Outcome Events Research Articles

Fasting vs no fasting prior to catheterisation laboratory procedures: the SCOFF trial.

Current guidelines recommend 6 hours of solid food and 2 hours of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no fasting strategy to fasting prior to cardiac catheterisation procedures which require conscious sedation. This is a multicentre, investigator-initiated, non-inferiority randomised trial conduced in Australia with a prospective open label blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention or cardiac implantable electronic device (CIED) related procedures were enrolled. Patients were randomised 1:1 to fasting as normal (6 hours solid food and 2 hours clear liquid) or no fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. 716 patients were randomised with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 versus 3.0 hours, Bayes factor >100 indicating extreme evidence of difference) and clear liquid fasting times (7.0 versus 2.4 hours, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no fasting arm. The estimate of the mean posterior difference in proportions in the primary composite outcome was -5.2% (95% CI -9.6 to -0.9, ) favouring no fasting. This result confirms non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36 to 4.67, Bayes factor >100). Secondary outcome events were similar. In patients undergoing cardiac catheterisation and CIED related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterisation laboratory procedures that require conscious sedation.

Aortic valve replacement versus conservative treatment in asymptomatic severe aortic stenosis: long-term follow-up of the AVATAR trial.

The question of when and how to treat truly asymptomatic patients with severe aortic stenosis (AS) and normal left ventricular (LV) systolic function is still subject to debate and ongoing research. Here, the results of extended follow-up of the AVATAR trial are reported (NCT02436655, clinical trials.gov). The AVATAR trial randomly assigned patients with severe, asymptomatic AS and LV ejection fraction ≥50% to undergo either early surgical aortic valve replacement (AVR) or conservative treatment with watchful waiting strategy. All patients had negative exercise stress testing. The primary hypothesis was that early AVR will reduce a primary composite endpoint comprising all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure (HF), as compared to conservative treatment strategy. A total of 157 low-risk patients (mean age 67 years, 57% men, mean Society of Thoracic Surgeons score 1.7%) were randomly allocated to either early AVR group (n=78) or conservative treatment group (n=79). In an intention-to-treat analysis, after a median follow-up of 63 months, the primary composite endpoint outcome event occurred in 18/78 patients (23.1%) in the early surgery group and in 37/79 patients (46.8%) in the conservative treatment group (hazard ratio [HR] early surgery vs. conservative treatment 0.42; 95% confidence interval [CI] 0.24-0.73, p=0.002). The Kaplan-Meier estimates for individual endpoints of all-cause death and HF hospitalization were significantly lower in the early surgery compared with the conservative group (HR 0.44; 95% CI 0.23-0.85, p=0.012 for all-cause death, and HR 0.21; 95% CI 0.06-0.73, p=0.007 for HF hospitalizations). The extended follow-up of the AVATAR trial demonstrates better clinical outcomes with early surgical AVR in truly asymptomatic patients with severe AS and normal LV ejection fraction compared with patients treated with conservative management on watchful waiting. NCT02436655 (ClinicalTrials.gov).

Two assumptions of the prior event rate ratio approach for controlling confounding can be evaluated by self-controlled case series and dynamic random intercept modeling

ObjectivesThe prior event rate ratio (PERR) is a recently developed approach for controlling confounding by measured and unmeasured covariates in real-world evidence research and observational studies. Despite its rising popularity in studies of safety and effectiveness of biopharmaceutical products, there is no guidance on how to empirically evaluate its model assumptions. We propose two methods to evaluate two of the assumptions required by the PERR, specifically, the assumptions that occurrence of outcome events does not alter the likelihood of receiving treatment, and that earlier event rate does not affect later event rate. Study Design and SettingWe propose using self-controlled case series (SCCS) and dynamic random intercept modeling (DRIM), respectively, to evaluate the two aforementioned assumptions. A nonmathematical introduction of the methods and their application to evaluate the assumptions are provided. We illustrate the evaluation with secondary analysis of deidentified data on pneumococcal vaccination and clinical pneumonia in The Gambia, West Africa. ResultsSCCS analysis of data on 12,901 vaccinated Gambian infants did not reject the assumption of clinical pneumonia episodes had no influence on the likelihood of pneumococcal vaccination. DRIM analysis of 14,325 infants with a total of 1719 episodes of clinical pneumonia did not reject the assumption of earlier episodes of clinical pneumonia had no influence on later incidence of the disease. ConclusionThe SCCS and DRIM methods can facilitate appropriate use of the PERR approach to control confounding. Plain Language SummaryThe prior event rate ratio is a promising approach for analysis of real-world data and observational studies. We propose two statistical methods to evaluate the validity of two assumptions it is based on. They can facilitate appropriate use of the prior even rate ratio.

