%), and high-risk (31.0%) groups, with strong discrimination ( C -statistic = 0.704; calibration slope = 0.952; Hosmer-Lemeshow p = 0.267). Population-attributable risks were highest for cesarean delivery (20.4%), low self-efficacy (18.9%), and depression (18.2%), with numbers needed to treat (NNT) ranging from 11 to 18. Conclusion This study confirms the multifactorial basis of early lactation failure, highlighting maternal psychosocial factors as key predictors. The validated risk tool enables identification of high-risk dyads for targeted nutritional support interventions.

HighlightsWhat are the main findings?Fracture incidence decreased from 9.5% to 1.64% after program implementation (RR 0.17; NNT ≈ 13).Among infants who fractured, post-program cases had lower peak ALP/PTH, earlier detection, and shorter LOS.What is the implication of the main finding?A protocolized bone health bundle can reduce fractures in extremely preterm/ELBW infants and is feasible for routine NICU practice.Results support multicenter evaluation to confirm generalizability, define core bundle components, and set quality benchmarks.Background: Metabolic bone disease (MBD) of prematurity predisposes extremely preterm and extremely low birth weight (ELBW) infants to atraumatic fractures. Evidence on fracture reduction after structured Bone Health Programs (BHPs) remains limited. Methods: We conducted a single-center retrospective cohort of NICU admissions (2014–2024) with gestational age < 28 weeks and/or birth weight < 1000 g, comparing a pre-program era with a standardized BHP that incorporated protocolized biochemical surveillance, a week 4 screening radiograph, optimized mineral targets, pharmacist review of parenteral minerals, and “handle-with-care” practices. The study aimed to evaluate whether implementation of a structured BHP reduced fracture incidence and improved biochemical and clinical outcomes in extremely preterm and ELBW infants. Prespecified effect measures were risk ratio (RR), risk difference (RD) with 95% confidence intervals, Fisher’s exact p values, and number needed to treat (NNT). Among infants with fractures, we compared clinical course and biochemical context across eras. Results: Of 708 eligible infants, 221 were born pre-program and 487 post-program with similar baseline characteristics. Fracture incidence decreased from 9.5% (21/221) to 1.64% (8/487); RR 0.17 (95% CI 0.08–0.38); RD −7.86 percentage points; p < 0.001; NNT ≈ 13. Among infants who fractured, length of stay was lower post-program (104.1 ± 28.3 vs. 172.0 ± 91.5 days). Peak alkaline phosphatase and parathyroid hormone were also lower in the post-program era (ALP 501.3 ± 71.2 vs. 972.5 ± 93.5 IU/L, p = 0.032; PTH 23.1 ± 12.5 vs. 38.4 ± 21.7 pmol/L, p = 0.027), whereas serum phosphate and 25 OH vitamin D did not differ significantly. The fracture burden per infant decreased following the BHP (1.50 ± 0.53 vs. 3.19 ± 3.08, p = 0.024). Age at first fracture was earlier post-program, consistent with scheduled imaging (48.4 ± 34.9 vs. 83.9 ± 37.3 days, p = 0.031). Conclusions: A structured BHP was associated with a large reduction in fracture incidence and more favorable biochemical profiles, together with shorter hospitalization among fracture cases. Program elements that combine scheduled imaging, biochemical triggers, nutritional optimization, parenteral mineral stewardship, and standardized handling may improve skeletal outcomes. Multicenter prospective evaluations should confirm generalizability and define core components.

ObjectiveTo evaluate the incidence of L5 radiculitis in patients undergoing posterior lumbar interbody fusion (PLIF) using a force-limited distance-measurable nerve root retractor (FLDM-NRR) combined with intraoperative neurophysiological monitoring (IONM), compared with conventional nerve root retraction.MethodsThis retrospective cohort study examined 234 patients with L4-L5 lumbar spinal stenosis (LSS) undergoing single-level PLIF from January 2022 to March 2024. Patients were categorized into the FLDM-NRR plus IONM group (n = 96) with force limitation ≤ 3.5 N, and the conventional nerve root retraction group (n = 138). The primary outcome was 3-month L5 radiculitis; Secondary outcomes included 1-year persistent neurological impairment, Japanese Orthopedic Association (JOA) scores, Oswestry Disability Index (ODI), Visual Analog Scale (VAS) pain scores, and achievement of minimal clinically important difference (MCID). Multivariable logistic regression, mixed-effects models, and hierarchical testing were applied.ResultsFLDM-NRR with IONM reduced the 3-month L5 radiculitis incidence (7.29% vs 18.12%, adjusted OR = 0.31, 95% CI 0.11–0.78; P = 0.017; absolute risk reduction (ARR) = 10.83%; number needed to treat (NNT) = 9), with greatest protection in the first postoperative week (3.13% vs 13.04%, P = 0.020). No significant difference was observed in 1-year persistent neurological impairment (3.13% vs 7.25% P = 0.200). The FLDM-NRR group showed superior ODI (18.43 ± 7.85% vs 21.17 ± 8.42%, P = 0.018) and higher MCID rates in VAS leg pain (95.8% vs 93.5%, P = 0.028). IONM demonstrated 85.71% sensitivity and 96.63% specificity in predicting postoperative complications. The FLDM-NRR system consistently upheld the predetermined force threshold in all instances without any device-related problems.ConclusionFLDM-NRR combined with IONM significantly reduces early L5 radiculitis after PLIF and provides short-term functional benefits. Long-term neuroprotection remains unproven and requires validation in prospective randomized trials.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13018-025-06429-0.

