11210 research outputs found
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Guidance for the methodological challenges of polytobacco use in tobacco regulatory science
No full textConnection, 1995 October 25
No full textSinai Samaritan Medical Center, Milwaukee, WI: Internal publication for staff and volunteers. This issue summarizes the year\u27s accomplishments.https://institutionalrepository.aah.org/alldocuments/2234/thumbnail.jp
Multicenter study on the safety of pulsed field ablation in over 40,000 patients: MANIFEST-US
No full textBackground: Pulsed field ablation (PFA) is emerging as the preferred energy source for atrial fibrillation ablation, largely because of its promising safety profile, including lower risks of esophageal injury, pulmonary vein stenosis, and phrenic nerve injury. However, rare complications may only emerge after treating many thousands of patients.
Objectives: This study sought to determine the real-world utilization and safety profile of the pentaspline PFA catheter in the United States.
Methods: In this retrospective analysis, invitations were sent to U.S. centers performing PFA with the pentaspline catheter. Centers submitted data on patient demographics, procedural details, and adverse events (AEs). The main outcomes included the incidence of major and minor procedure-related AEs.
Results: Of the 435 centers contacted, 102 participated, averaging 5.1 operators per center (range 1-16 operators per center). Each center treated a median of 412 patients (range 26-1,961 patients), totaling 41,968 patients between February 2024 and July 2025. The median patient age was 68 years (range 17-99 years), and 56% were male. Most patients underwent first-time ablation (73%), primarily for paroxysmal (54%) or persistent atrial fibrillation (37%). Pulmonary vein isolation was performed in 93% of patients, with extravenous lesions on the posterior wall (57%), cavotricuspid isthmus (31%), or mitral isthmus (14%). Major AEs occurred in only 0.63% of patients, including cardiac tamponade (0.16%), vascular injury requiring intervention (0.18%), and stroke (0.10%). Importantly, no cases of esophageal fistula, persistent phrenic nerve paralysis, or pulmonary vein stenosis occurred. Mortality at 30 days was rare (0.04%), but there was a potential signal for rare (0.019%) unexplained sudden death/cardiac arrest. Rare AEs included coronary spasm (0.10%) and acute renal failure requiring dialysis (0.02%). Minor complications were reported in 2.05%, mainly vascular issues (0.96%), pericarditis (0.52%), and self-limited esophageal dysmotility (0.04%).
Conclusions: In a real-world setting of unselected U.S. patients, PFA demonstrated a safety profile consistent with preferentiality to functional myocardial tissue ablation, without evidence of esophageal fistula or pulmonary vein stenosis. The major complication rate was ∼0.6%-mostly vascular AEs and pericardial tamponade. Stroke (∼1 in 1,000) and death (∼1 in 2,000) were rare. These data indicate that the initial implementation of pentaspline PFA has been overall safe
Low-dose triple-pill of telmisartan, amlodipine, and indapamide for initial hypertension yreatment: A GRADE-assessed meta-analysis of randomized trials
No full textIntroduction: FDA-approved GMRx2, a single-pill combination of telmisartan, amlodipine, and indapamide, has shown potential for improving blood pressure (BP) control.
Aim: We assessed the efficacy and safety of low-dose GMRx2 compared to placebo, or standard-care (monotherapy or dual therapy) in mild to moderate hypertension.
Methods: A meta-analysis of randomized controlled trials (RCTs) was conducted from PubMed, Embase, Cochrane, Scopus, and Web of Science from 2006 to June 2025. Random-effects model to pool mean difference (MD) for continuous outcomes and risk ratios (RR) for binary outcomes with 95% confidence intervals (CI).
Prospero-id: CRD420251108645 RESULTS: Four RCTs involving 1999 patients were included. Compared with control, low-dose GMRx2 significantly reduced office systolic BP at 4-6 weeks (MD -8.84 mmHg, 95% CI [-11.27; -6.46]) and 12 weeks (MD -5.52 mmHg, 95% CI [-6.85; -4.18]). It also increased the proportion of patients achieving target office BP at 4-6 weeks (66.7% vs. 50.2%, RR 1.20, 95% CI [1.08-1.43]) and 8-12 weeks (75.6% vs. 59.5%, RR 1.15, 95% CI [1.05-1.26]). No significant differences were observed in serious adverse events (P= 0.77) or treatment discontinuation (P= 0.30). However, low-dose GMRx2 had a higher incidence of hypokalemia (9% vs. 7%, RR 1.40, 95% CI [1.04-1.90]) and hyponatremia (5% vs. 3.7%, RR 1.59, 95% CI [1.04-2.42]).
Conclusion: Low-dose GMRx2 provides superior BP reduction and a well-tolerated safety profile in patients with mild to moderate hypertension. Nonetheless, it may increase the risk of hypokalemia and hyponatremia. Larger and longer-term RCTs are warranted to confirm
Inside Aurora Sinai Medical Center, 2003 September
No full textAurora Sinai Medical Center, Milwaukee, WI: Internal employee newsletter with workplace anniversaries, news, and events.https://institutionalrepository.aah.org/alldocuments/2255/thumbnail.jp
Stress hormone dysregulation in overweight male adults with obstructive sleep apnea
No full textIntroduction: Obstructive sleep apnea (OSA) may influence the hypothalamic-pituitary-adrenal (HPA) axis and result in subsequent physiological dysregulation. Given the inconsistent findings of the current literature and the lack of investigations on stress hormones, this study explored the potential impact of OSA on stress markers of adrenocroticotrophic hormone (ACTH), cortisol, and dehydroepiandrosterone (DHEA)/DHEA-S in male overweight OSA patients.