Implementation of a high-sensitivity troponin assay for adult patients presenting to the emergency department: The role of clinical decision support.

BackgroundThe objective of this study was to assess the health outcomes for patients presenting to the emergency department (ED) with cardiac chest pain following the implementation of an accelerated diagnostic protocol (ADP) using a high sensitivity troponin (hs-TnI) assay. MethodsThis prospective before-after cohort study used population-based linked health administrative data for adult patients presenting to a Canadian urban ED with chest pain of suspected cardiac origin over a two-year study period. The primary outcome was ED length of stay (LOS). Secondary outcomes included operational and clinical outcomes within 30 days of the index ED visit. ResultsDuring the study period, 4,339 patients were included, with 2,031 in the conventional troponin (c-TnI) group and 2,308 in the hs-TnI group. Overall, the median age was 56 years and 52% were male. The median ED LOS was reduced from 430 minutes to 400 minutes after protocol implementation (median difference = -30.0; 95% CI: -47.8 to -12.3). For discharged patients who underwent serial troponin tests, the LOS was 89 minutes shorter (95% CI: -110.8 to -67.2). The proportion of patients discharged increased from 73% to 78% after implementation (p=0.0001). At 30 days, there were no differences in hospital readmission or major adverse event outcomes. ConclusionsUsing clinical decision support, the implementation of a new hs-TnI assay and ADP was associated with shorter ED LOS and lower hospitalization for adult patients with chest pain assessed in the ED. These results suggest that the protocol is effective and safe in real-world clinical settings.

Comparing Two Methods for Testing the Efficiency of Sports Betting Markets

Sports betting markets can be considered strongly efficient if expected returns on all possible bets on an event are equal. If this form of efficiency holds, then there is a direct mapping from betting odds into probabilities of outcomes of sporting events. We compare two regression-based methods for testing this form of efficiency that have been used in previous research: One that uses normalized probabilities as the explanatory variable for event outcomes and one that uses the inverse of the decimal odds. We show that the normalized probability method produces good tests of the null hypothesis of strong market efficiency but that the inverse odds method does not, with results biased against finding favorite-longshot bias. We illustrate this finding using large datasets of bets and outcomes for tennis and soccer and also with realistic simulations.

Professional responsibility of a medical professional and patient safety from the perspective of a clinician

Responsibility of medical professionals has been discussed with varying degrees of intensity for many years among healthcare professionals and in the media. The established practice of holding a medical professional accountable when claims are received from patients and their legal representatives in the event of unfavorable treatment outcomes indicates that the guilt of a specialist in most cases is determined by his or her actions or inactions. The authors give arguments and discuss that, along with errors that occur directly to the medical professional, there are factors that influence the outcome of the treatment, including those caused by the characteristics of the patient himself, which cannot be foreseen and which generally remain unknown to the society.

Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery

Supplementing potassium in an effort to maintain high-normal serum concentrations is a widespread strategy used to prevent atrial fibrillation after cardiac surgery (AFACS), but is not evidence-based, carries risks, and is costly. To determine whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger. This open-label, noninferiority, randomized clinical trial was conducted at 23 cardiac surgical centers in the United Kingdom and Germany. Between October 20, 2020, and November 16, 2023, patients with no history of atrial dysrhythmias scheduled for isolated coronary artery bypass grafting (CABG) surgery were enrolled. The last study patient was discharged from the hospital on December 11, 2023. Patients were randomly assigned to a strategy of tight or relaxed potassium control (only supplementing if serum potassium concentration fell below 4.5 mEq/L or 3.6 mEq/L, respectively). Patients wore an ambulatory heart rhythm monitor, which was analyzed by a core laboratory masked to treatment assignment. The prespecified primary end point was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm-related events, clinical outcomes, and cost related to the intervention. A total of 1690 patients (mean age, 65 years; 256 [15%] females) were randomized. The primary end point occurred in 26.2% of patients (n = 219) in the tight group and 27.8% of patients (n = 231) in the relaxed group, which is a risk difference of 1.7% (95% CI, -2.6% to 5.9%). There was no difference between the groups in the incidence of at least 1 AFACS episode detected by any means or by ambulatory heart rhythm monitor alone, non-AFACS dysrhythmias, in-patient mortality, or length of stay. Per-patient cost for purchasing and administering potassium was significantly lower in the relaxed group (mean difference, $111.89 [95% CI, $103.60-$120.19]; P <.001). For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice of supplementing potassium to maintain a serum potassium concentration greater than or equal to 4.5 mEq/L. The lower threshold of supplementation was not associated with any increase in dysrhythmias or adverse clinical outcomes. ClinicalTrials.gov Identifier: NCT04053816.

