Aurora Health Care

A 77-year-old woman underwent cardiac computed tomography angiography (CCTA) for stable chest discomfort. CCTA revealed a dominant right coronary artery originating from the proximal left anterior descending artery and coursing between the aorta and right ventricular outflow tract before assuming its normal path in the right atrioventricular groove.

Background: Severe trauma and acute fluid loss are major causes of hypovolemia, linked to high morbidity and mortality if untreated. Intravenous fluid resuscitation, including plasma volume expanders (PVEs), is essential for restoring intravascular volume and perfusion. Polygeline, a gelatine-based colloid, is widely used; however, Indian real-world safety and effectiveness data remain limited. Objectives were to describe the demographic and clinico-epidemiological profile of Indian patients with hypovolemia and to evaluate the effectiveness and safety of Polygeline 3.5% intravenous infusion in routine clinical practice. Methods: This prospective, multicentre, open-label, post-marketing observational study enrolled 154 patients aged 18-65 years who received polygeline 3.5% IV infusion. Demographic and clinical characteristics were documented. Effectiveness was assessed by changes in hemodynamic parameters, urine output, respiratory rate, metabolic markers, pallor, and skin condition over 24 hours. Safety and tolerability were monitored throughout the study. Results: Hypovolemia was equally attributed to traumatic and non-traumatic causes. Among traumatic cases, 46% were classified as class II hypovolemia and 4.7% as class III, while non-traumatic cases showed fewer moderate to severe presentations. Over 24 hours, significant improvements were observed in hemodynamic parameters: mean systolic blood pressure increased from 99.99 to 119.11 mmHg, diastolic pressure from 61.68 to 74.43 mmHg, pulse rate declined from 104.60 to 85.53 bpm, respiratory rate from 21.57 to 18.82 breaths/min, and urine output increased from 21.08 to 218.90 mL (p<0.0001). One non-serious adverse drug reaction (0.6%) was reported and resolved without intervention. Conclusions: Polygeline 3.5% IV infusion demonstrated effective hemodynamic stabilization with a favourable safety profile in patients with hypovolemia of traumatic and non-traumatic origin.

315 Background: PCa has substantial inherited predisposition and certain germline variants like BRCA1/2 , ATM , HOXB13 , and DNA mismatch repair (MMR) genes are associated with an increased risk of PCa. This study follows men without a diagnosis of PCa, with known germline pathogenic/likely pathogenic variant (PV) in BRCA1/2 , DNA MMR genes associated with Lynch syndrome ( MLH1/PMS2 , MSH2 / MSH6 , EPCAM ), HOXB13 , ATM , CHEK2 , PALB2 , TP53 , NBN , RAD51C/D , BRIP1 , and FANCA-FANCM (NCT03805919). Methods: Up to 500 men, ages 30-75 years old (y/o) with a documented PV will enroll. Men undergo biennial mpMRI and annual PSA. Indication for prostate biopsy includes clinical, PSA, and/or MRI findings. Patients are followed at 12-month intervals to determine PSA, PCa diagnosis, and disease/survival status until death. Results: To date, 378 evaluable patients have enrolled: 353 (93%) Caucasian, 11 (3%) Hispanic, 7 (2%) Asian, 4 (1%) African-American, 2 (1%) bi-ethnic. 1 Indian-Asian. Median age was 47 y/o. The most common PV were: 180 (48%) BRCA2 , 94 (25%) BRCA1 , 22 (6%) CHEK2 , and 18 (5%) ATM . PVs in MLH1 / PMS2 , MSH2 / MSH6 , PALB2 , HOXB13 , TP53 , BRIP1 , RAD51D , EPCAM , NBN , and FANCA are &lt;4%. Eight patients carried more than one PV. A total of 782 MRIs were performed: 378 baselines, 228 at year 2, 121 at year 4, 30 at year 6, and 25 clinical. Indication for biopsy was present in 89 (24%) patients with 37 (10%) diagnosed with PCa. Of the 90 biopsies indicated, 1 refused and withdrew and 3 are still pending. Of those with PCa, 22 had BRCA1/2 PVs, 5 had MMR PVs, and 10 had non-MMR PVs. Median age at diagnosis was 62. 24 patients were diagnosed with Grade Group (GG) 1, 8 patients with GG2, 1 patient with GG3, 3 patients with GG4, 1 patient with GG5. 21 opted for active surveillance (AS), 10 opted for prostatectomy, 6 opted for radiation therapy. 5 patients on AS converted to definitive treatment after progression was noted at 1-year follow-up. Conclusions: mpMRI screening in men with PVs is feasible and can be used for early diagnosis, PCa monitoring, and facilitates PCa diagnosis at PSA levels below conventional thresholds. Correlative studies including cfDNA, PBMCs and PRS, are ongoing. Clinical trial information: NCT03805919 . Indication for biopsy. BiopsyPositive BiopsyNegative Biopsy Pending, Refused Total = 89 PSA WNL PSA Elevated PSA WNL PSA Elevated PSA WNL PSA Elevated PIRADS 1 13 0 4 0 9 0 0 PIRADS 2 15 1 3 5 6 0 0 PIRADS 3 23 5 1 11 3 2 1 PIRADS 4 34 <jats:td colspan="1" ro