People with dementia are at a higher risk of inappropriate medication use; however, limited data inform clinical outcomes of sodium-glucose cotransporter 2 inhibitor (SGLT2i) use in people with diabetes and comorbid dementia. We aim to investigate cardiovascular effectiveness and safety of SGLT2i vs dipeptidyl peptidase-4 inhibitors (DPP4i) in older community-dwelling adults with diabetes by dementia status. This population-based, target trial emulation cohort study used linkable administrative datasets of residents of Ontario, Canada. Eligible initiators of SGLT2i or DPP4i with diabetes aged ≥66 years (2016-2022) were stratified by dementia status and matched 1:1 on propensity score. The primary cardiovascular effectiveness outcome was composite of all-cause mortality or hospitalisation for ischaemic stroke, myocardial infarction or heart failure. We also investigated eight safety outcomes potentially related to SGLT2i. Incidence rate differences (IRDs) per 1000 person-years and the 95% CIs were estimated. Homogeneity in IRDs between strata was assessed using the Cochran's Q statistic. One year number needed to treat (NNT) or harm (NNH) was also estimated using the Aalen-Johansen estimator with death as a competing risk. We analysed 2481 pairs with dementia and 52,196 pairs without dementia. The absolute reduction in the composite effectiveness endpoint with SGLT2i vs DPP4i initiation was greater among those with dementia (IRD [95% CI] -61.1 [-78.2, -43.9]; NNT: 20), compared to no dementia (IRD -21.7 [-23.7, -19.7]; NNT: 43; homogeneity: p<0.001). Across the individual effectiveness endpoints, SGLT2i vs DPP4i initiation in people with dementia was associated with reduced all-cause mortality (IRD -51.2 [-65.7, -36.7]; NNT: 25) and hospitalisation for heart failure (IRD -16.4 [-24.6, -8.2]; NNT: 99). For safety outcomes, SGLT2i vs DPP4i initiators with dementia showed less acute kidney injury (IRD -39.7 [-55.0, -24.4]; NNT: 76) and increased genital infection (IRD 9.7 [3.7, 15.6]; NNH: 64). The absolute increase in diabetic ketoacidosis (IRD 1.1 [0.7, 1.6] vs 5.9 [2.1, 9.8]; NNH: 785 vs 109; homogeneity: p=0.015) with SGLT2i was greater among those with dementia vs no dementia. While SGLT2i might provide cardiorenal protection among those with dementia, closer monitoring may be warranted due to greater susceptibility to diabetic ketoacidosis.

Prophylactic colonic endoscopic submucosal dissection (ESD) defect closure may reduce delayed adverse events (DAEs) such as bleeding and perforation associated with ESD and facilitate same day discharge. We compared the effect of colonic ESD defect closure (closed group) with no closure (open group) on DAEs and overnight hospital admission. We performed a Western multicenter retrospective study on patients who underwent colon ESD. Rectal lesions were excluded. DAEs were defined as adverse events within 2weeks of ESD. Primary outcome measures were DAEs and overnight hospital admission. Multivariate analyses were performed. 560 patients underwent colon ESD and 364 (71.8%) patients had complete defect closure. Closed group had a significantly lower rate of delayed bleeding (1.7% vs 5.6%, p = 0.03) compared to open group. Multivariate analysis with adjusted odds ratios (aOR) revealed right sided polyps (aOR = 7.0) and anticoagulation/antiplatelet agents (aOR = 6.6) increased the risk while defect closure (aOR = 0.2) decreased the risk of delayed bleeding. Defect closure amplified the reduction in risk of delayed bleeding (2.4% vs 10.4%, p = 0.014) for right-sided polyps. Malignant polyps significantly increased the risk of delayed perforation (aOR = 3.3) and overnight hospitalization (aOR = 2.9). Defect closure (aOR = 0.6), traction use (aOR = 0.6) and topical hemostatic agent use (aOR = 0.4) significantly reduced the risk of overnight hospitalization. Prophylactic closure of colon ESD defects was associated with a significant reduction in delayed bleeding with number needed to treat (NNT) of 25.6 (especially for right sided polyps, NNT 12.5), and post-procedural overnight hospitalization. Prospective studies are needed to further validate these results.

