Patient Population Research Articles

GLP-1 Receptor Agonists Among Patients With Overweight or Obesity, Diabetes, and HFpEF on SGLT2 Inhibitors.

Although the use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with obesity and heart failure with preserved ejection fraction (HFpEF) has demonstrated improvement in cardiovascular outcomes, the incremental benefits of GLP-1 RA for patients already on sodium-glucose cotransporter 2 inhibitors (SGLT2is) remain underexplored. This study aimed to assess the incremental benefits of GLP-1 RA in patients with type 2 diabetes mellitus, overweight/obesity, and HFpEF receiving SGLT2i therapy. The authors conducted a retrospective cohort study using the TriNetX research database including patients≥18 years with type 2 diabetes mellitus, body mass index≥27kg/m2, and HFpEF on SGLT2i. Two cohorts were created based on GLP-1 RA prescription. The outcomes were heart failure exacerbation, all-cause emergency department visits/hospitalizations among others over a 12-month period. A total of 7,044 patients remained in each cohort after propensity score matching. There was a significantly lower risk of heart failure exacerbations, all-cause emergency department visits/hospitalizations, new-onset atrial arrhythmias, new-onset acute kidney injury, and pulmonary hypertension in the GLP-1 RA plus SGLT2i cohort compared with the SGLT2i-only cohort. The associated benefits persisted across different body mass indexes and ejection fractions as well as in patients with elevated natriuretic peptide. The risk of diabetic retinopathy was higher in the combination therapy group than with SGLT2i-only use. GLP-1 RA, in addition to SGLT2i, was associated with a significantly lower risk of heart failure hospitalizations in this patient population, suggesting a potential incremental benefit. This highlights the need for prospective studies to confirm the clinical benefits.

Cost containment analysis of superparamagnetic iron oxide (SPIO) injection in patients with ductal carcinoma in situ.

Recent studies have established the safety and efficacy of Superparamagnetic Iron Oxide (SPIO, Magtrace®) for delayed sentinel lymph node biopsy (SLNB) in patients with ductal carcinoma in situ (DCIS) who are undergoing mastectomy. The aim of our study was to measure cost containment with use of Magtrace® in comparison to upfront SLNB with traditional technetium-99 lymphatic tracer. A total of 41 patients at our institution underwent mastectomy with Magtrace® injection for DCIS and were included in our single-institution, retrospective analysis. For comparison, total charges data were obtained for an upfront SLNB at the time of mastectomy. Cost comparison analysis was then performed against charges for intraoperative Magtrace® injection with additional charges incorporated for those patients who required return to the operating room for delayed SLNB. Total cost containment for the cohort with use of Magtrace® was then measured. Of the 41 patients who underwent Magtrace® injection, two patients required return to the operating room for a delayed SLNB for invasive disease. Including these charges for a second encounter into our cost analysis, the use of Magtrace® still yielded an overall cost containment of $205,793.55 in our cohort when comparing to patients who underwent upfront SLNB. For patients who underwent Magtrace® injection and did not require return to the operating room, charges were reduced by $6,768.52 per patient. The use of Magtrace® for delayed SLNB in patients with DCIS undergoing mastectomy yielded a significant overall cost containment, further supporting its use in this patient population.