Effects of Semaglutide on Heart Failure Outcomes in Diabetes and Chronic Kidney Disease in the FLOW Trial

BackgroundPeople with type 2 diabetes (T2D) and chronic kidney disease (CKD) are at high risk for heart failure (HF) and premature death from cardiovascular (CV) causes. The FLOW (Research Study To See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease), which enrolled participants with T2D and CKD, demonstrated that semaglutide, a glucagon-like peptide-1 receptor agonist, reduced the incidence of the primary composite outcome (persistent ≥50% decline in estimated glomerular filtration rate, persistent estimated glomerular filtration rate <15 mL/min/1.73 m2, kidney replacement therapy, and kidney or CV death) by 24%. ObjectivesThis prespecified analysis examined the effects of semaglutide on HF outcomes in this high-risk population. MethodsParticipants were randomized (1:1) to once-weekly subcutaneous semaglutide 1 mg or placebo. The prespecified main outcome was a composite of HF events (new onset or worsening of HF leading to an unscheduled hospital admission or an urgent visit, with initiation of or intensified diuretic/vasoactive therapy) or CV death. HF data were collected by the investigator. CV death was adjudicated by an independent committee. ResultsA total of 3,533 randomized participants were followed for a median of 3.4 years. HF was present at baseline in 342 participants (19.4%) in the semaglutide group and 336 (19.0%) in the placebo group. In the overall trial population, semaglutide increased time to first HF events or CV death (HR: 0.73; 95% CI: 0.62-0.87; P = 0.0005), HF events alone (HR: 0.73; 95% CI: 0.58-0.92; P = 0.0068), and CV death alone (HR: 0.71; 95% CI: 0.56-0.89; P = 0.0036). The risk reduction for the composite HF outcome was similar in those with (HR: 0.73; 95% CI: 0.54-0.98; P = 0.0338) and without (HR: 0.72; 95% CI: 0.58-0.89; P = 0.0028) HF at baseline. The risk of HF outcomes (HF events or CV death) was generally higher in participants categorized as NYHA functional class III and those with the HF reduced ejection fraction subtype, regardless of treatment. ConclusionsSemaglutide substantially reduced the risk of time to first composite outcome of HF events or CV death, as well as HF events and CV death alone, in a high-risk population with T2D and CKD. These effects were consistent regardless of history of HF. (A Research Study To See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease [FLOW]; NCT03819153)

Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design

Direct oral anticoagulants are the standard of care for stroke prevention in eligible patients with atrial fibrillation and atrial flutter; however, bleeding remains a significant concern, limiting their use. Milvexian is an oral Factor XIa inhibitor that may offer similar anticoagulant efficacy with less bleeding risk. LIBREXIA AF (NCT05757869) is a global phase III, randomized, double-blind, parallel-group, event-driven trial to compare milvexian with apixaban in participants with atrial fibrillation or atrial flutter. Participants are randomly assigned to milvexian 100 mg or apixaban (5 mg or 2.5 mg per label indication) twice daily. The primary efficacy objective is to evaluate if milvexian is noninferior to apixaban for the prevention of stroke and systemic embolism. The principal safety objective is to evaluate if milvexian is superior to apixaban in reducing the endpoint of International Society of Thrombosis and Hemostasis (ISTH) major bleeding events and the composite endpoint of ISTH major and clinically relevant nonmajor (CRNM) bleeding events. In total, 15,500 participants from approximately 1,000 sites in over 30 countries are planned to be enrolled. They will be followed until both 430 primary efficacy outcome events and 530 principal safety events are observed, which is estimated to take approximately 4 years. The LIBREXIA AF study will determine the efficacy and safety of the oral Factor XIa inhibitor milvexian compared with apixaban in participants with either atrial fibrillation or atrial flutter. ClinicalTrials.gov NCT05757869.