Background: Intensive systolic blood pressure (SBP) lowering and sodium-glucose cotransport-2 inhibitor (SGLT2i) treatment can reduce the risk of incident heart failure (HF). Research Question: Based on the American Heart Association Predicting Risk of Cardiovascular Disease Events (PREVENT) estimated risk, what is the modeled number needed to treat (NNT) to a SBP &lt;120 mmHg or with a SGLT2i to prevent an incident diagnosis of HF? Goal: Estimate the 5-year number needed to treat (NNT 5 ) to prevent one HF event for intensive systolic blood pressure control and SGLT2i initiation according to PREVENT HF risk. Methods: Baseline (2000-02) data for 6,034 participants in the Multi-Ethnic Study of Atherosclerosis (MESA) were used to calculate PREVENT HF risk. Mean risk reduction estimates from randomized controlled trials targeting SBP &lt;120 mmHg [38% relative risk reduction (RRR)] and with SGLT2i (31% RRR) were applied to observed HF incidence rates in MESA for NNT 5 calculations across baseline HF risk, as well as N-terminal prohormone of brain natriuretic peptide (NT-proBNP), and diabetes related risk. Low, intermediate, and high 10-year HF risk were defined as &lt;5%, 5-14%, and &gt; 15%, respectively. Results: Mean age was 62 years, 53% were female, 61% were non-white, and 12% had diabetes. The median 10-year PREVENT HF risk was 4%, distributed across individuals with low (52%), intermediate (39%), and high risk (9%). Over 10-year follow-up, there were 198 incident HF cases (3.6 per 1,000 person-years). In the overall sample, the estimated NNT 5 was 112 for intensive SBP control and 199 for SGLT2i. There were large differences in NNT 5 for intensive SBP control and SGLT2i among individuals with low PREVENT HF risk (537 and 768) versus high PREVENT HF risk (34 and 45) ( Figure ). Among individuals with an intermediate PREVENT HF risk, those with NT-proBNP &gt; 125 pg/mL or diabetes had a lower NNT 5 for intensive SBP control (47 and 53) and SGLT2i (64 and 91) compared to those with NT-proBNP &lt;125 pg/mL or without diabetes (intensive SBP control: 209 and 137; SGLT2i: 310 and 183). Conclusions: Both intensive SBP control and SGLT2i had a stepwise lower NNT 5 to prevent the incident diagnosis of HF across higher PREVENT risk scores, with a lower NNT 5 for intensive SBP control compared to SGLT2i. Incorporation of NTproBNP and DM assessment among intermediate risk persons may further guide allocation of therapies to reduce the risk of HF.

Background and Purpose: National data and trends on the impact of frailty on ST-segment elevation myocardial infarction (STEMI) are lacking. Methods: Retrospective data were extracted from the United States National Inpatient Sample from October 2015 to 2021 for hospitalizations with a STEMI diagnosis. A total of 900,935 STEMI hospitalizations were included in the final cohort. Based on Risk Analysis Index (RAI) scores, hospitalizations are categorized into robust, normal, frail, and very frail groups. Results: Frail and very frail hospitalizations account for about 6% of total hospitalizations. The in-hospital mortality rates for robust, normal, frail, and very frail are 5.09%, 14.49%, 30.67%, and 32.88%, respectively. Compared to robust and normal hospitalizations, Frail and very frail hospitalizations are less likely to receive primary percutaneous coronary intervention (pPCI). For overall hospitalizations, the odds ratios for in-hospital mortality for pPCI treated robust, normal, frail, and very frail hospitalizations are 0.23 [95% CI (0.22-0.25)]; p&lt;0.001, 0.28 [95% CI (0.27-0.30)]; p&lt;0.001, 0.34 [95% CI (0.30-0.37)]; p&lt;0.001, and 0.35 [95% CI (0.30-0.42)]; p&lt;0.001, respectively. The reduction of in-hospital mortality with pPCI treatment is consistent after propensity score matching for each frailty groups. Fewer patients need to be treated to prevent one additional in-hospital death in the frail and very frail groups compared to the robust and normal groups (number needed to treat (NNT)=4 in the very frail group and NNT=5 in frail group, whereas NNT =10 in the robust group). Conclusions: This analysis highlights the worse in-hospital outcomes of frail and very frail hospitalizations for STEMI patients. Despite the fact that pPCI consistently shows a significant reduction in in-hospital mortality. frail and very frail hospitalizations are less likely to receive this treatment. This underscores the need for careful consideration of frailty in treatment decisions, as timely pPCI may improve outcomes even in these high-risk population.