Trends in Active Surveillance for Men With Intermediate-Risk Prostate Cancer

Initial management of intermediate-risk prostate cancer is evolving, with no clear recommendation for treatment. Data on utilization of active surveillance for patients with newly diagnosed intermediate-risk prostate cancer may help clarify emerging trends. To further characterize US national trends of initial management of intermediate-risk prostate cancer. This cohort study included patients with intermediate-risk prostate cancer diagnosed from January 1, 2010, to December 31, 2020. Eligible patients were diagnosed in US hospitals included in the National Cancer Database; National Comprehensive Cancer Network risk stratification guidelines were used to characterize as favorable vs unfavorable intermediate risk. Analysis was performed in September 2023. Active surveillance vs intervention with surgery and/or radiation or no treatment. Temporal trends in demographic, clinical, and socioeconomic factors among men with intermediate-risk prostate cancer and their association with the use of active surveillance; further subgroup analysis was conducted for those with favorable vs unfavorable intermediate risk classification. In total, 289 584 men diagnosed with intermediate-risk prostate cancer were identified from 2010 to 2020 (46 147 Black [15.9%], 230 071 White [79.5%]). Among patients, 153 726 (53.1%) underwent prostatectomy, 107 152 (37.0%) underwent radiotherapy, and 15 847 (5.5%) underwent active surveillance as initial treatment strategy. Overall, active surveillance quadrupled from 418 of 21 457 patients (2.0%) in 2010 to 2428 of 28 192 patients (8.6%) in 2020 for the entire cohort (P < .001). Active surveillance increased from 317 of 12 858 patients (2.4%) in 2010 to 2020 of 12 902 patients (13.5%) in 2020 in men with favorable intermediate-risk prostate cancer (P < .001). In the unfavorable intermediate-risk cohort, active surveillance increased from 101 of 8181 patients (1.2%) in 2010 to 408 of 12 861 patients (3.1%) in 2020 (P < .001). On multivariable analysis, use of active surveillance was associated with increased age (age 70-80 years vs <50 years: odds ratio [OR], 3.09; 95% CI, 2.66-3.59), lower Gleason score (3 + 3 vs 3 + 4: OR, 3.45; 95% CI, 3.25-3.66), early T stage (T2c vs T1a through T2a: OR, 0.35; 95% CI, 0.32-0.38), treatment at an academic center (community vs academic center: OR, 0.72; 95% CI, 0.67-0.78), higher level of education (communities with 21% or higher population without high school vs less than 7%: OR, 0.73; 95% CI, 0.67-0.79), insurance type (Medicare or other governmental service vs private: OR, 1.11; 95% CI, 1.07-1.16), proximity to treatment facility (greater than 120 miles vs less than 60 miles: OR, 0.75; 95% CI, 0.68-0.84), facility location (South Atlantic vs New England: OR, 0.54; 95% CI, 0.46-0.53), and lower income (less than $38 000 vs $63 000 or greater: OR, 1.22; 95% CI, 1.14-1.31). These findings highlight increasing implementation of active surveillance in the initial management of intermediate risk prostate cancer. Prospective data with improved risk stratification incorporating genomics and digital pathology artificial intelligence as well as novel surveillance strategies may continue to better delineate optimal treatment recommendations in this patient population.

Use of Bioimpedance Spectroscopy for Postoperative Fluid Management in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass

ObjectiveTo assess whether bioimpedance spectroscopy analysis (BIA) can be used as a potential tool to guide postoperative fluid management in patients who undergo cardiac surgery. DesignAn observational study. SettingA single, tertiary hospital. ParticipantsPatients who underwent cardiac surgery with cardiopulmonary bypass between June to November 2023 who were able to undergo BIA measurements. InterventionsNone. Measurements and Main ResultsCorrelations between BIA measurements of extracellular fluid (ECF) and total body water (TBW) volumes and daily changes in weight and 24-hour net intake and output (I/O) of fluids were assessed. Correlations between pre-discharge ECF volume as a percentage of TBW volume (ECF%TBW) and pre-discharge Pro-BNP (Pro-BNP) levels and readmissions were analyzed. Changes in daily ECF volume significantly correlated with daily weight changes (p<0.01) and 24-hr I/O (p<0.01). TBW volume significantly correlated with daily weight changes (p<0.01) and with 24-hr I/O (p=0.04). Daily weight changes did not correlate with 24-hr I/O (p=0.06). The patients with pre-discharge ECF%TBW(%) greater than or equal to 51 had significantly higher pre-discharge Pro-BNP than those with ECF%TBW(%) less than 51 (p<0.01). Patients who had heart failure revisits or admissions after discharge had a higher pre-discharge ECF%TBW(%) on index admission compared to patients that did not have heart failure readmissions (p=0.01). ConclusionsUtilization of BIA measurements in postoperative cardiac surgery patients may be a valuable tool to quantitatively determine fluid status to help guide fluid management in this patient population. Further studies validating the use of BIA for postoperative care in this population are warranted.

Parkinson's disease is associated with low striated esophagus contractility potentially contributing to the development of dysphagia.

Parkinson's disease (PD) is the second most common neurodegenerative disorder, and more than 80% of PD patients will develop oropharyngeal dysphagia. Despite its striated histology, proximity to airway, and potential negative impact of its dysfunction on bolus transport and airway safety, the contractile function of the striated esophagus in PD patients has not been systematically studied. Using our repository of clinical manometry and the Milwaukee ManoBank, we analyzed high-resolution manometry (HRM) studies of 20 PD patients, mean age 69.1 (range 38-87 years); 30 non-PD patients with dysphagia, mean age 64.0 (44-86 years); and 32 healthy volunteers, mean age 65.3 (39-86 years). Patients with abnormal findings based on Chicago Classification 4.0 were identified. Repeat analysis was performed in 20% of the manometric tracings by a different investigator with inter-rater concordance between 0.91 and 0.99. The striated esophageal contractile integral in PD patients was significantly lower than that in non-PD dysphagic patients and healthy controls (p = 0.03 and <0.01, respectively). This significant difference persisted after excluding patients with concurrent Chicago Classification motility disorders (p = 0.02 and 0.01, respectively). In both analyses, the distal esophageal contractile integral did not show any significant difference between groups (p = 0.58 and 0.93, respectively). PD is associated with a significant decrease in striated esophagus contractility compared to non-PD and healthy controls. This finding may play a pathophysiologic role in development of dysphagia in this patient population.

