Non-St Elevated Myocardial Infarction

LAS VEGAS, Nov. 1, 2023 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the third of four Late-Breaking Clinical Trial sessions at the VIVA23 conference, hosted at Wynn Las Vegas. VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning's 5 late-breaking clinical trial presentations. A Multicenter Trial Evaluation of the Neuroguard Carotid Artery Stent System With Integrated Embolic Protection: 30-Day and 1-year Outcomes of PERFORMANCE II Presented by: William A. Gray, MD The PERFORMANCE II study is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Neuroguard IEP 3-in-1 carotid stent and postdilation balloon system with integrated embolic protection (Contego Medical, Inc.) for the treatment of carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy. A total of 305 patients were enrolled at 40 sites in the United States and Europe. The study's primary endpoint is the 30-day rate of major adverse events, defined as death, all stroke, and myocardial infarction within 30 days of the index procedure, plus ipsilateral stroke between day 31 and 1 year. Events were adjudicated by an independent clinical events committee, and angiograms and duplex ultrasounds were evaluated by an independent core lab. Of the 305 patients enrolled, the mean age was 70, and 20% were symptomatic. 230 (75%) patients had physiologic high-risk criteria, and 75 (25%) patients had anatomic high-risk criteria. The mean baseline angiographic stenosis was 85%, and 34% of lesions were severely calcified. At 30 days, the all-stroke rate was 1.31% (4 patients) and 0.98% (3 patients) in an intention-to-treat and per-protocol analysis, respectively. There were no major strokes, no contralateral strokes, one (0.3%) death (cardiovascular), and two (0.7%) non–ST-segment elevation myocardial infarctions through 30-day follow-up. Among asymptomatic patients, the 30-day stroke rate was 0.81% (2 patients). There was one (0.37%) minor ipsilateral stroke between day 31 and 1 year. There were no major strokes and no neurological deaths at 1 year. Target lesion revascularization through 1 year was 1.47% (4 patients). These 1-year outcomes of the PERFORMANCE II study demonstrate the safety and durability of the Neuroguard carotid stent system in a high-surgical-risk patient population and are the lowest event rates ever reported in an adequately powered, multicenter trial of any type of carotid revascularization, regardless of patient risk. Acute Clinical and 90-Day Functional Outcomes in Pulmonary Embolism Patients Treated With Computer Assisted Vacuum Thrombectomy: Interim Analysis of the STRIKE-PE Study Presented by: Ido Weinberg, MD The STRIKE-PE study is evaluating real-world safety, performance, and long-term quality-of-life outcomes of computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra, Inc.) for the treatment of pulmonary embolism (PE). This prospective, international, multicenter study will enroll 600 patients with acute PE symptoms of ≤ 14 days and a right ventricular/left ventricular (RV/LV) ratio ≥ 0.9. Primary endpoints are the change in RV/LV ratio from baseline to 48 hours postprocedure and the incidence of major adverse events (MAEs) at 48 hours. Secondary endpoints include functional outcome measures. We report acute clinical and 90-day functional outcomes from an interim analysis. This interim analysis included 150 patients (mean age, 61.3 years; 54.7% male; 5.3% with high-risk PE; 94.7% with intermediate-risk PE). Patients presented with high thrombus burden (modified Miller score ≥ 12) in 80.7% of cases. Mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours postthrombectomy (∆ 25.7%; P < .0001). Four (2.7%) patients experienced an MAE(s) within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased (P < .0001). Borg dyspnea scale significantly improved from presentation to discharge and from presentation to 90-day follow-up (P < .0001). The 6-minute walk test distance significantly improved from discharge to 90-day follow-up (P < .0001). At 90-day follow-up, the New York Heart Association class proportion distribution was similar to that reported before the acute PE episode (P = .39). STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety. At 90-day follow-up, treatment with CAVT with the Indigo aspiration system improved patients' functional capacity by reducing dyspnea, increasing aerobic endurance, and improving cardiac symptoms. 