Background: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a progressive infiltrative cardiomyopathy with significant morbidity and mortality. Transthyretin (TTR) stabilizers such as Tafamidis and Acoramidis are reported to have increased clinical benefits; however, comparison of safety profiles remains limited. Thus, comparing their adverse event profile is essential for long-term treatment strategies. Methods: We systematically searched PubMed, Embase, and Cochrane CENTRAL for randomized controlled trials comparing tafamidis or acoramidis with placebo in patients with ATTR-CM. Two trials met inclusion criteria. Data were extracted for treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), discontinuation due to TEAEs, cardiac TEAEs, cardiac failure, and atrial fibrillation. Pooled analysis was performed using the inverse variance method with a random-effects model in RevMan. Risk ratios, risk differences, confidence intervals, and forest plots were generated. Results: Two RCTs were included. The incidence of any TEAE was comparable between TTR stabilizers and placebo (RR=1.00, 95% CI: 0.98–1.02, p=0.99), suggesting no increase in overall adverse events. TTR stabilizers were associated with a significant reduction in serious adverse events (RD=–0.07, 95% CI: –0.14 to –0.00, p=0.04), with a number needed to treat (NNT) of 14. Cardiac failure-related events were also significantly lower with treatment (RD=–0.10, 95% CI: –0.20 to –0.00, p=0.04), corresponding to an NNT of 10. No statistically significant differences were observed in discontinuations due to TEAEs , overall cardiac TEAEs, and atrial fibrillation. Conclusion: TTR stabilizers showed a favorable safety profile in ATTR-CM, with reduced rates of serious and cardiac failure-related adverse events and no increase in overall TEAEs. These findings support their clinical safety; however, limited study numbers and sample sizes warrant cautious interpretation and highlight the need for further research.

Background: Quantitative coronary plaque analysis from coronary computed tomographic angiography (CCTA) is a promising strategy for individualized cardiovascular disease (CVD) prevention. More population-level data is needed on how plaque burden can inform lipid lowering strategies to reduce CVD risk reduction. Objectives: To evaluate the prognostic utility of a total plaque volume (TPV)-based risk staging system and model its use in guiding lipid-lowering therapy in real-world patients undergoing clinically indicated CCTAs for evaluation of chest pain. Methods: We analyzed adult patients across a single-center NHS site who underwent clinically indicated CCTA with available AI-based quantitative plaque analysis. TPV was categorized into four risk stages (DECIDE 1–4) using predefined thresholds ( Table 1 ). The primary outcome was cardiac death or non-fatal MI. Secondary analyses reclassified prior myocardial infarction (MI) or early revascularization into DECIDE Stage 4. We modeled lipid-lowering strategies using both fixed-intensity treatment by DECIDE stage and stage-specific LDL-C goals to estimate risk reduction and number needed to treat (NNT) over 3-to-10-year durations. Results: Among the 2,827 patients, mean (SD) age was 58 (13) years, and 51.1% were female. Higher TPV stages were associated with progressively increased risk of CV death or MI (1.7%, 4.9%, 7.4%, 11.1% for stages 1–4, respectively) ( Figure 1 ). The fixed intensity strategy yielded a 10-year NNT of 52, which improved to 42 when using a stage-specific LDL-C goal strategy guided by plaque burden. Conclusions: Quantitative plaque burden measured by AI-enabled CCTA identifies patients at elevated long-term cardiovascular risk and may inform a personalized lipid-lowering strategy to mitigate risk.