Neighborhood-Level Disparities in Hypertension Prevalence and Treatment Among Middle-Aged Adults

Hypertension in middle-aged adults (35-50 years) is associated with poorer health outcomes in late life. Understanding how hypertension varies by race and ethnicity across levels of neighborhood disadvantage may allow for better characterization of persistent disparities. To evaluate spatial patterns of hypertension diagnosis and treatment by neighborhood socioeconomic position and racial and ethnic composition. In this cross-sectional study of middle-aged adults in Cuyahoga County, Ohio, who encountered primary care in 2019, geocoded electronic health record data were linked to the area deprivation index (ADI), a neighborhood disadvantage measure, at the US Census Block Group level (ie, neighborhood). Neighborhoods were stratified by ADI quintiles, with the highest quintile indicating the most disadvantage. Data were analyzed between August 7, 2023, and June 1, 2024. Essential hypertension. The primary outcome was a clinician diagnosis of essential hypertension. Spatial analysis was used to characterize neighborhood-level patterns of hypertension prevalence and treatment. Interaction analysis was used to compare hypertension prevalence by racial and ethnic group within similar ADI quintiles. A total of 56 387 adults (median [IQR] age, 43.1 [39.1-46.9] years; 59.8% female) across 1157 neighborhoods, which comprised 3.4% Asian, 31.1% Black, 5.5% Hispanic, and 60.0% White patients, were analyzed. A gradient of hypertension prevalence across ADI quintiles was observed, with the highest vs lowest ADI quintile neighborhoods having a higher hypertension rate (50.7% vs 25.5%) and a lower treatment rate (61.3% vs 64.5%). Of the 315 neighborhoods with predominantly Black (>75%) patient populations, 200 (63%) had a hypertension rate greater than 35% combined with a treatment rate of less than 70%; only 31 of 263 neighborhoods (11.8%) comprising 5% or less Black patient populations met this same criterion. Compared with a spatial model without covariates, inclusion of ADI and percentage of Black patients accounted for 91% of variation in hypertension diagnosis prevalence among men and 98% among women. Men had a higher prevalence of hypertension than women across race and ADI quintiles, but the association of ADI and hypertension risk was stronger in women. Sex prevalence differences were smallest between Black men and women, particularly in the highest ADI quintile (1689 [60.0%] and 2592 [56.0%], respectively). These findings show an association between neighborhood deprivation and hypertension prevalence, with disparities observed particularly among Black patients, emphasizing a need for structural interventions to improve community health.

Occupational Therapy Services and Delirium in the Geriatric Trauma Patient Population

Abstract Date Presented 03/22/24 Occupational Therapists (OTs) and Geriatricians in an acute care hospital trauma unit used the Confusion Assessment Method - Severity to set OT treatment frequency for patients with delirium. Descriptive data on this patient population is reviewed. Primary Author and Speaker: Deanna Stinner Contributing Authors: Neti N. Vora, Allison Hoffman

Effect of prematurely elevated late follicular progesterone on pregnancy outcomes following ovarian stimulation-intrauterine insemination for unexplained infertility: secondary analysis of the AMIGOS trial.

