Essentia Health

For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-relatedbleeding, was tested for superiority. Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval [CI], -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).

Cognitive behavioral therapy (CBT) skills training interventions are recommended first-line nonpharmacologic treatment for chronic pain, yet they are not widely accessible. To examine effectiveness of remote, scalable CBT-based chronic pain (CBT-CP) treatments (telehealth and self-completed online) for individuals with high-impact chronic pain, compared with usual care. This comparative effectiveness, 3-group, phase 3 randomized clinical trial enrolled 2331 eligible patients with high-impact chronic musculoskeletal pain from 4 geographically diverse health care systems in the US from January 2021 through February 2023. Follow-up concluded in April 2024. Participants were randomized 1:1:1 to 1 of 2 remote, 8-session, CBT-based skills training treatments: health coach-led via telephone/videoconferencing (health coach; n = 778) or online self-completed program (painTRAINER; n = 776); or to usual care plus a resource guide (n = 777). The primary outcome was attaining or exceeding the minimal clinically important difference (MCID) in pain severity score (≥30% decrease; score range, 0-10) on the 11-item Brief Pain Inventory-Short Form from baseline to 3 months; 6 and 12 months from baseline were secondary time points. Secondary outcomes at 3, 6, and 12 months included pain intensity, pain-related interference, PROMIS (Patient-Reported Outcomes Measurement Information System) social role and physical functioning; and patient global impression of change. Among 2331 eligible randomized individuals (mean age, 58.8 [SD, 14.3] years; 1712 [74%] women; 1030 [44%] rural/medically underserved), 2210 (94.8%) completed the trial. At 3 months, the adjusted percentage of participants achieving 30% or greater decrease in pain severity score was 32.0 (95% CI, 29.3-35.0) in the health coach group, 26.6 (95% CI, 23.4-30.2) in the painTRAINER group, and 20.8 (95% CI, 18.0-24.0) in the usual care group. Both intervention groups were significantly more likely to attain an MCID in pain severity compared with control (health coach vs usual care: relative risk [RR], 1.54 [95% CI, 1.30-1.82]; painTRAINER vs usual care: RR, 1.28 [95% CI, 1.06-1.55]), and the health coach program was more effective than the online self-completed painTRAINER program (health coach vs painTRAINER: RR, 1.20 [95% CI, 1.03-1.40]). Statistically significant benefits were observed for both intervention groups vs usual care at 6 and 12 months after randomization for the pain severity outcomes and for other secondary pain and functioning outcomes. Remote, scalable CBT-CP treatments (delivered either via telehealth or self-completed modules online) resulted in modest improvements in pain and related functional/quality-of-life outcomes compared with usual care among individuals with high-impact chronic pain. These lower-resource CBT-CP treatments could improve availability of evidence-based nonpharmacologic pain treatments within health care systems. ClinicalTrials.gov Identifier: NCT04523714.

Background: Gallbladder disease, one of the most common diseases in the United States, ranges from symptomatic gallstones to severe systemic infections from cholangitis. Little research is available on how often patients undergoing emergent cholecystectomy also have bacteremia. We hypothesized that blood cultures would be performed rarely in patients undergoing emergent cholecystectomy, and that positive cultures would be associated with worse outcomes. Methods: Exploratory retrospective observational cohort study of patients admitted to a single institution from January 17, 2011, to December 31, 2018, and undergoing emergent cholecystectomy by acute care surgeons within ∼72 hours, or three days, of admission. Analyses included descriptive and by-variable statistics, binary logistic regression, and negative binomial regression. Results: Of 892 patients undergoing emergent cholecystectomy, 145 (16.2%) had blood cultures obtained three days before or on the day of surgery, of whom 33 (22.8%) had at least one positive blood culture. Male and older patients had significantly higher rates of blood cultures being obtained. One-year post-discharge mortality and complication rates were significantly higher in those with blood cultures. Versus patients with negative blood cultures, those with positive cultures were significantly older and had higher rates of sepsis and septicemia, longer hospital stays, lower rates of being discharged home, and higher one-year post-discharge mortality rates (18.2% vs. 6.3%). Cholangitis, accounting for 29% of positive blood cultures, was diagnosed in 4.5% of emergent cholecystectomies performed. Gram-negative Escherichia coli were the most common bacteria isolates. Conclusions: Positive blood cultures were associated with significantly worse patient outcomes. Surgeons performing emergent cholecystectomies could consider implementing blood culture protocols to better identify patients at risk for greater hospital morbidity and post-discharge mortality.

ObjectivesTo evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD).DesignA secondary analysis of the randomised controlled trial ADAPTABLE was performed.SettingThe study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA.ParticipantsAmong 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%).InterventionsParticipants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months.Primary and secondary outcomes measuresThe primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion.ResultsEstimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints.ConclusionRace is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race.Trial registration numberNCT02697916.