Methods: This prospective, single-blind, cross-sectional study enrolled male overweight (body mass index \u3e25 kg/m2) OSA patients. The patients were grouped into mild/moderate and severe OSA groups based on the apnea/hypopnea index to investigate the differences in stress hormones. The inter-relationships among ACTH, cortisol, and DHEA in both groups were further analyzed in detail with Pearson\u27s correlations to determine the potential impact of OSA severity.
Results: Overall, 144 subjects were recruited. DHEA in saliva and serum DHEA-S were found significantly lower in the severe OSA group compared to the mild/moderate OSA group. Pearson\u27s correlations demonstrated that in both groups, ACTH and cortisol concentrations (morning and night) showed significant positive correlations. Significant relationships between night ACTH and DHEA-S in saliva (r = 0.368, p = 0.023) and blood (r = 0.361, p = 0.017) were also found in mild/moderate OSA group, but neither was noted in the severe group.
Conclusion: Severe OSA may impact the HPA axis by reducing concentrations of DHEA and DHEA-S without affecting cortisol and ACTH concentrations in male overweight OSA patients. This could possibly imply the dysregulation of DHEA/DHEA-S production in a much severe sleep disturbance situation
Obicetrapib for dyslipidemia with or without cardiovascular risk: A GRADE-assessed meta-analysis of randomized trials with trial sequential evidence
No full textAims: Obicetrapib, an oral cholesteryl ester transfer protein (CETP) inhibitor, has demonstrated potent LDL-C lowering in recent phase 2/3 trials. We evaluated Obicetrapib (1, 2.5, 5, and 10 mg) efficacy and safety in adults with dyslipidemia, with or without atherosclerotic cardiovascular disease (ASCVD) risk.
Materials and methods: We performed a meta-analysis of randomized controlled trials (RCTs) identified through PubMed, Cochrane, Scopus, and Web of Science up to June 2025. Dichotomous outcomes were analyzed as risk ratios (RRs) and continuous outcomes as mean differences (MDs), both with 95% confidence intervals (CIs).
Prospero id: CRD420251107076.
Results: Six RCTs including 3399 patients were analysed. Compared with placebo, Obicetrapib significantly reduced LDL-C at 8-12 weeks (MD -27.66 mg/dL (-26.96%); 95% CI -33.62 to -21.70; p \u3c 0.0001) and non-HDL-C (MD -35.41 mg/dL (-28.08%); 95% CI -39.42 to -31.39; p \u3c 0.0001). It also increased HDL-C (MD 70.85 mg/dL (141.7%); 95% CI 62.56-79.15; p \u3c 0.0001) and improved achievement of LDL-C targets:
Conclusion: Obicetrapib provides substantial improvements in lipid parameters with a favourable short-term adverse events rate. These results support its role as a potential adjunctive lipid-lowering agent irrespective of ASCVD risk. Longer-term trials are warranted to confirm its durability, cardiovascular outcomes, and safety
Vaccine acceptance in gravid patients in the COVID-19 era
No full textObjective: To describe risk factors for declining antepartum vaccination, including the novel COVID-19 vaccine during the COVID-19 pandemic.
Methods: Retrospective cohort study including women delivering at a single center in the fall and winter of 2021. Patients without vaccine data were excluded. Baseline characteristics collected from the electronic medical record included maternal age, nulliparity, body mass index, insurance, and self-identified race/ethnicity. Those who accepted the COVID-19 vaccine were compared to those who declined. Separate comparisons were done to assess those who accepted and those who declined influenza and tetanus, diphtheria, pertussis (Tdap) vaccines as well. Statistical analysis was performed using Student\u27s t-test, Fisher\u27s exact test, chi square, and logistic regression. The regression model assessed the impact of patient characteristics on vaccine acceptance and was adjusted for age, nulliparity, body mass index, insurance, and race/ethnicity.
Results: Vaccine data was available for 772 patients. The rate of acceptance was 46.1% for COVID-19 vaccine, 58.0% for influenza vaccine, and 80.8% for Tdap vaccine. Those who accepted the COVID-19 vaccine were older (34.3 ± 3.8 years vs 33.0 ± 4.8 years, p \u3c 0.001) and more frequently nulliparous (8.7% vs 2.9%, p \u3c 0.001) than those declining it. Those accepting Tdap were also older (33.8 ± 4.3 vs 32.7 ± 4.9 years, p = 0.006). Insurance type differed across groups for all three vaccines (p \u3c 0.001). Race differed between acceptance and refusal of the influenza and Tdap vaccines, but not the COVID-19 group. In the adjusted analysis, public insurance remained independently associated with reduced acceptance for COVID-19 (aOR 0.28, 95% CI 0.14-0.55) and influenza (aOR 0.38, 95% CI 0.20-0.73), but not for Tdap. Older age and nulliparity were independently associated with increased acceptance of COVID-19.
Conclusion: Public insurance in pregnancy is associated with a decreased likelihood of vaccine acceptance for the COVID-19 and influenza vaccines. Specific efforts for understanding the motivations for declining vaccination are needed to develop strategies to improve uptake in this population
Inside Aurora Sinai Medical Center, 2003 May
No full textAurora Sinai Medical Center, Milwaukee, WI: Internal employee newsletter with workplace anniversaries, news, and events.https://institutionalrepository.aah.org/alldocuments/2251/thumbnail.jp