30-Day Results From the C-Guardians Pivotal Trial of the CGuard™ Carotid Stent System Presented by: D. Christopher Metzger, MD C-GUARDIANS is a pivotal FDA investigational device exemption trial designed to evaluate safety and efficacy of the neuroprotective CGuard carotid stent (InspireMD, Inc.) in treating symptomatic and asymptomatic patients with carotid stenosis at a high risk for carotid endarterectomy (CEA). From July 2021 to June 2023, 316 patients (mean age, 69.0 years; 31.6% female; 25% symptomatic) were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the United States and the European Union. Procedures were performed utilizing the CGuard self-expanding stent, incorporating its patented woven Micronet mesh sleeve with small pore size of 150 µm designed to prevent plaque protrusion, utilizing approved embolic protection systems intraprocedurally. The primary endpoint is a composite of (1) incidence of major adverse events including death (all-cause mortality), any stroke, and myocardial infarction (DSMI) through 30 days post–index procedure and (2) ipsilateral stroke from day 31 to day 365 postprocedure. All events were adjudicated by a clinical events committee. Intraprocedural cerebral protection utilized approved distal embolic filters or proximal embolic protection with flow cessation, or both. At 30 days, total major adverse events included a cumulative DSMI of 0.95% and a cumulative stroke and death rate of 0.95% (intent to treat, 0.95%; per protocol, 0.63%). Events included an in-hospital retinal stroke and a clinically silent troponin elevation, with two additional strokes at 30 days, including a patient who did not take dual antiplatelet therapy (protocol violation). In the C-GUARDIANS pivotal trial, stenting with the CGuard carotid stent system in patients with obstructive carotid artery disease and at high risk for CEA had an overall stroke and death rate of 0.95% from the postprocedural interval to 30-day follow-up. The results support a potential "neuroprotective" effect of the CGuard stent from the procedure to 30-day follow-up. Stellarex Vascular E-Registry (SAVER) Gender Subgroup Analysis Presented by: Marianne Brodmann, MD The Stellarex Vascular E-Registry (SAVER) was a multicenter, international, prospective registry designed to assess the safety and efficacy of the Stellarex drug-coated balloon (DCB; Philips) in femoral, popliteal, and/or infrapopliteal arteries in a broad, real-world, claudicant or critical limb ischemia patient population. Patients with Rutherford clinical classification 2 to 6 who were indicated for percutaneous transluminal angioplasty were enrolled. The study was conducted with an individual DCB under normal clinical practice. The primary safety outcome was freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization (CD-TLR) through 12 months. The primary efficacy outcome was freedom from CD-TLR at 12 months. Final 12-month outcomes of the above-the-knee (ATK) cohort were evaluated, and a subgroup analysis was performed to assess differences in outcomes according to gender. The SAVER ATK study demonstrated excellent key safety and efficacy endpoints at 12 months in a real-world population. There were no differences in outcomes when stratified into gender subgroups, demonstrating the strong safety and performance of the Stellarex DCB in both male and female patients. Clinical Outcomes of Sirolimus-Coated Balloons Compared With Standard Balloon Angioplasty for Patients With Chronic Limb-Threatening Ischemia Presented by: Edward Choke, MBBS, PhD Sirolimus-coated balloons (SCBs) are a potential treatment option to improve outcomes for chronic limb-threatening ischemia (CLTI). However, clinical data for this novel treatment for CLTI are lacking. This study aimed to investigate the clinical outcomes of MagicTouch percutaneous transluminal angioplasty (PTA) SCB (Concept Medical, Inc.) compared to plain old balloon angioplasty (POBA) for patients with CLTI. The HOPE registry is a single-center prospective registry of all CLTI patients. Prospective data captured included preprocedure baseline demographics, angioplasty details, and postprocedure clinical outcomes. Consecutive CLTI patients (n = 347) with Rutherford 4, 5, or 6 presentations and de novo infrainguinal artery disease between August 2018 and October 2021 were analyzed. Patients were excluded if they received paclitaxel devices, thrombolysis, or atherectomy devices. Patients were divided into two groups according to whether they received an SCB in addition to POBA (n = 141) or POBA alone (n = 206). There were no statistically significant differences in the baseline demographics and lesion characteristics between the SCB and POBA groups. At 2 years, SCBs were associated with statistically significant higher freedom from clinically driven target lesion revascularization (75.2% vs 66.2%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.97; P = .037), higher amputation-free survival (69.5% vs 55.1%; HR, 0.64; 95% CI, 0.46-0.88; P = .007), and higher survival (72.9% vs 64.3%; HR, 0.71; 95% CI, 0.50-0.99; P = .047). At 2 years, SCBs were also numerically but not statistically significantly associated with higher freedom from major amputation (93.5% vs 87.1%; HR, 0.63; 95% CI, 0.27-1.45; P = .274). Compared to POBA alone, use of SCBs was associated with improved clinical outcomes at 2 years, and no early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCBs for treatment of CLTI. About the VIVA Foundation The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about the VIVA Foundation, visit . SOURCE The VIVA Foundation

