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Trial is designed to provide confirmational data on the clinical benefits of SuperSaturated Oxygen Therapy for heart attack patients.
October 15, 2024
By: Michael Barbella
Managing Editor
ZOLL has begun enrolling patients in its SuperSaturated oxygen Comprehensive Observational REgistry (SSCORE) trial, designed to evaluate the efficacy of SuperSaturated Oxygen (SSO2) Therapy to reduce heart failure and mortality in patients suffering from left anterior descending ST-elevation myocardial infarction (LAD STEMI) heart attacks. LAD STEMI heart attacks are often referred to as “widow makers” due to the high mortality rate associated with this condition. Additionally, SSCORE will collect data to substantiate the potential improvement in overall healthcare costs associated with heart failure prevention versus a lifetime of palliative treatment strategies. “Enrolling the first patient in the SSCORE study marks a significant milestone in advancing the use of SuperSaturated Oxygen Therapy to treat the most severe heart attacks,” ZOLL TherOx General Manager Matt Rochner said. “SSO2 Therapy has the potential to not only improve patient outcomes but also reduce the long-term costs of managing heart failure, a significant healthcare challenge. Our partnership with the Minneapolis Heart Institute and Allina Health allows us to advance this technology by collecting more evidence-based clinical and economic data, positioning SSO2 Therapy to become the standard of care for LAD STEMI patients.” The Minneapolis Heart Institute at Abbott Northwestern Hospital, a partner of Allina Health with multiple locations in Minneapolis, has adopted ZOLL’s SSO2 Therapy, leading to its position as first enroller in the study. LAD STEMI heart attack patients have higher mortality rates than those with other types of heart attacks. SSO2 Therapy is the first and only U.S. Food and Drug Administration-approved treatment that has been clinically proven to significantly reduce damage to cardiac muscle in heart attack patients after coronary angioplasty with stenting.1 The extent of damaged cardiac muscle is a strong predictor of future outcomes like rehospitalization and the development of heart failure.2 “These patients with LAD occlusion are at significant risk. Opening the artery is the first step but using SSO2 to further decrease infarct size is vital. This patient had an acute proximal LAD occlusion and I wanted to give him the best chance of preserving his heart function,” stated Dr. M. Nicolas Burke, director of Cardiovascular Emergency Services at Abbott Northwestern, who treated the first patient enrolled in SSCORE nationwide. SSO2 Therapy is indicated as an adjunct for patients who suffer LAD STEMI and are treated with traditional stenting within six hours of chest pain onset. The therapy delivers high levels of dissolved oxygen (seven to 10 times the amount normally found in the bloodstream) directly to the damaged heart muscle immediately after the coronary artery has been successfully opened via angioplasty and stenting. Multiple clinical trials have demonstrated the safety and efficacy of SSO2 Therapy to reduce infarct size, a strong predictor of subsequent outcomes.1,3-6 “The focus on reducing infarct size and improving microvascular function with SSO2 in the cath lab versus palliation of disease is a logical strategy that has been long awaited in this field,” said Dr. Jay Traverse, principal investigator and researcher at Allina’s Minneapolis Heart Institute Foundation, and an interventional cardiologist at Allina’s Minneapolis Heart Institute. “Persistently high readmission rates for these patients, who often develop heart failure following standard-of-care stenting of the LAD, have been an ongoing challenge for over two decades. SuperSaturated Oxygen Therapy has shown great promise to alleviate this problem, which improves the quality of life for the patient while relieving the financial burden on the healthcare system as a whole. We are excited to participate in this trial and look forward to seeing positive outcomes.” ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. Founded in 1922, the Asahi Kasei Group has consistently grown through the proactive transformation of its business portfolio to meet evolving needs. With more than 49,000 employees worldwide, the company provides solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its healthcare operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. References 1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75. 2 Stone GW et al. J Am Coll Cardiol. 2016;67(14):1674–83. 3 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405. 4 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9. 5 https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2020-ICD-10-PCS-Guidelines.pdf 6 Chen S, et al. Catheter Cardiovasc Interv. 2020; 1–7.
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