Antihypertensive deprescribing in frail long-term care residents (OptimizeBP): protocol for a prospective, randomised, open-label pragmatic trial

IntroductionAlthough antihypertensive medication use is common among frail older adults, observational studies in this population suggest blood pressure (BP) lowering may convey limited benefit and perhaps even harm. This protocol...

Left Atrial Appendage Opacification on Cardiac Computed Tomography in Acute Ischemic Stroke: TheClinical Implications of Slow-Flow.

Left atrial appendage (LAA) slow-flow may increase the risk of ischemic stroke. We studied LAA attenuation on cardiac computed tomography in patients with acute ischemic stroke. We used data from a prospective cohort of patients with acute ischemic stroke undergoing cardiac computed tomography during the acute stroke imaging protocol. We compared characteristics, functional outcome (modified Rankin scale: higher scores indicating worse outcome), stroke recurrence and major adverse cardiovascular events after 2-year follow-up between patients with LAA thrombus (filling defect<100 Hounsfield Unit (HU)), slow-flow (filling defect ≥100 HU) and normal filling. Of 421 patients, 31 (7%) had LAA thrombus, 69 (16%) slow-flow, and 321 (76%) normal filling. Patients with thrombus or slow-flow more often had known atrial fibrillation compared with normal filling (45%, 39%, and 9%, P<0.001). Patients with thrombus had higher National Institutes of Health Stroke Scale-scores compared with slow-flow and normal filling (18 [interquartile range, 9-22], 6 [interquartile range, 3-17], and 5 [interquartile range, 2-11], P<0.001). Compared with normal filling, there was no difference with slow-flow in functional outcome (median modified Rankin scale, 3 versus 2; acOR 0.8 [95% CI, 0.5-1.4]), stroke recurrence (adjusted hazard ratio, 0.8 [95% CI, 0.3-1.9]) or major adverse cardiovascular events (adjusted hazard ratio, 1.2 [95% CI, 0.7-2.1]), while patients with thrombus had worse functional outcome (median modified Rankin scale, 6, acOR, 3.3 [95% CI, 1.5-7.4]). In cryptogenic stroke patients (n=156) slow-flow was associated with stroke recurrence (27% versus 6%, aHR, 4.1 [95% CI, 1.1-15.7]). Patients with slow-flow had similar characteristics to patients with thrombus, but had less severe strokes. Slow-flow was not significantly associated with functional outcome or major adverse cardiovascular events, but was associated with recurrent stroke in patients with cryptogenic stroke.

Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial.

Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

Sodium-Glucose Cotransporter-2 Inhibitors, Dulaglutide, and Risk for Dementia : A Population-Based Cohort Study.

Both sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may have neuroprotective effects in patients with type 2 diabetes (T2D). However, their comparative effectiveness in preventing dementia remains uncertain. To compare the risk for dementia between SGLT2 inhibitors and dulaglutide (a GLP-1 RA). Target trial emulation study. Nationwide health care data of South Korea obtained from the National Health Insurance Service between 2010 and 2022. Patients aged 60 years or older who have T2D and are initiating treatment with SGLT2 inhibitors or dulaglutide. The primary outcome was the presumed clinical onset of dementia. The date of onset was defined as the year before the date of dementia diagnosis, assuming that the time between the onset of dementia and diagnosis was 1 year. The 5-year risk ratios and risk differences comparing SGLT2 inhibitors with dulaglutide were estimated in a 1:2 propensity score-matched cohort adjusted for confounders. Overall, 12 489 patients initiating SGLT2 inhibitor treatment (51.9% dapagliflozin and 48.1% empagliflozin) and 1075 patients initiating dulaglutide treatment were included. In the matched cohort, over a median follow-up of 4.4 years, the primary outcome event occurred in 69 participants in the SGLT2 inhibitor group and 43 in the dulaglutide group. The estimated risk difference was -0.91 percentage point (95% CI, -2.45 to 0.63 percentage point), and the estimated risk ratio was 0.81 (CI, 0.56 to 1.16). Residual confounding is possible; there was no adjustment for hemoglobin A1c levels or duration of diabetes; the study is not representative of newer drugs, including more effective GLP-1 RAs; and the onset of dementia was not measured directly. Under conventional statistical criteria, a risk for dementia between 2.5 percentage points lower and 0.6 percentage point greater for SGLT2 inhibitors than for dulaglutide was estimated to be highly compatible with the data from this study. However, whether these findings generalize to newer GLP-1 RAs is uncertain. Thus, further studies incorporating newer drugs within these drug classes and better addressing residual confounding are required. Ministry of Food and Drug Safety of South Korea.