AUSTIN, Texas--( BUSINESS WIRE )--ESO, the leading data and software company serving emergency medical services (EMS), fire departments, hospitals, state and federal agencies, today announced the findings of its 2023 ESO EMS Index . The Index tracks data for more than 2,600 EMS agencies nationwide across clinical performance and public health surveillance measures: stroke assessment for emergency department-diagnosed stroke, 12-lead EKG for patients with emergency department-diagnosed STEMI/NSTEMI, ketamine administration with weight recorded and end-tidal carbon dioxide release (EtCO 2 ) , EMS transport without lights and sirens, pediatric respiratory assessment, bystander CPR, critical incident reporting, and patients with suspected opioid overdose who were treated in place by EMS. Additionally, this year’s Index takes a deeper look at patient race/ethnicity and gender across metrics to identify inequities in care. “This is the sixth year of our annual EMS Index, and we continue to see how agencies and departments are using data to make meaningful and deliberate decisions that have a positive impact,” said Dr. Brent Myers, Chief Medical Officer for ESO. “As healthcare providers, we care about the well-being of our patients; research gives us a catalyst to identify gaps and disparities in care so we can overcome them.” Key Findings Include: 12-lead EKG: Approximately 83% of EMS patients who were diagnosed with a STEMI and 65% diagnosed with a NSTEMI in the emergency department had a documented 12-lead EKG. This indicates there is room for improvement in prehospital STEMI/NSTEMI identification. Pediatric respiratory assessment: Out of nearly 64,000 EMS encounters for pediatric patients with respiratory distress, 86% had both oxygen saturation (SpO2) and a respiratory rate documented. Ketamine administration with weight recorded and end-tidal carbon dioxide release (EtCO2) documented: In 80% of cases, patients administered ketamine had their weight documented in the EMS record – a 3% drop compared to 2021. Additionally, 60% of patients who received ketamine at a sedation-level dose had documented EtCO 2 monitoring. Opioid overdose and treatment in place: Overall, encounters for patients with suspected opioid overdose accounted for 2% of 911 records in 2022, which is slightly below the 2.6% margin in 2021. Eight percent of patients given naloxone for suspected overdose were not transported by EMS either due to patient refusal or protocol allowing treatment in place. “This year we’ve seen some fantastic improvements compared to our 2021 numbers, but also areas that warrant further attention across the entire EMS landscape,” added Dr. Myers. “Ketamine use in EMS has been a topic of interest in recent years due to patient safety concerns. As with any clinical intervention, selecting appropriate indications, dosage, and monitoring are foundational elements of patient safety. Additionally, as the Index findings indicates, there is opportunity for improvement in monitoring a patient’s EtCO 2 following administration of ketamine.” The full 2023 ESO EMS Index can be downloaded here. About the Index The dataset from the ESO Data Collaborative used for the ESO EMS Index is real-world, de-identified data, compiled and aggregated from more than 2,600 agencies across the United States that use ESO’s products and services and agreed to share their data for research and performance improvement purposes. This report is based on 11 million anonymized 911 encounters between January 1, 2022 and December 31, 2022, representing a full calendar year. About ESO ESO (ESO Solutions, Inc.) is dedicated to improving community health and safety through the power of data. Since its founding in 2004, the company continues to pioneer innovative, user-friendly software to meet the changing needs of today’s EMS agencies, fire departments, hospitals, state/provincial offices, and national/federal agencies. ESO currently serves thousands of customers throughout North America with a broad software portfolio, including the industry-leading ESO Electronic Health Record (EHR) , the next generation ePCR; ESO Health Data Exchange (HDE) , the first-of-its-kind healthcare interoperability platform; ESO Fire RMS, the modern fire Record Management System; ESO Patient Registry (trauma, burn and stroke registry software); and ESO State Repository . ESO is headquartered in Austin, Texas. For more information, visit www.eso.com .