Introduction: Spontaneous intracerebral hemorrhage (sICH) is a neurological condition associated with poor functional outcomes and high mortality. The role of surgical intervention is an area of ongoing research, with several trials showing mixed results. We conducted a meta-analysis to investigate the effectiveness of surgery compared to best medical management (BMM) in patients with sICH. Methods: We analyzed randomized controlled trials found through PubMed, Embase, and Cochrane databases. Studies that were not randomized control trials or included the pediatric population were excluded. Studies that investigated other causes of ICH such as vascular malformations or sinus thrombosis were also excluded. We used modified Rankin Scale (mRS) score of 0-3 at 180 days as the efficacy outcome. Mortality at 90 days was evaluated as the safety outcome. We assessed heterogeneity using a restricted maximum-likelihood estimator, along with the Q-test and I 2 statistic. Results: Four clinical trials, namely STICH-I, STICH-II, MISTIE, III and ENRICH, were included. STICH-II only enrolled patients with lobar sICH, while the other studies included lobar, basal ganglia, and thalamic hemorrhages. STICH-I and STICH-II trials randomized patients to BMM or invasive surgery (e.g., craniotomy, stereotactic and burr hole surgery). MISTIE-III and ENRICH trials randomized patients between BMM and minimally invasive surgery (MIS). When analyzed separately, invasive surgical intervention (OR 1.20, 95% CI [0.97, 1.48]) and MIS (OR 1.32, 95%CI [0.98, 1.76]) did not show any benefit over BMM. However, there was a higher likelihood of a favorable outcome (OR 1.24, 95% CI [1.05, 1.47]) and improved mortality (OR 0.79, 95% CI [0.63, 0.99]) with any surgical intervention (invasive or MIS) when compared to BMM. Conclusion: Our results showed better functional outcomes and improved mortality with surgical intervention in patients with sICH. Further research is warranted to elucidate these findings.

Introduction: Spontaneous coronary artery dissection (SCAD) is a significant cause of acute coronary syndrome in young women. Fibromuscular dysplasia (FMD) is frequently associated with SCAD, but its impact on clinical outcomes remains unclear. Hypothesis: We hypothesized that SCAD patients with concurrent FMD would have different clinical outcomes compared to those without FMD, potentially reflecting distinct pathophysiological mechanisms. Methods: Using the TriNetX Global Collaborative Network across 129 healthcare organizations, we performed a retrospective propensity-matched cohort study. SCAD patients (ICD-10: I25.42) with FMD (ICD-10: I77.3) were compared to those without FMD. After 1:1 propensity matching based on demographics and comorbidities, 857 patients per group were analyzed. Primary outcome was all-cause mortality; secondary outcomes included heart failure, cardiogenic shock, arrhythmias, and acute kidney injury over five years. Analysis included risk ratios (RR), odds ratios, and hazard ratios (HR) with 95% confidence intervals. Results: SCAD patients with FMD had significantly lower all-cause mortality (1.3% vs 6.5%; RR 0.199, 95% CI 0.105-0.377; p&lt;0.001), heart failure (4.7% vs 13.4%; RR 0.349, 95% CI 0.239-0.512; p&lt;0.001), and acute kidney injury (1.2% vs 4.7%; RR 0.257, 95% CI 0.128-0.514; p&lt;0.001). No significant differences were observed for cardiogenic shock, ventricular tachycardia, or atrial fibrillation. Conclusions: FMD is associated with markedly improved outcomes in SCAD patients, suggesting it represents a distinct, more favorable pathophysiological subtype. These findings support comprehensive FMD screening in SCAD patients for enhanced risk stratification and personalized management strategies.

Introduction Preclinical animal experiments and initial feasibility studies in humans have shown encouraging outcomes using the novel Saccular Endovascular Aneurysm Lattice (SEAL™) system for the treatment of both ruptured and unruptured wide‐neck intracranial aneurysms (IAs). The SEAL™ Interventional Pivotal IDE PMA Trial (SEAL™ IT) is designed to assess the safety and efficacy of the SEAL™ in patients with saccular IAs. This ongoing, prospective, multicenter trial includes three study arms and will enroll a total of 279 participants with wide‐neck bifurcation (WNBA), sidewall (SW), or acutely ruptured IAs across 50 U.S. sites. Methods Eligibility requirements include patients aged 20‐80 years with a wide‐neck saccular intracranial aneurysm (2‐19 mm) deemed suitable for treatment with the SEAL™ Intrasaccular Device (SID). Participants receive treatment using the SEAL™ device (Galaxy Therapeutics Inc.) and are monitored at discharge, and again at 3, 6, and 12 months, followed by yearly assessments for up to 5 years. The primary efficacy outcome is defined as complete aneurysm occlusion at 12 months without evidence of parent vessel stenosis or the need for retreatment, as determined by an independent core laboratory. Key safety outcomes include neurological death within 12 months, stroke occurring within the first 30 days, and ipsilateral stroke between 30 days and 1 year. Results As of submission, 163 WNBA, 58 WNSW, and 33 ruptured for a total of 254 patients (76.3% female; mean age 61.7 ± 11.3) have been enrolled at 50 sites. Mean aneurysm width was 5.2 ± 2.1, neck size of 3.7 ± 1.4, and neck‐to‐dome ratio of 1.4 ± 0.32. SEAL Arc was used in 63.6% and SEAL Base in 36.4%. Technical device success rate is 100% for WNBA, 94.8% WNSW, and 97.0% ruptured. The interim complete occlusion rate for the primary group is 84.5% at most recent date based on available imaging. Conclusion Preliminary data for the SEAL™ intrasaccular device is promising; Safety and effectiveness updates will be presented at the SVIN Conference.