What is the relationship between late follicular phase progesterone levels and clinic pregnancy and live birth rates in couples with unexplained infertility undergoing ovarian stimulation with IUI (OS-IUI)? Late follicular progesterone levels between 1.0 and <1.5 ng/ml were associated with higher live birth and clinical pregnancy rates while the outcomes in groups with higher progesterone levels did not differ appreciably from the <1.0 ng/ml reference group. Elevated late follicular progesterone levels have been associated with lower live birth rates after fresh embryo transfer following controlled ovarian stimulation and egg retrieval, but less is known about whether an association exists with outcomes in OS-IUI cycles. Existing studies are few and have been limited to ovarian stimulation with gonadotrophins, but the use of oral agents, such as clomiphene citrate and letrozole, is common with these treatments and has not been well studied. The study was a prospective cohort analysis of the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) randomized controlled trial. Frozen serum was available for evaluation from 2121 cycles in 828 AMIGOS participants. The primary pregnancy outcome was live birth per cycle, and the secondary pregnancy outcome was clinical pregnancy rate per cycle. Couples with unexplained infertility in the AMIGOS trial, for whom female serum from day of trigger with hCG was available in at least one cycle of treatment, were included. Stored frozen serum samples from day of hCG trigger during treatment with OS-IUI were evaluated for serum progesterone level. Progesterone level <1.0 ng/ml was the reference group for comparison with progesterone categorized in increments of 0.5 ng/ml up to ≥3.0 ng/ml. Unadjusted and adjusted risk ratios (RR) and 95% CI were estimated using cluster-weighted generalized estimating equations to estimate modified Poisson regression models with robust standard errors. Compared to the reference group with 110/1363 live births (8.07%), live birth rates were significantly increased in cycles with progesterone 1.0 to <1.5 ng/ml (49/401 live births, 12.22%) in both the unadjusted (RR 1.56, 95% CI 1.14, 2.13) and treatment-adjusted models (RR 1.51, 95% CI 1.10, 2.06). Clinical pregnancy rates were also higher in this group (55/401 clinical pregnancies, 13.72%) compared to reference group with 130/1363 (9.54%) (unadjusted RR 1.46, 95% CI 1.10, 1.94 and adjusted RR 1.42, 95% CI 1.07, 1.89). In cycles with progesterone 1.5 ng/ml and above, there was no evidence of a difference in clinical pregnancy or live birth rates relative to the reference group. This pattern remained when stratified by ovarian stimulation treatment group but was only statistically significant in letrozole cycles. The AMIGOS trial was not designed to answer this clinical question, and with small numbers in some progesterone categories our analyses were underpowered to detect differences between some groups. Inclusion of cycles with progesterone values above 3.0 ng/ml may have included those wherein ovulation had already occurred at the time the IUI was performed. These cycles would be expected to experience a lower success rate but pregnancy may have occurred with intercourse in the same cycle. Compared to previous literature focusing primarily on OS-IUI cycles using gonadotrophins, these data include patients using oral agents and therefore may be generalizable to the wider population of infertility patients undergoing IUI treatments. Because live births were significantly higher when progesterone ranged from 1.0 to <1.5 ng/ml, further study is needed to clarify whether this progesterone range may truly represent a prognostic indicator in OS-IUI cycles. Oklahoma Shared Clinical and Translational Resources (U54GM104938) National Institute of General Medical Sciences (NIGMS). AMIGOS was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development: U10 HD077680, U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936, and U10HD055925. Research made possible by the funding by American Recovery and Reinvestment Act. Dr Burks has disclosed that she is a member of the Board of Directors of the Pacific Coast Reproductive Society. Dr Hansen has disclosed that he is the recipient of NIH grants unrelated to the present work, and contracts with Ferring International Pharmascience Center US and with May Health unrelated to the present work, as well as consulting fees with May Health also unrelated to the present work. Dr Diamond has disclosed that he is a stockholder and a member of the Board of Directors of Advanced Reproductive Care, Inc., and that he has a patent pending for the administration of progesterone to trigger ovulation. Dr Anderson, Dr Gavrizi, and Dr Peck do not have conflicts of interest to disclose. N/A.

A Cost Analysis of Catheter Ablation for Atrial Fibrillation: A Canadian Pre-Post Study

BackgroundThere is a paucity of Canadian studies using patient-level data to analyze the costs of catheter ablation (CA) for atrial fibrillation (AF). We sought to identify the health care resource use, costs, and cost predictors of CA. MethodsA cost analysis was performed in a population of AF patients treated with CA in Central Zone Nova Scotia from 2010 to 2018. Costs were compared 2 years before ablation (pre-CA) with costs 2 years after (post-CA); the 3-month period post-CA was defined as the treatment window. Costs were also compared according to CA technology defined as before 2015 for patients treated with non-contact force sensing CA and after 2015 for patients treated with contact force sensing CA. ResultsHeart failure hospitalizations, AF-related emergency department visits, acute inpatient admissions, and cardioversions all decreased after ablation. The cost difference post-CA vs pre-CA was CAD$18,869 (95% confidence interval [CI], $15,570-$22,168). This increase in costs was driven by costs incurred during the treatment window, which was $21,439 (95% CI, $20,468-$22,409). After excluding treatment window costs, the mean year 1 post-CA cost was $11,223 (95% CI, $9113-$13,334) and year 2 post-CA cost was $4555 (95% CI, $3145-$5965); both were lower than the pre-CA costs. Costs remained stable over the time frame of the study period, with no influence from new technologies on cost. The post-CA cost difference between the post-2015 and pre-2015 groups was $2573 (95% CI, -$2336 to $7481) ConclusionsWe showed that although CA is expensive, it might be a cost-effective treatment modality for AF because of the associated reduction in costs and health care resource use.