Artificial-intelligent prediction model of occurrence of cerebral vasospasms based on machine-learning.

Background and Study Aims Symptomatic cerebral vasospasms are deleterious complication of the rupture of a cerebral aneurysm and potentially lethal. The existing scales used to classify the initial presentation of a subarachnoid haemorrhage (SAH), offer a blink of the outcome and the possibility of occurrence of symptomatic cerebral vasospasms. Altogether, they are neither sufficient to predict outcome or occurrence of events reliably nor do they offer a unite front. This study tests the common grading scales and factors, that otherwise effect the outcome, in an artificial-intelligent based algorithm in order to create a reliable prediction model for the occurrence of cerebral vasospasms. Material and Methods Applying the R environment an easy to operate command line was programmed to prognosticate the occurrence of vasospasms. Eighty-seven patients with aneurysmal SAH during a 24 months-period of time were included for study purposes. The Holdout and the Cross-Validation methods were used to evaluate the algorithm (65 patients validation set. 22 patients test set). The Support Vector Machines (ksvm) classification method provided a high accuracy. The medical data set included demographic data, the Hunt & Hess scale, Fisher grade, BNI scale, length of intervention for aneurysmal repair, etc. Results Our prediction model based on the AI algorithm demonstrated an accuracy of 61%-86% for the event of symptomatic vasospasms. For the subgroup analysis, patients of the surgical cohort 28,8% (n=13) developed symptomatic vasospasm, whereas admitted with Fisher scale grade 4 50% (n=7), with H&H 5 37,5% (n=5) and 28,5% (n=4) with BNI 5. Respectively, in the endovascular cohort vasospasms occurred in 31,8% (n=14) patients, with Fisher grade 4 69% (n=9), H&H 5 23% (n=3) and 7% (n=1) with BNI 5. Conclusion From our data, we may believe that the algorithm presented can help in identifying patients with SAH being at 'high' or 'low risk' for the development of symptomatic vasospasms. This risk balancing might further allow the treating physician to go for an early intervention trying to prevent permanent sequelae. Certainly, accuracy will improve with a higher caseload and more statistical coefficients.

Risk of Incident Cardiovascular Events Following Roux en Y Gastric Bypass versus Sleeve Gastrectomy: A Claims-Based Retrospective Cohort Study.

To compare the risk of incident cardiovascular disease (CVD) events following sleeve gastrectomy (SG) and Roux en Y gastric bypass (RYGB). Bariatric surgery is associated with reduced CVD risk but the differential effect of contemporary bariatric procedures is unclear. We used insurance claims to conduct a retrospective cohort study of CVD outcomes for patients who underwent RYGB versus SG between 2010 and 2021. Patients were followed for up to 5 years for a primary composite major adverse cardiovascular event (MACE) outcome as well as individual outcomes including myocardial infarction, stroke, heart failure, and arrhythmia. We compared cumulative risks of CVD events using multivariable Cox proportional hazards modeling, in overall cohorts and in sub-cohorts of older adults and those with type 2 diabetes (T2D) or pre-existing CVD and elevated morbidity. Matched, weighted cohorts of 13,545 SG and RYGB patients were observed for an average of 2.5 years after surgery, with 26.2% not lost to follow-up by the end of 5 years. There was no difference in MACE risk between procedures (aHR 1.01 for RYGB vs. SG [95% CI 0.90, 1.12]) in the overall cohort or among the subgroup of older adults (aHR 0.97 for RYGB vs. SG [95% CI 0.85, 1.10]). Patients with T2D experienced lower risk of MACE following RYGB compared to SG (aHR 0.78 [95% CI 0.66, 0.92]), as did those with pre-existing CVD or elevated morbidity prior to surgery (aHR 0.81 [95% CI 0.70, 0.93]). These findings further support the preferential use of RYGB over SG for patients with T2D or who have pre-existing CVD. However, among other groups of patients, including older adults, we did not observe a relative benefit of RYGB during the time horizon in this study.