CÚRAM SFI Research Centre for Medical Devices researchers have published in Nature Communications a key study establishing a new pre-clinical model to develop clinically relevant treatments for heart attacks. This research resulted from an established collaboration of CÚRAM with European institutions in Italy (University of Milano-Bicocca), France (University of Paris Est Créteil), Sweden (University of Gothenburg) and Lithuania (Lithuanian University of Health Sciences). Heart attacks (myocardial infarction (MI)) occur due to an acute complication of coronary artery disease and are a major cause of global mortality. The two main types of heart attack are ST-elevation (STEMI) and Non-ST elevation (NSTEMI). A non-ST-elevation is a type of heart attack that usually happens when your heart's oxygen needs are unmet. This condition gets its name because it doesn't have an easily identifiable electrical pattern like with an ST elevation that can be read from an electrocardiogram (ECG). Currently, preclinical models of heart attack mimic only full-thickness STEMI and hence cater only for an investigation into therapeutics and interventions directed at the NSTEMI subset of heart attack. In this new study, researchers have developed a preclinical model of NSTEMI by adopting a novel surgical procedure that closely resembles the complexity of clinical cases in humans. Researchers validated the presented model by comparing it with an established method to achieve STEMIs. They performed a detailed analysis at the main acute and late time points after the induction of NSTEMI, at 7 and 28 days, respectively. Dr Paolo Contessotto and Dr Renza Spelat said: "Advanced analyses on the affected heart tissue highlighted a distinctive pattern of alterations in the tissue, especially in the sugar moieties (glycans) which compose cardiac cell membranes and extracellular matrix (the network of proteins and other molecules that surround, support, and give structure to cells and tissues in the body). Identifying such changes in molecular elements that can be accessed and treated with injectable drugs sheds light on how we can develop targeted pharmacological solutions to correct these changes." Professor Abhay Pandit, CÚRAM Scientific Director and senior author of the study, said: "There is a need in the field to adopt clinically relevant models to study NSTEMI pathophysiology and reveal its functional differences with STEMI induction. This new model will facilitate the translation of future research in the field, enabling the discovery of new clinically relevant treatments for patients." Dr Mark Da Costa, Clinical Investigator at CÚRAM and senior author of the study, said: "Currently, NSTEMI is the most common presentation of acute heart attack. The concern is that NSTEMI patients have lower in-patient (during their admission for the primary NSTEMI) and short-term mortality rates but significantly higher long-term mortality than those of STEMI patients. A Danish registry study of 8,889 patients showed that the 5-year mortality after NSTEMI was 16%, and another registry study highlighted a 10-year survival rate of only around 50%. To the best of our knowledge, there are currently no models that can reproduce both the functional and histological characteristics of NSTEMIs. This novel model may specifically serve as a preclinical foundation to study interventions that could combat the short and long-term effects of NSTEMI." Ends Notes for editors Link to complete manuscript: Nature Communications volume 14, Article number: 995 (2023) This study was funded by the European Commission funding under the AngioMatTrain 7th Framework Programme (Grant Agreement Number 317304) and by the research grant from Science Foundation Ireland (SFI) co-funded under the European Regional Development Fund under Grant Number 13/RC/2073 and13/RC/2073_P2 to A.P