Hysteroscopic metroplasty: Ultrasound parameters to optimize fertility benefits?

IntroductionMetroplasty is a procedure used by some teams to correct certain uterine anomalies to improve fertility outcomes. Our goal was to evaluate hysteroscopic metroplasty in the management of nulliparous and infertile patients with a uterine anomalies. Material and methodsWe conducted a single-center, retrospective, observational study of women who underwent hysteroscopic metroplasty for infertility between January 1, 2015 and December 31, 2019. The primary endpoint was the occurrence of a live birth at 18 months post-surgery. The secondary endpoint was to identify predictive factors for the success of the procedure, in particular ultrasound criteria, and live-birth rate during total follow up. ResultsWe included 43 nulliparous patients with an average of 5.2±-2.4 years of primary infertility, including 84.2 % patients who had at least one IVF cycle prior to the surgery. The mean age was 37±5 years. The post-surgery live-birth rate was 27.9 % at 18 months and 53.5 % during the total postoperative follow-up (mean follow-up 4.5 ± 1 years). Pregnancies were obtained spontaneously after surgery for 8/28 (28.6 %) patients who were undergoing assisted reproduction technology before surgery. No intra- or postoperative complications were recorded. We did not identify any predictive ultrasound factors, pre- or postoperatively, for a live birth at 18 months post-surgery. DiscussionHysteroscopic metroplasty appears to improve the chances of a live birth in a population of nulliparous and infertile patients with at least one uterine pathology. Spontaneous pregnancy can occur after hysteroscopic metroplasty. The Congenital-Ultrasound-Malformation-by-Expert ultrasound criteria do not appear to be predictive of post-surgery outcomes.

Epileptic patients with shoulder anterior instability

From 2006 to 2020, we included epileptic and non-epileptic patients with anterior recurrent shoulder instability. We randomly adjusted the patients of the two groups according to the sex, age and type of management. We included 50 patients. For each included patient, we performed an in-depth CT-scan analysis and comparison of the glenoid bone loss: PICO method using the best-fit circle; and the Hill-Sachs lesion: the depth and width were given as a percentage of the humeral head diameter on an axial view. We also evaluated the engaging character of the involved lesion using the On-track/Off-track analysis. Those characteristics were compared between the two groups. We found a glenoid bone loss in 32 patients. Glenoid bone loss was not significantly greater in patients with epilepsy (p=0.052). A Hill-Sachs lesion was found in 42 patients (22 in epileptic group and 20 in non-epileptic group). Hill-Sachs lesions were significantly deeper and larger in the epileptic group. (depth: 22% vs 9%, p<0.001; width: 43% vs 28%, p=0.003). In the epileptic group 90% of the bone lesions were OFF-track versus 30% in the non-epileptic group. Thus, the epileptic patients presented more engaging bony lesions than non-epileptic patients (p=0.001) (OR=23). In a population of epileptic patients, Hill-Sachs lesions are larger and deeper than in patients with non- epileptic shoulder instability. By contrast, there is no significant difference regarding the characteristics of the glenoid bone loss if present. This implies that bone lesions in instable shoulders of epileptic patients need at least a bony stabilization procedure on the humeral side in the majority of cases.