Risk of falls or fall-related injuries associated with potentially inappropriate medication use among older adults with dementia.

Potentially inappropriate medications (PIMs) are prevalent in older adults with dementia and subsequent falls or fall-related injuries. The present study determined the risk of falls or fall-related injuries associated with PIM use in older adults with dementia. The National Health Insurance Service-Elderly Cohort Database 2.0 (NHIS-ECDB2.0) was used for this self-controlled case series (SCCS) study. This study included 1430 participants who went through exposure and non-exposure periods of PIM application among patients with dementia and experienced outcome events of falls or fall-related injuries between January 2016 and December 2019. The incidence of falls or fall-related injuries during the exposure and post-exposure periods was compared with that during the non-exposure period. Beers Criteria were used to define PIMs in patients with dementia. Negative binomial regression was conducted. The incidence rate ratio (IRR) was used to determine the risk of falls or fall-related injuries. During the exposure periods in which falls or fall-related injuries occurred, the mean number of PIMs among patients with dementia was 3.76 (SD = 2.99), and the most commonly used PIMs among patients with dementia were first-generation antihistamines (n = 283; 59.1%). Compared to the non-exposure period, the adjusted IRR during the exposure period was 1.57 (95% CI = 1.39-1.76). The risk of falls or fall-related injuries was increased when PIM use in patients with dementia was initiated (1-14days: IRR = 2.76, 95% CI = 2.31-3.28; 15-28days: IRR = 1.95, 95% CI = 1.48-2.56; ≥ 29days: IRR = 1.17, 95% CI = 1.01-1.35). Especially, an increased risk of falls or fall-related injuries was associated with greater PIM use among patients with dementia. Among older adults with dementia, PIMs significantly increase the risk of falls and fall-related injuries. Therefore, strategies should be developed to manage PIM prescriptions in patients with dementia to prevent falls.

Periodontal management may reduce hospitalization for acute coronary syndrome and stroke in older individuals

BackgroundThis study aimed to examine the impact of periodontal management on the occurrence of acute coronary syndrome and stroke using retrospective analysis of Japanese health insurance claims data. MethodsThe analysis included health insurance claims data of individuals aged ≥ 75 years who had been diagnosed with periodontal disease and received treatment between September 2016 and February 2017. Hospitalizations related to acute coronary syndrome and stroke were observed as outcome events during the follow-up period from March 2017 to March 2019. Covariates such as sex, age, place of residence, and chronic diseases were adjusted for using a generalized linear mixed model. ResultsThe study involved 117,010 participants with a mean age of 80.0 ± 4.0 years, and 44.7 % were male. The analysis suggested that supportive periodontal therapy significantly reduced the risk of hospitalization for acute coronary syndrome (adjusted odds ratio: AOR 0.88, P = 0.017). Supportive periodontal therapy also showed a borderline significant 13 % reduction in stroke hospitalizations. ConclusionsPeriodontal treatment is associated with a decreased risk of acute hospitalization. Regular periodontal management, aimed at minimizing oral chronic inflammation, can potentially lower the risk of developing acute coronary syndrome and stroke.

Combining Intravenous Thrombolysis and Dual Antiplatelet Treatment in Patients With Minor Ischemic Stroke: A Propensity Matched Analysis of the READAPT Study Cohort.