Background: Yoga is associated with improved cardiovascular risk factors, but its impact on major adverse cardiac events remains uncertain. We evaluated whether regular yoga practice is associated with a reduced incidence of acute coronary syndrome (ACS) in hypertensive adults using real-world data. Methods: We conducted a retrospective cohort study using the TriNetX research network. Adults aged ≥18 with ≥2 hypertension-related diagnoses were included. Cohort A (yoga group) comprised patients with ≥2 yoga-related encounters within a 1-month period. Cohort B (control group) included hypertensive adults with no documented yoga exposure. Patients with prior ACS were excluded. Propensity score matching (1:1) was performed based on age, sex, smoking history (F17., Z72.0), and type 2 diabetes (E11.), yielding 1,269,231 patients per group. The primary outcome was incident ACS (ICD-10: I20.0–I23.*) within 3 years after index. Secondary outcomes included all-cause mortality, stroke/transient ischemic attack (TIA), and cardiac arrest. Outcomes were assessed using risk ratios (RR), hazard ratios (HR), and Kaplan-Meier survival. Results: Over 3 years, ACS occurred in 0.6% of the yoga group (n=7,317) vs. 2.0% of the non-yoga group (n=25,672), corresponding to an absolute risk reduction of 1.4%, RR of 0.30 (95% CI: 0.29–0.31), and HR of 0.41 (95% CI: 0.40–0.42; p&lt;0.0001). The number needed to treat (NNT) was 71. Kaplan-Meier curves showed early and sustained divergence in ACS-free survival beginning at 6 months. Stroke/TIA occurred in 2.1% of yoga patients vs. 5.2% in controls (RR: 0.40; HR: 0.54; p&lt;0.0001). Cardiac arrest occurred in 0.6% vs. 0.9%, respectively (RR: 0.66; HR: 0.88; p&lt;0.0001). All-cause mortality was higher in the yoga group (12.0% vs. 6.9%, HR: 2.29; p&lt;0.0001), potentially reflecting residual confounding, reverse causation, or inclusion of nonspecific counseling codes such as Z71.89. Conclusion: In this large, matched real-world cohort, regular yoga practice was associated with a significantly reduced risk of ACS, stroke/TIA, and cardiac arrest among hypertensive adults. These findings support yoga as a complementary strategy in cardiovascular prevention. Further investigation is warranted to clarify unexpected mortality trend.

Introduction: Lipid lowering therapies have value in reducing adverse atherosclerotic cardiovascular disease (ASCVD) events and are recommended in primary and secondary prevention of ASCVD. Beyond p values, absolute risk reduction (ARR) and number needed to treat (NNT), the fragility index (FI) has emerged as a useful metric to assess robustness of clinical trial results. It describes the minimum number of participants whose event outcome would have to change to turn a statistically significant result into a nonsignificant one. Thus, the higher the FI, the more robust the trial. Research Question: What is the FI of the randomized controlled trials (RCTs) from which the 2019 ACC/AHA Guideline on Primary Prevention and 2022 Expert Consensus Decision Pathway (ECDP) derive their lipid-lowering therapy recommendations? Methods: All cited RCTs and those from meta-analyses referenced in the lipid portion of the 2019 Guideline on Primary Prevention and 2022 EDCP were eligible for inclusion. Exclusion criteria included primary endpoints other than all-cause mortality or cardiovascular events, nonpharmacological interventions, and the absence of published statistical analysis. Results: Forty-two trials were included. Twenty RCTs (47.6%) had an FI of 0. Of them, 16 met target enrollment, 3 underenrolled, and 1 did not report target enrollment. There were 11 studies (26.2%) with an FI greater than the number lost to follow up (median FI 47), suggesting that even if all these subjects were to have adverse events, the result would likely still be significant. Five of these studies were statin versus placebo (median FI 21); 1 was statin versus usual care (FI 67); 2 were moderate versus high intensity statin (median FI 40); 1 was statin versus statin and ezetimibe (FI 47); 1 was statin with PCSK9 inhibitor versus statin (FI 118); 1 was bempedoic acid versus placebo (FI 31). Seven studies had an FI&gt;0 but did not report the number lost to follow-up, and 4 RCTs had a number lost to follow-up greater than the FI (Table). Conclusion: RCTs that include statins, ezetimibe, PCSK9 inhibitors, and bempedoic acid show higher FIs. However, there is variability within these trials, with some having an FI greater than zero and even fewer having a number lost to follow-up less than the FI. The diversity in this strength of evidence is particularly apparent at low or moderate intensity statin dosing.

Estimated cardiac deaths associated with treating chronic lymphocytic leukemia with ibrutinib versus zanubrutinib in the United States

Number of cardiac deaths associated with ibrutinib versus zanubrutinib for the treatment of chronic lymphocytic leukemia: A European risk-based estimation

Reduction of infections with intravenous immunoglobulin in chronic lymphocytic leukemia: A single-center retrospective analysis