Impact of scleral lens wear on IOP in a population of irregular cornea patients

Impact of scleral lens wear on IOP in a population of irregular cornea patients

Acute Kidney Injury in Hospitalized Patients With Exertional Rhabdomyolysis

An association between serum creatine kinase (CK) levels and the risk of kidney failure in patients with exertional rhabdomyolysis (ERM) has been suggested. However, the actual incidence of AKI in hospitalized patients with ERM along with the contributing cofactors that may increase the risk of AKI have rarely been investigated. To examine the incidence of kidney injury in hospitalized patients with ERM and to identify additional cofactors that might contribute to the development of kidney injury in patients with ERM. This retrospective cohort study was conducted in a diverse community population of patients 18 years or older with ERM who were hospitalized across Kaiser Permanente Northern California between January 1, 2009, and December 31, 2019. Patients were initially identified through electronic screening for all-cause rhabdomyolysis admissions, followed by manual medical record reviews to verify their eligibility for the study. The diagnosis of AKI and chronic kidney disease (CKD) was determined using KDIGO (Kidney Disease Improving Global Outcomes) criteria and confirmed by medical record review. Data analysis was performed from October 1, 2023, to January 31, 2024. History of strenuous physical exercise before hospitalization for ERM. Development of AKI, CKD, and compartment syndrome and number of deaths. Among 3790 patients hospitalized for rhabdomyolysis between 2009 and 2019 in Kaiser Permanente Northern California, 200 (mean [SD] age, 30.5 [8.5] years; 145 [72.5%] male) were confirmed to have ERM via medical record review. Seventeen patients (8.5%) developed AKI, none developed CKD, 1 (0.5%) developed compartment syndrome, and there were no fatalities. There was no association between serum CK levels and the risk of AKI. However, the risk of AKI was significantly higher in patients with ERM who used nonsteroidal anti-inflammatory drugs (NSAIDs) before admission (11 of 17 with AKI [64.7%] vs 40 of 183 without AKI [21.9%], P < .001) or experienced dehydration (9 of 183 without AKI [52.9%] vs 9 of 17 with AKI [4.9%], P < .001). This analysis suggests that eliminating preadmission NSAID use and dehydration could reduce the risk of potential AKI in patients with ERM by 92.6% (95% CI, 85.7%-96.1%) in this population. The findings of this cohort study of hospitalized patients with ERM suggest that serum CK elevation alone is insufficient as an indicator of AKI in patients with ERM. Concurrent risk factors, such as NSAID use or dehydration, may be associated with AKI development in patients with ERM.

The Effect of Semaglutide on Mortality and COVID-19-Related Deaths: An Analysis From the SELECT Trial.

Patients with overweight and obesity are at increased risk of death from multiple causes, including cardiovascular (CV) death, with few therapies proven to reduce the risk. This study sought to assess the effect of semaglutide 2.4mg on all-cause death, CV death, and non-CV death, including subcategories of death and death from coronavirus disease-2019 (COVID-19). The SELECT (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity) trial randomized 17,604 participants≥45 years of age with a body mass index≥27kg/m2 with established CV disease but without diabetes to once-weekly subcutaneous semaglutide 2.4mg or placebo; the mean trial duration was 3.3 years. Adjudicated causes of all deaths, COVID-19 cases, and associated deaths were captured prospectively. Of 833 deaths, 485 (58%) were CV deaths, and 348 (42%) were non-CV deaths. Participants assigned to semaglutide vs placebo had lower rates of all-cause death (HR: 0.81; 95%CI: 0.71-0.93), CV death (HR: 0.85; 95%CI: 0.71-1.01), and non-CV death (HR: 0.77; 95%CI: 0.62-0.95). The most common causes of CV death with semaglutide vs placebo were sudden cardiac death (98 vs 109; HR: 0.89; 95%CI: 0.68-1.17) and undetermined death (77 vs 90; HR: 0.85; 95%CI: 0.63-1.15). Infection was the most common cause of non-CV death and occurred at a lower rate in the semaglutide vs the placebo group (62 vs 87; HR: 0.71; 95%CI: 0.51-0.98). Semaglutide did not reduce incident COVID-19; however, among participants who developed COVID-19, fewer participants treated with semaglutide had COVID-19-related serious adverse events (232 vs 277; P = 0.04) or died of COVID-19 (43 vs 65; HR: 0.66; 95%CI: 0.44-0.96). High rates of infectious deaths occurred during the COVID-19 pandemic, with less infectious death in the semaglutide arm, and resulted in fewer participants in the placebo group being at risk for CV death. Compared to placebo, patients treated with semaglutide 2.4mg had lower rates of all-cause death, driven similarly by CV and non-CV death. The lower rate of non-CV death with semaglutide was predominantly because of fewer infectious deaths. These findings highlight the effect of semaglutide on mortality across a broad population of patients with CV disease and obesity. (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity [SELECT]; NCT03574597).