The optimal treatment for acute minor ischemic stroke is still undefined. and options include dual antiplatelet treatment (DAPT), intravenous thrombolysis (IVT), or their combination. We aimed to investigate benefits and risks of combining IVT and DAPT versus DAPT alone in patients with MIS. This is a prespecified propensity score-matched analysis from a prospective multicentric real-world study (READAPT [Real-Life Study on Short-Term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or Transient Ischemic Attack]). We included patients with MIS (National Institutes of Health Stroke Scale score at admission ≤5), without prestroke disability (modified Rankin scale [mRS] score ≤2). The primary outcomes were 90-day mRS score of 0 to 2 and ordinal mRS distribution. The secondary outcomes included 90-day risk of stroke and other vascular events and 24-hour early neurological improvement or deterioration (≥2-point National Institutes of Health Stroke Scale score decrease or increase from the baseline, respectively). From 1373 patients with MIS, 240 patients treated with IVT plus DAPT were matched with 427 patients treated with DAPT alone. At 90 days, IVT plus DAPT versus DAPT alone showed similar frequency of mRS 0 to 2 (risk difference, 2.3% [95% CI -2.0% to 6.7%]; P=0.295; risk ratio, 1.03 [95% CI 0.98-1.08]; P=0.312) but more favorable ordinal mRS scores distribution (odds ratio, 0.57 [95% CI 0.41-0.79]; P<0.001). Compared with patients treated with DAPT alone, those combining IVT and DAPT had higher 24-hour early neurological improvement (risk difference, 20.9% [95% CI 13.1%-28.6%]; risk ratio, 1.59 [95% CI 1.34-1.89]; both P<0.001) and lower 90-day risk of stroke and other vascular events (hazard ratio, 0.27 [95% CI 0.08-0.90]; P=0.034). There were no differences in safety outcomes. According to findings from this observational study, patients with MIS may benefit in terms of better functional outcome and lower risk of recurrent events from combining IVT and DAPT versus DAPT alone without safety concerns. URL: https://www.clinicaltrials.gov; Unique identifier: NCT05476081.

Comparison of Sitting versus Nonsitting Position for the Resection of Brain Metastases in the Posterior Fossa in a Contemporary Cohort.

For surgery of brain metastases, good immediate postoperative functional outcome is of utmost importance. Improved functional status can enable further oncologic therapies and adverse events might delay them. Pros and cons of either sitting or prone positioning for resective surgery of the posterior fossa are debated, but contemporary data on direct postoperative outcome are rare. The aim of our study was to compare the functional outcome and adverse events of surgery for brain metastases in the sitting versus the nonsitting position in the direct postoperative setting. We retrospectively compared surgery of metastases located in the posterior fossa over a 3-year period in two level-A neurosurgical centers. Center 1 performed surgery exclusively in the sitting, while center 2 performed surgery only in the nonsitting position. Worse functional outcome (Karnofsky performance scale) and functional deterioration were seen in the "sitting" group. We found significantly more "sitting" patients to deteriorate to a KPS score of ≤60%. In this study, treating patients with brain metastases in the sitting position resulted in a number needed to harm (NNH) of 2.3 and was associated with worse outcome and more adverse events. Therefore, we recommend the nonsitting position for surgery of brain metastases of the posterior fossa.

A deep neural network approach to heart murmur detection using spectrogram and peak interval features

Congenital heart disease affects about 1% of newborns, posing risks like heart failure and mortality. Developing countries often lack resources for diagnosis and treatment. The George B. Moody PhysioNet Challenge 2022 aims to develop systems for detecting murmurs and clinical outcome events using phonocardiogram (PCG) data, offering a cost-effective method for diagnosing cardiac diseases without invasive procedures. We proposed a deep learning model for this task and achieved the 5th rank out of 40 teams in both Track 1 (murmur detection) and Track 2 (clinical outcome prediction). This paper describes our methods and additional experiments. To extract features from the PCG, we employed techniques including Constant Q Transform (CQT) and Mel-scaled spectrogram (Mel-spectrogram) to generate two-dimensional representations in the frequency–time domain. Additionally, we extracted the Peak Interval (PI) feature, which measures the distance between peaks in the PCG data. This feature is useful because the peak intervals should be shorter in PCG recordings with murmurs. We also considered the sequence and mean of PI as additional features. Our proposed system, titled ‘Phonocardiogram-based Heart murmur Detection using Spectrogram and PI features (SpectroHeart),’ employs the Mel-spectrogram and PI features to detect heart murmurs and assess clinical outcomes. We believe that our deep learning-based system has great potential for automatically detecting heart signals from PCG.