Cardio Delirium Day: national study on the prevalence of delirium in Italian cardiology wards

To date delirium prevalence in the adult acute Italian hospital cardiac population is unknown. In a multicenter study, we assessed the prevalence of delirium over a single day among a population of patients admitted to acute cardiac hospital wards in Italy. This is a point prevalence study (called "Cardio Delirium Day") which involved 55 Italian cardiologic centers (23 North, 18 Central, 12 South, 2 Sardinia) that collected data on 152 patients older than 65 years hospitalized on March 15, 2023. Delirium was assessed on the same day in all patients using the Confusion Assessment Method for the Intensive Care Unit algorithm, a validated and briefly administered tool which does not require specialized training. We also collected data about clinical variables, functional and nutritional status, dementia, comorbidity, medications, and physical restraints. The mean sample age was 79.0 ± 10 years (33% female). Delirium was diagnosed in 25 patients (16.4%); 17.1% were hospitalized in the intensive cardiac care unit and 13.8% in the cardiology ward (p=NS). Hyperactive was the commonest subtype (48%), followed by mixed (36%) and hypoactive type (8%). In a multivariate logistic regression, male sex (odds ratio [OR] 3.81, 95% confidence interval [CI] 1.18-12.26; p=0.025), chronic obstructive pulmonary disease (OR 0.24, 95% CI 0.063-0.66; p=0.008), sensorial deficit (OR 3.75, 95% CI 1.18-11.95; p=0.025), sleep deprivation (OR 5.81, 95% CI 1.47-22.9; p=0.012) and the presence of ≥3 precipitating factors (OR 7.63, 95% CI 2.32-25.2; p=0.001) were independent predictors of delirium. Delirium occurred in 16.4% of patients in a cardiology setting. The "Cardio Delirium Day" project might become a useful method to assess delirium over time and sensitize the interest and the culture of Italian cardiology in this important aspect of hospital care.

Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Factors predicting the return of spontaneous circulation rate of cardiopulmonary resuscitation in China: Development and evaluation of predictive nomogram

BackgroundThis study aimed to construct and internally validate a probability of the return of spontaneous circulation (ROSC) rate nomogram in a Chinese population of patients with cardiac arrest (CA). MethodsPatients with CA receiving standard cardiopulmonary resuscitation (CPR) were studied retrospectively. The minor absolute shrinkage and selection operator (LASSO) regression analysis and multivariable logistic regression evaluated various demographic and clinicopathological characteristics. A predictive nomogram was constructed and evaluated for accuracy and reliability using C-index, the area under the receiver operating characteristic curve (AUC), calibration plot, and decision curve analysis (DCA). ResultsA cohort of 508 patients who had experienced CA and received standard CPR was randomly divided into training (70 %, n = 356) and validation groups (30 %, n = 152) for the study. LASSO regression analysis and multivariable logistic regression revealed that thirteen variables, such as age, CPR start time, Electric defibrillation, Epinephrine, Sodium bicarbonate (NaHCO3), CPR Compression duration, The postoperative prothrombin (PT) time, Lactate (Lac), Cardiac troponin (cTn), Potassium (K+), D-dimer, Hypertension (HBP), and Diabetes mellitus (DM), were found to be independent predictors of the ROSC rate of CPR. The nomogram model showed exceptional discrimination, with a C-index of 0.933 (95 % confidence interval: 0.882–0.984). Even in the internal validation, a remarkable C-index value of 0.926 (95 % confidence interval: 0.875–0.977) was still obtained. The accuracy and reliability of the model were also verified by the AUC of 0.923 in the training group and 0.926 in the validation group. The calibration curve showed the model agreed with the actual results. DCA suggested that the predictive nomogram had clinical utility. ConclusionsA predictive nomogram model was successfully established and proved to identify the influencing factors of the ROSC rate in patients with CA. During cardiopulmonary resuscitation, adjusting the emergency treatment based on the influence factors on ROSC rate is suggested to improve the treatment rate of patients with CA.

Prevalence of cardiovascular autonomic neuropathy in an admixed population of patients with type 1 diabetes. Lessons from a pioneer multicentre study in Brazil

AIMSTo evaluate the prevalence of cardiovascular autonomic neuropathy (CAN) and its associated factors in Brazilian patients with type 1 diabetes (T1D). MethodsThis cross-sectional, multicentre study was conducted in 14 public clinics in ten Brazilian cities. From 1760 patients, 1712 were included (97.3 %): 953 females (55.7 %), 930 (54.3 %) Caucasians, aged 29.9 ±11.9 years and with diabetes duration of 15.4 ± 9.2 years. CAN was evaluated using cardiovascular autonomic reflex tests. ResultsThe prevalence of CAN was 23.4 %. Multivariable hierarchical logistic regression showed CAN associated with age, smoking, lower socioeconomic status, higher yearly medical appointments, insulin therapeutic regimens, higher levels of HbA1c, total cholesterol, uric acid, diastolic blood pressure and heart rate, presence of retinopathy, diabetic kidney disease and a tendency to be associated with severe hypoglycemia. Lower health-related quality of life was also found in univariate analysis in these patients. ConclusionsPatients with T1D presented an important prevalence of CAN that was associated with other diabetes-related chronic complications, and also with demographic, clinical and laboratorial traditional risk factors. Considering lack of formal policy, our data could be used for guiding public health approach to awareness and CAN’s screening, diagnosis and clinical management in patients with T1D in Brazil.

Assessing surgical risk calculators on hernia repair candidates with cirrhosis.

Several risk calculators have been developed and deployed to help surgeons estimate the mortality risk that comes with performing hernia repair surgery on patient with severe liver disease. This study seeks to evaluate the accuracy of these risk calculators on patients with cirrhosis and identify the most suitable population of patient to use these calculators on. The American College of Surgeons National Surgery Quality Improvement Program (NSQIP) 2013-2021 datasets were queried for patients who underwent hernia repair surgery. Mayo Clinic's "Post-operative Mortality Risk in Patients with Cirrhosis" risk calculator, Model for End-Stage Liver Disease (MELD) calculator, NSQIP's Surgical Risk Calculator, and a surgical 5-item modified frailty index were assessed to determine whether they accurately predict mortality following abdominal hernia repair. In total, 1368 patients met inclusion criteria. Receiver operating characteristic (ROC) curve analysis of the 4 mortality risk calculators resulted in the following: NSQIP Surgical Risk Calculator = 0.803 (p < 0.001); "Post-operative Mortality Risk in Patients with Cirrhosis" with an etiology of "Alcoholic or Cholestatic" yielded an AUC = 0.722 (p < 0.001); MELD score yielded an AUC = 0.709 (p < 0.001); and the modified 5-item frailty index yielded an AUC = 0.583 (p = 0.04). The NSQIP Surgical Risk Calculator more accurately predicts 30-day mortality in patients with ascites undergoing hernia repair. However, if the patient is missing one of the 21 input variables required by this calculator, Mayo Clinic's 30-day mortality calculator should be consulted before the more widely used MELD score.

Cardioneural ablation-the first case series without the use of fluoroscopy.

Cardioneural ablation (CNA) and fluoroless ablation (FA) are emerging procedures and movements in contemporary in electrophysiology. Ablation of ganglionated plexus (GP) inputs in the atrium has been successfully targeted as a treatment for symptomatic bradyarrhythmias due to increased parasympathetic tone. As most of these patients are young, avoidance of ionizing radiation is of critical importance to limit potential long term deleterious effects. With widespread use of 3D electroanatomic mapping systems and advanced intracardiac echo (ICE) imaging, fluoroless ablation has become more widely adopted. However, fluoroless CNA has not been widely performed. The objective of this study is to demonstrate that CNA can be done safely and effectively without fluoroscopy. At a single-center, consecutive patients undergoing CNA with a fluoroless approach are described. GP mapping and ablation were performed in both atria. From the right atrium (RA), the right atrium-superior vena cava (RA-SVC GP), the posteromedial ganglionated plexus (PMLGP), which can be accessed from the right atrium-coronary sinus ostium, and the Vein of Marshall GP (VOM-GP) were evaluated. From the left atrium (LA), the superior left atrial ganglionated plexus (LSGP), the left inferior ganglionated plexus (LIGP), the right anterior ganglionated plexus (RAGP), and the right inferior ganglionated plexus (RIGP) were targeted. Over the study period, beginning on January 31, 2021, 30 consecutive subjects (15 females/15 males) aged 42.9 ± 13.6years underwent GP ablation. The average subject had 9.5 (± 9.2) episodes of syncope prior to ablation. The average CHADS2-VA2SC score was zero. The average LVEF was 64.8% (± 4.9). Two of the subjects had concomitant ablations, six failed prior medical therapy, and one had a prior pacemaker placed. All of the procedures were done without fluoroscopy. The average follow-up was 604 (± 366) days. There were 8 patients that did not improve symptomatically postfirst ablation. Four of the eight underwent repeat ablation and have subsequently improved. 26/30 patients symptomatically improved after the 1st or 2nd ablation. There were no complications noted. In comparison to the traditional CNA with fluoroscopy, this proof of concept study reveals fluoroless GP ablation can be performed safely. In addition, the durability and success rate are comparable to other studies of CNA. Given the young age of the cohort and the longitudinal risks of ionizing radiation, fluoroless CNA is a feasible procedure for this patient population.